TRANSFER SYSTEM FOR USE IN A PHARMACEUTICAL BARRIER SYSTEM, IN PARTICULAR AN ISOLATOR, BETA COMPONENT FOR USE IN A TRANSFER SYSTEM, BARRIER SYSTEM, IN PARTICULAR AN ISOLATOR, AND PRODUCTION FACILITY

Abstract

The invention relates to a transfer system (1) for use in a barrier system (2) and to a beta component (8) for use in a transfer system (1) and to a barrier system (2) and to a production facility (3).

Claims

1. A transfer system (1) for a barrier system, the barrier system comprising a sterile isolation region (4) which is separated from a non-sterile operating region (6) by a partition (5), the transfer system (1) configured to transfer objects from the operating region (6) to the isolation region (4) and vice versa and the transfer system (1) comprising an alpha component (7) and a beta component (8), the alpha component (7) having an alpha flange (9) for connection to the partition (5) and an openable and closable alpha closure unit (10), the beta component (8) having a beta flange (37) and a removable beta closure unit for coupling to the alpha component (7), the beta component (8) further having a beta container (11) with a receiving space (12), wherein in the receiving space (12) of the beta component (8) there is arranged a magazine device (13) which comprises at least two receptacles (14) for objects (19), the objects (19) being intended to be transferred from the receiving space (12), through the beta flange (37) and to the isolation region (4), the magazine device (13) configured such that one of the receptacles (14) can be positioned in a removal position (16) each time so that, in the removal position (16), the objects (19) received in the receptacle (14) are positioned so as to be removed through the beta flange (37) and the alpha flange (9) and transferred to the isolation region (4).

2. A beta component (8) for use in a transfer system (1) for a barrier system, the barrier system comprising a sterile isolation region (4) which is separated from a non-sterile operating region (6) by a partition (5), the transfer system (1) being configured to transfer objects from the operating region (6) to the isolation region (4) and vice versa and the transfer system (1) comprising an alpha component (7) and a beta component (8), the alpha component (7) having an alpha flange (9) which is connected to the partition (5) and has an openable and closable alpha closure unit (10), the beta component (8) having a beta flange (37) and a removable beta closure unit for coupling to the alpha component (7), the beta component (8) further having a beta container (11) with a receiving space (12), wherein in the receiving space (12) of the beta component (8) there is arranged a magazine device (13) which comprises at least two receptacles (14) for objects (19), the objects (19) being intended to be transferred from the receiving space (12), through the beta flange (37) and to the isolation region (4), the magazine device (13) configured such that one of the receptacles (14) can be positioned in a removal position (16) so that, in the removal position (16), the objects (19) received in the receptacle (14) are arranged for removal through the beta flange (37).

3. The transfer system (1) according to claim 1, wherein the beta component (8) comprises a connection (26) for a sterilization medium, by which a sterilization medium can be supplied to the receiving space (12) in order to sterilize said receiving space and any objects (19) located therein.

4. The transfer system (1) according to claim 1, wherein the beta component (8) comprises a collecting basin (28) for sterilization medium or its condensate and a bottom (29) of the collecting basin (28) has a gradient (30) toward a drain (27).

5. The transfer system (1) according to claim 1, wherein the magazine device (13) is designed to move the receptacles (14) of the magazine device (13) on a simple closed curve (39) in order to move them into or out of the removal position (16).

6. The transfer system (1) according to claim 1, wherein the magazine device (13) is configured to rotate the receptacles (14) of the magazine device (13) about an axis of rotation (38) in order to move them into or out of the removal position (16).

7. The transfer system (1) according to claim 1, wherein the magazine device (13) is configured to provide full receptacles (14) on a first side (40) of the beta flange (37) at a first distance (42) and to move the receptacles (14) after they have been positioned in the removal position (16) on the beta flange (37) to a second side (41) of the beta flange (37) which is opposite the first side (40), wherein the receptacles (14) are mounted on the second side (41) at a second distance (43) that is smaller than the first distance (42).

8. The transfer system (1) according to claim 1, wherein 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).

9. The transfer system (1) according to claim 1, wherein a pull-out drawer-like insert (17) is provided in each receptacle (14) for receiving the objects (19) to be transferred, wherein the transfer system (1) is configured such that when the alpha component (7) and the beta component (8) are connected to one another and are open, the insert (17) of the receptacle (14), which is currently positioned in the removal position, can be moved from the receiving space (12), through the alpha flange (10) and into the isolation region (4).

10. The transfer system (1) according to claim 1, wherein the beta component (8) comprises rollers (32) by which the beta component (8) can be moved, wherein a position of the beta flange (37) relative to the rollers (32) can be vertically adjusted by a vertical adjustment device (33).

11. The transfer system (1) according to claim 1, wherein the magazine device (13) is configured as a paternoster system (46) so that the receptacles (14) are arranged a whole way around the paternoster system (46).

12. A barrier system having a transfer system (1) according to claim 1, wherein a centering device (21) is arranged in the barrier system.

13. A production plant (3) comprising a barrier system according to claim 12.

14. The transfer system according to claim 1, wherein the barrier system includes an isolator (2).

15. The transfer system according to claim 1, wherein the beta container (11) is dimensionally stable.

16. The transfer system according to claim 9, wherein the pull-out drawer-like insert (17) is replaceable.

17. The transfer system according to claim 3, wherein the beta component (8) comprises a drain (27) for removing sterilization medium from the receiving space (12).

18. The transfer system according to claim 4, wherein the collecting basin (28) forms a bottom surface of the receiving space (12).

19. The transfer system according to claim 6, wherein the axis of rotation (38) extends horizontally or vertically.

20. The transfer system according to claim 8, wherein the coupling side (34) is opposite the loading side (35).

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0045] In the following, the invention will be explained in more detail on the basis of the drawings. The same elements are provided-only once if appropriate-with the same reference signs. In the drawings:

[0046] FIG. 1 is a first simplified view of an advantageous transfer system arranged as intended on a barrier system in the open state;

[0047] FIG. 2 shows part of the transfer system in the closed state looking at the alpha port;

[0048] FIG. 3 is a side view of part of the transfer system in the open state;

[0049] FIG. 4 is a side view of a variant of the beta component of the transfer system;

[0050] FIG. 5 is a side view of another variant of the beta component of the transfer system;

[0051] FIG. 6 is a plan view of another variant of the beta component of the transfer system;

[0052] FIG. 7 is a side view of another variant of the beta component of the transfer system;

[0053] FIG. 8 is a side view of another variant of the beta component of the transfer system;

[0054] FIG. 9 is a side view of another variant of the beta component of the transfer system; and

[0055] FIG. 10 is a side view of another variant of the beta component of the transfer system.

DETAILED DESCRIPTION

[0056] FIG. 1 is a simplified view of a transfer system 1. The transfer system 1 is intended or designed for arrangement or assembly on or in an isolator 2 (as an example of a barrier system; the following explanations of examples of an isolator are to be understood to also be valid for other barrier systems) which is only indicated by dashed lines in FIG. 1 here for reasons of clarity. The isolator 2 is part of a production facility 3, which is also only shown schematically by a dashed rectangle in the present case.

[0057] The isolator 2 is designed or constructed in such a way that it enables sterile handling of products, for example pharmaceutical or medical products. For this purpose, the isolator 2 forms a sterile isolation region 4 which is separated from a non-sterile operating region 6 at least by a partition 5. In this respect, the isolator 2 at least comprises the partition 5 in order to separate the sterile isolation region 4 from the non-sterile operating region 6.

[0058] The isolator 2 may also comprise additional components that are provided in known isolators of the type in question but not shown here for reasons of clarity.

[0059] The transfer system 1 serves or is designed to enable objects to be moved from the operating region 6 to the isolation region 4 while maintaining sterility in the isolation region 4. For this purpose, the transfer system 1 has an alpha component 7 intended for arrangement on the isolator 2 or the separating element 5 and a beta component 8 which can be coupled to the alpha component and in which the objects 15 to be transferred can be stored under sterile conditions.

[0060] The alpha component 7 comprises an alpha flange 9 which, as shown in FIG. 1, is intended for arrangement in the partition 5 or is integrated into the partition 5 when used as intended. Furthermore, the alpha component 7 has an alpha closure unit 10, which is pivotally mounted on the alpha flange 9 and can be moved into an open and a closed position. In the present case, the alpha closure unit 10 can only be opened if the beta component 8 is coupled to the alpha component 7 as intended. Otherwise, the alpha component 7 remains closed to maintain sterility.

[0061] The beta component 8 has a beta flange 37 and a removable beta closure unit 25, which serve for coupling it to the alpha component 7. The beta component 8 further comprises a beta container 11, which is dimensionally stable in the present case, with a receiving space 12. The beta container 11 is shown schematically in FIG. 1.

[0062] Within the context of the invention, a magazine 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 closure unit 10 and to the isolation region 4.

[0063] Within the context of the invention, the magazine device 13 is designed such that one of the receptacles 14 can be positioned in a removal position 16. In the removal position 16, the objects 15 received in the receptacle 14 are positioned such that they can be transferred to the isolation region 4 through the alpha flange 9 (or through the beta flange 37). For example, as illustrated in FIG. 1, a drawer-like insert 17 can be mounted in each receptacle 14 so as to be guided by means of guide means 18, which in the present case are designed as guide rails. The insert 17 serves or is designed to receive the objects 19 to be transferred. In order to transfer the objects, the insert 17 can be pulled out of the receiving space 12 by means of the guide means 18. The corresponding insert 17 can be moved out of the beta container 11 in a removal direction 20. The transfer system 1 can be configured (as shown in FIG. 1) such that a receptacle 14 located 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 alpha flange 9.

[0064] A centering device 21 can be arrangeable or arranged in the isolation region 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 on the insert 17 can be designed to be complementary to one another. In particular, the engagement elements 22, 23 can be designed such that they can be brought into engagement with one another in order to center the insert 17 in a centering position such that the insert 17 is fixed in a vertical direction 24 in a force-fitting or form-fitting manner on at least one side, in particular on both sides, and the insert 17 is in particular also pre-positioned, in particular fixed, in its position in a force-fitting or form-fitting manner in a horizontal plane.

[0065] The engagement element 22, which is arranged on the side of the insert 17, can be designed, for example, as a centering sleeve or centering groove. The engagement element 23, which is arranged on the side of the centering device 21, can be designed, for example, as a centering bolt or centering pin and can have a complementary shape to the centering sleeve or centering groove. In this way, support in the vertical direction 24 and centering in the horizontal plane (orthogonal to the vertical direction 24) can be achieved. This can prevent the insert 17 from sagging. Objects 19 can be accurately positioned and automatically removed precisely and easily.

[0066] Corresponding engagement elements 22 can be provided on a plurality of, or each, insert 17 of the magazine device 13. This allows the inserts 17 to be uniformly positioned.

[0067] FIG. 2 shows the transfer system 1 seen from the isolation region 4 and in a closed state. The beta component 8 is only partially shown; in particular the beta container 11 is not completely shown, but only its connection to the beta flange 37.

[0068] FIG. 3 is a side view of the transfer system 1 in an open state with the insert 17 pulled out.

[0069] FIG. 4 is a side view of a beta component 8 of a transfer system 1. The beta component 8 comprises a connection 26 for a sterilization medium, by means of 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 in order to sterilize the receiving space and the objects 19 located therein. The beta component 8 can in particular comprise a drain 27 to remove sterilization medium from the receiving space 12.

[0070] The beta component 8 can comprise a collecting basin 28 for sterilization medium or its condensate. A bottom 29 of the collecting basin 28 preferably has a gradient 30 (indicated by arrows), the gradient 30 being directed toward the drain 27. The collecting basin 28 can in particular form a bottom surface of the receiving space 12.

[0071] The beta component 8 can comprise a substructure 31, which can be removable from the beta container 11, or can be designed, for example, to be integrally connected thereto. The substructure 31 can be used to transport the beta component 8. For this purpose, the substructure 31 can comprise rollers 32. Other designs are possible. For example, the substructure 31 can have 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 by means of a vertical adjustment device 33.

[0072] The beta flange 37 of the beta component 8 is arranged on a coupling side 34 of the beta component 8. The beta component 8 can have a closable loading opening 36 on a loading side 35 of the beta component 8. The coupling side 34 can be arranged opposite the loading side 35, as shown, for example, in FIGS. 4 and 5. The coupling side 34 can be offset by 90 to the loading side 35.

[0073] FIG. 5 shows a variant of a beta component 8 in which the receptacles 14 are arranged the whole way around a paternoster system 46. The magazine device 13 is designed as a paternoster system 46 so that the receptacles 14 are arranged the whole way around the paternoster system 46 and can be guided past the beta flange 37.

[0074] The receptacles 14 of the magazine device 13 are moved on a simple closed curve 39 in order to move them into or out of the removal position 16.

[0075] As illustrated in FIGS. 6 and 7, the magazine device 13 can be designed to rotate the receptacles 14 of the magazine device 13 about an axis of rotation 38. By means of the rotational movement, the receptacles 14 can be moved into or out of the removal position 16. In the beta component 8, which is shown from above in FIG. 6, the axis of rotation 38 extends vertically. In the beta component 8, which is shown from the side in FIG. 7, the axis of rotation 38 extends horizontally. In the present examples in FIGS. 6 and 7, the receptacles 14 move on a circular path in both cases.

[0076] As illustrated in FIGS. 8 and 9, the magazine device 13 may be configured to provide full receptacles 14 on a first side 40 of the beta flange 37 at a first distance 42 and to move the receptacles 14, after they have been positioned in the removal position 16 on the beta flange 37, to a second side 41 of the beta flange 37 which is opposite the first side 40 (as viewed from the beta flange 37). The receptacles 14 are mounted on the second side 41 at a second distance 43 that is smaller than the first distance 42.

[0077] In FIG. 8, the first side 40 is below the beta flange 37. In FIG. 9, the first side 40 is above the beta flange 9.

[0078] In the example in FIG. 10, the magazine device 13 is designed to rotate the receptacles 14 of the magazine device 13 about a horizontal axis of rotation 38. In the example in FIG. 10, the receptacles 14 move on a circular path. The receptacles are mounted, similarly to in the paternoster system in FIG. 5, in such a way that they maintain their orientation during rotation. They therefore always extend horizontally. For this purpose, they are each suspended in the magazine device 13 in a manner in which they are mounted so as to pivot about a secondary axis 45.