Method for dispensing, in particular aseptically dispensing, a medium, in particular a medicament

Abstract

The invention relates to a method for dispensing, in particular aseptically dispensing, a medium (2), in particular a medicament, into containers (4), the interior (5) of which can be or is closed in a sterile manner, in particular by means of a container closure (6), wherein containers (4) are received in a magazine interior (7) of a magazine (3) and wherein the magazine interior (7) is sealed off towards the outside of the magazine in a sterile manner, wherein the magazine (3) is coupled to a dispensing apparatus (1) via a transfer-port arrangement (8), wherein the dispensing apparatus (1) has a dispensing unit (9) and a dispensing interior (10), wherein the magazine interior (7) and the dispensing interior (10) are coupled to one another via a through-opening (11) in the transfer-port arrangement (8) and, as part of the coupling operation, the magazine interior (7) and the dispensing interior (10) are connected to one another, wherein the containers (4) are fed from the magazine (3) to the dispensing unit (9) individually and in an aligned state through the through-opening (11) and, in the dispensing interior (10), the medium (2) is dispensed into the containers (4).

Description

[0001] Method for, in particular aseptically, filling a medium, in particular a medicament

[0002] The present invention relates to a method for, in particular aseptically, filling a medium, in particular a medicament, as well as a filling device for, in particular aseptically, filling a medium, in particular a medicament, according to claim 12, a magazine according to claim 14 and a magazine according to claim 15.

[0003] Medicine filling systems are known in various designs from the state of the art. Medicine filling systems typically include a washing station, a sterilization station, a separating station, a filling station, and a capping station.

[0004] 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.

[0005] The sterilization station is usually connected to the isolator itself via a sterile tunnel. The isolator then houses the other stations. First, a separation station is provided within the isolator to separate the sterilized containers and / or container closures for filling and to feed the containers and / or container closures in a separated and aligned manner to a conveyor system of the filling station. Second, the actual filling station and the closure station for closing the filled containers with the container lids are also located within the isolator.

[0006] As an alternative to feeding via a sterile tunnel from the sterilization station, the containers and / or container closures can also be washed and / or sterilized separately. Typically, these are then fed to the singulation station in the isolator either in bulk or in batches, i.e., sterilely packaged in larger storage containers. There, they are then unpacked and fed, separated and aligned, to a conveyor system in the filling station. Transfer to the isolator is typically 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.

[0007] Such filling systems are designed for filling a single medication in large quantities and, on the one hand, require a considerable amount of space for installation. On the other hand, cleaning, converting, sterilizing, and preparing the system for a different medication or a different container size is very complex and time-consuming. Furthermore, the introduction of containers, particularly in batches through locks, for example in the form of nested vials, and the introduction of container closures, particularly as bulk material, through a transfer port arrangement is relatively complex and space-intensive, since the unpacking and / or alignment and / or separation of the containers and / or container closures takes place in the protected interior of the filling system.

[0008] It is a challenge to improve the known state of the art.

[0009] The invention is based on the problem of designing and developing the known method in such a way that further optimization is achieved with regard to the challenge mentioned.

[0010] The above problem is solved by the features of claim 1.

[0011] The key idea is to provide a method in which the containers to be filled are fed from a magazine to the filling device in an individual and aligned manner. This makes it possible to provide a particularly compact filling device and / or a particularly small and compact filling chamber within the filling device. Separation and alignment of the containers in the filling system, and in particular in the filling chamber, is thus unnecessary. In particular, the washing and / or sterilization of the containers can take place at a different location and they can then be transported in the magazine to the filling device and there introduced directly into the filling chamber in an individual and aligned manner for filling. The proposed method is used for the, in particular aseptic, filling of a medium, in particular a medication, into containers.The interior of the containers can be closed or is closed in a sterile manner, in particular with a container closure. The containers are accommodated in a magazine interior of a magazine. The magazine interior is sealed in a sterile manner on the outside of the magazine. The magazine is coupled to a filling device via a transfer port arrangement, wherein the filling device has a filling unit and a filling interior. Furthermore, the magazine interior and the filling interior are coupled to one another via a through-opening of the transfer port arrangement and, as part of the coupling process, the magazine interior and the filling interior are connected to one another. The containers are fed individually and in an aligned manner from the magazine through the through-opening of the filling unit and the medium is filled into the containers in the filling interior.

[0012] According to the embodiment of claim 2, container closures can be provided by the magazine and / or by a separate magazine of the filling device. This allows the filling device to be particularly compact and / or the filling chamber to be particularly small.

[0013] Claims 3 and 4 describe preferred arrangements of the containers and / or container closures in the respective magazine, in particular the respective magazine. They enable a particularly simple and reliable, aligned, and individual feeding of the respective component, container and / or container closure, to the filling device.

[0014] Claims 5 and 6 describe preferred embodiments of the transfer port arrangement which enable a particularly simple and contamination-free transfer of the containers and / or container closures from the magazine(s) into the filling device.

[0015] According to the preferred embodiment according to claim 7, the containers are sealed in the filling chamber. This enables particularly secure provision of filled containers. The preferred embodiment according to claim 8 enables particularly simple and secure discharge of the filled containers from the filling device.

[0016] A particularly simple and safe filling of the containers is achieved according to the preferred embodiments of claims 9 and 10.

[0017] According to claim 11, the filling interior is designed to be particularly compact.

[0018] According to a further teaching according to claim 12, which has independent significance, the problem described at the outset is solved by a filling device for, in particular aseptically, filling a medium, in particular a medicament.

[0019] The filling device has a storage or storage holder for the medium to be filled and a conveyor device for conveying the medium to be filled to a filling unit. The filling device further has a filling unit and a filling interior in which the medium can be filled into containers by means of the filling unit. In addition, the filling device has an alpha port to which the beta port of a magazine can be coupled. During the coupling process, a magazine interior with containers received therein and the filling interior can be connected to one another so that containers from the magazine can be fed individually and aligned from the magazine interior to the filling interior and the medium can be filled into the containers in the filling interior by means of the filling unit.

[0020] Reference may be made to all statements relating to the proposed procedure.

[0021] Claim 13 describes further preferred developments of the filling device, which enable a particularly compact construction and simple and safe operation.

[0022] According to a further teaching according to claim 14, which also has independent significance, a magazine is claimed with a magazine interior that is sterilely sealed towards the outside of the magazine and with containers arranged therein. In these, it is provided that the container interiors of the containers can be or are closed in a sterile manner, in particular with container closures. Furthermore, the magazine has a beta port for coupling the magazine to an isolator, in particular a filling device. During the coupling process, the magazine interior and an interior of the isolator, in particular a filling interior, can be connected to one another via a through-opening. The containers are arranged and received in the magazine interior in such a way that the containers can be fed individually and aligned through the through-opening to the interior of the isolator.Because the containers can be aligned and fed to the isolator individually, separating and / or aligning the containers in the filling system is no longer necessary. This enables a compact filling system and simple and safe operation.

[0023] Reference may be made to all statements relating to the proposed method and the proposed filling device.

[0024] According to a further teaching according to claim 15, which also has independent significance, a magazine is claimed with a magazine interior that is sterilely sealed towards the outside of the magazine and with container closures arranged therein for closing sterile-closable containers. The magazine has a beta port for coupling the magazine to an isolator, in particular a filling device. During the coupling process, the magazine interior and an interior of the isolator, in particular a filling interior, can be connected to one another via a through-opening. The container closures are arranged and received in the magazine interior in such a way that the containers can be fed individually and in an aligned manner through the through-opening to the interior of the isolator. Because the containers can be fed to the isolator in an aligned and individual manner, separating and / or aligning the containers in the filling system can be dispensed with.This enables a compact filling system and simple and safe operation.

[0025] Reference is made to all statements regarding the proposed method, the filling device, and the proposed magazine. The invention is explained in more detail below with reference to a drawing that merely represents exemplary embodiments. The drawing shows:

[0026] Fig. 1 shows a proposed filling device with proposed magazines for carrying out a proposed method,

[0027] Fig. 2 shows the filling interior of the proposed filling device from Fig. 1 with coupled magazines in a perspective view,

[0028] Fig. 3 shows the filling interior of the proposed filling device from Fig. 1 with coupled magazines in a plan view,

[0029] Fig. 4 is a perspective view of the feeding of the container closures through a transfer port arrangement from a connected magazine into the filling chamber,

[0030] Fig. 5 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 and

[0031] Fig. 6 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.

[0032] The preferred embodiment illustrated in the figures relates to a filling device 1 for, in particular, aseptically filling a medium 2, in particular a medicament, and to a method for, in particular, aseptically filling a medium 2, in particular a medicament. Furthermore, preferred embodiments of the proposed magazines 3 are illustrated.

[0033] With the filling device 1 shown in the exemplary embodiment, media such as medications can be filled, particularly aseptically, into containers 4. The container interior 5 of the containers 4 can be sealed or closed in a sterile manner. This is preferably achieved with a container closure 6.

[0034] The containers 4 are accommodated in a magazine interior 7 of a magazine 3, and the magazine interior 7 is sealed in a sterile manner from the outside of the magazine. The containers 4 are accommodated in a sterile manner in the magazine 3.

[0035] The magazine 3 can now be coupled to the filling device 1 via a transfer port arrangement 8. The filling device 1 also has a filling unit 9 and a filling interior 10. The filling interior 10 is sterile here. Here, and preferably, the filling unit 9 is at least partially accommodated in the filling interior 10.

[0036] The magazine interior 7 and the filling interior 10 are coupled to one another via a through-opening 11 of the transfer port arrangement 8, and during the coupling process, the magazine interior 7 and the filling interior 10 are connected to one another. Preferred embodiments of this coupling are described below in connection with Figures 5 and 6.

[0037] According to the proposal, the containers 4 are now fed from the magazine 3 in an individual and aligned manner through the through-opening 11 of the filling unit 9 and the medium 2 is filled into the containers 4 in the filling interior 10.

[0038] Coupling the magazine 3 with the containers 4 to be filled to the filling device 1 and the individualized and aligned feeding of the containers 4 into the interior of the filling device 1, followed by the filling of the medium 2 into the containers 4, as shown in Figures 2 and 3, enables a compact filling device 1 as well as simple and reliable filling. In particular, the individualized and aligned feeding of the containers 4 eliminates the need for a separating device and / or an alignment device in the interior of the filling device 1.

[0039] Here, it can be provided in particular that the individual and aligned feeding of the containers 4 and / or container closures 6 through the through-opening 11 into the filling interior 10 takes place essentially in the sequence of filling and / or in the sequence of closing the container closures 6.

[0040] Preferably, the transfer of the containers 4 and / or the container closures 6 from the magazine 3 for filling and / or closing the magazine 3 takes place without separation. This means without further separation in the filling chamber 10. In particular, vibration spiral conveyors and / or a pick-and-place robot for separation and / or alignment in the filling chamber 10 can be dispensed with.

[0041] In the exemplary embodiment, the filling interior 10 is preferably delimited by boundary walls, the transfer port arrangement 8, and optionally by at least one filter 12 for filtering the air to be supplied to and / or discharged from the filling interior 10. Here, and preferably, the filter 12 serves to supply and / or discharge air by means of the air flow unit 13.

[0042] Furthermore, it is preferably provided here that container closures 6 for sterilely closing the containers 4 are accommodated in the magazine 3, and / or that container closures 6 for sterilely closing the containers 4 are accommodated in a magazine interior 7 of a separate magazine 3.

[0043] The provision of the container closures 6 in the same magazine 3 and / or, as shown in the embodiment, in a separate magazine 3 also enables a compact, easy-to-use and safe filling device 1.

[0044] Preferably, the magazine interior 7 of the separate magazine 3 is sealed off from the magazine exterior in a sterile manner. In the exemplary embodiment, it is coupled to a filling device 1 via a further transfer port arrangement 14. Here and preferably, this further transfer port arrangement 14 is designed essentially the same as the transfer port arrangement 8 of the magazine 3 with the containers 4. In the separate magazine 3, too, the magazine interior 7 and the filling interior 10 are coupled to one another via a through-opening 11 in the transfer port arrangement 8, and during the coupling process, the magazine interior 7 and the filling interior 10 are connected to one another. Then, here too and preferably, it is provided that the container closures 6 are fed from the separate magazine 3 in an individual and / or aligned manner through the through-opening 11 of the filling unit 9, as shown in Figures 2 to 4.

[0045] By means of the procedure described above, the containers 4 can be closed particularly easily and safely after filling in the filling chamber 10, in particular in a sterile manner.

[0046] In the exemplary embodiment, and preferably, it is provided that the containers 4 and / or the container closures 6 are accommodated in a spiral and / or meandering manner in the respective magazine 3. This is indicated by dashed lines in Fig. 1 and shown in Fig. 3 for the containers 4 in the magazine 3. This arrangement enables a particularly simple and reliable, individual and aligned transfer from the magazine 3 into the interior of the filling device 1.

[0047] Furthermore, it is preferably provided here that the containers 4 and / or the container closures 6 are connected in the respective magazine 3 via a connector 15. The connector 15 is preferably flexible here. In the exemplary embodiment, the connector 15 is a film. This is shown in Fig. 3 for both the containers 4 and the container closures 6. Alternatively, however, this can also be provided, for example, only for the containers 4 or only for the container closures 6.

[0048] Preferably, the containers 4 and / or the container closures 6 are held in a single row and / or in a double row and / or in a triple row and / or in a quadruple row in the connector 15. In Fig. 3, the containers 4 are held in a single row and the container closures 6 in a double row. This makes it particularly easy to feed them individually and in an aligned manner through the through-opening 11, in particular into the filling chamber 10. In the exemplary embodiment, the containers 4 and / or the container closures 6 are conveyed from the, in particular respective, magazine 3 by means of the connector 15. Here they are also conveyed, here pulled, further into the filling chamber 10. This makes the individual and aligned feeding of the containers 4 and / or container closures 6 particularly easy, safe and space-saving.

[0049] In the exemplary embodiment, the container conveyor drive for conveying the containers 4 and / or the container closures 6 from the, in particular, respective, magazine 3 is arranged in the filling interior 10 and / or is assigned to the filling device 1. This is shown, for example, in Fig. 4 for the container closures 6.

[0050] The transfer port arrangement 8 is preferably configured as follows. It has an alpha port 16 on the filling device 1 and a beta port 17 that can be coupled to the alpha port 16, in particular associated with a magazine 3 that can be connected to the filling device 1.

[0051] The alpha port 16 has an alpha through-opening 18 and an alpha closure 19 for closing the alpha through-opening 18, in particular in an airtight manner. Here and preferably, the alpha closure 19 is made of a rigid material, in particular metal and / or plastic. The beta port 17 has a beta through-opening 20 and a beta closure 21 for closing the beta through-opening 20, in particular in an airtight manner. Here and preferably, the beta closure 21 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.

[0052] In the coupled state, the alpha closure 19 and / or the beta closure 21 is / are preferably pivotable about a, in particular common, pivot axis 22 to release the common passage opening 11 and to transfer the containers 4 and / or container closures 6 through the common passage opening 11. This is shown in Figures 5 and 6.

[0053] The pivot axis 22 is here and further preferably arranged off-center to the common through-opening 11 and / or in the region of the common through-opening 23.

[0054] Here, and preferably, the area of ​​the common through-opening 23 is the area of ​​the transfer port arrangement 8 in which, in the coupled state, it connects the magazine interior 7 of the corresponding magazine 3 and the filling interior 10. In particular, the area of ​​the common through-opening 23 is the area in which the beta closure 21 and / or the alpha closure 19 are in their closed position.

[0055] Furthermore, it is preferably provided here that the connector 15 is attached to a component of the transfer port arrangement 8, in particular the beta closure 21. This enables particularly simple conveyance of the containers 4 and / or container closures 6 into the filling chamber 10.

[0056] By fastening the connector 15 to the transfer port arrangement 8, in particular the beta closure 21, for example as shown in Fig. 4 by a clamp 24, it can be picked up particularly easily by a conveyor drive 25 and the containers 4 and / or container closures 6 can be conveyed from the respective magazine 3.

[0057] As shown in Fig. 4, it is particularly preferred if the connector 15 is brought into the filling interior 10 when the magazine 3 is coupled to the filling device 1, in particular when the beta closure 21 is pivoted into the filling interior 10. For this purpose, a clamping holder 26 for the connector 15 is provided on the beta closure 21. Although this is only shown for the container closures 6 in Fig. 4, it is nevertheless provided here and preferably also for the containers 4. The filling device 1 has a conveyor drive 25 for the containers 4 and / or for the container closures 6 in order to convey them out of the, in particular respective, magazine 3. Preferably, the, in particular respective, conveyor drive 25 has a clamping device 27 and / or a roller arrangement 28 and / or a winding device (not shown) for the connector 15.In the exemplary embodiment, a clamping device 27, in particular a pivotable one, is provided, which feeds the connector 15 here and preferably to a roller arrangement 28, by means of which the containers 4 and / or container closures 6 are conveyed from the, in particular respective, magazine 3. This is shown for the container closures 6 in Fig. 4, but is carried out analogously in the exemplary embodiment for the containers 4. It can also be provided that, in addition to or alternatively to the roller arrangement 28, a winding device is provided for the connector 15.

[0058] In the exemplary embodiment, the connector 15 is conveyed into a container 29. Here, and preferably, this part is connected to the filling device 1 or via a, in particular aseptic, transfer port arrangement 8.

[0059] Furthermore, it is preferably provided here that the containers 4 are sealed in a sterile manner, in particular automatically, in the filling chamber 10. In the exemplary embodiment, the sealing is carried out by a handling device 30. Here, the sealing is carried out by placing the container closures 6 onto the containers 4 filled with the medium 2. In the exemplary embodiment, the sealing preferably takes place in the sequence in which the containers 4 are conveyed through the through-opening 11 into the filling chamber 10.

[0060] As shown in Figures 2 and 3, the handling device 30 is arranged at least partially within the filling chamber 10. The handling device 30 receives the container closures 6 and places them onto the containers 4. Here, the container closures 6 are conveyed, separated and aligned, from the magazine 3 into the filling chamber 10 by means of the connector 15 for the container closures 6, where they are then picked up by the handling device 30 and preferably also separated from the connector 15 by the handling device 30. Here, and preferably, the handling device 30 is designed as a robot. Here, and preferably, it has at least two axes of movement.

[0061] The container 4 can be sealed and / or sealed in a sterile manner after filling by means of a container closure 6. For example, as explained above. The container 4 can be, for example, a so-called vial, as shown in the exemplary embodiments. In particular, the container 4 can be designed as a vial, injection bottle, ampoule, injection syringe, or the like. The container 4 is preferably made of glass.

[0062] In the exemplary embodiment, the container 4 and / or preferably the container closure 6 has a piercing port for piercing with a needle, by means of which the medium 2 can be removed from the container 4. This allows the medium 2 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 4 has been filled with the medium 2 and closed.

[0063] Preferably, the container closure 6 is a closure that can be connected to the container 4 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 4 after filling and then secures to it. The container 4 is then sterilely sealed.

[0064] Alternatively, the container unit can also be designed as an injection syringe, for example, as a prefillable syringe. In this case, the container 4 is preferably formed by a syringe body, and the container closure 6 is formed by a plunger stopper of the injection syringe.

[0065] Preferably, the capacity of the container 4 is between 0.5 and 200 ml, more preferably between 0.5 and 40 ml, more preferably between 0.5 and 20 ml.

[0066] As shown in Figures 2 and 3, the filling interior 10 is preferably at least partially divided by a partition wall 31 into two compartments. One for filling into the containers 4 and one for closing the containers 4. The partition wall 31 has a partition wall through-opening

[0067] 32 for the containers 4 for transport from filling to closing.

[0068] Furthermore, a receiving magazine 33 is preferably provided here, as shown in Fig. 1. The receiving magazine 33 is intended to receive the filled and, if applicable, sealed containers 4. The receiving magazine 33 has a receiving magazine interior 34 for receiving filled containers 4, and the receiving magazine interior 34 is preferably sealed in a sterile manner towards the outside of the magazine. It is sterile.

[0069] It is coupled here and preferably via a further transfer port arrangement 14 to a filling device 1. The further transfer port arrangement 14 is here and preferably designed identically to the described transfer port arrangement 8. The receiving magazine interior 34 and the filling interior 10 are coupled to one another via a through-opening 11 of the further transfer port arrangement 14 and, as part of the coupling process, the magazine interior 7 of the receiving magazine 33 and the filling interior 10 are connected to one another. Subsequently, here and preferably, the containers 4, after filling and / or closing, are fed from the filling interior 10, in particular individually and / or aligned, through the through-opening 11 to the receiving magazine 33, as shown in Fig. 3. In the exemplary embodiment, they are pressed through the through-opening 11 by the respective subsequent container 4 into the receiving magazine 33.Preferably, the closed containers 4 are fed into the receiving magazine 33 in the sequence in which they were filled and / or closed.

[0070] Furthermore, it is preferably provided here that the containers 4 are moved, in particular semi-continuously and / or linearly, through the filling chamber 10. This is shown in Figures 2 and 3 and allows the filling chamber 10 to be designed particularly compactly.

[0071] To move the containers 4 through the filling interior 10, in particular for filling and closing, a container movement device 35 is provided here, in particular in the filling interior 10. The container movement device 35 is provided here and preferably in addition to the conveyor drive 25 for conveying the containers 4 from the magazine 3. The container movement device 35 here and preferably has a container guide 36 for guiding the movement of the containers 4 in the filling interior 10. In the exemplary embodiment, the container movement device 35 has a drive unit 37 and a conveyor screw 38. The container movement device 35 here and preferably conveys the containers 4 from the transfer port arrangement 8, via which the magazine 3 with the unfilled containers 4 is connected, to the transfer port arrangement 8, via which the receiving magazine 33 is connected.

[0072] Here, and preferably, the container movement device 35 is adjustable such that, during conveying, it prevents the transfer port arrangement 8 from closing to the magazine 3 with the containers 4 to be filled and / or the receiving magazine 33 and, when adjusted, enables the transfer port arrangement 8 to close. To enable the transfer port arrangement 8 to close, in the exemplary embodiment and preferably the conveyor screw 38 is movable, in particular linearly, out of the area of ​​the transfer port arrangement 8, as indicated in Fig. 3 by the double arrow.

[0073] Furthermore, it is preferably provided here that the filling device 1 has a weighing arrangement 39 which weighs the respective container 4 before and / or during and / or after filling.

[0074] As already explained, a compact design of the filling device 1 and the filling chamber 10 is particularly advantageous. Preferably, the volume of the filling chamber 10 is less than or equal to 0.5 m 3 , preferably less than or equal to 0.05 m 3 , further preferably less than or equal to 0.02 m 3

[0075] Additionally or alternatively, it can be provided that the floor area of ​​the filling interior 10 is less than or equal to 1 m 2 , preferably less than or equal to 0.1 m 2 , further preferably less than or equal to 0 .05 2 , is.

[0076] It can be provided that the base area of ​​the magazine 3 and / or the receiving magazine 33 is greater than or equal to the base area of ​​the filling interior 10. The proposed filling device 1 according to the further independent teaching serves for the particularly aseptic filling of a medium 2, in particular a medicament. An exemplary embodiment is shown in Fig. 1.

[0077] The filling device 1 has a storage 40 or a storage holder 41 for the medium 2 to be filled and a conveyor device 42 for conveying the medium 2 to be filled to a filling unit 9. The filling device 1 further has a sterile, sealable filling interior 10, in which the medium 2 can be filled or is filled into container 4 by means of the filling unit 9.

[0078] Furthermore, the filling device 1 here has an alpha port 16, to which the beta port 17 of a magazine 3 can be coupled. The alpha port 16 and the beta port 17 of the magazine 3 form the transfer port arrangement 8.

[0079] In the exemplary embodiment, and preferably, it is provided that the containers 4 and / or the container closures 6 are detached from the connector 15 in the region of the transfer port arrangement 8, through which they are introduced into the filling interior 10 or into the interior of the isolator. 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 19 and / or the beta closure 21 of the transfer port arrangement 8. In the exemplary embodiment, this is shown for the containers 4 in Figures 2 and 3. Here, the connector 15 is detached from the containers 4 above the alpha closure 19 and / or the beta closure 21 and then guided away in the conveying direction behind the alpha closure 19 and / or the beta closure 21, in particular downwards.Figures 2, 3, and especially 4 show the release of the connector 15 from the container closures 6 above the alpha closure 19 and / or the beta closure 21. Here, the handling device 30 releases the container closures 6 from the connector 15, here and preferably by picking them out.

[0080] In the exemplary embodiment, and preferably, the filling device 1, in particular for each magazine 3 to be connected, has a magazine holder 43 for holding and / or coupling to the filling device 1. During the coupling process, the magazine interior 7 with containers 4 accommodated therein and the filling interior 10 can be connected to one another, so that containers 4 from the magazine 3 can be fed individually and aligned from the magazine interior 7 to the filling interior 10, and in the filling interior 10, the medium 2 can be filled into the containers 4 by means of the filling unit 9.

[0081] Here, and preferably, the filling unit 9 or the isolator has a controller 44 for the same. This controller 44 here and preferably controls the filling unit 9 and / or the conveyor device 42 and / or the container movement device 35 and / or the conveyor drive 25. Additionally, the controller 44 can monitor the filling process, in particular by means of the sensor 45.

[0082] Reference is made to all statements regarding the proposed method. The proposed filling device 1 may have all the features described in connection with the method individually or in combination.

[0083] Furthermore, it is preferably provided here that the filling device 1 is designed as an insulator, as is also shown in Fig. 1.

[0084] In the exemplary embodiment and preferably, the filling device 1 together with the magazine 46 providing the containers, optionally with the magazine 47 providing the container closures and optionally with the receiving magazine 33 forms a filling device arrangement 48.

[0085] In the exemplary embodiment, the reservoir 40 for the medium 2 is preferably arranged outside the filling interior 10. Here, it is designed as a reservoir 40 that can be separated from the filling device 1. Here, it is connectable or connected to the filling unit 9, preferably by means of a connection 49, in particular an aseptic one. Here, the medium 2 is preferably guided from the reservoir 40 by means of a hose 50 to the filling unit 9, where the medium 2 is filled into the containers 4. Filling into the containers 4 takes place here, preferably, by means of a curved filling needle 51, as shown in Fig. 2.

[0086] Here and preferably, at least the filling needle 51 has a lifting drive 52, by means of which the filling needle 51 is immersed in the container 4 for filling.

[0087] A conveying device 42 is provided for conveying the medium 2. Here, and preferably, the conveying device 42 is arranged outside the filling chamber 10. In the exemplary embodiment, the conveying device 42 is a pump, here, and preferably, a peristaltic pump 53. This enables particularly simple and defined filling of the medium 2 into the containers 4 by means of the conveying device 42.

[0088] In the exemplary embodiment, two containers 4 are filled simultaneously. For this purpose, the filling unit 9 has two filling needles 51. Furthermore, two pumps, in particular peristaltic pumps 53, are provided. A conveying device 42 conveys the medium 2 to each of the filling needles 51.

[0089] Additionally or alternatively, it can be provided here that a conveying device 42, in particular a peristaltic pump, conveys the medium 2 to several filling needles 51. This is preferably done for each filling needle 51 by means of a separate hose 50.

[0090] In the exemplary embodiment, a substantially laminar air flow is preferably provided in the filling chamber 10, preferably from top to bottom. Additionally, an overpressure or a negative pressure compared to the ambient air can be provided in the filling chamber 10. To generate the air flow, the filling device 1 has an air flow unit 13. This unit preferably conveys air through a filter 12 into the filling chamber 10.

[0091] Furthermore, the filling device 1 preferably comprises at least one sensor 45 for monitoring, in particular for monitoring temperature and / or humidity and / or pressure and / or particles and / or germs. The sensor 45 or sensors 45 preferably monitor the filling chamber 10. Additionally or alternatively, a nutrient solution container 54, for example a Petri dish, can be provided for monitoring the filling process in the filling chamber 10. This is preferably introduced into the filling chamber 10 via the magazine 3, in particular the magazine 3 with the containers 4.

[0092] To fill the medium 2 into the containers 4 using the filling device 1, the magazine 3 with the containers 4, if applicable, the storage device 40, if applicable, the magazine 3 with the container closures 6, and if applicable, the receiving magazine 33 are connected to the filling device 1. The filling process into the containers 4 then preferably begins here.

[0093] Figures 5 and 6 show a preferred embodiment of a transfer port arrangement 8 for connecting 49 a magazine 3 to the filling device 1. These will be used to explain preferred configurations of the alpha port 16, which is preferably provided on the filling device 1, and the beta port 17, which is preferably provided on the magazine 3.

[0094] The alpha port 16 has an alpha through-opening 18 and an alpha closure 19 for closing the alpha through-opening 18. The beta port 17 has a beta through-opening 20 and a beta closure 21 for closing the beta through-opening 20. Here, the alpha through-opening 18 and the beta through-opening 20 form a common through-opening 11 in the coupled state.

[0095] In the coupled state, the alpha closure 19 and / or the beta closure 21 is / are pivotable about a, in particular common, pivot axis 22 to release the common through-opening 11 and to transfer the components through the common through-opening 11.

[0096] The pivot axis 22 is arranged here and preferably off-center relative to the common through-opening 11 and in the region of the common through-opening 23, as shown in Figures 5 and 6. This enables a secure and particularly easy-to-handle coupling for the sterile transfer of comparatively large components, here the container 4 and / or container closures 6, compared to the through-opening 11, and a comparatively small space in the interior.

[0097] The alpha shutter 19 and the beta shutter 21 pivot here in such a way that the through opening 11 is divided into two differently sized openings by the alpha shutter 19 and / or beta shutter 21 in the open position, as shown in Fig. 6b).

[0098] Furthermore, it is preferably provided here that the alpha through-opening 18 and / or the beta through-opening 20 can be reclosed by pivoting about the, in particular common, pivot axis 22 of the alpha closure 19 or the beta closure 21. This allows sterility in the filling device 1 and / or in the magazine 3 to be maintained even after the transfer port arrangement 8 has been decoupled.

[0099] As shown in Figures 5 and 6, the alpha port 16 here and preferably further comprises an alpha frame 55. The alpha through-opening 18 is formed in the alpha frame 55. The alpha through-opening 18 is substantially rectangular. The edges of the alpha through-opening 18 are rounded. Additionally or alternatively, the beta port 17 comprises a beta frame 56. The beta through-opening 20 is provided in the beta frame 56. The beta through-opening 20 is substantially rectangular. The edges of the beta through-opening 20 are rounded. In the exemplary embodiment, the common through-opening 11 is substantially rectangular. Such a configuration enables a compact structure and low space requirements compared to the components to be transferred. Although a substantially rectangular shape is advantageous, the through-openings 11 can alternatively also have a different shape.

[0100] Alpha port 16 and / or beta port 17 can have a closure element 57, which is removed before coupling alpha port 16 to beta port 17. This can be, for example, a film or the like, which is attached, in particular welded, to alpha frame 55 or beta frame 56 in an airtight manner to close the respective through-opening 11. This closure element 57 is provided in addition to alpha closure 19 or beta closure 21. This is shown by way of example in the enlarged view of Fig. 1 using the magazine 3 accommodating the containers 4.

[0101] An embodiment of a coupling process is shown in Figures 5 and 6. In the coupled state, a force-fitting and / or form-fitting connection, in particular a snap connection 58, is formed here and preferably between the Alpha port 16 and the Beta port 17. The connection is preferably formed between the Alpha frame 55 and the Beta frame 56 and / or between the Alpha closure 19 and the Beta closure 21. In Fig. 5a), the connecting elements 59 of the connection on the Alpha frame 55 and on the Beta frame 56 are shown in the separated state, while in Fig. 5b) they are shown in the connected state. The further coupling steps of the Alpha port 16 and the Beta port 17 are then illustrated in Figs. 5a) and 5b).

[0102] Furthermore, the embodiment provides that the transfer port arrangement 8 has a guide 60 for guiding a coupling movement of Alpha-Port

[0103] 16 and beta port 17. As shown in Fig. 5, the guide 60 is provided here by the alpha frame 55 and the beta frame 56. Alternatively or additionally, the guide 60 can also be provided by the alpha closure 19 and the beta closure 21. The provision of the guide 60 supports particularly simple coupling of the beta port 17 to the alpha port 16. In the exemplary embodiment in Fig. 5, the guide 60 is provided at least in part by the connecting elements 59 of the connection, here and preferably, on the alpha frame 55 and the beta frame 56. In addition, in the exemplary embodiment, the guide 60 is also provided by closure connecting elements 61. These are here and preferably in the form of corresponding elevations or cutouts in the alpha closure 19 and the beta closure 21, respectively.

[0104] As Fig. 2 further shows, it is preferably provided that within the scope of the coupling a connection between Alpha port 16 and Beta port

[0105] 17 is generated by a, in particular linear, relative movement of alpha port 16 and beta port 17. In the exemplary embodiment and preferably, the previously described snap connection 58 is generated within the scope of this, in particular linear, relative movement.

[0106] Additionally or alternatively, a locking of the alpha port 16 and the beta port 17 in the coupled state can also be provided. This locking is preferably positive-locking. In the exemplary embodiment, the locking exists in addition to the previously described non-positive and / or positive connection. The locking is generated by a movement separate from the relative movement establishing the connection between the alpha port 16 and the beta port 17.

[0107] The locking of Alpha port 16 and Beta port 17 is provided here and preferably outside the interior spaces to be connected by the transfer port arrangement 8, here the magazine interior 7 and the filling interior 10. It is provided here by the Alpha frame 55 and the Beta frame 56.

[0108] The beta frame 56 preferably has at least one locking element 62, which is locked by the alpha port 16. In the exemplary embodiment, two locking elements 62 are provided, particularly opposite one another with respect to the common through-opening 11. These are locked here and preferably by a locking bracket 63. In the exemplary embodiment, this is provided on the alpha port 16 and / or is U-shaped. As the comparison of Fig. 5b) with Fig. 6a) shows, each leg of the locking bracket 63 locks a locking element 62.

[0109] Furthermore, in the exemplary embodiment and preferably, an actuating device 64 is provided for opening and / or closing the alpha through-opening 18 and / or the beta through-opening 20, in particular the common through-opening 11.

[0110] In the exemplary embodiment, locking the lock and opening the respective through-opening 11 can be effected by an actuating movement of the actuating device 64. Additionally or alternatively, unlocking the lock and closing the respective through-opening 11 can be effected by an actuating movement of the actuating device 64. In the exemplary embodiment, and preferably, the actuating device 64 adjusts the previously described locking bracket 63 for locking. The actuating device 64 can be actuated manually or by a motor, in particular with a motor.

[0111] The actuating device 64 is provided here by the alpha port 16. It is actuated here and preferably from outside the two interior spaces connected by the transfer port arrangement 8.

[0112] In the exemplary embodiment, the actuating device 64 comprises a lever. In the exemplary embodiment, the lever is pivoted for actuation. Here, and preferably, it acts on the locking bracket 63 via a gear-rack coupling (not shown). Upon actuation of the actuating device 64, locking is initially effected. This can be seen when comparing Figs. 5b) and 6a). Further actuation of the actuating device 64 then causes the alpha shutter 19 and / or the beta shutter 21 to open, as shown in Fig. 6b).

[0113] To effect opening, the actuating device 64 first engages a pivoting mechanism 65 for pivoting the alpha shutter 19 and / or the beta shutter 21. Here, the lever is coupled to a rack 66 of the pivoting mechanism 65, as shown on the left in Fig. 5 according to illustration AA and in Fig. 6 according to illustrations BB and CC. Upon further actuation of the actuating device 64, the rack 66 then effects an adjustment of the alpha shutter 19 and / or the beta shutter 21, here by rotating a gear 67 coupled to the alpha shutter 19 and / or the beta shutter 21.

[0114] Preferably, the alpha closure 19 and / or the beta closure 21 is pivoted substantially toward the side of the alpha port 16 during opening. Here, the alpha closure 19 and the beta closure 21 are pivoted together into the filling interior 10. When decoupling the transfer port arrangement 8, the actuating device 64 is preferably actuated in the opposite direction. Here, the alpha closure 19 and / or the beta closure 21 is then first pivoted back into the closed position. This is done via the rack 66 and the gear 67. The actuating device 64 then disengages the pivoting mechanism 65 again. Further actuation of the pivoting mechanism 65 in the opposite direction unlocks the locking mechanism. This sequence is shown in Fig. 6b), Fig. 6a) and Fig. 5b).

[0115] In the exemplary embodiment, and preferably, a locking mechanism 68 is provided which enables unlocking only after the alpha closure 19 and / or beta closure 21 has been completely closed.

[0116] By a relative movement of the alpha port 16 and the beta port 17, the beta port 17 can be separated from the alpha port 16 after unlocking, so that the decoupled state of the transfer port arrangement 8 shown in Fig. 1 a) is then established.

[0117] In the exemplary embodiment, the pivot bearing for the common pivot axis 22 is provided by the Alpha port 16, in particular by the Alpha frame 55. In contrast, in Figures 5 and 6, the pivot mechanism 65 is shown open to illustrate its operation. These illustrations clearly show that the gear 67 and the rack 66 of the pivot mechanism 65 are housed in the Alpha shutter 19. The Beta shutter 21 is held by the Alpha shutter 19, and its movement is guided by it.

[0118] Furthermore, the exemplary embodiment provides that the alpha port 16, in particular the alpha frame 55, has a seal 69 for sealing, in particular airtight, the alpha frame 55 and the alpha closure 19 in the closed position of the alpha closure 19. In addition, a seal 69 of the transfer port arrangement 8 is preferably provided here for sealing between the alpha frame 55 and the beta frame 56 in the coupled state. This seal 69 is preferably provided here by the alpha frame 55 and / or the beta frame 56. In the exemplary embodiment, the seal 69 is provided by the alpha frame 55. Additionally or alternatively, the beta port 17, in particular the beta frame 56, can have a seal 69 for sealing, in particular airtight, the beta frame 56 and the beta closure 21 in the closed position of the beta closure 21. In the exemplary embodiment, the seal 69 is preferably provided by the casing.

[0119] Here and preferably, the alpha port 16 and / or the beta port 17 are multi-use. In particular, the beta port 17, especially if a magazine 3 has it, can be designed as a single-use port. Such a port cannot then be reconnected to an alpha port 16 here and preferably after being uncoupled from an alpha port 16.

[0120] According to a further teaching, a magazine 3 is proposed with a magazine interior 7 that is sterilely sealed towards the outside of the magazine and with containers 4 arranged therein. The container interiors 5 of the containers 4 can be closed or sealed in a sterile manner, in particular with container closures 6. The magazine 3 has a beta port 17 for coupling the magazine 3 to an isolator, in particular to the filling device 1. During the coupling process, the magazine interior 7 and an interior of the isolator, in particular the filling interior 10, can be connected to one another via a through-opening 11. According to the proposal, the containers 4 are arranged and received in the magazine interior 7 in such a way that the containers 4 can be fed individually and aligned through the through-opening 11 to the interior of the isolator.

[0121] Reference is made to all statements regarding the proposed method and the proposed filling device 1. By using such a magazine 3, a particularly compact isolator or a particularly compact filling device 1 can be used.

[0122] According to a further teaching, a magazine 3 is proposed with a magazine interior 7 that is sterilely sealed towards the outside of the magazine and with container closures 6 arranged therein for closing sterilely sealable containers 4. The magazine 3 has a beta port 17 for coupling the magazine 3 to an isolator, in particular to the filling device 1. During the coupling process, the magazine interior 7 and an interior of the isolator, in particular the filling interior 10, can be connected to one another via a through-opening 11. According to the proposal, the container closures 6 are arranged and received in the magazine interior 7 in such a way that the containers 4 can be fed individually and aligned through the through-opening 11 to the interior of the isolator.

[0123] Reference is made to all statements regarding the proposed method, filling device 1, and the proposed magazine 3. By using such a magazine 3, a particularly compact isolator or filling device 1 can be used.

[0124] At least before coupling the respective magazine 3 to the isolator, in particular the filling device 1, there is an overpressure here and preferably in the magazine interior 7 compared to the environment.

[0125] With regard to the design of the magazine 3, the containers 4 and their arrangement as well as the design of the beta port 17, reference may be made to the above explanations.

[0126] 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.

[0127] Here and preferably, the filling interior 10 and / or the container interior 5 and / or the magazine interior 7 or the magazine interiors 7 are sterile according to section 4.31 of the aforementioned Annex 1, preferably according to Grade B, more preferably according to Grade A.

[0128] Additionally or alternatively, the filling interior 10 and / or the container interior 5 and / or the magazine interior 7 or the magazine interiors 7 are low-particle in accordance with Section 4.27 of the aforementioned Annex 1, preferably in accordance with Grade B, more preferably in accordance with Grade A. Additionally or alternatively, the filling interior 10 and / or the container interior 5 and / or the magazine interior 7 or the magazine interiors 7 are here and preferably low-particle in the sense of the Guidance for Industry - Sterile Drug Products - Produced by Aseptic Processing - Current Good Manufacturing Practice of the US 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).

[0129] Here, and preferably, the filling interior 10 and / or the container interior 5 and / or the magazine interior 7 or the magazine interiors 7 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 closing of the container unit.

[0130] List of reference symbols

[0131] 1 filling device

[0132] 2 media

[0133] 3 Magazine

[0134] 4 containers

[0135] 5 Container interior

[0136] 6 Container closure

[0137] 7 Magazine interior

[0138] 8 Transfer port arrangement

[0139] 9 Filling unit

[0140] 10 Filling interior

[0141] 11 Passage opening

[0142] 12 filters

[0143] 13 Air flow unit

[0144] 14 additional transfer port arrangement

[0145] 15 Connector

[0146] 16 Alpha Port

[0147] 17 Beta Port

[0148] 18 Alpha through hole

[0149] 19 Alpha shutter

[0150] 20 Beta through hole

[0151] 21 Beta shutter

[0152] 22 Swivel axis

[0153] 23 Area of ​​the common passage opening

[0154] 24 clamping

[0155] 25 Conveyor drive

[0156] 26 clamp bracket

[0157] 27 clamping device

[0158] 28 Roller arrangement

[0159] 29 Container

[0160] 30 Handling device

[0161] 31 Partition wall

[0162] 32 Partition wall opening

[0163] 33 Recording magazine 34 Recording magazine interior

[0164] 35 Container movement device

[0165] 36 Container guidance

[0166] 37 Drive unit

[0167] 38 screw conveyor

[0168] 39 Weighing arrangement

[0169] 40 storage

[0170] 41 Memory holder

[0171] 42 Conveyor system

[0172] 43 Magazine holder

[0173] 44 Control

[0174] 45 Sensor

[0175] 46 container supply magazine

[0176] 47 Container closures supplying magazine

[0177] 48 Filling device arrangement

[0178] 49 connection

[0179] 50 hose

[0180] 51 Filling needle

[0181] 52 lifting drive

[0182] 53 Peristaltic pump

[0183] 54 nutrient solution containers

[0184] 55 alpha frames

[0185] 56 Beta frames

[0186] 57 locking element

[0187] 58 Snap connection

[0188] 59 fasteners

[0189] 60 guide

[0190] 61 locking fasteners

[0191] 62 locking element

[0192] 63 locking bracket

[0193] 64 Actuating device

[0194] 65 Swivel mechanism

[0195] 66 rack

[0196] 67 gear

[0197] 68 Locking mechanism

[0198] 69 Seal

Claims

Patent claims 1. A method for, in particular aseptically, filling a medium (2), in particular a medicament, into containers (4), the container interior (5) of which is sterilely sealable or sealed, in particular with a container closure (6), wherein containers (4) are accommodated in a magazine interior (7) of a magazine (3) and wherein the magazine interior (7) is sterilely sealed to the outside of the magazine, wherein the magazine (3) is coupled to a filling device (1) via a transfer port arrangement (8), wherein the filling device (1) has a filling unit (9) and a filling interior (10), wherein the magazine interior (7) and the filling interior (10) are coupled to one another via a through-opening (11) of the transfer port arrangement (8), and during the coupling process, the magazine interior (7) and the filling interior (10) are connected to one another,wherein the containers (4) from the magazine (3) are fed individually and aligned through the through-opening (11) of the filling unit (9) and the medium (2) is filled into the containers (4) in the filling interior (10).

2. Method according to claim 1, characterized in that container closures (6) for sterile closing of the containers (4) are accommodated in the magazine (3), and / or that container closures (6) for sterile closing of the containers (4) are accommodated in a magazine interior (7) of a separate magazine (3) and wherein the magazine interior (7) of the separate magazine (3) is sterilely sealed towards the magazine exterior, preferably that the magazine (3) is coupled to a filling device (1) via a further transfer port arrangement (14), wherein the magazine interior (7) and the filling interior (10) are coupled to one another via a through-opening (11) of the transfer port arrangement (8) and, as part of the coupling process, the magazine interior (7) and the filling interior (10) are connected to one another, further preferably that the container closures (6) from the separate magazine (3) are fed individually and / or aligned through the through-opening (11) of the filling unit (9).

3. Method according to claim 1 or 2, characterized in that the containers (4) and / or the container closures (6) are accommodated in a spiral and / or meandering manner in the, in particular respective, magazine (3).

4. Method according to one of the preceding claims, characterized in that the containers (4) and / or the container closures (6) in the, in particular respective, magazine (3) are connected via a connector (15), in particular by a film, preferably that the containers (4) and / or the container closures (6) are conveyed out of the, in particular respective, magazine (3) by means of the connector (15).

5. Method according to one of the preceding claims, characterized in that the transfer port arrangement (8) has an alpha port (16) and a beta port (17) which can be coupled to the alpha port (16), in particular associated with a magazine (3) which can be connected to the filling device (1), that the alpha port (16) has an alpha through-opening (18) and an alpha closure (19) for closing the alpha through-opening (18), that the beta port (17) has a beta through-opening (20) and a beta closure (21) for closing the beta through-opening (20), preferably,that the alpha through-opening (18) and the beta through-opening (20) form a common through-opening (11) in the coupled state, and wherein in the coupled state the alpha closure (19) and / or the beta closure (21) is / are pivotable about a, in particular common, pivot axis (22) to release the common through-opening (11) and to transfer the containers (4) and / or container closures (6) through the common through-opening (11), further preferably that the pivot axis (22) is arranged off-center to the common through-opening (11) and / or in the region of the common through-opening (23).

6. Method according to one of the preceding claims, characterized in that the connector (15) is fastened to a component of the transfer port arrangement (8), in particular the beta closure (21), preferably that when pivoting the connector (15) is brought into the filling interior (10) during coupling.

7. Method according to one of the preceding claims, characterized in that the containers (4) are closed in a sterile manner in the filling interior (10), in particular in an automated manner, preferably in that the containers (4) are closed in a sterile manner in the filling interior (10) by a handling device (30), preferably by placing the container closures (6) on the containers (4) filled with the medium (2).

8. Method according to one of the preceding claims, characterized in that a receiving magazine (33) is provided for receiving the filled containers (4), preferably that a receiving magazine (33) has a magazine interior (7) for receiving filled containers (4) and that the magazine interior (7) of the receiving magazine (33) is sealed in a sterile manner towards the outside of the magazine, preferably that the magazine (3) is coupled to a filling device (1) via a further transfer port arrangement (14), wherein the magazine interior (7) of the receiving magazine (33) and the filling interior (10) are coupled to one another via a through-opening (11) of the further transfer port arrangement (14) and, as part of the coupling process, the magazine interior (7) of the receiving magazine (33) and the filling interior (10) are connected to one another, further preferably that the containers (4) are removed from the filling interior (10) after filling and / or closing,in particular individually and / or aligned, are fed through the through opening (11) to the receiving magazine (33).

9. Method according to one of the preceding claims, characterized in that the containers (4), in particular semi-continuously and / or linearly, are conveyed through the filling interior (10).

10. Method according to one of the preceding claims, characterized in that the filling device (1) has a weighing arrangement (39) which weighs the respective container (4) before and / or during and / or after filling.

11. Method according to one of the preceding claims, characterized in that the volume of the filling interior (10) is less than or equal to 0.5 m 3 , preferably less than or equal to 0.05 m 3 , further preferably less than or equal to 0.02 m 3 and / or that the base area of the filling interior (10) is less than or equal to 1 m 2 , preferably less than or equal to 0.1 m2 , further preferably less than or equal to 0.05 m 2 and / or that the base area of the magazine (3) is greater than or equal to the base area of the filling interior (10).

12. Filling device for, in particular aseptically, filling a medium (2), in particular a medicament, wherein the filling device (1) has a storage (40) or a storage holder (41) for the medium (2) to be filled and a conveying device (42) for conveying the medium (2) to be filled to a filling unit (9), wherein the filling device (1) has a filling interior (10) in which the medium (2) can be filled into containers (4) by means of the filling unit (9), and wherein the filling device (1) has an alpha port (16) to which the beta port (17) of a magazine (3) can be coupled, and wherein, within the scope of the coupling process, a magazine interior (7) with containers (4) accommodated therein and the filling interior (10) can be connected to one another,so that containers (4) from the magazine (3) can be fed individually and aligned from the magazine interior (7) to the filling interior (10) and in the filling interior (10) the medium (2) can be filled into the containers (4) by means of the filling unit (9).

13. Filling device according to claim 12, characterized in that the storage (40) is arranged outside the filling interior (10), and / or, that the conveying device (42) is arranged outside the filling interior (10), and / or that the conveying device (42) is a pump, in particular a peristaltic pump (53), and / or that the reservoir (40) can be connected to the filling unit (9) by means of a connection (49), in particular an aseptic one, and / or that the filling device (1) is designed as an insulator.

14. Magazine with a magazine interior (7) which is sterilely sealed towards the outside of the magazine and containers (4) arranged therein, wherein the container interiors (5) of the containers (4) can be closed or are closed in a sterile manner, in particular with container closures (6), wherein the magazine (3) has a beta port (17) for coupling the magazine (3) to an isolator, in particular a filling device (1), and during the coupling process the magazine interior (7) and an interior of the isolator, in particular a filling interior (10), can be connected to one another via a through opening (11), and wherein the containers (4) are arranged and received in the magazine interior (7) in such a way that the containers (4) can be fed individually and in an aligned manner through the through opening (11) to the interior of the isolator.

15. Magazine with a magazine interior (7) which is sterilely sealed towards the outside of the magazine and container closures (6) arranged therein for closing sterilely sealable containers (4), wherein the magazine (3) has a beta port (17) for coupling the magazine (3) to an isolator, in particular a filling device (1), and during the coupling process the magazine interior (7) and an interior of the isolator, in particular a filling interior (10), can be connected to one another via a through opening (11), and wherein the container closures (6) are arranged and received in the magazine interior (7) in such a way that the containers (4) can be fed individually and in an aligned manner through the through opening (11) to the interior of the isolator.

Images