DE102021114896A1 - Transfer bag, transfer procedure and transfer set - Google Patents

Abstract

The invention deals, inter alia, with the problem of being able to transfer a transfer item in a second step in preparation for a transfer of a transfer item from a transfer bag into a sterile area, of introducing the transfer item into the transfer bag in a sterile manner. This is achieved, among other things, by a transfer bag, inside which a cutting tool is placed in a sterile condition. The transfer bag can be coupled with an outer packaging of the transfer item for a sterile transfer of the transfer item from the outer packaging into the transfer bag. In addition to a transfer bag, the invention also relates to a method and a transfer set.

Description

The invention relates to a transfer bag for the sterile transfer of a transfer item from the transfer bag (5) into a sterile area according to the preamble of claim 1, a method for the sterile transfer of a transfer item packaged sterile in an outer packaging from an outer packaging to a transfer bag and a transfer set.

In order to fill medical preparations, it is often necessary to provide a medical active ingredient, sterile tools and/or packaging material in a sterile environment, in particular for filling individual doses of the medical active ingredient. The medicinal active substance can, for example, be filled into ampoules that can be closed with a stopper. Sterile areas are used for sterile filling, it being necessary for the sterile filling of a medical active ingredient in a sterile area to introduce the sterile packaging material and/or work equipment into the sterile area in addition to the medical active ingredient.

A sterile area or an aseptic area is to be understood as meaning any sterile workplace that is shielded from the outside and is generally delimited by appropriate walls and is protected in a special way against the ingress of dirt, particles and germs or other contamination. In particular, a sterile area fulfills the classification of the cleanliness of the room according to the ISO 14644-1 standard (class ISO 4.8 or 5) or the requirements of the EU-GMP guidelines for human and veterinary medicinal products, Annex 1 (manufacturing of sterile medicinal products). Appropriate protection is usually achieved by low-turbulence displacement flow using conditioned, filtered air (H14 filter). For the purposes of the invention, a sterile area is also to be understood, in particular, as isolators and RABS (restricted barrier access systems).

For the sterile introduction of sterile packaging material into a sterile area, various lock systems are known from the prior art, which comprise a wall with a lock to which a transfer container with transfer goods packed in a sterile manner, such as packaging material or medical substances, for transferring the transfer goods from the non-sterile environment can be docked in the sterile area. For this purpose, the transfer containers have standardized interfaces that can be coupled to the lock.

The interfaces can be designed, for example, as an annular flange forming an opening with a closure inserted therein to form a seal.

Common airlock systems are, for example, alpha-beta port systems, in which transfer containers are docked to an airlock that can be closed with an airlock door in such a way that a non-sterile outside of the airlock door and a non-sterile outside of a lock of the transfer container cover each other and to produce a Connection between the inside of the transfer container and the sterile area, the lock door can be removed together with the lock of the transfer container from the lock opening. When the lock door is opened and during the transfer of the transfer item from the inside of the transfer container into the sterile area, contamination of the transfer item with particles and germs brought in from the outside environment can be at least essentially ruled out.

Similar to a deposit system, such transfer containers can be made available by the manufacturer of the goods to be transferred, for example, and sent back to the manufacturer after use. α/β-port systems are associated with high costs.

An alternative are transfer bags intended for single use, which are mostly made of plastic, in which the transfer material is packaged in a sterile manner and which can be disposed of after the transfer material has been transferred to the sterile area. However, as with α/β-port systems, this is usually associated with high costs.

Exemplary transfer bags show the EP2504101B1 , the EP0865382B1 or the US5816772 A. From the EP2504101B1 and the US5816772 A are known here transfer bags made of plastic with a connecting flange worked into the transfer bag made of a material different from plastic. From the EP0865382B1 a transfer bag with a connecting flange made of the plastic material of the transfer bag is known.

The transfer bags mentioned have the disadvantage that the transfer material to be transferred has to be sterilely packaged in the transfer bag by the manufacturer. With these transfer bags, it is therefore not possible to transfer individual transfer items or groups of transfer items that are not packed in transfer bags adapted to the lock system into a transfer bag with an interface tailored to the lock system of the sterile area in a sterile manner on site in order to transfer the material to be transferred to the sterile area using the transfer bag.

Against this background, it is an object of the invention to provide a transfer bag and a method for transferring a transfer item packaged sterilely in an outer packaging into a transfer bag, which make it possible to insert the sterile packaged transfer item directly into the transfer bag at the point of use. It should be avoided that only the manufacturer's sterile packaging of the transfer item can be used to transfer the transfer item into the sterile area. Furthermore, it should also be possible for partial quantities or small quantities of individual transfer goods, which are not produced in large series, or individually composed groups of transfer goods, to be able to be transferred sterile to a sterile area, in particular an aseptic work area.

These tasks are solved by a transfer bag with the features of claim 1 and a method with the features of claim 7. The tasks are also solved by a transfer set according to claim 13.

• Die sterile Übergabe des Transferguts aus der Umverpackung in den Transferbeutel (nachfolgend auch als „erster Transferschritt“ bezeichnet) dient dabei vorbereitend für den sterilen Transfer des Transferguts aus dem Transferbeutel in einen Sterilbereich (nachfolgend auch als „zweiter Transferschritt“ bezeichnet), wobei der Transferbeutel eine für den zweiten Transferschritt vorgesehene Schnittstelle mit einer Öffnung aufweist, die an eine Schleuse des Sterilbereichs koppelbar ist. Die Schnittstelle kann beispielsweise einen Ringflansch mit einer Öffnung und einen in der Öffnung dichtend eingesetzten Verschluss umfassen. Über die Schnittstelle kann der Transferbeutel an die Schleuse des Sterilbereichs gekoppelt und dadurch eine sterile Verbindung zwischen dem Sterilbereich und einem Innenvolumen des Transferbeutels zur sterilen Übergabe des Transferguts in den Sterilbereich hergestellt werden.

One aspect of the invention provides a method for the sterile transfer of a transfer item packaged sterile in an outer packaging from the outer packaging into a transfer bag:

• The sterile transfer of the transfer item from the outer packaging into the transfer bag (hereinafter also referred to as the "first transfer step") serves in preparation for the sterile transfer of the transfer item from the transfer bag to a sterile area (hereinafter also referred to as the "second transfer step"), with the transfer bag has an interface provided for the second transfer step with an opening which can be coupled to a lock of the sterile area. The interface can, for example, comprise an annular flange with an opening and a closure sealingly inserted in the opening. The transfer bag can be coupled to the lock of the sterile area via the interface and a sterile connection can thereby be established between the sterile area and an inner volume of the transfer bag for the sterile transfer of the transfer material into the sterile area.

The transfer bag has a non-sterile outside and a sterile inside that encloses a volume. The transfer material is already packaged sterile in an outer packaging. The outer packaging can in particular be outer packaging made of plastic, for example a plastic film. The outer packaging also consists of a non-sterile outside and a sterile inside, with the inside enclosing a volume in which the transfer material is enclosed in a sterile manner.

1. a) Stoffschlüssiges Verbinden der Außenseite der Umverpackung mit der Außenseite des Transferbeutels in einem ersten Transferbereich des Transferbeutels,
2. b) Einbringen eines Einschnitts in den ersten Transferbereich über eine Schnittlänge, sowie
3. c) Überführen des sterilen Transferguts aus der Umverpackung in den Transferbeutel durch den Einschnitt.

The method comprises the following steps, preferably in the order given here:

1. a) Cohesively connecting the outside of the outer packaging to the outside of the transfer bag in a first transfer area of the transfer bag,
2. b) making an incision in the first transfer area over an incision length, and
3. c) Transferring the sterile transfer material from the overpack into the transfer bag through the incision.

The outer sides of the outer packaging and the transfer bag are preferably connected in a materially bonded manner by gluing. An expedient connection can be made here by means of an adhesive applied to or between the outer sides of the outer packaging and the transfer bag or by means of a two-sided adhesive tape section. The adhesive tape section is coated on both sides with a contact adhesive. The use of a two-sided piece of adhesive tape offers the advantage of easy handling without additional tools and a very short processing time.

Alternatively, the integral connection according to method step a) can also be produced by heat-sealing the outside of the transfer bag and the outer packaging. It must be ensured that only the outside of the transfer bag and the outer packaging are welded together. In order to create the material connection between the outside of the transfer bag and the outer packaging by welding, the transfer bag should be accessible from its inside, i.e. from the inside of the transfer bag or its volume. The welding can be done with heat (thermal welding) and/or with ultrasound, for example.

An incision is expediently made in the materially bonded connection of the outsides of the transfer bag and the outer packaging according to method step b) to connect the volumes of the transfer bag and the outer packaging using a cutting tool, with the cutting tool already being sterilely enclosed in the volume of the transfer bag during production of the transfer bag or after was terminally sterilized together with the transfer bag prior to insertion. To make the incision, the cutting tool can be operated manually from the outside in order to penetrate the materially connected outer sides of the transfer bag and the outer packaging. Through this incision, the transfer material in a sterile manner from the outer packaging can be transferred to the transfer bag.

The incision can advantageously be kept open by a retractor for the sterile transfer of the transfer material from the outer packaging into the transfer bag, the retractor being contained in the transfer bag in a sterile manner for this purpose, analogously to the cutting tool.

As an alternative or in addition, further sterile tools can also be introduced into the transfer bag, which are required to produce the materially bonded connection of the transfer bag and the outer packaging, for example a painting aid (squeegee) or an electric welding device.

The area of the transfer bag that includes the material connection with the outer packaging is referred to below as the first transfer area.

The internal volume of the transfer bag is advantageously subdivided into a first transfer area and a second transfer area of the transfer bag, which is separated therefrom, after the transfer item has been transferred into the transfer bag. The separation of the first transfer area from the second transfer area can take place in particular by thermal welding along a weld seam. In this case, the material to be transferred is located in the second transfer area and the cutting tool advantageously remains in the first transfer area and can be discarded after the incision has been made by separating the first transfer area from the second transfer area. The first transfer area can be separated from the second transfer area by cutting along the weld seam or directly in thermal welding when the weld seam is separated. As a result, the second transfer area of the transfer bag is closed in a sterile manner after the transfer item has been transferred into this second transfer area.

• Der Transferbeutel bildet ein geschlossenes und innenseitig sterilisiertes Volumen, in welches ein Transfergut aufgenommen werden kann, wobei in dem Transferbeutel ein Schneidwerkzeug steril eingeschlossen ist. Dabei enthält der Transferbeutel eine Schnittstelle mit einer Öffnung, über die der Transferbeutel mit einer Schleuse eines Sterilbereiches gekoppelt werden kann, um das in den Transferbeutel eingebrachte Transfergut in einem zweiten Transferschritt aus dem Transferbeutel in den Sterilbereich zu übergeben.

The invention also relates to a transfer bag for carrying out the method described above:

• The transfer bag forms a closed volume that is sterilized on the inside, in which a transfer item can be accommodated, with a cutting tool being enclosed in a sterile manner in the transfer bag. The transfer bag contains an interface with an opening via which the transfer bag can be coupled to a lock of a sterile area in order to transfer the transfer material placed in the transfer bag out of the transfer bag into the sterile area in a second transfer step.

In this case, the cutting tool can be enclosed completely and freely movable in the transfer bag. However, it is also possible for the cutting tool to be sterilely enclosed in the transfer bag only with a section comprising a blade of the cutting tool and in particular for a handling aid, such as a handle of the cutting tool, to protrude from the transfer bag through a sealed opening. A handling aid protruding from the transfer bag makes it easier to use and guide the cutting tool.

A cutting tool included in the transfer bag provides a simple and safe way to open the transfer bag from the inside in a sterile manner by making an incision as indicated in the method description above.

For ease of manufacture, the transfer bag is advantageously made from two plastic foils which are brought into alignment and which are welded to one another around the circumference on the outside. As a result, a very cost-effective transfer bag that is easy to manufacture can be provided.

The transfer bag is sterilized on the inside during manufacture, together with the cutting tool and the interface located inside.

In the event that the cutting tool is to be located only partially with its cutting device inside the transfer bag, the cutting tool can advantageously have a cuff or a collar made of a weldable plastic for easy connection to the transfer bag, which in the course of the manufacturing process is bonded to the plastic, in particular the plastic films of the transfer bag is welded.

The cutting edge of the cutting tool located in the transfer bag is advantageously provided with a detachable protective cap. This can prevent the transfer bag from being opened unintentionally.

The cutting tool can also be designed as a folding or snap knife or as scissors. The foldable tool can be arranged in a box located in the transfer bag, from which the foldable tool jumps up or out, for example at the push of a button. The box can also be materially connected to the transfer bag. A surface of Box can advantageously serve as a cutting base.

In an expedient embodiment, the cutting tool can be arranged in a pocket, an indentation or protuberance or a bulge of the transfer bag. In order to reduce the freedom of movement of the cutting tool, the pocket or the indentation or protuberance can also be separated from the first transfer area of the transfer bag, in which the cutting tool is located, by a tearable (peelable) thermal weld seam. In addition or as an alternative, the cutting tool can also be detachably mounted in a holding device, for example made of hard plastic. These measures can avoid or at least reduce the risk of the transfer bag being accidentally severed.

In an advantageous embodiment, a retractor is contained in the transfer bag next to the cutting tool. Retractors are spreading tools with which cuts and openings can be widened, kept open and cut or opening edges can be covered. The use of a retractor makes it easier to transfer the transfer item from the outer packaging into the transfer bag through the previously made incision, without the transfer item being able to come into contact with the cut edges of the incision, which are critical with regard to sterility.

The transfer bag expediently consists of a thermoplastic and in particular a translucent plastic and in particular a plastic film. A thermoplastic expands the processing options, particularly with regard to weldability. A translucent plastic allows not only a simple inspection of the contents of the transfer bag, but also a safe and accurate visual guidance of the cutting tool when making the incision.

In an advantageous development, the transfer bag comprises a first transfer area for carrying out a first transfer step and a second transfer area for carrying out a second transfer step, the cutting tool being arranged in the first transfer area and the interface being arranged in the second transfer area. The first and second transfer areas are separated from one another, for example by a thermal weld seam or by clamping the transfer bag with a clamp along a clamping line. In this way, the cutting tool in particular can be removed from the transfer bag after use without damaging sterility.

In an advantageous embodiment, the interface of the transfer bag is an adapter plate with an opening therein, the adapter plate being freely enclosed within the transfer bag. This facilitates both the manufacture of the transfer bag and the handling of the transfer bag and the adapter plate. In addition, after use, the adapter plate can simply be removed from the transfer bag, sterilized and inserted into a new transfer bag. As a result, production costs can be reduced compared to transfer bags with an interface that is integrally integrated into the transfer bag, such as a ring flange.

It is particularly advantageous if the adapter plate is enclosed in a separate volume within the second transfer area of the transfer bag. The separate volume can be formed by a partition arranged in the second transfer area or by a liner, so that the adapter plate and the transfer material are enclosed in separate volumes of the second transfer area after the first transfer step has been carried out. This can reduce the risk of accidental contact with a critical contact area ("ring of concern") described below when performing the second transfer step.

Another aspect of the invention provides a transfer set for the sterile transfer of a transfer item packaged in a sterile manner in an outer packaging from the outer packaging into a transfer bag. The transfer set includes a transfer bag with an interface and an opening arranged in the interface for coupling the interface to a lock of a sterile area and transferring the transfer material from the transfer bag into the sterile area, according to a second transfer step. A cutting tool is enclosed in the transfer bag. The transfer set also includes a connection means for the material connection of an outside of the transfer bag to an outside of the outer packaging of the product to be transferred (transfer item) via a first transfer section of the transfer bag.

The connecting means is preferably an adhesive, in particular a section of a two-sided adhesive tape.

• Die Grundidee des zweiten Transferschritts besteht darin, die im Inneren des Transferbeutels befindliche Adapterplatte feldkraftschlüssig mit einer Schleuse des insb. als aseptischer Arbeitsbereich ausgebildeten Sterilbereiches zu koppeln, so dass zwischen der Schleuse und der Adapterplatte ein Abschnitt des Transferbeutels, insbesondere eine Wand bzw. ein Folienabschnitt, eingeklemmt wird. Die Schnittstelle, insbesondere die Adapterplatte, kommt dabei mit der Schleuse nicht in unmittelbarem Kontakt. Zur Herstellung einer Öffnung im Transferbeutel und zur Herstellung einer Verbindung des Innenvolumens des Transferbeutels und des Sterilbereiches wird ein Folienabschnitt des Transferbeutels unter Sterilbedingungen aus dem Sterilbereich heraus auf- oder abgetrennt.

For better understanding, the second transfer step for the transfer of the transfer material from the transfer bag into the sterile area with a preferred embodiment of the interface - namely in the form of the above adapter plate - is described below, the second transfer step for alone or in combination with the embodiments of the transfer bag and/or the transfer set is considered to be the subject of the invention:

• The basic idea of the second transfer step is to couple the adapter plate located inside the transfer bag with a sluice of the sterile area, which is especially designed as an aseptic work area, with a field force fit, so that a section of the transfer bag, in particular a wall or a film section, is located between the sluice and the adapter plate , is trapped. The interface, in particular the adapter plate, does not come into direct contact with the lock. To create an opening in the transfer bag and to create a connection between the inner volume of the transfer bag and the sterile area, a foil section of the transfer bag is cut open or separated from the sterile area under sterile conditions.

By using an adapter plate as an interface, a sufficiently large contact surface, acting as a sealing surface, can be created between the transfer bag and the sheath for the transfer of the transfer material from the transfer bag into the sterile area, with the opening in the adapter plate serving as a transfer opening after the transfer bag has been separated . The risk of contamination during the transfer can be significantly reduced by openings that are suitably large and can be produced at particularly advantageous points in the transfer bag due to the mobility of the adapter plate.

1. a) Bereitstellen des Transferbeutels, in dem sich das Transfergut sowie eine als Adapterplatte ausgebildete Schnittstelle befindet,
2. b) feldkraftschlüssiges Verbinden der in dem Transferbeutel befindlichen Adapterplatte über bzw. mit einer Schleusenöffnung der Schleuse unter Fixierung eines ersten Folienabschnitts des Transferbeutels zwischen der Adapterplatte und der Schleuse,
3. c) Abtrennen eines zweiten Folienabschnitts des Transferbeutels zwischen Adapterplatte und der Schleusenöffnung zur Verbindung des Innenvolumens des Transferbeutels mit dem Sterilbereich,
4. d) Übernahme des Transferguts aus dem Transferbeutel in den Sterilbereich durch die Schleusenöffnung.

Specifically, the second transfer step for the sterile transfer of a transfer item packaged in a sterile manner in the transfer bag through a lock of a sterile area comprises at least the following steps:

1. a) Provision of the transfer bag, in which the transfer material and an interface designed as an adapter plate are located,
2. b) field force-locking connection of the adapter plate located in the transfer bag via or with a lock opening of the lock while fixing a first foil section of the transfer bag between the adapter plate and the lock,
3. c) Separation of a second foil section of the transfer bag between the adapter plate and the sluice opening for connecting the inner volume of the transfer bag to the sterile area,
4. d) Acceptance of the transfer material from the transfer bag into the sterile area through the lock opening.

The second film section is in particular the section of the transfer bag located above the opening of the adapter plate. The second film section is arranged within the first film section.

In order to prevent the separated second film section from falling down in an uncontrolled manner, the second film section is advantageously clamped between the lock door and a closure of the adapter plate inserted into the opening. The deadlock can be caused, for example, by a force-fit coupling of the lock door and the lock.

To produce a clean separation of the second film section, especially for a clean cut edge, a circumferential gap, especially an annular gap, can be formed between the lock door and the lock wall and between the opening of the adapter plate and the closure inserted therein. A separating device can be guided cleanly in the gap and fraying or tearing of the foil of the transfer bag is prevented and the cut edge at the incision is minimized and fixed.

1. a) Kraftfeldschlüssiges Fixieren des zweiten Folienabschnittes zwischen einem die Schleusenöffnung verschließenden Schleusenverschlusses (Schleusentüre) und einem lösbar in einer Öffnung der Adapterplatte gehaltenen Verschlussteils,
2. b) Entfernung eines zwischen der Schleusenöffnung und dem Schleusenverschluss befindlichen Dichtmittels zur Herstellung eines umlaufenden Spaltes zwischen der Schleusenöffnung und dem Schleusenverschluss,
3. c) Öffnen der Schleuse durch Entfernen des Schleusenverschlusses mit dem daran anhaftenden Verschlussteil, einschließlich dem abgetrennten zweiten Folienabschnitt, aus der Schleusenöffnung, wobei der Schleusenverschluss in das Innere des insb. als aseptischer Arbeitsbereich ausgebildeten Sterilbereiches bewegt wird,
4. d) Einstülpen des Transferbeutels über die Schleusenöffnung in den Sterilbereich hinein zum Überdecken von beim Abtrennen des zweiten Folienabschnitts entstandenen Schnittkanten des Transferbeutels und dem dem Rand der Schleusenöffnung
5. e) Ausstülpen des Transferbeutels aus dem Sterilbereich,
6. f) Verschließen der Schleusenöffnung mit dem Schleusenverschluss,
7. g) Einsetzen des unter b) genannten Dichtmittels,
8. h) Entfernen des Transferbeutels mit der Adapterplatte von der Schleuse,
9. i) Entfernen des Verschlussteils und des abgetrennten zweiten Folienabschnitts von dem Schleusenverschluss.

The second transfer step can also include at least one of the following steps:

1. a) Force field-locking fixing of the second film section between a lock closure (lock door) closing the lock opening and a closure part held detachably in an opening of the adapter plate,
2. b) Removal of a sealant located between the sluice opening and the sluice closure to create a circumferential gap between the sluice opening and the sluice closure,
3. c) Opening the lock by removing the lock with the closure part adhering thereto, including the severed second foil section, from the lock opening, whereby the lock is moved into the interior of the sterile area, which is designed in particular as an aseptic work area,
4. d) Inverting the transfer bag over the lock opening into the sterile area to cover the cut edges of the transfer bag and the edge of the lock opening that occurred when the second film section was cut off
5. e) everting the transfer bag out of the sterile area,
6. f) Closing the sluice opening with the sluice lock,
7. g) Insertion of the sealant mentioned under b),
8. h) removing the transfer bag with the adapter plate from the sheath,
9. i) removing the closure part and the severed second film section from the lock closure.

The second transfer step described above can be used to connect a transfer bag to a lock in a sterile area while providing a sufficiently large connecting surface that ensures adequate sterility (sterility) for a sterile transfer of the transfer material from the transfer bag into the sterile area.

In an advantageous development of the second transfer step, the adapter plate of the transfer bag is designed in at least two parts, with the adapter plate comprising a base plate with the opening and a closure part held detachably in the opening. The closure part is used to clamp the second film section to be separated on or with the lock door.

The base plate and the closure part are expediently detachable and preferably connected to one another in a force-fitting manner, in particular magnetically. For this purpose, holding means, for example in the form of permanent magnets, can be arranged on the base plate and the closure part can be ferromagnetic, or vice versa. As a result, the closure part can be held detachably in the opening of the base plate and removed from it in a simple manner.

It is particularly advantageous if a circumferential gap is formed between an edge of the opening in the base plate and an outer edge of the closure part. A separating device designed as a scalpel, for example, can be guided easily and safely in the gap.

In an expedient embodiment, the closure part of the adapter plate can have a central opening. The closure part is especially designed as a circular ring. The central opening provides an easy manipulation option for grasping and grasping the closure part. Alternatively or additionally, however, other holding or handling aids, in particular holding brackets, can also be arranged on the closure part.

Furthermore, handling aids, especially in the form of hooks or handles, can also be arranged on the base plate of the adapter plate. The handling aids can preferably also include magnets fastened to them for the detachable fastening of the closure part to the base plate.

Another aspect of the invention provides a lock for a sterile area with a sterile area wall (wall), the wall of the sterile area having a preferably planar contact surface for contacting the adapter plate of a transfer bag and a lock opening being arranged in the contact surface. A lock (lock door) can be inserted or used in the lock opening. In the contact surface, a field force-locking coupling means for coupling the adapter plate to the contact area is formed, so that when the adapter plate is coupled to the contact area, a foil section of the transfer bag is clamped flat.

The coupling forces are preferably in the order of magnitude between 100N and 500N.

Flat pinching is to be understood in particular as a coupling surface between the adapter plate and the sheath, in particular in the contact area of the sheath, which covers more than just one edge region of the sheath closure. The edge area is to be understood in particular as an area which extends radially from the sluice opening, for example 2 cm, 3 cm or 5 cm. The field force-locking coupling means is thus designed with such a large area that there is at least 2 cm, 3 cm, 5 cm or more between the lock opening and an edge of the field-force locking coupling means. It is preferred if there is at least 10 cm or particularly preferably 20 cm or more between the lock opening or the edge of the lock opening and the edge of the coupling means in each direction.

Furthermore, a force-fit coupling means for coupling to the adapter plate can also be arranged on or in the sluice lock.

In an advantageous embodiment, the or each coupling means can be designed as a magnetic foil. By using a magnetic foil, large-area coupling areas can be created for coupling to a ferromagnetic adapter plate, whereby a sealing surface between the lock opening and the edge of the coupling means can be made sufficiently large to transfer the transfer material into the sterile area. The larger the coupling surface or the coupling means is selected, the lower are the surface-specific necessary holding forces that the coupling means has to exert. This allows the Risk of contamination are advantageously influenced.

It is expedient if a preferably circumferential gap is formed between the sluice opening and the sluice closure. The circumferential gap can run congruently with a circumferential gap between the aforementioned adapter plate and the closure means inserted into the opening of the adapter plate. This enables a simple separation or detachment of a foil section of the transfer bag held between the adapter plate and the coupling means.

A cutting device is preferably arranged in the interior of the sterile area in order to separate a foil section of the transfer bag. The cutting device can be a scalpel. The scalpel is preferably guided centrally on a compass-like guide device. This enables the cutting device to be guided precisely relative to the aforementioned gap between the lock door and the lock opening. As an alternative to this, however, the cutting device for separating the film section can also be designed as a heating/cutting device.

The subject matter of the invention is therefore also a lock system which comprises the lock described above and the transfer bag described above.

Advantageous embodiments of the invention result from the following description of the accompanying figures. The description can equally be related to the embodiments according to the invention of the transfer bag, the lock, a lock system and corresponding methods.

• 1 eine schematische Darstellung eines Verfahrensschritts zur Übergabe von Transfergut aus einer Umverpackung in einen Transferbeutel, wobei ein doppelseitiges Klebeband auf eine Außenseite des Transferbeutels angebracht wird,
• 2 eine schematische Darstellung eines auf den Verfahrensschritt aus 1 folgenden Verfahrensschritts zum stoffschlüssigem Verbinden der Außenseite des Transferbeutels mit einer Außenseite der Umverpackung unter Nutzung einer Andrückhilfe (Rakel),
• 3 eine schematische Darstellung eines auf den Verfahrensschritt aus 2 folgenden Verfahrensschritts zum Einbringen eines Einschnitts in den mit der Umverpackung verbundenen Transferbeutel,
• 4 eine schematische Darstellung eines auf den Verfahrensschritt aus 3 folgenden Verfahrensschritts zum Transfer des Transferguts in den Transferbeutel,
• 5 eine schematische Darstellung eines Transferbeutels, der eine als Adapterplatte ausgebildete Schnittstelle zur Übergabe von Transfergut in einen Sterilbereich enthält,
• 6 eine schematische Darstellung einer Schleuse für einen Sterilbereich in verschlossenem Zustand,
• 7 bis 11 eine schematische Darstellung eines Schleusensystems mit einer Schleuse gemäß 6 und einem erfindungsgemäßen Transferbeutel in verschiedenen Zuständen, nämlich:
• 7 die Schleuse, an welche der Transferbeutel magnetisch gekoppelt wird,
• 8 die Schleuse, an welche der Transferbeutel magnetisch gekoppelt ist,
• 9 die Schleuse, bei welcher ein Halter eines Schleusenverschlusses entfernt wird,
• 10 die Schleuse, wobei ein Folienabschnitt des Transferbeutels abgetrennt wird,
• 10 A einen schematischen Querschnitt der Schleuse im Zustand gemäß 10,
• 11 die Schleuse, wobei der Schleusenverschluss aus einer Schleusenöffnung entfernt wird,
• 11A und B den entfernten Schleusenverschluss gemäß 11 mit einem daran gekoppelten Adapterring und dazwischen befindlichem Folienabschnitt in einer schematischen Querschnittsansicht (11 A) und in einer Draufsicht (11 B),
• 12 das Umstülpen einer Tasche (Liner) des Transferbeutels durch die Schleusenöffnung hindurch,
• 12 A eine schematische Querschnittsansicht gemäß 12,
• 13 die Entnahme eines Transferguts aus dem Transferbeutel, nach Auftrennen eines Innenbeutels
• 14 ein Rückstülpen der Tasche des Transferbeutels durch die Schleusenöffnung hindurch,
• 15 das Verschließen der Schleusenöffnung mit dem Schleusenverschluss,
• 16 das Entkoppeln des Transferbeutels von der Schleuse sowie
• 17 die Darstellung einer Schleuse und einer mit der Schleuse koppelbaren Adapterplatte eines Transferbeutels in einer Explosionsdarstellung und
• 18 die Darstellung einer zirkelförmig geführten Schneidevorrichtung.

They show:

• 1 a schematic representation of a method step for transferring transfer goods from an outer packaging into a transfer bag, with a double-sided adhesive tape being attached to an outside of the transfer bag,
• 2 a schematic representation of the process step 1 the following method step for materially connecting the outside of the transfer bag to an outside of the outer packaging using a pressing aid (squeegee),
• 3 a schematic representation of the process step 2 the following method step for making an incision in the transfer bag connected to the outer packaging,
• 4 a schematic representation of the process step 3 the following process step for transferring the transfer material into the transfer bag,
• 5 a schematic representation of a transfer bag that contains an interface designed as an adapter plate for transferring transfer material to a sterile area,
• 6 a schematic representation of a lock for a sterile area in the closed state,
• 7 until 11 a schematic representation of a lock system with a lock according to FIG 6 and a transfer bag according to the invention in different states, namely:
• 7 the lock to which the transfer bag is magnetically coupled,
• 8th the lock to which the transfer bag is magnetically coupled,
• 9 the sluice in which a holder of a sluice lock is removed,
• 10 the sluice, whereby a foil section of the transfer bag is separated,
• 10A a schematic cross section of the lock in the state according to FIG 10 ,
• 11 the sluice, whereby the sluice closure is removed from a sluice opening,
• 11A and B the removed lock according to 11 with an adapter ring coupled to it and a film section in between in a schematic cross-sectional view ( 11a) and in a plan view ( 11B) ,
• 12 turning a pocket (liner) of the transfer bag inside out through the lock opening,
• 12A a schematic cross-sectional view according to FIG 12 ,
• 13 the removal of a transfer item from the transfer bag after separating an inner bag
• 14 turning the pocket of the transfer bag back through the lock opening,
• 15 closing the sluice opening with the sluice lock,
• 16 the decoupling of the transfer bag from the lock as well as
• 17 the representation of a sluice and an adapter plate of a transfer bag that can be coupled with the sluice in an exploded view and
• 18 the representation of a compass-shaped guided cutting device.

In the figures 1 until 4 shows the sterile transfer of a transfer item 2 located in an outer packaging 20 into an internally sterilized, closed transfer bag 5 in the sense of a first transfer step. The transfer bag 5 is sterilized on the inside, ie the inner volume V is germ-free.

The transfer bag 5 has an interface 200 in the form of an annular flange 201 with an opening 203 therein, the opening being closed with a lid 202 . The transfer bag 5 can be coupled in a sterile manner to a lock of a sterile area via the interface 200 in order to transfer the transfer material 2 in a second sterile transfer step from the transfer bag 5 into the sterile area. The sterile area can be, for example, an aseptic work area for waste and packaging of medical preparations, in particular a clean room, an isolator or a sterile workbench. In specific applications, the invention can be used, in particular, to transfer components for the production of sterile preparations, for filling non-medical liquids or for sterility testing into a sterile, in particular aseptic, work area, e.g. in microbiological laboratories in which the sterility of the outer skin of objects packed in bags is checked should be checked.

In order to carry out the second transfer step, it is necessary to provide the transfer item 2 in a transfer bag with a suitable interface 200 . If the transfer item 2 is not already provided by the manufacturer in a transfer bag with a suitable interface 200, the transfer item must be transferred to a transfer bag with an interface suitable for the lock of the sterile area on site, i.e. at the processing site in which the transfer item is used . This is often the case for products that are customer-specific and/or manufactured in very small series, or for specifically assembled groups of transfer goods, or for components packaged in series without a transfer device.

In the example shown here, the transfer material 2 is a number of sealing plugs which are enclosed in a sterile manner in the outer packaging 20 made of plastic by the manufacturer. The outside 21 of the outer packaging 20 is not sterile. The sealing plugs can be used in the sterile area, for example to seal a container into which a liquid has been filled under sterile conditions in the sterile area. Other transfer goods, such as crimp caps, agar plates, set-up tools, sterile packaged products for outer skin sterility tests, ampoules, tablets or spare parts required in the sterile area can also be processed as transfer goods. Other types of outer packaging, e.g. blister packaging, are also possible.

the one from 1 The transfer bag 5 that can be seen consists of two plastic films lying one on top of the other, which form an upper side and an underside of the transfer bag and are thermally welded to one another to form a closed inner volume V. A cutting tool 61, which is hook-shaped here and has a cutting edge 61', is placed in the inner volume V so that it can move freely and is at least partially arranged in a first transfer area TF1. The hook-shaped blade 61 'of the cutting tool 61 can be provided with a protective cap, not shown here. The interface 200 is arranged in a second transfer area TF2. In this example, the first and second transfer areas TF1 and TF2 are initially connected, ie not separated from one another. However, it would also be possible to separate the two transfer areas TF1/TF2, for example by a dividing wall. In addition or as an alternative, it is possible for the interface 200 to be arranged in its own inner bag (liner) in the transfer area TF2, or for the transfer area TF2 to have a further dividing wall by circumferential welding of the transfer bag, which serves as an inner bag and which the interface 200 in one separate volume. A possible separation of the interface 200 via an inner bag 60 is in the 1 until 5 indicated by dashed lines.

In preparation for the transfer of the transfer item 2 into the transfer bag 5, according to 1 First, a double-sided adhesive tape 62 with a protective film 63 is stuck onto the non-sterile outside 50 of the transfer bag 5 and the protective film 63 is removed. The area of the adhesive bond is advantageously treated beforehand with hydrogen peroxide (H ₂ O ₂ ) in order to increase the polarity of the films and thus to increase the resulting adhesive strength. It is also advantageous to carry out wet bonding in order to avoid air bubbles between the films. If, for example, a mixture of isopropanol and water is used, e.g. in a weight ratio of 70%:30%, the area of the incision is additionally disinfected by the preparatory steps. Additionally or alternatively, the area of the bond can advantageously a surface treatment to modify the Be subjected to polarity, in particular a corona discharge. This increases the wettability and thus the adhesive effect of the adhesive of the adhesive tape. With this connection forces in the order of magnitude between 100 and 500 N can be achieved.

The outer packaging 20 is now placed on the double-sided adhesive tape 62 and pressed on manually, preferably with a pressing aid (squeegee) 100, cf. 2 . The non-sterile outer sides 50 or 21 of the outer packaging 20 or of the transfer bag 5 are thus connected to one another in a materially bonded manner.

To produce a passage opening, after the protective cap has been removed from the cutting tool 61, its cutting edge 61' is used to make an elongated incision 65 in the adhesive tape 62 and the outer sides 21 and 50 of the outer packaging 20 and the transfer bag 5 connected thereto, cf. 3 . In this case, the cutting tool 61 is guided manually from outside the transfer bag 5 .

The sterile inner volumes of the outer packaging 20 and the transfer bag 5 are connected to one another by the incision 65 while maintaining the sterility of the inner volumes. Through the incision 65 according to 4 the transfer material 2 can now be pushed out of the outer packaging 20 into the interior, ie the inner volume V, of the transfer bag 5.

Since the outsides 21 and 50 of the transfer bag 5 and outer packaging 20 cover each other in the area around the incision 65 fixed by the adhesive strip 62, the risk of contamination of the transfer item 2 during the transfer process by germs or particles introduced from the outside is excluded.

During the transfer of the transfer item 2 into the transfer bag 5 , the incision 65 can advantageously be kept open by a retractor (not shown here) in order to prevent the transfer item 2 from coming into contact with the cut edges of the incision 65 . For this purpose, a retractor is introduced into the sterile transfer bag 5 in addition to the cutting device 61 . The cut edges of the incision 65 represent the only minor risk of contamination of the transfer item 2 during the transition from the outer packaging 2 into the transfer bag 5, which is why the use of a retractor improves the sterile conditions by opening the incision 65 as wide as possible so that the transfer item 2 can be pushed through the incision 65 into the transfer bag 5 without touching the cut edges of the incision 65.

Following the transfer of the transfer material 2 into the transfer bag 5 (first transfer step), a section of the transfer bag 5 can be clamped off or, as in the following example 5 shown, heat sealed along a weld seam 64 and then separated from the transfer bag 5. The cutting tool 61 that is no longer required, together with the protective cap and possibly the retractor, can remain in the separated section of the transfer bag 5 . The separation takes place in such a way that the double-sided adhesive tape 62 together with the incision 65 and the outer packaging 20 located thereon are also separated. The weld seam 64 is placed between the first and the second transfer area TF1/TF2 and thus delimits these two transfer areas from one another.

After the first transfer step has been carried out, an internally sterile transfer bag 5 with the transfer material 2 enclosed therein is available for further use and in particular for carrying out the second transfer step described below as an example for further transferring the transfer material 2 from the transfer bag 5 into a sterile area.

In 5 a further embodiment of a transfer bag 5 is shown, wherein in addition to the cutting tool 61 and possibly a retractor, the transfer bag 5 also contains an interface in the form of an adapter plate 54 for coupling the transfer bag 5 to a lock of a sterile area. The adapter plate 54 is expediently separated from the remaining volume of the second transfer area TF2 by a partition wall 60 forming an inner bag. However, the formation of an inner bag in the transfer bag 5 can also be dispensed with.

in the in 5 State shown was the transfer material 2 analogous to the description of the embodiment of 1 until 4 already transferred to the transfer bag 5. The transfer item 2 is therefore located next to the adapter plate 54 in the transfer bag 5, in particular in the second transfer area TF2.

The first transfer area TF1 of the transfer bag 5, which includes the double-sided adhesive tape 62 and the incision 65 located therein and the cutting tool 61, was separated from the second transfer area TF2 of the transfer bag 5 by a weld seam 64, so that the transfer bag 5 has two separate chambers V1 or V2 has. the inside 5 The transfer bag 5 shown can be separated into two parts along the weld seam 64 in order to separate the first transfer area TF1, which is no longer required for further use, from the second transfer area disconnect TF2. The transfer material 2 and the adapter plate 54 remain enclosed in a sterile manner in the chamber or the volume V2 of the second transfer area TF2.

The adapter plate 54 consists of a flat and approximately rectangular base plate 55 with a circular adapter opening 56 introduced therein.

The adapter opening 56 forms a passage opening on the transfer bag side to the sterile area. The diameter of the adapter opening 56 corresponds to the diameter of the related 6 sluice opening 31 of the sluice 30 described in more detail below therefore at least substantially match.

At the radially outer edge of the adapter opening 56 , a closure means in the form of a circular ring, referred to below as the adapter ring 57 , is introduced concentrically and is releasably held by holding means in the form of a retaining clip 58 . The closure means (adapter ring 57) is not used for the complete (sealing) closure of the adapter opening, but as a clamping aid for a foil section of the transfer bag, as explained below, and can therefore also assume shapes other than that of a circular ring.

The retaining brackets 58 are firmly connected to the base plate 55 on the base plate side, e.g. welded, and have permanent magnets on the area overlapping the adapter opening 56 for the force-fit connection with the adapter ring 57, which is made of magnetic material here. Other forms of detachable connection of base plate 55 and adapter ring 57 are possible.

The second transfer step is described below using the transfer bag 5 described, compared to the transfer bag 5 of 1 until 4 does not have an annular flange 201 attached to the outside of the transfer bag, but has the adapter plate 54 that is completely enclosed in the transfer bag 5 and is freely movable as an interface for coupling to a lock of a sterile area.

The interface in the form of the adapter plate 54 and an associated sluice 30 or a sluice system with such a sluice and their use for the sterile transfer of the transfer material 2 in a sterile area are based on the 6 until 17 explained in more detail.

In 6 is one for use with the second transfer portion TF2 of the transfer bag according to FIG 5 provided sluice 30 of a sterile area is shown, the sluice 30 being arranged in a wall 10 of the sterile area, which is only hinted at here. The non-sterile external environment of the sterile area is indicated here with the reference number A (outside) and the sterile interior with the reference number I (inside).

In the embodiment of FIG 6 a rectangular, flat contact area 39 for contacting the adapter plate 54 is arranged, with a circular lock opening 31 being arranged centrally in the contact area 39 . The lock opening 31 can be closed with a lock door 32 . The lock door 32 has a slightly smaller diameter than the lock opening 31, which is why a ring-shaped circumferential annular gap, referred to here as the lock gap 36, is formed between the lock opening 31 and the lock door 32 when the lock door 32 is arranged in the lock opening 31. The sluice gap 36 can be sealed by a sealing ring or a cover that can be inserted therein (not shown). The sealing ring is inserted or removed from the inside I.

The outside contact area 39 of the sluice 30 is equipped with a field force-locking and flat coupling means 37 in the form of a magnetic foil embedded in the contact area 39 in the wall 10 . The coupling means 37 is cast, for example, in the wall 10 made of Plexiglas. As a result, damage to the coupling means 37 can be ruled out.

The coupling means 37 embodied as a magnetic foil can also be attached to the contact area 39 on the outside or inside, in particular glued or screwed on. As an alternative to a magnetic foil or in addition, the coupling means 37 can also be designed in the form of permanent magnets or electromagnets.

Positioning aids 12 designed like a frame for guiding and receiving the adapter plate 54 are also attached around the rectangularly designed contact area 39 of the lock 30 . The positioning aids can also serve to absorb the (vertical) forces of the adapter plate caused by gravity. As a positioning aid - not shown here - other structures on the system area 39 and the adapter plate 54 to serve. Which interlock according to a key/lock principle without the foil section 67 lying in between losing its integrity or sealing effect as a result.

Furthermore, the sluice door 32 is also provided with a force-fit coupling means 38 . Analogous to the coupling means 37 of the wall, this is also magnetic and is designed, for example, as a magnetic foil for detachable coupling to the adapter ring 57 of the adapter plate 54 .

• In einem ersten Schritt, vgl. 7, wird die in dem Transferbeutel 5 befindliche und darin frei bewegliche Adapterplatte 54 über ihre Grundplatte 55 auf dem Anlagebereich 39 der Schleuse 30 feldkraftschlüssig befestigt. Die feldkraftschlüssige Kopplung erfolgt dabei über das Kopplungsmittel 37 in Form der in der Wandung 10 eingelassenen oder dort befestigten Magnetfolie. Hierdurch wird ein erster Folienabschnitt 67 des Transferbeutels 5 im Anlagebereich 39 zwischen der Wandung 10 und der Grundplatte 55 über die gesamte Fläche verklemmt. Über die Positionierhilfen 12 kann die Adapteröffnung 56 der Adapterplatte 54 dabei deckungsgleich über der Schleusenöffnung 31 positioniert werden.

As in the 7 until 16 shown, the transfer of the transfer item 2 takes place from the already in connection with 5 described transfer bag 5 into the sterile area through the second transfer step with the following steps:

• In a first step, cf. 7 , the adapter plate 54 located in the transfer bag 5 and freely movable therein is fastened via its base plate 55 to the contact area 39 of the lock 30 in a force-fitting manner. The field force-locking coupling takes place via the coupling means 37 in the form of the magnetic foil embedded in the wall 10 or fastened there. As a result, a first foil section 67 of the transfer bag 5 is clamped in the contact area 39 between the wall 10 and the base plate 55 over the entire surface. The adapter opening 56 of the adapter plate 54 can be positioned congruently over the lock opening 31 via the positioning aids 12 .

At the same time, the adapter ring 57 is connected to the lock door 32 via the magnetic coupling means 38 of the lock door 38 with a force fit, with a second film section 68 of the transfer bag being clamped in between.

In 8th the transfer bag 5 is shown connected to the lock 30, the base plate 55 of the adapter plate 54 being coupled to the contact area 39 of the lock 30 in a force-fitting manner.

Positioning aids 12 designed like a frame for guiding and receiving the adapter plate 54 are also attached around the rectangularly designed contact area 39 of the lock 30 . The positioning aids can also serve to absorb the (vertical) forces of the adapter plate caused by gravity.

After that, in the in 9 shown step a holder 34 of the lock closure (lock door 32) on the inside of the lock 30 removed. In the exemplary embodiment shown here, the sluice door 32 is releasably connected to the sluice 30 by means of a centrally attached fastening rod 33 via a skeletal bracket 34, here in the form of a threaded pin. The holder 34 is magnetically connected to the inside of the wall 10 via fastening means 35 and is removed after the adapter plate 54 has come into contact with the contact area 39 of the wall 10 on the outside. The lock door 32 is now held in position by the magnetic force of the adapter ring 57 . In other embodiments, the connection can also be formed via a hinge or another mechanical connection.

in the in 10 In the step shown, a region of the first film section 67 clamped on the outside between the adapter plate 54 and the wall 10 is then severed by a cutting device 11 . For this purpose, the cutting device 11 is guided along the annular gap, ie the lock gap 36 brought into alignment and the annular gap 59 of the adapter plate 54 . This can, as in 10 shown, done by a manually guided cutting tool 11. In other embodiments, however, the cutting tool 11 can also be guided by a cutting tool guided in the form of a compass, the center point of which is connected to the axis of the fastening rod 33 . In the process, a circular second film section 68 is separated from the clamped first film section 67 .

In 10A a schematic cross-sectional view of the lock is shown in this position. The adapter plate 54 is separated from the transfer item 2 by an additional partition 60, according to the 5 shown embodiment of the transfer bag 5. The partition 60 forms in the volume of the transfer bag 5 an inner bag (liner) with a volume V2B, in which the adapter plate 54 is located. The volume V2B of the transfer bag 5 is separated from a volume V2A, which contains the item 2 to be transferred. Before transferring the transfer material 2 through the lock 30 into the sterile area, the dividing wall 60 must be separated. The inner bag (liner) is already manufactured during the manufacture of the transfer bag by introducing the partition 60 into the volume of the transfer bag 5 and packaging the adapter plate 54 in the inner bag (liner) before sterilization, so that the second transfer area TF2 of the transfer bag 5 is Execution of the second transfer step forms two separate volumes V2A and V2B. The inner bag (liner) can prevent the transfer item 2 from coming into contact with a critical point referred to as a 'ring of concern', which is described in more detail below.

After the second film section 68 has been separated, the lock door 32 is opened removed from the sluice opening 31 ( 11 ). The adapter ring 57 detaches itself from the magnetic retaining brackets 38 of the adapter plate 57 and remains attached to the lock door 32 as a result of the force-fit coupling means 38 of the lock door 32 . This is possible because the coupling forces between the adapter ring 57 and the lock door 32 are designed to be greater than the coupling forces between the adapter ring 57 and the retaining bracket 58 Sluice opening 31 removed.

In the 11A and 11B the lock door 32 removed from the lock opening with the attached adapter ring 57 and the second film section 68 clamped in between and separated from the film section 67 is shown in a cross section and in a top view.

The inner bag (liner) of the transfer bag 5 can now be drawn into the interior I of the lock 30 through the opening 31 of the lock 30 thus cleared, compare 12 , And then, for example, with the cutting device 11 already mentioned above, are opened. In 12A a schematic cross-sectional view of the lock is shown in this position, in which the transfer material 2 can then be transferred from the transfer bag 5 into the interior (ie onto the inside I of the lock 30), cf. 13 .

The division of the interior volume V of the transfer bag 5 into the two volumes V2A and V2B via the partition 60 is intended to prevent the transfer material 2 from being transferred directly, e.g. manually, into the interior after the lock has been opened, since there is a risk of Transfer good 2 to touch the cut edges of the severed second film section 68. By turning the inner bag inside out, the areas that are critical in terms of sterility, namely the cut edges, also known as the so-called 'ring of concern' 69, can be covered before the transfer item 2 is accepted, in order to prevent contamination of the transfer item 2 by touching the cut edges ('ring of concern' 69) to rule out.

After the transfer item 2 has been transferred from the transfer bag 5 to the sterile area, the inner bag (liner) is removed as shown in 14 shown, turned inside out and the wall 10 of the lock closed with the lock door 32, see 15 . Thereafter, the annular gap 36 of the sluice opening 31 can be sealed with a sealant, such as a sealing ring.

After the sluice opening 31 has been closed by the sluice door 32, the adapter plate 54 with the transfer bag attached to it is removed from the outside of the sluice 30 by releasing the coupling of the coupling means 37. At the same time or in a subsequent step, the adapter ring 57 can also be removed from the sluice lock 32 together with the severed second film section 68 of the transfer bag 5 . The adapter plate 54 including the adapter ring 57 can then be sterilized and used in a new transfer bag.

For clarification is in 17 the wall 10 of the sluice 30 with the sluice opening 31, the sluice door 32 that can be used therein, and the adapter plate 54 with the adapter opening 56 and the adapter ring 57 that is used therein are shown in an exploded view without a transfer bag.

In 18 shows a compass-shaped cutting device 11 of the sterile area for guided severing of the film section 68 of the transfer bag 5 clamped between the adapter ring 57 and the lock door 32 along the annular gaps 36/59, with the cutting device 11 being used in this regard via the central fastening rod 33 of the lock door 32 as the center of the Movement is performed in a circular manner.

reference list

TF1

first transfer area

TF2

second transfer area

V1

volume 1

V2A..

Volume 2A

V2B

Volume 2B

I

Sterile area interior

A

Sterile area outside

1

sterile area (inside)

2

transfer goods

4

lock system

5

transfer pouch

10

sterile area wall

11

Cutting device (in the sterile area)

12

Positioning aids/stop elements

20

Outer packaging (for transfer goods)

21

(Non-sterile) outside of the overpack

30

sluice

31

sluice opening (circle opening)

32

Sluice door or sluice closure

33

fastening rod (airlock door)

34

fasteners (framework)

35

holding frame (lock door)

36

sluice gap (annular)

37

Coupling medium/magnetic foil (plant area)

38

Coupling agent/magnetic foil (lock door)

39

investment area

50

(non-sterile) outside of the transfer bag

51

(Sterile) inside of the transfer bag

54

adapter plate

55

base plate (adapter plate)

56

adapter opening

57

Adapter ring (locking part in the adapter opening)

58

Magnetic holder / retaining bracket (adapter plate)

59

annular gap (adapter plate)

60

partition wall

61

Cutting tool (in transfer bag) with protective cap

61'

cutting edge

62

double-sided tape

63

masking strips

64

Weld

65

incision

67

first slide section

68

second slide section

69

"Ring on Concern"

100

pressing aid

200

interface

201

connection flange (interface)

202

cover (connecting flange)

203

opening (interface)

QUOTES INCLUDED IN DESCRIPTION

This list of documents cited by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Patent Literature Cited

• EP 2504101 B1 [0009]
• EP 0865382 B1 [0009]
• US5816772 [0009]

Claims (15)

Transfer bag (5) sterilized on the inside and forming a closed volume (V), which has an interface (200; 54) for coupling to a transfer lock (30) of a sterile area for the sterile transfer of a transfer item (2) from the transfer bag (5) into the sterile area contains, wherein the interface (200; 54) has an opening (203; 56) through which the transfer material (2) from the transfer bag (5) can be carried out into the sterile area, characterized in that the transfer bag (5) inside the closed Volume (V) has a freely movable cutting tool (61) therein. Transfer bag (5) after claim 1 , characterized in that the transfer bag (5) is formed from a first plastic film and a second plastic film which are circumferentially welded to one another. Transfer bag (5) according to any one of the preceding Claims 1 or 2 , characterized in that the transfer bag (5) consists of a thermoplastic, in particular translucent plastic. Transfer bag (5) according to one of the preceding claims, characterized in that the transfer bag (5) has a first transfer area (TF1) and a second transfer area (TF2), the cutting tool (61) in the first transfer area (TF1) and the interface (200; 54) are arranged in the second transfer area (TF2) and wherein the first transfer area (TF1) is separated from the second transfer area (TF2). Transfer bag (5) after claim 4 , characterized in that the second transfer area (TF2) comprises two separate volumes (V2A, V2B), wherein the two volumes (V2A, V2B) are separated from each other by a partition (60), the interface (200; 54) in the one volume (V2B) and the transfer item (2) is arranged in the other volume (V2A). Transfer bag (5) according to one of the preceding claims, characterized in that the interface (200; 54) is designed as an adapter plate (54) which can move freely in the volume (V) of the transfer bag (5) and has a central opening (56). Method for the sterile transfer of a transfer item (2) sterilely packaged in an outer packaging (20) from an outer packaging (20) into a transfer bag (5) with a sterilized, closed volume (V), preparing for a subsequent transfer step for transferring the transfer item ( 2) from the transfer bag (5) into a sterile area via an interface (200; 54) which has an opening (203; 56) through which the transfer bag (5) can be passed, comprising the following steps, preferably in this order: a) Cohesively connecting the outside (21) of the outer packaging (20) to the outside (50) of the transfer bag (5) in a first transfer area (TF1) of the transfer bag (5), b) Making an incision (65) in the first transfer area (TF1) over an incision length, c) transferring the transfer item (2) from the outer packaging (20) into the transfer bag (5) through the incision (65). procedure after claim 7 , characterized in that the material connection in method step a) takes place by means of an adhesive and in particular by means of a two-sided adhesive tape section (62). Procedure according to one of Claims 7 or 8th , characterized in that the material connection in method step a) takes place by thermal welding of the outer sides (50; 21) of the transfer bag (5) and the outer packaging (20). Procedure according to one of Claims 7 until 9 , characterized in that the incision (65) is made in method step b) by a cutting tool (61) located in the transfer bag (5). Procedure according to one of Claims 7 until 10 , characterized in that the transfer bag (5) has the first transfer area (TF1) and a second transfer area (TF2) separated therefrom, the interface (200; 54) of the transfer bag (5) being arranged in the second transfer area (TF2). procedure after claim 11 , characterized in that the second transfer area (TF2) of the transfer bag (5) is separated from the first transfer area (TF1) of the transfer bag (5) and sealed in a sterile manner after the transfer item (2) has been transferred into the second transfer area (TF2), in particular by a thermal welding process. Transfer set for the sterile transfer of a transfer item packaged in a sterile manner in an outer packaging (20) from the outer packaging (20) into a transfer bag (5) in preparation for a subsequent transfer step for transferring the transfer item (2) from the transfer bag (5) into a sterile area, comprising a Transfer bag (5) with an opening (203; 56) having interface (200; 54) for coupling to a transfer lock (30) and transfer of the transfer item (5) from the transfer bag (5) to the sterile area in the subsequent transfer step and a connecting means (62) for the material connection of the Outsides (21; 50) of the outer packaging (20) and the transfer bag (5) via a first transfer area (TF1), the transfer bag (5) forming a sterile, closed volume (V) and a cutting tool (11) inside the closed volume is included. transfer set after Claim 13 , characterized in that the connecting means (62) is an adhesive, in particular a section of a two-sided adhesive tape (62). transfer set after Claim 13 or 14 , Wherein the transfer bag (5) is a transfer bag (5) according to one of Claims 1 until 6 is.

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