EP4046713A1 - Beta-container for alpha-beta location system - Google Patents

Abstract

A beta container for an alpha-beta port system has an in particular flexible sleeve (6) for receiving transport material and a flange part (1) which has a through-opening (1.3) for transferring transport material from and/or into the Cover, a first interface (1.1) for the reversible connection to an alpha connection of the alpha-beta port system, and a second interface (1.2) for the detachable attachment of a beta cover (5) for closing the through-opening, wherein an edge ( 6.1) the sleeve is materially connected to a first surface (2.1) of a ring (2) which surrounds a lateral surface of the flange part, the first surface and lateral surface having different materials; and/or an elastic bellows (8) is fastened to the flange part, in particular in the through-opening, in such a way that in the relaxed state it overlaps the second interface and/or protrudes from the through-opening on the side facing away from the casing and that it, in particular through a beta cover (5) attached to the second interface and/or on a side of the second interface facing the casing, and/or at least one, in particular passive, transponder (9) for transmitting an identification is arranged on, in particular in, the flange part .

Description

The present invention relates to a beta container for an alpha-beta port system, an alpha-beta port system with the beta container, a use of the beta container and a method for producing the beta container.

Alpha-beta port systems (also "rapid transfer port") are known in principle and are used to transfer material quickly and without contamination from a container, the beta container, into an isolation room and/or from the isolation room into the container.

The so-called alpha port has an alpha connection and an alpha door, the beta container has a flange part for connection to the alpha connection (of the isolation room). A beta cover for closing the beta container can be detachably fastened to the flange part and, after the beta container or flange part has been connected to the alpha connection, is connected to the alpha door and released from the beta container or transferred to it so that it can be opened together with this, the non-sterile face of the beta lid being covered by the alpha door.

An object of an embodiment of the present invention is to provide an advantageous alpha-beta port system and/or an advantageous beta container therefor and/or to improve the manufacture thereof.

This object is solved by a beta container with the features of claim 1. Claims 10-12 protect an alpha-beta port system with one or more beta containers described here, a use of a beta container described here or a method for the production thereof. The dependent claims relate to advantageous developments.

According to one embodiment of the present invention, a beta container for, in particular, an alpha-beta port system(s) has a cover that transports material in one embodiment accommodates goods to be transported or is set up or used for this purpose.

In one embodiment, the sheath is flexible. As a result, handling can be improved in one embodiment. In another embodiment, the shell is rigid. As a result, their content can be protected in one embodiment. In one embodiment, the casing is closed, in particular hermetically sealed, except for its edge mentioned below or its connection to the flange part mentioned below.

According to one embodiment of the present invention, the beta container has a flange part which has a through opening for the transfer of transport material from and/or into the envelope, a first interface for reversible connection to an alpha connection of the alpha-beta port system, and a second interface for releasably attaching a beta cap to close the port.

In one embodiment, the first and/or second interface (each) is a bayonet lock interface. In this way, in one embodiment, the flange part can be fastened to the alpha connection or port or the beta cover to the flange part particularly securely, easily and/or quickly.

According to one aspect of the present invention, an edge of the sleeve is or will be materially bonded to a preferably radially outer surface of a ring, which is referred to here as the first surface without loss of generality, which surrounds a lateral surface of the flange part, in a further development welded. In one embodiment, the edge of the sleeve is or will be materially bonded to the first surface of the ring over the entire ring circumference and/or over an axial width of at least 5 mm and/or the first surface of the ring is a radially outer surface facing away from the lateral surface and/or the shell covers the ring on at least 50%, preferably at least 90%, of the first surface. In one embodiment, the ring is or will be connected to the flange part, in particular the lateral surface of the flange part, in a form-fitting and/or material-locking manner, preferably via or by means of the first seal(s) explained below. In particular, in one embodiment, the first surface and/or lateral surface has one or more shoulders, preferably at least one indentation, preferably an annular groove, and/or at least one, preferably circumferential, projection. As a result, in one embodiment, the tightness and/or connection between the shell and the flange part can be improved.

According to one embodiment of the present invention, the first surface (of the ring) and the outer surface (of the flange part) have different materials. In one embodiment, the first surface and the outer surface, in a further development the ring and the flange part, are made of different materials.

In one embodiment, this enables a particularly advantageous connection of the casing to the flange part, in particular if the casing (edge) material cannot be welded to the lateral surface or can only be welded with difficulty, in particular not or only with difficulty can be firmly bonded, and at the same time an optimal choice of material for the casing and Flange part, in particular a (better) sterilizable, in particular autoclavable, flange part or the like.

According to a further aspect of the present invention, which is particularly advantageously combined with the aspect of the ring, but can also be realized independently of this, an elastic bellows is or is attached to the flange part, preferably in the through-opening, in such a way that it is in a relaxed state State overlaps the second interface and/or protrudes from the through-opening on the side facing away from the casing and that it, in one embodiment, can be compressed or is or will be compressed.

Thus, in one embodiment, the bellows initially compressed by the cover fastened to the second interface expands automatically during or through or after opening the cover via the second interface and/or out of the through-opening, preferably out of the flange part or via one facing away from the casing outer face of the flange addition.

As a result, transport material can advantageously be better protected during transfer in one embodiment.

According to a further aspect of the present invention, which can be particularly advantageously combined with the aspect of the ring and/or the aspect of the bellows, but can also be implemented independently thereof, at least one transponder, which is passive in one embodiment, is or will be an identification is transmitted or set up or used for this purpose, preferably an RFID transponder or the like, arranged on, in one embodiment, in the flange part.

In this way, in one embodiment, the handling of the beta container can be improved, in particular its logistics and/or safety. The arrangement in the flange part or under an outer surface of the flange part allows the transponder to be protected particularly well in one embodiment.

In one embodiment, a seal, which is referred to here as the first seal without loss of generality, is arranged between the ring, in particular an inner peripheral surface of the ring, and the lateral surface. In a further development, the seal is or will be positively and/or materially attached to the ring, in particular the inner peripheral surface, and/or positively and/or materially bonded to the lateral surface (of the flange part) or connected thereto, in one embodiment at Production of the seal, in particular by injecting or injection molding or the like.

As a result, in one embodiment, the tightness and/or connection between the sleeve or ring and the flange part can be improved.

In one embodiment, the lateral surface (of the flange part) and the first seal are made of different materials, in one embodiment the lateral surface, in a further development the flange part and the first seal are made of different materials. Additionally or alternatively, in one embodiment, at least one surface, in particular the first surface and/or one or the inner peripheral surface opposite the lateral surface, of the ring on the one hand and the first seal on the other hand have different material; in one embodiment, the at least one surface of the ring is made of different materials , In particular the first surface and / or inner peripheral surface, in a development of the ring, and the seal made of different materials.

As a result, sealing of the container can advantageously be improved; in a further development, different thermal expansions of the ring and flange part can be compensated for in this way.

In one embodiment, a seal is or will be arranged on a side of the second interface of the flange part facing away from the casing, preferably on an end face of the flange part facing away from the casing, which is referred to here as the second seal without loss of generality, which has a beta attached to the second interface -Lid seals, embraces in one version, or is set up for this purpose. The second gasket is preferably arranged on an inner peripheral surface of the flange part.

As a result, in one embodiment, transport material can be better protected during transfer.

In one embodiment, the second seal is or will be connected to the first seal, in particular by one or more webs distributed over the circumference, in a further development it is produced together with this or these, preferably by injection or injection molding or injection molding or the like.

This may improve manufacturing and/or secure the first and second seals in one embodiment.

In one embodiment, the or one or more of the web(s) extends through a channel of the flange part.

As a result, in one embodiment, production can be improved and/or the web or webs can be protected.

In a preferred embodiment, the transponder is or will be in the first seal, the second seal or particularly preferably in the or one of the web(s) and/or a channel of the flange part, preferably in the web or one of the webs running through a channel of the flange part, preferably cast in together with the first and/or second seal when the web is being produced.

As a result, the transponder can be protected particularly well in one embodiment.

In one embodiment, the bellows is or will be fastened in the through-opening in a frictionally, form-fitting and/or cohesive manner via a preferably ring-shaped connecting body.

As a result, in one embodiment, the fastening of the bellows can be improved, in particular simplified and/or its reliability increased.

In one embodiment, the flange part has a higher heat deflection temperature according to DIN EN ISO 75-1, -2, -3 than the ring and/or the sleeve.

Additionally or alternatively, in one embodiment, the lateral surface of the flange part and an inner peripheral surface of the ring opposite it, preferably the flange part and the ring, cannot be welded to one another or are made of materials that cannot be welded to one another.

Additionally or alternatively, in one embodiment, the flange part, in particular its lateral surface, and/or the connecting body and/or the beta cover (each) has polycarbonate (PC) or the like; in a further development, the lateral surface, in particular the flange part, and/or or the compound body and/or the beta lid thereof.

Additionally or alternatively, in one embodiment, the ring, in particular its first surface and/or the inner peripheral surface opposite the lateral surface, and/or the casing, in particular its edge, (each) has polyethylene (PE) or the like, preferably PE-HD or PE- EVOH-PE or the like, in a further development the first surface and/or inner peripheral surface, in particular the ring, and/or the edge, in particular the casing, consists of this. In a development, the sleeve can additionally or alternatively have a Tyvek film or the like.

Additionally or alternatively, in one embodiment, the first and/or the second seal and/or the bellows and/or the web(s) each have EPDM or particularly preferably silicone or the like the second seal and/or the bellows and/or the web(s) thereof.

In this way, in one embodiment, the flange part and beta cover can be sterilized particularly well and/or the connection to the alpha connection or the fastening of the cover can be improved and additionally or alternatively particularly advantageous, particularly cheap and/or flexible, covers can be used and/or the sealing and/or connection between ring surface and seal or seal and flange part lateral surface can be improved.

According to an embodiment of the present invention, an alpha-beta port system comprises one or preferably more beta containers as described herein and one or more alpha ports with (each) a mating interface for reversibly connecting this or one this beta container(s) via its first interface.

According to one embodiment of the present invention, a beta container described here is used or provided for this purpose, in particular, for the sterile transfer of material from the interior of the container into an isolation space of one or the alpha-beta port system and/or from the isolation space into the interior of the container furnished.

In one embodiment, an identification is transmitted by the transponder, which in one embodiment can improve logistics and/or security.

Additionally or alternatively, the beta container or its flange part is reversibly connected to one or the alpha port of the alpha-beta port system via its first interface and its beta cover is connected to an alpha door of the alpha port and opened.

In one embodiment, the identification is transmitted from the transponder before connection, which in one embodiment can improve logistics. Additionally or alternatively, in one embodiment, the Identification from the transponder when connecting, which in one embodiment can improve security. Additionally or alternatively, in one embodiment, the identification is transmitted by the transponder after connection, as a result of which the logistics and/or security can be (further) improved in one embodiment.

Additionally or alternatively, in one embodiment, the bellows relaxes, preferably as a result of this opening, and as a result preferably projects out of the through-opening and/or overlaps the second interface.

According to one embodiment of the present invention, a method for manufacturing a beta container described here has the step: materially connecting the edge of the casing to the ring, and in one embodiment positively and/or materially connecting the ring and flange part and/or, preferably for this purpose or by arranging, preferably producing, the first seal between the lateral surface and the ring, in one embodiment together with the second seal and optionally the web(s), in particular with casting of the transponder.

In a further development, the edge of the sleeve is connected to the ring that is (still) spaced apart from the flange part, as a result of which the handling of the sleeve and ring can be made easier in one embodiment. In another development, the edge of the sleeve is connected to the ring that has already been joined to the flange part, as a result of which the connection can be improved in one embodiment.

Additionally or alternatively, in a further development, the first seal, in one embodiment together with the second seal and optionally the web(s), in particular with casting of the transponder, before or after the ring is bonded to the edge of the shell between the Lateral surface and the ring arranged, in particular manufactured.

According to an embodiment of the present invention, a or the method for manufacturing a beta container described herein comprises the step of: fastening the bellows to the flange part, preferably in the through opening, and in a Development Compression of the bellows fastened in the passage opening by the cover fastened at the second interface.

According to one embodiment of the present invention, a or the method for manufacturing a beta container described here has the step: arranging the at least one transponder on, in particular in, the flange part, in particular in the channel and/or before manufacturing the web.

In one embodiment, the flange part of the beta container is in one piece (manufactured). In this way, the stability and/or tightness can be improved in one embodiment. In another embodiment, it is made up of several parts. In other words, the term flange part does not necessarily imply a one-piece component.

In one embodiment, the beta container is intended for one-time use ("single use"), in particular set up, or is used for this purpose. As a result, in one embodiment, the casing in particular can be optimized, in particular with regard to weight, fatigue strength or the like. In another embodiment, the beta container is intended for repeated or repeated use, in particular set up, or is used for this purpose. As a result, the environment can be protected in one embodiment.

Fig. 1:

einen beta-Behälter nach einer Ausführung der vorliegenden Erfindung in Explosionsdarstellung;

Fig. 2:

einen Schnitt durch ein Flanschteil des Behälters mit befestigtem beta-Deckel und komprimiertem Faltenbalg;

Fig. 3:

den Schnitt der Fig. 2 mit entferntem Deckel und entspanntem Faltenbalg;

Fig. 4:

eine perspektivische Ansicht des Flanschteils; und

Fig. 5:

ein alpha-beta-Portsystem mit dem beta-Behälter nach einer Ausführung der vorliegenden Erfindung.

• Fig. 1 zeigt einen beta-Behälter nach einer Ausführung der vorliegenden Erfindung in Explosionsdarstellung mit
  • einem Flanschteil 1, der eine erste Schnittstelle 1.1 zum reversiblen Anschluss an einen alpha-Anschluss 10 eines alpha-beta-Portsystems in an sich bekannter Weise sowie eine Durchgangsöffnung 1.3 aufweist,
  • einer Hülle 6, deren Rand 6.1 mit einer ersten Oberfläche 2.1 eines Rings 2 verschweißt ist bzw. wird,
  • einer ersten Dichtung 3, die zwischen einer inneren Umfangsfläche 2.2 des Rings 2 und einer Mantelfläche 1.4 des Flanschteils 1 angeordnet ist bzw. wird und dadurch Mantel- und innere Umfangsfläche bzw. Flanschteil und Ring miteinander verbindet,
  • einer zweiten Dichtung 4, die zusammen mit der ersten Dichtung hergestellt ist bzw. wird,
  • einem beta-Deckel 5, der in an sich bekannter Weise mittels bzw. an einer zweiten Schnittstelle 1.2 des Flanschteils 1 lösbar befestigt ist bzw. wird bzw. hierzu eingerichtet ist,
  • einem elastischen Faltenbalg 8, der über einen Verbindungskörper 7 in der Durchgangsöffnung befestigt ist bzw. wird, und
  • einem RFID-Chip 9, der in einem Steg 34, der die erste und zweite Dichtung verbindet und in einem Kanal 1.34 des Flanschteils 1 angeordnet bzw. hergestellt ist bzw. wird, eingegossen ist bzw. wird.
• Fig. 2 zeigt einen Schnitt durch das Flanschteil des Behälters mit an der zweiten Schnittstelle befestigtem beta-Deckel, der dadurch den Faltenbalg auf eine hüllenzugewandte Seite der zweiten Schnittstelle (links in Fig. 2) komprimiert.
• Fig. 3 zeigt den Schnitt der Fig. 2 mit entferntem Deckel. Der dadurch entspannte Faltenbalg übergreift die zweite Schnittstelle und ragt auf der hüllenabgewandten Seite (rechts in Fig. 3) aus der Durchgangsöffnung heraus.

Further advantages and features emerge from the dependent claims and the exemplary embodiments. This shows, partially schematized:

Figure 1:

an exploded view of a beta container according to an embodiment of the present invention;

Figure 2:

a section through a flange portion of the container with attached beta lid and compressed bellows;

Figure 3:

the cut of the 2 with cover removed and bellows relaxed;

Figure 4:

a perspective view of the flange part; and

Figure 5:

an alpha-beta port system with the beta container according to an embodiment of the present invention.

• 1 Figure 13 shows an exploded view of a beta container according to an embodiment of the present invention
  • a flange part 1, which has a first interface 1.1 for reversible connection to an alpha connection 10 of an alpha-beta port system in a manner known per se and a through opening 1.3,
  • a sleeve 6, the edge 6.1 of which is welded to a first surface 2.1 of a ring 2,
  • a first seal 3, which is or is arranged between an inner circumferential surface 2.2 of the ring 2 and a lateral surface 1.4 of the flange part 1 and thereby connects the lateral and inner circumferential surface or flange part and ring with one another,
  • a second gasket 4 made together with the first gasket,
  • a beta cover 5, which is or will be detachably fastened in a manner known per se by means of or at a second interface 1.2 of the flange part 1, or is set up for this purpose,
  • an elastic bellows 8 fixed in the through-hole via a connecting body 7, and
  • an RFID chip 9 cast in a web 34 connecting the first and second seals and arranged or manufactured in a channel 1.34 of the flange part 1.
• 2 shows a section through the flange part of the container with the beta lid attached to the second interface, which thereby places the bellows on a side of the second interface facing the casing (left in 2 ) compressed.
• 3 shows the cut of the 2 with the lid removed. The resulting relaxed bellows overlaps the second interface and protrudes on the side facing away from the hull (on the right in 3 ) out of the passage opening.

In addition, 3 a weld seam 26 between the casing edge 6.1 and ring surface 2.1 is indicated.

In the perspective partial flange view of 4 the flange part is shown transparently in order to illustrate the first and second seals 3, 4 and the four webs 34 distributed over the circumference connecting them, with the RFID chip 9 being cast in one of the webs. For this purpose, silicone is injected in one shot, so that at the same time the second seal 4 is produced, the RFID chip is fixed and the ring is connected to the flange part.

Although exemplary embodiments have been explained in the preceding description, it should be pointed out that a large number of modifications are possible. In addition, it should be noted that the exemplary implementations are only examples and are not intended to limit the scope, applications, or construction in any way. Rather, the above description gives the person skilled in the art a guideline for the implementation of at least one exemplary embodiment, with various changes, in particular with regard to the function and arrangement of the components described, being able to be made without departing from the scope of protection as it emerges from the claims and these equivalent combinations of features.

Reference character list

1

flange part

1.1

first interface

1.2

second interface

1.3

passage opening

1.4

lateral surface

1.34

channel

2

ring

2.1

first surface

2.2

inner peripheral surface

3

first seal

4

second seal

5

beta lid

6

Covering

6.1

edge

7

connecting body

8th

bellows

9

transponder

10

Alpha connection

26

Weld

34

web

Claims (12)

beta container for an alpha-beta port system, with: a, in particular flexible, sleeve (6) for receiving transport material; and a flange part (1), the a through-opening (1.3) for the transfer of transport material out of and/or into the casing, a first interface (1.1) for reversible connection to an alpha port of the alpha-beta port system, and a second interface (1.2) for the detachable attachment of a beta cover (5) for closing the passage opening having; characterized in that an edge (6.1) of the sleeve is materially connected to a first surface (2.1) of a ring (2) which surrounds a lateral surface (1.4) of the flange part, wherein the first surface and lateral surface have different material; and/or by that an elastic bellows (8) is fastened to the flange part, in particular in the through-opening, in such a way that in the relaxed state it overlaps the second interface and/or projects out of the through-opening on the side facing away from the casing and that it, in particular through one at the second interface attached beta-lid (5) and/or on a shell-facing side of the second interface, is compressible; and/or because at least one, in particular passive, transponder (9) for transmitting an identification is arranged on, in particular in, the flange part. Beta container according to Claim 1, characterized in that a first seal (3) is arranged between the ring and the lateral surface, in particular is fastened to the ring and/or the lateral surface in a form-fitting and/or material-locking manner. Beta container according to the preceding claim, characterized in that the first seal and at least one surface of the ring, in particular the first surface, and/or the first seal and the lateral surface have different material and/or on a side facing away from the shell a second seal (4) is arranged at the second interface, in particular on an inner peripheral surface of the flange part, in order to seal, in particular to encompass, a beta cover attached to the second interface. Beta container according to the preceding claim, characterized in that the second seal is connected to the first seal, in particular by at least one web (34), in particular is produced together with the latter. Beta container according to the preceding claim, characterized in that the at least one web reaches through a channel (1.34) of the flange part, Beta container according to one of the preceding claims, characterized in that the transponder is arranged in the first seal, the second seal or the web and/or one, in particular the channel of the flange part. Beta container according to one of the preceding claims, characterized in that the bellows is fastened in the through-opening via a connecting body (7) in a frictional, form-fitting and/or material-locking manner. Beta container according to one of the preceding claims, characterized in that the ring and shell are welded together, that the flange part has a higher heat deflection temperature according to DIN EN ISO 75-1, -2, -3 than the ring and/or the shell, that the lateral surface of the flange part and an inner peripheral surface (2.2) of the ring opposite it cannot be welded to one another, that the flange part, in particular its lateral surface, and/or the connecting body and/or the beta cover has polycarbonate or the like, that the ring, in particular its first surface, and/or the sleeve comprises polyethylene or the like, that the first and/or second seal and/or the web and/or the bellows comprises EPDM, silicone or the like, and/or that the transponder is an RFID transponder is. A beta container according to any one of the preceding claims, having the beta lid releasably attachable to the second interface. Alpha-beta port system with at least one beta container according to one of the preceding claims and at least one alpha port with a counter-interface for the reversible connection of this beta container via its first interface. Use of a beta container according to one of the preceding claims for the sterile transfer of material from the interior of the container into an isolation space of an alpha-beta port system and/or from the isolation space into the interior of the container, wherein - an identification is transmitted by the transponder; and or; - In particular before, during and/or after, the beta container is reversibly connected to an alpha port of the alpha-beta port system via its first interface and its beta cover is connected to an alpha door of the alpha port and opened ; and or - In particular, as a result of this opening, the bellows relaxes and thereby overlaps the second interface and/or protrudes from the through-opening. A method of making a beta container according to any one of the preceding claims, including at least one of the steps: - Cohesively connecting the edge of the casing to the ring, in particular spaced apart from or joined to the flange part, and in particular arranging, in particular producing, the first seal between the lateral surface and the ring, in particular together with the second seal and/or in front of or after the ring is bonded to the edge of the casing; - Fastening the bellows to the flange part, in particular in the through-opening, and in particular compressing the bellows fastened in the through-opening by the cover fastened to the second interface; and or - Arranging the at least one transponder on, in particular in, the flange part, in particular in the channel and/or before producing the web.

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