TW201726500A - Method of packaging a multi-monodose container - Google Patents

Abstract

A methods are described for packaging a foldable container including covering a multi-monodons container in an expanded configuration with a hermetically-sealable overwrap, the multi-monodons container including a row of interconnected monodons pharmaceutical vials, each of the monodons pharmaceutical vials enclosing at least one pharmaceutical agent, the interconnected monodons pharmaceutical vials connected to one another by one or more articulating joints sufficiently flexible to form a folded configuration of the multi-monodons container; exerting a force on at least one of the monodons pharmaceutical vials; bending the one or more articulating joints to form the folded configuration of the multi-monodons container in response to the exerted force; and sealing the hermetically-sealable overwrap to form a hermetic seal around the folded configuration of the multi-monodons container.

Description

Method of packaging a container that can be folded

The present invention relates to the field of packaging containers, and more particularly to a method of packaging a container that can be folded.

All subject matter of the priority application is hereby incorporated by reference in its entirety as if the subject matter is not

In one aspect, a method of packaging a multi-dose container includes, but is not limited to, covering a molded structure with a hermetically sealable overwrap, the molded structure including a first portion and a second portion, the first portion comprising the rows An interconnected single dose vial, each of the interconnected single dose vials enclosing a dose of at least one medicament; the second portion is attached to the first portion and includes a textured surface pattern, The textured surface pattern is positioned to direct airflow between the first portion and a region adjacent the second portion; the molded structure covered from the hermetically sealable overwrap At least a portion of the exhausted air, at least a portion of the exhausted air flowing at least partially through the textured surface pattern of the second portion of the molded structure; by sealing the airtight seal An overwrap is bonded to at least a portion of a surface of the molded structure to form a hermetic seal around the rows of interconnected single dose vials; and the second portion of the molded structure is Place The mold structure separated from the first portion. In addition to the foregoing aspects, other method aspects are described in the claims, drawings and text forming a part of the invention.

In one aspect, a method of packaging a multi-dose container includes, but is not limited to, covering a molded structure with a hermetically sealable overwrap comprising a row of interconnected single dose vials, the interconnect Each of the single-dose vials encloses a dose of at least one agent, and a textured surface pattern positioned to guide the first portion of the molded structure and the second portion of the molded structure Airflow between adjacent regions; exhausting at least a portion of the air from the periphery of the molded structure covered by the hermetically sealable outer wrap such that at least a portion of the discharged air flows at least partially The textured surface pattern on the molded structure; and forming a hermetic seal around the rows of interconnected single dose vials. In addition to the foregoing aspects, other method aspects are described in the claims, drawings and text forming a part of the invention.

In one aspect, a multiple single dose container includes, but is not limited to, a molded structure comprising a first portion and a second portion, the first portion comprising a row of interconnected single dose vials, each of the interconnected single dose vials having An interior volume configured to hold a dose of at least one medicament; and the second portion is attached to the first portion, the second portion comprising a textured surface pattern, the textured surface pattern being positioned to guide Airflow between the first portion and a region adjacent to the second portion. In addition to the foregoing aspects, other multi-dose container aspects are described in the claims, drawings and text forming a part of the invention.

In one aspect, a multiple single dose container includes, but is not limited to, a molded structure comprising a row of interconnected single dose vials, each of the interconnected single dose vials having at least one medicament configured to hold a dose. An interior volume; and a textured surface pattern positioned to direct airflow between the first portion of the molded structure and a region adjacent the second portion of the molded structure. In addition to the foregoing aspects, other multi-dose container aspects are described in the claims, drawings and text forming a part of the invention.

In one aspect, a method of packaging a collapsible container includes, but is not limited to, covering a multi-single dose container in an expanded configuration with a hermetically sealed overwrap comprising a row of interconnected single doses of medicament a bottle, each of the single dose vials enclosing a dose of at least one medicament; and one or more articulating joints that will treat the single dose of the row of interconnected single dose vials Each of the bottles is coupled to at least one adjacent single dose vial, the one or more articulating joints being flexible enough to reversibly match the flat outer surface of each of the single dose vials with the at least a flat outer surface of an adjacent single dose vial to form a folded configuration of the multiple single dose container; at least one of a single dose vial in the row of interconnected single dose vials Applying a force to the at least one adjacent single dose vial; applying in response to at least one of the single dose vials in the rows of interconnected single dose vials The force bending the one or more hinges a joint to form the folded configuration of the multiple single dose container; and sealing the hermetically sealable outer wrap to form a hermetic seal around the folded configuration of the multiple single dose container therein . In addition to the foregoing aspects, other method aspects are described in the claims, drawings and text forming a part of the invention.

In one aspect, a method of packaging a multi-dose container includes, but is not limited to, covering a plurality of single-dose containers with a hermetically sealed overwrap comprising a row of interconnected single-dose vials, Each of the single-dose vials encloses a dose of at least one medicament; and one or more articulating joints that each of the single-dose vials in the rows of interconnected single-dose vials Connected to at least one adjacent single dose vial, the one or more articulating joints being flexible enough to reversibly match the flat outer surface of each of the single dose vials to the at least one adjacent a flat outer surface of the single dose vial to form a folded configuration of the multiple single dose container; applied over at least a portion of an outer surface of the hermetically sealable outer wrap covering the multiple single dose container a force applied to the one or more articulating joints of the multiple single dose container; at least air is expelled from the plurality of single dose containers covered by the hermetically sealable outer wrap Part of; The seal covering the plurality of single-dose container can be hermetically sealed outer wrap, to the multiple single-dose containers hermetically sealed therein. In addition to the foregoing aspects, other method aspects are described in the claims, drawings and text forming a part of the invention.

The foregoing summary is illustrative only and is not intended to be limiting. Other aspects, embodiments, and features will become apparent from the Detailed Description of the Drawings.

In the following detailed description, reference is made to the accompanying drawings In the figures, like reference characters generally refer to the The illustrative embodiments described in the detailed description, drawings and claims are not to be construed as limiting. Other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the invention.

Apparatus and methods for packaging multiple single dose containers are described herein. In one aspect, a multi-single dose container includes a molded structure comprising a row of interconnected single dose vials positioned and directed to a first portion of the molded structure and adjacent to a second portion of the molded structure The textured surface pattern of the airflow between the regions. In one aspect, each of the single dose vials in a row of interconnected single dose vials is connected to at least one adjacent single dose vial via one or more articulating joints. Each of the single dose vials in a row of interconnected single dose vials encloses a dose of at least one agent (eg, a vaccine or therapeutic). A method of packaging multiple single dose containers includes hermetically sealing the rows of interconnected single dose containers in a hermetically sealable outer wrap. The textured surface pattern on the molded structure is configured to assist in the hermetic sealing of the outer wrap during the process of hermetically sealing the rows of interconnected single-dose vials in a hermetically sealed outer wrap Air or/or inert gas is withdrawn or evacuated.

Referring to Figure 1, an embodiment of a method of packaging a multi-dose container that can be used as the context of one or more methods and/or devices described herein is illustrated. Figure 1 shows a step diagram of a method 100 of packaging multiple single dose containers. The method 100 includes covering the molded structure with a hermetically sealable overwrap in step 110, the molded structure including a first portion and a second portion, the first portion comprising a row of interconnected single dose vials, Each of the interconnected single dose vials encloses a dose of at least one medicament, the second portion being attached to the first portion and including a textured surface pattern, the textured surface pattern being positioned An air flow between the first portion and a region adjacent to the second portion is directed. The method 100 includes discharging at least a portion of air around a molding structure covered by a hermetically sealable overwrap in step 120, at least a portion of the exhausted air flowing at least partially through the second portion of the molded structure Textured surface pattern. The method 100 includes forming a hermetic seal around the rows of interconnected single dose vials by bonding the hermetically sealable overwrap to at least a portion of the surface of the molded structure in step 130. The method 100 includes separating the second portion of the molded structure from the first portion of the molded structure in step 140.

In one aspect, the method 100 is performed by packaging multiple single dose containers with one or more components of the mechanical device. In one aspect, method 100 is performed by packaging one or more components of a mechanical device to package a plurality of single dose containers. For example, the method can include using a mechanical device to cover the molded structure of the single dose vial, evacuating at least a portion, forming a seal, and separating the first portion of the molded structure from the second portion of the molded structure. In one aspect, the method 100 is performed automatically by one or more components of the mechanical device. In one aspect, synergistically forming a plurality of single dose containers (eg, cooperatively forming a molded structure), filling each of the interconnected single dose vials with a dose of at least one agent, and sealing the interconnected single dose of the drug Bottle to perform method 100.

The method 100 of packaging multiple single dose containers includes covering the molded structure with a hermetically sealable overwrap. In some embodiments, the method includes covering the entirety of the molded structure. For example, the method can include covering the molded structure with a hermetically sealable pouch sized to receive the entirety of the molded structure. In some embodiments, the method includes covering at least a portion of the molded structure. For example, the method can include covering the entire first portion of the molded structure comprising the rows of interconnected single dose vials and at least a portion of the second portion of the molded structure with a hermetically sealable overwrap. For example, at least a portion of the second portion of the molded structure can extend beyond the opening or edge defined by the hermetically sealable overwrap. In one aspect, covering the molded structure with a hermetically sealable overwrap includes transporting at least one of the molded structure and the hermetically sealable overwrap using a transport mechanism. For example, the method can include moving a molded structure to be covered by a hermetically sealable overwrap, moving a hermetically sealable overwrap to cover the molded structure, or a combination thereof.

Figure 2 shows a further step diagram illustrating a method 100 of packaging multiple single dose containers. In some embodiments, the method 100 includes inserting the molded structure into an opening defined by the hermetically sealable overwrap, as shown in step 200. For example, the method can include inserting a molded structure that forms a multi-single dose container through an airtightly sealed bag, a hermetically sealable bag, or an opening of a hermetically sealable sleeve. In some embodiments, the method 100 includes first inserting a first portion of the molded structure into an opening defined by the hermetically sealable overwrap such that the second portion of the molded structure is adjacent to the outer wrap that is hermetically sealed The opening defined by the object is as shown in step 210. For example, the molded structure can be inserted in a particular orientation through an opening defined by the hermetically sealable overwrap such that the second portion of the molded structure comprising the textured surface pattern is closest to the opening through which air or inert gas will pass The opening is injected and/or discharged.

In one embodiment, a method 100 of packaging a multi-dose container includes positioning a molded structure between a first layer of a hermetically sealable overwrap and a second layer of a hermetically sealable overwrap; The first and second edges of the hermetically sealable outer wrap are sealed together as shown in step 220. For example, the method can include positioning a multi-single dose container between a first layer and a second layer of a hermetically sealable overwrap using a horizontal flow mechanism having a conveyor, such as in a hermetically sealed outer wrap Between the roller sheets of the object. Mechanical means for covering the container with the overwrap are commercially available (e.g., from Bosch Packaging Technology, Weiblingen, Germany).

3 is a step diagram showing a further aspect of a method of packaging multiple single dose containers. The method 100 of packaging multiple single dose containers includes covering the molded structure with a hermetically sealable overwrap. In one aspect, the method 100 includes covering the molded structure with a hermetically sealable bag, as shown in step 300. For example, the hermetically sealable overwrap may comprise a medical grade heat sealable foil pouch (eg, from Bemis Healthcare Packaging, Oshkosk, WI; Oliver-Tolas, Healthcare Packaging, Grand Rapids, MI). In one aspect, the method 100 includes covering the molded structure with a hermetically sealable sleeve, as shown in step 310. For example, the hermetically sealable overwrap may comprise a medical grade heat sealable overwrap in tubular form (e.g., from Bemis Healthcare Packaging, Oshkosk, WI).

In one aspect, a method 100 of packaging a multi-dose container includes covering the molded structure with a hermetically sealable foil laminate, as shown in step 320. For example, the method can include covering the molded structure with a hermetically sealed polyester/foil/polyethylene laminate. Other non-limiting examples of foil laminates include polyester/foil/nylon/polyethylene laminates and coated paper/foil/polyethylene laminates. In one aspect, the method includes covering the molded structure with a hermetically sealed metallized laminate. For example, the method can include overcoating a hermetically sealable polymer film (eg, polyethylene terephthalate (PET)) that is metallized or coated with a thin layer of aluminum, nickel, and/or chromium. Structure.

In one aspect, the method 100 includes in step 330 of using polyester, foil, polypropylene, cast polypropylene, polyethylene, high density polyethylene, metallocene polyethylene, linear low density polyethylene, or a metallized film. At least one of the resulting hermetically sealable overwraps covers the molded structure. In one aspect, method 100 includes using a layer comprising at least one of polyester, foil, polypropylene, cast polypropylene, polyethylene, high density polyethylene, metallocene polyethylene, linear low density polyethylene, or metallized film. The press member covers the molded structure. For example, the method can include covering the molded structure with a metallized polyester/polyethylene laminate.

In one aspect, a method 100 of packaging a multi-dose container includes covering the molded structure with a gas impermeable overwrap, as shown in step 340. For example, the method can include covering the molded structure with an oxygen impermeable overwrap configured to prevent oxygen from contacting the hermetically sealed multiple single dose container. For example, the method can include covering the molded structure with an outer wrap that is configured to be impermeable to an inert gas that maintains an inert gas environment (eg, a nitrogen-rich environment) within the sealed overwrap.

In one aspect, a method 100 of packaging a multi-dose container includes covering the molded structure with a vapor permeable overwrap, as shown in step 350. For example, the method can include laminates configured to create a vapor or moisture barrier (eg, polyester/foil/polyethylene laminate, polyester/metallized polyethylene laminate or coated paper/foil/ Polyethylene laminate) covers the molded structure of multiple single dose containers.

In one aspect, a method 100 of packaging a multi-dose container includes covering the molded structure with a light-impermeable overwrap, as shown in step 360. For example, the method can include covering a molded structure of a plurality of single dose containers with a hermetically sealable overwrap that is opaque and configured to produce a light blocking member (eg, a foil laminate). In one aspect, the light-impermeable overwrap is impermeable to ultraviolet, visible, and/or near-infrared radiation.

In one aspect, a method 100 of packaging a multi-dose container includes covering the molded structure with an electrostatic discharge protective overwrap, as shown in step 370. For example, the method can include covering a molded structure of a plurality of single dose containers with a hermetically sealable overwrap having antistatic properties (eg, a polyester/aluminum foil/antistatic low density polyethylene laminate).

Airtight seal with moisture/vapor barrier layer, light blocking layer, gas barrier layer and/or electrostatic discharge barrier layer in the form of a bag, bag, sleeve or layer (eg sheet) for use in the methods described herein Overwraps are commercially available, for example, from Bemis Company, Inc., Oshkosh, WI; Pall Corporation, Port Washington, NY.

In some embodiments, the multiple single dose container comprises a molded structure comprising a first portion and a second portion, the first portion comprising a row of interconnected single dose vials, interconnected single doses of medicament Each of the bottles encloses a dose of at least one medicament, and the second portion is attached to the first portion, the second portion comprising a textured surface pattern, the textured surface pattern being positioned An air flow between the first portion and a region adjacent to the second portion is directed.

In some embodiments, the multiple single dose container comprises a molded structure comprising a first portion and a second portion, the first portion comprising a row of interconnected single dose vials, each of the interconnected single dose vials An interior volume having at least one medicament configured to receive a dose; and the second portion is attached to the first portion, the second portion comprising a textured surface pattern, the textured surface pattern being positioned An air flow between the first portion and a region adjacent to the second portion is guided.

4 shows a schematic diagram of a non-limiting example of a multiple single dose container for a method of packaging multiple single dose containers as shown in FIG. In this non-limiting example, the multiple single dose container 400 includes a molded structure 410 that includes a first portion 420 and a second portion 430. The first portion 420 includes a row of interconnected single dose vials 440, each of which holds a dose of at least one medicament. The second portion 430 is attached to the first portion 420 and includes a textured surface pattern 450 that is positioned to direct airflow between the first portion 420 and the region 460 (dot pattern) (shown as a series in this non-limiting example) Parallel line), region 460 is adjacent to second portion 430. In this non-limiting example, region 460 adjacent to second portion 430 is a space adjacent the edge of second portion 430. The textured surface pattern 450 on the molded structure 410 is configured to assist in drawing or discharging air and/or inert gas during the process of hermetically sealing the multiple single dose container 400 within the hermetically sealable outer wrap.

In one aspect, the molded structure of the multiple single dose container as described herein is formed using a molding manufacturing process. For example, a first portion of the molded structure comprising the rows of interconnected single dose vials and a second portion of the molded structure comprising the textured surface pattern can be formed by a blow molding process. For example, a first portion of the molded structure comprising the rows of interconnected single dose vials and a second portion of the molded structure comprising the textured surface pattern can be formed by an injection molding manufacturing process. In one aspect, the molded structure including the first portion and the second portion is formed by a blow-fill-seal manufacturing process. For example, a first portion of the molded structure comprising the rows of interconnected single dose vials and a second portion of the molded structure comprising the textured surface pattern can be formed by a blow-fill-seal manufacturing process.

In one aspect, the molded structure including the first portion and the second portion is formed by a blow molding manufacturing process. See, for example, U.S. Patent No. 3, 325, 860 to the name of "Molding and Sealing Machines" to Hansen, entitled "Apparatus for Blow Molding a Container with Breachable Sealing Members", which is incorporated herein by reference. . In one aspect, the blow molding manufacturing process includes at least the steps of: melting a plastic resin to form a hollow molten plastic resin tube (parison), clamping the two halves of the mold around the hollow tube and keeping it closed, The parison is expanded into the cavity by allowing the parison to assume the shape of the cavity, and the air is discharged from the die portion and the plastic resin is cooled. For example, pharmaceutical grade plastic resins (eg, polyethylene and/or polypropylene) can be hot extruded (vertical hot extrusion) or injection molded to form a hanging vertical tube or hollow cylinder (parison). For example, particles of polyethylene and/or polypropylene can be fed into the extruder and melted at temperatures above 160 degrees Celsius. The extruded parison is enclosed by a two-part mold that seals the lower end of the parison. The extruded parison is cut on the mold. The formed molding structure is cooled and taken out of the mold.

In one aspect, the molded structure including the first portion and the second portion is formed by a blow-fill-seal manufacturing process. For example, a multi-dose container comprising a dose of at least one agent can be formed by an aseptic process, forming a molded structure in an aseptic process, filling with at least one agent, and sealing in an uninterrupted sequence of operations in a sterile environment. For example, the molded structure including the first portion and the second portion can be formed using a highly automated blow-fill-seal or form-fill-seal manufacturing process. For example, a multi-single dose container can be produced by: 1) forming a molded structure comprising a first portion of a single dose vial having rows of interconnected vials and a textured surface pattern having flow directing properties a second part, 2) filling each of the interconnected single-dose vials with a dose of at least one agent, and 3) sealing each of the interconnected single-dose vials to at least one of the doses The medicament is enclosed therein. For example, a multi-dose container can be formed, filled with at least one agent, and sealed using a method comprising at least the steps of: delivering a sterile solution comprising the at least one agent to a blow-fill-seal or a bacterial-screening program Form-fill-seal machine; supply sterile filtered compressed air and plastic material (eg polyethylene, polypropylene or polyethylene/polypropylene copolymer) to the machine; plastic particles under pressure (eg up to 350 bar) Extrusion as a hot hollow moldable plastic parison; two halves of the mold defining the outer surface of the molded structure of the multi-dose container are closed around the parison to seal the base while the parison is cut by a hot blade Top; plastic material is formed into multiple single-dose containers by vacuum and/or sterile air pressure; each of the interconnected single-dose vials is immediately filled with a metered volume of a solution containing at least one agent; once the desired volume is filled Each of the interconnected single-dose vials, the fill unit is raised and each of the interconnected single-dose vials is automatically sealed; With release formed in a continuous loop in the automatic filling and sealing of multiple single-dose container. Mechanical devices for blow-fill-seal and/or form-fill-seal manufacturing processes are available from commercial sources (e.g., from Rommelag USA, Inc., Evergreen, CO; Weiler Engineering Inc., Elgin, IL).

In one aspect, the molded structure including the first portion and the second portion is formed by an injection molding manufacturing process. For example, a first portion of a molded structure comprising a row of interconnected single dose vials and a second portion of a molded structure comprising a textured surface pattern can be formed from a resin (eg, a thermoplastic material) by injection The ram or screw is forced to form a suitably shaped mold. The pressure is maintained until the thermoplastic material is sufficiently hardened to remove the mold and release the formed molding structure.

In one aspect, a multiple single dose container comprising a molded structure is formed using one or more molds. In one aspect, one or more molds are designed for blow molding. For example, the mold can include two concave members that, when closed, form a cavity that defines the outer surface of the molded structure of the multiple single dose container. In one aspect, one or more molds are designed for injection molding manufacturing. For example, the mold can include a cavity that forces the plastic polymer or resin into the cavity under pressure, the mold defining the outer and inner surfaces of the single dose vial that constitutes the multiple single dose container. In one aspect, each of the one or more molds is formed of stainless steel or aluminum and precision machined to provide a mold for the outer and/or inner features of the molded structure of the multiple single dose container. Other non-limiting materials used to form the mold for blow molding and/or dip molding include tantalum, copper, aluminum, steel, chromium, nickel, stainless steel, and alloys thereof.

In one aspect, the molded structure of the multiple single dose container comprising the first portion and the second portion is made of a biocompatible material. For example, the molded structure can be made of a material that is safe and compatible with the contents of a single dose vial, such as a pharmaceutical in dry or liquid form. For example, a biocompatible material (eg, a biocompatible polymer or resin) is sufficiently inert to prevent release from the biocompatible material in an amount sufficient to affect the stability and/or safety of the agent enclosed therein or The material is filtered out into the contents of a single dose vial. For example, a biocompatible material is a type of component that does not significantly absorb the dosage form (eg, an agent in a dry or liquid formulation), and/or does not allow the components of the agent to migrate through the type of biocompatible material. Non-limiting examples of biocompatible materials include polyvinyl chloride, fluoropolymers, polyurethanes, polycarbonates, fluorenone, acrylic, polypropylene, low density polypropylene, high density polypropylene, nylon, enamel, thermoplastic Elastomers and thermoplastic polyesters.

In one aspect, the molded structure comprising the first portion and the second portion is made of at least one thermoplastic material. For example, a molded structure of a multi-single dose container comprising a first portion having a row of interconnected single dose vials and a second portion having a textured surface pattern may use a blow molding or infusion molding process Made of a thermally bendable or moldable plastic polymer material. Non-limiting examples of thermoplastic materials include ethylene vinyl acetate, cyclic olefin copolymers, ionomers, fluoropolymers, polyurethanes, polyethylene terephthalate (PET), polyethylene terephthalate Alcohol ester G (PETG), acrylic, cellulose, polymethyl methacrylate, acrylonitrile butadiene styrene, nylon, polylactic acid, polybenzimidazole, polycarbonate, polyether oxime, polyether ether ketone , polyether phthalimide, polyethylene, polyphenylene ether, polyphenylene sulfide, polypropylene, polystyrene, polyvinyl chloride and polytetrafluoroethylene.

In one aspect, the at least one thermoplastic material comprises a form of polyethylene. For example, the thermoplastic material can include polyethylene in low density (LDPE) or branched form. For example, the thermoplastic material can include polyethylene in high density (HDPE) or linear form. For example, the thermoplastic material can include linear low density polyethylene (LLDPE) that combines the clarity and density of the LDPE with the toughness of the HDPE.

In one aspect, the at least one thermoplastic material comprises a form of polypropylene. For example, the thermoplastic material can comprise polypropylene in a high crystalline form. For example, the thermoplastic material can include an isotactic form of polypropylene having an organic group on the same side of the polymer chain. For example, the thermoplastic material can comprise a polypropylene in a higher impact form, such as syndiotactic to an alternating organic group above and below the polymer chain, or a random sequence atactic with an organic side chain. In one aspect, the polypropylene is modified with polyethylene or rubber to improve impact resistance, reduce stiffness and improve transparency.

In one aspect, the molded structure comprising the first portion and the second portion is made of at least one biocompatible thermoplastic material. Non-limiting examples of biocompatible thermoplastics include polyvinyl chloride, fluoropolymers, polyurethanes, polycarbonates, acrylics, polypropylenes, low density polypropylenes, high density polypropylenes, nylons, and enamel resins. Additional non-limiting examples of biocompatible thermoplastics include thermoplastic polyolefin elastomer (TEO), styrene ethylene butylene styrene (SEBS), thermoplastic vulcanizate (TPV), thermoplastic polyurethane (TPU), copolymer thermoplastics. (COPE) and polyether copolyacetamide (PEBA).

In one aspect, the molded structure of the multiple single dose container is made of glass using a blow molding or injection molding manufacturing process. For example, the molten glass may be formed into a molded structure using a press-blowing process or a blow-blowing process. In both processes, the molten glass is pressed or blown into a parison and then blown into a mold that defines the outer surface of the molded structure. In one aspect, the molded structure is made of borosilicate glass. For example, the molded structure can be made of Type I borosilicate glass.

In one aspect, the molded structure of the multiple single dose container is made of a transparent material. For example, the molded structure of the multiple single dose container can be made of a transparent material to allow a user to view the tip of a needle (e.g., a syringe needle) in a single dose vial that forms part of a multiple single dose container. For example, a molded structure of a multi-single dose container can be made of a transparent material using a blow molding or injection molding manufacturing process. In some embodiments, the transparent material comprises glass. For example, the transparent material can include type I borosilicate glass. In some embodiments, the transparent material comprises the form of a transparent thermoplastic material. For example, the transparent material can include a copolymer of vinyl acetate and ethylene. For example, the transparent material can include polyethylene in a low density form. For example, the transparent material may comprise polyvinyl chloride, especially unplasticized polyvinyl chloride. For example, the transparent material can include a cyclic olefin copolymer. See, for example, U.S. Patent No. 6,951,898, to the name of </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> <RTIgt;

In one aspect, the molded structure of the multiple single dose container is made of an opaque material. For example, the molded structure of the multiple single dose container including the first portion and the second portion may be made of an opaque plastic such as polypropylene PP. In one aspect, the molded structure of the multiple single dose container is made of a colored material. For example, a molded structure comprising a first portion and a second portion of a multi-single dose container can be made of a colored material, such as amber glass or a thermoplastic material, which limits the amount of light or ultraviolet radiation that can pass through a single dose vial. . For example, a molded structure comprising a first portion and a second portion of a multi-single dose container can be made of an extruded thermoplastic material that includes a color configured to impart a single dose vial (eg, amber). Dyes or pigments.

In one aspect, one or more additives are included in the material of the molded structure from which the multi-single dose container is made. For example, the one or more additives may include a lubricant, a stabilizer, an antioxidant, a plasticizer, an antistatic agent, or a slip agent. In one aspect, a method of making a molded structure of a multiple single dose container includes adding one or more of a lubricant, a stabilizer, an antioxidant, a plasticizer, an antistatic agent, a slip agent, or a combination thereof. For example, a lubricant such as zinc stearate may be used during the molding or extrusion process to promote flow of the molten thermoplastic on the metal surface of the mold. For example, one or more stabilizers (eg, organometallic compounds, fatty acid salts, and inorganic oxides) can be added to the thermoplastic to delay or prevent the polymer from exposure to heat, light, and/or UV during the manufacturing process. Degradation to improve the aging properties of thermoplastics. For example, one or more antioxidants that inhibit free radical formation (eg, aromatic amines, hindered phenols, thioesters, and phosphites) can be added to the thermoplastic to prevent degradation of the thermoplastic by oxidation. For example, one or more plasticizers (eg, phthalates, dioctyl phthalate) can be added to the thermoplastic during processing to achieve softness, flexibility, and melt flow. For example, one or more antistatic agents can be used to prevent static charges from accumulating on the plastic surface. For example, one or more slip agents, such as polyolefins, can be added to the thermoplastic material to reduce the coefficient of friction of the material. In one aspect, the outer surface of the multiple single dose container is surface treated. For example, the surface treatment may include the deposition of a corona discharge or other thin layer of plastic to improve properties such as ink adhesion, adhesion to other films, heat sealability or gas barrier properties.

Returning to FIG. 4, the molded structure 410 of the multiple single dose container 400 includes a first portion 420 and a second portion 430. The first portion 420 of the molded structure 410 of the multiple single dose container 400 includes a row of interconnected single dose vials 440. In this non-limiting example, the rows of interconnected single dose vials 440 comprise five interconnected single dose vials in a row. In one aspect, the rows of interconnected single dose vials comprise at least two interconnected single dose vials. In one aspect, the rows of interconnected single dose vials comprise three or more interconnected single dose vials. In one aspect, the rows of interconnected single-dose vials comprise two, three, four, five, six, seven, eight, nine or ten interconnected single-dose vials At least one. In one aspect, the rows of interconnected single dose vials comprise from about 2 to about 30 interconnected single dose vials. For example, the first portion of the molded structure can include a row of interconnected single-dose vials, and the rows of interconnected single-dose vials include 2 vials, 3 vials, 4 vials, 5 vials, 6 Bottle, 7 bottles, 8 bottles, 9 bottles, 10 bottles, 11 bottles, 12 bottles, 13 bottles, 14 bottles, 15 bottles, 16 bottles, 17 bottles, 18 bottles, 19 bottles, 20 bottles, 21 bottles, 22 bottles, 23 bottles, 24 bottles, 25 bottles, 26 bottles, 27 bottles, 28 bottles, 29 bottles or 30 bottles. In some embodiments, the multiple single dose container includes more than 30 bottles.

In one aspect, the first portion of the molded structure includes a row of 20 to 30 interconnected single dose vials. For example, the first portion of the molded structure can include a row of 25 interconnected single dose vials. In one aspect, the first portion of the molded structure comprises a row of 20 to 30 interconnected single dose vials, and the rows of 20 to 30 interconnected single dose vials are configured to be divided into 3 to 10 A group of interconnected single-dose vials. For example, the first portion of the molded structure includes a row of 20 to 30 interconnected single dose vials, and the rows of 20 to 30 interconnected single dose vials are configured to be divided into 3 vials, 4 A group of 5 bottles, 5 bottles, 6 bottles, 7 bottles, 8 bottles, 9 bottles or 10 bottles. For example, a multi-single dose container can include a strip of 25 interconnected single dose vials configured to be divided into groups of 5 vials.

In one aspect, each of the interconnected single dose vials is polygonal in cross section perpendicular to the axis formed by the first and second portions of the molded structure. In one aspect, each of the interconnected single dose vials is square, triangular, hexagonal, or polygonal in cross-section perpendicular to the axis formed by the first and second portions of the molded structure.

5A-5C illustrate aspects of a multiple single dose container 400 having a row of interconnected single dose vials 440 having different cross-sectional shapes. Figure 5A is a top plan view of a multiple single dose container 400a comprising a row of interconnected single dose vials 440a. In one aspect, each of the interconnected single dose vials 440a is square in a cross section perpendicular to the axis formed by the first and second portions of the molded structure. Figure 5B is a top plan view of a multiple single dose container 400b comprising a row of interconnected single dose vials 440b. In one aspect, each of the interconnected single dose vials 440b is triangular in cross section perpendicular to the axis formed by the first and second portions of the molded structure. Figure 5C is a top plan view of a multiple single dose container 400c comprising a row of interconnected single dose vials 440c. In one aspect, each of the interconnected single dose vials 440c is hexagonal in cross section perpendicular to the axis formed by the first and second portions of the molded structure. Multiple single dose containers 400a, 400b, and 400c having different cross-sectional shapes include the structure shown in Figure 4, i.e., a first portion comprising a row of interconnected single-dose vials adjacent to the first portion and including texturing A second portion of the surface pattern, the textured surface pattern is positioned to direct airflow between the first portion and a region adjacent the second portion.

Each of the interconnected single-dose vials in the multiple single-dose container encloses a dose of at least one agent. In one aspect, a dose of at least one agent is formulated for parenteral or oral administration. In one aspect, the dose of at least one agent is in liquid form. For example, a dose of at least one agent can be dissolved or suspended in a liquid formulation suitable for oral or parenteral administration. In one aspect, the dose of at least one agent is in lyophilized form. For example, a dose of at least one agent can be in a lyophilized or dried form that is intended to be reconstituted with water (eg, distilled water or water for injection) prior to use in the subject. In one aspect, the at least one pharmaceutical agent is intended to be administered to a human. In one aspect, the at least one pharmaceutical agent is intended for veterinary administration.

In one aspect, the dose of at least one agent comprises a prophylactic agent, such as an agent capable of preventing a medical condition or an infectious disease. In one aspect, the dose of at least one agent comprises a dose of at least one vaccine. For example, a dose of at least one agent can include a dose of at least one vaccine that is capable of eliciting immunity against or preventing infection by one or more infectious agents. In one aspect, the dose of at least one agent comprises a dose of at least one vaccine configured to immunize one or more infectious agents, diseases or conditions, non-limiting examples of one or more infectious agents, diseases or conditions including anthrax, tuberculosis (BCG), cholera, dengue, diphtheria, tetanus, whooping cough, hemorrhagic fever, Haemophilus b (Hib), hepatitis A, hepatitis B, human papillomavirus, influenza, Japanese encephalitis, malaria, measles, meninges Meningitis meningitis, mumps, poliovirus, rubella, varicella virus, plague, pneumococcus, rabies, Rift Valley fever, rotavirus, rabies, rubella, smallpox, sputum encephalitis, typhoid fever, yellow fever and band Herpes zoster (Zoster). In one aspect, the dose of at least one agent comprises a dose of two or more vaccines. For example, a dose of at least one agent can include a dose of a DPT vaccine, and the DPT vaccine includes a vaccine against diphtheria, tetanus, and whooping cough.

In one aspect, the dose of at least one agent comprises a dose of at least one therapeutic agent. For example, a dose of at least one agent can include one or more drugs capable of treating a medical condition. Non-limiting examples of therapeutic agents include immunoglobulins, antibiotics (eg, penicillin, cefuroxime, ceftazidime), interferons (eg, interferon alpha, beta or gamma), peripheral vasodilators (eg, alprostadil), anticoagulation Agents (eg, fondapainux), gonadotropins (eg, follitropin), anabolic hormones (eg, somatropin), bone forming agents (eg, teriparatide, HIV or other antibiotics) Viral drugs (eg enfuvirtide), contraceptives (eg medroxyprogesterone acetate), anti-inflammatory agents (eg etanercept, adalimumab, serotonin) Body antagonists (such as sumatriptan), GRH analogs (such as leuprolide), chemotherapy, insulin, hormones, anti-infectives, and the like.

In one aspect, the medicament comprises an active ingredient. In one aspect, the active ingredient comprises one or more vaccines. In one aspect, the active ingredient comprises one or more therapeutic agents. In some embodiments, the agent includes an additional inactive ingredient (eg, an excipient) configured to preserve, stabilize, or otherwise protect the active ingredient in the agent. Non-limiting examples of inactive ingredients or excipients include solvents or cosolvents (such as water or propylene glycol), buffers, antimicrobial preservatives, antioxidants or wetting agents (such as polysorbates or poloxamers).

In one aspect, each of the interconnected single dose vials includes an internal volume that holds a dose of at least one medicament. In one aspect, each of the interconnected single dose vials has an internal volume configured to hold a dose of at least one medicament. In one aspect, the internal volume of the at least one medicament containing a dose is sufficient to accommodate a single dose volume of medicament and a minimum overfill volume of medicament. In one aspect, the internal volume of the at least one medicament containing a dose is sufficient to accommodate a single dose volume of medicament, a minimum overflow volume of medicament, and a headspace above the medicament. For example, the internal volume of each of the interconnected single-dose vials containing multiple single-dose containers can be about 0.75 milliliters, for a 0.5 milliliter single dose of medicament, 0.1 milliliters of overflow and 0.15 milliliters above the liquid medicament. The head space is sufficient volume. In one aspect, the internal volume is from about 0.2 milliliters to about 6.0 milliliters. For example, the internal volume of each of the interconnected single-dose vials of multiple single-dose containers is 0.2 mL, 0.3 mL, 0.4 mL, 0.5 mL, 0.6 mL, 0.7 mL, 0.8 mL, 0.9 mL, 1.0 mL, 1.1 mL, 1.2 mL, 1.3 mL, 1.4 mL, 1.5 mL, 1.6 mL, 1.7 mL, 1.8 mL, 1.9 mL, 2.0 mL, 2.1 mL, 2.2 mL, 2.3 mL, 2.4 mL, 2.5 mL, 2.6 mL, 2.7 mL, 2.8 mL, 2.9 mL, 3.0 mL, 3.1 mL, 3.2 mL, 3.3 mL, 3.4 mL, 3.5 mL, 3.6 mL, 3.7 mL, 3.8 mL, 3.9 mL, 4.0 mL, 4.1 mL, 4.2 mL, 4.3 mL, 4.5 mL 4.6 mL, 4.7 mL, 4.8 mL, 4.9 mL, 5.0 mL, 5.1 mL, 5.2 mL, 5.3 mL, 5.4 mL, 5.5 mL, 5.6 mL, 5.7 mL, 5.8 mL, 5.9 mL, or 6.0 mL.

In some embodiments, the internal volume of the at least one medicament containing a dose is greater than 6.0 milliliters. For example, the internal volume of each of the interconnected single dose vials can be at least twice the volume of a single dose volume of medicament to accommodate two doses of medicament. For example, each of the interconnected single dose vials may have an internal volume of 10 milliliters and is configured to hold two 3 milliliter single dose volumes of medicament.

In one aspect, each of the interconnected single dose vials has an internal volume configured to hold a single dose of at least one medicament. For example, the internal volume of each of the interconnected single dose vials can be sized to accommodate a single dose volume of at least one agent. In one aspect, a single dose volume of at least one agent can be expressed in milliliters (mL) or cubic centimeters (cc). In one aspect, the single dose volume comprises a liquid or lyophilized formulation of at least one agent configured for intramuscular, intradermal, subcutaneous, intravenous or intraperitoneal injection. In one aspect, a single dose volume comprises a liquid or lyophilized formulation of at least one agent configured for administration by the mouth, nose, eye, urethra, anus or vagina. In one aspect, the single dose volume comprises a liquid or lyophilized formulation of at least one agent configured for intraocular injection. In one aspect, the single dose volume comprises a liquid or lyophilized formulation configured to be injected into at least one agent in the central nervous system.

In one aspect, the single dose volume of at least one agent depends on the type of agent. In one aspect, the single dose volume of the at least one agent is a clinically determined effective or therapeutic dose of the at least one agent. For example, the recommended dose for a generic vaccine ranges from 0.05 mL for a BCG (tuberculosis) vaccine to 1.0 mL for a hepatitis A vaccine. In one aspect, the single dose volume of at least one agent depends on the site of injection, such as intramuscular, subcutaneous or intradermal. For example, a single dose volume of intramuscular injection of a liquid drug can be as high as 5 mL. See, for example, Hopkins & Arias (2013) "Large volume IM injections: A review of best practices", Oncology Nurse Advisor November/February, which is incorporated herein by reference. In one aspect, the single dose volume of the at least one agent depends on the size of the individual that will receive the at least one agent. For example, a single dose volume may depend on the size of the intended recipient (eg, child and adult), such as body weight. For example, a single dose volume for subcutaneous injection of a medicament can be 0.5 mL, 1 mL, or 2 mL, depending on the size of the child or adult. In one aspect, the single dose volume of the agent is from about 0.01 mL to about 5 mL. For example, in some embodiments, the single dose volume of the agent can be 0.01 mL, 0.02 mL, 0.05 mL, 0.075 mL, 0.1 mL, 0.15 mL, 0.2 mL, 0.25 mL, 0.3 mL, 0.35 mL, 0.4 mL, 0.45 mL , 0.5 mL, 0.55 mL, 0.6 mL, 0.65 mL, 0.7 mL, 0.75 mL, 0.8 mL, 0.85 mL, 0.9 mL, 1.0 mL, 1.25 mL, 1.5 mL, 1.75 mL, 2.0 mL, 2.25 mL, 2.5 mL, 2.75 mL, 3.0 mL, 3.25 mL, 3.5 mL, 3.75 mL, 4.0 mL, 4.25 mL, 4.5 mL, 4.75 mL, or 5.0 mL.

In one aspect, the internal volume of each of the interconnected single dose vials is configured to hold two or more doses of at least one medicament. For example, each of the interconnected single dose vials of the multiple single dose container can be configured to hold two or more single dose volumes of at least one medicament.

In one aspect, each of the interconnected single dose vials of the multiple single dose container comprises a different medicament. For example, multiple single-dose containers can be configured to be used for the transport and storage of a particular number of individual doses of multiple drugs for a single patient over a limited period of time (eg, a single medical clinic visit). For example, in some embodiments, a multiple single dose container comprising six interconnected single dose vials is configured to store and transport each of a single dose of HepB, RV, DTaP, HiB, PCV, and IPV vaccines, bottles Each of them has a vaccine for administration to children according to a regular vaccine schedule for 2 month old recommendations. For example, in some embodiments, a multiple single dose container comprising four interconnected single dose vials is configured to store and transport each of a single dose of a DTaP, IPV, MMR, and VAR vaccine, each of the bottles There is a vaccine for administration to children based on a regular vaccine schedule for 4-6 years of age. See the Immunization Practice Advisory Committee (ACIP) for immunization schedules recommended for people from 0 to 18 years of age - USA, 2013" ACIP Children/Youth Working Group, MMWR 62:1-8 (2013), which Into this article.

For example, in some embodiments, multiple single dose containers comprising interconnected single dose vials can be used to store multiple doses of immunoglobulin therapeutics that can be administered to a patient continuously as directed by a medical professional. Several types of immunoglobulin therapeutics are available, which are typically administered continuously in a dosage volume relative to the patient's body weight. An aliquot of the immunoglobulin therapeutic can be stored in a separate single-dose vial of a multi-dose container to minimize waste of the immunoglobulin therapeutic and to enable immunoglobulin in the vial The patient is administered to the patient in a manner that minimizes the likelihood of contamination of the treatment. For example, in some embodiments, a multiple single dose container comprising an interconnected single dose vial can be used to store multiple doses of an injectable administered antiviral therapeutic. For example, in some embodiments, multiple single-dose containers comprising interconnected single-dose vials can be used to store multiple doses of an injectable administered antibiotic treatment. For example, in some embodiments, multiple single dose containers comprising interconnected single dose vials can be used to store a dose of a biological agent comprising a therapeutic protein. For example, in some embodiments, multiple single dose containers comprising interconnected single dose vials can be used to store a dose of a biological agent comprising an antibody (eg, a monoclonal or polyclonal antibody). For example, in some embodiments, a multiple single dose container comprising an interconnected single dose vial can be used to store multiple doses of an injectable administered treatment that is typically administered continuously to a single patient such that one multiple single dose container can include Injectable doses for standard sequences administered to a single individual patient in a time series under the direction of a medical professional. For example, in some embodiments, a multi-dose container comprising an interconnected single-dose vial can be used to store a dose of an injectable administered therapeutic, the administered therapeutic having multiple components administered separately, for example, applied to Different antibiotics and/or antiviral agents for individual patients in need.

In one aspect, the internal volume of the at least one medicament containing a dose comprises a headspace volume of the at least one medicament above the dose. In one aspect, the interior volume of the at least one medicament containing a dose comprises an inert gas filled headspace. For example, a headspace above a dose of liquid or at least one agent in lyophilized/solid form may be filled with an inert gas. In one aspect, the internal volume of the at least one medicament containing a dose comprises a nitrogen-filled headspace. For example, each of the interconnected single dose vials can be configured to hold nitrogen in a headspace above a dose of at least one agent. For example, each of the interconnected single dose vials can be configured to contain carbon dioxide in a headspace above a dose of at least one agent. In one aspect, the internal volume of the at least one medicament that contains a dose includes a headspace that is filled with a rare gas. For example, each of the interconnected single dose vials can be configured to contain at least one of argon, helium, neon or xenon in a headspace above a dose of at least one agent. The process of forming, filling and sealing a bottle of a multi-dose container may further comprise purging the atmosphere/oxygen in the headspace above a dose of at least one agent prior to the addition of the inert gas.

In one aspect, each of the interconnected single dose vials includes an access portion. In one aspect, the access portion includes a hole defined by a wall of a single dose vial. In one aspect, the entry portion is adjacent to the internal volume of the single dose vial. For example, the access portion can include a hole or opening defined by the end of the wall that forms a single dose vial that allows access to the internal volume of the single dose vial. For example, the access portion includes an opening in a single dose vial for accessing a dose of at least one medicament encapsulated therein. For example, the access portion is large enough to accommodate a passage of a needle, such as a syringe needle.

In one aspect, each of the interconnected single dose vials includes a closure that covers the access portion. In some embodiments, the closure includes a removable cover. In some embodiments, the removable cover is broken or twisted to expose the entry portion of the single dose vial. In one aspect, the access portion is an opening or aperture defined by the wall of a single dose vial. For example, the removable cover can be broken or twisted to expose an opening or aperture through which the closed at least one medicament can be accessed. In one aspect, the closure includes a closure that the needle can pierce. For example, the closure can include a material that the needle can pierce, and a needle attached to the syringe can pass through the material to enter the internal volume of the single dose vial. For example, the closure can include a removable cover that is broken or twisted to reveal material that the needle can pierce, through which the needle attached to the syringe can enter the internal volume of the single dose vial.

In one aspect, each of the interconnected single dose vials includes an access portion that the needle can pierce. In one aspect, the entry portion pierceable by the needle is configured to allow the needle to enter the internal volume of the single dose vial through a material pierceable by the needle forming at least a portion of the multiple single dose container. For example, the entry portion into which the needle can be pierced can include a needle pierceable access portion of the thermoplastic material used to form the multiple single dose container. For example, the top of the blow-fill-seal bottle can include an entry portion that the needle can pierce. For example, the needle can pierce the entry portion can include a sealed portion formed by melting or heat sealing the wall at the open end of each of the single dose vials to cover the entry portion. For example, the sealing portion formed by melting or heat sealing the wall at the open end of each of the single dose vials may also be piercable by the needle to allow the needle to pass through the sealing portion to enter the internal volume of the bottle. In some embodiments, each of the interconnected single dose vials forming the multiple single dose container can include a removable cover that, once removed, exposes the entry portion that the needle can pierce.

In one aspect, the entry portion that the needle can pierce includes additional components that are added to each of the interconnected single dose vials. In one aspect, the entry portion that the needle can pierce includes an insert. For example, the entry portion that the needle can pierce can include an insert that is added to the row of interconnected single dose vials that are blow molded or injection molded. In one aspect, the entry portion that the needle can pierce includes an entry portion that the rubber needle can pierce. For example, the closure can include a rubber septum pierceable by a needle that is inserted into the access portion and held in place by an aluminum seal that is crimped around the tapered neck region of the bottle. For example, the entry portion of the rubber needle that can be pierced is made of bromobutyl or chlorobutyl synthetic rubber. In one aspect, the entry portion of the rubber needle that can be pierced is further protected by a plastic flip cover.

In one aspect, each of the interconnected single dose vials includes a removable cover that covers the access portion. In one aspect, each of the interconnected single dose vials includes a shearable cover that covers the access portion. For example, the severable cover can be cut during the blow-fill-seal manufacturing process so that it can be easily cut from the remainder of the single-dose vial to reveal the entry portion (eg, the needle accessible access portion) during use. This way is formed. In one aspect, each of the interconnected single dose vials includes a twistable cover that covers the access portion. For example, the twistable cover can be made during the blow-fill-seal manufacturing process such that the cover that is twistable during use can be easily twisted from the remainder of the single dose vial to expose the access portion (eg, the accessible portion of the needle) ) formed in such a way. In one aspect, the removable cover is formed by a second molding process after forming the base of the rows of interconnected single dose vials. In one aspect, the removable cover is an insert that is added during the molding process. See, for example, U.S. Patent No. 3,993,223, issued to Welker & Brady, entitled "Dispensing Container"; U.S. Patent No. 6,626,308, entitled "Hermetically Sealed Container with Self-Draining Closure" by Weiler, entitled "Blow Molded Container Having an" U.S. Patent No. 4,319,701, the entire disclosure of which is incorporated herein by reference.

In one aspect, each of the interconnected single dose vials includes an insert that covers the entry portion. For example, each of the interconnected single dose vials can include a removable cover that is added to each of the interconnected single dose vials. In one aspect, the insert is added to each of the interconnected single dose vials during the molding process. See, for example, U.S. Patent No. 4,319,701, issued to, the entire entire entire content of In one aspect, the insert at least partially includes another sterile element that is added to each of the interconnected single dose vials after the molding process. For example, the insert can include a tip type cover, a metal part, or a luer joint. In one aspect, the insert is one of a co-molded tip and cap insert for creating a calibrated drop, a multi-entry rubber plug insert, or a controllable diameter injection molded insert. In one aspect, the insert is a septum. For example, an insertion technique can be used to insert a sterile tip and cap insert into each of the interconnected single dose vials.

In one aspect, each of the interconnected single dose vials includes a luer connector or a connector. For example, each of the interconnected single-dose vials can include a luer connector that is suitably sized to mate with a syringe that includes a Luer lock, thereby allowing removal of the contents of the bottle without the use of a syringe needle Things. See, for example, U.S. Patent No. 4,643,309, the entire disclosure of which is incorporated herein by reference.

Returning to Figure 4, the second portion 430 of the molded structure 410 includes a textured surface pattern 450 that is positioned to direct airflow between the first portion and the region adjacent the second portion. For example, the second portion of the molded structure can include a textured surface pattern configured to assist in sealing the multi-single dose container from sealing within the hermetically sealable overwrap Air and/or inert gas is withdrawn or discharged from the hermetically sealed outer wrap. In one aspect, the textured surface pattern positioned to direct airflow between the first portion and the region adjacent the second portion includes a concave surface pattern positioned to direct airflow between the first portion and a region adjacent the second portion. For example, the textured surface pattern can include a series of recesses or grooves on the surface of the second portion of the molded structure. In one aspect, the textured surface pattern positioned to direct airflow between the first portion and the region adjacent the second portion includes a convex surface pattern positioned to direct airflow between the first portion and a region adjacent the second portion . For example, the textured surface pattern can include a series of ridges on the surface of the second portion of the molded structure. In one aspect, the depressions or protrusions are made after the molding structure is fabricated to form a textured surface pattern. For example, a recessed surface pattern (eg, a series of recesses or grooves) can be etched into the surface of the second portion of the molded structure. For example, a raised surface pattern, such as a series of ridges, can be created on the surface of the second portion of the molded structure. In one aspect, the formation of a depression or bulge in the textured surface pattern is performed during the fabrication process of the molded structure. For example, the recessed and/or convex textured surface pattern can be incorporated into a mold for forming a molded structure. For example, the recessed and/or convex textured surface pattern can be incorporated into a mold for blow molding manufacturing of multiple single dose containers. For example, the recessed and/or convex textured surface pattern can be incorporated into a mold for injection molding multiple single dose containers. For example, the recessed and/or convex textured surface pattern can be incorporated into a mold for blow-fill-seal fabrication of multiple single dose containers.

In one aspect, at least a portion of the textured surface pattern includes channels aligned in parallel with the directed airflow between the first portion and a region adjacent the second portion. For example, the textured surface pattern can include a series of parallel lines that are convex and/or concave on the surface of the second portion of the molded structure. For example, the textured surface pattern can include a series of broken (eg, hashed or punctiform) lines that are convex and/or concave on the surface of the second portion of the molded structure. In one aspect, at least a portion of the textured surface pattern includes parallel channels that are recessed on a surface of the second portion of the molded structure, the parallel channels being adjacent the first portion of the molded structure and adjacent the second portion (eg, adjacent to the second portion) Airflow alignment between the areas of the end edges). In one aspect, at least a portion of the textured surface pattern includes parallel channels that protrude over a surface of the second portion of the molded structure, the parallel channels being between the first portion of the molded structure and the region adjacent the second portion Airflow alignment. In one aspect, at least a portion of the textured surface pattern includes a channel positioned at an angle relative to the directed airflow that converges or approaches convergence to be parallel to the directed airflow. Other textured surface patterns are contemplated, including, but not limited to, a v-shaped pattern, a curved pattern, a hash or a dot pattern.

A second portion of the molded structure including the textured surface pattern is attached to the first portion of the molded structure. In one aspect, the second portion is attached to the first portion adjacent the bottom portion of the rows of interconnected single dose vials. A non-limiting example is provided in FIG. FIG. 6 shows a schematic view of a multiple single dose container 600 including a molded structure 610 having a first portion 620 and a second portion 630. The first portion 620 includes a row of interconnected single dose vials 640. The second portion 630 includes a textured surface pattern 650. The second portion 630 is shown attached to the first portion 620 near the bottom of the rows of interconnected single dose vials 640. Each of the interconnected single dose vials 640 of the multiple single dose container 600 also includes an entry portion 660 that the needle can pierce through which the injection needle can pass. The multiple single dose container 600 also includes at least one label 670, and at least one label 670 includes at least one sensor 680. Tag 670 includes information about at least one medicament. The at least one sensor 680 includes at least one of a temperature sensor, a humidity sensor, a light sensor, or an oxygen sensor.

In some embodiments, the first portion 620 of the molded structure 610 includes a row of interconnected single dose vials 640 joined by one or more hinged joints 645. In one aspect, at least one of the interconnected single dose vials is coupled to at least one adjacent single dose vial via an articulating joint, the articulating joint being flexible enough to at least one of the interconnected single dose vials The flat outer surface reversibly mates with the flat outer surface of at least one adjacent single dose vial. For example, a multiple single dose container can include a row of interconnected single dose vials connected by one or more articulating joints, non-limiting aspects of which are described in more detail in Figures 22A-22E. One or more articulating joints are configured to allow multiple single dose containers to be folded into a more compact configuration for shipping and storage.

In some embodiments, the articulating joint functions only after the second portion of the molded structure is separated from the first portion of the molded structure, ie, bends. For example, in some embodiments, the articulating joint can only reversibly fit the flat outer surface of the single dose vial to the flat outer surface of an adjacent single dose vial after removal of the second portion of the molded structure. In some embodiments, the articulating joint is functional, ie, bendable, in a completed molded structure. For example, the articulating joint can be positioned to extend the length of the first portion and the second portion of the molded structure. For example, an articulating joint can be positioned between and extending the length of each of the interconnected single dose vials.

In one aspect, the second portion is attached to the first portion adjacent the top of the row of interconnected single dose vials. A non-limiting example is provided in FIG. FIG. 7 shows a schematic diagram of a multiple single dose container 700 including a molded structure 710 having a first portion 720 and a second portion 730. The first portion 720 includes a row of interconnected single dose vials 740. In some embodiments, each of the interconnected single dose vials 740 is coupled to at least one adjacent single dose vial 740 by one or more articulating joints 745. The second portion 730 includes a textured surface pattern 750. The second portion 730 is shown attached to the first portion 720 near the top of the rows of interconnected single dose vials 740. The multiple single dose container 700 also includes a closure 760, such as a twistable lid, designed to be removed to expose an access portion for entering a closed medicament with, for example, an injection needle. The multiple single dose container 700 also includes a label 770 that includes at least one sensor 780. Tag 770 includes information about at least one medicament. The at least one sensor 780 includes at least one of a temperature sensor, a humidity sensor, a light sensor, or an oxygen sensor.

In one aspect, the multiple single dose container includes at least one label. In one aspect, the at least one label is associated with at least one surface of a molded structure of the multiple single dose container. In one aspect, the at least one label is attached to at least one surface of the molded structure of the multiple single dose container. In one aspect, the at least one label is associated with or coupled to the first portion of the molded structure. In one aspect, the at least one label is associated with or coupled to a second portion of the molded structure. In one aspect, the label is associated with or attached to each of the interconnected single dose vials.

The label includes information regarding at least one medicament contained within each of the interconnected single dose vials forming the multiple single dose container. For example, the label may include the proprietary name of the agent, the definitive name or intrinsic name of the agent, the strength of the agent, the route of administration, the warning (if any), the warning statement (if any), the net quantity, the manufacturer Name, expiration date, lot number, recommended storage conditions, recommended single dose volume (if multiple doses per bottle), barcode, lot number, national drug number, controlled substance plan information (if any), RF Identification (RFID) tags or combinations thereof. For liquid form agents, the label can include strength per total volume (eg, 500 mg/10 mL) and intensity per milliliter (eg, 50 mg/1 mL). For pharmaceutical agents in powder form, the label can include the amount of medicament per vial (eg, in milligrams). The label may also include instructions for reconstituting the agent in lyophilized or powder form and the strength of the agent in the reconstituted volume. For additional information on container labels, see, for example, "Guidance for Industry: Safety Considerations for Container Labels and Carton Labelling Design to Minimize Medication Errors, Food and Drug Administration," April 2013, which is incorporated herein by reference.

In one aspect, each of the interconnected single dose vials includes a label. For example, each of the single dose vials that make up the rows of interconnected single dose vials can have separate labels. In one aspect, the label is associated with at least one surface of each of the interconnected single dose vials. In one aspect, the label is printed on the outer surface of each of the single dose vials that make up the rows of interconnected single dose vials. For example, the labels can be printed onto each of the single dose vials using thermal transfer overprinting, laser marking systems, continuous ink jets, or thermal ink jets. For example, the label can be printed on a portion of the removable cover associated with the single dose vial.

In one aspect, the label is attached to at least one surface of each of the interconnected single dose vials. For example, the label can be attached to one or more outer surfaces of each of the interconnected single dose vials. For example, the label can be attached to a removable cover associated with each of the interconnected single dose vials. In one aspect, the label is printed separately and includes an adhesive for adhering at least a portion of the label to at least one surface of the multiple single dose container. For example, the label can be printed separately and attached to the removable cover of each of the interconnected single dose vials that make up the multiple single dose container with an adhesive. For example, the label can be printed separately onto a label that includes a pressure sensitive adhesive. For example, the label can be printed separately onto a label that is adhered to each of the interconnected single dose vials that make up the multiple single dose container with a separate pressure sensitive adhesive sheet (eg, a transparent adhesive strip). .

In one aspect, a label comprising a wet adhesive or pressure sensitive adhesive is applied to each of the molded structure and/or the interconnected single dose vials using a wet glue labeler or a pressure sensitive label applicator. In one aspect, the wet glue labeling machine includes a hot melt label applicator. For example, a hot melt label applicator can be used to apply a label with a solid glue at room temperature, the solid glue becoming a liquid upon application of heat. In one aspect, the wet glue labeling machine includes a pre-label applicator. For example, a pre-applied label applicator can be used to apply a wet label that is pre-coated with an adhesive.

In one aspect, the label includes an in-mold labeling technique that applies the label to the molded structure as the molded structure is formed. For example, at least one label can be applied during blow molding of the molded structure. For example, at least one label can be applied during injection molding of the molded structure. In one aspect, the label is embossed onto the surface of the molded structure. In one aspect, the label is embossed on the surface of the molded structure. In one aspect, at least one of the labels is etched into the surface of the molded structure.

In one aspect, the multiple single dose container includes at least one label having at least one sensor. For example, a multiple single dose container can include a label with a sensor configured to detect or monitor environmental exposure of multiple single dose containers. For example, a multi-single dose container can include a label with a sensor configured to detect or monitor environmental exposure to multiple single dose containers due to rupture in the secondary package. In one aspect, the molded structure includes at least one tag that includes at least one sensor. In one aspect, the first portion of the molded structure includes at least one tag that includes at least one sensor. In one aspect, each of the interconnected single dose vials includes a label comprising at least one of a temperature sensor, a humidity sensor, a light sensor, or an oxygen sensor. For example, each of the interconnected single-dose vials comprising multiple single-dose containers can include a tag with a sensor configured to detect or monitor each bottle for environmental conditions (eg, temperature, humidity, Exposure to light or oxygen). For example, the tag can include at least one sensor configured to detect or monitor environmental exposure due to rupture in a secondary package (eg, a vacuum seal cover).

In one aspect, the tag includes at least one temperature sensor. In one aspect, the temperature sensor is configured to monitor a temperature offset, such as a transport or storage temperature for a given medicament outside of the recommended range. For example, the temperature sensor can be configured to monitor whether multiple single dose containers and/or individual single dose vials and potential heat sensitive agents stored therein are exposed to excessive heat during shipping and/or storage. For example, the temperature sensor can include a chemical composition that gradually and/or irreversibly changes color in response to changes in temperature exposure. In one aspect, the temperature sensor includes a substrate, such as a paper laminate, having an indicator dye configured to change color in response to a change in temperature. On the one hand, the change in color is irreversible. See, for example, U.S. Patent No. 5,085,802 to the name of "Time Temperature Indicator with Distinct End Point" by Jalinski; U.S. Patent No. 5,254,473 to Patel, entitled "Solid State Device for Monitoring Integral Values of Time and Temperature of Perishables"; and Prusik U.S. Patent No. 6,544,925, the disclosure of which is incorporated herein by reference. In one aspect, the temperature sensor is configured to monitor cumulative thermal exposure. For example, the temperature sensor can include a HEATmarker® indicator (from Temptime Corporation, Morris Plains, NJ) that gradually changes color in response to cumulative thermal exposure. For example, the temperature sensor can include a Timestrip PLUS Duo (Timestrip from the United Kingdom) for cumulative detection of temperature offsets above or below a specified threshold. In one aspect, the temperature sensor is configured to detect a threshold or limit a temperature level. For example, the temperature sensor may comprise an indicator LIMITmarker ^TM (from Temptime Corporation, Morris Plains, NJ), or 3M ^TM MonitorMark ^TM time-temperature indicator (from 3M, St. Paul, Minnesota), and wherein the label if the contents have been exposed At potentially damaging threshold temperatures, the indicator irreversibly changes color. In one aspect, the temperature sensor is configured to monitor whether the multiple single dose container and/or its freeze sensitive content is exposed to an inappropriate freezing temperature during shipping and/or storage. For example, a temperature sensor may include FREEZEmarker® indicator (from Temptime Corporation, Morris Plains, NJ) or 3M ^TM Freeze Watch ^TM indicator (from 3M, St. Paul, Minn.), The indicator in response to the freeze event irreversibly Change the color. See, for example, Kartoglu & Milstien (2014) "Tools and approachached to ensure quality of vaccines throughout the cold chain", Expert Rev Vaccines 13: 843-854, which is incorporated herein by reference. Other time-temperature indicators include VITSAB®, CheckPoint® (from Vitsab International, Sweden), Fresh-Check®.

In one aspect, the label includes a vaccine vial monitor (VVM) to indicate cumulative thermal exposure of the vaccine vial to determine if the cumulative thermal history of the product has exceeded a preset limit. In one aspect, the vaccine vial monitor includes at least one of a VVM 30, VVM 14, VVM 7, or VVM 2 indicator depending on the thermal stability of the product. For example, the VVM30 tag has an end point of 30 days at 37 °C and an endpoint of more than 4 years at 5 °C, while the VVM2 tag has a 2 day end point at 37 °C and a 225 day end point at 5 °C. For more information on international specifications for vaccine bottle monitors, see Vaccine Bottle Monitors published on July 26, 2011, PQS Performance Specifications, World Health Organization, WHO / PQS / E06 / IN05.2, which is incorporated by reference. This article.

In one aspect, the tag includes at least one humidity sensor. For example, the label can include a sensor configured to detect exposure to moisture due to rupture in a secondary package covering/sealing multiple single dose containers. For example, the humidity sensor may include a response to exposure to moisture and water colorimetric detection tag changes color (e.g., 3M ^(TM) thin water contact indicator, St. Paul, Minnesota from 3M Company). See also, for example, U.S. Patent No. 4,098,120, issued to thesssss.

In one aspect, the tag includes at least one photo sensor. For example, the at least one sensor can include a light sensor configured to monitor whether the multiple single dose containers and/or the individual single dose vials that make up the multiple single dose container have been exposed to light. A light sensor can be used to detect potential cracks in the hermetically sealed outer wrap. For example, the light sensor can include a photoresistor, a light dependent resistor, or a photocell associated with a radio frequency identification (RFID) tag. For example, the light sensor can include a light collecting photovoltaic module (from, for example, Electric Film, LLC, Newburyport, MA).

In one aspect, the label includes at least one oxygen sensor. For example, a multi-single dose container can include at least one label having an oxygen sensor configured to detect potential breakage in the hermetically sealed outer wrap prior to use. In one aspect, the oxygen indicator is a light based oxygen indicator. For example, the oxygen sensor can comprise tris(4,7-diphenyl-1,10-phenanthroline) ruthenium (II) packaged in a case-permeable material such as ruthenium rubber. Perchlorate, [Ru(dpp) ₃ ](ClO ₄ ) ₂ . The luminescence associated with [Ru(dpp) ₃ ](ClO ₄ ) ₂ is quenched in the presence of oxygen. For example, the oxygen sensor may include a label attached and / or oxygen sensor O2xyDot ^TM vial (from OxySense® Dallas, TX). In one aspect, the oxygen indicator is a colorimetric indicator configured to change color in response to exposure to oxygen. For example, the oxygen sensor may include redox dye-based indicator than color, such as Ageless Eye ^TM (from Mitsubishi Gas Company, Japan). In one aspect, the oxygen sensor comprises a redox dye-based oxygen indicator that is activated by a colorimetric light. For example, an oxygen sensor can include a light-exciting dye that is "primed" with ultraviolet or visible light and that further changes color in response to oxygen exposure. See, for example, Mills (2005) "Oxygen indicators and intelligent inks for packaging food," Chem. Soc. Rev. 34: 1003-1011, which is incorporated herein by reference. U.S. Patent No. 8,707,766, the disclosure of which is incorporated herein by reference. U.S. Patent No. 8,501,100 to Fukui, entitled "Oxygen detection using metalloporphyrins", which is incorporated herein by reference.

Additional information regarding colorimetric package sensors is described in Kamal el Deen (2013) "The Intelligent Colorimetric Timer Indicator Systems to Develop Label Packaging Industry in Egypt" Int. Design J. 4:295-304.

In one aspect, the tag includes an electronic device. In one aspect, the tag includes an Xpress PDF temperature monitoring tag (from PakSense, Boise, ID) that includes a built-in USB connection point and generates a PDF file containing a complete time and temperature history. In one aspect, the label includes printed electronics. For example, the label includes a printed RFID tag. For example, the label may include a print temperature sensor using ThinFilm technology (from, for example, Thin Film Electronics ASA, Oslo, Norway).

In one aspect, the tag includes a smart radio frequency identification (RFID) tag. For example, RFID tags can be integrated with sensors (eg, temperature and/or light sensors) for wirelessly monitoring environmental conditions. See, for example, Cho et al. (2005) "A 5.1-W UHF RFID Tag Chip integrated with Sensors for Wireless Environmental Monitoring", Proceedings of ESSCIRC, Grenoble, France, 2005, pp. 279-282, which is incorporated by reference. Into this article.

Figure 8 shows a further step diagram of the method of packaging multiple single dose containers as shown in Figure 1. FIG. 8 is a step diagram showing aspects of a method 100 of packaging multiple single dose containers. The method 100 of packaging a plurality of single dose containers includes, in step 120, extracting at least a portion of air from a periphery of a molded structure covered by a hermetically sealable overwrap, at least a portion of which is at least partially flow molded. The textured surface pattern of the second part of the structure. For example, the method includes reducing the total volume of the packaged multi-dose containers by removing at least a portion of the air from the hermetically sealable overwrap prior to closure. In some embodiments, the method includes using a vacuum source to evacuate at least a portion of the air surrounding the multiple single dose container. In one aspect, a method 100 of packaging a multiple single dose container includes inserting, in step 800, a flow conduit connected to a vacuum source at a location near a textured surface pattern on a second portion of the molded structure to a hermetically sealed a portion of the outer wrap defined by the outer wrap; sealing a portion of the hermetically sealable outer wrap around the inserted flow conduit to form a pocket around the molded structure; and extracting from the bag around the molded structure At least a portion of the air causes at least a portion of the extracted air to at least partially flow through the textured surface pattern of the second portion of the molded structure.

In one aspect, a method of packaging a multi-single dose container in a hermetically sealable outer wrap includes using an inert gas. For example, the method can include injecting an inert gas around the hermetically sealable overwrap and the multiple single dose container prior to sealing the multiple single dose container in the hermetically sealable outer wrap. In some embodiments, the method 100 includes injecting an inert gas around a molded structure covered by a hermetically sealable overwrap; and discharging the inertness of the injection from around the molded structure covered by the hermetically sealable overwrap. At least a portion of the discharged inert gas at least partially flows at least partially through the textured surface pattern of the second portion of the molded structure, as described in step 810. For example, the method can include creating an oxygen-free and/or inert atmosphere surrounding the molded structure and the rows of interconnected single-dose vials by injecting an inert gas into the hermetically sealable overwrap of the overmolded structure. . In one aspect, method 100 includes injecting nitrogen around a molded structure covered by a hermetically sealable overwrap, as shown in step 820. In one aspect, the method 100 includes injecting a rare gas around a molded structure covered by a hermetically sealable overwrap, as shown in step 830. For example, the method can include injecting at least one of argon, helium, neon or xenon into the hermetically sealable outer wrap.

In one embodiment, the method 100 of packaging a plurality of single dose containers includes discharging at least a portion of the air from a molded structure covered by a hermetically sealable overwrap prior to injecting the inert gas, as shown in step 840. For example, the method can include drawing at least a portion of the air from around the molded structure covered by the hermetically sealable overwrap prior to injecting the inert gas. For example, the method can include exchanging air from the surrounding of the molded structure covered by the hermetically sealable overwrap with an inert gas. For example, the method can include purging or flushing air surrounding the molded structure covered by the hermetically sealable overwrap with an inert gas.

In some embodiments, the method comprises vacuum sealing a plurality of single dose containers using a vacuum source in the presence of an inert gas. For example, a method of packaging a multi-dose container can include inserting a flow conduit connected to a vacuum source adjacent to a textured surface pattern on a second portion of the molded structure by a hermetically sealable overwrap. a portion of the outer envelope of the hermetically sealable seal is sealed around the inserted flow conduit to form a pocket around the molded structure; and at least a portion of the injected inert gas is withdrawn from the pocket surrounding the molded structure At least a portion of the extracted injected inert gas flows at least partially through the textured surface pattern on the second portion of the molded structure. In one embodiment, the flow conduit is for venting at least a portion of the air, injecting an inert gas, and covering from the hermetically sealed overwrap prior to forming a hermetic seal around the rows of interconnected single dose vials. At least a portion of the injected inert gas is exhausted around the molded structure. In one embodiment, the first flow conduit is for discharging at least a portion of the air and/or the injected inert gas, and the second flow conduit is for injecting an inert gas.

9A-9F illustrate additional aspects of a method of packaging multiple single dose containers including flow conduits. 9A is a schematic illustration of a horizontal side view of a molded structure 410 of a multiple single dose container. The molded structure 410 includes a first portion 420 that includes a row of interconnected single dose vials and a second portion 430 that includes a textured surface pattern 450. In this non-limiting example, the textured surface pattern 450 is shown on one surface of the second portion 430, but it is also contemplated that the textured surface pattern may be present on more than one surface of the second portion. Figures 9B-9F illustrate non-limiting steps in a molded structure 410 for packaging multiple single dose containers. 9B is a schematic illustration of a horizontal side view of a molded structure 410 that includes a first portion 420, a second portion 430, and a textured surface pattern 450 that are covered by a hermetically sealable overwrap 900. In this non-limiting example, the hermetically sealable overwrap 900 is shown as covering the pocket of the molded structure 410, but it is also contemplated to cover the molded structure of the hermetically sealable sleeve or the hermetically sealable top layer. / bottom layer. FIG. 9C is a schematic illustration of a horizontal side view of a molded structure 410 including a first portion 420 and a second portion 430 covered by a hermetically sealable overwrap 900. Also shown is a flow conduit connected to the vacuum source 920 and inserted into an opening defined by the hermetically sealable overwrap 900 at a location adjacent the textured surface pattern 450 of the second portion 430 of the molded structure 410. 910. A sealer 940 (eg, a pressure seal) is used to form a pressure seal 930 that forms a hermetic seal around the molded structure 410 with a portion of the hermetically sealable overwrap 900 and the inserted flow conduit 910 Bag 950. 9D is a horizontal side view of a molded structure 410 including a first portion 420 and a second portion 430 that are covered by a hermetically sealable overwrap 900 and within the hermetic sealed bag 950. It is also shown that air (air) 960 is exhausted (arrow) from the hermetically sealable bag 950 by a flow conduit 910 that is connected to a vacuum source 920. The exhausted air 960 is shown as at least partially flowing through the textured surface pattern 450 of the second portion 430 of the molded structure 410. FIG. 9E is a schematic illustration of a horizontal side view of a molded structure 410 covered by a hermetically sealable overwrap 900. Also shown is a hermetically sealable seal 970 formed around a row of interconnected single dose vials associated with the first portion 420 of the molded structure 410. In this non-limiting example, a portion of the hermetically sealable overwrap 900 has been sealed/bonded to the surface of the second portion 430 of the molded structure while still being connected to the flow conduit 910 and the vacuum source 920. Figure 9F is a schematic illustration of a horizontal side view showing the second portion 430 of the molded structure separated from the first portion 420 of the molded structure. The first portion 420 comprising a row of interconnected single dose vials is shown sealed within the hermetically sealable overwrap 900.

10A-10G illustrate additional aspects of a method of packaging multiple single dose containers including flow conduits. FIG. 10A is a schematic illustration of a horizontal side view of a molded structure 410 of a multiple single dose container. The molded structure 410 includes a first portion 420 that includes a row of interconnected single dose vials and a second portion 430 that includes a textured surface pattern 450. In this non-limiting example, the textured surface pattern 450 is shown on one surface of the second portion 430, but it is contemplated that the textured surface pattern may be present on more than one surface of the second portion. Figures 10B-10G illustrate non-limiting steps in a molded structure 410 for packaging multiple single dose containers. FIG. 10B is a schematic illustration of a horizontal side view of a molded structure 410 covered by a hermetically sealable overwrap 900. In this non-limiting example, the hermetically sealable overwrap 900 is shown as covering the pocket of the molded structure 410, but it is also contemplated to cover the molded structure of the hermetically sealable sleeve or the hermetically sealable top layer. / bottom layer. FIG. 9C is a schematic illustration of a horizontal side view of a molded structure 410 covered by a hermetically sealable overwrap 900 that is injected with an inert gas 1000. In one aspect, the inert gas 1000 is nitrogen. In one aspect, the inert gas 1000 is a noble gas such as argon, helium, neon or xenon. In some embodiments, the air surrounding the molded structure 410 has been exhausted from the hermetically sealable overwrap 900 prior to injecting the inert gas 1000. In some embodiments, air surrounding the molded structure 410 is purged or flushed from the hermetically sealable overwrap 900 during the injection of the inert gas 1000. FIG. 10D is a schematic illustration of a horizontal side view of a molded structure 410 that includes a first portion 420 and a second portion 430 that are covered by a hermetically sealable overwrap 900. Also shown is a flow connected to the vacuum source 920 and inserted into the opening defined by the hermetically sealable overwrap 900 at a location adjacent the textured surface pattern 450 of the second portion 430 of the molded structure 410. Pipe 910. A sealer 940 (eg, a pressure seal) is used to form a pressure seal 930 that forms a hermetic seal around the molded structure 410 with a portion of the hermetically sealable overwrap 900 and the inserted flow conduit 910 Bag 950. FIG. 10E is a schematic illustration of a horizontal side view of a molded structure 410 that includes a first portion 420 and a second portion 430 that are covered by a hermetically sealable overwrap 900 and within the hermetic sealed bag 950. Also shown is an inert gas 1000 that is discharged from the hermetic sealed bag 950 (arrow) by a flow conduit 910 that is connected to a vacuum source 920. The exhausted inert gas 1000 is shown to at least partially flow through the textured surface pattern 450 of the second portion 430 of the molding structure 410. FIG. 10F is a schematic illustration of a horizontal side view of a molded structure 410 covered by a hermetically sealable overwrap 900. Also shown is a hermetically sealable seal 970 formed around a row of interconnected single dose vials associated with the first portion 420 of the molded structure 410. In this non-limiting example, a portion of the hermetically sealable overwrap 900 has been sealed/bonded to the surface of the second portion 430 of the molded structure while still being connected to the flow conduit 910 and the vacuum source 920. Figure 10G is a schematic illustration of a horizontal side view showing the second portion 430 of the molded structure separated from the first portion 420 of the molded structure. The first portion 420 comprising a row of interconnected single dose vials is shown sealed within the hermetically sealable overwrap 900.

Figure 11 shows a further step diagram of the method of packaging multiple single dose containers as shown in Figure 1. The method 100 includes forming a hermetic seal around a row of interconnected single dose vials by bonding a hermetically sealable overwrap to at least a portion of the surface of the molded structure, as shown in step 130. In one aspect, the formation of a hermetic seal comprises a heat seal, a pressure seal or a chemical seal that can be hermetically sealed. In one aspect, forming the hermetic seal includes at least one of folding, rolling up, crimping, welding, fusing, welding, heat sealing, blister sealing, or induction sealing.

In one aspect, forming a hermetic seal around a row of interconnected single dose vials includes the use of a closure or sealer. In one aspect, the closure or sealing machine comprises a heat sealer, a blister sealer or an induction sealer. In one aspect, the closure or sealing machine comprises a belt sealer, a heat sealer, a clamp-type sealer, a glue sealer or a rotary sealer. For example, the closure or sealer can include a heat seal that uses heat to seal the overwrap (eg, a plastic overwrap). For example, the closure or sealer can include a blister sealer that seals the filled plastic blister onto the coated paperboard sheet by applying heat. For example, the closure or sealer can include an induction sealer that seals the foil laminate to the container using an electromagnetic field. Other non-limiting examples of closures or sealing machines include folding machines, tuck closures, crimp closures, fusion sealers, melt sealers, weld sealers, rigid container sealers, or bag or bag sealers. For example, the closure or sealer can include a pack sealer that uses the application of heat to seal the open edge of the bag that can be hermetically sealed.

In one aspect, forming a hermetic seal around a row of interconnected single dose vials includes using a closure or sealer in the presence of a closure material. In one aspect, the closure material can include at least one of an adhesive, a pressure sensitive tape, or an adhesive tape. In one aspect, the closure or sealing machine comprises a glue sealer, a tape sealer or a belt sealer.

In one aspect, forming a hermetic seal around the rows of interconnected single dose vials includes a gas impermeable seal formed around the rows of interconnected single dose vials, as shown in step 1100. For example, the method can include heat sealing the gas-impermeable outer wrap to at least a portion of the surface of the molded structure to form a gas impermeable seal around the rows of interconnected single dose vials. In one aspect, forming a hermetic seal around the rows of interconnected single dose vials includes forming a vapor impermeable seal around the rows of interconnected single dose vials, as shown in step 1110. For example, the method can include heat sealing the vapor-impermeable outer wrap to at least a portion of the surface of the molded structure to form a vapor barrier around the rows of interconnected single dose vials. In one aspect, forming a hermetic seal around the rows of interconnected single dose vials includes forming a light impermeable seal around the rows of interconnected single dose vials, as shown in step 1120. For example, the method can include heat sealing the light impermeable overwrap to at least a portion of the surface of the molded structure to form a light impermeable seal around the rows of interconnected single dose vials. In one aspect, forming a hermetic seal around the rows of interconnected single dose vials includes forming an electrostatic discharge protective seal around the rows of interconnected single dose vials, as shown in step 1130. For example, the method can include thermally sealing the electrostatic discharge protective overwrap to at least a portion of the surface of the molded structure to form an electrostatic discharge protective barrier around the rows of interconnected single dose vials.

In one aspect, forming a hermetic seal around the rows of interconnected single dose vials includes forming a hermetic seal around the rows of interconnected single dose vials at a balanced or near equilibrium pressure, as in step 1140. Show. In one aspect, the method includes forming a hermetic seal around the rows of interconnected single dose vials at or near the pressure within the sealed single dose vial. In one aspect, forming a hermetic seal around the rows of interconnected single dose vials includes forming a hermetic seal around the rows of interconnected single dose vials under positive pressure, as shown in step 1150. For example, the method can include forming a hermetic seal around the rows of interconnected single dose vials at a pressure above the pressure in the sealed single dose vial.

Figure 12 shows a further step diagram of the method of packaging multiple single dose containers as shown in Figure 1. The method 100 includes bonding a hermetically sealable overwrap to at least a portion of a surface of the molded structure, as shown in step 130. For example, the method includes physically bonding/sealing a hermetically sealable overwrap (eg, foil/laminate) to the surface of a molded structure (eg, a thermoplastic molded structure). In one aspect, bonding the hermetically sealable overwrap to at least a portion of the surface of the molded structure includes bonding the hermetically sealable overwrap to the molded structure adjacent the second portion of the molded structure The surface of the first portion is as shown in step 1200. For example, the method can include bonding a hermetically sealable laminate overwrap to a portion of the molded structure adjacent the base of the rows of interconnected single dose vials. For example, the method can include bonding a hermetically sealable overwrap to a location on the molded structure that will be associated with the first portion and the rows of interconnected single dose vials when the second portion is removed. In one aspect, bonding the hermetically sealable overwrap to at least a portion of the surface of the molded structure includes bonding the hermetically sealable overwrap between each of the interconnected single dose vials The surface of the first portion of the molded structure is as shown in step 1210. For example, the method can include incorporating a hermetically sealable overwrap along the surface of the molded structure between and around each of the single dose vials to produce a separately packaged/sealed single dose vial.

In one aspect, bonding the hermetically sealable overwrap to at least a portion of the surface of the molded structure includes applying heat to bond the hermetically sealable overwrap to at least a portion of the surface of the molded structure, as in the step 1220 is shown. For example, bonding at least a portion of the hermetically sealable overwrap to the surface of the molded structure can include applying heat to cause the hermetically sealed overwrap to melt onto the molded structure, or vice versa. In one aspect, bonding the hermetically sealable overwrap to at least a portion of the surface of the molded structure includes applying pressure to bond the hermetically sealable overwrap to at least a portion of the surface of the molded structure, as in the step Shown at 1230. In one aspect, bonding the hermetically sealable overwrap to at least a portion of the surface of the molded structure includes chemically bonding the hermetically sealable overwrap to at least a portion of the surface of the molded structure, as in step 1240. Show. For example, bonding at least a portion of the hermetically sealable overwrap to the surface of the molded structure can include the use of an adhesive or glue. For example, bonding at least a portion of the hermetically sealable overwrap to the surface of the molded structure can include "melting" the hermetically sealable overwrap to the molded structure using a chemical (eg, a solvent), or vice versa Of course.

In one embodiment, a method 100 of packaging a multi-dose drug container includes at least partially penetrating a hermetically sealable overwrap to add a frangible portion between each of the interconnected single dose vials The hermetically sealed outer wrap is as shown in step 1250. For example, the method can include adding a frangible portion between each of the single-dose vials to allow for separate single-dose vials without damaging the hermetic seal of other single-dose vials in the row. The interconnected single dose vials of the row are separated and opened. In one aspect, the perforations of the hermetically sealable overwrap can overlap or align with the frangible perforation pattern associated with the molded structure, such as between each of the single dose vials.

In one embodiment, a method 100 of packaging a multiple single dose container includes applying at least one label having at least one sensor to an outer surface of a hermetically sealable outer wrap, as shown in step 1260. For example, the method can include applying a label having information about the encapsulated at least one medicament and at least one sensor to monitor an environment encountered by the packaged multiple single dose container during shipping and storage. In one aspect, the method includes applying at least one label having a temperature sensor to an outer surface of the hermetically sealable overwrap. Non-limiting aspects of the tag and environmental sensor have been described above.

The method 100 of packaging a multiple single dose container includes separating a second portion of the molded structure from the first portion of the molded structure, as shown in step 140. For example, the method can include removing a tab comprising a textured surface pattern that forms a second portion of the molded structure. For example, the method can include removing a tab comprising a textured surface pattern from a region above or below a row of interconnected single dose vials. See, for example, Figures 6 and 7. In one aspect, separating the second portion from the first portion includes cutting the second portion from the first portion using a knife, saw, or other sharp blade. In one aspect, separating the second portion from the first portion includes cutting the second portion from the first portion using a hot wire or a blade. For example, the second portion can be separated from the first portion by passing a hot wire or blade into the biocompatible thermoplastic material comprising the molded structure between the first portion and the second portion. In one aspect, separating the second portion from the first portion includes using a water jet. In one aspect, separating the second portion from the first portion includes using a laser. In one aspect, the molded structure is formed with a frangible portion between the first portion and the second portion of the molded structure to facilitate separation.

Figure 13 shows a step diagram of a method 1300 of packaging multiple single dose containers. The method 1300 includes covering the molded structure with a hermetically sealable overwrap in step 1310, the molded structure comprising a row of interconnected single dose vials and a textured surface pattern, interconnected single doses of drug Each of the bottles encloses a dose of at least one medicament positioned to direct airflow between the first portion of the molded structure and the region adjacent the second portion of the molded structure. The method 1300 includes discharging at least a portion of the air around the molding structure covered by the hermetically sealable overwrap in step 1320, at least a portion of the exhausted air flowing at least partially through the textured surface pattern on the molded structure . The method 1300 includes forming a hermetic seal around the rows of interconnected single dose vials in step 1330.

The method 1300 includes covering the molded structure with an outer wrap that is hermetically sealed. In some embodiments, the method includes covering the entirety of the molded structure. For example, the method can include covering the molded structure with a hermetically sealable pouch that is sized to receive the entirety of the molded structure. In some embodiments, the method includes covering at least a portion of the molded structure. For example, at least a portion of the molded structure can extend beyond the opening or edge of the hermetically sealable overwrap.

Figure 14 shows a further step diagram illustrating a method 1300 of packaging multiple single dose containers. In some embodiments, the method 1300 includes inserting the molded structure into the opening defined by the hermetically sealable overwrap in step 1400. For example, a method of packaging multiple single dose containers can include inserting a molded structure that forms a multiple single dose container through an opening of a hermetically sealed bag or bag. For example, a method of packaging multiple single dose containers can include inserting a molded structure that forms a multiple single dose container through an opening at either end of a hermetically sealable sleeve. In one embodiment, the method 1300 includes positioning the molding structure between the first layer of the hermetically sealable overwrap and the second layer of the hermetically sealable overwrap in step 1410; The first layer of the hermetically sealable overwrap and one or more edges of the second layer are sealed together. For example, the method can include transferring a plurality of single dose containers between two layers of a hermetically sealable overwrap. In one aspect, method 1300 includes covering the molded structure with a hermetically sealed bag in step 1420. In one aspect, method 1300 includes covering the molded structure with a hermetically sealable sleeve in step 1430. Non-limiting aspects of overmolding a molded structure with a hermetically sealable overwrap have been described herein above.

In one aspect, a method 1300 of packaging a multi-dose container includes covering the molded structure with a hermetically sealed foil laminate in step 1440. For example, the method can include covering the molded structure in a polyester/foil/polyethylene laminate. Other non-limiting aspects of foil laminates have been described above. In one aspect, the method includes forming with at least one of polyester, foil, polypropylene, cast polypropylene, polyethylene, high density polyethylene, metallocene polyethylene, linear low density polyethylene, or a metallized film. A hermetically sealed outer wrap covers the molded structure. In one aspect, method 1300 includes covering the molded structure with a gas impermeable overwrap in step 1450. In one aspect, method 1300 includes covering the molded structure with a vapor impermeable overwrap in step 1460. In one aspect, method 1300 includes covering the molded structure with a light-impermeable overwrap in step 1470. In one aspect, method 1300 includes covering the molded structure with an electrostatic discharge protective overwrap in step 1480. Non-limiting aspects of gas-impermeable, vapor-impermeable, light-impermeable, and/or ESD-protective hermetic seal wraps have been described herein above.

The method 1300 of packaging a multi-dose container includes covering the molded structure with a hermetically sealed overwrap. The molded structure of the multiple single dose container comprises a row of interconnected single dose vials enclosing a dose of at least one medicament; and a textured surface pattern positioned to guide the first portion of the molded structure and Airflow between regions adjacent to the second portion of the molded structure. Figure 15 shows aspects of the molded structure. 15 is a schematic illustration of a multiple single dose container 1500 including a molded structure 1510 that includes a row of interconnected single dose vials 1520 and a textured surface pattern 1530 in an interconnected single dose vial 1520. Each of the packages is dosed with at least one medicament, and the textured surface pattern 1530 is positioned to direct airflow between the first portion of the molded structure 1510 and the region adjacent the second portion of the molded structure 1510.

In one aspect, a molded structure 1510 comprising a row of interconnected single dose vials 1520 and a textured surface pattern 1530 is formed by a blow-fill-seal manufacturing process. In one aspect, a molded structure 1510 comprising a row of interconnected single dose vials 1520 and a textured surface pattern 1530 is formed by a blow molding process. In one aspect, a molded structure 1510 comprising a row of interconnected single dose vials 1520 and a textured surface pattern 1530 is formed by an injection molding manufacturing process. In one aspect, the molded structure 1510 comprising rows of interconnected single dose vials 1520 and textured surface pattern 1530 is formed from at least one biocompatible material. In one aspect, the molded structure 1510 comprising a row of interconnected single dose vials 1520 and a textured surface pattern 1530 is formed from at least one thermoplastic material. In one aspect, the molded structure 1510 comprising rows of interconnected single dose vials 1520 and textured surface pattern 1530 is formed from at least one biocompatible thermoplastic material. Non-limiting aspects of forming a molded structure from a biocompatible, thermoplastic, and biocompatible thermoplastic material have been described herein above.

In one aspect, the rows of interconnected single dose vials 1520 include two or more interconnected single dose vials. In one aspect, the rows of interconnected single dose vials 1520 include from 2 to 30 interconnected single dose vials. For example, rows of interconnected single-dose vials may include 2, 3, 4, 5, 6, 7, 7, 8, 9, and 10 bottles. 11 bottles, 12 bottles, 13 bottles, 14 bottles, 15 bottles, 16 bottles, 17 bottles, 18 bottles, 19 bottles, 20 bottles, 21 bottles, 22 bottles, 23 Bottle, 24 bottles, 25 bottles, 26 bottles, 27 bottles, 28 bottles, 29 bottles or 30 bottles. In one aspect, each of the interconnected single dose vials 1520 is square, triangular, hexagonal, or polygonal in horizontal cross-section, non-limiting examples of which are illustrated in Figures 5A-5C.

In one aspect, each of the interconnected single dose vials 1520 packages a dose of at least one medicament. In one aspect, the dose of at least one agent is formulated for at least one of oral or parenteral administration. In one aspect, the dose of at least one agent comprises a dose of at least one vaccine. In one aspect, the dose of at least one agent comprises a dose of at least one therapeutic agent. In one aspect, the dose of at least one agent is in liquid form. In one aspect, the dose of at least one agent is in lyophilized form. Non-limiting examples of vaccines and therapeutics have been described herein above.

In one aspect, each of the interconnected single dose vials 1520 includes an internal volume that holds the dose of at least one medicament. In one aspect, each of the single dose vials 1520 has an internal volume of from about 0.2 milliliters to about 6.0 milliliters. For example, the internal volume of each of the single-dose vials is 0.2 mL, 0.3 mL, 0.4 mL, 0.5 mL, 0.6 mL, 0.7 mL, 0.8 mL, 0.9 mL, 1.0 mL, 1.1 mL, 1.2 mL, 1.4 mL, 1.5 mL, 1.6 mL, 1.7 mL, 1.8 mL, 1.9 mL, 2.0 mL, 2.1 mL, 2.2 mL, 2.3 mL, 2.4 mL, 2.5 mL, 2.6 mL, 2.7 mL, 2.8 mL, 2.9 mL, 3.0 mL, 3.1 mL 3.2 mL, 3.3 mL, 3.4 mL, 3.5 mL, 3.6 mL, 3.7 mL, 3.8 mL, 3.9 mL, 4.0 mL, 4.1 mL, 4.2 mL, 4.3 mL, 4.4 mL, 4.5 mL, mL, 4.8 mL, 4.9 mL 5.0 mL, 5.1 mL, 5.2 mL, 5.3 mL, 5.4 mL, 5.5 mL, 5.6 mL, 5.7 mL, 5.8 mL, 5.9 mL, or 6.0 mL.

In one aspect, maintaining the internal volume of the dose of at least one agent comprises an inert gas filled headspace. For example, the headspace above a dose or amount of at least one agent in liquid or lyophilized form may include an inert gas such as nitrogen or a noble gas.

In one aspect, each of the interconnected single dose vials 1520 includes a closure 1540 that covers the access portion. In one aspect, the access portion is an opening or aperture defined by the wall of a single dose vial. In some embodiments, the closure includes a removable cover. In some embodiments, the removable cover is broken or twisted to expose the entry portion of the single dose vial. For example, the removable cover can be broken or twisted to expose an opening or aperture through which the closed at least one medicament can be accessed. In one aspect, the closure includes a closure that the needle can pierce. For example, the closure can include a material that the needle can pierce, and a needle attached to the syringe can pass through the material to enter the internal volume of the single dose vial. For example, the closure can include a removable cover that is broken or twisted to reveal material that the needle can pierce, through which the needle attached to the syringe can enter the internal volume of the single dose vial.

In one aspect, each of the interconnected single dose vials 1520 includes an access portion that the needle can pierce. In one aspect, the needle-piercable access portion is configured to allow the needle to enter the interior volume of the single-dose vial through a material that can be pierced by a needle forming at least a portion of the multi-single dose container. For example, the entry portion into which the needle can be pierced can include a needle pierceable access portion of the thermoplastic material used to form the multiple single dose container. For example, the top of the blow-fill-seal bottle can include an entry portion that the needle can pierce. For example, the entry portion into which the needle can be pierced may include a sealing portion formed by welding or heat sealing the wall at the open end of each of the single dose vials to cover the entry portion. For example, the sealing portion formed by welding or heat sealing the wall at the open end of each of the single dose vials may also be pierceable by the needle to allow the needle to pass through the sealing portion to enter the internal volume of the bottle. In some embodiments, each of the interconnected single dose vials forming the multiple single dose container can include a removable cover that, once removed, exposes the entry portion that the needle can pierce. In one aspect, the entry portion that the needle can pierce includes an insert. For example, the entry portion into which the needle can be pierced may include an insert that is added to the row of interconnected single dose vials that are blow molded or injection molded. In one aspect, the entry portion that the needle can pierce includes a rubber entry portion that the needle can pierce. For example, the entry portion into which the needle can be pierced may include a rubber septum that is inserted into the access portion and held in place by an aluminum seal that is crimped around the tapered neck region of the bottle. In one aspect, the rubber entry portion that the needle can pierce is further protected by a plastic flip cover.

In one aspect, at least one of the single dose vials 1520 is attached to at least one adjacent single dose vial 1520 by an articulating joint 1525 that is sufficiently flexible to reversibly fit at least one of the single dose vials 1520 A flat outer surface is associated with a flat outer surface of at least one adjacent single dose vial 1520. For non-limiting examples, see, for example, Figures 22A-22E.

The molded structure 1510 of the multiple single dose container 1500 includes a textured surface pattern 1530. In one aspect, at least a portion of the textured surface pattern 1530 includes channels that are aligned in parallel with the directed airflow between the regions of the first portion of the molded structure and the second portion of the molded structure. In one aspect, the textured surface pattern 1530 is on the outer surface of at least one of the interconnected single dose vials 1520 as shown in FIG. In one aspect, the textured surface pattern is on a surface of the molded structure adjacent to the rows of interconnected single dose vials. In one aspect, the textured surface pattern is on a tab portion adjacent the top of the rows of interconnected single dose vials, as shown in FIG. In one aspect, the textured surface pattern is on a tab portion adjacent the bottom of the rows of interconnected single dose vials, as exemplified in FIG. In some embodiments, the tab portion including the textured surface pattern and adjacent the top or bottom of the row of interconnected single dose vials is separated from the remainder of the molded structure during the packaging process.

In one aspect, the textured surface pattern 1530 positioned to direct airflow between the first portion of the molded structure 1510 and the region adjacent the second portion of the molded structure 1510 includes a recessed surface pattern that is Positioned to direct airflow between the first portion of the molded structure and the region adjacent the second portion of the molded structure 1510. In one aspect, the textured surface pattern 1530 positioned to direct airflow between the first portion of the molded structure 1510 and the region adjacent the second portion of the molded structure 1510 includes being positioned to be guided over the molded structure. A convex surface pattern of airflow between the first portion and a region adjacent the second portion of the molded structure 1510. Non-limiting aspects of depressions and protrusions have been described herein above.

In one aspect, the molded structure 1510 includes at least one label 1550, and the at least one label 1550 includes at least one sensor 1560. In one aspect, each of the interconnected single dose vials 1520 includes a label 1550 that includes at least one of a temperature sensor, a humidity sensor, a light sensor, or an oxygen sensor. Non-limiting aspects of the tag and the sensor associated with the tag have been described herein above.

Figure 16 is a step diagram showing a method of packaging a multi-dose container, as shown in Figure 13. The method 1300 of packaging a plurality of single dose containers includes discharging at least a portion of air around a molding structure covered by a hermetically sealable overwrap in step 1320, at least a portion of which is at least partially flow molded Structurally textured surface pattern. For example, the method includes reducing the total volume of the packaged multi-dose containers by removing at least a portion of the air from the hermetically sealable overwrap prior to closure. In some embodiments, the method includes using a vacuum source to expel at least a portion of the air surrounding the multiple single dose container. In one aspect, a method 1300 of packaging a plurality of single-dose containers includes inserting, in step 1600, a flow conduit connected to a vacuum source into an opening defined by a hermetically sealable overwrap; the hermetically sealed outer wrapper a portion of the pressure is sealed around the inserted flow conduit to form a pocket around the molded structure; and at least a portion of the air is exhausted from the pocket around the molded structure, at least a portion of the exhausted air At least partially flowing through the textured surface pattern on the molded structure.

In one aspect, a method of packaging a multi-single dose container in a hermetically sealable outer wrap includes using an inert gas. For example, the method can include injecting an inert gas into the hermetically sealable outer wrap and around the multiple single dose container prior to sealing the multiple single dose container in the hermetically sealable outer wrap. In some embodiments, the method 1300 includes injecting an inert gas around a molded structure covered by a hermetically sealable overwrap; and discharging the inertness of the injection from around the molded structure covered by the hermetically sealable overwrap. At least a portion of the gas causes at least a portion of the discharged injected inert gas to flow at least partially through the textured surface pattern on the molded structure, as shown in step 1610. For example, the method can include producing an inert gas into a hermetically sealable overwrap covering the molded structure, creating a perimeter of the molded structure and the rows of interconnected single dose vials Oxygen-free and / or inert atmosphere. In one aspect, method 1300 includes injecting nitrogen around a molded structure covered by a hermetically sealable overwrap, as shown in step 1620. In one aspect, method 1300 includes injecting a rare gas around a molded structure covered by a hermetically sealable overwrap, as shown in step 1630. For example, the method can include injecting at least one of argon, helium, neon or xenon into the hermetically sealable outer wrap.

In one embodiment, the method 1300 of packaging a multiple single dose container includes discharging at least a portion of the air around a molded structure covered by a hermetically sealable overwrap prior to injecting the inert gas, as shown in step 1640. For example, the method can include drawing at least a portion of the air from around the molded structure covered by the hermetically sealable overwrap prior to injecting the inert gas. For example, the method can include exchanging air surrounding the molded structure covered by the hermetically sealable overwrap with an inert gas. For example, the method can include purging or flushing air surrounding the molded structure covered by the hermetically sealable overwrap with an inert gas.

In some embodiments, the method comprises vacuum sealing a plurality of single dose containers using a vacuum source in the presence of an inert gas. For example, a method of packaging a multi-dose container can include inserting a flow conduit connected to a vacuum source at a location adjacent to the textured surface pattern on the second portion of the molded structure by a hermetically sealable overwrap. a portion of the outer envelope of the hermetically sealable outer seal is sealed around the inserted flow conduit to form a pocket around the molded structure; and from the pocket around the molded structure At least a portion of the injected inert gas is withdrawn such that at least a portion of the injected inert gas flows at least partially through the textured surface pattern on the molded structure. In one embodiment, the flow conduit is for venting at least a portion of the air prior to forming a hermetic seal around the rows of interconnected single dose vials, injecting an inert gas, and covering from the outer wrap that is hermetically sealed At least a portion of the injected inert gas is exhausted around the molded structure. In one embodiment, the first flow conduit is for discharging at least a portion of the air and/or the injected inert gas, and the second flow conduit is for injecting an inert gas.

Figure 17 is a step diagram showing aspects of a method of packaging a multi-dose container as shown in Figure 13. The method 1300 includes forming a hermetic seal around the rows of interconnected single dose vials in step 1330. In one aspect, forming a hermetic seal around the rows of interconnected single dose vials includes forming a gas impermeable seal around the rows of interconnected single dose vials in step 1700. In one aspect, forming a hermetic seal around the rows of interconnected single dose vials includes forming a vapor impermeable seal around the rows of interconnected single dose vials in step 1710. In one aspect, forming a hermetic seal around the rows of interconnected single dose vials includes forming a light impermeable seal around the rows of interconnected single dose vials in step 1720. In one aspect, forming a hermetic seal around the rows of interconnected single dose vials includes forming an electrostatic discharge protective seal around the rows of interconnected single dose vials in step 1730. In one aspect, forming a hermetic seal around the rows of interconnected single dose vials includes forming a gas tight seal around the rows of interconnected single dose vials at a balanced or near equilibrium pressure in step 1740 seal. In one aspect, forming a hermetic seal around the rows of interconnected single dose vials includes forming a hermetic seal around the rows of interconnected single dose vials under positive pressure in step 1750.

Figure 18 is a step diagram showing aspects of a method of packaging a multiple single dose container as shown in Figure 13. The method 1300 also includes forming a hermetic seal around the rows of interconnected single dose vials in step 1330. In one aspect, forming a hermetic seal around the rows of interconnected single dose vials includes forming a hermetic seal around the entirety of the molded structure comprising the rows of interconnected single dose vials in step 1800. In one aspect, forming a hermetic seal around the rows of interconnected single dose vials includes bonding at least a portion of the hermetically sealable overwrap to at least a portion of the surface of the molded structure in step 1810. In one aspect, forming a hermetic seal around the rows of interconnected single dose vials includes incorporating at least a portion of the hermetically sealable overwrap into each of the interconnected single dose vials in step 1820 At least a portion of the surface of the molded structure around and between. In one aspect, forming a hermetic seal around the rows of interconnected single dose vials includes applying heat to the hermetically sealable overwrap in step 1830 to form a single dose of interconnected drug in a row A hermetic seal is formed around the bottle. In one aspect, forming a hermetic seal around the rows of interconnected single dose vials includes applying pressure to the hermetically sealable overwrap in step 1840 to surround the rows of interconnected single dose vials A hermetic seal is formed. In one aspect, forming a hermetic seal around the rows of interconnected single dose vials includes chemically bonding the hermetically sealed outer wrap in step 1850 to form a row of interconnected single dose vials. Hermetic seal.

In one aspect, method 1300 includes separating a first portion of the molded structure from a second portion of the molded structure in step 1860. In one aspect, the method includes separating a hermetically sealed row of interconnected single dose vials from a tab comprising a textured surface pattern. For example, the method can include separating a hermetically sealed row of interconnected single dose vials from tabs located at the top or bottom of the molded structure, the tabs comprising a textured surface pattern.

In one aspect, the method 1300 includes at least partially penetrating the hermetically sealable overwrap in step 1870 to add a frangible portion to a single dose vial in a row of interconnected single dose vials A hermetically sealed overwrap between each.

In one aspect, method 1300 includes applying at least one tag having at least one sensor to an outer surface of the hermetically sealable overwrap in step 1880. For example, the method can include applying at least one label including information regarding the identity and use of the medicament and a temperature sensor to monitor temperature conditions during transport and storage of the packaged multiple single dose container. Non-limiting aspects of labeling with sensors have been described herein above.

Figure 19 illustrates a method of packaging a collapsible container. 19 is a step diagram showing a method 1900 of packaging a collapsible container. The method 1900 includes covering, in step 1910, a multi-single dose container in an expanded configuration with a hermetically sealable overwrap comprising a row of interconnected single dose vials, each of a single dose vial Encapsulating a dose of at least one agent; and one or more articulating joints connecting each of the single dose vials in a row of interconnected single dose vials to at least one adjacent single dose vial The one or more articulating joints are flexible enough to reversibly fit the flat outer surface of each of the single dose vials to the flat outer surface of the at least one adjacent single dose vial to form a multiple single dose container Folding configuration. The method 1900 includes applying a force to at least one of the single dose vials in a row of interconnected single dose vials in step 1920, the applied force being toward at least one adjacent single dose vial. Method 1900 includes bending one or more articulating joints in step 1930 in response to applying a force on at least one of the single dose vials in a row of interconnected single dose vials to form a folded configuration of the multiple single dose containers type. The method 1900 includes sealing the hermetically sealable overwrap in step 1940 to form a hermetic seal around the folded configuration of the multiple single dose container therein.

20 is a step diagram showing another aspect of a method 1900 of packaging a collapsible container. Method 1900 includes covering a plurality of single dose containers with a hermetically sealable overwrap 1910. In one aspect, covering a multi-single dose container in an expanded configuration with a hermetically sealable overwrap includes inserting a multi-single dose container in an expanded configuration through an opening defined by a hermetically sealable overwrap in step 2000. For example, it is possible to move a gas-tight seal on a multi-single-dose container of an expanded configuration by moving a multi-single-dose container of an expanded configuration into a hermetically sealable overwrap (eg, a hermetically sealed bag) At least one of the wrap, or a combination thereof, is inserted into the multi-dose container of the expanded configuration into a hermetically sealable outer wrap. In one aspect, covering a multi-single dose container of the expanded configuration with a hermetically sealable overwrap includes positioning the multi-single dose container of the expanded configuration in a first layer of a hermetically sealable overwrap in step 2010 And between the second layer of the hermetically sealable overwrap; and sealing the first layer and the one or more edges of the hermetically sealable overwrap together. For example, a multi-single dose container of an expanded configuration can be moved between two wound sheets (eg, a foil laminate) of a hermetically sealable overwrap and sealed on at least one edge to at least partially A multi-single dose container is enclosed therein. In one aspect, covering a multi-single dose container in an expanded configuration with a hermetically sealable overwrap comprises covering the multi-dose container in an expanded configuration with a hermetically sealed bag in step 2020. In one aspect, covering a multi-single dose container of the expanded configuration with a hermetically sealable overwrap includes covering the multi-dose container of the expanded configuration with a hermetically sealed sleeve in step 2030.

21 is a step diagram showing a further aspect of a method of packaging a collapsible container 1900. In one aspect, the multiple single dose container covering the expanded configuration includes a multi-single dose container that is covered with an airtight seal foil laminate in an expanded configuration in step 2100. In one aspect, the multiple single dose container covering the expanded configuration includes a multi-single dose container in an expanded configuration covered with a hermetically sealable overwrap in step 2110, the hermetically sealable overwrap from polyester Made of at least one of foil, polypropylene, cast polypropylene, polyethylene, high density polyethylene, metallocene polyethylene, linear low density polyethylene or metallized film. In one aspect, the multiple single dose container that covers the expanded configuration includes a multi-single dose container that is covered with a gas impermeable overwrap in step 2120 to cover the expanded configuration. In one aspect, the multiple single dose container covering the expanded configuration includes a multi-single dose container that covers the expanded configuration with a vapor impermeable overwrap in step 2130. In one aspect, the multiple single dose container that covers the expanded configuration includes a multi-single dose container that covers the expanded configuration with a light-impermeable overwrap in step 2140. In one aspect, the multiple single dose container covering the expanded configuration includes a multiple single dose container that is covered with an electrostatic discharge protective overwrap in an expanded configuration in step 2150. Non-limiting aspects of covering multiple single dose containers with a hermetically sealable overwrap have been described herein above and are applicable to multiple single dose containers of the expanded configuration with a hermetically sealed overwrap.

22A-22E illustrate aspects of a multiple single dose container comprising a row of interconnected single dose vials connected to each other by one or more hinged joints. 22A is a schematic illustration of a multi-single dose container 2200 in an expanded configuration. The multiple single dose container 2200 includes an interconnected single dose vial 2220 in a row 2210. The multiple single dose container 2200 also includes one or more articulating joints 2230 that connect each of the single dose vials 2220 in the interconnected single dose vials 2220 of the rows 2210 to at least one adjacent single dose of the drug. Bottle 2220. Each of the single dose vials 2220 also includes a closure 2240 and a label 2250 that includes a sensor 2260.

22B is a schematic illustration of a top view of a multiple single dose container 2200 in an expanded configuration. In this view, each of the single dose vials 2220 in the interconnected single dose vials 2210 in rows 2210 are joined to adjacent single dose vials 2220 at the edges by hinged joints 2230. The multiple single dose container 2200 in an expanded configuration has a first rectangular package cross section 2270 (dashed line).

In some embodiments, the multiple single dose container includes one or more hinged joints. In one aspect, the one or more articulating joints are splittable. For example, an articulating joint that connects a single dose vial to an adjacent single dose vial is splittable, allowing separation of the two single dose vials. In one aspect, the articulating joint is at least one of tearable, splittable, tearable, breakable, breakable, or separable. For example, an articulating joint that attaches a single dose vial to an adjacent single dose vial can be tearable, splittable, tearable, breakable, breakable, or separable. At least one of them. In one aspect, the subset of articulating joints that connect a single dose vial in a multiple single dose container is splittable. For example, a subset of splittable articulating joints can be used to divide a large multi-dose container (eg, having 25 single-dose vials) into smaller multiple single-dose containers (eg, having five single-dose vials). In one aspect, all of the hinged joints that connect the single dose vials in multiple single dose containers are splittable. For example, a splittable articulating joint can be used to detach or separate each of a single dose vial from other single dose vials in a multiple single dose container.

In one aspect, the multiple single dose container 2200 is formed by a blow molding manufacturing process. In one aspect, the multiple single dose container 2200 is formed by a blow-fill-seal manufacturing process. In one aspect, the multiple single dose container 2200 is formed by an injection molding process. Non-limiting aspects of making multiple single dose containers by a molding process have been described herein above.

In one aspect, the articulating joint 2230 is formed as a single entity with a single dose vial, such as from a single mold. In one aspect, the articulating joint 2230 is formed separately and then attached to a single dose vial. For example, one or more hinged joints for joining rows of glass bottles may be formed from a flexible plastic resin that is subsequently attached to a glass bottle. In one aspect, one or more articulating joints 2230 are formed from a first material and a single dose vial 2220 is formed from a second material. For example, the hinged joint can be formed from a flexible plastic material while the single dose vial is formed from a relatively rigid plastic material. For example, the hinged joint can be formed from a flexible plastic material while the single dose vial is formed from glass.

In one aspect, the multiple single dose container 2200 is formed from at least one biocompatible material. In one aspect, the multiple single dose container 2200 is formed from at least one thermoplastic material. In one aspect, the multiple single dose container 2200 is formed from at least one biocompatible thermoplastic material. Non-limiting examples of biocompatible, thermoplastic, and biocompatible thermoplastic materials used to form multi-single dose containers have been described herein above.

In one aspect, the interconnected single dose vials 2220 of rows 2210 comprise two or more interconnected single dose vials in a row. In the non-limiting example of FIG. 22A, the multiple single dose container 2200 includes five interconnected single dose vials 2220. In one aspect, the rows of interconnected single dose vials comprise three or more interconnected single dose vials. In one aspect, the rows of interconnected single-dose vials comprise two, three, four, five, six, seven, eight, nine or ten interconnected single-dose vials At least one. In one aspect, the rows of interconnected single dose vials comprise from about 2 to about 30 interconnected single dose vials. For example, rows of interconnected single-dose vials may include 2 vials, 3 vials, 4 vials, 5 vials, 6 vials, 7 vials, 8 vials, 9 vials, 10 vials, 11 bottles, 12 bottles, 13 bottles, 14 bottles, 15 bottles, 16 bottles, 17 bottles, 18 bottles, 19 bottles, 20 bottles, 21 bottles, 22 bottles, 23 Bottle, 24 bottles, 25 bottles, 26 bottles, 27 bottles, 28 bottles, 29 bottles or 30 bottles. In some embodiments, the multiple single dose container includes more than 30 single dose vials.

In one aspect, the multiple single dose container comprises a row of 20 to 30 interconnected single dose vials. For example, a multiple single dose container can include a row of 25 interconnected single dose vials. For example, a mold for blow molding or injection molding may include a mold for 25 single single dose vials interconnected by an articulated joint. For example, a multiple single dose container comprising 25 interconnected single dose vials can be manufactured, filled with a suitable medicament, sealed and packaged in a folded configuration for ease of dispensing. In one aspect, the multiple single dose container comprises a row of 20 to 30 interconnected single dose vials configured to be divided into groups of 3 to 10 interconnected single dose vials. For example, a multi-dose container comprises a row of 20 to 30 interconnected single-dose vials configured to have 3, 4, 5, 6, 7, 7 and 8 A group of bottles, 9 bottles or 10 bottles. For example, a multiple single dose container can include a strip of 25 bottles configured to be divided into groups of 5 bottles. In this manner, a large strip of interconnected single dose vials can be manufactured, filled with a drug, sealed, and then separated into smaller units for packaging and dispensing.

In one aspect, each of the interconnected single dose vials is polygonal in a horizontal cross section. In the non-limiting example of Figure 22B, the horizontal cross-section of the interconnected single-dose vials 2220 is rectangular. In one aspect, each of the interconnected single dose vials has a horizontal cross section that is square, triangular, hexagonal, or polygonal. Non-limiting examples of different cross-sectional shapes of single-dose vials in a row of interconnected single-dose vials are shown in Figures 5A-5C.

Each of the single dose vials 2220 encloses a dose of at least one agent. In one aspect, the dose of at least one agent comprises a dose of at least one vaccine. In one aspect, the dose of at least one agent comprises a dose of at least a therapeutic agent. Non-limiting examples of vaccines and therapeutics have been described herein above. In one aspect, the dose of at least one agent is in liquid form. For example, a dose of at least one agent (eg, a vaccine) is dissolved and/or suspended in a liquid medium (eg, water for injection). In one aspect, the dose of at least one agent is in lyophilized form. For example, a dose of at least one agent (eg, a vaccine) is prepared in lyophilized form for reconstitution with a liquid medium (eg, water) for injection prior to administration to a subject.

In one aspect, each of the single dose vials 2220 in the single dose vials 2220 of the rows 2210 includes an internal volume of at least one medicament that maintains a dose. In one aspect, the internal volume is from about 0.2 ml to about 6.0 ml. For example, the internal volume of each of the single-dose vials is approximately 0.2 mL, 0.3 mL, 0.4 mL, 0.5 mL, 0.6 mL, 0.7 mL, 0.8 mL, 0.9 mL, 1.0 mL, 1.1 mL, 1.2 mL, 1.3 mL , 1.4 mL, 1.5 mL, 1.6 mL, 1.7 mL, 1.8 mL, 1.9 mL, 2.0 mL, 2.1 mL, 2.2 mL, 2.3 mL, 2.4 mL, 2.5 mL, 2.6 mL, 2.7 mL, 2.8 mL, 2.9 mL, 3.0 mL, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.7, 4.8 mL, 4.9 mL, 5.0 mL, 5.1 mL, 5.2 mL, 5.3 mL, 5.4 mL, 5.5 mL, 5.6 mL, 5.7 mL, 5.8 mL, 5.9 mL, or 6.0 mL. In some embodiments, the internal volume of each single dose vial is greater than 6.0 ml.

In one aspect, the internal volume of the at least one medicament that maintains a dose includes an inert gas-filled headspace. For example, a headspace above a dose of at least one agent can include nitrogen or a noble gas such as argon, helium, neon or xenon.

In one aspect, each of the single dose vials 2220 in the interconnected single dose vials 2220 of the rows 2210 includes a closure 2240. In one aspect, the closure 2240 includes a twisted or broken closure. In one aspect, each of the single dose vials 2220 in the interconnected single dose vials 2220 of the rows 2210 includes a needle permeable access portion. Non-limiting aspects of the closure and/or the piercing access portion of a single dose vial for multiple single dose containers have been described herein above.

In one aspect, the articulating joint 2230 is frangible. For example, one or more of the articulating joints can be accompanied by frangible portions, such as perforations in the molding material, which allows the single dose vials to be separated from each other.

In one aspect, the multiple single dose container 2200 is configured to form an expanded configuration (as shown in Figures 22A and 22B) and a folded configuration. Figures 22C and 22D show a multiple single dose container 2200 in a collapsed configuration. Figure 22C is a side view showing the multiple single dose container 2200 in a collapsed configuration. In this configuration, the articulating joint 2230 has been bent to flatten the outer outer surface of each of the single dose vials 2220 in the interconnected single dose vials 2220 of the rows 2210 with at least one adjacent single dose. The flat outer surface of the vial 2220 is reversibly matched. Figure 22D is a top plan view of a multiple single dose container 2200 in a collapsed configuration. The interconnected single dose vials 2220 of rows 2210 have been folded along the articulating joint 2230 to form a folded configuration. The multiple single dose container 2200 in a collapsed configuration has a second rectangular package cross-sectional area 2280 (dashed line).

In one aspect, the expanded configuration of the multiple single dose container 2200 has a first rectangular package cross-sectional area 2270, and the folded configuration of the multiple single dose container 2200 has a second rectangular package cross-sectional area 2280. 22E shows the juxtaposition of the first rectangular package cross-sectional area 2270 of the multiple single-dose container 2200 in the expanded configuration and the second rectangular package cross-sectional area 2280 of the multiple single-dose container 2200 in the collapsed configuration. The second rectangular package cross-sectional area 2280 is smaller than the first rectangular package cross-sectional area 2270.

A further non-limiting aspect of a multi-single-dose container having an articulated joint is described in U.S. Patent Application Serial No. 14/736,542, the entire disclosure of which is incorporated herein by reference.

In one aspect, the multiple single dose container includes at least one label, and at least one label includes at least one sensor. Returning to Figure 22A, each of the single dose vials 2220 includes at least one label 2250, and at least one label 2250 includes at least one sensor 2260. In one aspect, each of the single dose vials 2220 includes at least one label 2250, the at least one label 2250 including at least one of a temperature sensor, a humidity sensor, a light sensor, or an oxygen sensor. Non-limiting aspects of the label and the environmental sensor for use with the label have been described herein above.

23 is a step diagram showing aspects of a method 1900 of packaging a collapsible container. The method 1900 includes covering the multiple single dose container in an expanded configuration with a hermetically sealable overwrap, as shown in step 1910. The method 1900 further includes applying a force on at least one of the single dose vials in the rows of interconnected single dose vials, the applied force being directed to at least one adjacent single dose vial, as shown in step 1920. In one aspect, method 1900 includes applying a force on at least one of a single dose vial in a row of interconnected single dose vials with at least one mechanical probe, as shown in step 2300. For example, the method can include applying a force using one or more pistons configured to contact and push at least one end of the rows of interconnected single dose vials. In one aspect, method 1900 includes applying a force on at least one of a single dose vial in a row of interconnected single dose vials using pressurized gas, as shown in step 2310. For example, the method can include applying a force directed to at least one end of the rows of interconnected single dose vials with pressurized gas from one or more nozzles.

In one aspect, method 1900 includes, in step 2320, applying a force toward a first adjacent single dose vial on a first single dose vial at a first end of a row of interconnected single dose vials, and A force is applied to the second adjacent single dose vial on the second single dose vial at the second end of the row of interconnected single dose vials. For example, the method can include applying a force to the ends of the rows of interconnected single dose vials with one or more pistons. For example, the method can include applying a force with a pressurized gas at both ends of a row of interconnected single dose vials. In one aspect, method 1900 includes applying, in step 2330, a force toward a first adjacent single dose vial at a first single dose vial at a first end of a row of interconnected single dose vials, while A force is applied to the second adjacent single dose vial at the second single dose vial at the second end of the row of interconnected single dose vials. For example, the method can include simultaneously applying a force across the rows of interconnected single dose vials. In one aspect, method 1900 includes, in step 2340, sequentially applying a single adjacent dose vial to a first single dose vial at a first end of a row of interconnected single dose vials The force and the force toward the second adjacent single dose vial is applied to the second single dose vial at the second end of the row of interconnected single dose vials. For example, the method can include sequentially applying the force to one end of a row of interconnected single dose vials and then applying to the other end.

24 is a step diagram showing a further aspect of a method 1900 of packaging a collapsible container. In some embodiments, the method 1900 includes discharging at least a portion of the air from a multi-single dose container in a collapsed configuration covered by a hermetically sealable overwrap, as shown in step 2400. For example, the method can include drawing at least a portion of the air from around the multiple single dose container prior to sealing the hermetically sealable outer wrap. In one aspect, the method 1900 includes inserting, in step 2410, a flow conduit connected to a vacuum source into an opening defined by a hermetically sealable overwrap, the pressure seal being hermetically sealed around the inserted flow conduit A portion of the overwrap forms a pocket around the folded configuration of the multiple single dose container and draws at least a portion of the air from the pocket around the folded configuration of the multiple single dose container.

In some embodiments, the method 1900 includes injecting an inert gas around a folded configuration of a multi-single dose container covered by a hermetically sealable overwrap; and from a single dose covered by a hermetically sealable overwrap At least a portion of the injected inert gas is drawn around the folded configuration of the container, as shown in step 2420. For example, the method can include creating an inertness-free gas around the rows of interconnected single-dose vials by injecting an inert gas around the folded configuration of the multiple single-dose container covered by the hermetically sealable overwrap. / or oxygen atmosphere. In one aspect, injecting an inert gas around a folded configuration of a multi-single dose container covered by a hermetically sealable overwrap comprises including a multi-dose container covered by a hermetically sealable overwrap in step 2430 Nitrogen is injected around the folded configuration. In one aspect, injecting an inert gas around a folded configuration of a multi-single dose container covered by a hermetically sealable overwrap includes multiple single dose containers covered by a hermetically sealable overwrap in step 2440 A rare gas is injected around the folded configuration. For example, the method can include injecting at least one of argon, helium, neon or krypton into a hermetically sealable outer wrap around a folded configuration of the multiple single dose container. In one aspect, expelling the injected inert gas from the collapsed configuration of the multiple single dose container covered by the hermetically sealable overwrap includes inserting the flow conduit connected to the vacuum source into a hermetically sealed seal in step 2450 An opening defined by the overwrap; a portion of the outer wrap that is hermetically sealed around the inserted flow conduit to form a pocket around the folded configuration of the multiple single dose container, and from the multiple At least a portion of the injected inert gas is expelled from the bag surrounding the folded configuration of the dose container.

In one embodiment, a method 190 of packaging a collapsible container includes discharging at least a portion of air from a collapsed configuration of a multi-single dose container covered by a hermetically sealable overwrap, followed by folding of the multiple single dose container An inert gas is injected around the mold as shown in step 2460. In one aspect, expelling at least a portion of the air from around the folded configuration of the multiple single dose container includes drawing air around the folded configuration of the multiple single dose container covered by the hermetically sealable overwrap prior to injecting the inert gas At least part. In one aspect, discharging at least a portion of the air surrounding the folded configuration of the multiple single dose container covered by the hermetically sealable overwrap includes exchanging air for inert gas. In one aspect, at least a portion of the venting air surrounding the folded configuration of the multiple single dose container covered by the hermetically sealable overwrap includes purging or sweeping air from around the folded configuration of the multiple single dose container. In one embodiment, the flow conduit is for venting air around a folded configuration of a multi-single dose container covered by a hermetically sealable overwrap, injecting an inert gas around the folded configuration of the multiple single dose container, and At least a portion of the injected inert gas is discharged around the folded configuration of the multi-single dose container covered by the hermetically sealable overwrap, after which a hermetic seal is formed around the folded configuration of the multiple single dose container. In one embodiment, the first flow conduit is for injecting an inert gas and the second flow conduit is for discharging at least a portion of the injected inert gas.

25 is a step diagram showing a further aspect of a method 1900 of packaging a folded container. The method 1900 includes sealing the hermetically sealable overwrap in step 1940 to form a hermetic seal around the folded configuration of the multiple single dose container therein. In one aspect, method 1900 includes thermally sealing a hermetically sealable overwrap in step 2500 to form a hermetic seal around the folded configuration of the multiple single dose container therein. In one aspect, method 1900 includes pressure sealing a hermetically sealable overwrap in step 2510 to form a hermetic seal around the folded configuration of the multiple single dose container therein. In one aspect, the method 1900 includes chemically sealing the hermetically sealable overwrap in step 2520 to form a hermetic seal around the folded configuration of the multiple single dose container therein. In one aspect, the outer seal that seals hermetically sealable comprises an outer wrap that is hermetically sealed by a heat seal, a pressure seal, or a chemical seal. In one aspect, the sealing comprises at least one of folding, rolling up, crimping, welding, fusing, welding, heat sealing, blister sealing, or induction sealing.

In one aspect, method 1900 includes sealing a hermetically sealable overwrap to form a gas impermeable seal around the folded configuration of the multiple single dose container therein. In one aspect, method 1900 includes sealing a hermetically sealable overwrap to form a vapor impermeable seal around the folded configuration of the multiple single dose container therein. In one aspect, method 1900 includes sealing a hermetically sealable overwrap to form a light impermeable seal around the folded configuration of the multiple single dose container therein. In one aspect, method 1900 includes sealing a hermetically sealable overwrap to form an electrostatic discharge protective seal around the folded configuration of the multiple single dose container therein.

In one aspect, the method 1900 includes sealing at least a portion of the hermetically sealable overwrap in step 2530 to form a pocket around the folded configuration of the multiple single dose container; injecting an inert gas into the multiple single dose container Forming a pocket formed around the folded configuration; discharging at least a portion of the injected inert gas from the formed pocket around the folded configuration of the multiple single dose container; and sealing the formed pocket to a plurality of single doses therein A hermetic seal is formed around the folded configuration of the container.

In one aspect, method 1900 includes attaching at least one tag to an outer surface of a hermetically sealable overwrap in step 2540, the at least one tag including at least one sensor. In one aspect, method 1900 includes attaching at least one tag to an outer surface of a hermetically sealable overwrap in step 2550, the at least one tag including at least one temperature sensor. Non-limiting aspects of the tag and associated environmental sensor have been described herein above.

Figures 26A-26E illustrate additional aspects of the method of packaging a folded container as shown in Figure 19. Figure 26A is a top plan view of a multi-single dose container 2600 in an extended configuration covered by a hermetically sealable overwrap 2605. The multiple single dose container 2600 includes a row of interconnected single dose vials 2610. Each of the single dose vials 2610 is coupled to at least one adjacent single dose vial 2610 by an articulating joint 2615. The articulating joint 2615 is flexible enough to reversibly match the flat outer surface of each of the single dose vials 2610 with the flat outer surface of at least one adjacent single dose vial 2610 to form a folded configuration of the multiple single dose container 2600 type. Figure 26B shows a top view of a multi-single dose container 2600 in an extended configuration covered by a hermetically sealable overwrap 2605. The illustrated force 2625 is applied to the first single dose vial 2610 of the rows of interconnected single dose vials 2610 of the multiple single dose container 2600. In this non-limiting example, force 2625 is applied by mechanical probe 2620. In one aspect, the mechanical probe 2620 is a piston-like device that pushes the first single-dose vial to an adjacent single-dose vial to initiate a folding chain reaction. Figure 26C shows a top view of a multi-single dose container 2600 in an extended configuration covered by a hermetically sealable overwrap 2605. The articulating joint 2615 is shown to be curved corresponding to the force 2625 applied by the mechanical probe 2620 (arrow 2630). The articulating joint 2615 that bends the flat outer surface of the adjacent single dose vial 2610 will reversibly fit to form a folded configuration of the multiple single dose container. Figure 26D shows a top view of a multi-single dose container 2600 in a collapsed configuration covered by a hermetically sealable overwrap 2605. In this non-limiting example, flow conduit 2640 coupled to vacuum source 2645 is shown inserted into an opening defined by a hermetically sealable overwrap 2605. In one aspect, a portion of the hermetically sealable overwrap 2605 is pressure sealed around the inserted flow conduit 2640 to form a pocket 2650 around the folded configuration of the multiple single dose container 2600. Air 2655 exiting from bag 2650 around the folded configuration of multiple single dose container 2600 by vacuum source 2645 is also shown. Figure 26E shows a top view of a multi-single dose container 2600 in a collapsed configuration covered by a hermetically sealable overwrap 2605. The seal 2660 has been formed with a hermetically sealable overwrap 2605 to hermetically seal the folded configuration of the multiple single dose container 2600 therein.

27A-27E illustrate additional aspects of the method of packaging a folded container as shown in FIG. Figure 27A is a top plan view of a multi-single dose container 2700 in an extended configuration covered by a hermetically sealable overwrap 2705. The multiple single dose container 2700 includes a row of interconnected single dose vials 2710. Each of the single dose vials 2110 is coupled to at least one adjacent single dose vial 2710 via an articulating joint 2715. The articulating joint 2715 is flexible enough to reversibly match the flat outer surface of each of the single dose vials 2710 with the flat outer outer surface of at least one adjacent single dose vial 2710 to form a folded configuration of the multiple single dose container 2700 type. Figure 27B shows a top view of a multi-single dose container 2700 in an extended configuration covered by a hermetically sealable overwrap 2705. The illustrated force 2725 is applied to the first single dose vial 2710 of the rows of interconnected single dose vials 2710 of the multiple single dose container 2700. In this non-limiting example, force 2725 is applied by mechanical probe 2720. In one aspect, the mechanical probe 2720 is a piston-like device that pushes the first single-dose vial to an adjacent single-dose vial to initiate a folding chain reaction. Figure 27C shows a top view of a multi-single dose container 2700 in an extended configuration covered by a hermetically sealable overwrap 2705. The articulating joint 2715 is shown as being curved corresponding to the force 2725 applied by the mechanical probe 2720 (arrow 2730). The articulating joint 2715 that bends the planar outer surface of the adjacent single dose vial 2710 will reversibly fit to form a folded configuration of the multiple single dose container. Figure 27D shows a top view of a multi-single dose container 2700 in a collapsed configuration covered by a hermetically sealable overwrap 2705. The inert gas is shown to be injected 2735 (arrow) into the hermetically sealable overwrap 2705 and around the multiple single dose container 2700 in a collapsed configuration. Figure 27E shows a top view of a multi-single dose container 2700 in a collapsed configuration covered by a hermetically sealable overwrap 2705. In this non-limiting example, flow conduit 2740 coupled to vacuum source 2745 is shown inserted into an opening defined by a hermetically sealable overwrap 2705. In one aspect, a portion of the hermetically sealable overwrap 2705 is pressure sealed around the inserted flow conduit 2740 to form a pocket 2750 around the folded configuration of the multiple single dose container 2700. Injection of inert gas 2755 (arrow) from bag 2750 around the folded configuration of multiple single dose container 2700 is also illustrated by vacuum source 2745. Figure 27F shows a top view of a multi-single dose container 2700 in a collapsed configuration covered by a hermetically sealable overwrap 2705. The seal 2760 has been formed with a hermetically sealable overwrap 2705 to hermetically seal the folded configuration of the multiple single dose container 2700 therein.

28 is a step diagram showing a method 2800 of packaging multiple single dose containers. The method 2800 includes covering, in step 2810, a multi-single dose container with a hermetically sealable overwrap comprising a row of interconnected single dose vials, each of the single dose vials a dose of at least one agent; and one or more hinged joints that connect each of the single dose vials in a row of interconnected single dose vials to at least one adjacent single dose vial, Said one or more articulating joints being flexible enough to reversibly cooperate the flat outer surface of each of the single dose vials with the flat outer surface of at least one adjacent single dose vial to form a multi-dose container Folded configuration. The method 2800 includes applying a force on at least a portion of the outer surface of the hermetically sealable overwrap covering the multiple single dose containers in step 2820, the applied force being directed to one or more articulating joints of the multiple single dose container. The method 2800 includes, in step 2830, expelling at least a portion of the air from a plurality of single dose containers covered by a hermetically sealable overwrap. The method 2800 includes sealing in a step 2840 a hermetically sealed outer wrap covering a plurality of single dose containers to hermetically seal the multiple single dose containers therein.

29 is a step diagram showing a further aspect of a method 2800 of packaging multiple single dose containers. Method 2800 includes covering a plurality of single dose containers with a hermetically sealable overwrap, as shown in step 2810. In one aspect, covering the plurality of single dose containers with the hermetically sealable overwrap includes inserting the multiple single dose containers into the opening defined by the hermetically sealable overwrap in step 2900. In one aspect, covering the plurality of single dose containers with the hermetically sealable overwrap includes positioning the multiple single dose containers in the first layer of the hermetically sealable outer wrap and the hermetically sealed outer wrap in step 2910 Between the second layers of the article; and sealing the first layer of the hermetically sealable outer wrap and one or more edges of the second layer together. In one aspect, covering the multiple single dose container with a hermetically sealable overwrap includes covering the multiple single dose container with a hermetically sealed bag in step 2920. In one aspect, covering the multiple single dose container with the hermetically sealable overwrap includes covering the multiple single dose container with a hermetically sealed sleeve in step 2930. In one aspect, covering the multiple single dose container with the hermetically sealable overwrap includes covering the multiple single dose container with a hermetically sealed foil laminate in step 2940. In one aspect, the multi-dose container is covered with a hermetically sealable overwrap comprising polyester, foil, polypropylene, cast polypropylene, polyethylene, high density polyethylene, metallocene polyethylene, linear low density The hermetically sealable overwrap formed by at least one of the polyethylene or metallized film covers the multiple single dose container. In one aspect, covering a plurality of single dose containers with a hermetically sealable overwrap includes covering a plurality of single dose containers with a gas impermeable overwrap in step 2950. In one aspect, covering a plurality of single dose containers with a hermetically sealable overwrap includes covering a plurality of single dose containers with a vapor impermeable overwrap in step 2960. In one aspect, covering the plurality of single dose containers with the hermetically sealable overwrap includes covering the multiple single dose containers with the light impermeable overwrap in step 2970. In one aspect, covering the plurality of single dose containers with the hermetically sealable overwrap includes covering the multiple single dose containers with the electrostatic discharge protective overwrap in step 2980. Non-limiting aspects of covering multiple single dose containers with a hermetically sealed overwrap have been described herein above.

30 is a step diagram showing a further aspect of a method 2800 of packaging multiple single dose containers. The method 2800 includes applying a force on at least a portion of an outer surface of the hermetically sealable outer wrap that covers the multiple single dose container, as shown in step 2820. The applied force is directed to one or more articulating joints of the multiple single dose container. In one aspect, applying a force on at least a portion of an outer surface of the hermetically sealable outer wrap covering a plurality of single dose containers includes using one or more mechanical probes in step 3000 to cover the energy of the multiple single dose container A force is applied to at least a portion of the outer surface of the tightly sealed outer wrap. For example, the method can include using one or more mechanical probes to push the hermetically sealed overwrap to one or more of the underlying hinge joints in close proximity to the multiple single dose container. In one aspect, applying a force on at least a portion of the outer surface of the hermetically sealable outer wrap covering the plurality of single dose containers includes using a pressurized gas in the step 3010 to seal the multiple single dose containers in a hermetically sealable manner. A force is applied to at least a portion of the outer surface of the wrap. For example, the method can include pushing the hermetically sealable overwrap to one or more of the underlying hinge joints in close proximity to the multiple single dose container using pressurized gas from one or more high pressure nozzles.

The method 2800 includes, in step 2830, extracting at least a portion of the air from a plurality of single dose containers covered by a hermetically sealable overwrap. For example, the method can include extracting at least a portion of the air from around the multiple single dose container prior to sealing the multiple single dose container in the hermetically sealable outer wrap. In some embodiments, expelling at least a portion of the air from the plurality of single dose containers covered by the hermetically sealable overwrap includes inserting a flow conduit connected to the vacuum source into the multi-dose container covered in step 3020 a hermetically sealable overwrap; a portion of the hermetically sealable overwrap is pressure sealed around the inserted flow conduit to form a pocket around the multiple single dose container; and from a bag around the multiple single dose container At least a portion of the air is exhausted. In one aspect, the method includes expelling at least a portion of the air while applying a force on at least a portion of an outer surface of the hermetically sealable outer wrap covering the plurality of single dose containers.

In some embodiments, method 2800 includes injecting an inert gas around a multi-dose container covered by a hermetically sealable overwrap; and discharging from a multi-dose container covered by a hermetically sealable overwrap At least a portion of the inert gas is as shown in step 3030. In one aspect, injecting an inert gas around a multi-dose container covered by a hermetically sealable overwrap includes injecting nitrogen in a step 3040 around a multiple single dose container covered by a hermetically sealable overwrap. In one aspect, injecting an inert gas around the multi-dose container covered by the hermetically sealable overwrap includes injecting a rare gas around the multiple single dose container covered by the hermetically sealable overwrap in step 3050. For example, the method can include injecting at least one of argon, helium, neon or xenon around a multi-single dose container covered by a hermetically sealable overwrap.

In some embodiments, the method 2800 of packaging a multiple single dose container includes discharging at least a portion of air from a plurality of single dose containers covered by a hermetically sealable overwrap prior to injecting an inert gas around the multiple single dose container, as in the steps 3060 is shown. For example, the method can include extracting air, exchanging air with an inert gas, and/or purging or flushing the air with an inert gas.

The method 2800 includes discharging at least a portion of the injected inert gas from a plurality of single dose containers covered by a hermetically sealable overwrap, as shown in step 3030. For example, the method can include discharging at least a portion of the injected inert gas from the outer seal that is hermetically sealed under vacuum. In one aspect, discharging at least a portion of the injected inert gas from a plurality of single dose containers covered by the hermetically sealable overwrap includes inserting a flow conduit connected to the vacuum source into an outer wrap that is hermetically sealed. Opening; sealing a portion of the hermetically sealable outer wrap around the inserted flow conduit to form a pocket around the multiple single dose container; and expelling the injected inert gas from the bag surrounding the multiple single dose container At least part of it. In one aspect, the method includes expelling at least a portion of the injected inert gas while applying a force on at least a portion of an outer surface of the hermetically sealable outer wrap covering the plurality of single dose containers.

31 is a step diagram showing a further aspect of a method 2800 of packaging multiple single dose containers. Method 2800 includes sealing a hermetically sealable overwrap covering a plurality of single dose containers to hermetically seal the multiple single dose container therein, as shown in step 2840. In one aspect, the method 2800 includes sealing, in step 3100, a first layer of the hermetically sealable overwrap to a second layer of the hermetically sealable overwrap to hermetically seal the multiple single dose container therein. . In one aspect, method 2800 includes, in step 3110, bonding at least a portion of a hermetically sealable overwrap covering a plurality of single dose containers to at least a portion of a surface of a multiple single dose container to hermetically seal the multiple single dose container In it. In one aspect, incorporating at least a portion of the hermetically sealable overwrap includes bonding at least a portion of the hermetically sealable overwrap covering the plurality of single dose containers to the one or more hinged joints in step 3120 At least a portion of the surface of the associated multiple single dose container is to hermetically seal the multiple single dose container therein. In one aspect, combining at least a portion of the hermetically sealable overwrap includes covering more than one of each of the single dose vials in a row of interconnected single dose vials in step 3130 At least a portion of the hermetically sealable outer wrap of the dose container is bonded to at least a portion of the surface of the multi-dose container. For example, a hermetically sealable overwrap can be bonded to the surface of a multi-dose container to form a separately wrapped/hermetic sealed single dose vial. In one aspect, the hermetically sealable overwrap includes perforations that are aligned with the frangible hinge joint, and the frangible hinge joint allows the individually packaged/hermetic sealed single dose vials to be separated from one another. In one aspect, sealing the hermetically sealable overwrap comprises thermally sealing a hermetically sealable overwrap covering the plurality of single dose containers in step 3140 to hermetically seal the multiple single dose container therein. In one aspect, sealing the hermetically sealable overwrap comprises pressure sealing the outer seal of the multi-dose container in a step 3150 to hermetically seal the multiple single dose container therein. In one aspect, sealing the hermetically sealable overwrap comprises chemically sealing a hermetically sealable overwrap covering the plurality of single dose containers in step 3160 to hermetically seal the multiple single dose container therein.

In one aspect, method 2800 includes forming a gas impermeable seal around the multiple single dose container. In one aspect, method 2800 includes forming a vapor impermeable seal around the multiple single dose container. In one aspect, method 2800 includes forming a light impermeable seal around the multiple single dose container. In one aspect, method 2800 includes forming an electrostatic discharge protective seal around a multiple single dose container.

32 is a step diagram showing a further aspect of a method 2800 of packaging multiple single dose containers. In one aspect, method 2800 includes attaching at least one tag to an outer surface of a hermetically sealable overwrap in step 3200, the at least one tag including at least one sensor. In one aspect, method 2800 includes attaching at least one tag to an outer surface of a hermetically sealable overwrap in step 3210, the at least one tag including at least one temperature sensor. Non-limiting aspects of the tag and associated environmental sensor have been described herein above.

In one aspect, the method 2800 of packaging a multiple single dose container further comprises bending the hermetically sealed multiple single dose container at one or more articulating joints of the multiple single dose container in step 3220 to form a collapsed configuration; and adding a third The covering is held in a folded configuration with a multi-single dose container that hermetically seals. For example, once the multiple single dose container has been sealed in a hermetically sealable outer wrap, the hermetically sealed multiple single dose container can be folded along the length of the hinged joint connecting the single dose vial to create a more compact configuration. type. This compact configuration can be further covered with a third package, such as a shrink wrap, to hold the hermetically sealed multiple single dose container in a compact or folded configuration.

In one aspect, the method of packaging a multiple single dose container 2800 further includes at least partially penetrating the hermetically sealable overwrap in step 3230 to add the frangible portion to the rows of interconnected single dose vials A hermetically sealed overwrap between each of the single dose vials. For example, the hermetically sealable overwrap may include perforations for allowing single dose vials to be separated from each other.

Figures 33A-33D illustrate additional aspects of a method of packaging multiple single dose containers. Figure 33A shows a top view of a multiple single dose container 3300 covered by a hermetically sealable overwrap 3305. The multiple single dose container 3300 includes a row of interconnected single dose vials 3310 connected by one or more articulating joints 3315. FIG. 33B shows a top view of a multiple single dose container 3300 covered by an overwrap 3305. In this non-limiting example, a force is applied while at least a portion of the injected inert gas is expelled from the hermetically sealable outer wrap. In this non-limiting example, a plurality of mechanical probes 3325 are used to apply a force on the outer surface of the hermetically sealable overwrap 3305 that covers the multiple single dose container 3300. Each of the mechanical probes 3325 exerts a force on the outer surface of the hermetically sealable overwrap 3305 at a position adjacent to the hinge joint 3315 or the hinge joint 3315. In this non-limiting example, flow conduit 3330 coupled to vacuum source 3335 is shown inserted into an opening defined by a hermetically sealable overwrap 3305. In some embodiments, a portion of the hermetically sealable overwrap 3305 is pressure sealed to the flow conduit 3330 to form a pocket around the multiple single dose container 3300. It is also shown that at least a portion of the air is expelled from the airtightly sealed overwrap 3305 by an arrow 3340 by a vacuum source 3335. Figure 33C shows a top view of a multiple single dose container 3300 and a row of single dose vials 3310 that hermetically seal 3345 within a hermetically sealable overwrap 3305. In some embodiments, the hermetically sealed multiple single dose container is bent at one or more articulating joints to form a folded and more compact configuration. Figure 33D shows a top view of a multi-single dose container 3300 hermetically sealed in a hermetically sealable overwrap 3305. The multiple single dose container 3300 and the hermetically sealable outer wrap 3305 are bent at the articulation joint 3315 to bring the single dose vials 3310 closer together in a folded configuration. In some embodiments, the multiple single dose container 3300 in a collapsed configuration is further covered by a third cover 3350.

Figures 34A-34D show top views of an embodiment of a method of packaging multiple single dose containers. Figure 34A shows a top view of a multiple single dose container 3400 covered by a hermetically sealable overwrap 3405. The multiple single dose container 3400 includes a row of interconnected single dose vials 3410 connected by one or more articulating joints 3415. It is also shown that inert gas 3420 is injected (arrow) into a hermetically sealable overwrap 3405 that covers multiple single dose containers 3400. Figure 34B shows a top view of a multiple single dose container 3400 covered by an overwrap 3405. In this non-limiting example, a force is applied while at least a portion of the injected inert gas is expelled from the hermetically sealable outer wrap. In this non-limiting example, a plurality of mechanical probes 3425 are used to apply a force on the outer surface of the hermetically sealable overwrap 3405 that covers the multiple single dose container 3400. Each of the mechanical probes 3425 exerts a force on the outer surface of the hermetically sealable overwrap 3405 at a position aligned with the articulating joint 3415 or adjacent to the articulating joint 3415. In this non-limiting example, flow conduit 3430 is shown coupled to a vacuum source 3435 that is inserted into an opening defined by a hermetically sealable overwrap 3405. In some embodiments, a portion of the hermetically sealable overwrap 3405 is pressure sealed to flow conduit 330 to form a pocket around the multiple single dose container 3400. Also shown is at least a portion of the inert gas injected through the vacuum source 3435 from the hermetically sealable overwrap 3405 (3360). Figure 34C shows a top view of a multiple single dose container 3400 and a row of single dose vials 3410 that hermetically seal 3445 within a hermetically sealable overwrap 3405. In some embodiments, the hermetically sealed multiple single dose container is bent at one or more articulating joints to form a folded and more compact configuration. Figure 34D shows a top view of a multi-single dose container 3400 hermetically sealed in a hermetically sealable overwrap 3405. The multiple single dose container 3400 and the hermetically sealed outer wrap 3405 are bent at the articulating joint 3415 to bring the single dose vials 3410 closer together in a folded configuration. In some embodiments, the multiple single dose container 3400 in a collapsed configuration is further covered by a third cover 3450.

Those skilled in the art will recognize that the components, devices, articles, and discussions accompanying them are used as examples, and various configuration modifications are contemplated for clarity of the concepts. Accordingly, as used herein, the specific examples set forth and the accompanying discussion are intended to represent a more general category. In general, the use of any particular example is intended to indicate its category, and the particular components, devices, and articles that are not included are not to be construed as limiting.

With respect to the use of substantially any plural and/or singular terms in the present invention, the plural may be translated into the singular and/or singular to plural. For the sake of clarity, various singular/plural substitutions are not explicitly set forth herein.

In some cases, one or more components herein may be referred to as "configured to", "configured by", "configurable to", "operable/operated to", "suitable/applicable" ", "can", "conformity/conformity", etc. Those skilled in the art will recognize that such terms (e.g., "configured to") may generally include components in an active state and/or components in an inactive state and/or components in a standby state, unless the context requires otherwise. .

While the specific aspects of the subject matter described herein have been shown and described, the subject matter of the subject matter of the subject matter described herein, All such changes and modifications are within the true spirit and scope of the subject matter described herein. The terms used herein, and particularly the terms used in the appended claims (e.g., the subject matter of the appended claims) are generally intended as "open" terms (for example, the term "comprising" should be interpreted as" The term "having" is to be interpreted as "having at least" and the term "comprising" is to be interpreted as "including but not limited to," and so forth. If intended to introduce a particular number of claims, such intent is to be explicitly stated in the claims, and in the absence of such a statement, there is no such intent. For example, as an aid to understanding, the following claims may contain the use of the &quot;at least one&quot; and &quot;one or more&quot; However, the use of such phrases is not to be construed as meaning that any claim that is incorporated in the claim of the claims A claim containing such a statement, even if the same claim includes the phrase "one or more" or "at least one" and the indefinite article such as "a" or "an" (for example, "A (a)" and / or "an" should generally be interpreted to mean "at least one" or "one or more"); the same applies to the use of the claim to introduce the claim. Definite article. In addition, even if a particular number of recited claims is explicitly recited, such statements are generally to be construed as meaning the at least the recited number (for example, an unmodified statement without the other modifiers. Refers to at least two statements or two or more statements). Further, in those cases where a idiom similar to "at least one of A, B, and C, etc." is used, generally such a configuration means that those skilled in the art will understand the meaning of the idiom (for example, "having A, B" "Systems of at least one of C and C" will include, but are not limited to, having A alone, B alone, C alone, A and B, A and C together, B and C together, and/or A, B, C together. System, etc.). In those cases where a idiom similar to "at least one of A, B, or C" is used, such a configuration generally means that those skilled in the art will understand the meaning of the idiom (eg, "with A, B, or C. "At least one system" will include, but is not limited to, systems having A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, C, etc. ). In general, a transitional word and/or phrase that generally means two or more optional terms, whether in the specification, the claims, or the drawings, should be understood as envisaged to include one of the terms, either The possibility of both terms, unless the context dictates otherwise. For example, the phrase "A or B" will generally be understood to include the possibilities of "A" or "B" or "A and B."

All of the above-mentioned U.S. patents, U.S. patent application publications, U.S. patent applications, foreign patents, foreign patent applications and non-patent publications, which are incorporated by reference in the specification and/or in This application is inconsistent.

While various aspects and embodiments are disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for illustrative purposes and are not intended to be limiting.

400‧‧‧Multiple single dose containers

400a‧‧‧multiple single dose containers

400b‧‧‧multiple single dose containers

400c‧‧‧multiple single dose containers

410‧‧‧Molded structure

420‧‧‧Part 1

430‧‧‧Part II

440‧‧‧Single dose vials

440a‧‧‧Single dose vials

440b‧‧‧Single dose vials

440c‧‧‧ single dose vials

450‧‧‧Textured surface pattern

460‧‧‧ area

600‧‧‧multiple single dose containers

610‧‧‧Molded structure

620‧‧‧Part 1

630‧‧‧Part II

640‧‧‧Single dose vials

645‧‧‧Hinged joint

650‧‧‧Textured surface pattern

670‧‧‧ label

680‧‧‧ sensor

700‧‧‧Multiple single dose containers

710‧‧‧Molded structure

720‧‧‧Part 1

730‧‧‧Part II

740‧‧‧Single dose vials

745‧‧‧Hinged joint

750‧‧‧Textured surface pattern

760‧‧‧Closed

770‧‧‧ label

780‧‧‧ sensor

900‧‧‧Seamable sealed overwrap

910‧‧‧Flow pipe

920‧‧‧vacuum source

930‧‧‧ Pressure seals

940‧‧‧Sealing device

950‧‧‧ airtight sealed bag

960‧‧‧air

970‧‧‧Seal

1000‧‧‧Inert gas

1500‧‧‧multiple single dose containers

1510‧‧‧Molded structure

1520‧‧‧Single dose vials

1525‧‧‧Hinged joint

1530‧‧‧Textured surface pattern

1540‧‧‧Closed

1550‧‧‧ label

1560‧‧‧ sensor

2200‧‧‧Multiple single dose containers

2210‧‧‧Single dose vials

2220‧‧‧Single dose vials

2230‧‧‧Hinged joint

2240‧‧‧Closed

2250‧‧‧ label

2260‧‧‧ sensor

2270‧‧‧First rectangular package cross section

2280‧‧‧Second rectangular package cross-section area

2600‧‧‧Multiple single dose containers

2605‧‧‧Envelopes that can be hermetically sealed

2610‧‧‧Single dose vials

2615‧‧‧Hinged joint

2620‧‧‧Mechanical probe

2625‧‧‧ force

2630‧‧‧ arrow

2640‧‧‧Flow pipe

2645‧‧‧vacuum source

2650‧‧‧ forming a bag around the folded configuration

2655‧‧‧Air

2660‧‧‧Seal

2700‧‧‧Multiple single dose containers

2705‧‧‧Envelopes that are hermetically sealed

2710‧‧‧Single dose vials

2715‧‧‧Hinged joint

2720‧‧‧Mechanical probe

2725‧‧‧ force

2730‧‧‧ arrow

2735‧‧‧Inert gas

2740‧‧‧Flow pipe

2745‧‧‧Vacuum source

2750‧‧‧ forming a bag around the folded configuration

2755‧‧‧Inert gas

2760‧‧‧Seal

3300... multi-dose container

3305‧‧‧Envelopes that can be hermetically sealed

3310‧‧‧Single dose vials

3315‧‧‧Hinged joint

3325‧‧‧Mechanical probe

3330‧‧‧Flow pipe

3335‧‧‧Vacuum source

3340‧‧‧ arrow

3345‧‧‧ Hermetic seal

3350‧‧‧3rd cover

3400‧‧‧Multiple single dose containers

3405‧‧‧Overwrapping

3410‧‧‧Single dose vials

3415‧‧‧Hinged joint

3420‧‧‧Inert gas

3425‧‧‧Mechanical probe

3430‧‧‧Flow pipe

3435‧‧‧vacuum source

3440‧‧‧ arrow

3445‧‧‧ Hermetic seal

3450‧‧‧3rd cover

Figure 1 shows a step diagram of a method of packaging multiple single dose containers.

Figure 2 shows a further step diagram of the method of packaging multiple single dose containers as shown in Figure 1.

Figure 3 shows a further step diagram of the method of packaging multiple single dose containers as shown in Figure 1.

4 is a schematic illustration of an embodiment of a multiple single dose container containing a molded structure having rows of interconnected single dose vials and a textured surface pattern.

5A is a schematic illustration of a top view of a molded structure having rows of interconnected single dose vials and a textured surface pattern.

Figure 5B is a schematic illustration of a top view of a molded structure having rows of interconnected single dose vials and a textured surface pattern.

Figure 5C is a schematic illustration of a top view of a molded structure having rows of interconnected single dose vials and a textured surface pattern.

6 is a schematic illustration of an embodiment of a multiple single dose container comprising a molded structure having rows of interconnected single dose vials and a textured surface pattern.

7 is a schematic illustration of an embodiment of a multiple single dose container comprising a molded structure having rows of interconnected single dose vials and a textured surface pattern.

Figure 8 shows a further step diagram of the method of packaging multiple single dose containers as shown in Figure 1.

Figure 9A shows a horizontal side view of an embodiment of a molded structure.

Figure 9B illustrates a horizontal side view of an embodiment of a molded structure covered by a hermetically sealable overwrap.

Figure 9C illustrates a horizontal side view of an embodiment of a molded structure covered by a hermetically sealable overwrap and pressure seal.

Figure 9D shows a horizontal side view of an embodiment of a molded structure and air discharge covered by a hermetically sealable overwrap.

Figure 9E shows a horizontal side view of an embodiment of a molded structure covered by a hermetically sealable overwrap and forming a hermetic seal.

Figure 9F shows a horizontal side view of an embodiment of a molded structure covered by a hermetically sealable overwrap.

Figure 10A shows a horizontal side view of an embodiment of a molded structure.

Figure 10B illustrates a horizontal side view of an embodiment of a molded structure covered by a hermetically sealable overwrap.

Figure 10C shows a horizontal side view of a molded structure covered by a hermetically sealable overwrap and an embodiment in which an inert gas is injected.

Figure 10D shows a horizontal side view of an embodiment of a molded structure and pressure seal covered by a hermetically sealable overwrap.

Figure 10E shows a horizontal side view of an embodiment of a molded structure covered by a hermetically sealable overwrap and an exhaust of injected inert gas.

Figure 10F shows a horizontal side view of an embodiment of a molded structure covered by a hermetically sealable overwrap and forming a hermetic seal.

Figure 10G shows a horizontal side view of an embodiment of a molded structure covered by a hermetically sealable overwrap.

Figure 11 shows a further step diagram of a method of packaging a multiple single dose container such as that shown in Figure 1.

Figure 12 shows a further step diagram of a method of packaging a multiple single dose container such as that shown in Figure 1.

Figure 13 shows a step diagram of a method of packaging multiple single dose containers.

Figure 14 shows a further step diagram of the method of packaging multiple single dose containers as shown in Figure 13.

15 is a schematic illustration of an embodiment of a multiple single dose container comprising a molded structure having rows of interconnected single dose vials and a textured surface pattern.

Figure 16 shows a further step diagram of the method of packaging multiple single dose containers as shown in Figure 13.

Figure 17 shows a further step diagram of the method of packaging multiple single dose containers as shown in Figure 13.

Figure 18 shows a further step diagram of the method of packaging multiple single dose containers as shown in Figure 13.

Figure 19 is a step diagram showing a method of packaging a multi-dose container.

Figure 20 shows a further step diagram of the method of packaging multiple single dose containers as shown in Figure 19.

Figure 21 shows a further step diagram of the method of packaging multiple single dose containers as shown in Figure 19.

Figure 22A is a side elevational view of an embodiment of a multiple single dose container in an elongated configuration.

Figure 22B is a top plan view of an embodiment of a multiple single dose container in an elongated configuration.

Figure 22C is a side elevational view of an embodiment of a multiple single dose container in a collapsed configuration.

Figure 22D is a top plan view of an embodiment of a multiple single dose container in an elongated configuration.

Figure 22E shows the overlap of the rectangular package cross-sectional areas of the elongated and folded configuration of the multiple single dose container.

Figure 23 shows a further step diagram of the method of packaging multiple single dose containers as shown in Figure 19.

Figure 24 shows a further step diagram of the method of packaging multiple single dose containers as shown in Figure 19.

Figure 25 shows a further step diagram of the method of packaging multiple single dose containers as shown in Figure 19.

Figure 26A shows a top view of an embodiment of a package foldable multiple single dose container.

Figure 26B shows a top view of an embodiment of a package foldable multiple single dose container.

Figure 26C shows a top view of an embodiment of a package foldable multi-dose container.

Figure 26D shows a top view of an embodiment of a package foldable multiple single dose container.

Figure 26E shows a top view of an embodiment of a package foldable multiple single dose container.

Figure 27A shows a top view of an embodiment of a package foldable multiple single dose container.

Figure 27B shows a top view of an embodiment of a package foldable multiple single dose container.

Figure 27C shows a top view of an embodiment of a package foldable multiple single dose container.

Figure 27D shows a top view of an embodiment of a package foldable multiple single dose container.

Figure 27E shows a top view of an embodiment of a package foldable multiple single dose container.

Figure 27F shows a top view of an embodiment of a package foldable multiple single dose container.

Figure 28 shows a step diagram of a method of packaging multiple single dose containers.

Figure 29 shows a further step diagram of the method of packaging multiple single dose containers as shown in Figure 28.

Figure 30 shows a further step diagram of the method of packaging multiple single dose containers as shown in Figure 28.

Figure 31 shows a further step diagram of the method of packaging multiple single dose containers as shown in Figure 28.

Figure 32 shows a further step diagram of a method of packaging a multiple single dose container as shown in Figure 28.

Figure 33A shows a top view of an embodiment of a packaged multi-dose container.

Figure 33B shows a top view of an embodiment of a packaged multi-dose container.

Figure 33C shows a top view of an embodiment of a packaged multi-dose container.

Figure 33D shows a top view of an embodiment of a packaged multi-dose container.

Figure 34A shows a top view of an embodiment of a packaged multi-dose container.

Figure 34B shows a top view of an embodiment of a packaged multi-dose container.

Figure 34C shows a top view of an embodiment of a packaged multi-dose container.

Figure 34D shows a top view of an embodiment of a packaged multi-dose container.

100‧‧‧ method

110~140‧‧‧Steps

Claims (84)

A method of packaging a collapsible container, comprising: covering a multi-single dose container in an expanded configuration with a hermetically sealable overwrap comprising: rows of interconnected single dose vials, Each of the single dose vials encloses a dose of at least one medicament; and one or more articulating joints that will be in the single dose vial in the row of interconnected single dose vials Each of the plurality is connected to at least one adjacent single dose vial, the one or more hinged joints being flexible enough to bring the flat outer surface of each of the single dose vials adjacent to the at least one The flat outer surface of the single dose vial reversibly matches to form a folded configuration of the multiple single dose container; on at least one of the single dose vials in the row of interconnected single dose vials Applying a force that is directed toward the at least one adjacent single dose vial; in response to at least one of the single dose vials in the row of interconnected single dose vials Applying the force, bending the one or more Hinging the joint to form the folded configuration of the multiple single dose container; and sealing the hermetically sealable outer wrap to form a gas tight seal around the folded configuration of the multiple single dose container therein seal. The method of claim 1, wherein the covering the multi-dose container in an expanded configuration with the hermetically sealable overwrap comprises: being defined by the hermetically sealable overwrap The opening is inserted into the multiple single dose container in an expanded configuration. The method of claim 1 , wherein the covering the multi-dose container in an expanded configuration with the hermetically sealable overwrap comprises: positioning the multiple single dose container in an expanded configuration Between the first layer of the hermetically sealable overwrap and the second layer of the hermetically sealable overwrap; and the first layer and the first layer of the hermetically sealable overwrap One or more edges of the second layer are sealed together. The method of claim 1, wherein the covering the multi-dose container in an expanded configuration with the hermetically sealable overwrap comprises: covering the expanded structure with a hermetically sealed bag or sleeve The multiple single dose container of the type. The method of claim 1, the covering the multi-dose container in an expanded configuration with the hermetically sealable overwrap comprises: covering the expanded configuration with a hermetically sealable foil laminate The multiple single dose container. The method of claim 1, wherein the multi-single dose container in an expanded configuration with the hermetically sealable overwrap comprises: a polyester, a foil, a polypropylene, a cast polypropylene The hermetically sealable overwrap formed by at least one of polyethylene, high density polyethylene, metallocene polyethylene, linear low density polyethylene or metallized film covers the multiple single dose container in an expanded configuration. The method of claim 1, wherein the covering the multi-dose container in an expanded configuration with the hermetically sealable overwrap comprises: covering the expanded configuration with a gas impermeable overwrap The multiple single dose container. The method of claim 1, wherein the covering the multi-dose container in an expanded configuration with the hermetically sealable overwrap comprises covering the expanded configuration with a vapor impermeable overwrap The multiple single dose container. The method of claim 1, wherein the covering the multi-dose container in an expanded configuration with the hermetically sealable overwrap comprises: covering the expanded configuration with a light-impermeable overwrap The multiple single dose container. The method of claim 1, wherein the covering the multi-dose container in an expanded configuration with the hermetically sealable overwrap comprises: covering the expanded configuration with an electrostatic discharge protective overwrap The multiple single dose container. The method of claim 1 wherein the multiple single dose container is formed by blow-fill-seal manufacturing. The method of claim 1 wherein the multiple single dose container is formed from at least one biocompatible thermoplastic material. The method of claim 1, wherein the rows of interconnected single-dose vials comprise: two or more interconnected single-dose vials in a row. The method of claim 1, wherein the horizontal cross section of each of the single dose vials is a square, a triangle, a hexagon, or a polygon. The method of claim 1, wherein the dose of the at least one agent comprises: a dose of at least one vaccine. The method of claim 1, wherein the dose of at least one agent comprises: a dose of at least one therapeutic agent. The method of claim 1 wherein the dose of at least one agent is in liquid form. The method of claim 1, wherein the dose of at least one agent is in a lyophilized form. The method of claim 1, wherein each of the single dose vials in the row of single dose vials comprises an internal volume containing the dose of at least one medicament. The method of claim 19, wherein the internal volume containing the dose of at least one medicament comprises an inert gas-filled headspace. The method of claim 1 wherein each of the single dose vials in the rows of interconnected single dose vials comprises an entry portion pierceable by the needle. The method of claim 1 wherein the articulating joint is frangible. The method of claim 1 wherein the expanded configuration of the multiple single dose container has a first rectangular package cross-sectional area and the folded configuration of the multiple single dose container has a second rectangular package In the cross-sectional area, the second rectangular package cross-sectional area is smaller than the first rectangular package cross-sectional area. The method of claim 1, wherein the multiple single dose container comprises at least one label, the at least one label comprising at least one sensor. The method of claim 1, wherein each of the single-dose vials in the rows of interconnected single-dose vials comprises a label, the label comprising a temperature sensor, a humidity sensor, At least one of a light sensor or an oxygen sensor. The method of claim 1, wherein applying a force on the at least one of the single dose vials in the rows of interconnected single dose vials comprises using at least one mechanical probe at A force is applied to the at least one of the single dose vials in the rows of interconnected single dose vials. The method of claim 1, wherein applying a force on the at least one of the single-dose vials in the rows of interconnected single-dose vials comprises: using a pressurized gas in the A force is applied to the at least one of the single dose vials in a row of interconnected single dose vials. The method of claim 1, wherein applying a force on the at least one of the single dose vials in the rows of interconnected single dose vials comprises: facing a first adjacent single a dose vial is applied to the first single dose vial at the first end of the row of interconnected single dose vials, and toward the second adjacent single dose vial in the row of mutual A force is applied to the second single dose vial at the second end of the continuous single dose vial. The method of claim 28, further comprising simultaneously applying the force to the first adjacent single dose vials at the first end of the rows of interconnected single dose vials Applying the force on the first single dose vial and toward the second adjacent single dose vial at the second end of the row of interconnected single dose vials Said on the second single dose vial. The method of claim 28, further comprising sequentially applying the first adjacent single dose vials to the first end of the rows of interconnected single dose vials toward the first adjacent single dose vial Applying the force on the first single dose vial and toward the second adjacent single dose vial at the second end of the rows of interconnected single dose vials The second single dose vial. The method of claim 1 , comprising: discharging at least a portion of the air around the folded configuration of the multiple single dose container covered by the hermetically sealable overwrap; and sealing the energy A hermetically sealed overwrap forms a hermetic seal around the folded configuration of the multiple single dose container therein. The method of claim 31, wherein expelling the at least a portion of the air from the folded configuration of the multiple single-dose container covered by the hermetically sealable overwrap comprises: a flow conduit connected to the vacuum source is inserted into the opening defined by the hermetically sealable outer wrap; a portion of the hermetically sealable outer wrap is pressure sealed around the inserted flow conduit to The folded configuration of the multiple single dose container forms a pocket; and the at least a portion of the air is expelled from the pocket around the folded configuration of the multiple single dose container. The method of claim 1, comprising: injecting an inert gas around the folded configuration of the multiple single-dose container covered by the hermetically sealable overwrap; and sealing from a gas-tight seal At least a portion of the injected inert gas is exhausted around the folded configuration of the multiple single dose container covered by the outer wrap. The method of claim 33, wherein the at least the injected inert gas is discharged from the folded configuration of the multiple single-dose container covered by the hermetically sealable overwrap. a portion includes: inserting a flow conduit connected to a vacuum source into an opening defined by the hermetically sealable overwrap; pressure sealing the hermetically sealed outer wrap around the inserted flow conduit Part of forming a pocket around the folded configuration of the multi-dose container; and discharging the injected inert gas from the pocket surrounding the folded configuration of the multiple single dose container Said at least part of. The method of claim 33, wherein injecting an inert gas around the folded configuration of the multiple single-dose container covered by the hermetically sealable overwrap comprises: being airtight by the energy Nitrogen is injected around the folded configuration of the multiple single dose container covered by the sealed overwrap. The method of claim 33, wherein injecting the inert gas around the folded configuration of the multiple single-dose container covered by the hermetically sealable overwrap comprises: A rare gas is injected around the folded configuration of the multiple single dose container covered by the hermetically sealed outer wrap. The method of claim 33, further comprising: said covering from said hermetically sealable overwrap prior to injecting said inert gas around said folded configuration of said multiple single dose container At least a portion of the air is exhausted around the folded configuration of the multiple single dose container. The method of claim 1, wherein the hermetically sealable overwrap is sealed to form the hermetic seal around the folded configuration of the multiple single dose container therein, including: heat sealing The hermetically sealable overwrap forms the hermetic seal around the folded configuration of the multiple single dose container therein. The method of claim 1, wherein the hermetically sealable overwrap is sealed to form the hermetic seal around the folded configuration of the multiple single dose container therein, including: a pressure seal The hermetically sealable overwrap forms the hermetic seal around the folded configuration of the multiple single dose container therein. The method of claim 1, wherein the hermetically sealable overwrap is sealed to form the hermetic seal around the folded configuration of the multiple single dose container therein, including: a chemical seal The hermetically sealable overwrap forms the hermetic seal around the folded configuration of the multiple single dose container therein. The method of claim 1, further comprising attaching at least one tag to an outer surface of the hermetically sealable overwrap, the at least one tag comprising at least one sensor. The method of claim 1, further comprising: attaching at least one tag to an outer surface of the hermetically sealable overwrap, the at least one tag comprising at least one temperature sensor. A method of packaging a plurality of single-dose containers, comprising: covering the multiple single-dose containers with a hermetically sealed overwrap comprising: rows of interconnected single-dose vials, Each of the single-dose vials encloses a dose of at least one medicament; and one or more articulating joints that each of the single-dose vials in the rows of interconnected single-dose vials Connected to at least one adjacent single dose vial, the one or more articulating joints being flexible enough to cause a flat outer surface of each of the single dose vials to be adjacent to the at least one adjacent single dose The flat outer surface of the vial is reversibly matched to form a folded configuration of the multiple single dose container; on at least a portion of the outer surface of the hermetically sealable outer wrap covering the multiple single dose container Applying a force that is directed toward the one or more articulating joints of the multiple single dose container; draining from the multiple single dose container covered by the hermetically sealable outer wrap At least one part of the air ; And a sealing covering the plurality of the single-dose container can be hermetically sealed outer wrap, to the multiple single-dose containers hermetically sealed therein. The method of claim 43, wherein covering the multiple single-dose container with the hermetically sealable overwrap article comprises: inserting the plurality of openings defined by the hermetically sealable overwrap Single dose container. The method of claim 43, wherein the covering the plurality of single-dose containers with the hermetically sealable overwrap comprises: positioning the plurality of single-dose containers in a hermetically sealable overwrap a layer between the second layer of the hermetically sealable overwrap; and sealing the one or more edges of the first and second layers of the hermetically sealable overwrap together. The method of claim 43, wherein covering the multiple single dose container with the hermetically sealable overwrap comprises covering the multiple single dose container with a hermetically sealed bag. The method of claim 43, wherein covering the multiple single dose container with the hermetically sealable overwrap comprises covering the multiple single dose container with a hermetically sealable sleeve. The method of claim 43, wherein covering the multiple single dose container with the hermetically sealable overwrap comprises covering the multiple single dose container with a hermetically sealable foil laminate. The method of claim 43, wherein the covering the multi-dose container with the hermetically sealable overwrap comprises: using polyester, foil, polypropylene, cast polypropylene, polyethylene, high A hermetically sealable overwrap formed from at least one of density polyethylene, metallocene polyethylene, linear low density polyethylene or metallized film covers the multiple single dose container. The method of claim 43, wherein covering the multiple single dose container with the hermetically sealable overwrap comprises covering the multiple single dose container with a gas impermeable overwrap. The method of claim 43, wherein covering the multiple single dose container with the hermetically sealable overwrap comprises covering the multiple single dose container with a vapor impermeable overwrap. The method of claim 43, wherein covering the multiple single dose container with the hermetically sealable overwrap comprises covering the multiple single dose container with a light impermeable overwrap. The method of claim 43, wherein covering the multiple single dose container with the hermetically sealable overwrap comprises covering the multiple single dose container with an electrostatic discharge protective overwrap. The method of claim 43, wherein the multiple single dose container is formed by a blow-fill-seal manufacturing process. The method of claim 43, wherein the multiple single dose container is formed from at least one biocompatible thermoplastic material. The method of claim 43, wherein the rows of interconnected single-dose vials comprise two or more single-dose vials in a row. The method of claim 43, wherein the horizontal cross section of each of the single dose vials in the rows of interconnected single dose vials is square, triangular, hexagonal or polygonal. The method of claim 43, wherein the dose of at least one agent comprises a dose of at least one vaccine. The method of claim 43, wherein the dose of at least one agent comprises a dose of at least one therapeutic agent. The method of claim 43, wherein the dose of at least one agent is in liquid form. The method of claim 43, wherein the dose of at least one agent is in lyophilized form. The method of claim 43, wherein each of the single dose vials in the rows of interconnected single dose vials comprises an internal volume containing the dose of at least one medicament. The method of claim 62, wherein the internal volume containing the dose of at least one medicament comprises an inert gas-filled headspace. The method of claim 43, wherein each of the single dose vials in the rows of interconnected single-dose vials comprises a needle-permeable access portion. The method of claim 43, wherein the multiple single dose container comprises at least one label, the at least one label comprising at least one sensor. The method of claim 43, wherein each of the single dose vials in the rows of interconnected single dose vials comprises a label comprising a temperature sensor, a humidity sensor, At least one of a light sensor or an oxygen sensor. The method of claim 43, wherein applying a force on the at least a portion of the outer surface of the hermetically sealable outer wrap covering the multi-single dose container comprises: using a pressurized gas Applying a force on the at least a portion of the outer surface of the hermetically sealable outer wrap covering the multi-single dose container. The method of claim 43, wherein the expelling the at least a portion of the air from the plurality of single dose containers covered by the hermetically sealable overwrap comprises: flowing a stream connected to a vacuum source a conduit is inserted into the opening defined by the hermetically sealable overwrap; a portion of the hermetically sealable overwrap is pressure sealed around the inserted flow conduit for the plurality of single doses Forming a pocket around the container; and discharging the at least a portion of the air from the pocket around the multiple single dose container. The method of claim 43, further comprising: injecting an inert gas around the plurality of single-dose containers covered by the hermetically sealable overwrap; and from the outer envelope that is hermetically sealed At least a portion of the inert gas injected is discharged around the multiple single dose container covered by the object. The method of claim 69, wherein injecting the inert gas around the plurality of single-dose containers covered by the hermetically sealable overwrap comprises: wrapping the outer envelope by the hermetic seal Nitrogen is injected around the multiple single dose container covered by the object. The method of claim 69, wherein injecting the inert gas around the plurality of single-dose containers covered by the hermetically sealable overwrap comprises: wrapping the outer envelope by the hermetic seal A rare gas is injected around the multiple single dose container covered by the object. The method of claim 69, further comprising: the plurality of sheets covered by the hermetically sealable overwrap prior to injecting the inert gas into the hermetically sealable overwrap The at least a portion of the air is exhausted around the dose container. The method of claim 43, wherein applying a force on the at least a portion of the outer surface of the hermetically sealable overwrap covering the multi-single dose container comprises utilizing one or more A mechanical probe applies the force on the at least a portion of the outer surface of the hermetically sealable outer wrap covering the multi-single dose container. The method of claim 43, wherein the hermetically sealable overwrap covering the multiple single dose container is sealed to hermetically seal the multiple single dose container therein, including: A first layer of a tightly sealed overwrap is sealed to a second layer of a hermetically sealable overwrap to hermetically seal the multiple single dose container therein. The method of claim 43, wherein the hermetically sealable overwrap covering the multiple single dose container is sealed to hermetically seal the multiple single dose container therein, including: a cover At least a portion of the hermetically sealable overwrap of the multiple single dose container is bonded to at least a portion of the surface of the multiple single dose container to hermetically seal the multiple single dose container therein. The method of claim 75, wherein at least a portion of the hermetically sealable overwrap covering the multiple single dose container is bonded to at least a portion of a surface of the multiple single dose container to The multiple single dose container is hermetically sealed therein, comprising: bonding at least a portion of the hermetically sealable outer wrap covering the multiple single dose container to associated with the one or more articulating joints At least a portion of the surface of the multiple single dose container to hermetically seal the multiple single dose container therein. The method of claim 75, wherein the at least a portion of the hermetically sealable overwrap is bonded to the at least a portion of the surface of the multi-single dose container therein comprises: Combining at least a portion of the hermetically sealable overwrap covering the multiple single dose container around each of the single dose vials in the rows of interconnected single dose vials To at least a portion of the surface of the multiple single dose container. The method of claim 43, wherein sealing the hermetically sealable overwrap covering the multiple single dose container to hermetically seal the multiple single dose container therein comprises: heat sealing the cover The hermetically sealable outer wrap of the multiple single dose container is to hermetically seal the multiple single dose container therein. The method of claim 43, wherein sealing the hermetically sealable overwrap covering the multiple single dose container to hermetically seal the multiple single dose container therein comprises: a pressure seal covering the The hermetically sealable outer wrap of the multiple single dose container is to hermetically seal the multiple single dose container therein. The method of claim 43, wherein sealing the hermetically sealable overwrap covering the multiple single dose container to hermetically seal the multiple single dose container therein comprises: chemically sealing the The hermetically sealable outer wrap of the multiple single dose container is to hermetically seal the multiple single dose container therein. The method of claim 43, further comprising attaching at least one tag to an outer surface of the hermetically sealable overwrap, the at least one tag comprising at least one sensor. The method of claim 43, further comprising attaching at least one tag to an outer surface of the hermetically sealable overwrap, the at least one tag comprising at least one temperature sensor. The method of claim 43, further comprising: bending the multi-single-dose container that is hermetically sealed at the one or more articulating joints of the multiple single-dose container to form a folded configuration; A third covering retains the multi-single dose container that is hermetically sealed in the folded configuration. The method of claim 43, comprising: at least partially penetrating the hermetically sealable overwrap in a single dose vial in the row of interconnected single dose vials A frangible portion is added to each of the hermetically sealable overwraps between each.