Filling unit for filling a medium

Abstract

The invention relates to a filling unit for filling a medium (2), in particular a medicament, having at least one container (3) and at least one container closure (4), the at least one container (3) and the at least one container closure (4) being arranged in an at least partially flexible sleeve (5), the sleeve (5) closing off a filling unit interior (7) from the outside of the filling unit (1) such that the filling unit (1) is designed as an isolator (8), the filling unit (1) having a pouring unit (10) and a port (11), the port (11) being connected or connectable to the pouring unit (10) and the medium (2) to be filled being feedable to the pouring unit (10) from outside the filling unit via the port (11).

Description

[0001] Filling unit for filling a medium

[0002] The present invention relates to a filling unit for filling a medium according to claim 1, a use of a filling unit according to claim 13, a filling device for filling a medium, in particular aseptically, into a filling unit according to claim 14, and a method for filling a medium, in particular a drug, into a container of a filling unit according to claim 15, in particular aseptically.

[0003] In pharmaceutical production in general, and in the filling of medications and / or active ingredients in particular, there is a trend towards smaller batch sizes and more flexible systems. Therefore, filling system suppliers are focusing on developing smaller and more flexible systems.

[0004] A key requirement in the filling of medications and / or active pharmaceutical ingredients (APIs) is ensuring purity. To achieve this, filling typically takes place in a protected area provided by the filling system. In this area, the medication and / or API, the containers to be filled, and the container closures are introduced into the filling system and the protected area via their respective airlocks. It is essential to prevent contamination, particularly by germs and / or particles. Once introduced into the filling system, the containers are automatically and systematically transported to the actual filling station, filled with the medication and / or API, and then conveyed to a sealing station where they are sealed. If the medication or API is changed, the filling station is usually thoroughly cleaned before filling with the next medication or API.The active ingredient is continued.

[0005] Furthermore, it is also known to provide these protected spaces by means of a building section which is entered and exited through airlocks.

[0006] Such facilities and / or building sections require high investments, need a relatively large amount of space, and especially with smaller batches and / or frequent changes of medication or active ingredient, the conversion and cleaning are relatively complex.

[0007] Therefore, it is a challenge to improve the known state of the art in such a way that simple, safe and cost-effective filling of media such as medicines and / or active ingredients is made possible even with smaller batches and / or frequent changes of medicine.

[0008] The invention is based on the problem of designing and further developing the known filling unit in such a way that further optimization is achieved with regard to the aforementioned challenge.

[0009] The above problem is solved by the features of claim 1.

[0010] The essential consideration is to provide a filling unit for dispensing a medium, comprising at least one container and at least one container closure, wherein the at least one container and the at least one container closure are arranged within an at least partially flexible shell. This shell encloses the interior of the filling unit from the outside, thus designing the filling unit as an insulator. Furthermore, the filling unit includes a filling unit and a connection, the connection being connected to and / or connectable with the filling unit, and the medium to be dispensed being feedable to the filling unit from outside the filling unit via this connection.

[0011] Here, the filling unit's housing forms a protective shell for the filling process. This allows the filling unit to provide a germ-free or germ-free, as well as particle-free or low-particle, environment for filling, thus eliminating the need for the filling system itself to provide a separate protective chamber. The medium is introduced into the housing via a connection and then filled into the container using the filling unit located inside the housing. By having the filling unit provide a protective shell for the filling process, the filling system can be designed much more simply and compactly. Furthermore, this design allows the filling unit to be configured as a single-use unit, eliminating the need for complex cleaning when changing media, as a different filling unit can simply be used.

[0012] The further developments according to claims 2 to 4 describe preferred arrangements of the containers and the container closures which ensure safe and easy filling and / or closing.

[0013] According to the further developments of claims 5 and 6, a preferred manipulator interface is described which describes a particularly simple coupling of the manipulator interface with the manipulator as well as a particularly simple filling and / or closing by means of a manipulator.

[0014] Claims 7 to 9 describe preferred embodiments of the filling unit with a container closure unit, which simplifies the closing of the containers with the container closures.

[0015] Claims 10 and 11 describe preferred embodiments of a holding device which ensures that the containers and, if applicable, the container closures are held securely.

[0016] According to a further teaching according to claim 13, which has independent significance, the use of a filling unit according to one of claims 1 to 12 for the aseptic filling of a medium, in particular a drug, into at least one container and for sealing the same is claimed.

[0017] Reference may be made to all statements regarding the proposed filling unit.

[0018] According to a further teaching as claimed in claim 14, which also has independent significance, a filling device is claimed for filling, in particular aseptically, a medium into a filling unit with a storage container and / or a storage holder for the medium to be filled outside the filling unit and with a conveying device for conveying the medium to be filled into the filling unit. Reference may be made to all descriptions of the proposed filling unit and the proposed use.

[0019] According to a further teaching according to claim 15, which also has independent significance, a method for filling, in particular aseptically, a medium, in particular a drug, into a container of a filling unit is described, wherein the filling unit has at least one container and a shell, wherein a storage container containing the medium to be filled is connected to the filling unit, in particular to a connection of the filling unit, and the medium is introduced into the shell and the medium is filled into the interior of the at least one container by means of the filling unit.

[0020] Reference may be made to all statements concerning the proposed filling unit, the use of a filling unit and the proposed filling device.

[0021] The invention will now be explained in more detail with reference to a drawing that merely illustrates exemplary embodiments. The drawing shows

[0022] Fig. 1 in a) an embodiment of a proposed filling unit and in b) an embodiment of a proposed filling device with a proposed filling unit connected to it,

[0023] Fig. 2 schematically shows the filling and closing of a container in a proposed filling unit,

[0024] Fig. 3 shows a cutaway section through a proposed filling unit in a) before the container closure is picked up, with the manipulator interface coupled to the end effector, and in b) the holding unit of the holding device with the manipulator interface attached to it, before the manipulator interface is coupled to the end effector. Fig. 4 shows in a) a further embodiment of a proposed filling unit and in b) a further embodiment of a proposed filling device with a proposed filling unit connected to it.

[0025] Fig. 5 schematically shows in a) the picking up of the lid and in b) the filling in a further proposed filling unit and in c) a section through the manipulator interface according to the illustration in Fig. 5a) and

[0026] Fig. 6 in a) a module of a holding device from the filling unit of the further embodiment from Fig. 4 in a three-dimensional representation and in b) and c) connected modules for holding devices of preferred embodiments of filling units.

[0027] The embodiment shown in the figures, which is preferred in this respect, relates to a filling unit 1. This unit serves for the filling, in particular aseptic, of the medium 2. This medium can in particular be a drug and / or an active ingredient.

[0028] As shown in Fig. 1 or in Fig. 4, which shows a further embodiment, the filling unit 1 has at least one container 3 and at least one container closure 4, wherein the at least one container 3 and the at least one container closure 4 are arranged in an at least partially flexible shell 5.

[0029] Container 3 has an interior chamber 6 into which the medium 2 is poured. Afterwards, container 3 can be sealed, particularly in a sterile manner.

[0030] Furthermore, the filling unit 1 has a shell 5. The shell 5 encloses the inner chamber 7 of the filling unit 1 from the outside, so that the filling unit 1 is designed as an isolator 8. The shell 5 of the filling unit 1 provides a sterile filling environment for filling the medium 2 into the interior of the container 6.

[0031] The shell 5 protects the filling process from environmental influences, in particular from contamination by particles and / or germs. The shell 5 thus provides a protective covering for the filling process, so that a protective space no longer needs to be provided by the filling device 9 or filling system itself, but rather a protective covering can be provided by the shell 5 of the filling unit 1.

[0032] Furthermore, the filling unit 1 has a filling unit 10 and a connection 11, wherein the connection 11 is connected and / or connectable to the filling unit 10, and wherein the medium 2 to be filled can be supplied to the filling unit 10 from outside the filling unit 1 via the connection 11.

[0033] Connection 11 is used for the sterile introduction of the medium to be filled.

[0034] 2 from outside the filling unit 1 into the casing 5. In the exemplary embodiment, it is designed as a transfer port 12 for the medium 2. Then, a filling unit 10, connected or connectable to the connection 11, is provided for filling the container interior 6 with the medium 2 introduced into the casing 5 via the connection 11.

[0035] The proposed design of the filling unit 1 allows for a particularly simple and space-saving design of the filling device 9 for filling the medium 2. In particular, a germ-free or germ-free or particle-free environment for filling can be provided by the filling unit 1 itself.

[0036] It has also proven particularly advantageous if the filling unit 1 is designed as a single-use unit. Such a design as a disposable item allows for high flexibility, as product changes can be carried out quickly and lengthy preparation and cleaning times are eliminated. With filling unit 1, after the medium 2 has been filled into the container unit 13, it can be sterilely sealed in the sleeve 5, and then the sleeve 5 can be opened and the sealed containers 3 removed. By filling and sealing the containers 3 with the sleeve 5 unopened, the risk of cross-contamination can at least be reduced, if not eliminated.

[0037] In the exemplary embodiment, and preferably, a container 3 and a container closure 4 form a container unit 13. The container closure 4 allows the container 3 to be sterilely sealed within the outer casing 5 after filling. The container 3 can, for example, be a vial, as shown in the exemplary embodiments. In particular, the container 3 can be designed as an injection vial or a penetrating vial. The container 3 is preferably made of glass and / or plastic. The container closure 4 is preferably made of plastic.

[0038] The container unit 13, in particular the container closure 4, preferably has a port for piercing with a needle, by means of which the medium 2 can be removed from the container 3. This allows the medium 2 to be drawn onto an injection syringe particularly easily and safely. In the exemplary embodiment, and preferably, the port is provided that it remains intact after the container unit 13 has been filled with the medium 2 and closed.

[0039] Preferably, the container closure 4 is a positive-locking and / or force-locking closure that can be connected to the container 3. In the exemplary embodiment, it is designed as a snap-lock closure 14. It can simply be pressed onto the container 3 after filling and then locks onto it. The container 3 is then sterilely sealed.

[0040] Alternatively, the container unit 13 can also be designed as an injection syringe, for example as a pre-fillable 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.

[0041] Preferably, the capacity of the container unit 13 is between 0.5 and 200 ml, more preferably between 0.5 and 40 ml, and even more preferably between 0.5 and 40 ml. The filling unit 1 can have only a single container 3. Preferably, however, a filling unit 1 has several containers 3, as is also shown in the embodiment of Fig. 1. In particular, the filling unit 1 can have at least 2, preferably at least 10, more preferably at least 50, more preferably at least 100, more preferably at least 200, and more preferably at least 500 containers 3. It then preferably has a corresponding number of container closures 4.

[0042] Furthermore, it is preferably provided, as shown in Fig. 1, that the casing 5 completely encloses the containers 3 and / or container closures 4. The casing 5 is at least partially made of plastic and / or at least partially flexible. Here, and preferably, it is predominantly made of plastic film. Preferably, the plastic is polyethylene (PE) and / or polycarbonate (PC) and / or polypropylene and / or perfluoroalkoxy (PFA) and / or polyetheretherketone (PEEK). The casing 5 is designed such that, after filling with the medium 2, a sealed container unit 13 can be removed by opening the casing 5 while maintaining the sterility of the container interior 6. For this purpose, the container 3 can be closed with the container closure 4 after filling within the closed casing 5, and then the casing 5 can be opened.

[0043] The casing 5 is designed to be at least partially transparent. This allows the filling process and / or the sealing of the containers 3 to be observed from the outside.

[0044] The filling unit 10 can, in particular, have a filling needle 15. This needle is inserted into the interior of the container 6 to fill the medium 2. In a further embodiment, the filling unit 10 can have several filling needles 15. To fill the medium 2, the filling unit 10, specifically its filling needle 15, can be moved through a container opening 16 into the interior of the container 6 and / or, after filling, moved out of the interior of the container 6. This is done with the housing 5 closed. The housing 5 provides the necessary flexibility for this.

[0045] While Figures 1 to 3 show an embodiment with one filling needle 15, Figures 4 and 5 show embodiments with two filling needles 15. The picking up and placing of the container closure 4 and / or closing is carried out here, and preferably in the embodiments, in the same way as can be seen by comparing Figures 2b) and 5b), which show the picking up of the container closure 4.

[0046] Fig. 5b) shows how the first and second filling needles 15 together enter the container interior 6 through the container opening 16 to fill the container 3. This step corresponds to the step shown in Fig. 2d).

[0047] It can also be provided that the different filling needles 15 are immersed one after the other into the containers 3 and fill in the respective medium 2.

[0048] Figure 5c) schematically shows that the filling unit 10 can also have three, four, or more filling needles 15. This allows a first medium 2 to be introduced into a container 3 through the first filling needle 15, and a second medium 2, which differs from the first medium 2, to be introduced into the container 3.

[0049] In the exemplary embodiment, the at least one container 3 is openly received in the filling unit 1, as shown in Fig. 1.

[0050] Furthermore, the filling unit 1 has a holding device 17 and optionally a further holding device 17. In the exemplary embodiment, the containers 3 are held in the holding device 17. Additionally, as shown in the exemplary embodiment, the container closures 4 can be held in the holding device 17. Alternatively, the container closures 4 can be held in a further holding device 17. Preferably, the further holding device 17 is then fixed to the containers 3 and / or the holding device 17.

[0051] Preferably, the holding device 17 and / or the further holding device 17 are designed as a plastic injection molded part and / or plastic printed part. Here, and preferably, the holding device 17 has a recess 18 for the filling needle 15. The filling needle 15 moves into this recess when the containers 3 are closed with the container closures 4. This is shown in Fig. 2.

[0052] In the embodiment shown in Fig. 4, the holding device 17 is designed in multiple parts, whereas in the embodiment shown in Fig. 1 it is designed in one piece. The holding device 17 in Fig. 4 has at least one module 52 with container receptacles 62 for the containers 3 and optionally a frame 53; here, and preferably, two modules 52 and a frame 53. In principle, a holding device 17 formed from modules 52 can be designed without a frame.

[0053] Exemplary embodiments of such modules 52 are shown in Fig. 6. As shown in Figs. 6b) and 6c), the modules 52 can be connected to each other by frictional and / or positive locking. This is implemented here in the form of a plug-in connection, particularly in the form of a puzzle. This makes it possible to assemble a holding device 17 of different sizes for a filling unit 1 in a particularly simple manner. Holding devices 17 composed of modules 52 can be provided in the proposed filling units 1 with or, alternatively, without a frame 53. In Figs. 4 and 5, an exemplary holding device 17 with a frame 53 and two modules 52 held therein is shown. In the exemplary embodiment, the modules 52 are connected to the frame 53 by frictional and / or positive locking.Guide elements, in particular a stop 54 or several stops 54 and / or a retaining strip 55 or several retaining strips 55, and / or a snap connection 56 or several snap connections 56, can be provided for this connection.

[0054] Furthermore, it is preferably provided that the container closure 4, in particular the container closures 4, are arranged above a nominal fill level 19 of the container 3.

[0055] In the exemplary embodiment, and preferably, the container closure 4, or more specifically the container closures 4, are arranged above the container opening 16. Particularly preferably, the container closure 4, or more specifically the container closures 4, are arranged above the container opening 16. This allows the container closures 4 to at least partially cover the container openings 16, thus further reducing the risk of contamination. They can then be arranged, in particular, concentrically or offset from the container opening 16. This preferably refers to the arrangement of the container 3 and the container closures 4 in the delivery state of the filling unit 1.

[0056] Furthermore, and preferably, the distance between the container opening 16 and the container closure 4 is less than 5 mm, preferably less than 3 mm, more preferably less than 1 mm, and more preferably less than 0.5 mm. Arranging the container closures 4 as close as possible to the container openings 16 can result in a high degree of overlap of the container opening 16.

[0057] As shown in Fig. 5c), it can be provided that the majority, in particular each, of the container closure 4 in the holding device 17 covers the respective container opening 16 of the container 3 associated with it from a view from above at least 30%, preferably at least 50%, further preferably at least 80%, further preferably completely.

[0058] As further illustrated in the figures, the filling unit 1 preferably has a manipulator interface 20 for engaging a manipulator 21 located outside the filling unit 1. An end effector 22 of a manipulator 21 can engage this interface from outside the filling unit 1 (filling unit exterior). This enables particularly simple and safe filling and / or sealing of the containers 3 by means of the manipulator 21 inside the casing 5.

[0059] In the exemplary embodiment, the manipulator interface 20 and the filling unit 10 are permanently connected and / or designed as a unit.

[0060] Furthermore, and preferably, the manipulator interface 20 is designed for magnetic coupling with the manipulator 21. The manipulator interface 20 preferably includes a coupling element 23, in particular a metal element and / or a magnetic element. This element can, in particular, be injection-molded into the manipulator interface 20.

[0061] Additionally or alternatively, the manipulator interface 20 can be attached or fastened to the manipulator 21 or its end effector 22 by means of a snap-fit ​​connection 57.

[0062] In this way, the manipulator 21 can accommodate the manipulator interface 20 with its end effector 22 in a particularly simple manner. Preferably, the end effector 22 has a negative feedback element 24. This is preferably a coil and / or a magnet. For example, a coupling force between the end effector 22 and the manipulator interface 20 can then be switched on and off by energizing the coil. This allows magnetic coupling to be realized in a particularly simple manner with the coupling element 23 and / or the negative feedback element 24. Additionally or alternatively, the end effector 22 and the manipulator interface 20 can be designed as a self-centering and / or self-aligning system during coupling.

[0063] As shown in the figures, the filling unit 1 preferably has a container closure unit 25 for receiving the at least one container closure 4 and for closing the container 3 with the container closure 4. This unit serves to receive a container closure 4 arranged separately from the container 3 and to close the container 3 with the container closure 4. This is shown in Fig. 2.

[0064] Preferably, the manipulator interface 20 and / or the container closure unit 25 and / or the filling unit 10 are arranged on a top side of the shell 5, as shown in the figures. With this configuration, the shell 5 can be reliably kept outside the travel path of the manipulator 21.

[0065] Here, and preferably, external fastenings and / or support structures for the casing 5 provided in the filling unit 1 can be dispensed with. The figures further show that the manipulator interface 20 and / or the container closure unit 25 and / or the filling unit 10, particularly in the case of a fully expanded casing 5, is / are arranged above, preferably over, the containers 3.

[0066] Additionally or alternatively, it may be provided that the manipulator interface 20 and / or the container closure unit 25 and / or the filling unit 10 is / are arranged above the containers 3 and / or container closures 4 when the shell 5 is contracted by drawing the gas from the filling unit 1, particularly in the delivery state before connection to the filling device 9.

[0067] To place the container closure 4 onto the container 3, the container closure unit 25 is movable in such a way that it can receive the container closure 4 and place it onto the container 3. This is done with the cover 5 closed. The cover 5 provides the necessary flexibility for this.

[0068] Additionally or alternatively, the container closure unit 25 and the filling unit 10 and / or the manipulator interface 20 can be designed as a single unit. This simplifies the manufacture of the filling unit 1. Preferably, the manipulator interface 20 and / or the filling unit 10 and / or the container closure unit 25 are injection-molded parts, preferably plastic injection-molded parts. Such a design is shown in the figures. Preferably, the filling needle 15 is injection-molded here and preferably also into the filling unit 10.

[0069] In the exemplary embodiment, the casing 5, as shown in the figures, is designed to be flexible at least in the area around the manipulator interface 20 and / or is designed as a plastic film in the area around the manipulator interface 20. This allows relative movement of the manipulator interface 20, in particular including the filling unit 10 and / or the container closure unit 25, relative to the at least one container 3 and / or container closure 4 of the filling unit 1. By means of the manipulator interface 20, the manipulator 21 can move the filling unit 10 relative to the container 3 and / or the container closure unit 25 relative to the container 3 from outside the filling unit 1.

[0070] Preferably, the filling unit 10 and / or the container closure unit 25 is movable relative to the containers 3, in particular by means of the manipulator 21, such that filling into all containers 3 or closing them with the container closures 4 is possible, preferably without requiring any relocation of the containers 3 and / or container closures 4 held in the holding device 17 and / or further holding devices 17 within the filling unit 1. The necessary flexibility for this is provided by the casing 5.

[0071] In the exemplary embodiment, and preferably, the manipulator interface 20 and / or the filling unit 10 and / or the container closure unit 25 are gas-tightly connected to flexible sections 26 of the casing 5, particularly preferably by a material bond. It can, for example, be welded and / or bonded to the rest of the casing 5.

[0072] Furthermore, and preferably, it is provided here that the container closure unit 25 receives the container closure 4 in a force-fit and / or form-fit manner. Preferably, the container closure unit 25 has a container closure receptacle 28, in particular designed as a snap-in retainer 27, for receiving the container closure 4.

[0073] The container closure receptacle 28 serves to receive the container closure 4 inside the casing 5. The container closure receptacle 28 is preferably formed by a snap-in contour 29 and / or designed as a snap-in retainer 27. It is preferably, except for the part used to receive and / or release the container closure 4, essentially fixed to the manipulator interface 20. Particularly preferably, the snap-in retainer 27 is formed integrally with the container closure receptacle 28 and / or the manipulator interface 20. The container closure 4 can be received and / or released from outside the filling unit 1 by the manipulator 21, in particular the end effector 22, by means of the container closure receptacle 28. Furthermore, it is preferably provided that the container closure unit 25 has a flexible section 26 for releasing the container closure 4.This flexible section enables the manipulator 21, in particular the end effector 22, to release the container closure 4 from the container closure unit 25. This is shown in Fig. 2. The flexible section can, for example, be made of silicone. Here, and preferably, the flexible section enables the filling unit 1 to be sealed from the outside and the container closure 4 to be released from the container closure unit 25 from outside the filling unit 1. For this purpose, in the exemplary embodiment, the manipulator 21, in particular the end effector 22, has a plunger 30. This plunger can push the container closure 4 out of the container closure unit 25 from outside the filling unit 1 by deforming the flexible section 26.

[0074] The container closure unit 25 of the filling unit 1 can be designed without bellows. Accordingly, it can be provided that the locking contour 29 of the container closure unit 25 is essentially fixed to the manipulator interface 20. "Essentially" here means, preferably, that the locking contour 29 can perform the necessary spring movements transverse to a receiving direction for picking up and releasing a container closure 4, but that length compensation in the receiving direction relative to the manipulator interface 20 is prevented.

[0075] The design of the container closure unit 25 enables a particularly simple pick-and-place of the container closures 4 within the filling unit 1 and thus a particularly simple closing of the containers 3.

[0076] Filling unit 1 is preferably designed without actuators. In particular, filling unit 1 itself does not have an actuator 32 for filling the medium 2 into the containers 3 and / or no actuator 32 for closing the containers 3. This allows for a particularly simple and cost-effective design.

[0077] Furthermore, it is preferably provided here that the holding device 17

[0078] The device has retaining ribs 33 for holding the containers 3 and / or the container closures 4. Preferably, the same retaining ribs 33 hold both a container

[0079] 3 and a container closure 4, as shown in Fig. 1 a). This preferably applies both to the delivery state of the filling unit 1 and to the state after filling and closing. However, the holding position of the container 3 and / or the container closure 4 may differ. Preferably, however, only either the holding position of the container 3 or only the holding position of the container closure 4 differs.

[0080] The holding device 17, in particular the holding webs 33, are here and preferably designed in such a way that they allow the containers 3 to be closed, in particular by springing up the holding webs 33.

[0081] As shown in the exemplary embodiment, the retaining webs 33 extend upwards over a container 3 and / or hold a container closure.

[0082] 4 above container 3.

[0083] As can be seen in the figures, the container closure 4 is held here, and preferably, above the container 3 to which it is assigned, such that its lower edge is below the upper edge of the container 3.

[0084] In the exemplary embodiment, retaining webs 33 are provided around the circumference of a container 3 and / or container closure 4. Preferably, a container 3 and / or a container closure 4 is held by at least two, and in the exemplary embodiment by at least three, retaining webs 33.

[0085] The retaining webs 33 extend here and preferably over at least half the container height, preferably 80% of the container height, and further preferably over the height of container 3 and associated container closure 4. The latter is shown in Figures 5 and 6.

[0086] Preferably, the containers 3 and / or container closures 4 are arranged in the holding device such that a space is formed by a group of containers 3 and / or container closures 4 adjacent to the space. Preferably, at least one retaining web 33, or in Fig. 5c) three retaining webs 333, is arranged in at least one of these spaces. Additionally or alternatively, when a container closure 4 is picked up and / or placed down with the container closure unit 25, a filling needle 15, or in the embodiment of Fig. 5c) two filling needles 15, can be inserted into one of these spaces.

[0087] Furthermore, it can be provided that a free space with at least one retaining rib 33 and a free space for immersion with a filling needle 15 are arranged alternately around a container 3, as shown schematically in Figures 5c) and 6.

[0088] The holding device 17 of Figures 4 to 6, or its modules 52, has a base plate 58 from which the holding webs 33 extend upwards. Base plate 58 has recesses 59. In the exemplary embodiment, one base recess 59 is provided for each container 3.

[0089] Furthermore, and preferably, the holding device 17 includes a holding unit 34 for securing the filling unit 10 and / or the container closure unit 25 and / or the manipulator interface 20. This is shown in Fig. 3. This design is particularly advantageous for storing and / or transporting the filling unit 1. Securing the filling unit 10 and / or the container closure unit 25 and / or the manipulator interface 20 by a holding unit 34 prevents, in a very simple and reliable manner, the containers 3 and / or container closures 4 from separating from the holding device 17 and / or damaging it during storage and / or transport. Additionally or alternatively, this can facilitate coupling with the manipulator 21, in particular the end effector 22, since the manipulator interface 20 is thus held in a defined position. This facilitates approaching and coupling it with the end effector 22.

[0090] Figure 3 shows that the holding unit 34 for securing the filling unit 10 and / or the container closure unit 25 and / or the manipulator interface 20 is formed directly on the holding device 17. Alternatively, the holding unit 34 can also be designed as a separate component. This is shown by way of example in Figure 5. Here, the holding unit 34 is connected to the holding device 17 by frictional and / or positive locking. In the exemplary embodiment, the connection is designed as a snap connection 56. The connection is preferably designed to be detachable from the holding device 17, in particular detachable without damage. As shown in Figure 5, the holding unit 34 is received in a container receptacle 62 for a container 3. Here, it is held by retaining webs 33 for a container 3. In the exemplary embodiment of Figure 5, the holding unit 34 is mounted in a container receptacle 62 for a container 3.5 the holding unit 34 is provided at the edge of the holding device 17, additionally or alternatively a holding unit 34 can also be enclosed by containers 3, in particular essentially in the middle of the holding device 17.

[0091] As previously described, in the exemplary embodiments, the holding unit 34 serves to secure the filling unit 10 and / or the container closure unit 25 and / or the manipulator interface 20. The filling unit 10, the container closure unit 25, or the manipulator interface 20 is preferably aligned with the holding unit 34, preferably by means of the snap-in retainer 27. In the exemplary embodiment, retaining contours 60 are formed on the holding unit 34 for this purpose. These contours preferably prevent the filling unit 10, the container closure unit 25, or the manipulator interface 20 from detaching and / or rotating. The connection is thus designed as a snap-in connection 56, preferably one that is rotationally secure.

[0092] Preferably, a negative pressure relative to the environment is maintained in the filling unit 1 during storage and / or transport. This allows the containers 3 and / or container closures 4 and / or the filling unit 10 and / or the container closure unit 25 and / or the manipulator interface 20 to be fixed in their position. Furthermore, damage to the casing 5 can be detected by "air intake." To fill the containers 3, the filling unit 1 is preferably pressurized.

[0093] Furthermore, it is preferably provided that the filling unit 10 is movable relative to the container 3 via the manipulator interface 20. Additionally or alternatively, the container closure unit 25 can be moved relative to the container 3 via the manipulator interface 20.

[0094] The filling unit 10 and / or the container closure unit 25 and / or the manipulator interface 20 can then be detached from the holding unit 34, preferably by means of the manipulator 21. Detachment from the manipulator interface 20 preferably occurs by means of the plunger 30 of the manipulator 21, in particular the end effector 22.

[0095] Particularly for the filling of pharmaceuticals and / or active ingredients, it can be advantageous if the filling unit 1 has a sterility indicator 35 by means of which the maintenance of a sterile environment during filling can be verified. This can be, for example, a Petri dish and / or a container 3 with culture medium. Furthermore, the filling unit 1 can have a sampling unit, in particular a swab. Samples can be taken with this and presented to the sterility indicator 35. Preferably, the sampling unit is connected to the manipulator interface 20, in particular permanently connected, or connectable for sampling purposes.

[0096] In particular, the sterility indicator 35 and / or the sample unit can also be held in the holding device 17. For example, it can be formed by a container 3, in particular a vial. This can then be filled with a nutrient medium.

[0097] Additionally or alternatively, the filling unit 1, particularly in its casing 5, can have a sterilization indicator 36. The sterilization indicator 36 indicates that the filling unit 1 has been sterilized. For example, it can be designed to have a display that indicates sterilization of the filling unit 1, such as a color change during sterilization or other indication of sterilization by the sterilization indicator 36.

[0098] In the exemplary embodiment, and preferably, the connection 11 is an aseptic connection 11. Such aseptic connections 11 are known from the prior art, particularly for connecting tubing 37 in laboratory applications, and are also referred to as "aseptic connectors." They allow sterile fluid transfer. These are marketed by various manufacturers under different brand names such as AseptiQuik, MicroCNX, Kleenpak, or Opta in various configurations.

[0099] Furthermore, the filling unit 1 can have a pipe and / or a hose 37 for connecting the filling unit 10 to a storage tank 38 located outside the filling unit 1, containing the medium 2 to be filled. Here, and preferably, the connection 11 is formed at one end of the hose 37. In the exemplary embodiment, this is the aseptic connection 11. The connection 11 is preferably a force-fit and / or form-fit connection 11. However, it can also be provided as a material-fit connection 11 to the storage tank 38.

[0100] Aseptic connectors 11 can be designed as single-use connectors. In this case, they allow for a single sterile connection. However, there are also multi-use connectors that can be sterilised and reconnected. Such multi-use connectors are generally resealable.

[0101] For example, the aseptic port 11 can have a pull tab, the removal of which, after connecting the port 1 1 to its mating port, allows a fluid connection to be established.

[0102] Both the provision of an aseptic connection 11 and, additionally or alternatively, a hose 37 for connecting the connection 11 to the filling unit 10 enable a particularly simple and flexible connection of the filling unit 1 to a storage tank 38 containing the medium 2 to be filled.

[0103] The connection 11 can have a filter 39 for filtering the medium 2 conveyed through it.

[0104] Additionally or alternatively, a filter 39 can be provided in the hose 37 and / or between the connection 11 and the filling unit 10. This is illustrated in Fig. 4a), but can also be provided in the other embodiments, for example.

[0105] Here, and preferably, the hose 37 does not pass through the casing 5 and / or the casing 5 is designed without a hose inside. Here, and preferably, the hose 37 is connected to the filling unit 10, in particular the filling needle 15, outside the casing 5.

[0106] Here, and preferably, the casing 5 is essentially gas-tight. Only the connection 11 and, if present, a gas port 40 allow gas transit from the outside of the filling unit into the casing 5. The filling unit 1 can have a gas port 40, in particular with a gas port filter 41, for pumping gas into the filling unit 1, especially into its casing 5, and / or for releasing gas from the filling unit 1, especially from its casing 5. Preferably, the gas port 40 is connected to the filling unit 1 via a gas port hose. Two gas ports 40 can also be provided, with one preferably serving as the gas inlet and the other as the gas outlet.

[0107] Alternatively or additionally to a gas port 40, it can be provided that gas is pumped into or out of the filling unit 1 via the connection 11. This allows the casing 5 to be inflated. An integrity test of the filling unit 1 can then be performed. In the exemplary embodiment, the integrity test is an integrity test of the casing 5 of the filling unit 1 before and / or after filling. In principle, however, such a test can also be performed additionally or alternatively during filling.

[0108] The gas port 40 can be connected to the manipulator interface 20, in particular via a gas port hose. Preferably, however, the gas port 40 is connected separately from the manipulator interface 20 to the filling unit 1, in particular to the flexible casing 5. Preferably, gas introduced into the filling unit 1 via the gas port 40 flows into the casing 5 from below, in particular from a bottom side, as shown in Fig. 1. In principle, gas can be pumped into the filling unit 1 via the gas port 40 and / or released and / or extracted from the filling unit 1, in particular using the gas conveying device 42.

[0109] According to a further embodiment, the filling unit 1 may have a further gas port 40, in particular with a further gas port filter 41. The further gas port 40 may also have the features described in connection with the gas port 40, individually or in combination. Preferably, gas is released and / or extracted from the filling unit 1 via the further gas port 40, particularly with the gas conveying device 42. This is illustrated, for example, in Fig. 4, but may also be provided in the other embodiments.

[0110] In the exemplary embodiment, the filling device 9 has a control unit 43. The control unit 43 controls, here and preferably, the manipulator 21, in particular including the end effector 22, and / or the conveying device 44 and / or the gas conveying device 42.

[0111] It is further proposed to use a filling unit 1 of the described type for the aseptic filling of a medium 2, in particular a drug, into at least one container 3 and for sealing the same.

[0112] Reference may be made to all descriptions of the proposed filling unit 1. Filling unit 1 is preferably designed as described above. It can have the described features individually or in combination.

[0113] Furthermore, a filling device 9 is proposed for filling, in particular aseptically, a medium 2 into a filling unit 1, comprising a storage reservoir 38 or a storage holder 45 for the medium 2 to be filled outside the filling unit 1 and a conveying device 44 for conveying the medium 2 to be filled into the filling unit 1. The filling unit 1 is preferably designed as described above. It can have the described features individually or in combination. Reference may be made to all embodiments of the proposed filling unit 1 and its proposed use.

[0114] Furthermore, a filling device 9 is proposed for filling a medium 2, particularly aseptically, into a filling unit 1. This is shown in Fig. 1b. A filling unit according to the proposed design is attached to the filling device 9.

[0115] I connected. The filling device 9 and the filling unit 1 form a filling device arrangement 46.

[0116] The filling device 9 has a storage reservoir 38 and / or a storage holder 45. This allows the medium 2 to be supplied outside the filling unit 1. Furthermore, the filling device 9 has a conveying device 44 for conveying the medium 2 to be filled into a filling unit 1. The filling unit 1 is preferably designed as described above. It can have the described features individually or in combination.

[0117] In the embodiment shown in Fig. 1, the storage holder 45 carries a storage container 38 with the medium 2 to be dispensed. In this embodiment, the storage container 38 is designed as a plastic bag. It is a single-use container. It has a storage connection, which is designed here as an aseptic connection.

[0118] II. The storage connection is connected to the connection 11 of the filling unit 1 for filling. This creates an aseptic connection. In this embodiment, the storage connection is located at one end of a storage hose 47 of the storage unit 38. This allows for particularly easy connection of the filling unit 1 to the storage unit 38. The storage connection and the connection 11 of the filling unit 1 are preferably connected by force-fit and / or form-fit. Additionally or alternatively, the storage connection and the connection 11 of the filling unit 1 can also be connected by material bonding.

[0119] The conveying device 44 for conveying the medium 2 to be filled into a filling unit 1 is designed here as a pump, in particular as a peristaltic pump. It is designed here as a hose pump 37, which forces the medium 2 to be conveyed through the hose 37 by external mechanical deformation. In the exemplary embodiment, and preferably, the conveying device 44 engages the hose 37 of the filling unit 1 for conveying. Additionally or alternatively, however, it can also be provided that it engages the storage hose 47 of the storage tank 38. Here, it is arranged outside the filling unit 1. The conveying device 44 is preferably arranged in the filling device 9 next to and / or above the filling unit 1 and / or below the storage tank 38.

[0120] As shown in Fig. 4, the filling device 9 can have two or more reservoirs 38 and / or two or more conveying units 44. Preferably, the filling device 9 has one reservoir 38 and / or one conveying unit 44 for each filling needle 15. In this case, the respective medium 2 is preferably supplied from a reservoir 38 to each of the filling needles 15 by means of an associated conveying unit 44. For details regarding multiple reservoirs 38 and conveying units 44, please refer to the respective description. In such an embodiment, different media can be supplied to a container 3 and mixed only within the container 3. Fig. 4 shows an example of such a filling device 9; however, a filling device 9 can also have three or four reservoirs 38 and / or conveying units 44, and the filling unit 10 can, as described, also have three or four filling needles 15.

[0121] Furthermore, the filling device 9 includes a manipulator 21 for filling the medium 2 into the at least one container 3. This manipulator is arranged outside the filling unit 1. It engages the manipulator interface 20 of the filling unit 1 to fill the medium 2 into the containers 3 and / or to close the containers 3. This is shown in Fig. 1 b).

[0122] The manipulator 21 is, in this context, preferably a robot with at least two, preferably at least three, axes of motion. In particular, the robot can have at least two, preferably three, rotary axes and / or at least two, preferably at least three, translational axes. In the exemplary embodiment, the robot is designed as an industrial robot, in particular a five-axis or six-axis industrial robot. However, it can also be designed as a SCARA robot or as a gantry robot.

[0123] In the exemplary embodiment, the filling device 9 further comprises a gas supply device 42, in particular a gas pump. This is arranged outside the filling unit 1. In the exemplary embodiment, the gas supply device 42 is connected to a gas port 40 of the filling unit 1. Alternatively, however, it can also be connected to the connection 11. It serves to introduce and / or extract gas, in particular air, into or from the filling unit 1. Preferably, sterile and / or particle-free air is pumped into the housing 5 of the filling unit 1. To ensure this, appropriate air filters are provided. Here, and preferably, the gas port 40 of the filling unit 1 has corresponding gas port filters 41. Additionally or alternatively, the gas supply device 42 can also be used to create a protective atmosphere in the housing 5 of the filling device 9.

[0124] The gas port 40 is preferably configured as an aseptic connection 11. The gas port 40 is preferably connected to a corresponding aseptic connection 11 of the gas supply device 42. Such aseptic connections 11 are known from the prior art, particularly for connecting hoses 37 in laboratory applications, and are also referred to as "aseptic connectors".

[0125] The filling device 9 of Fig. 1 b) further comprises a receptacle 31 for the, in particular aligned and / or fixed, receptacle 31 of the filling unit 1.

[0126] Furthermore, the filling device 9 can include a weighing unit 48. The weighing unit 48 can be used to check the quantity of medium 2 filled into the individual containers 3 of the filling unit 1. The filling unit 1 can be arranged on the weighing unit 48, and / or the containers 3 can be moved to the weighing unit 48 individually or in groups, for example, by means of the manipulator 21 and a container handling unit not described in detail. Preferably, a container 3 is weighed before, during, and / or after filling. In the exemplary embodiment, the weighing unit 48 is integrated into the receptacle 31. In the exemplary embodiment, the filling unit 1, here the manipulator 21, in particular its end effector 22, has a container closure unit 25. This will be described in more detail in connection with the method.

[0127] Furthermore, a method is proposed for filling, in particular aseptically, a medium 2, in particular a drug, into a container 3 of a filling unit 1, in particular of the type described, wherein the filling unit 1 has at least one container 3 and a shell 5, wherein a storage unit 38 containing the medium 2 to be filled is connected to the filling unit 1, in particular to a connection 11 of the filling unit 1, and the medium 2 is introduced into the shell 5 and the medium 2 is filled into the interior 6 of the at least one container 3 by means of the filling unit 10.

[0128] Preferably, the filling device 9 described above is used for carrying out the process.

[0129] Reference may be made to all statements concerning the proposed filling unit 1, the proposed use and the proposed filling device 9.

[0130] A preferred embodiment for filling the medium 2 is described below.

[0131] For filling, the filling unit 1 is preferably first connected to or on the filling device 9.

[0132] The gas supply unit 42 is connected to the gas port 40. Preferably, gas, here ambient air, is first pumped into the filling unit 1, here the casing 5 of the filling unit 1. This is done using the gas supply unit 42. In this way, an integrity test can be performed. A pressure test is carried out to check whether the casing 5 is airtight. Since the gas is filtered before being pumped into the casing 5, sterility is maintained. In the exemplary embodiment, gas, in particular partially, is released from the casing 5 before filling begins. Preferably, a slight overpressure relative to the ambient air pressure prevails in the casing 5 during filling.

[0133] The integrity test of the filling unit 1, in particular of the casing 5 of the filling unit 1, is particularly preferably carried out before the connection 11 of the storage unit 38 and / or before the fluid connection of the storage unit 38 to the filling unit 1. In this way, it can only be connected if the filling unit 1 has passed the integrity test.

[0134] In the exemplary embodiment, the manipulator 21 is connected to the filling unit 1, in particular to the manipulator interface 20. This preferably takes place before or after the connection 11 of the gas conveying device 42 to the gas port 40. Particularly preferably, the connection 11 of the manipulator 21 to the manipulator interface 20 takes place before the integrity test.

[0135] In the exemplary embodiment, the storage tank 38 is connected to the connection 11. In the exemplary embodiment, the hose 37 is inserted into the peristaltic pump.

[0136] If the holding device 17 has the holding unit 34, the manipulator 21 here and preferably releases the filling unit 10 and / or the container closure unit 25 and / or the manipulator interface 20 from the holding unit 34.

[0137] In the exemplary embodiment, the container closure unit 25 is attached to the holding unit 34 by its locking contour 29. For release, it is preferably provided that the manipulator 21 releases the container closure unit 25 from the holding unit 34. In the exemplary embodiment, the manipulator 21 preferably lifts the container closure unit 25 from the holding unit 34 and / or presses against the holding unit 34 with the plunger 30.

[0138] To fill the containers 3, the manipulator 21 with the container closure unit 25 here and preferably now first approaches a container closure 4 and picks it up, as shown in Fig. 2.

[0139] Initially, the container closure 4 is held in the holding device 17. As shown in Fig. 2, retaining webs 33, in the exemplary embodiment three retaining webs 33, of the holding device 17 have locking hooks 49 for holding a container closure 4. The further container closures 4 are preferably held in the holding device 17 in the same way.

[0140] A container 3 associated with the container closure 4 is held here, preferably by the same retaining ribs 33. The other containers 3 are preferably held in the holding device 17 in the same manner. This is shown in Fig. 1.

[0141] In the exemplary embodiment, the container closure unit 25 receives the container closure 4 with its snap-fit ​​contour 29. It is held by force and / or form-fit. In this exemplary embodiment, the snap-fit ​​contour 29 is formed by several, here three, snap tabs 50. These form a snap-fit ​​retainer 27. For receiving 31, the snap tabs 50 move between the retaining ribs 33 that hold the container closure 4 to be received and snap into the container closure 4. In this exemplary embodiment, the snap tabs 50 snap into the same groove 51 of the container closure 4 in which the locking hooks 49 also hold the container closure 4. This is shown in Fig. 2b).

[0142] As shown in Fig. 6, a retaining bar 33 can have, in particular, one or two locking hooks 49. In the case of one locking hook 49, this preferably serves to hold a container closure 4. In the case of two locking hooks 49, one locking hook 49 preferably serves to hold a container closure 4 and the other locking hook 49 to hold a container 3, as shown in Fig. 5.

[0143] The manipulator 21 can now lift the container closure 4 with the container closure unit 25 out of the holding device 17. The snap tabs 50 and the retaining bars 33 are designed such that the container closure unit 25 can safely lift the container closure 4 out of the holding device 17.

[0144] In this embodiment, the container opening 16 is released from the closure, as shown in Fig. 2c). The container 3 can then be filled with the medium 2. For this purpose, the filling unit 10 is moved towards the container 3 to be filled. This is accomplished here by the manipulator 21. The filling needle 15 is inserted into the container 3, as shown in Fig. 2d). The medium 2 can then be filled into the container 3. It is conveyed by the conveying device 44 into the interior of the container 6. Afterwards and / or during filling, the filling needle 15 is withdrawn from the container 3. This movement is effected by the manipulator 21. Due to the flexibility of the housing 5, these movements of the filling unit 10 relative to the container 3 are very easy. After filling, the container 3 can be closed with the container closure 4.

[0145] A plunger 30 can be provided to release the container closure 4 from the container closure unit 25, particularly after a container 3 has been closed with the container closure 4. In the exemplary embodiment, an actuator 32 is preferably provided on the manipulator 21, in particular its end effector 22, to move the plunger 30. The plunger 30 is shown in the sections of Fig. 3.

[0146] The sealing of the container 3 is shown in Figures 3e) and 3f). The container sealing unit 25, with the container closure 4 held within it, moves towards the container 3 to be sealed next. This is preferably the one that was previously filled. The container closure unit 25 can then place the container closure 4 onto the filled container 3 and seal it. In this embodiment, the closure is a snap closure. Alternatively, the container closure 4 can be crimped or glued. Here, the container 3 is sealed sterilely with the container closure 4.

[0147] By lifting, the container closure unit 25 can then release the container closure 4, as shown in Fig. 2f). Additionally or alternatively, the container closure 4 can be released by means of the plunger 30. For this purpose, the plunger 30 can be moved by the actuator 32 relative to the manipulator interface 20 towards the container closure 4. It then preferably pushes the container closure 4 out of the container closure unit 25 via the flexible section 26. This principle becomes clear when comparing Figs. 1 and 3. The container unit 13 is then properly and sterilely closed. Preferably, to release the container closure 4 from the container closure unit 25, the manipulator flange 21 is lifted by the manipulator 21 relative to the holding device 17; however, the plunger 30 remains stationary relative to the holding device 17 when the container closure 4 is released, particularly by adjustment by the actuator 32.

[0148] In a further embodiment of the method, the container closure unit 25 lifts the sealed container 3 into an elevated position in the holding device 17 after the container closure 4 has been closed and / or before it has been released. This facilitates the subsequent removal of the sealed containers 3 from the holding device 17. In this elevated position, the locking hooks 49 of the retaining webs 33 preferably engage in the groove 51 of the container closure 4.

[0149] Now the next container 3 can be filled and / or the next container 3 can be closed. This is preferably done as described previously.

[0150] It is particularly noteworthy that the filling unit 1 is designed here, and preferably without actuators. All actuators 32, which are required for filling and / or closing the containers 3, are provided here, and preferably separately from the filling unit 1, in particular on the manipulator 21.

[0151] After the containers 3 have been filled, a further integrity test can be performed. For this purpose, the shell 5 is preferably subjected to a pressure test by the gas conveying device 42. The integrity of the shell 5 is checked here, and preferably, in particular, before and / or after the medium 2 has been filled into the interior of the container 6. In the exemplary embodiment, the shell 5 is subjected to a pressure test for this purpose. In this test, an overpressure relative to the ambient pressure is generated in the shell 5, and it is checked whether the pressure is maintained.

[0152] By filling and subsequently sealing the container unit 13 or the container units 13 in the intact and / or unopened casing 5, the risk of contamination can be significantly reduced.

[0153] The shell 5 can be formed section by section by a membrane 61. In the exemplary embodiment, and preferably, a lower part of the shell 5 is formed by a membrane 61. This is preferably provided in the lower region of the shell 5. In the exemplary embodiment, it is attached to the holding device from below and allows gas inflow and / or outflow through bottom recesses 59. The membrane 61 represents a microbial barrier. It preferably has a log reduction value (LRV) of less than five (according to ASTM F1608) and / or maximum penetration at less than 0.3% pmax (according to ASTM F2638).

[0154] The membrane 61 preferably has a thickness of less than or equal to 250 pm, more preferably less than or equal to 200 pm, and more preferably less than or equal to 180 pm. Additionally or alternatively, the membrane 61 has a thickness greater than or equal to 150 pm, and more preferably greater than or equal to 175 pm. In the exemplary embodiment, the thickness is essentially 178 pm.

[0155] The air permeability (Bendtsen Air Permeability according to ISO 5636-3) is preferably between 400 mL / min and 700 mL / min, and preferably between 550 mL / min and 600 mL / min. In the exemplary embodiment, 572 mL / min is provided.

[0156] The moisture vapor transmission rate (MVTR according to TAPPI T523) of the membrane 61 is preferably between 1000 g / m² / 24 hr and 2000 g / m² / 24 hr, preferably between 1400 g / m² / 24 hr and 1800 g / m² / 24 hr. In the exemplary embodiment, a moisture vapor transmission rate of essentially 1615 g / m² / 24 hr is provided for the membrane 61. Such membranes 61 are marketed, for example, by DuPont under the trademark Tyvek.

[0157] The provision of a membrane 61 facilitates and simplifies steam sterilization of the filling unit 1, particularly after the manufacturing of the filling unit 1 and before filling the containers 3 by means of the filling device 9. The described embodiments of the individual figures may also alternately include individual features of the other embodiments, either individually or in combination. In particular, the embodiment of Figures 1 to 3 may also include a holding device 17 as shown and described in connection with Figures 4 to 6, or the embodiment of Figure 4 may also include a filling unit 10 and / or container closure unit 25 and / or manipulator interface 20 as described in connection with Figures 1 to 3.

[0158] It may be provided that the filling unit 1 is sterilized, in particular before being connected to the filling device 9 and / or before filling the medium 2.

[0159] Sterilization is preferably carried out by means of radiation, in particular X-rays and / or gamma radiation and / or electron beam irradiation. Alternatively or additionally, sterilization can also be carried out by means of another sterilization method, for example steam sterilization and / or ethylene oxide sterilization. Additionally or alternatively, the components of the filling unit 1 can be pre-sterilized and the filling unit 1 can be manufactured under sterile conditions.

[0160] Sterile here means, 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.

[0161] Here, and preferably, the filling unit 1 inside the casing 5 and / or inside the container 6 is sterile in accordance with section 4.31 of the aforementioned Annex 1, preferably in accordance with Grade B, further preferably in accordance with Grade A.

[0162] Additionally or alternatively, the filling unit 1 within the casing 5 and / or in the container interior 6 is low in particles according to section 4.27 of the aforementioned Annex 1, preferably according to Grade B, further preferably according to Grade A. Additionally or alternatively, the filling unit 1 and / or the interior of the casing 5 (filling unit interior 7) is here and preferably low in particles in accordance with 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) dated September 2004, Pharmaceutical CGMPs, Section IV. A Critical Area - Class 100 (ISO 5).

[0163] Here, and preferably, the filling unit 1 and / or the interior of the casing 5 (filling unit interior 7) exhibits less than or equal to 3520 particles greater than or equal to 0.5 pm / m3 (3520 > 0.5 pm / m3).

[0164] The previously described low particle count is maintained here, preferably before filling and / or during filling and / or during closing of the container unit 13.

[0165] If the filling unit 1 is designed as a single-use unit, it here and preferably constitutes a single-use system within the meaning of the aforementioned Annex 1 or is used for filling as such.

[0166] The described embodiments make it possible to provide a protective cover during the filling of a medium 2 using the filling unit 1 itself, thus eliminating the need for a separate filling system or filling device 9. This enables simple, safe, and cost-effective filling of a medium 2, particularly for small batches and / or frequent medication changes.

[0167] Reference symbol list

[0168] 1 filling unit

[0169] 2 Medium

[0170] 3 containers

[0171] 4 Container closure

[0172] 5 cases

[0173] 6 Container interior

[0174] 7 Filling unit interior

[0175] 8 Insulator

[0176] 9 Filling device

[0177] 10 Filling unit

[0178] 11 connection

[0179] 12 T transfer port

[0180] 13 container units

[0181] 14 Snap fastener

[0182] 15 Filling needle

[0183] 16 Container opening

[0184] 17 Holding device

[0185] 18 Exclusion

[0186] 19 Nominal fill level

[0187] 20 Manipulator interface

[0188] 21 Manipulator

[0189] 22 End effector

[0190] 23 coupling element

[0191] 24 Negative feedback element

[0192] 25 Container closure unit

[0193] 26 flexible section

[0194] 27 Snap-in bracket

[0195] 28 Container closure holder

[0196] 29 Rast contour

[0197] 30 pestles

[0198] 31 recording

[0199] 32 Actuator

[0200] 33 Support bridge 34 Holding unit

[0201] 35 Sterility indicator

[0202] 36 Sterilization indicator

[0203] 37 hose

[0204] 38 memory

[0205] 39 filters

[0206] 40 Gasport

[0207] 41 Gasport filters

[0208] 42 Gas supply system

[0209] 43 Control

[0210] 44 Support facility

[0211] 45 Memory bracket

[0212] 46 Filling device arrangement

[0213] 47 Storage hose

[0214] 48 weighing units

[0215] 49 locking hooks

[0216] 50 snap tabs

[0217] 51 Nut

[0218] 52 Module

[0219] 53 frames

[0220] 54 attacks

[0221] 55 Retaining strip

[0222] 56 Snap connection

[0223] 57 Snap-in connection

[0224] 58 Base plate

[0225] 59 floor recesses

[0226] 60 Holding contour

[0227] 61 Membran

[0228] 62 Container capacity

Claims

Patent claims 1. Filling unit for filling a medium (2), in particular a medicinal product, with at least one container (3) and at least one container closure (4), wherein the at least one container (3) and the at least one container closure (4) are arranged in an at least partially flexible shell (5), wherein the shell (5) closes off a filling unit interior (7) from outside the filling unit (1), so that the filling unit (1) is designed as an isolator (8), wherein the filling unit (1) has a filling unit (10) and a connection (11), wherein the connection (11) is connected and / or connectable to the filling unit (10) and wherein the medium (2) to be filled can be supplied to the filling unit (10) from outside the filling unit (1) via the connection (11).

2. Filling unit according to claim 1, characterized in that the at least one container (3) is openly received in the filling unit (1), and / or that the at least one container (3) is held in a holding device (17), and / or that the at least one container closure (4) is held in a further holding device (17) and / or in the holding device (17).

3. Filling unit according to claim 1 or 2, characterized in that the container closure (4) is arranged above the nominal fill level (19) of the container (3), preferably that the container closure (4) is arranged above the container opening (16), further preferably that the container closure (4) is arranged above the container opening (16), in particular concentrically or offset.

4. Filling unit according to one of the preceding claims, characterized in that the distance between the container opening (16) and the Container closure (4) less than 5 mm, preferably less than 3 mm, further preferably less than 1 mm, further preferably less than 0.5 mm.

5. Filling unit according to one of the preceding claims, characterized in that the filling unit (1 ) has a manipulator interface (20) for engaging a manipulator (21 ) arranged outside the filling unit (1 ) at the manipulator interface (20), and / or that the manipulator interface (20) and the filling unit (10) are designed as a unit.

6. Filling unit according to one of the preceding claims, characterized in that the manipulator interface (20) is designed for magnetic coupling with the manipulator (21).

7. Filling unit according to one of the preceding claims, characterized in that the filling unit (1 ) has a container closure unit (25) for receiving the at least one container closure (4) and for closing the container (3) with the container closure (4), and / or that the container closure unit (25) and the filling unit (10) and / or the manipulator interface (20) are designed as a unit.

8. Filling unit according to one of the preceding claims, characterized in that the container closure unit (25) receives the container closure (4) in a force-fit and / or form-fit manner, preferably that the container closure unit (25) has a snap-fit ​​holder (27) for receiving the container closure (4).

9. Filling unit according to one of the preceding claims, characterized in that the container closure unit (25) has a flexible section (26) for releasing the container closure (4).

10. Filling unit according to one of the preceding claims, characterized in that the holding device (17) has retaining webs (33) for holding the containers (3) and / or the container closures (4), preferably that the same retaining webs (33) hold both a container (3) and a container closure (4) hold, and / or that the holding device (17), in particular the retaining bars (33), are designed in such a way that they allow the containers (3) to be closed, in particular by springing up the retaining bars (33).

11. Filling unit according to one of the preceding claims, characterized in that the holding device (17) is a holding unit (34) for fixing the filling unit (10) and / or the container closure unit (25) and / or the manipulator interface (20).

12. Filling unit according to one of the preceding claims, characterized in that the filling unit (10) is movable relative to the container (3) via the manipulator interface (20), and / or that the container closure unit (25) is movable relative to the container (3) via the manipulator interface (20), and / or that the filling unit (10) and / or the container closure unit (25) and / or the manipulator interface (20) can be detached from the holding unit (34) by means of the manipulator (21).

13. Use of a filling unit (1 ) according to one of claims 1 to 12 for aseptic filling of a medium (2), in particular a drug, into at least one container (3) and for sealing the same.

14. Filling device for, in particular aseptic, filling a medium (2) into a filling unit (1) for, in particular aseptic, filling a medium (2) into a filling unit (1) with a storage (38) and / or a storage holder (45) for the medium (2) to be filled outside the filling unit (1) and with a conveying device (44) for conveying the medium (2) to be filled into the filling unit (1), preferably that the filling unit (1) is designed according to one of the preceding claims.

15. Method for filling, in particular aseptically, a medium (2), in particular a drug, into a container (3) of a filling unit (1), in particular according to one of claims 1 to 12, wherein the filling unit (1) comprises at least one container (3), a container closure (4) and a casing (5), wherein a storage container (38) containing the medium (2) to be filled is connected to the filling unit (1), in particular to a connection (11) of the filling unit (1), and the medium (2) is introduced into the casing (5) and the medium (2) is filled into the interior (6) of the at least one container (3) by means of the filling unit (10).

Images