DE102021114896B4 - Transfer bag, transfer method and transfer set - Google Patents

Abstract

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) can be passed from the transfer bag (5) into the sterile area, characterized in that the transfer bag (5) is inside the closed Volume (V) has a freely movable cutting tool (61) therein.

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 sterilely packaged in an outer packaging from an outer packaging into a transfer bag and a transfer set.

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

A sterile area or an aseptic area is understood to mean any sterile workstation that is shielded from the outside and usually delimited by appropriate walls and which is protected in a special way against the ingress of dirt, particles and germs or other contamination. In particular, a sterile area meets 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 (manufacture of sterile medicinal products). Appropriate protection is usually achieved through low-turbulence displacement flow using air-conditioned, filtered air (H14 filter). For the purposes of the invention, a sterile area also includes 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 include a wall with a lock to which a transfer container with sterilely packaged transfer goods, such as packaging material or medical substances, for transferring the transfer goods from the non-sterile environment can be docked into the sterile area. 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 sealingly therein.

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

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

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

Examples of transfer bags are shown here EP2504101B1 , the EP0865382B1 or the US5816772 A. From the EP2504101B1 and the US5816772 A transfer bags made of plastic with a connecting flange made of a material other than plastic incorporated into the transfer bag are known. From the EP0865382B1 a transfer bag with a connecting flange made from the plastic material of the transfer bag is known.

The transfer bags mentioned have the disadvantage that the transfer material to be transferred must already be packaged sterilely into the transfer bag by the manufacturer. With these transfer bags it is therefore not possible to transfer individual transfer goods or assembled groups of transfer goods that are not packed in transfer bags adapted to the lock system directly on site in a sterile manner into a transfer bag with an interface tailored to the lock system of the sterile area transfer the transfer material 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 sterile in an outer packaging into a transfer bag, which make it possible to introduce the sterile packaged transfer item into the transfer bag in a sterile manner directly at the place of use. The aim is to avoid 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 be made possible for partial quantities or small quantities of individual transfer goods, which in particular are not produced in large series, or individually assembled groups of transfer goods, to be transferred sterilely into 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 further 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.

In one aspect of the invention, a method is specified for the sterile transfer of a transfer item that is sterilely packaged in an outer packaging from the outer packaging into a transfer bag:

• The sterile transfer of the transfer material from the outer packaging into the transfer bag (hereinafter also referred to as the “first transfer step”) serves as a preparation for the sterile transfer of the transfer material from the transfer bag into a sterile area (hereinafter also referred to as the “second transfer step”), whereby the transfer bag has an interface provided for the second transfer step with an opening which can be coupled to a lock in the sterile area. The interface can, for example, comprise an annular flange with an opening and a closure inserted sealingly in the opening. The transfer bag can be coupled to the lock of the sterile area via the interface, thereby establishing a sterile connection 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 packed sterile in an outer packaging. The outer packaging can in particular be an 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 process includes the following steps, preferably in the order given here:

1. a) materially 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 a cutting length, as well
3. c) Transfer the sterile transfer material from the outer packaging into the transfer bag through the incision.

Preferably, the outsides of the outer packaging and the transfer bag are cohesively connected by gluing. An expedient connection can be made via an adhesive applied to or between the outside 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 adhesive tape section offers the advantage of easy handling without additional tools and a very short processing time.

Alternatively, the cohesive connection according to method step a) can also be produced by thermally welding the outer sides of the transfer bag and the outer packaging. It must be ensured that only one outside of the transfer bag and the outer packaging are welded together. In order to produce the cohesive connection of the outside of the transfer bag and the outer packaging by welding, the transfer bag should expediently be accessible from its inside, i.e. from the inside of the transfer bag or its volume. Welding can be carried out, for example, with heat (thermal welding) and/or with ultrasound.

Appropriately, in the cohesive connection of the outer sides of the transfer bag and the outer packaging according to method step b), an incision is made for connecting the volumes of the transfer bag and the outer packaging by means of a cutting tool, the cutting tool already being sterilely enclosed in the volume of the transfer bag when the transfer bag is manufactured or after was terminally sterilized together with the transfer bag before insertion. The cutting tool can be operated manually from the outside to make the incision in order to penetrate the cohesively connected outer sides of the transfer bag and the outer packaging. Through this incision, the transfer material can be removed in a sterile manner The outer packaging must 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, for which purpose the retractor is contained sterile in the transfer bag analogous to the cutting tool.

Alternatively or additionally, other tools that are required to produce the cohesive connection of the transfer bag and the outer packaging, for example a painting aid (squeegee) or an electric welding device, can also be inserted sterile into the transfer bag.

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

Advantageously, after the transfer material has been transferred into the transfer bag, the internal volume of the transfer bag is divided into a first transfer area and a second transfer area of the transfer bag separated therefrom. The separation of the first transfer area from the second transfer area can be carried out in particular by thermal welding along a weld seam. Here, the transfer material is located in the second transfer area and the cutting tool advantageously remains in the first transfer area and can be separated 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 sealed in a sterile manner after the transfer material has been transferred to 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 and internally sterilized volume in which a transfer item can be received, with a cutting tool being sterilely enclosed in the transfer bag. The transfer bag contains an interface with an opening through which the transfer bag can be coupled to a lock in a sterile area in order to transfer the transfer material introduced into the transfer bag from the transfer bag to the sterile area in a second transfer step.

The cutting tool can be completely and freely movably enclosed 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 cutting edge 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 enclosed 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 shown in the description of the method above.

For simple production, the transfer bag is advantageously made from two plastic films that are brought into alignment and which are welded together on the outside. This makes it possible to provide a very cost-effective and easy-to-manufacture transfer bag.

The inside of the transfer bag is sterilized during production, including the cutting tool and the interface inside.

In the event that the cutting tool should only be partially located 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 is bonded to the plastic in the course of the manufacturing process. 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 unwanted opening of the transfer bag.

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 pops up or out, for example at the push of a button. The box can also be cohesively connected to the transfer bag. A surface of the The 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 in the transfer bag. In order to reduce the freedom of movement of the cutting tool, the pocket or the indentation or protrusion 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. Additionally or alternatively, 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 in addition to the cutting tool. Retractors are spreading tools that can be used to expand cuts and openings, keep them open and cover the edges of the cut or opening. The use of a retractor makes it easier to transfer the transfer material from the outer packaging into the transfer bag through the previously made incision, without the transfer material being able to come into contact with the cut edges of the incision, which are critical in terms of sterility.

The transfer bag expediently consists of a thermoplastic and in particular translucent plastic and in particular a plastic film. A thermoplastic expands the processing options, particularly in terms of weldability. In addition to making it easy to check the contents of the transfer bag, a translucent plastic also enables the cutting tool to be guided safely and accurately when making the incision.

In an advantageous development, the transfer bag comprises a first transfer region for carrying out a first transfer step and a second transfer region for carrying out a second transfer step, the cutting tool being arranged in the first transfer region and the interface being arranged in the second transfer region. The first and second transfer areas are separated from each other, for example by a thermal weld 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 violating the sterility (sterility).

In an advantageous embodiment, the interface of the transfer bag is an adapter plate with an opening therein, the adapter plate being enclosed in the transfer bag in a freely movable manner. This makes both the production of the transfer bag and the handling of the transfer bag and the adapter plate easier. In addition, after use, the adapter plate can simply be removed from the transfer bag, sterilized and inserted into a new transfer bag. This allows manufacturing costs to 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 or a liner arranged in the second transfer area, 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 unwanted contact with a critical contact area (“Ring of Concern”) described below when carrying out the second transfer step.

In another aspect of the invention, a transfer set is provided for the sterile transfer of a transfer item that is sterilely packaged in an outer packaging from the outer packaging into a transfer bag. The transfer set comprises 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 to the sterile area, according to a second transfer step. A cutting tool is included in the transfer bag. The transfer set further comprises a connecting means for materially connecting an outside of the transfer bag to an outside of the outer packaging of the product to be transferred (goods to be transferred) 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 transferring the transfer material from the transfer bag into the sterile area is described below with a preferred configuration of the interface - namely in the form of the above-mentioned adapter plate - whereby the second transfer step for is considered to be the subject of the invention alone or in combination with the embodiments of the transfer bag and/or the transfer set:

• The basic idea of the second transfer step is to couple the adapter plate located inside the transfer bag in a field-positive manner with a lock of the sterile area, which is designed in particular as an aseptic work area, so that a section of the transfer bag, in particular a wall or a film section, between the lock and the adapter plate , gets 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 film section of the transfer bag is opened or separated from the sterile area under sterile conditions.

By using an adapter plate as an interface, a contact surface that is sufficiently large and acts as a sealing surface can be created between the transfer bag and the lock 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 transfer can be significantly reduced by openings that are suitably large and can be produced at particularly advantageous locations 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.

In detail, the second transfer step for the sterile transfer of a transfer item packaged sterile in the transfer bag through a lock of a sterile area includes at least the following steps:

1. a) providing the transfer bag in which the transfer material and an interface designed as an adapter plate are located,
2. b) field force-fitting connection of the adapter plate located in the transfer bag over or with a lock opening of the lock while fixing a first film section of the transfer bag between the adapter plate and the lock,
3. c) separating a second film section of the transfer bag between the adapter plate and the lock opening to connect the inner volume of the transfer bag to the sterile area,
4. d) Taking 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 avoid an uncontrolled falling of the separated second film section, the second film section is advantageously clamped between the lock door and a closure of the adapter plate inserted into the opening. The jamming can occur, for example, through a field force coupling between the lock door and the lock.

In order to produce a clean separation of the second film section, in particular for a clean cutting edge, a circumferential gap, in particular an annular gap, can be formed between the lock door and the lock wall as well as between the opening of the adapter plate and the closure inserted therein. A separating device can be guided cleanly in the gap and the film of the transfer bag is prevented from fraying or tearing and the cutting 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 further comprise at least one of the following steps:

1. a) Force field-locking fixing of the second film section between a lock closure (lock door) that closes the lock opening and a closure part that is detachably held in an opening in the adapter plate,
2. b) removal of a sealant located between the lock opening and the lock closure to create a circumferential gap between the lock opening and the lock closure,
3. c) opening the lock by removing the lock closure with the closure part adhering to it, including the separated second film section, from the lock opening, the lock closure being 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 created when the second film section was separated and the edge of the lock opening
5. e) removing the transfer bag from the sterile area,
6. f) closing the lock opening with the lock closure,
7. g) inserting the sealant mentioned under b),
8. h) removing the transfer bag with the adapter plate from the lock,
9. i) Removing the closure part and the separated second film section from the lock closure.

Through the second transfer step described above, a connection of a transfer bag to a lock of a sterile area can be provided while providing a sufficiently large connection surface, which ensures sufficient assurance of 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, the adapter plate comprising a base plate with the opening and a closure part releasably held in the opening. The closure part serves 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 field force-locking 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 designed to be ferromagnetic, or vice versa. As a result, the closure part can be easily and detachably held in the opening of the base plate and removed therefrom.

It is particularly advantageous if a circumferential gap is formed between an edge of the opening of the base plate and an outer edge of the closure part. A separating device designed, for example, as a scalpel 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 designed in particular as a circular ring. The central opening offers an easy handling option for gripping 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 attached to them for releasably attaching the closure part to the base plate.

In another aspect of the invention, a lock for a sterile area is provided with a sterile area wall (wall), wherein the wall of the sterile area has a preferably flat contact surface for contact with the adapter plate of a transfer bag and wherein a lock opening is arranged in the contact surface. A lock closure (lock door) can be inserted into the lock opening. A field force-locking coupling means for coupling the adapter plate to the contact area is formed in the contact surface, so that when the adapter plate is coupled to the contact area, a film section of the transfer bag is clamped flat.

The coupling forces are preferably between 100N and 500N.

Flat clamping is understood to mean in particular a coupling surface between the adapter plate and the lock, in particular in the contact area of the lock, which covers more than just an edge area of the lock closure. The term edge area is to be understood in particular as an area which extends radially of the lock opening, for example 2 cm, 3 cm or 5 cm. The field force-locking coupling means is designed to have 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 in each direction between the lock opening or the edge of the lock opening and the edge of the coupling means.

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

In an advantageous embodiment, the or each coupling means can be designed as a magnetic film. By using a magnetic film, 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 agent is selected, the lower the area-specific holding forces that the coupling agent must exert. This allows the Risk of contamination can be influenced advantageously.

It is expedient if a preferably circumferential gap is formed between the lock opening and the lock closure. The circumferential gap can be congruent 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 separation of a film section of the transfer bag held between the adapter plate and the coupling agent.

To separate a film section of the transfer bag, a cutting device is preferably arranged in the interior of the sterile area. The cutting device can be a scalpel. The scalpel is preferably guided centrally on a compass-like guide device. This enables precise guidance of the cutting device relative to the aforementioned gap between the lock door and the lock opening. Alternatively, the cutting device for separating the film section can also be designed as a heating/cutting device.

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

Advantageous embodiments of the invention result from the following description of the attached 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.

It shows:

• 1 a schematic representation of a process 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 a process step 1 the following process 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 a process step 2 the following process step for making an incision in the transfer bag connected to the outer packaging,
• 4 a schematic representation of a 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 into a sterile area,
• 6 a schematic representation of a lock for a sterile area in a closed state,
• 7 until 11 a schematic representation of a lock system with a lock according to 6 and a transfer bag according to the invention in various 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 lock, in which a holder of a lock closure is removed,
• 10 the lock, whereby a film section of the transfer bag is separated,
• 10A a schematic cross section of the lock in the state according to 10 ,
• 11 the lock, whereby the lock closure is removed from a lock opening,
• 11A and B the removed lock closure according to 11 with an adapter ring coupled to it and a film section in between in a schematic cross-sectional view ( 11 A) and in a top view ( 11 B) ,
• 12 turning a pocket (liner) of the transfer bag inside out through the lock opening,
• 12 A a schematic cross-sectional view according to 12 ,
• 13 the removal of a transfer item from the transfer bag after tearing open an inner bag
• 14 the pocket of the transfer bag is pushed back through the lock opening,
• 15 closing the lock opening with the lock closure,
• 16 decoupling the transfer bag from the lock and
• 17 the representation of a lock and an adapter plate of a transfer bag that can be coupled to the lock in an exploded view and
• 18 the representation of a circularly guided cutting device.

In the figures 1 until 4 the sterile transfer of a transfer item 2 located in an outer packaging 20 into an internally sterilized, closed transfer bag 5 is shown in the sense of a first transfer step. The transfer bag 5 is sterilized on the inside, that is, the internal 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 located therein, the opening being closed with a lid 202. Via the interface 200, the transfer bag 5 can be coupled to a lock of a sterile area in a sterile manner in order to transfer the transfer material 2 in a sterile manner from the transfer bag 5 into the sterile area in a second transfer step. The sterile area can be, for example, an aseptic work area for waste and packaging of medical preparations, in particular a clean room, isolator or a sterile workbench. In specific applications, the invention can in particular be used to transfer components for the production of sterile preparations, for filling non-medical liquids or for testing for sterility into a sterile, in particular aseptic, work area, for example in microbiological laboratories in which the sterility of the outer skin of objects packed in bags is important should be checked.

To carry out the second transfer step, it is necessary to provide the transfer material 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 on site, i.e. at the processing site in which the transfer item is used, into a transfer bag with an interface that matches the lock of the sterile area . This is often the case for products that are customer-specific and/or manufactured in small series, or for specifically assembled groups of transfer goods or for components packaged as standard without a transfer device.

In the example shown here, the transfer material 2 is a number of sealing plugs that are sterilely enclosed by the manufacturer in the outer packaging 20 made of plastic. The outside 21 of the outer packaging 20 is not sterile. The closure plugs can be used in the sterile area, for example, to close 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 out 1 The visible transfer bag 5 consists of two plastic films lying one on top of the other, which form an upper side and a lower side of the transfer bag and are thermally welded together circumferentially to form a closed internal volume V. In the internal volume V, a hook-shaped cutting tool 61 with a cutting edge 61 'is inserted in a freely movable manner and is at least partially arranged in a first transfer area TF1. The hook-shaped cutting edge 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, i.e. not separated from one another. However, it would also be possible to separate the two transfer areas TF1/TF2, for example by a partition. Additionally or alternatively, it is possible that the interface 200 is arranged in its own inner bag (liner) in the transfer area TF2 or that the transfer area TF2 has a further partition wall by circumferential welding of the transfer bag, which serves as an inner bag and which the interface 200 in one separates its own volume. A possible separation of the interface 200 via an inner bag 60 is in the 1 until 5 indicated by dashed lines.

Preparation for the transfer of the transfer material 2 into the transfer bag 5 is carried out according to 1 First, a double-sided adhesive tape 62 with a protective film 63 is glued to the non-sterile outside 50 of the transfer bag 5 and the protective film 63 is removed. The area of the bond is advantageously treated in advance with hydrogen peroxide (H ₂ O ₂ ) to increase the polarity of the films and thus to increase the resulting adhesive strength. It is also advantageous to carry out wet bonding to avoid air bubbles between the films. For example, if you use a mixture of isopropanol and water, for example in a weight ratio of 70%:30%, the area of the incision is additionally disinfected through the preparatory steps. Additionally or alternatively, the area of the bonding can advantageously be subjected to surface treatment to modify the Polarity is subjected, in particular to a corona discharge. This increases the wettability and thus the adhesive effect of the adhesive of the adhesive tape. This allows connecting forces of between 100 and 500 N to be achieved.

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

To produce a passage opening, after removing the protective cap from the cutting tool 61, an elongated incision 65 is made with its cutting edge 61 'in the adhesive tape 62 and the associated outer sides 21 and 50 of the outer packaging 20 and the transfer bag 5, cf. 3 . The cutting tool 61 is guided manually from outside the transfer bag 5.

The sterile internal volumes of the outer packaging 20 and the transfer bag 5 are connected to one another through the incision 65 while maintaining the sterility of the internal volumes. Through the incision 65 you can 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 material 2 during the transfer process by germs or particles introduced from the outside is excluded.

When transferring the transfer material 2 into the transfer bag 5, the incision 65 can advantageously be kept open by a retractor (not shown here) in order to avoid contact of the transfer material 2 with the cut edges of the incision 65. For this purpose, a retractor is inserted into the sterile transfer bag 5 in addition to the cutting device 61. The cut edges of the incision 65 form the only, minor risk of contamination of the transfer material 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 material 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 example below 5 shown, thermally welded along a weld seam 64 and then separated from the transfer bag 5. In the separated section of the transfer bag 5, the cutting tool 61 that is no longer required, together with the protective cap and, if necessary, the retractor, can remain. The separation takes place in such a way that the double-sided adhesive tape 62 along with the incision 65 and the outer packaging 20 located thereon are also separated. The weld seam 64 is placed between the first and second transfer areas TF1/TF2 and thereby delimits these two transfer areas from one another.

After carrying out the first transfer step, 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 transfer of 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 in a sterile area. The adapter plate 54 is expediently separated from the remaining volume of the second transfer area TF2 via a partition 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 In the state shown, the transfer material 2 was analogous to the description of the exemplary embodiment 1 until 4 already transferred to the transfer bag 5. The transfer material 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 as well as 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 chambers separated from one another V1 or V2. The in 5 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 an adapter opening 56, here circular in shape, inserted therein. The base plate serves for coupling to a contact area 39 of a lock wall 10 of a lock 30 of a sterile area, described in more detail below.

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 in connection with 6 The lock opening 31 of the lock 30 described in more detail below therefore at least essentially corresponds.

At the radially outer edge of the adapter opening 56, a closure means shaped as a circular ring, hereinafter referred to as an adapter ring 57, is concentrically introduced and releasably held by holding means shaped here as a retaining bracket 58. The closure means (adapter ring 57) does not serve to completely (seal) close the adapter opening, but rather as a clamping aid for a film section of the transfer bag, as explained below, and can therefore also take on shapes other than that of a circular ring.

The holding brackets 58 are firmly connected to the base plate 55 on the base plate side, for example welded, and have permanent magnets in the area overlapping the adapter opening 56 for a field force-locking connection to the adapter ring 57, which is formed here from magnetic material. Other forms of detachable connection of base plate 55 and adapter ring 57 are possible.

The second transfer step is carried out below using the transfer bag 5 described, which is 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 rather the adapter plate 54, which is completely enclosed and freely movable in the transfer bag 5, as an interface for coupling to a lock in a sterile area.

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

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

In the wall 10 of the sterile area, which separates the sterile inside I of the sterile area from the non-sterile outside A of the sterile area, in the exemplary embodiment of 6 a rectangular, flat contact area 39 is arranged for contact with the adapter plate 54, 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 annular gap, here referred to as the lock gap 36, is created between the lock opening 31 and the lock door 32 when the lock door 32 is arranged in the lock opening 31. The lock 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 lock 30 is equipped with a field force-locking and flat coupling means 37 in the form of a magnetic foil embedded in the wall 10 in the contact area 39. The coupling agent 37 is, for example, cast in the wall 10 made of Plexiglas. This can prevent damage to the coupling means 37.

The coupling means 37 designed 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 film or in addition, the coupling means 37 can also be designed in the form of permanent or electromagnets.

Frame-like positioning aids 12 for guiding and receiving the adapter plate 54 are also attached around the rectangular contact area 39 of the lock 30. The positioning aids can simultaneously serve to absorb the gravity-related (vertical) forces of the adapter plate. Other structures on the system area 39 and the adapter plate 54 can also serve as a positioning aid - not shown here serve. Which interlock according to a key/lock principle, without the film section 67 in between losing its integrity or sealing effect.

Furthermore, the lock door 32 is also provided with a field force-locking 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 releasable coupling with 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.

Like in the 7 until 16 shown, the transfer of the transfer goods 2 takes place from the already in connection with 5 transfer bag 5 described 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 on the contact area 39 of the lock 30 in a field-positive manner. The field force coupling takes place via the coupling means 37 in the form of the magnetic foil embedded in the wall 10 or attached there. As a result, a first film section 67 of the transfer bag 5 is clamped over the entire surface in the contact area 39 between the wall 10 and the base plate 55. The adapter opening 56 of the adapter plate 54 can be positioned congruently above the lock opening 31 using 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 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 field force-locking manner.

Frame-like positioning aids 12 for guiding and receiving the adapter plate 54 are also attached around the rectangular contact area 39 of the lock 30. The positioning aids can simultaneously serve to absorb the gravity-related (vertical) forces of the adapter plate.

Then in the in 9 In the step shown, a holder 34 of the lock closure (lock door 32) is removed from the inside of the lock 30. In the exemplary embodiment shown here, the lock door 32 is detachably connected to the lock 30 by means of a centrally mounted fastening rod 33 via a skeletal holder 34, here in the form of a set screw. 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 is in 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, an area of the first film section 67 clamped on the outside between adapter plate 54 and wall 10 is then cut through 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 congruence 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 circularly guided cutting tool whose center is connected to the axis of the fastening rod 33. A circular second film section 68 is separated from the clamped first film section 67.

In 10A a schematic cross-sectional representation of the lock is shown in this position. The adapter plate 54 is separated from the transfer material 2 by an additional partition 60, according to in 5 shown embodiment of the transfer bag 5. The partition 60 forms an inner bag (liner) with a volume V2B in the volume of the transfer bag 5, 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 transfer material 2. Before transferring the transfer material 2 through the lock 30 into the sterile area, the partition 60 must be separated. The inner bag (liner) is already manufactured during the production of the transfer bag by introducing the partition 60 into the volume of the transfer bag 5 and packing the adapter plate 54 in the inner bag (liner) before sterilization, so that the second transfer area TF2 of the transfer bag 5 is in front Execution of the second transfer step forms two separated volumes V2A and V2B. With the inner bag (liner), contact of the transfer material 2 with a critical point called a 'ring of concern' can be prevented, which is described in more detail below.

After the second film section 68 has been separated, the lock door 32 is removed the lock opening 31 removed ( 11 ). The adapter ring 57 detaches from the magnetic retaining brackets 38 of the adapter plate 57 and remains attached to the lock door 32 due to the field force-locking 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. At the same time, the separated second film section 68 clamped between the lock door 32 and the adapter ring 57 is removed together with the lock door 32 from the Lock opening 31 removed.

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

Through the opening 31 of the lock 30 that has been cleared in this way, the inner bag (liner) of the transfer bag 5 can now be pulled into the interior I of the lock 30, compare 12 , and then opened, for example with the previously mentioned cutting device 11. In 12A a schematic cross-sectional representation 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 (i.e. onto the inside I of the lock 30), cf. 13 .

The division of the internal 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, for example by hand, into the interior after the lock has been opened, since there is a risk of the Transfer material 2 to touch the cut edges of the separated 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 taking over the transfer material 2 in order to prevent contamination of the transfer material 2 by touching the cut edges ('Ring of Concern' 69) to be excluded.

After the transfer material 2 has been taken over from the transfer bag 5 into the sterile area, the inner bag (liner), as in 14 shown, turned inside out and the wall 10 of the lock is closed with the lock door 32, compare 15 . The annular gap 36 of the lock opening 31 can then be sealed with a sealant, such as a sealing ring.

After the lock opening 31 has been closed through the lock door 32, the adapter plate 54 with the transfer bag attached to it is removed from the outside of the lock 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 lock closure 32 together with the separated 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, in 17 the wall 10 of the lock 30 with the lock opening 31, the lock door 32 that can be inserted therein and the adapter plate 54 with the adapter opening 56 and the adapter ring 57 inserted therein are shown in an exploded view without a transfer bag.

In 18 a circularly guided cutting device 11 of the sterile area is shown for the guided cutting of the film section 68 of the transfer bag 5 clamped between the adapter ring 57 and the lock door 32 along the annular gap 36/59, with the cutting device 11 in this regard via the central fastening rod 33 of the lock door 32 as the center of the Movement is circular.

Reference symbol 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 bag

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 outer packaging

30

sluice

31

Lock opening (circle opening)

32

Lock door or lock lock

33

Fastening rod (lock door)

34

Fasteners (support frame)

35

Support frame (lock door)

36

Lock gap (ring-shaped)

37

Coupling agent/magnetic foil (system 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 (closure 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'

Cut

62

double-sided tape

63

Cover 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)

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) can be carried out from the transfer bag (5) into the sterile area, characterized in that the transfer bag (5) is inside the closed Volume (V) has a freely movable cutting tool (61) therein. Transfer bag (5). 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 together. Transfer bag (5) according to 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). Claim 4 , characterized in that the second transfer area (TF2) comprises two separate volumes (V2A, V2B), the two volumes (V2A, V2B) being separated from each other by a partition (60), the interface (200; 54) being in one volume (V2B) and the transfer material (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 is freely movable 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) packed sterile in an outer packaging (20) from an outer packaging (20) into a transfer bag (5) with a sterilized, closed volume (V), in preparation for a subsequent transfer step for handing over 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 following steps, preferably in this order: a) materially 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) introducing a Incision (65) in the first transfer area (TF1) over a cutting length, c) transferring the transfer material (2) from the outer packaging (20) into the transfer bag (5) through the incision (65). Procedure according to Claim 7 , characterized in that the cohesive 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 the Claims 7 or 8th , characterized in that the cohesive connection in process step a) takes place by thermally welding the outer sides (50; 21) of the transfer bag (5) and the outer packaging (20). Procedure according to one of the Claims 7 until 9 , characterized in that an incision (65) is made in method step b) by a cutting tool (61) located in the transfer bag (5). Procedure according to one of the 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 according to 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) after transferring the transfer material (2) into the second transfer area (TF2) and sealed in a sterile manner, in particular by a thermal welding process. Transfer set for the sterile transfer of a transfer item packed sterile 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 interface (200; 54) having an opening (203; 56) for coupling to a transfer lock (30) and transferring the transfer material (5) from the transfer bag (5) to the sterile area in the subsequent transfer step and a connecting means (62) for the cohesive connection of the outer sides (21; 50) of the outer packaging (20) and the transfer bag (5) via a first transfer area (TF1), wherein the transfer bag (5) forms a sterile, closed volume (V) and a cutting tool (11) is contained within the closed volume. 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.

Images