BETA COMPONENT OF A TRANSFER SYSTEM FOR A STERILE ISOLATION REGION, STERILE ISOLATION REGION, ASEPTIC FILLING SYSTEM, AND A METHOD OF OPERATING SUCH A FILLING SYSTEM

Abstract

The present invention relates to a beta-component of a transfer system for a sterile isolation region, a sterile isolation region, an aseptic filling system, and a method of operating such a filling system.

Claims

1. A beta-component (24) of a transfer system (22) comprising a receiving space (36), a beta-flange (26), a casing (44) defining the receiving space (36), and a beta-closure unit (30), wherein the beta-closure unit (30) is detachably attached to the beta-flange (26) for opening and closing the receiving space (36), and the beta-flange (26) and the beta-closure unit (30) are configured for coupling to an alpha-flange (28) and an alpha-closure unit (29) of an alpha-port (27) of the transfer system (22), wherein the beta-component (24) comprises a holding device (50) for holding an object (20) in a defined position and orientation, which is arranged on a side of the beta-closure unit (30) facing the receiving space.

2. A sterile isolation region (12) with a partition (16) by which the sterile isolation region is separated from a non-sterile operating region (14), wherein the partition (16) comprises an alpha-port (27) of a transfer system (22) for introducing objects (24) from the operating region (14) into the isolation region (12), wherein a filling device (18) is arranged in the isolation region (12), which filling device (18) is configured to fill a medium (32) into closable containers (34) by a filling needle (20), wherein a beta-component (24) according to claim 1 is coupled to the alpha-port (27), wherein upon opening of a closure unit (31) of the transfer system (22) formed by the alpha-closure unit (29) and beta-closure unit (30) coupled to each other, the holding device (50) is moved into the interior of the isolation region (12).

3. A filling system (10) with a sterile isolation region (12) according to claim 2, wherein a handling device (40) is arranged in the isolation region (12), which handling device (40) is configured to open the beta-closure unit (30) and the alpha-closure unit (29) in the coupled state and/or to remove the object held in the holding device (50) from the holding device (50) and/or to place the object therein.

4. The filling system (10) according to claim 3, further comprising a detection unit (42) which includes machine vision and whose field of view comprises at least the transfer system (22), so that a position and/or orientation of the object, (20), can be detected by the detection unit (42).

5. The sterile isolation region (12) according to claim 2, wherein the closure unit (31), which is formed by the alpha-closure unit (29) and beta-closure unit (30) coupled to one another, can be transferred into a fixed open position during opening.

6. The beta-component (24) according to claim 1, wherein the casing (44) of the receiving space (36) of the beta-component (24) is configured to be detachable from the beta-flange (26).

7. The beta-component (24) according to claim 11, wherein the filling needle (20) is connected to a tube (43) which extends out of the receiving space (36).

8. The beta-component (24) according to claim 7, wherein the beta-component (24) comprises a return device for the tube (43), which, when the filling needle (20) is moved back into the receiving space (36), also moves the tube (43) back into the receiving space.

9. The beta-component (24) according to claim 1, wherein the beta-flange of the beta-component (24) and the alpha-flange (28) of the alpha-port (22) are configured to be connected to each other with a bayonet lock and the beta-closure unit (30) and the alpha-closure unit (29) are configured to be connected to each other with a bayonet lock.

10. A method of operating a filling system (10) according to claim 3, wherein the method comprises the steps of: attaching the beta-component (24) to the alpha-port (27) in the partition (16), wherein the object (20) is located in the receiving space (36) of the beta-component (24) in the holding device (50); performing a decontamination cycle in the isolation region (12); opening the transfer system (22) by the handling device (40); removing the object (20) by the handling device (40), from the holding device (50); placing the object (20) in an object holding device (19) of the filling device (18) by the handling device (40); .

11. The beta-component (24) according to claim 1, wherein the object (20) held by the holding device (50) is a filling needle (20).

12. The beta-component (24) according to claim 6, wherein the casing (44) is formed by a flexible plastic bag or is formed by a dimensionally stable sterilizable container.

13. The beta-component (24) according to claim 7, wherein the tube (43) comprises a sterile connector (48) at an end facing away from the filling needle (20) for connection to a feed tank (46).

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0041] The invention is described in more detail below with reference to the figures, wherein identical or functionally identical elements are, if applicable, only marked once with reference signs.

[0042] FIG. 1 an aseptic filling system;

[0043] FIG. 2 the aseptic filling system shown in FIG. 1 in an operational state;

[0044] FIG. 3 a transfer system (alpha-port with docked beta-component); and

[0045] FIG. 4 the transfer system from FIG. 3 in an open state.

DETAILED DESCRIPTION

[0046] FIG. 1 shows an aseptic filling system 10. The filling system 10 is used for filling a medium 32 into closable containers 34. The aseptic filling system 10 is configured with an isolation region 12 closed off from the outside, which is separated from an operating region 14 by a partition 16.

[0047] A filling device 18 is arranged in the isolation region 12. In the present case, a handling device 40 is also arranged in the isolation region 12, which will be discussed in detail later.

[0048] The filling device 18 comprises a needle holding device 19 which is configured to hold a filling needle 20 and in which the filling needle 20 can be arranged respectively for carrying out filling operations. The needle holding device 19 forms a holder for the filling needle 20. Needle holding device 19 can also be arranged in the filling device 18 in such a way that it is moved by the latter as part of the filling operations.

[0049] The partition 16, by which the isolation region 12 is separated from the operating region 14, comprises a transfer system 22. The transfer system 22 is used for the insertion, in particular the aseptic transfer, of objects from the operating region 14 into the isolation region 12.

[0050] The transfer system 22 comprises a replaceable beta-component 24 and an alpha-port 27 fixedly disposed in the partition 16.

[0051] The replaceable beta-component 24 is configured with a beta-flange 26 (shown partially transparent in FIG. 1). The replaceable beta-component 24 further comprises a detachable respectively openable beta-closure unit 30 (see, for example, FIG. 2). The beta-closure unit 30 is designed in a quasi lid-like manner.

[0052] The alpha-port 27, which is fixedly disposed in the partition 16, includes an alpha-flange 28 connected to the partition 16 and an alpha-closure unit 29 which is pivotally movably supported relative to the alpha-flange 28.

[0053] The beta-component 24 is configured for coupling with the alpha-port 27 fixedly disposed in the partition 16. For coupling, the beta-flange 26 is sealingly connected to the alpha-flange 28. The Beta-closure unit 30 is connected to alpha-closure unit 29 so that both sealingly abut each other with their respective outer sides and can only be moved together. In the connected state, the beta-closure unit 30 and the alpha-closure unit 29 form a closure unit 31 of the transfer system 22. In the closed state, the alpha-closure unit 29 forms the side of the closure unit 31 facing the isolation region 12, and the beta-closure unit 30 forms the side of the closure unit 31 facing away from the isolation region 12. The closure unit 31 pivots into the isolation region 12 when opened.

[0054] To couple the alpha-port 27 and beta-component 24, they are connected to each other by means of a bayonet lock through a rotary movement of the beta-component 24. Thereby, the beta-flange 26 engages sealingly with the alpha-flange 28. Correspondingly, the beta-closure unit 30 engages sealingly with the alpha-closure unit 29. Other coupling methods are likewise within the spirit of the invention.

[0055] The beta-component 24 comprises a receiving space 36 accessible via the beta-closure unit 30 and otherwise closed, and a casing 44 of the receiving space 36 detachable from the beta-flange 26. In the present case, the casing 44 is formed by a flexible plastic bag (also referred to as a beta-bag). The casing 44 can also be formed by a dimensionally stable sterilizable container, for example a stainless steel container.

[0056] The beta-closure unit 30 as part of the closure unit 31 opens and closes the receiving space 36 towards the isolation region 12 in the assembled state. The beta-closure unit 30 is designed as a roundish lid-like unit for this purpose. The alpha-closure unit 29 is pivotably supported on the alpha-flange 28 via a hinge mechanism 45. The beta-closure unit 30 is detachable from the beta-flange 26 so that, when coupled to the alpha-closure unit 29, it follows the pivoting movement of the latter when opened. It is readily apparent from FIG. 4 that the transfer system 22 includes a locking mechanism 60. The locking mechanism 60 can only be unlocked when the alpha-closure unit 29 is coupled to the beta-closure unit 30.

[0057] For insertion of the filling needle 20 into the isolation region 12, the filling needle 20 is initially arranged in the beta-component 24 in the receiving space 36. The filling needle 20 is connected to a tube 43 which extends out of the receiving space 36 and comprises a sterile-connector 48 at its end facing away from the filling needle 20 for connection to a feed tank 46.

[0058] A holding device 50 is arranged in the receiving space 36 of the beta-component 24 for holding the filling needle 20 in a precise position. The holding device 50 is arranged on the detachable beta-closure unit 30, as shown clearly in FIGS. 3 and 4. When the beta-component 24 is coupled to the alpha-port 27 and the closure unit 31 is opened, the filling needle 20 held in the holding device 50 is moved into the isolation region 12.

[0059] The handling device 40 arranged in the isolation region 12 is designed as a robot arm in the present case. The handling device 40 is configured to open the closure unit 31 (alpha-closure unit 29 and beta-closure unit 30 connected to each other in the coupled state) and to remove the filling needle 20 from the holding device 50 and insert it into the needle holding device 19. When the use of the filling needle 20 is completed, the filling needle 20 can be moved back into the holding device 50 by means of the handling device 40.

[0060] The filling system 10 comprises an optional detection unit 42, which is set up for machine vision and whose field of view comprises the transfer system 22 and, in the present case, the needle holding device 19, so that a position of the filling needle 20 can be detected by the detection unit 42 and the handling device 40 can be controlled and regulated accordingly in order to remove the filling needle 20 from the holding device 50 and place it in the needle holding device 19 and, after completion of use, transfer it back to the holding device 50.

[0061] When the filling needle 20 is removed, the form-flexible bag-like casing 44 is, so to speak, compressed as the tube 43 is pulled into the isolation region, as shown in FIG. 2.

[0062] The casing 44 can also be designed as a semi dimensionally stable bellows unit. A casing 44 of this type can be designed to be compressible and/or variable in its extension in the direction towards the beta-flange 26, but rigid transverse thereto.

[0063] The closure unit 31 (or rather the alpha-closure unit 29 and the beta-closure unit 30 coupled to it) can be transferred to a fixed open position during opening, as shown in FIG. 2. In the fixed open position, the alpha-closure unit 29 or rather the overall closure unit 31 and thus also the beta-closure unit 30 and the holding device 50 arranged thereon are determined in their position.

[0064] The filling needle 20 is connected via the tube 43 by means of the sterile-connector 48 to the feed tank 46, which contains the medium 32. The feed tank 46 is in turn connected by means of a sterile-connector 52 on the feed tank side to a tube section which passes through a peristaltic pump 56. A medium-filter 58 is arranged in the connecting tube line between the peristaltic pump 56 and the sterile-connector 48 on the side of the filling needle 20.