WO2025157920A1 - Transfer-port arrangement for transferring components into and/or out of a pharmaceutical isolator - Google Patents

Abstract

The invention relates to a transfer-port arrangement for transferring components (2) into and/or out of a pharmaceutical isolator (5), comprising an alpha port (6), which is associated in particular with the isolator (5), and comprising a beta port (7), which can be coupled to the alpha port (6) and is in particular associated with a magazine (9) which can be connected to the isolator (5), wherein the alpha port (6) has an alpha through-opening (13) and an alpha closure (14) for closing the alpha through-opening (13), wherein the beta port (7) has a beta through-opening (15) and a beta closure (16) for closing the beta through-opening (15), wherein, in the coupled state, the alpha through-opening (13) and the beta through-opening (15) form a common through-opening (17), and wherein, in the coupled state, the alpha closure (14) and/or the beta closure (16) is or are pivotable about a pivot axis (18), in particular a common pivot axis, to release the common through-opening (17) and to transfer the components (2) through the common through-opening (17), wherein the pivot axis (18) is arranged off-centre with respect to the common through-opening (17) and in the region of the common through-opening (17).

Description

Transfer port arrangement for transferring components into and/or out of a pharmaceutical isolator

The present invention relates to a transfer port arrangement for transferring components into and/or out of a pharmaceutical isolator according to claim 1, an isolator arrangement according to claim 11 and a method for coupling a transfer port arrangement according to claim 12. Furthermore, the present invention relates to a port of a transfer port arrangement according to claim 13, a magazine with a magazine interior for receiving components according to claim 14 and an isolator with an isolator interior according to claim 15.

Transfer port arrangements for pharmaceutical isolators are known in various variants from the state of the art.

For example, filling systems for pharmaceuticals are often designed as isolators. These filling systems typically have a washing station, a sterilization station, a separating station, a filling station, and a sealing station.

In the washing station, the containers and/or container closures to be filled are washed and then transferred to the sterilization station. Sterilization of the containers and/or container closures takes place there.

The sterilization station is usually connected to the isolator itself via a sterile tunnel. The isolator then houses the other stations. First, the isolator contains a separation station for separating the sterilized containers and/or container closures for filling and feeding them in an aligned and separated state to a conveyor system of the filling station. Second, the isolator also houses the actual filling station and the closure station for closing the filled containers with the container lids.

As an alternative to feeding via a sterile tunnel from the sterilization station, the containers and/or container closures can also be washed separately and/or sterilized. These are then usually fed sterilely packaged as bulk goods or in batches, for example as nested vials, in larger containers to the singulation station in the isolator, where they are then unpacked and fed, singly and aligned, to a conveyor device in the filling station. Transfer into the isolator is usually via a transfer port arrangement. This has an alpha port, which is provided on the isolator side, and a beta port, which is provided on the outer packaging for the goods to be fed to the isolator. Unpacking and/or aligning and/or singling the containers and/or container closures in the protected interior of the isolator is relatively space-intensive and can be complex.

The transfer port arrangement enables sterile transfer from the outer packaging to the isolator and significantly reduces the risk of contamination.

Transfer port arrangements are available from various manufacturers. In these cases, the pivot axis on the Alpha port is typically located inside the isolator. Docking the Beta port to the Alpha port, opening the transfer port arrangement, and transferring components from the docked outer packaging is relatively complex and requires a comparatively large amount of space in the isolator.

The invention is based on the problem of designing and developing the known transfer port arrangements in such a way that a further optimization is achieved with regard to the aforementioned challenge.

The above problem is solved by the features of claim 1.

The fundamental idea is to provide a transfer port arrangement in which the pivot axis is arranged in the area of the through-opening and off-center to it. Preferably, opening the through-opening then divides the through-opening into two different sized areas. This creates a simple connection for transferring comparatively large components through the through-opening and, at the same time, the space required for opening the through-opening of the transfer port arrangement into the areas created by this connected interior spaces are kept as low as possible and the handling of the transfer port arrangement is as simple as possible.

The proposed transfer port arrangement is used to transfer components into and/or out of a pharmaceutical isolator. The transfer port arrangement has an alpha port and a beta port that can be coupled to the alpha port. The alpha port has an alpha through-opening and an alpha closure for closing the alpha through-opening, while the beta port has a beta through-opening and a beta closure for closing the beta through-opening. The alpha through-opening and the beta through-opening form a common through-opening when coupled. In the coupled state, the alpha closure and/or the beta closure can be pivoted about a pivot axis, in particular a common one, to release the common through-opening and to transfer the components through the common through-opening. The pivot axis, in particular a common one, is arranged off-center to the common through-opening and in the region of the common through-opening. Accordingly, relatively large components can be transferred through the transfer port arrangement compared to the through-opening, while at the same time a relatively small space is required in the interior spaces connected by the transfer port arrangement for the operation of the transfer port arrangement.

The resealability of the alpha through-opening and/or the beta through-opening proposed in the further development according to claim 2 enables the alpha port and/or the beta port to be separated without the risk of contamination of the isolator or the connected body, in particular the magazine.

In the further development according to claim 3, preferred designs of the through-openings are described, which enable the transfer port arrangement to be as compact as possible in comparison to the size of the components to be transferred. A particularly secure coupling or a particularly simple coupling and/or decoupling of the transfer port arrangement can be achieved by the preferred embodiments according to claims 4 to 8.

A particularly simple operation of the transfer port arrangement will be achieved by embodiments according to claims 9 and 10.

According to a further teaching according to claim 12, which has independent significance, an isolator arrangement is claimed comprising an isolator with an isolator interior and a magazine with a magazine interior. Here, the isolator and the magazine can be coupled via the described transfer port arrangement, and the isolator interior and the magazine interior can be connected via the transfer port arrangement.

Reference may be made to all statements concerning the proposed transfer port arrangement.

According to a further teaching according to claim 12, which also has independent significance, a method for coupling the described transfer port arrangement is claimed, in which a beta port of the transfer port arrangement is coupled to the alpha port of the transfer port arrangement.

Reference may be made to all statements regarding the proposed transfer port arrangement and the proposed isolator arrangement.

According to a further teaching according to claim 13, which also has independent significance, a port of a transfer port arrangement of the type described is claimed.

Reference may be made to all statements relating to the proposed transfer port arrangement, the proposed isolator arrangement and the proposed method.

According to a further teaching according to claim 14, which also has independent significance, a magazine with a magazine interior for receiving components, wherein the magazine interior is defined by the magazine is sterilely sealed or lockable towards the outside of the magazine, wherein the magazine has a port which is designed as a beta port of the transfer port arrangement according to one of claims 1 to 11.

Reference may be made to all statements relating to the proposed transfer port arrangement, the proposed isolator arrangement, the proposed method and the proposed port.

According to a further teaching according to claim 15, which also has independent significance, an isolator with an isolator interior, in particular for filling a medium into a container, wherein the isolator has a port which is designed as an alpha port of the transfer port arrangement according to one of claims 1 to 11, is claimed.

Reference may be made to all statements relating to the proposed transfer port arrangement, the proposed isolator arrangement, the proposed method, the proposed port and the proposed magazine.

In the following, the invention is explained in more detail with reference to a drawing which merely represents exemplary embodiments. In the drawing,

Fig. 1 shows a proposed isolator arrangement with a proposed transfer port arrangement and proposed magazines,

Fig. 2 shows a representation of the transfer port arrangement with alpha port and beta port in a) decoupled and in b) after a first coupling step of coupling a magazine to the filling device,

Fig. 3 shows a representation of the transfer port arrangement with alpha port and beta port in a) after a further coupling step of coupling a magazine to the filling device and in b) in the coupled state, Fig. 4 shows the interior of the isolator from Fig. 1 with magazines coupled via the proposed transfer port arrangement in a perspective view and

Fig. 5 is a perspective view of the feeding of the container closures through a proposed transfer port arrangement from a connected magazine into the interior of the isolator.

The embodiment shown in the figures and thus preferred relates to a transfer port arrangement 1 for transferring components 2, in particular containers 3 and/or container closures 4, into and/or out of a pharmaceutical isolator s. The transfer port arrangement 1 1 has an alpha port 6 and a beta port 7 that can be coupled to the alpha port 6.

In the embodiment of Fig. 1 and preferably, the alpha port 6 is assigned to an isolator 5. The isolator 5 can in particular be a filling device 8 for filling media, in particular medications. The beta port 7 is assigned to a magazine 9. The magazine 9 here and preferably accommodates containers 3 for filling with the medium 10 or containers 3 already filled with the medium 10. The magazine 9 can be connected here and preferably via the transfer port arrangement 1 to the isolator 5. Containers 3 to be filled can then be fed from the magazine 9 to the isolator 5. After the containers 3 have been filled and closed, they are then fed here and preferably to another magazine 9, here a receiving magazine 11. The alpha port 6 and the beta port 7 each form a proposed port.

The isolator 5 and the magazine 9 form a proposed isolator arrangement 12. The magazine 9 can be connected to the isolator 5 using the proposed method via the proposed transfer port arrangement 1.

The Alpha port 6 has an Alpha through-opening 13 and an Alpha closure 14 for closing the Alpha port, in particular in an airtight manner. Through opening 13. Here and preferably the Alpha closure

14 made of a rigid material, in particular metal and/or plastic. The beta port 7 has a beta through-opening 15 and a beta closure 16 for closing the beta through-opening 15, in particular in an airtight manner. Here and preferably, the beta closure 16 has a core made of a rigid material, in particular metal and/or plastic. In the exemplary embodiment and preferably, the core has a sheath made of a softer material, here and preferably a silicone. The sheath is here and preferably produced by overmolding.

Here the alpha passage opening 13 and the beta passage opening

15 have a common through-opening 17 in the coupled state. The through-openings 17 are here and preferably of the same size.

In the coupled state, the alpha closure 14 and/or the beta closure 16 is/are pivotable about a, in particular common, pivot axis 18 to release the common through-opening 17 and to transfer the components 2 through the common through-opening 17. Here and preferably, the alpha closure 14 and the beta closure

16 are the same size. As shown in Figures 2 and 3, the alpha shutter 14 and the beta shutter 16 pivot here and preferably congruently.

According to the proposal, the pivot axis 18 is off-center to the common through-opening 17 and in the area of the common through-opening

17, as shown in Figures 2 and 3. This enables a secure and particularly easy-to-handle coupling for the sterile transfer of comparatively large components 2 compared to the through-opening 17 and a comparatively small space in the interior, here of the isolator 5 and/or magazine 9.

If the pivot axis 18 were arranged outside the area of the common through-opening 17, for example laterally to the transfer port arrangement 1 on the insulator wall, the pivot space required by the closure elements 19 in the interior of the insulator 5 would be significantly larger. The alpha shutter 14 and the beta shutter 16 pivot here in such a way that the through opening 17 is divided into two differently sized openings by the alpha shutter 14 and/or beta shutter 16 in the open position, as shown in Fig. 3b).

Here and preferably, the area of the common through-opening 17 is the area of the transfer port arrangement 1 in which, in the coupled state, it connects the magazine interior 9 of the corresponding magazine 9 and the interior of the insulator 5, here the filling interior 20.

Preferably, the area of the common through-opening is an area of 5 cm around the area in which the beta shutter 16 and/or the alpha shutter 14 are in their closed position.

In particular and in the exemplary embodiment, the area of the common through-opening 17 is the area in which the beta closure 16 and/or the alpha closure 14 are in their closed position.

Furthermore, it is preferably provided here that the alpha through-opening 13 and/or the beta through-opening 15 can be reclosed by pivoting about the, in particular common, pivot axis 18 of the alpha closure 14 or the beta closure 16. This allows sterility in the isolator 5 and/or the magazine 9 to be maintained even after the transfer port arrangement 1 has been decoupled.

As shown in Figures 2 and 3, the alpha port 6 here and preferably has an alpha frame 21. The alpha through-opening 13 is formed in the alpha frame 21. The alpha through-opening 13 is substantially rectangular. The edges of the alpha through-opening 13 are rounded. Additionally or alternatively, the beta port 7 has a beta frame 22. The beta through-opening 15 is provided in the beta frame 22. The beta through-opening 15 is substantially rectangular. The edges of the beta through-opening 15 are rounded. In the exemplary embodiment, the common through-opening 17 essentially rectangular in shape. Such a configuration enables a compact structure and a small space requirement compared to the components 2 to be transferred. While an essentially rectangular shape is advantageous, the through-openings 17 can alternatively have a different shape.

The alpha port 6 and/or the beta port 7 can have a closure element 19, which is removed before coupling the alpha port 6 to the beta port 7. This can be, for example, a film or the like, which is attached, in particular welded, in particular to the alpha frame 21 or beta frame 22 in an airtight manner to close the respective through-opening 17. This closure element 19 is provided in addition to the alpha closure 14 or beta closure 16. This is shown by way of example in the enlarged view of Fig. 1 using the magazine 9 accommodating the containers 3.

An embodiment of a coupling process is shown in Figures 2 and 3. In the coupled state, a force-fitting and/or form-fitting connection, in particular a snap connection 23, is formed here and preferably between the Alpha port 6 and the Beta port 7. The connection is preferably formed between the Alpha frame 21 and the Beta frame 22 and/or between the Alpha closure 14 and the Beta closure 16. In Fig. 2a), the connecting elements 24 of the connection on the Alpha frame 21 and the Beta frame 22 are shown in the separated state, while in Fig. 2b) they are shown in the connected state. The further coupling steps of the Alpha port 6 and the Beta port 7 are then illustrated in Figures 3a) and 3b).

Furthermore, in the exemplary embodiment, the transfer port arrangement 1 is provided with a guide 25 for guiding a coupling movement of the alpha port 6 and the beta port 7. As shown in Fig. 2, the guide 25 is provided by the alpha frame 21 and the beta frame 22. Alternatively or additionally, the guide 25 can also be provided by the alpha closure 14 and the beta closure 16. By providing the guide 25, a particularly simple coupling of the beta port 7 with the alpha port 6 is supported. In the exemplary embodiment of Fig. 2, the guide 25 is provided at least in part by the connecting elements 24 of the connection, here and preferably, on the alpha frame 21 and the beta frame 22. In addition, in the exemplary embodiment, the guide 25 is also provided by closure connecting elements 26. These are here and preferably in the form of corresponding elevations 27 or cutouts

28 formed in the alpha shutter 14 or beta shutter 16.

As Fig. 2 further shows, it is preferably provided here that, within the scope of the coupling, a connection between the alpha port 6 and the beta port 7 is created by a relative movement, in particular a linear movement, of the alpha port 6 and the beta port 7. In the exemplary embodiment, and preferably, the previously described snap connection 23 is created within the scope of this relative movement, in particular a linear movement.

Additionally or alternatively, a locking mechanism 29 of Alpha Port 6 and Beta Port 7 can be provided in the coupled state. This locking mechanism is here and preferably form-fitting. In the exemplary embodiment, the locking mechanism

29 in addition to the previously described non-positive and/or positive connection. The locking mechanism 29 is generated by a relative movement separate from the movement establishing the connection between Alpha Port 6 and Beta Port 7.

The locking of Alpha Port 6 and Beta Port 7 is provided here and preferably outside the interior spaces to be connected by the transfer port arrangement 1, i.e., in the exemplary embodiment, outside the magazine interior 9 and the isolator interior 30 or filling interior 20. It is provided here by the Alpha frame 21 and the Beta frame 22.

Preferably, the beta frame 22 has at least one locking element 31, which is locked by the alpha port 6. In the exemplary embodiment, two locking elements 31 are provided, particularly opposite one another with respect to the common through-opening 17. These are locked here and preferably by a locking bracket 32. In the exemplary embodiment, this is provided on the alpha port 6 and/or is U-shaped. As the comparison of Fig. 2b) with Fig. 3a) shows, each leg of the locking bracket 32 locks a locking element 31.

Furthermore, in the exemplary embodiment and preferably, an actuating device 33 is provided for opening and/or closing the alpha through-opening 13 and/or the beta through-opening 15, in particular the common through-opening 17.

In the exemplary embodiment, locking of the lock 29 and opening of the respective through-opening 17 can be effected by an actuating movement of the actuating device 33. Additionally or alternatively, unlocking of the lock 29 and closing of the respective through-opening 17 can be effected by an actuating movement of the actuating device 33. In the exemplary embodiment, and preferably, the actuating device 33 adjusts the previously described locking bracket 32 to the lock 29. The actuating device 33 can be actuated manually or by a motor, in particular with a motor.

The actuating device 33 is provided here by the alpha port 6. It is actuated here and preferably from outside the two interior spaces connected by the transfer port arrangement 1, in the exemplary embodiment from outside the isolator interior space 30 and the magazine interior space 9.

In the exemplary embodiment, the actuating device 33 has a lever 34. In the exemplary embodiment, the lever 34 is pivoted for actuation. Here, and preferably, it acts on the locking bracket 32 via a gear-rack coupling (not shown). Upon actuation of the actuating device 33, the locking mechanism 29 is initially effected. This can be seen when comparing Figures 2b) and 3a). Further actuation of the actuating device 33 then causes the alpha shutter 14 and/or the beta shutter 16 to open, as shown in Figure 3b).

To effect the opening, the actuating device 33 first couples a pivoting mechanism 35 for pivoting the alpha shutter 14 and/or the beta shutter 16. Here, the lever 34 is coupled to a rack 36 of the pivoting mechanism 35, as shown on the left. shown in Fig. 2 according to view AA and Fig. 3 according to views BB and CC. Upon further actuation of the actuating device 33, the rack 36 then effects an adjustment of the alpha shutter 14 and/or the beta shutter 16, here by rotating a gear 37 coupled to the alpha shutter 14 and/or the beta shutter 16.

Preferably, the alpha closure element 14 and/or the beta closure element 16 are pivoted substantially toward the side of the alpha port 6 during opening. Here, the alpha closure 14 and the beta closure 16 are pivoted together into the interior of the insulator 5.

When decoupling the transfer port arrangement 1, the actuating device 33 is preferably actuated in the opposite direction. Here, the alpha closure element 14 and/or the beta closure element 16 are then pivoted back into the closed position. This is done via the rack 36 and the gear 37. The actuating device 33 then disengages the pivoting mechanism 35 again. Further actuation of the pivoting mechanism 35 in the opposite direction unlocks the locking mechanism 29. This process is shown in Fig. 3b), Fig. 3a), and Fig. 2b).

In the exemplary embodiment, and preferably, a locking mechanism 38 is provided which enables unlocking only after the alpha closure 14 and/or beta closure 16 have been completely closed.

By a relative movement of Alpha Port 6 and Beta Port 7, after unlocking, Beta Port 7 can be separated from Alpha Port 6, so that the decoupled state of the transfer port arrangement 1 shown in Fig. 1a) is then established.

As shown in Fig. 1, in the exemplary embodiment, the pivot bearing 39 for the common pivot axis 18 is provided by the Alpha port 6, in particular by the Alpha frame 21. In contrast, in Figures 2 and 3, the pivot mechanism 35 is shown open to illustrate its operation. These illustrations clearly show that The gear 37 and the rack 36 of the pivot mechanism 35 are housed in the alpha shutter 14. The beta shutter 16 is held by the alpha shutter 14 and its movement is guided by it.

Furthermore, the exemplary embodiment provides that the alpha port 6, in particular the alpha frame 21, has a seal 40 for sealing, in particular airtight, the alpha frame 21 and the alpha closure 14 in the closed position of the alpha closure 14. Additionally, a seal 40 of the transfer port arrangement 1 is preferably provided here for sealing between the alpha frame 21 and the beta frame 22 in the coupled state. This seal 40 is preferably provided here by the alpha frame 21 and/or the beta frame 22. In the exemplary embodiment, the seal 40 is provided by the alpha frame 21.

Additionally or alternatively, the beta port 7, in particular the beta frame 22, can have a seal 40 for, in particular, an airtight seal between the beta frame 22 and the beta closure 16 in the closed position of the beta closure 16. In the exemplary embodiment, the seal 40 is preferably provided by the casing.

Here, and preferably, the Alpha Port 6 and/or the Beta Port 7 are multi-use. In particular, the Beta Port 7, especially if a magazine 9 has it, can be designed as a single-use port. Such a port cannot then be reconnected to an Alpha Port 6 here, and preferably after being uncoupled from an Alpha Port 6.

According to a further teaching, an isolator arrangement 12 is proposed with an isolator 5 with an isolator interior 30 and a magazine 9 with a magazine interior 9, wherein the isolator 5 and the magazine 9 can be coupled via the transfer port arrangement 1 of the type described and the isolator interior 30 and the magazine interior 9 can be connected via the transfer port arrangement 1.

Reference may be made to all statements relating to the proposed transfer port arrangement 1. In the exemplary embodiment, the isolator 5 is a filling device 8. It is used for the aseptic filling of a medium 10, in particular a medicament.

The filling device 8 has a storage 41 or a storage holder 41 for the medium 10 to be filled and a conveyor device 42 for conveying the medium 10 to be filled to a filling unit 43. The filling device 8 further has a filling interior 20, the isolator interior 30, which can be closed off from the outside in a particularly sterile manner, in which the medium 10 can be filled into container 3 by means of the filling unit 43. The filling interior 20 is sterile here. Here and preferably, the filling unit 43 is at least partially accommodated in the filling interior 20.

Furthermore, the filling device 8 has an alpha port 6, to which the beta port 7 of a magazine 9 can be coupled. The alpha port 6 and the beta port 7 of the magazine 9 form the transfer port arrangement 1. During the coupling process, the magazine interior 9 with containers 3 accommodated therein and the filling interior 20 can be connected to one another, so that containers 3 from the magazine 9, in particular individually and aligned, can be fed from the magazine interior 9 to the filling interior 20 and the medium 10 can be filled into the containers 3 in the filling interior 20 by means of the filling unit 43.

In the exemplary embodiment and preferably, the filling device 8 together with the magazine 9 providing the containers 3, optionally with the magazine 9 providing the container closures 4 and optionally with the receiving magazine 11 forms a filling device arrangement 8.

In the exemplary embodiment, the reservoir 41 for the medium 10 is preferably arranged outside the filling interior 20. Here, it is designed as a reservoir 41 that can be separated from the filling device 8. Here, it is connectable or connected to the filling unit 43 by means of a connection 44, in particular an aseptic one. Here, and preferably, the medium 10 is guided from the reservoir 41 by means of a hose 45 to the filling unit 43, where the medium 10 is filled into the containers 3. Filling into the containers 3 takes place here, and preferably, by means of a curved filling needle 46, as shown in Fig. 4. Here and preferably, at least the filling needles 46 have a lifting drive 47, by means of which the filling needle 46 is immersed in the container 3 for filling.

A conveying device 42 is provided for conveying the medium 10. Here, and preferably, the conveying device 42 is arranged outside the filling chamber 20. In the exemplary embodiment, the conveying device 42 is a pump, here and preferably a peristaltic pump 48. This enables particularly simple and defined filling of the medium 10.

In the exemplary embodiment, two containers 3 are filled simultaneously. For this purpose, the filling unit 43 has two filling needles 46. Furthermore, two pumps, in particular peristaltic pumps 48, are provided. Each conveying device 42 conveys the medium 10 to one of the filling needles 46.

Additionally or alternatively, it can be provided here that a conveying device 42, in particular a peristaltic pump, conveys the medium 10 to several filling needles 46. This is preferably done for each filling needle 46 by means of a separate hose 45.

In the exemplary embodiment, a substantially laminar air flow is preferably provided in the filling interior 20, here and preferably from top to bottom. Additionally, an overpressure or a negative pressure compared to the ambient air can be provided in the filling interior 20. To generate the air flow, the filling device 8 has an air flow unit 49. This unit, here and preferably, conveys air through a filter 50 12 into the filling interior 20 10.

In the exemplary embodiment, the filling interior 20 is preferably delimited by boundary walls, the transfer port arrangement 1, and optionally by at least one filter 50 for filtering the air to be supplied to and/or discharged from the filling interior 20. Here, and preferably, the filter 50 serves to supply and/or discharge air by means of the air flow unit 49. Furthermore, the filling device 8 preferably comprises at least one sensor 51 for monitoring temperature and/or humidity and/or pressure and/or particles and/or germs. The sensor 51 or sensors 51 preferably monitor the filling chamber 20. Additionally or alternatively, a nutrient solution container 52, for example a Petri dish, can be provided for monitoring the filling process in the filling chamber 20. This is preferably introduced into the filling chamber 20 via the magazine 9, in particular the magazine 9 with the containers 3.

In order to fill the medium 10 into the containers 3 with the filling device 8, the magazine 9 with the containers 3, if applicable the storage 41, if applicable the magazine 9 with the container closures 4 and if applicable the receiving magazine 11 are connected to the filling device 8.

In the exemplary embodiment and preferably, the filling device 8 has, in particular for each magazine 9 to be connected, a magazine holder 53 for holding and/or coupling to the filling device 8.

According to a further teaching, a method for coupling a transfer port arrangement 1 of the type described is proposed, wherein a beta port 7 of the transfer port arrangement 1 is coupled to the alpha port 6 of the transfer port arrangement 1.

Reference may be made to all statements relating to the proposed transfer port arrangement 1 and the proposed isolator arrangement 12.

According to a further teaching, a port of a transfer port arrangement 1 is proposed, wherein the port is designed as an alpha port 6 of the transfer port arrangement 1 of the type described and/or that the port is designed as a beta port 7 of the transfer port arrangement 1 of the type described.

Reference may be made to all statements relating to the proposed transfer port arrangement 1, the proposed isolator arrangement 12 and the proposed method. According to a further teaching, a magazine 9 is proposed with a magazine interior 9 for receiving components 2, wherein the magazine interior 9 is sealed or lockable in a sterile manner from the magazine exterior 9 by the magazine 9, and wherein the magazine 9 has a port designed as a beta port 7 of the transfer port arrangement 1 of the type described. The magazine interior 9 is here and preferably sterile.

Reference may be made to all statements relating to the proposed transfer port arrangement 1, the proposed isolator arrangement 12, the proposed method and the proposed port.

The components 2 can be, in particular, containers 3 and/or container closures 4. The containers 3 can be sealed and/or sealed in a sterile manner by means of a container closure 4 after filling.

In the exemplary embodiment, and preferably, it is provided that the containers 3 and/or the container closures 4 are accommodated in a spiral and/or meandering manner in the respective magazine 9. This is indicated by dashed lines in Fig. 1. This arrangement enables a particularly simple and reliable, individual and aligned transfer from the magazine 9 into the interior of the isolator 5, in particular of the filling device 8.

Furthermore, it is preferably provided here that the containers 3 and/or the container closures 4 are connected in the, in particular respective, magazine 9 via a connector 54. The connector 54 is preferably flexible here. In the exemplary embodiment, the connector 54 is a film. This is shown in Fig. 4 for both the containers 3 and the container closures 4. Alternatively, however, this can also be provided, for example, only for the containers 3 or only for the container closures 4. Here, all containers 3 accommodated in a magazine 9 are connected to the connector 54, in the exemplary embodiment to the film.

Preferably, the containers 3 and/or the container closures 4 are held in a row of one and/or in a row of two and/or in a row of three and/or in a row of four in the connector 54. In Fig. 4, the Containers 3 are held in a single row, and container closures 4 are held in a double row. This allows them to be easily fed individually and aligned through the through-opening 17, particularly into the filling chamber 20.

In the exemplary embodiment, the containers 3 and/or the container closures 4 are conveyed from the respective magazine 9 by means of the connector 54. From there, they are also conveyed further into the interior of the isolator 5, in particular the filling interior 20. This makes the individual and aligned feeding of the containers 3 and/or container closures 4 particularly simple, safe, and space-saving.

In the exemplary embodiment, the drive for conveying the containers 3 and/or the container closures 4 from the, in particular, respective, magazine 9 is arranged in the filling interior 20 and/or assigned to the filling device 8. This is shown, for example, in Fig. 5 for the container closures 4.

Furthermore, it is preferably provided here that the connector 54 is attached to a component 2 of the transfer port arrangement 1, in particular the beta closure 16. This enables particularly simple conveyance of the containers 3 and/or container closures 4 into the filling chamber 20.

By fastening the connector 54 to the transfer port arrangement 1, in particular the beta closure 16, for example as shown in Fig. 5 by a clamp 55, it can be picked up particularly easily by a conveyor drive 56 and the containers 3 and/or container closures 4 can be conveyed from the respective magazine 9.

As shown in Fig. 5, it is particularly preferred if the connector 54 is brought into the filling interior 20 when coupling the magazine 9 to the filling device 8, in particular when pivoting the beta closure 16 into the filling interior 20.

Preferably, the conveyor drive 56 has a clamping device 57 and/or a roller arrangement 58 and/or a winding device (not shown) for the connector 54. In the exemplary embodiment, a, in particular A pivotable clamping device 57 is provided, which feeds the connector 54 here and preferably to a roller arrangement 58, by means of which the containers 3 and/or container closures 4 are conveyed from the, in particular, respective, magazine 9. This is shown for the container closures 4 in Fig. 4, but is carried out analogously in the exemplary embodiment for the containers 3. It can also be provided that, in addition to or alternatively to the roller arrangement 58, a winding device is provided for the connector 54.

In the exemplary embodiment, the connector 54 is conveyed into a container 59. Here, and preferably, this part is connected to the filling device 8 or via a, in particular aseptic, transfer port arrangement 1.

In the exemplary embodiment, and preferably, it is provided that the containers 3 and/or the container closures 4 are detached from the connector 54 in the region of the transfer port arrangement 1, through which they are introduced into the filling interior 20 or into the interior of the isolator 5. The detachment can take place, for example, in a region of 20 cm, preferably 10 cm, more preferably 5 cm around and above the alpha closure 14 and/or the beta closure 16 of the transfer port arrangement 1. In the exemplary embodiment, this is shown for the containers 3 in Fig. 4. Here, the connector 54 is detached from the containers 3 above the alpha closure 14 and/or the beta closure 16 and then guided downwards in the conveying direction behind the alpha closure 14 and/or the beta closure 16. Figures 4 and particularly 5 show the release of the connector 54 from the container closures 4 above the alpha closure 14 and/or the beta closure 16. Here, the handling device releases the container closures 4 from the connector 54, here and preferably by picking them out.

It should be noted that here and preferably the isolator 5 or the filling unit 43 has a controller 60. This controller 60 here and preferably controls the filling unit 43 and/or the conveyor device 42 and/or the container movement device 3 and/or the conveyor drive 56. In addition, the controller 60 44 can monitor the filling process, in particular by means of the sensor 51 45. The container 3 can be sealed and/or sealed in a sterile manner after filling by means of a container closure 4. The container 3 can, for example, be a so-called vial, as shown in the exemplary embodiments. In particular, the container 3 can be designed as a vial, injection bottle, ampoule, injection syringe, or the like. It is preferably made of glass.

In the exemplary embodiment, the container 3 and/or preferably the container closure 4 has a piercing port for piercing with a needle, by means of which the medium 10 can be removed from the container 3. This allows the medium 10 to be drawn onto an injection syringe particularly easily and safely. In the exemplary embodiment, and preferably, it is provided that the piercing port remains intact after the container unit 3 has been filled with the medium 10 and closed.

Preferably, the container closure 4 is a container closure 4 that can be connected to the container 3 in a form-fitting and/or force-fitting manner. In the exemplary embodiment, it is designed as a snap-in closure. It can simply be pressed onto the container 3 after filling and then secures to it. The container 3 is then sterilely sealed.

Alternatively, the container unit 3 can also be designed as an injection syringe, for example, as a prefillable syringe. In this case, the container 3 is preferably formed by a syringe body, and the container closure 4 by a plunger stopper of the injection syringe.

Preferably, the capacity of the container 3 is between 0.5 and 200 ml, more preferably between 0.5 and 40 ml, more preferably between 0.5 and 20 ml.

Sterile here and preferably means "sterile" as defined in the Guidelines - The Rules Governing Medicinal Products in the European Union Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 1 - Brussels, 22 August 2022. Here and preferably, the filling interior 20 and/or the interior of the isolator 5 and/or the container interior 3 and/or the magazine interior 9 or the magazine interiors 9 are sterile according to section 4.31 of the aforementioned Annex 1, preferably according to Grade B, more preferably according to Grade A.

Additionally or alternatively, the filling interior 20 and/or the interior of the isolator 5 and/or the container interior 3 and/or the magazine interior 9 or the magazine interiors 9 are low in particles according to section 4.27 of the aforementioned Annex 1, preferably according to Grade B, more preferably according to Grade A.

Additionally or alternatively, the filling interior 20 and/or the interior of the isolator 5 and/or the container interior 3 and/or the magazine interior 9 or the magazine interiors 9 here and preferably have a low particle content in accordance with the Guidance for Industry - Sterile Drug Products - Produced by Aseptic Processing - Current Good Manufacturing Practice of the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologies Evaluation and Research (CBER), Office of Regulatory Affairs (ORA) from September 2004, Pharmaceutical CGMPs, Section IV. A Critical Area - Class 100 (ISO5).

Here, and preferably, the filling interior 20 and/or the interior of the insulator 5 and/or the container interior 3 and/or the magazine interior 9 or the magazine interiors 9 have less than or equal to 3520 particles greater than or equal to 0.5 pm/m3 (3520 > 0.5 pm/m3). The previously described low particle content is maintained here and preferably before filling and/or during filling and/or during the closing of the container unit 3.

According to a further teaching, an isolator 5 with an isolator interior 30 is proposed, in particular for filling a medium 10 into a container 3, wherein the isolator interior is sealed or lockable in a sterile manner from the isolator exterior by the isolator 5. The isolator 5 has a port, which is designed as an alpha port 6 of the transfer port arrangement 1 of the type described. Reference may be made to all statements relating to the proposed transfer port arrangement 1, the proposed isolator arrangement 12, the proposed method, the proposed port and the proposed magazine 9.

List of reference symbols

1 transfer port arrangement

2 components

3 containers

4 Container closure

5 Insulator

6 Alpha Port

7 Beta Port

8 Filling device

9 Magazine

10 Medium

11 Recording magazine

12 Insulator arrangement

13 Alpha through hole

14 Alpha shutter

15 Beta through hole

16 Beta shutter

17 Passage opening

18 Swivel axis

19 Closure element

20 Filling interior

21 Alpha frames

22 beta frames

23 Snap connection

24 connecting elements

25 leadership

26 locking connecting elements

27 surveys

28 excerpts

29 Locking

30 Insulator interior

31 Locking element

32 locking brackets

33 Actuating device lever

Swivel mechanism rack

gear

locking mechanism

Pivot bearing

Seal

memory

conveyor system

Filling unit

Connection

Hose

Filling needle

Lifting drive

Peristaltic pump

Air flow unit filter

sensor

Nutrient solution container

Magazine holder

connector

clamping

Conveyor drive

clamping device

Roller arrangement

container

Steering

Claims

Patent claims 1. Transfer port arrangement for transferring components (2) into and/or out of a pharmaceutical isolator (5) with an alpha port (6), in particular associated with the isolator (5), and with a beta port (7) which can be coupled to the alpha port (6), in particular associated with a magazine (9) which can be connected to the isolator (5), wherein the alpha port (6) has an alpha through-opening (13) and an alpha closure (14) for closing the alpha through-opening (13), wherein the beta port (7) has a beta through-opening (15) and a beta closure (16) for closing the beta through-opening (15), wherein the alpha through-opening (13) and the beta through-opening (15) form a common through-opening (17) in the coupled state, and wherein in the coupled state the alpha closure (14) and/or the Beta closure (16) for releasing the common through-opening (17) and for transferring the components (2) through the common through-opening (17) is/are pivotable about a, in particular common, pivot axis (18), wherein the pivot axis (18) is arranged off-center to the common through-opening (17) and in the region of the common through-opening (17). 2. Transfer port arrangement according to claim 1, characterized in that the alpha through-opening (13) and/or the beta through-opening (15) can be reclosed by pivoting about the, in particular common, pivot axis (18) of the alpha closure (14) or the beta closure (16). 3. Transfer port arrangement according to claim 1 or 2, characterized in that the alpha port (6) has an alpha frame (21) and the alpha through-opening (13) is formed in the alpha frame (21), and/or that the beta port (7) provides a beta frame (22) and the beta through-opening (15) is provided in the beta frame (22), and/or that the alpha through-opening (13) and/or the beta through-opening (15) and/or the common through-opening (17) is substantially rectangular. 4. Transfer port arrangement according to one of the preceding claims, characterized in that a force-fitting and/or form-fitting connection, in particular a snap connection (23), is formed between the alpha port (6) and the beta port (7) in the coupled state, preferably that the connection is formed between the alpha frame (21) and the beta frame (22) and/or that the connection is formed between the alpha closure (14) and the beta closure (16). 5. Transfer port arrangement according to one of the preceding claims, characterized in that the transfer port arrangement (1) has a guide (25) for guiding a coupling movement of the alpha port (6) and the beta port (7), preferably that the guide (25) is provided by the alpha frame (21) and the beta frame (22) and/or that the guide (25) is provided by the alpha closure (14) and the beta closure (16). 6. Transfer port arrangement according to one of the preceding claims, characterized in that, as part of the coupling, a connection between the alpha port (6) and the beta port (7) is created by a relative movement, in particular a linear movement, preferably in that the snap connection (23) is created as part of the linear relative movement. 7. Transfer port arrangement according to one of the preceding claims, characterized in that between the alpha port (6) and the beta port (7) in the coupled state there is a, in particular positive, locking mechanism (29), preferably that between the alpha port (6) and the beta port (7) in the coupled state there is the locking mechanism (29) in addition to the non-positive and/or positive connection, and/or that within the scope of the coupling the positive locking mechanism (29) is generated by a relative movement separate from the connection between the alpha port (6) and the beta port (7). 8. Transfer port arrangement according to one of the preceding claims, characterized in that the locking of the alpha port (6) and the beta port (7) is provided outside the interior spaces to be connected by the transfer port arrangement (1), and/or that the locking (29) is provided by the alpha frame (21) and the beta frame (22). 9. Transfer port arrangement according to one of the preceding claims, characterized in that the transfer port arrangement (1) has an actuating device (33) for opening and/or closing the alpha through-opening (13) and/or the beta through-opening (15), in particular the common through-opening (17), preferably that the locking of the lock (29) and the opening of the respective through-opening (17) can be effected by an actuating movement of the actuating device (33), and/or that the unlocking of the lock (29) and the closing of the respective through-opening (17) can be effected by an actuating movement of the actuating device (33). 10. Transfer port arrangement according to one of the preceding claims, characterized in that the actuating device (33) is provided by the alpha port (6), and/or that the actuating device (33) is actuated outside the two interior spaces connected by the transfer port arrangement (1). 11. Insulator arrangement with an insulator (5) with an insulator interior (30) and a magazine (9) with a magazine interior (9), wherein the insulator (5) and the magazine (9) can be coupled via the transfer port arrangement (1) according to one of claims 1 to 13 and the insulator interior (30) and the magazine interior (9) can be connected via the transfer port arrangement (1). 12. A method for coupling a transfer port arrangement (1) according to one of claims 1 to 11, wherein a beta port (7) of the transfer port arrangement (1) is coupled to the alpha port (6) of the transfer port arrangement (1). 13. Port of a transfer port arrangement (1 ), wherein the port is designed as an alpha port (6) of the transfer port arrangement (1 ) according to one of claims 1 to 11 and/or that the port is designed as a beta port (7) of the transfer port arrangement (1) according to one of claims 1 to 11. 14. Magazine with a magazine interior for receiving components (2), wherein the magazine interior (9) is or can be closed off in a sterile manner from the magazine exterior (9) by the magazine (9), wherein the magazine (9) has a port which is designed as a beta port (7) of the transfer port arrangement (1) according to one of claims 1 to 11. 15. Isolator with an isolator interior (30), in particular for filling a medium (10) into a container (3), wherein the isolator (5) has a port which is designed as an alpha port (6) of the transfer port arrangement (1) according to one of claims 1 to 11.