TW201317164A - Liner-based shipping and dispensing containers for the substantially sterile storage, shipment, and dispense of materials - Google Patents

Abstract

A liner-based assembly including an overpack, a liner disposed within the overpack, and a filling connector securable to at least one of the overpack and the liner and including a membrane for substantially aseptic filling, The membrane may be an elastomeric stopper, which may be configured for re-scaling with or without the assistance of heat. The liner-based assembly may further include a dispense connector that is operably connected with the overpack and/or the liner. The dispense connector may comprise or be operably connected to a one-way valve, the one-way valve having an elastomeric portion defining an opening and generally operably coupled with a plug member positioned within the opening. In a closed position, the elastomeric portion may be sealed against the plug member, and when a pressure is applied against the elastomeric portion, the elastomeric portion may flex in a manner configured to permit only one-way flow through the opening.

Description

Liner-based shipping and dispensing for substantially aseptic storage, transport and dispensing of materials container

This case relates to a novel and advantageous delivery and dispensing system. In particular, the present invention relates to a novel and advantageous liner-based system for substantially aseptic storage, transport and dispensing of materials for use in the bioengineering and pharmaceutical industries, and such systems may be Completely or essentially abandonable.

Many substances such as media, buffers, reagents, and other biological materials are widely used by biotechnology companies in, for example, research and development, vaccine manufacturing and use, protein production and purification, and other biological developments. For the safe and effective use of the intended purpose of the substance, and in order to comply with various rules and procedures, such materials must be pure and sterile.

The container system can be used in biopharmaceutical and other industries for storing, transporting, mixing, reacting, treating, and/or dispensing materials such as those described above. Such materials are generally susceptible to damage and/or very expensive and/or such materials must be maintained in a sterile environment. Therefore, any container system for such materials must be substantially airtight to prevent contamination of the material and to prevent leakage of the material into the external environment. In addition, the container system must be safe, sterile, reliable, and leak-proof so that the container system can withstand the stresses of shipping and dispensing.

Container systems for storing and dispensing such materials as described above, as well as other liquid-based contents, typically include a container, and/or liner A cylinder, a top cover and a connector, the top cover can be used to seal and protect the contents when the contents of the storage system are not dispensed, and the connector can be used to dispense contents from the container. However, conventional storage and dispensing container systems are typically not provided, particularly in disposable container systems, which are not provided to allow safe and reliable transport of such materials of this type. In particular, such conventional dispensers may not be sufficient to maintain or ensure the purity of the contents of the dispenser and, for example, such conventional dispensers are unable to prevent gas or other contaminants from entering the contents stored in the liner. Likewise, where the delivered material is toxic or harmful, the user may undesirably expose the substance during delivery to a conventional storage and dispensing container system that is not configured to permit safe and reliable shipping.

Accordingly, there is a need for dispensers that limit or substantially eliminate contamination and/or degradation of the contents of the dispenser. Further, from the standpoint of satisfying the final distribution of the contents, it is necessary to isolate the contents of the dispenser from the environment.

In one embodiment, the present invention relates to a liner-based assembly for pressure dispensing. The liner-based assembly can include a second layer of packaging, a liner within the second layer of packaging, and a fill connector secured to at least one of the second layer of packaging and the liner, and the connector includes A film for substantially aseptic filling. In some cases, the film can be a resealable elastomeric stop that can be configured to reseal with or without the aid of heat. The liner and the second layer of packaging can be illuminated to achieve a sterile effect. Lining-based The assembly can further include a dispense connector operatively coupled to the second layer package and/or the liner on the fill connector. The dispense connector can include a one-way valve, or the dispense connector can be operatively coupled to the one-way valve. The one-way valve can have an elastomeric portion that defines an opening and is generally operatively coupled to a plunger member located within the opening. The plunger member can be relatively stiff compared to the elastomer portion. In the closed position, the elastomeric portion can be sealed relative to the plunger member, and when pressure is applied to the elastomeric portion, the elastomeric portion can be configured to allow only one-way flow to bend through the opening. The liner can be configured to contract away from the second layer of packaging during pressure dispensing. Additionally, the liner-based assembly can include a portable pressure source for pressurizing the annular space between the second layer of packaging and the liner to retract the liner and dispense the contents of the liner.

In another embodiment, the present invention is directed to a method for providing a sterile delivery and pressure dispensing system. The method includes providing a second layer of packaging and a liner disposed within the second layer of packaging; illuminating the second layer of packaging and liner to obtain a sterile effect; and securing the connector to the second layer of packaging and liner In at least one of the connectors, the connector includes a film that, in some cases, can be an elastomeric stop for substantially aseptic filling. Additionally, the film can be a resealable elastomeric stop. The method can further include filling the liner by piercing the elastomeric stopper with a needle and flowing the substance into the liner through the needle. After the filling is completed, the needle can be removed, and in some cases, heat can be applied to aid in the resealing of the elastomeric stop. The headspace gas can also be removed from the interior of the liner after the fill liner is completed. A check valve can be provided on the connector for permission The headspace gas passes in a direction away from the liner. The method can also provide a dispensing connector operatively coupled to the second layer of packaging and/or liner, the dispensing connector including a one-way valve or operatively coupled to the one-way valve. A portable pressure source can be provided for pressurizing the annular space between the second layer of packaging and the liner. The portable pressure source can, for example, be a disposable compressed gas cartridge.

In another embodiment, the present invention is directed to a liner-based assembly for pressure dispensing. The liner-based assembly can include: a second layer package; a liner cylinder within the second layer package, the liner cylinder configured to introduce a gas or fluid into the annular space between the second layer package and the liner cylinder And then dispensing away from the second layer of packaging; and dispensing a connector, the dispensing connector being securable to at least one of the second layer of packaging and the liner, the dispensing connector including a channel in fluid communication with the annular space, and the dispensing connection The occupant includes or is operatively coupled to a one-way dispensing valve in fluid communication with the interior of the liner. The one-way valve can include an elastomeric portion that defines an opening and is generally operatively coupled to a plunger member located within the opening, the plunger member being relatively stiff compared to the elastomer portion. In the closed position, the elastomeric portion can be sealed relative to the plunger member, and when pressure is applied to the elastomeric portion, the elastomeric portion can be configured to allow only one-way flow to bend through the opening. In some embodiments, the liner and the second layer of packaging can be illuminated.

While the invention has been described with respect to the embodiments of the present invention It will be appreciated that the various embodiments of the present invention can be modified in various obvious forms without From the spirit and scope of the case. Therefore, the drawings and detailed description are to be regarded as

This case relates to a novel and advantageous delivery and dispensing system. More particularly, in some embodiments, the present invention relates to a novel and advantageous liner-based system for materials that must maintain the purity of a substance or a certain high purity level during shipping and/or dispensing, wherein In some cases, the liner-based system can be completely or substantially disposable. For example, in one aspect, the shipping and dispensing system of the present invention can be configured for single use and/or substantially maintains air tightness for use in some industries that must remain substantially pure and free of use. Contaminated and/or sterile materials such as those used in, for example, the biopharmaceutical and analytical process industries. Examples of some types of materials that can be used in embodiments of the present invention include, but are not limited to, reagents, buffers, cell culture media, or other sterile media. Applications may include, but are not limited to, sterile media delivery, vaccine manufacturing, filling and formulation, bioreactor feed and collection, pharmaceutical process fluid delivery, highly sealed operations, in-process effusion, and delivery buffers. However, it should be recognized that the embodiments of the present invention can also be applied to a wide variety of materials in a variety of industries. For example, the dispenser of the present invention may contain (but is not limited to) use: ultrapure liquids such as acids, solvents, bases, photoresists, slurries, detergents, cleaning formulations, dopants, inorganics, organics, metalorganics , TEOS and biological solutions, DNA and RNA solvents and reagents, pharmaceuticals, nanomaterials (including, for example, fullerenes, inorganic nanoparticles, Sol-gels and other ceramics) and radioactive chemicals; insecticides/fertilizers; paints/glosses/solvents/coating materials, etc.; powder cleaning solutions; for example, lubricants for the automotive or aerospace industries; for example, Foods such as, but not limited to, condiments, cooking oils and soft drinks; reagents or other substances used in the biomedical or research industry; for example, hazardous substances used by the military; polyurethanes; pesticides; chemical raw materials; ; petroleum and lubricants; adhesives; sealants; health and oral hygiene products and bathroom products; or any other substance that can be dispensed by, for example, pressure dispensing. Substances that can be used in the examples of the present invention can have any viscosity, including high viscosity and low mucus liquids. Those skilled in the art will recognize the benefits of the disclosed embodiments, and thus those skilled in the art will recognize the applicability of the disclosed embodiments for various industries and for transporting and dispensing various products.

The use, generation, and/or storage of some of the materials that can be used in embodiments of the present invention can be subject to various rules, procedures, and/or standards. Thus, in some embodiments of the present invention, the use of a liner-based system and/or a liner-based system may meet the criteria of the United States Pharmacopeia (USP). In particular, some embodiments of the present invention may be adapted to meet Level VI USP guidelines to ensure biocompatibility with plastics. USP's official reference standards are highly characterized samples of APIs, excipients, impurities, degradation products, dietary supplements, pharmacopoeia reagents, and performance assays. These samples are designated for use in official USP-NF testing and testing. USP also provides provisions in the Food Chemicals Codex and verification materials, high quality chemical samples. Test standards for services in analytical, clinical, pharmaceutical, and research laboratories. USP's reference standards are used in more than 130 countries around the world. The USP reference standard based directly on the official monograph in USP-NF is considered to be the official US standard. The USP-NF standards and procedures are implemented by the US Food and Drug Administration (FDA) and USP. The use of the reference standard is valid when it proves to be in compliance with statutory requirements.

In other embodiments, the various components or all components of the delivery and dispensing system of the present invention in the liner may be, or may be, an animal derived component free (ADCF). For example, the use of ADCF substances may be important because the possibility of bovine spongiform encephalopathy ("BSE") and bovine spongiform encephalopathy affecting humans has become a serious problem. Thus, for example, suppliers of many major animal source components for cell culture and fermentation processes are increasingly concerned with the potential for substances to be contaminated with prions. Viruses can also be present in materials derived from animal sources. Many important drugs and vaccine products are made by mammalian cell culture or bacterial fermentation, so the biosafety of these drugs and vaccine products is extremely important. However, it is difficult to ensure that any substance from an animal source does not carry any infection. Safety is not guaranteed even if it is designed to minimize the biohazard from one batch to the next. Thus, the use of ACDF materials for storing, transporting, and dispensing biological media and/or biopharmaceutical media may be advantageous.

In some embodiments, the liner-based system of the present invention can accommodate up to about 200 liters. Alternatively, the liner-based system can accommodate up to approximately 20 liter. Alternatively, the liner-based system can accommodate from about 1 liter to 5 liters or less. It should be understood that the dimensions of the containers cited are merely examples, and that the liner-based systems of the present invention can be readily adapted for use in shipping and dispensing containers of various sizes and shapes. In some embodiments, the entire liner-based system of the present invention can be used in a single use and then discarded. In other embodiments, for example, the second layer of packaging may be reused, while the liner and/or any connector may only be used in a single use.

Figure 1 illustrates one embodiment of a liner-based shipping and dispensing system 100 of the present invention. In some embodiments, the shipping and dispensing system 100 can include a second layer package 102, a liner cylinder 104, and one or more connectors or connector assemblies, which can be ( For example, a filler connector or connector assembly and/or a dispense connector or connector assembly, as will be described in further detail below.

The second layer package 102 can include a second layer of packaging walls 106, an interior cavity 108, and an outlet 110. The second layer package 102 can comprise any suitable material or combination of materials such as, but not limited to, one or more polymers including plastic, nylon, ethylene vinyl alcohol copolymer (EVOH), polyolefin, or Other natural or synthetic polymers. In a further embodiment, the second layer package 102 can use polyethylene terephthalate (PET), polyethylene naphthalate (PEN), poly(butyl butyl 2,6-naphthalate). ) (PBN), polyethylene (PE), linear low density polyethylene (LLDPE), low density polyethylene (LDPE), medium density polyethylene (MDPE), high density polyethylene (HDPE), polypropylene (PP) And/or made of a fluoropolymer such as, but not limited to, polychlorotrifluoroethylene (PCTFE), polytetrafluoroethylene (PTFE), Fluorinated ethylene propylene (FEP) and perfluoroalkoxy (PFA). The second layer of package 102 can have any suitable shape or arrangement such as, but not limited to, a bottle, a can, a drum, and the like.

As noted above, the shipping and dispensing system 100 can include a liner cylinder 104 that can be disposed within the second layer package 102. The liner cylinder 104 can include a liner cylinder wall 112, an interior cavity 114, and an outlet 116. The outlet 116 of the liner cylinder 104 can include a mating portion 118. The mating portion 118 can be made of the same or a different material than the remainder of the liner 104, or the mating portion 118 can be stiffer, more resilient, and/or less flexible than the remainder of the liner. The mating portion 118 can include threads 120 that can be coupled to complementary threads on the connector or connector assembly (discussed in greater detail below). However, it should be appreciated that the mating portion 118 can additionally or alternatively include any other member for coupling with the connector, such as, but not limited to, a snap fit or friction fit member, a bayonet member, or any other suitable Combinations of mechanisms or mechanisms for coupling, as will be appreciated by those skilled in the art. In some embodiments, the connector or connector assembly can be coupled to the outlet 110 of the second layer of packaging 102 or can also be coupled to the outlet 110.

In some embodiments, the liner 104 can be a substantially flexible shrinkable liner, while in other embodiments, the liner can be slightly rigid but still shrinkable (eg, a rigid shrinkable liner). The liner cylinder 104 can be fabricated using any suitable material or combination of materials such as, but not limited to, any of the materials or combinations of materials listed above with respect to the second layer package 102. However, the second layer package 102 and the liner cylinder 104 do not have to be the same material Made of materials. In some embodiments, the thickness of one or more selected materials and the materials or materials thereof may determine the stiffness of the liner 104. The liner cylinder 104 can have one or more layers, and the liner cylinder 104 can have any desired thickness. The liner 104 can have a thickness of, for example, from about 0.05 mm to about 3 mm, or any other suitable thickness.

The liner 104 can be configured to include any desired shape that attracts the user and/or aids in the shrinkage of the liner. In some embodiments, the liner 104 can be sized and shaped to substantially conform to the interior of the second layer package 102. Likewise, the liner cylinder 102 can have a relatively simple design with a generally smooth outer surface, or the liner cylinder can have a relatively complex design including, for example, without limitation, indentations and/or protrusions. In some embodiments, the liner wall 112 can include a generally textured surface to minimize adhesion. For example, in some embodiments, the surface can include a plurality of bumps, scales, or protrusions, each of the plurality of bumps, scales, or protrusions can have any suitable size, such as, but not limited to, self-approximately Sizes from 0.5 μm to 100 μm. The textured features can be spaced from each other by any suitable distance. In some embodiments, the texturing can, for example, comprise a frame, such as a grid or gantry. An example of a suitable texturing feature is described in more detail in U.S. Provisional Patent Application Serial No. 61/334,006, filed on May 12, 2010, entitled,,,,,,,,,,,,,,,,,,, This application is hereby incorporated by reference in its entirety. Liner cylinder 104 can have a relatively thin liner wall 112 that is relatively thinner than the thickness of second layer packaging wall 106. In some embodiments, the liner 102 can be To be flexible such that the liner wall 112 can be easily shrunk, such as vacuum achieved via the outlet 116 or via pressure between the liner wall 112 and the second layer of packaging wall 106 (referred to herein as being located in the liner wall 112 and The annular space between the second layer of packaging walls 106 is contracted.

In a further embodiment, the liner 104 can have a shape that is different from the shape of the second layer of packaging 102 but complementary to the shape of the second layer of packaging 102 when the liner 104 is inflated or filled to allow the liner to be lining 104 can be disposed in the second layer of package 102. In some embodiments, the liner cylinder 104 can be removably attached to the interior of the second layer of packaging wall 102. The liner cylinder 104 can provide a barrier layer, such as a gas barrier layer, for the drive gas that migrates from the annular space between the liner cylinder wall 112 and the second layer of packaging walls 106. Thus, the liner 104 can generally ensure and/or maintain the purity of the contents within the liner.

In some embodiments, particularly in embodiments where lining of the liner contents must be substantially maintained, the liner 102 can be comprised of a material that can help ensure or maintain the sterile environment of the contents disposed in the liner. For example, in some embodiments, the liner can be composed of any other suitable material of TK8 manufactured by ATM1 of Danbury, Connecticut. As noted above, in some embodiments, the liner cylinder 104 can comprise multiple layers. The plurality of layers may comprise one or more different polymers or other suitable materials. In some embodiments, the thickness, layer and/or composition of the layers of the liner and/or liner may be limited or eliminated by limiting or eliminating typical disadvantages or problems associated with conventional liners or packages (such as weld cracking, pinholes). , gas entrainment and / or any other means of contamination) to allow the liner-based Safe and substantially non-contaminating transport of the contents of the system. Similarly, or in addition, the liner cylinder 104 can also contribute to the present case by arranging the liner cylinder to substantially conform to the shape of the second layer package when the liner cylinder is filled, thereby reducing the amount of movement of the contents during transport. Safe and substantially non-contaminating transport of the contents of the shipping and dispensing system 100. Moreover, in embodiments where the liner cylinder substantially conforms to the shape of the second layer package, the amount of movement of the liner during transport can be reduced or substantially reduced, thereby advantageously reducing or eliminating the occurrence of pinholes.

The second layer package 102 and the liner cylinder 104 can each be fabricated using any suitable manufacturing process, such as, but not limited to, injection blow molding, injection stretch blow molding, extrusion, and the like, and the second layer of packaging 102 and liner The cylinders 104 can each be fabricated as a single component or can be a combination of multiple components. In some embodiments, the second layer package 102 and the liner cylinder 104 may be blow molded in a nested manner, which is also referred to as co-blowing molding. Examples of liner-based systems and methods utilizing co-blowing techniques have been described in more detail in the US Provisional Application entitled "Nested Blow Molded Liner and Overpack and Methods of Making Same" on July 12, 2011. This application is hereby incorporated by reference in its entirety by reference. In some embodiments, the liner can be blow molded into the formed second layer package whereby the second layer package can act as a liner liner and the blow molding can be referred to as "double blow molding" "Double Blow Molding" is described in more detail in U.S. Provisional Application Serial No. 61/703,996, filed on Sep. 21, 2012, entitled "Liner-based Shipping and Dispensing Systems," The text is hereby incorporated by reference in its entirety. In such embodiments, the second layer of packaging can be made by any suitable process.

Examples of liners of this type and second layer packages that can be used are disclosed in more detail in the following application: Application on October 10, 2011, entitled "Substantially Rigid Collapsible Liner, Container and/or Liner for Replacing Glass Bottles, and Enhanced Flexible Liners, International PCT Application No. PCT/US11/55558; International Patent Application No. PCT/US11/55558, filed on October 10, 2011, entitled "Nested Blow Molded Liner and Overpack and Methods of Making Same" PCT/US11/55560; International Patent Application No. PCT/US11/64141, entitled "Generally Cylindrically-Shaped Liner for Use in Pressure Dispense Systems and Methods of Manufacturing the Same", December 9, 2011; Application for US Provisional Application No. 61/468,832 entitled "Liner-Based Dispenser" on March 29, 2011; application for US Provisional Application entitled "Liner-Based Dispensing Systems" on August 19, 2011 Case No. 61/525,540; US Provisional Application No. 61/703,996 filed on September 21, 2012, entitled "Liner-based Shipping and Dispensing Systems" US Patent Application No. 11/915,996, entitled "Fluid Storage and Dispensing Systems and Processes", June 5, 2006; application entitled "Material Storage and Dispensing System" on October 7, 2010 And Method With Degassing International PCT Application No. PCT/US10/51786; International PCT Application No. PCT/US10/41629; U.S. Patent No. 7,335,721; U.S. Patent Application Serial No. 11/912,629; U.S. Patent Application Serial No. 12/ No. 302,287; and International PCT Application No. PCT/US08/85264, each of which is incorporated herein in its entirety by reference. For example, the second layer package 102 and the liner cylinder 104 for use in the present shipping and dispensing system 100 can include any of the embodiments, features, and/or enhancements disclosed in any of the above-identified applications. Including, but not limited to, flexible, rigidly shrinkable, two-dimensional, three-dimensional, welded, molded, gusseted and/or non-gusseted liners and/or wrinkled liners and/or included Liner for methods of limiting or eliminating blockage and liners sold under the brand name NOWpak® of ATM1, Inc.

As noted above, the liner cylinder 104 can include a mating portion 118 that can include a coupling member such as, but not limited to, a thread 120 for coupling with a complementary thread on a connector or connector assembly. Various types of connectors or connector assemblies can be used in the shipping and dispensing system 100 of the present case. In one embodiment, the shipping and dispensing system 100 can include one or both of a shipping and filling connector and a dispensing connector assembly, which will be described in more detail below. Each of them.

As illustrated in FIG. 1 , in some embodiments, the shipping and filling connector 122 of the present disclosure can include complementary threads 124 that can be coupled to the threads 120 on the mating portion 118 of the liner 104 . however, It will be appreciated that, as with the mating portion 118, the connector 122 may additionally or alternatively include any other member for coupling with one or more portions of the liner-based system, such as, but not limited to, A snap fit or friction fit member, a bayonet member, or any other suitable mechanism or combination of mechanisms for coupling, as will be appreciated by those skilled in the art.

In some embodiments, the connector 122 can be configured for aseptic filling of the interior cavity 114 of the liner cylinder 104. In some embodiments, the connector 122 can include a membrane 126 that can be completed via the membrane 126. The film 126 can be, for example, a resealable stop made of an elastomeric material such that a fill tube or a filling needle such as, but not limited to, a non-coring needle can pass through the film The liner cylinder 104 is filled. After removal of the fill tube or fill needle, the elastomeric material of film 126 can be resealed, thereby eliminating or substantially eliminating bacterial intrusion into liner cylinder 104. In some embodiments, the resealing of film 126 can be aided by the use of heat, such as by laser. The connector 122 that allows for aseptic filling eliminates the need for expensive and complicated separators. More specifically, the shipping and dispensing system 100, or more specifically, the second layer of packaging 102 and/or the liner 104 may be sterile and irradiated to provide a second layer of packaging 102 and/or liner 104 It becomes a separator itself. In general, for some of these embodiments of the connector 122, during filling and transport of the filled liner, the contents of the interior cavity 114 of the liner 104 are never exposed to the external environment, thereby completely or Substantially prevent contamination of the contents. In one embodiment, the conveying and filling connector 122 may be, or may be similar to New Milford, CT of Medical Instill Technologies, Inc. brand name of the filling connector Intact ^TM Sterile Filling System of sale. Although a connector for a film having an elastomeric substance is described, it should be understood that within the spirit and scope of the present invention, a sterile connector can be provided using, for example, any suitable Class VI plastic or a combination of Class VI plastics. .

The dispensing connector or assembly may or may be used in embodiments of the present invention. In some cases, the dispensing assembly can include a dispensing connector, a feature for dispensing via pressure dispensing, and/or a one-way dispensing valve. In some embodiments, the dispense connector may include a dispensing feature, and features such as those described above for filling, thereby allowing the same connector to be used for filling and dispensing, while in other cases, dispensing connections The connector can be a connector that is separate from the connector used to fill the liner-based system. Thus, in some embodiments, the dispense connector can be directly coupled to the connector 122 for filling and/or transporting the container, or the dispense connector can be coupled over the connector 122. In other embodiments in which the dispensing connector is separate from the connector 122 for filling and/or shipping, some or all of the dispensing connectors may be coupled to the connector 122 for filling and/or shipping. The filling and/or shipping connectors are removed from the liner and the second layer packaging system. The dispensing connector can be composed of any suitable material, such as metal, plastic, or any other material or combination of materials. In some embodiments, the dispense connector may be comprised of materials that may be suitable for use in a sterile environment, such as those listed above, or any other suitable material, or a combination of materials.

The dispensing assembly may also include content for dispensing a liner-based system The characteristic structure of the object. In some embodiments, the dispensing assembly can be configured to work with existing static systems, such as an existing pressure dispensing system that is not portable. In other embodiments, the dispensing system can be configured to be substantially fully portable. In general, the dispensing feature of the dispensing assembly can include a pressurized air inlet that generally allows the gas pressure intake line to be inserted into or coupled to the dispensing connector and allows gas pressure to enter The gas line is in fluid communication with the annular space between the liner cylinder 104 and the second layer package 102. In this system, a fluid, gas or other suitable substance can be introduced into the annular space to push the contents of the filled liner 104 out of the liner 104. In embodiments where the dispensing connector can be coupled to or coupled to the filling connector 122, the dispensing assembly can also include one or more turns, the one or more ports can include a dip tube, The dip tubes can extend any suitable distance into the interior of the liner cylinder 104 that can be used, for example, to pierce the film 126 on the fill connector 122.

The dispensing assembly may also include a one-way dispensing valve 200 as illustrated in FIG. In some embodiments, the dispense valve 200 can act as a non-contaminant barrier layer to protect the contents of the liner from air, moisture, bacteria, and/or any other harmful contaminants during dispensing. The one-way valve 200 can generally only allow material to flow in one direction during dispensing, i.e., only allow material to flow out of the valve without flowing back into the liner. In this manner, the one-way valve 200 operates similar to a valve in the cardiovascular system. The one-way valve 200 can include an elastomeric portion 202 that can be coupled to the plunger 204 of the valve and that abuts the plunger 204 of the valve. The plunger 204 can be relatively stiff compared to the elastomer portion 202. For example, as seen in FIG. 2, in some embodiments, the elastomeric portion 202 can generally surround the outlet tube 206. The elastomer portion 202 can be generally tapered to provide a relatively small dispensing opening 210 in which the plunger 204 can be positioned. The plunger 204 can generally seal the dispensing end of the elastomer portion 202 when the contents are being dispensed. In use, the one-way valve 200 can be used to dispense a substance in a substantially sterile manner. During the pressure dispensing, the contents of the liner can be directed toward the one-way valve 200, thereby creating a pressure on the valve 200. The pressure created by the force of the substance on the valve 200 causes the elastomer portion 202 to open. Then, due to the pressure applied to the substance, the substance can pass through the valve 200, thereby ensuring direct flow only in the dispensing direction 220. When the desired amount of material is dispensed, the pressure source can be reduced and the pressure source can be finally closed so that the elastomer portion 202 itself begins to enclose at the thicker portion of the substrate 208, thereby preventing any material from entering and squeezing. The remaining material in the valve 200 is discharged. In one embodiment, the connector may be a dispenser, or may be similar to New Milford, CT of Medical Instill Technologies, Inc. Brand name ^{Pure-Dose TM One-Way Visco} -Elastic Valve connector dispenser of sale or dispensing valve . In other embodiments, the valve may be comprised of any other suitable material, including any other plastic or plastic or combination of other materials.

As similar to Medical Instill Technologies, Inc. The brand name Intact ^TM Sterile Filling System and brand name Pure-Dose ^TM One-Way filling connector Visco-Elastic Valve sales of their connector and the connector and the connector dispenser The valve is further described in the following patents: U.S. Patent No. 7,997,447; U.S. Patent No. 7,992,597; U.S. Patent No. 7,980,276; U.S. Patent No. 7,975,453; U.S. Patent No. 7,967,034; U.S. Patent No. 7,966,746; U.S. Patent No. 7,954,521 U.S. Patent No. 7,886,937; U.S. Patent No. 7, 861, 129; U.S. Patent No. 7, 861, 750; U.S. Patent No. 7,850,051; U.S. Patent No. 7,845,517; U.S. Patent No. 7,810,677; U.S. Patent No. 7,798,185; U.S. Patent No. 7,780,023; U.S. Patent No. 7,779, 609; U.S. Patent No. 7, 726, 357; U.S. Patent No. 7, 678, 089; U.S. Patent No. 7,669,390; U.S. Patent No. 7,665,923; U.S. Patent No. 7,651,291; U.S. Patent No. 7,637,401; U.S. Patent No. 7,637,400; No. 7,628,184; U.S. Patent No. 7, 556, 509; U.S. Patent No. 7, 416, 066; U.S. Patent No. 7, 311, 944; U.S. Patent No. 7, 331, 944; U.S. Patent No. 7,322, 491; U.S. Patent No. 7, 270, 158; U.S. Patent No. 7,077,176; U.S. Patent No. 7,000,806; Each of the patents is hereby incorporated by reference in its entirety.

The liner-based system may also include features to help prevent or limit blockage. In general, occlusion can be described as the condition that occurs when the liner cylinder eventually contracts to the liner itself or shrinks into the interior of the liner to form a occlusion point disposed over a large amount of liquid. When a blockage occurs, the blockage can hinder the full use of the liquid placed within the liner, which is a serious problem because, for example, in biotechnology and/or pharmaceuticals Many of the materials used in the industry can be very expensive. A variety of ways to prevent or deal with occlusion are described in PCT Application No. PCT/US08/52506, entitled "Prevention Of Liner Choke-off In Liner-based Pressure Dispensation System", dated January 30, 2008. This application is hereby incorporated by reference in its entirety. An additional way to prevent or deal with clogging is described in International PCT Application No. PCT/US11, entitled "Substantially Rigid Collapsible Liner, Container and/or Liner for Replacing Glass Bottles, and Enhanced Flexible Liners", dated October 10, 2011. This application was previously incorporated herein by reference in its entirety.

In use, in some embodiments, the liner-based system can reach the first filling position, for example, where the fully assembled system includes the second layer package 102, the liner cylinder 104, and the fill connector 122. In some cases, the second layer package 102, the liner cylinder 104, and/or the connector can be illuminated or sterilized at the manufacturing location such that the sterilization process need not be performed at the filling location. As part of the sterilization process, the liner cylinder can be vented and thus can be in a contracted state, and the liner cylinder can be substantially free of gas, and the liner cylinder can be ready for filling after reaching, for example, a fill location. In other embodiments, the fill connector 122 and/or the second layer package 102, the liner cylinder 104, and/or the fill connector may be provided at the fill location to be illuminated and/or sterilized at the fill location prior to filling.

At the fill position, the fill connector 122 can be used to aseptically fill the contents of the liner. As explained above, in some embodiments, the fill link The adapter can be configured to include a closed needle that can pierce the film of the sealable liner. Once the needle has passed through the film, the needle can be opened to allow the substance to be introduced into the liner in a sterile manner. In some embodiments, any headspace can be removed from the liner after the filling is completed. The headspace generally refers to, for example, any gas space in the liner that may be present above the material stored in the liner. The headspace may be undesired because the headspace allows some of the headspace gas to enter the material, which in turn contaminates the material. Limiting or eliminating headspace may be especially important for systems that may be transported. The movement of substances in the liner tank that may occur when the headspace is present can cause foaming, foaming, stress, protein damage and/or gas contamination of the material, while maintaining the purity of the contents of the system is critical The situation may be extremely unsatisfactory. The headspace can be removed by introducing a suitable gas or fluid into the annular space between the liner and the second layer of packaging. The increased pressure in the annulus itself can push the liner, thereby forcing any excess gas in the liner to drain. For example, in some embodiments, this can be accomplished by including, for example, a sterile outlet valve that is part of the fill connector 122 that can allow any headspace to be in the isolated portion of the fill connector 122. Removed or retrieved. In some embodiments, the outlet valve may be a one-way valve that may only allow headspace gas to be removed from the liner cylinder, and the one-way valve may not allow headspace gas to return to the liner. In other embodiments, the headspace may be removed at the dispensing location prior to dispensing.

Once the liner cylinder has been filled, and in some embodiments, the headspace has been substantially removed, the fill connector can be resealed as described above, thereby no The lining cylinder 104 is sealed. In some cases, system 100 can then be shipped to a second location, while in other cases, the populated system can be stored at the first location prior to being dispensed at the first location.

The dispense connector or dispense connector assembly can be coupled to system 100 prior to dispensing. In some embodiments, the headspace gas may be removed at the dispensing location just prior to dispensing, for example, substantially in the same manner as described above. Depending on the embodiment used, in some cases, the filler connector may also include features for dispensing, and thus it may not be necessary to add another connector for dispensing to the system. However, in other embodiments, a portion of the fill connector or the entire fill connector may be removed from the liner and the second layer package, and the dispense connector and/or assembly may be coupled to the liner and the second The layers are packaged for dispensing. In other embodiments, the dispense connector and/or the dispense assembly can be coupled to or coupled to the fill connector. In embodiments where the dispense connector can be coupled to or coupled to the fill connector, one portion of the dispense connector can pierce the fill connector film 126 to allow access to the liner material for dispensing. Once the dispense connector and/or dispense assembly has been operatively coupled to the liner cylinder 104 and/or the second layer package 102, it can be dispensed. The dispensing can be performed by pressure dispensing, as discussed in more detail below.

In some embodiments, the dispensing connector and/or assembly, liner, and/or second layer package may be discarded after dispensing. However, in other embodiments, one or more of the dispensing connectors/components, liners, or second layer packages may be cleaned, sterilized, and reused in another cycle.

Figure 3 is a general illustration of a particular dispensing period during liquid dispensing according to one embodiment. How to operate the system of the case during the pressure distribution period. One end of the gas pressure intake line 306 can be coupled to a pressurized inlet port of the distribution connector 360, and the other end of the gas pressure inlet line 306 can be coupled to a pressurized gas or fluid source 340. In one embodiment, the gas or fluid source 340 can be adjusted to push pressurized gas or fluid into the region of the annular space between the inner wall 320 of the container and the outer wall 310 of the liner. It can be seen that as the amount of gas or amount of fluid increases in the space between the container wall 320 and the liner wall 310, the collapsible liner 312 will begin to contract itself, which will force the contents M of the liner 312 to rise through The connector 360 is assigned. In some embodiments, the dispense connector 360 can include a one-way dispense valve, while in other embodiments, the one-way outlet valve 362 can be remote from the dispense connector 360 but operatively coupled to the dispense connector 360. The pressurized gas or fluid may be continuously added until substantially all of the contents M of the liner 312 have been dispensed. Once the liquid dispensing has been completed and/or the liner cylinder 312 has been substantially emptied, the gas pressure inlet line 306 can be removed from the pressurized gas inlet to the connector 360, in some embodiments, the dispensing connector 360 is added. The pressurized gas inlet may also release compressed gas in the annular space between the inner wall 320 of the container and the inner wall 310 of the liner. As discussed above, in some embodiments, the liner and/or connector can be removed and discarded while the second layer of packaging can be cleaned, sterilized, and reused. In other embodiments, the second layer of packaging may also be discarded after a single use.

In some embodiments, a controlled and varied introduction of pressurized gas or liquid into the annular space between the inside of the vessel wall 320 and the outside of the liner wall 310 can be used to mix the contents of the liner. In some of these embodiments In the middle, the headspace may not be removed before mixing to make room for mixing. For example, a controlled cycle of compression and depressurization that produces compression and relaxation of the liner can mix the contents of the liner. In use, this embodiment will allow for the aseptic mixing of the contents of the liner without the need for an impeller or agitator. Since the introduction of objects into the interior of the liner can increase the risk of contamination, the introduction of an impeller or agitator into the liner can advantageously help minimize the risk of contamination. In other embodiments, two containers can be used to mix two or more substances.

The use of pressure rationing can be superior to methods currently used in related industries, such as dispensing by peristaltic pumps. The use of a pump to dispense the contents of the liner can cause material and system to foam and cause stress on the material and system, which may be undesirable because the purity of the contents of the liner may be critical. Using pressure rationing can help avoid or eliminate these problems. In addition, in some cases, higher rate dispensing may be achieved via pressure dispensing rather than pump dispensing.

As explained above, in some embodiments, the entire storage and dispensing system can be configured to be portable, as illustrated in FIG. In some embodiments of the portable storage and dispensing system 400, a pressure source 460 can be included as part of the dispensing assembly 420. Pressure source 460 can be used to pressure the contents of liner cylinder 412 by forcing, for example, gas into the annular space between the inner wall of second layer package 420 and outer wall 410 of liner cylinder 412. In some embodiments, the pressure source 460 can be directly coupled to the dispense connector as illustrated in FIG. 4, or integrated with the dispense connector illustrated in FIG. 4 via any suitable means; In an example, the pressure source can be remotely coupled to the dispense connector via any suitable member, such as a tubing or hose. In some embodiments, pressure source 460 can comprise, for example, a carbon dioxide (CO ₂ ) cartridge, a nitrogen (N ₂ ) cartridge, or other disposable compressed gas cartridge. In other embodiments, the pressure source can be connected generally to the dispensing assembly generally in a detachable manner or in an integrated manner. Although specific embodiments have been described herein, it should be understood that the pressure source can be positioned on the dispenser and/or at any suitable location in the vicinity of the dispenser by any suitable means. While the pressure source has been discussed as a disposable cartridge for a disposable system, in other embodiments, the pressure source can be any suitable or known pressure source to which the dispenser can be operatively coupled. In some embodiments, the user can activate the dispensing system by activating a pressure source. The pressure source can be activated or "turned on" in a variety of suitable manners, such as, but not limited to, activated or "on" via a button, pull switch, slide switch, or any other suitable combination of actuators or actuators. In some embodiments, such as in a fully disposable and/or recyclable embodiment (where the pressure source can include, for example, a CO ₂ cartridge, an N ₂ cartridge, or other disposable compressed gas cartridge), the pressure source can be Start the compressed gas cylinder to start, as one familiar with the art should know. In some embodiments, activating the pressure source allows the contents of the liner or dispensing system to be dispensed. In still further embodiments, the contents of the liner or dispensing system may be continuously dispensed until the pressure source is deactivated, or, for example, in the case of a compressed gas cylinder until the contents of the pressure source are completely or substantially depleted Up to and/or until the contents of the liner are substantially depleted or lowered to the desired level. For example, in some embodiments, the one-way dispense valve 480 can be coupled to the dispense connector 420 as described above, while in other embodiments, the one-way dispense valve 480 can be remote from the dispense connector 420, but the one-way dispense valve 480 The mating connector 420 can be operatively coupled by any suitable member, such as a conduit.

In one embodiment, the portable pressure source 460 can be, or can be similar to, a portable pressure source and dispensing system sold under the brand name Tap-A-Draft of Sturman BG, LLC of Woodland Park, CO. Portable pressure sources and dispensing systems are traditionally used to maintain and dispense carbonated beverages. In general, since the liquid stored in the container attached to the Tap-A-Draft system is poured through the Tap-A-Draft dispensing connector, gas such as CO ₂ , nitrogen or argon is allowed to enter the container to remain inside the container. pressure. Such portable pressure sources and dispensing systems, similar to the pressure dispensing assemblies sold under the brand name Tap-A-Draft of Sturman BG, LLC, are described in further detail in the following patents: U.S. Patent No. 5,395,012; U.S. Patent No. 5,443,186 U.S. Patent No. 5,979,713; U.S. Patent No. 6,036,054; U.S. Patent No. 7,845,522; U.S. Patent No. D 582,722; U.S. Patent Publication No. 2009/0242044; Each of the examples is hereby incorporated by reference in its entirety.

In another embodiment, the liner can be first filled with a solid material such as, but not limited to, a peptide, an API, and the like. The solids can occupy a relatively small space within the liner. The liner-based system can then be stored, or otherwise the liner-based system can be shipped to another location, where the liner can be filled with sterile liquid. In order to dissolve the solid in the liquid, Shake the liner or otherwise move the liner. The contents of the liner can then be dispensed or shipped to another location for dispensing. In use, this embodiment can be substantially similar to the embodiments described above. The use of this embodiment will allow the user to not have to deliver solid material to a new container for aseptic mixing, thereby, for example, minimizing the risk of contamination and saving time, labor and any associated costs. Alternatively, two or more containers may be used to mix the contents of one or more liners.

In some embodiments, the dispensers disclosed herein can include more than one liner tank that can contain different materials. The dispensing assembly can include a connector/cover that can be attached to or aligned with the adapter of each of the liner cylinders. Alternatively, a liner can contain two or more compartments that can contain different materials. The dispensing assembly can draw material from some or all of the liner cylinders, and the dispensing assembly can, for example, be mixed prior to dispensing the material from the dispenser such that the resulting material dispensed from the dispenser can be all or some of the liner cylinders a mixture of contents. In some embodiments, one or more of the liner cylinders may not be completely filled and/or the headspace may not be removed and/or the headspace may be introduced into the liner to be set aside in one or more liners Mixed space.

This embodiment can also be advantageously used for materials that may be unstable and require curing of the catalyst. Thus, one liner can contain material and the other liner can contain a catalyst, thereby allowing a mixture of both the applied material and the catalyst. In a plurality of liner embodiments, the ratio of material included in each liner in the mixture can be controlled in a variety of ways, such as by varying the applied pressure, by varying the size of the end device that is configured as a nozzle, By changing The size of the passage through the connector/cover is controlled by varying the size of any dip tube used or by any other suitable method or combination of methods.

In some dispenser embodiments, the liner, the second layer of packaging, and/or the connector may be configured for dispensing of high flow or relatively high viscosity contents. In one embodiment, the high flow dispensing or high viscosity dispensing can be achieved by providing a larger orifice size in the liner, the second layer of packaging, and/or the dispensing assembly, which will allow for larger orifice sizes. For higher flow rates or larger flow paths for substances with relatively higher viscosities.

In some cases, embodiments of the liner of the present invention may be dispensed at a pressure of less than about 100 psi, or preferably at a pressure of less than about 50 psi, and more preferably less than about 20 psi. Distribution under pressure. However, in some cases, depending on the intended use or application involved, the contents of the liner of some embodiments may be dispensed at a significantly lower pressure as may be desired.

In an additional embodiment, the dispensing assembly including the connector may also include control elements to control intake and discharge. For example, the controller can be operatively coupled to the control element to control the dispensing of the liquid from the liner cylinder. One or more sensors may also be included in some embodiments to sense inlet pressure and/or outlet pressure. In this regard, the control elements can be utilized to detect when the liner is near emptying. A component for controlling the dispensing of a fluid from a liner cylinder and determining when the liner is nearly empty is described, for example, in U.S. Patent No. 7,172,096, entitled "Liquid Dispensing System", issued February 6, 2007, and international application. Date is June 11, 2007 PCT Application No. PCT/US07/70911, entitled "Liquid Dispensing Systems Encompassing Gas Removal," each of which is incorporated herein by reference in its entirety herein It is described in International Patent Application No. PCT/US2011/055558, the entire disclosure of which is hereby incorporated by reference.

In an additional or alternative embodiment illustrated in FIG. 5, the emptying detection mechanism can include a liner and a second layer packaging system 502, the liner and second layer packaging system 502 being operatively coupled to indirect pressure dispensing Component 504. The dispensing assembly 504 can include a pressure sensor or sensor 506, a pressure solenoid or other control valve 508, and a vent solenoid or other control valve 510. A microcontroller can be used to control the pressure solenoid 508 and/or the exhaust port solenoid 510. The outlet fluid pressure can be read and measured via pressure sensor 506. If the pressure is too low, ie below the set value, the pressure solenoid 508 can be opened for a period of time (P _on ), thereby allowing more pressurized gas or other substance to be introduced between the second layer of packaging and the liner. The annular space and increased outlet fluid pressure. If the pressure is too high, i.e. higher than the predetermined value, the exhaust port solenoid 510 may be turned on, a period of time (P _vent), thereby slightly releasing the pressure in the annular space between the packing and the second layer of the liner cylinder, And thus the outlet fluid pressure is released. As can be seen in Figure 6, as the contents of the liner are nearly empty, the liquid pressure drops 610. The drop in fluid pressure triggers the pressure solenoid to open for a longer period of time. The increase in the time (P _on ) at which the pressure solenoid opens is rapidly rising 612 as the liner approaches the evacuation. Therefore, the amount of time (P _on ) the pressure valve is open can be used to determine when the end of the dispense has been reached.

Alternatively or additionally, the frequency of the on/off switching of the inlet pressure solenoid can be monitored. As noted above, as the liner is nearly empty, the inlet pressure will need to be increased to maintain a constant liquid outlet pressure. As the liner is nearly emptied, the inlet pressure solenoid can thus be turned on/off at a higher frequency to allow the desired amount of pressurized gas to enter the annular space between the liner and the vessel. The frequency of this on/off switching can be a useful emptying detection indication. Mechanisms such as the evacuation detection mechanisms disclosed herein can help save time and energy, and thus save money.

After the dispensing is completed or substantially completed and the liner is emptied or substantially emptied, the end user may discard the liner-based system and/or recycle or reuse some or all of the liner-based system, including the Parts or the entire fastener/connector assembly. To assist in making the dispenser described herein more sustainable, a dispenser comprising any second layer package, one or more liners, handles, etc. or one or more components of the dispenser may be biodegradable material Or biodegradable polymers, including but not limited to: polyhydroxyalkanoates (PHAs), such as poly-3-hydroxybutyrate (PHB) , polyhydroxyvalerate (PHV) and polyhydroxyhexanoate (PHH); polylactic acid (PLA); polybutylene succinate (PBS); polycaprolactone (PCL); polyanhydride; polyethylene Alcohol; starch derivatives; cellulose esters such as cellulose acetate and nitrocellulose and derivatives of the above (Cesus); and the like. Likewise, in some embodiments, and when suitable for industrial applications, the dispenser or one or more of the elements of the dispenser may be made of materials that may be recycled or recycled, and in some In an embodiment, the materials may be used by the same or different end users for another process, thereby allowing the or the end user to reduce the environmental impact of the materials or reduce the overall emissions of the materials. For example, in one embodiment, the dispenser or one or more of the elements of the dispenser may be made of an incinable material such that heat generated from the materials may be captured by the same or different end users And incorporated or used in another process. In general, the dispenser or one or more of the elements of the dispenser may be made of a material that can be recycled or converted into a reusable raw material.

In one embodiment of the present disclosure, the storage and dispensing system 700 can include an additional optional packaging component 720 in which the liner and second layer package 702 can be positioned. In some cases, the package component 720 can be used to relatively easily store, transport, and/or carry the liner and second layer package 702. The package component 720 can be generally a box of corrugated material such as, but not limited to, paperboard. However, in other embodiments, package component 720 can be comprised of any suitable material or combination of materials including, for example, paper, wood, metal, glass, or plastic. The package component 720 can include one or more stiffening elements 730 that can provide support and/or stability for the liner and second layer package 702 disposed in the package component 720. The stiffening element 730 can be positioned in the package element 720 at any suitable or desired height. For example, as seen in Figure 7, a stiffening element 730 can be provided adjacent the top of the body of the second layer of packaging and liner 702. However, in other embodiments, one or more stiffening elements can be positioned on the second layer Other areas of the package, such as positioned at the bottom of the second layer of packaging, or positioned in the middle of the second layer of packaging. In another embodiment, the stiffening element may substantially fill substantially all of the space or a portion of the space that is not occupied by the liner and the second layer of packaging. The one or more stiffening elements 730 can be comprised of any suitable material or combination of materials such as, but not limited to, the materials listed above for the packaged components. In some embodiments, one or more of the stiffening elements 730 can be composed of the same material as the rest of the packaged component 720, although it is not necessary to use the same materials. The package component 720 can also have one or more handles or handle slots/openings 740 that can cause the package component 720 to be relatively easily moved and/or handled. Package component 720 can be any desired shape, and in some cases, package component 720 can be a generally rectangular enclosure, as illustrated. A plurality of systems, such as those illustrated in Figure 7, can be easily and conveniently packaged for storage and/or shipping due to the rectangular box shape of the packaged components. In addition, the package component can further protect the liner and the second layer of packaging disposed in the package component from exposure, such as exposure to potentially harmful ultraviolet light.

In some embodiments including the package component 720, the liner and the second layer packaging system may not include a handle or a flange because the storage unit 720 can provide a handle slot/opening and support that is otherwise provided by the flange. Thus, the costs associated with liners and second layer packages for handles and/or flanges can be reduced or eliminated in such embodiments. Nonetheless, in other embodiments, in embodiments including a package component, the liner and the second layer package may still include a handle and/or a flange.

In still further embodiments, co-blowing molded or nested preforms and liners (such as those filed on October 10, 2011, entitled "Nested Blow Molded Liner and Overpack and Methods of Making Same" Their preforms and liners are described in PCT Application No. PCT/US11/55560, the disclosure of which is hereby incorporated herein incorporated by reference in its entirety in its entirety in its entirety in its entirety. Two or more separate materials may be filled in the space between the layers. The dispenser can be configured to mix individual materials during dispensing.

In other embodiments, the dispenser of the present invention may include a baffle, a baffle feature, or other discontinuities in one or more of the inner surfaces of the dispenser to delay inclusion during storage and/or delivery. Precipitation of suspended solids in the dispenser.

The dispensers described herein can be provided in any suitable shape including, but not limited to, square, rectangular, triangular or tapered, cylindrical, or any other suitable polygonal or other shape. Differently shaped dispensers can improve packing density during storage and/or delivery and can reduce overall delivery costs. Additionally, differently shaped dispensers can be used to distinguish dispensers from each other to provide an indication of the content provided within the dispenser or to identify which application or applications or applications to use for the content. In still further embodiments, the dispensers described herein can be configured in any suitable shape to "refit" the dispenser with an existing dispensing assembly or dispensing system.

In some embodiments, the dispenser described herein can include symbols and/or words molded to the dispenser or one or more of the components of the dispenser. The Such symbols and/or text may include, but are not limited to, names, logos, indications, warnings, and the like. The molding can be performed during or after the manufacturing process of the dispenser or one or more of the components of the dispenser. In one embodiment, the molding can be easily accomplished during the manufacturing process by, for example, stamping the dispenser or a mold of one or more of the dispensers. These molded symbols and/or words (for example) can be used to distinguish products.

In some embodiments, one or more color and/or absorbent materials may be added to the dispenser or to the dispensing during or after the manufacturing process to help protect the contents of the dispenser from the external environment. The material of one or more of the components, to decorate the dispenser, or to indicate or identify content within the dispenser, or otherwise distinguish between multiple dispensers, and the like. Color can be added using, for example, dyes, pigments, nanoparticles, or any other suitable mechanism. The absorbent material can include materials that absorb ultraviolet light, infrared light, and/or radio frequency signals, and the like.

As such, in some embodiments, the dispenser or one or more of the elements of the dispenser may have different textures or finishes. As with color and molded symbols and/or text, different textures or finishes can be used to differentiate the product to provide an indication of what is provided within the dispenser, or to identify which application or applications the content will be used for, etc. Wait. In one embodiment, the texture or finish may be designed to be substantially non-slip texture or finish, etc., and include the texture or finish or add the texture or finish to one of the dispensers or the dispenser or Multiple components can help improve the grip or handling of the packaging system and, in turn, reduce or minimize the risk of dispensing the dispenser. Texture or finish can be made, for example, by appropriate The dispenser of the surface features or the mold of one or more of the dispensers is easily completed during the manufacturing process. In other embodiments, the molded dispenser can be coated with a textured or modified surface. In some embodiments, a texture or finish may be provided on substantially the entire dispenser or substantially all of the one or more components of the dispenser. However, in other embodiments, the texture or finish may be provided only on one portion of the dispenser or on one of the one or more components of the dispenser.

Likewise, in some embodiments, the dispenser or one or more of the outer walls and/or inner walls of the dispenser may have any suitable coating provided on the outer and/or inner walls. The coating can increase material compatibility, reduce permeability, increase strength, increase pinhole resistance, increase stability, provide antistatic capability or otherwise reduce static, and the like. The coatings may include coatings of polymers or plastics, metals, glasses, adhesives, and the like, and such coatings may be fabricated in a manufacturing process by, for example, coating a preform for blow molding. The coating during the application, or such coating, may be applied after fabrication, such as by spraying, dipping, filling, and the like.

In some embodiments, the dispenser can include one or more handles. The one or more handles can have any shape or size, and the one or more handles can be located at any suitable location of the dispenser. The type of handle may include, but is not limited to, a handle on the top and/or side; an ergonomic handle; a removable or detachable handle; molded into the dispenser or after the dispenser is manufactured (such as borrowing a handle provided by, for example, a snap fit, an adhesive, a riveting, a screw connection, a bayonet fit, etc.; Different handles and/or handling options are available, and these handles and / or handling options may be visual (eg, but not limited to) the intended contents of the dispenser, the application of the dispenser, the size and shape of the dispenser, the intended dispensing system of the dispenser, and the like.

In some embodiments, the dispenser may include two or more layers, such as a second layer of packaging and liner, a plurality of second layers of packaging, or a plurality of liners. In a further embodiment, the dispenser can include at least three layers that can help ensure enhanced sealing of the contents in the dispenser, increase structural strength, and/or reduce permeability, and the like. Any of the layers may be made of the same or different materials such as, but not limited to, the materials previously discussed herein.

In some embodiments, and when applied to an industrial application, the dispenser or one or more of the elements of the dispenser may be made of a material that may be recycled or reclaimed; and in some embodiments, the materials The same process may be used by the same or different end users, thereby allowing the or the user to reduce the environmental impact of the materials or to reduce the overall emissions of the materials. For example, in one embodiment, the dispenser or one or more of the elements of the dispenser may be made of an incinable material such that heat generated from the materials may be captured by the same or different users and Incorporated or used in another process. In general, the dispenser or one or more of the elements of the dispenser may be made of a material that may be recycled, or the materials may be converted into a reusable raw material.

In some embodiments, structural features can be designed into the dispenser that can add strength and integrity to the dispenser or one or more of the dispensers. For example, the base of the dispenser (or in some The flanges, tops, and sides in the embodiments may all be areas that experience increased shaking and external forces during filling, transport, installation, and use (eg, dispensing). Thus, in one embodiment, an increased thickness or structural system (eg, a bridge design) can be added to the support stress region of the dispenser, which can add strength and integrity to the dispenser. In addition, any connection area in the dispenser may also experience increased stress during use. Thus, any of these regions may include structural features that increase strength via, for example, increased thickness and/or specially tailored designs. In a further embodiment, a triangle may be used to add strength to any of the above structures; however, other design or mechanical support features may also be used.

In some embodiments, a dispenser comprising any second layer package or one or more liners or one or more of the dispensers may include reinforcement features such as, but not limited to, a screen, One or more fibers, epoxy resins, or resins, etc., which may be integrated or added to one or more of the dispenser or the dispenser or one of the dispenser or the dispenser or More parts of the component to increase reinforcement or strength. This reinforcement can assist in high pressure dispensing applications or in applications that dispense high viscosity contents or corrosive contents.

In some embodiments, the dispenser can include a level sensing feature or sensor. The level sensing feature or sensor can use a visual mechanism, an electronic mechanism, an ultrasonic mechanism, or other suitable mechanism for identifying, indicating, or determining the level of content stored in the dispenser. For example, in one embodiment, the dispenser or part of the dispenser The material may be made of a substantially translucent or transparent material that can be used to view the level of content stored in the dispenser or portion of the dispenser.

In a further embodiment, the flow metering technique can be integrated into the connector or operatively coupled to the connector for direct measurement of the material delivered from the packaging system to the downstream process. Direct measurement of the delivered material provides the end user with data that can help ensure process repeatability or reproducibility. In one embodiment, the flow meter can provide an analog reading or a digital reading of the flow of material. Other components of the flow meter or system can take into account the characteristics of the material (including but not limited to viscosity and concentration) and other flow parameters to provide accurate flow measurements. Additionally or alternatively, the flow meter can be configured to process and accurately measure the particular substance stored in the dispenser and dispensed from the dispenser. In one embodiment, the inlet pressure can be circulated or adjusted to maintain a substantially constant outlet pressure or flow rate.

Embodiments of the various shipping and dispensing systems of the present invention have several advantages over conventional packaging systems. Many advantages have been pointed out throughout the application, and such advantages include, but are not limited to, sterility from the time of filling to completion of the dispensing; bacterial intrusion substantially reduced or eliminated during filling; contents of the liner Longer storage period; portable dispensing; automatic dispensing of aseptic dispensing; easier portable dispensing, which eliminates manual pump dispensing. Other advantages will be recognized by those skilled in the art, and such advantages may vary depending on the industry application.

In the above description, various embodiments of the invention have been presented for purposes of illustration and description. The embodiments are not intended to be exhaustive or to present the invention Limited to the precise form disclosed. In light of the above teachings, obvious modifications or variations are possible. The embodiments were chosen and described in order to provide a description of the embodiments of the invention Specific use. All such modifications and variations are within the scope of the invention as determined by the scope of the appended claims.

100‧‧‧Transport and distribution system

102‧‧‧Second layer packaging

104‧‧‧ liner

106‧‧‧Second layer packaging wall

108‧‧‧Internal cavity

110‧‧‧Export

112‧‧‧ liner wall

114‧‧‧Internal cavity

116‧‧‧Export

118‧‧‧Matching part

120‧‧‧Thread

122‧‧‧Transport and fill connectors

124‧‧‧Complementary thread

126‧‧‧film

200‧‧‧One-way dispensing valve

202‧‧‧ Elastomers

204‧‧‧Plunger

206‧‧‧Export tube

208‧‧‧Base

210‧‧‧ dispensing opening

220‧‧‧Orientation direction

306‧‧‧ gas pressure intake line

310‧‧‧ Side wall of the liner

312‧‧‧ liner

320‧‧‧The inner wall of the container

340‧‧‧ gas or fluid source

360‧‧‧With connector

362‧‧‧One-way outlet valve

400‧‧‧Portable storage and distribution system

410‧‧‧ outer wall

412‧‧‧ liner

420‧‧‧With connector

460‧‧‧pressure source

480‧‧‧One-way dispensing valve

502‧‧‧ liner and second layer packaging system

504‧‧‧Indirect pressure distribution components

506‧‧‧ Pressure Sensor/Sensor

508‧‧‧Pressure solenoid

510‧‧‧Exhaust port solenoid

610‧‧‧Liquid pressure drop

612‧‧‧ rise

700‧‧‧Storage and distribution system

702‧‧‧ liner and second layer packaging

720‧‧‧Package components

730‧‧‧Reinforcement components

740‧‧‧Handle or handle slot/opening

Although the patent specification ends with a specific claim that is expressly stated and clearly claimed as the subject matter of the various embodiments of the present invention, the present invention will be better understood from the following description in conjunction with the accompanying drawings in which: FIG. A cross-sectional view of a shipping and dispensing system of one embodiment of the present invention.

Figure 2 is a cross-sectional view of the outlet valve of the dispensing connector in accordance with one embodiment of the present invention.

Figure 3 is a schematic illustration of a dispensing system in accordance with one embodiment of the present invention.

Figure 4 is a schematic illustration of a dispensing system in accordance with another embodiment of the present invention.

Figure 5 illustrates a shipping and storage system for indirect pressure dispensing in accordance with one embodiment of the present invention.

Figure 6 illustrates statistics relating to the indirect pressure dispensing method illustrated in Figure 5 provided in graphical form in accordance with one embodiment of the present invention.

Figure 7 is a diagram of a package component including an embodiment of the present disclosure. A cross-sectional view of the delivery and dispensing system.

100‧‧‧Transport and distribution system

102‧‧‧Second layer packaging

104‧‧‧ liner

106‧‧‧Second layer packaging wall

108‧‧‧Internal cavity

110‧‧‧Export

112‧‧‧ liner wall

114‧‧‧Internal cavity

116‧‧‧Export

118‧‧‧Matching part

120‧‧‧Thread

122‧‧‧Transport and fill connectors

124‧‧‧Complementary thread

126‧‧‧film

Claims (20)

A liner-based assembly for pressure dispensing, the assembly comprising: a second layer package; a liner disposed within the second layer package; and a fill connector to which the fill connector can be secured At least one of the second layer of packaging and the liner, the connector comprising a film for substantially aseptic filling. The liner-based assembly of claim 1 wherein the film comprises a resealable elastomeric stop. The liner-based assembly of claim 2, wherein the resealable elastomeric stop is configured for resealing by heat. The liner-based assembly of claim 2, wherein the liner and the second layer of packaging are illuminated. The liner-based assembly of claim 1, the assembly further comprising a distribution connector operatively coupled to the second layer package and the liner cylinder on the filler connector Connected, the dispense connector is at least one of: includes a one-way valve or is operatively coupled to a one-way valve. The liner-based assembly of claim 5, wherein the liner cylinder is retractable away from the second layer package. The liner-based assembly of claim 6, further comprising a portable pressure source for pressurizing an annular space between the second layer of packaging and the liner to retract the liner The contents of the liner are dispensed. The liner-based assembly of claim 5, wherein the one-way valve includes an elastomeric portion defining an opening and operatively coupled to a plunger member located within the opening, The plunger member is relatively stiff compared to the elastomer portion, wherein in a closed position the elastomer portion is sealable relative to the plunger member, and wherein the elastomer portion is applied when a pressure is applied to the elastomer portion It can be configured to allow only one-way flow to bend through one of the openings. A method for providing a sterile delivery and pressure dispensing system, the method comprising the steps of: providing a second layer of packaging and a liner disposed within the second layer of packaging; illuminating the second layer of packaging and liner To obtain a sterile effect; and to secure a connector to at least one of the second layer package and the liner, the connector comprising a film for substantially aseptic filling. The method of claim 9 wherein the film comprises a resealable cartridge Sexual stop. The method of claim 10, the method further comprising the step of filling the liner by piercing the elastomeric stopper with a needle and passing a substance through the needle into the liner. The method of claim 11, the method further comprising the step of removing the needle after the filling is completed and heat is applied to help reseal the elastomeric stop. The method of claim 11, the method further comprising the step of removing headspace gas from the interior of the liner after completion of filling the liner. The method of claim 13 wherein the connector includes a one-way valve for allowing headspace gas to exit the liner in one direction. The method of claim 9, the method further comprising the step of providing a connector operatively coupled to at least one of the second layer package and the liner, the dispense connector being At least one of: includes a one-way valve or is operatively coupled to a one-way valve. The method of claim 15, wherein the step of providing a connector is provided The step includes the step of providing a portable pressure source for pressurizing an annular space between the second layer of packaging and the liner. The method of claim 16 wherein the portable pressure source comprises a disposable compressed gas cartridge. A liner-based assembly for pressure dispensing, the assembly comprising: a second layer package; a liner disposed within the second layer package, the liner being configured to introduce a gas or fluid to The second layer of packaging and the liner are then retracted from the second layer of packaging; and a dispensing connector is affixed to the second layer of packaging and at least one of the liners The dispensing connector includes one passage in fluid communication with the annular space, and is at least one of: at least one unidirectional dispensing valve in fluid communication with one of the interiors of the liner or operatively coupled thereto One-way dispensing valve. The liner-based assembly of claim 18, wherein the one-way valve includes an elastomeric portion defining an opening and operatively coupled to a plunger member located within the opening, The plunger member is relatively stiff compared to the elastomer portion, wherein in a closed position the elastomer portion is sealable relative to the plunger member, and wherein the elastomer portion is applied when a pressure is applied to the elastomer portion It can be configured to allow only one-way flow to bend through one of the openings. The liner-based assembly of claim 18, wherein the liner and the second layer of packaging are illuminated.