Transfer system, beta component of transfer system, barrier system and production plant
By designing a transfer system with storage device and centering device, the problem of limited reception capacity of the existing transfer system is solved, efficient and reliable transfer and sterilization of multiple objects is achieved, and the risk of pollution is reduced.
Patent Information
- Application Number
- CN202510131803.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2024-02-08
- Filing Date
- 2025-02-06
- Publication Date
- 2025-08-08
AI Technical Summary
The existing transfer system has limited reception capacity, and only a single object can be placed into a β container, and frequent replacement of β components increases the risk of contamination.
A transfer system is designed, including an alpha component and a beta component. The beta component has a storage device that can accommodate multiple objects, and through the combination of a storage device and a centering device, efficient, reliable transfer and sterilization of objects are achieved.
It improves the efficiency of object transfer and reduces the risk of pollution. Through the combination of storage device and centering device, the simultaneous transfer and sterilization of multiple objects is achieved, reducing the complexity of operation and pollution risk.
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Figure CN120437337A_ABST
Abstract
Description
Technical Field
[0001] In production plants used in the pharmaceutical industry, ensuring the sterility of the products involved during production is often important. Particularly high demands are placed on the separation of potent drugs from the environment. Background Art
[0002] For this purpose, corresponding production facilities often have barrier systems. In this sense, a barrier system can be a so-called isolator, whose isolation zone is completely isolated and sealed from the environment. However, in this context, the term barrier system also includes RAB (Restricted Access Barrier) systems. The isolation zone of a RAB system is also referred to below as the isolation zone.
[0003] A RAB system represents a physical barrier between the production area and its operator environment. The production area is protected by special machine guards, including machine enclosures, securely locked doors, and, for example, glove ports. Based on the type of ventilation, RAB systems can be categorized as active or passive. Active RAB systems are equipped with special ventilation, while passive RAB systems are connected to the existing cleanroom ceiling of the surrounding Class B room. They are an attractive option for existing cleanrooms, improving production quality and for applications requiring greater flexibility. When properly operated as an integrated system, RAB technology can achieve the microbiological quality of the isolator.
[0004] However, isolators are completely closed systems in which the operator and process areas or isolation zones are completely separated. Pharmaceutical isolators are usually equipped with a fully repeatable and validated bio-decontamination system (usually H2O2) and related process ventilation technology, which can ensure temperature control through heating or cooling, as well as a constant overpressure control of the process area relative to the operator environment to avoid the ingress of contaminated air. For example, if the active ingredient is to be prevented from escaping, the isolator is usually operated under negative pressure.
[0005] An isolation zone, or closed environment with its own atmosphere, meets specific requirements for purity and contamination-free conditions while also preventing the escape of potent active pharmaceutical ingredients (APIs) into the environment. In other words, a barrier system, isolator, or RAB system creates an area separated from the environment where the product can be processed sterilely and contained. In this sense, "enclosed" specifically refers to an airtight separation that prevents the ingress of contaminants and the escape of substances or products (e.g., active pharmaceutical ingredients) contained within the isolator.
[0006] The isolation zone is separated from the operating area, located outside the barrier system, where operators can be present, at least by a partitioning structure. The partitioning element is usually part of the enclosure surrounding the isolation zone. In the operating area, personnel can use remote control devices and / or glove ports to manipulate products and objects in the barrier system (isolator or RAB system).
[0007] As is known, so-called transfer systems (also known as rapid transfer ports) are capable of moving objects from an operating area to an isolation area (or vice versa) while ensuring that the isolation area is separated from the environment. Such transfer systems include an α component and a β component that functionally interacts therewith. The α component includes an α port integrated into the isolation structure, which is connected to or integrated into the isolation structure via an α flange. Furthermore, the α component includes an openable and closable α closure unit for opening and closing the α port. The α closure unit is pivotally mounted on the α flange.
[0008] The beta component includes a removable beta closure unit and a beta flange for coupling to the alpha component. When the alpha and beta components are used or coupled as intended, they form a lock that allows objects to be introduced into the isolation zone while ensuring that the isolation zone remains sterile. When coupled, the beta closure unit is connected to the alpha closure unit and can move with it. Therefore, when the alpha closure unit is opened, the beta closure unit pivots together with the alpha closure unit.
[0009] The beta container is also arranged on the beta flange and closed by the beta closure unit. The beta container is particularly dimensionally stable. Objects to be introduced into the isolation zone or removed from the barrier system can be placed in the beta container. The beta container thus includes a receiving space within it for storing objects.
[0010] The beta flange and the alpha flange have fixed predefined dimensions. Various standardized dimensions are known.
[0011] A common problem with known transfer systems is that their capacity is limited, and only single objects, or objects required for only one step in the barrier system setup process, can be placed in the beta container. After the object is introduced, the new beta component must be docked with the other objects required for the barrier system and opened. Each beta component is sterilized or autoclaved. However, frequent replacement of docked beta components is undesirable because, in addition to the associated effort, it also increases the risk of contamination. Summary of the Invention
[0012] Therefore, to ensure process safety and efficiency, a method is needed to quickly and safely introduce the desired object into the barrier system.
[0013] The object of the present invention is to provide an improved solution to the above-mentioned problem, whereby objects can be introduced into a barrier system in an efficient and process-reliable manner.
[0014] This object is achieved by a transfer system for a barrier system with a sterile isolation zone and a beta component for such a transfer system.
[0015] The barrier system is separated from the non-sterile operating area by a partition structure. The transfer system is designed to transfer objects from the operating area to the isolation area, and vice versa. The transfer system includes an α component and a β component. The α component has an α flange for connecting to the partition structure and an openable and closable α closure unit, and the β component has a removable β closure unit and a β flange for coupling to the α component.
[0016] The beta component further comprises a particularly dimensionally stable beta container with a receiving space.
[0017] It can now be provided within the scope of the invention that a storage device is provided in the receiving space of the beta component. The storage device can accommodate a plurality of objects which are to be transferred from the receiving space via the beta flange to the isolation area.
[0018] The multiple receiving portions in the beta-component, in particular in the storage device, have the advantage of saving changeover time, since there is no need to dock individual canisters or beta-components. Furthermore, the increased risk of drug contamination during docking and undocking due to multiple changeovers is also ameliorated within the scope of the present invention, or the risk is reduced by avoiding multiple changeovers.
[0019] The storage device may comprise at least two containers for objects, wherein the objects are intended to be transferred from the receiving space to the isolation zone via the beta flanges.
[0020] The storage device in the receiving space or beta container can be designed so that one of the receiving parts is placed in a removal position. In this removal position, the objects received in the corresponding receiving part are positioned so that they can be removed via the beta flange (and the alpha flange if connected) and transferred to the isolation area. In the removal position, the objects held in the receiving part are positioned so that they can be removed via the beta flange and the alpha flange (if coupled). They can be removed from within the barrier system, for example, via a glove port or by a robot installed in the barrier system.
[0021] In particular, the problem addressed by the invention is solved by a transfer system having the features of claim 1 and a beta component having the features of claim 2 .
[0022] The beta component may include a connection structure for a sterilization medium. Via the connection structure, the sterilization medium may be supplied to the receiving space for sterilizing the receiving space and any objects located therein. The beta component may also include a discharge channel for removing the sterilization medium from the receiving space.
[0023] The beta component can be designed as a SIP (Steam In Place) tank that can be autoclaved internally, for example, with sterile steam and compressed air connected on one side and condensate or waste water discharged on the other side, in particular via the aforementioned drain channel.
[0024] After sterile steam and compressed air are applied to the beta component, an autoclave process (e.g., 121° C. for at least 25 minutes; other process parameters, i.e., temperature and dwell time, may also be used) is performed within the beta component. The beta component is designed as a pressure-tight object.
[0025] The ability to sterilize the beta-component and its contents together is particularly advantageous in combination with a storage device. This allows multiple objects in the beta-component or its receiving space to be sterilized simultaneously. Furthermore, the receiving space or its contents can be moved during the sterilization process, which helps avoid cold spots and improves the sterilization process.
[0026] The beta component can include a collection basin for the sterilization medium or its condensate. The bottom of the collection basin can have a slope toward the drain channel, with the collection basin forming the bottom surface of the receiving space. This ensures efficient and complete removal of the sterilization medium or its condensate. The drain channel is preferably located at the deepest point of the collection basin. This deepest point of the collection basin forms the deepest point of the receiving space. In particular, the receiving space is designed without any local depressions that are not connected to the drain channel by a slope. This facilitates the complete drainage of the sterilization medium or its condensate.
[0027] The storage device can be designed so that the receiving parts of the storage device can be moved along a simple closed curve to move them into and out of the removal position. This allows the receiving parts to be easily moved or guided to move them into and out of the removal position. The curve can be circular, elliptical, or egg-shaped. Within the meaning of the present invention, the curve can also have a rectangular shape, which may have rounded corners.
[0028] The storage device can be designed so that the receiving parts of the storage device can be rotated about a rotation axis to move them into or out of the removal position. The rotation axis can extend horizontally or vertically. This simple rotational movement is structurally simple to implement and ensures that all receiving parts are moved into the removal position in the same way.
[0029] The storage device can be designed to provide a complete receiving portion, i.e., a receiving portion containing the objects to be transferred, at a first distance on a first side of the beta flange, and after the objects are placed in a removal position on the beta flange, the receiving portion is moved to a second side of the beta flange opposite the first side. The storage device can effectively guide the receiving portion through the beta flange. The receiving portion can be installed on the second side at a second distance less than the first distance. After the objects are removed, the receiving portion can be effectively installed for more compact storage. The movement path of the receiving portion can generally extend along a straight line, particularly in this example. Corresponding guidance of the receiving portion is structurally easy to implement.
[0030] The beta flange of the beta component can be located on the coupling side of the beta component, and the beta component can have a closable loading opening on the loading side of the beta component. In particular, the coupling side can be arranged opposite the loading side. However, the coupling side and the loading side can also be offset by 90° relative to each other. This offset arrangement of the coupling side and the loading side maximizes the openable area, facilitating loading.
[0031] Each receiving section can be equipped with a pull-out, drawer-like, and particularly replaceable, insert for receiving the object to be transferred. The transfer system is designed so that when the α and β components are connected and opened, the insert of the receiving section, currently in the removal position, can be moved from the receiving space to the isolation zone via the α flange. The insert allows for precise and repeatable positioning of objects. The replaceable insert can be removed from the barrier system along with the object. This is particularly advantageous for reassembling the receiving sections more tightly after removing the insert and object.
[0032] These objects can be placed in the insert outside the beta component. The insert can then be inserted into the beta component. The beta component can then be closed and supplied with a sterilization medium to sterilize its interior and the objects and insert placed therein.
[0033] The beta component can be mobile. The beta component can include movable rollers. The position of the beta flange can be adjusted vertically relative to the rollers by means of a vertical adjustment device. This allows the beta component to be moved flexibly, for example to be connected to the sterilization medium and then brought to its position of use. For example, the vertical adjustment device can be connected to the alpha port in different positions. The movable beta component with the storage device can be easily moved from the loading position to the position of use on the barrier system. If the beta component also includes a connection structure for the sterilization medium, it can also be easily moved to the sterilization medium supply point and from there to the barrier system. All objects can be loaded, sterilized and then introduced into the barrier system in a single movement sequence.
[0034] The storage device can be designed as a paternoster system, with the receptacles arranged in a ring around the paternoster system. This allows for efficient movement of the receptacles and a space-saving arrangement. In particular, the holders can accommodate objects and / or inserts of various geometries.
[0035] According to the invention, it can be provided that the transfer system has at least one centering device assigned to the insert, which centering device can be arranged in the isolation area or can be arranged in the isolation area when the transfer system is used as intended. According to the invention, the centering device and the insert each have at least one engaging element, wherein the engaging elements on the centering device and the insert are designed to be complementary to each other so that they can engage with each other in order to position the insert in a central position so that the insert is fixed in the vertical direction at least on one side, in particular on both sides (top and bottom) in a force-fit or form-fit manner. In particular, the engaging elements on the centering device and the insert are designed to be complementary to each other so that they can engage with each other in order to position the insert in a central position so that the insert is also pre-positioned, in particular fixed in its position in the horizontal plane, in a force-fit or form-fit manner.
[0036] For the purposes of the present invention, "fixed on one side in the vertical direction" means that the insert rests at least partially against the centering device and is therefore supported at the base. "Fixed" means that the insert is not jerked into the centering position, i.e., it is not held in the centering position under tension, but rather guided into the centering position without tension and then locked there. In this sense, "pre-positioned" means fixed in a position with a certain amount of play, so that only slight movements around the fixed position in the horizontal plane are possible.
[0037] For example, the insert can be fixed in a force-fitting manner by means of rubber jaws, so that the insert is fixed and cannot slip.
[0038] According to the present invention, a barrier system (in particular an isolator) is also provided with a partition structure, by which a sterile isolation zone can be or is separated from a non-sterile operating area, wherein the barrier system has a transfer system for transferring objects from the operating area to the isolation zone, and vice versa. The barrier system is characterized in that the transfer system is designed according to the above-mentioned invention, and wherein the centering device is arranged in the isolation zone.
[0039] The combination of the storage device and the centering device makes it possible, in particular, to reliably remove objects from the receiving portion or load them into the container using robots. The various inserts can always be positioned safely and reproducibly, thus reliably defining the position of the object.
[0040] When the transfer system is used as intended, the centering device is arranged in the isolation zone.
[0041] According to the present invention, there is also provided a production plant, characterized in that it comprises the barrier system according to the above invention.
[0042] Different inserts or receptacles can be customized for specific objects. For example, inserts or receptacles can be provided for format components that are autoclaved and inserted. Other objects can include precipitation plates, contact test or other EM materials such as contact swabs and culture media, flushing caps, and bacterial counting tips. Furthermore, inserts or receptacles can be provided for troubleshooting tools such as robotic tools, tweezers, or wrenches. Furthermore, inserts or receptacles can be provided for robotic grippers or other materials used for sampling, sterilization, or labeling.
[0043] The insert or receiving portion may have identification features. For example, these may be optical features (such as a barcode or QR code). The identification features may also be stored on an RFID chip or other contactless readable feature carrier.
[0044] The insert or receiving portion can be arranged in a pivotable manner in the storage device. In particular, in a storage device in which the receiving portion is rotatably arranged, the receiving portion can always store objects horizontally.
[0045] According to the present invention, the storage device can be moved automatically within the transfer system. However, the storage device can also be moved or operated manually, for example, using a handwheel or one or more levers or various actuating devices. In particular, for example, a rotational movement of the storage device or a receptacle within the storage device can advantageously be achieved using a handwheel. The movement of the receptacle can be performed automatically or manually. The inserts of the transfer system can be moved automatically or manually. For example, the inserts can be extended and retracted using a lever or handwheel. Automatic movement can be achieved, for example, using an electric motor, or using a hydraulic or pneumatic drive. BRIEF DESCRIPTION OF THE DRAWINGS
[0046] In the following, the invention will be explained in more detail on the basis of the accompanying drawings. Identical elements are provided with the same reference numerals and are only provided once where appropriate. In the drawings:
[0047] Figure 1 is a first simplified illustration of an advantageous transfer system in an open state, arranged as intended on a barrier system;
[0048] Figure 2 shows a portion of the transfer system in a closed state as viewed from the α port;
[0049] Figure 3 is a side view of a portion of the transfer system in the open state;
[0050] Figure 4 is a side view of a variant of the β component of the transfer system;
[0051] Figure 5 is a side view of another variation of the β component of the transfer system;
[0052] Figure 6 is a plan view of another variant of the β component of the transfer system;
[0053] Figure 7 is a side view of another variation of the β component of the transfer system;
[0054] Figure 8 is a side view of another variation of the β component of the transfer system;
[0055] Figure 9 is a side view of another variation of the transfer system beta component; and
[0056] Figure 10 FIG. 4 is a side view of another variation of the transfer system β component. DETAILED DESCRIPTION
[0057] Figure 1 is a simplified view of the transfer system 1. The transfer system 1 is intended or designed to be arranged or assembled on or inside an isolator 2 (as an example of a barrier system; the following explanation of the isolator example also applies to other barrier systems) and is only used here for the sake of clarity. Figure 1 The isolator 2 is part of a production device 3, which is also schematically represented by a dashed rectangle in this example.
[0058] The isolator 2 is designed or constructed to enable aseptic processing of products, such as pharmaceuticals or medical products. To this end, the isolator 2 forms a sterile isolation zone 4, which is separated from a non-sterile operating area 6 by at least a partition structure 5. In this regard, the isolator 2 includes at least a partition structure 5 to separate the sterile isolation zone 4 from the non-sterile operating area 6.
[0059] The isolator 2 may also comprise other components which are provided in known isolators of related type but are not shown here for the sake of clarity.
[0060] The transfer system 1 is used or designed to enable objects to be moved from an operating area 6 to an isolation area 4 while maintaining sterility in the isolation area 4. For this purpose, the transfer system 1 has an α-component 7 for arrangement on the isolator 2 or the separating element 5, and a β-component 8, which can be coupled to the α-component and in which the objects 15 to be transferred can be stored under sterile conditions.
[0061] α component 7 includes α flange 9, such as Figure 1As shown, the α-flange is intended to be arranged in or integrated into the partition structure 5 when used as intended. Furthermore, the α-component 7 has an α-closing unit 10 that is pivotally mounted on the α-flange 9 and can be moved between an open and closed position. In the present case, the α-closing unit 10 can only be opened when the β-component 8 is coupled to the α-component 7 as intended. Otherwise, the α-component 7 remains closed to maintain sterility.
[0062] The beta component 8 has a beta flange 37 and a removable beta closure unit 25 for coupling it to the alpha component 7. The beta component 8 also comprises a beta container 11 which is dimensionally stable in this example and has a receiving space 12. The beta container 11 is as shown in FIG. Figure 1 shown.
[0063] In the context of the present invention, the storage device 13 is arranged in the receiving space 12 of the beta component 8 and comprises at least two receptacles 14 for objects 15. The objects 15 are intended to be transferred from the receiving space 12 through the alpha closed unit 10 and to the isolation zone 4.
[0064] In the context of the present invention, the storage device 13 is designed so that one of the receptacles 14 can be located in a removal position 16. In the removal position 16, the objects 15 received in the receptacles 14 are positioned so that they can be transferred via the α flange 9 (or via the β flange 37) to the isolation zone 4. For example, Figure 1 As shown, a drawer-like insert 17 can be mounted in each receiving portion 14 so as to be guided by a guide device 18, which in this example is designed as a guide rail. The insert 17 is used or designed to receive an object 19 to be transferred. In order to transfer the object, the insert 17 can be pulled out of the receiving space 12 by the guide device 18. The respective insert 17 can be removed from the beta container 11 along the removal direction 20. The transfer system 1 can be configured (as Figure 1 ) is shown such that the receiving portion 14 in the removal position 16 is arranged such that the corresponding insert 17 is aligned with the removal direction 20 . The removal direction 20 extends through the α flange 9 .
[0065] The centering device 21 can be arranged or already arranged in the isolation zone 4. The centering device 21 and the insert 17 can each have at least one engagement element 22, 23. The engagement elements 22, 23 on the centering device 21 and the insert 17 can be designed to complement each other. In particular, the engagement elements 22, 23 can be designed so that they can engage with each other to position the insert 17 in a centered position, so that the insert 17 is fixed in a vertical direction 24 on at least one side, in particular on both sides, in a force-fitting or form-fitting manner. In particular, the insert 17 is also pre-positioned, in particular fixed in its position in a horizontal plane, in a force-fitting or form-fitting manner.
[0066] The engaging elements 22 provided on the side of the insert 17 can be designed, for example, as centering sleeves or centering grooves. The engaging elements 23 provided on the side of the centering device 21 can be designed, for example, as centering bolts or centering pins, and can have a shape complementary to the centering sleeves or centering grooves. This allows for support in the vertical direction 24 and centering in a horizontal plane (perpendicular to the vertical direction 24). This prevents the insert 17 from sagging. Object 19 can be precisely positioned and automatically removed with precision and ease.
[0067] A corresponding engagement element 22 may be provided on a plurality of or each insert 17 of the storage device 13. This allows the inserts 17 to be positioned consistently.
[0068] Figure 2 The transfer system 1 is shown in the closed state, seen from the isolation zone 4. The beta component 8 is only partially shown; in particular the beta container 11 is not shown in its entirety, but only its connection to the beta flange 37 is shown.
[0069] Figure 3 is a side view of the transfer system 1 in the open state with the insert 17 pulled out.
[0070] Figure 4 1 is a side view of the beta component 8 of the transfer system 1. The beta component 8 includes a connection structure 26 for a sterilization medium, via which the sterilization medium can be supplied to the receiving space 12. Steam (water vapor) is preferably used as the sterilization medium. H2O2 vapor can also be introduced into the beta component 8 as the sterilization medium. The sterilization medium can be supplied to the receiving space 12 to sterilize the receiving space and the objects 19 located therein. The beta component 8 can, in particular, include a discharge channel 27 for removing the sterilization medium from the receiving space 12.
[0071] The beta component 8 may comprise a collecting basin 28 for the sterilization medium or its condensate. The bottom 29 of the collecting basin 28 preferably has a slope 30 (indicated by arrows) pointing towards the drain channel 27. The collecting basin 28 may in particular form the bottom surface of the receiving space 12.
[0072] The beta component 8 may include a substructure 31 that can be removed from the beta container 11 or designed to be integrally connected thereto, for example. The substructure 31 can be used to transport the beta component 8. To this end, the substructure 31 may include rollers 32. Other designs are also possible. For example, the substructure 31 may include recesses for attaching a lifting fork. In particular, the position of the beta flange 37 relative to the rollers 32 and / or the substructure 31 can be vertically adjusted using a vertical adjustment device 33.
[0073] The beta flange 37 of the beta component 8 is arranged on the coupling side 34 of the beta component 8. The beta component 8 may have a closable loading opening 36 on the loading side 35 of the beta component 8. The coupling side 34 may be arranged at the opposite position of the loading side 35, for example Figure 4 and Figure 5 The coupling side 34 may be offset from the loading side 35 by 90°.
[0074] Figure 5 A variant of the beta component 8 is shown, in which the receiving portion 14 is arranged annularly around a paternoster system 46. The storage device 13 is designed as a paternoster system 46 so that the receiving portion 14 can be arranged completely around the paternoster system 46 and can be guided through the beta flange 37.
[0075] The receiving parts 14 of the storage device 13 are moved on a simple closed curve 39 in order to move them into or out of the removal position 16 .
[0076] like Figure 6 and Figure 7 As shown, the storage device 13 can be designed so that the receiving portion 14 of the storage device 13 can be rotated about the rotation axis 38. By means of the rotational movement, the receiving portion 14 can be moved into or out of the removal position 16. Figure 6 In the β component 8 shown in the figure above, the rotation axis 38 extends vertically. Figure 7 In the beta component 8 shown from the side in FIG, the axis of rotation 38 extends horizontally. Figure 6 and Figure 7 In the present example in FIG, the receiving part 14 moves on a circular path in both cases.
[0077] like Figure 8 and Figure 9 As shown, the storage device 13 can be configured to provide a complete receiving portion 14 at a first distance 42 on a first side 40 of the beta flange 37, and to move the receiving portion 14 to a second side 41 of the beta flange 37 opposite to the first side 40 after having been positioned in the removal position 16 on the beta flange 37, wherein the receiving portion 14 is installed on the second side 41 at a second distance 43, and the second distance 43 is smaller than the first distance 42.
[0078] exist Figure 8 In the embodiment, the first side 40 is located below the beta flange 37. Figure 9 In the embodiment, the first side 40 is located above the β flange 9.
[0079] exist Figure 10 In the example of FIG, the storage device 13 is designed so that the receiving portion 14 of the storage device 13 is rotated about the horizontal rotation axis 38. Figure 10 In the example, the receiving part 14 moves along a circular path. The receiving part is mounted in the same manner as Figure 5 Similar to the paternoster system in FIG, they are mounted in such a way that they maintain their orientation during rotation. Therefore, they always extend horizontally. For this purpose, they are each suspended in a storage device 13 and are mounted so that they can pivot about a second axis 45.
Claims
1. A transfer system (1) for a barrier system, in particular an isolator (2), the barrier system comprising a sterile isolation zone (4), the sterile isolation zone (4) being separated from a non-sterile operating zone (6) by a partition structure (5), the transfer system (1) being designed to be able to transfer objects from the operating zone (6) to the isolation zone (4) and vice versa, the transfer system (1) comprising an α-component (7) and a β-component (8), the α-component (7) having an α-flange (9) for connecting to the partition structure (5) and an openable and closable α-closing unit (10), the β-component (8) having a β-flange (37) and a removable β-closing unit for coupling to the α-component (7), the β-component (8) also having a particularly dimensionally stable β-container (11) with a receiving space (12), characterized in that A storage device (13) is arranged in the receiving space (12) of the beta component (8), the storage device comprising at least two receptacles (14) for objects (19) intended to be transferred from the receiving space (12) to the isolation zone (4) via the beta flanges (37), the storage device (13) being designed such that one of the receptacles (14) can be positioned in a removal position (16) at a time, so that in the removal position (16) the object (19) received in the receptacle (14) is positioned so that it can be removed and transferred to the isolation zone (4) via the beta flanges (37) and the alpha flanges (9).
2. A beta component (8) for use in a transfer system (1), the transfer system (1) being used for a barrier system, in particular an isolator (2), the barrier system comprising a sterile isolation zone (4), the sterile isolation zone (4) being separated from a non-sterile operating zone (6) by a partition structure (5), the transfer system (1) being designed to be able to transfer objects from the operating zone (6) to the isolation zone (4) and vice versa, the transfer system (1) comprising an α component (7) and a β component (8), the α component (7) having an α flange (9) for connection to the partition structure (5) and an openable and closable α closure unit (10), the β component (8) having a β flange (37) and a removable β closure unit for coupling to the α component (7), the β component (8) also having a particularly dimensionally stable β container (11) with a receiving space (12), characterized in that A storage device (13) is arranged in the receiving space (12) of the beta component (8), the storage device comprising at least two receptacles (14) for objects (19) intended to be transferred from the receiving space (12) to the isolation zone (4) via the beta flange (37), the storage device (13) being designed such that one of the receptacles (14) can be positioned in a removal position (16), whereby in the removal position (16) the object (19) received in the receptacle (14) is arranged for removal via the beta flange (37).
3. The transfer system (1) according to claim 1 or the beta component (8) according to claim 2, wherein The beta component (8) comprises a connection structure (26) for a sterilization medium, by means of which the sterilization medium can be supplied to the receiving space (12) in order to sterilize the receiving space and any objects (19) located therein, wherein the beta component (8) in particular comprises a discharge channel (27) for removing the sterilization medium from the receiving space (12).
4. The transfer system (1) according to claim 1 or claim 3 or the beta component (8) according to claim 2 or claim 3, wherein The beta component (8) comprises a collecting basin (28) for the sterilization medium or its condensate, the bottom (29) of which has a slope (30) towards the discharge channel (27), wherein the collecting basin (28) in particular forms the bottom surface of the receiving space (12).
5. The transfer system (1) according to claim 1, 3 or 4 or the beta component (8) according to claim 2, 3 or 4, wherein The storage device (13) is designed so that the receiving portion (14) of the storage device (13) can be moved on a simple closed curve (39) in order to move the receiving portion into or out of the removal position (16).
6. The transfer system (1) according to claim 1, 3, 4 or 5 or the beta component (8) according to claim 2, 3, 4 or 5, wherein The storage device (13) is designed to enable the receiving portion (14) of the storage device (13) to be rotated about a rotation axis (38) in order to move the receiving portion into or out of the removal position (16). In particular, the rotation axis (38) extends horizontally or vertically.
7. The transfer system (1) according to claim 1, 3 or 4 or the beta component (8) according to claim 2, 3 or 4, wherein The storage device (13) is designed to provide a complete receiving portion (14) at a first distance (42) on a first side (40) of the beta flange (37) and to move the receiving portion (14) to a second side (41) of the beta flange (37) opposite to the first side (40) after having been positioned in a removal position (16) on the beta flange (37), wherein the receiving portion (14) is mounted on the second side (41) at a second distance (43) that is smaller than the first distance (42).
8. Transfer system (1) according to any one of the preceding claims or beta component (8) according to any one of the preceding claims, characterized in that The beta flange (37) of the beta component (8) is arranged on a coupling side (34) of the beta component (8), and the beta component (8) has a closable loading opening (36) on a loading side (35) of the beta component (8), in particular, the coupling side (34) is opposite the loading side (35).
9. The transfer system (1) according to any one of the preceding claims or the beta component (8) according to any one of the preceding claims, wherein A pull-out, drawer-like, in particular replaceable insert (17) for receiving an object (19) to be transferred is provided in each receiving portion (14), wherein the transfer system (1) is designed such that when the α component (7) and the β component (8) are connected to one another and opened, the insert (17) of the receiving portion (14) currently located in the removal position can be moved from the receiving space (12) via the α flange (9) into the isolation zone (4).
10. The transfer system (1) according to any one of the preceding claims or the beta component (8) according to any one of the preceding claims, wherein The beta component (8) comprises a roller (32) by means of which the beta component (8) can be moved. In particular, the position of the beta flange (37) relative to the roller (32) can be vertically adjusted by a vertical adjustment device (33).
11. The transfer system (1) according to any one of the preceding claims or the beta component (8) according to any one of the preceding claims, wherein The storage device (13) is designed as a paternoster system (46), so that the receiving portion (14) can be arranged completely around the paternoster system (46).
12. A barrier system, in particular an isolator (2), having a transfer system (1) according to any one of the preceding claims, wherein: In particular, a centering device (21) is arranged in the barrier system, in particular the isolator (2).
13. A production plant (3) comprising a barrier system, in particular an isolator (2) according to claim 12.