Functional module and method for moving to a batching station located in a containment processing area

Abstract

The designed functional module (2) is intended to be moved to the batching station (3) located in the processing area (93) of the containment (9), and sterile liquid is injected into the container there. The containment (9) is provided in the installation area (8) for positioning purposes, wherein the containment (9) and the processing area (93) are surrounded by the housing (90). The functional module (2) includes an element carrier (23), functional elements (230) for mounting on the element carrier (23), and a medium pipeline (231) connected to the functional elements (230). The assembled assembly composed of the element carrier (23), the functional elements (230) accommodated by the element carrier, and the medium pipeline (231) connected to the functional elements can be moved from the retracted initial position to the extended working position on the batching station (3) through the transfer port (260) leading to the processing area (93). The functional module (2) is used for aseptically filling liquid medicine or venom into a plurality of containers, and these containers are combined in a reservoir. In the second embodiment, the functional module (2) has an airtight container (28) with a sterilized inner chamber (29), in which an assembled and sterilized assembly is arranged, and the assembly includes an element carrier (23), functional elements (230) accommodated by the element carrier, and a medium pipeline (231) connected to the functional elements. Finally, a method for moving the functional module (2) to the batching station (3) located in the processing area (93) is proposed.

Description

Technical Field

[0001] The present invention relates to a functional module for moving to a batching station in a containment processing area and aseptically injecting a liquid into a container there. The containment is provided in an installation area for positioning purposes, where the containment and the processing area are surrounded by a housing. The functional module includes an element carrier, functional elements for mounting on the element carrier, and a media line connected to the functional elements. Furthermore, the object of the present invention is to provide a method for moving the designed functional module to the batching station. Background Art

[0002] Up to now, the functional module assembly of a filling machine batching station for aseptically filling a liquid into a container, especially a medicine bottle, must first enter the containment processing area through a rapid transfer port (RTP). Then the assembly is assembled in the processing area, so it is necessary to perform manual intervention in the processing area. This workflow is time-consuming, has risks of incorrect operation and introduction of impurities, and is also expensive in terms of equipment technology. Summary of the Invention

[0003] In view of the hitherto imperfect solutions in this field outlined in the above background art, the task of the present invention is to at least reduce the manual activities in the processing chamber, thereby making the workflow more time-efficient, less error-prone, of higher quality, and with less equipment. In particular, the risk of contamination caused by manual activities in the processing area must be eliminated. For this purpose, a special device must be developed and a method for using the device must be proposed.

[0004] The designed functional module is intended to be moved to a batching station located in a containment processing area and aseptically inject a liquid into a container there. The containment is provided in an installation area for positioning purposes, where the containment and the processing area are surrounded by a housing. The functional module includes an element carrier, functional elements for mounting on the element carrier, and a media line connected to the functional elements. The assembled assembly (composed of the element carrier, the functional elements accommodated by the element carrier, and the media line connected to the functional elements) can be moved from a retracted initial position to an extended working position on the batching station through a transfer port leading to the processing area.

[0005] The following details the particularly advantageous details of the functional module: The functional module is used for aseptically filling a liquid medicine or venom into a plurality of containers, and these containers are combined in a reservoir. When processing oxygen-sensitive liquids, a protective gas such as nitrogen must be superimposed. The containment housing has a rear wall assembly surrounding the processing area. The transfer port is formed by an opening in a flange adapter upper molding mounted on the rear wall.

[0006] In the first version of the functional module, the component carrier particularly has a front piece fixed at the very front and an end piece fixed at the rear. The front piece stops at the retracted initial position located at the transfer port. On the other hand, the end piece is designed to strike the transfer port when reaching the extended working position and to allow the media pipelines of the functional module to pass through. The functional module installed at the transfer port extends into the transfer unit adjacent to the processing area when it is in the retracted initial position. The transfer port forms the interface between the processing area and the transfer unit. On the outer wall of the containment shell that surrounds the transfer unit towards the installation area, there are the following:

[0007] a) A transfer connector, preferably designed as a rapid transfer port (RTP), for the protected introduction of pre-sterilized functional elements and media pipelines into the transfer unit; and

[0008] b) Glove ports, usually configured in pairs, for maintaining a sterile atmosphere for activities in the transfer unit, especially assembly work, i.e., equipping the component carrier with functional elements and media pipelines connected to the functional elements.

[0009] The second version of the functional module particularly includes:

[0010] a) An airtight container with a sterilized inner chamber; and

[0011] b) An assembled and sterilized assembly in the container, which includes a component carrier, functional elements accommodated by the component carrier, and media pipelines connected to the functional elements (these media pipelines lead to one or several external connectors), and a front piece firmly arranged at the very front of the component carrier.

[0012] In the retracted initial position, the assembly is inside the container, and the front piece closes the container passage in an airtight manner. To reach the working position, the assembly can first be removed from the container through the front piece and enter the dosing station in the processing area via the transfer port.

[0013] On the functional module, there are:

[0014] a) One or several connectors outside the container, which are connected to the media pipelines from inside the container, and the connector is used to connect at least one supply pipeline; and

[0015] b) An actuator located outside the container for moving the assembly, which includes a component carrier with a front piece, functional elements accommodated by the component carrier, and media pipelines connected to the functional elements.

[0016] The functional module is installed at the transfer port, so that it extends into the transfer unit adjacent to the processing area and can extend to the installation area, or the functional module can be freely extended as a whole to the installation area. One or several external connectors and actuators for moving components (including element carriers with front pieces, functional elements accommodated by the element carriers, and media pipelines connected to the functional elements) can be accessed from the installation area. The transfer unit can be open towards the installation area, for example, based on an opening in the outer wall.

[0017] When using the first version of the functional module, the following basic method steps should be carried out specifically:

[0018] a) Outside the processing area, provide an element carrier equipped with a functional element and a media pipeline connected to the functional element; and

[0019] b) Move the assembled component (including the element carrier, the functional element accommodated by the element carrier, and the media pipeline connected to the functional element) in a decontaminated or sterilized state from the retracted initial position through the sealed transfer port to the extended working position on the batching station. The transfer port is provided on the housing wall surrounding the processing area.

[0020] The following particularly advantageous details of the method for using the first version of the functional module are given: In the sealable transfer unit adjacent to the processing area and facing the installation area, the element carrier with the functional element and the media pipeline is provided and assembled under sterile conditions. When the element carrier partially extends into the processing area, the front piece firmly connected to the front end of the element carrier opens the transfer port between the processing area and the transfer unit. In this position, the processing area, the transfer unit, and the element carrier are decontaminated by preferably introducing a decontaminant from the processing area side and simultaneously from the transfer unit side. Subsequently, under the condition of maintaining sterility, the pre-sterilized functional element and the media pipeline are introduced into the transfer unit through the transfer joint. Finally, using the glove port, while maintaining the sterile atmosphere of the transfer unit, the element carrier is equipped with the functional element and connected to the media pipeline.

[0021] In the initial position, the assembled component (including the element carrier, the functional element accommodated by the element carrier, and the media pipeline connected to the functional element) is located in the transfer unit, and the front piece installed at the frontmost part of the element carrier is at the transfer port. To reach the working position, the assembled component is guided or supported in a trolley manner and moved out of the transfer unit to the batching station until the end piece at the rear of the element carrier touches the transfer port. The component is moved out to the working position by pushing the component out of the transfer unit or pulling it out of the processing area, for example, by means of a robot installed in the processing area.

[0022] When using the second version of the functional module, the following basic method steps should be carried out specifically:

[0023] a) Provision of the functional module, including:

[0024] aa) An airtight container with a sterilized inner chamber; and

[0025] ab) A component assembled and sterilized in the container, the component including an element carrier with a front piece, a functional element accommodated by the element carrier, and a media line connected to the functional element, the media line leading to a common external connection or respective connections, wherein the component is retracted in an initial position within the container, the front piece closing the container passage in an airtight manner, and for reaching the working position, the component is first guided in a sliding manner through the front piece, removed from the container and extended to the dosing station;

[0026] b) Sealingly mounting the functional module in the initial position of the transfer port with the outer surface of the front piece facing the processing area;

[0027] c) Simultaneously purifying the processing area and the front piece;

[0028] d) Pushing the component to the dosing station to reach the working position; finally

[0029] e) Connecting the supply line to one or more external connections, wherein

[0030] f) The method step e) can be optionally carried out between the method steps c) and d) or between the method steps b) and c).

[0031] The following gives method details that are particularly advantageous when using the second version of the functional module: The functional module is mounted in the transfer port in such a way that

[0032] a) The functional module extends into a transfer unit adjacent to the processing area and can be extended to the installation area, or the functional module can be freely extended as a whole to the entire installation area; and

[0033] b) One or more external connections and an actuator for moving the component (the component including an element carrier with a front piece, a functional element accommodated by the element carrier, and a media line connected to the functional element) can be accessed from the installation area and / or from the transfer unit. Description of the Drawings

[0034] It shows:

[0035] Figure 1A - A perspective view of the containment, in which the processing area and the first version of the functional module moved to the working position within the processing area are visible;

[0036] Figure 1B - According to Figure 1A A transparent side view of the structure;

[0037] Figure 2A - Figure 1A A perspective exploded view of the functional module;

[0038] Figure 2B - Figure 2A An alternative perspective exploded view of;

[0039] Figure 3A - Figure 1A Perspective view of an unassembled functional module moved to the working position in the processing area;

[0040] Figure 3B - Figure 3A Alternative perspective view;

[0041] Figure 4A - Figure 3B (Functional element inserted into the functional module) Perspective view;

[0042] Figure 4B - Figure 4A Alternative perspective view;

[0043] Figure 5 - Figure 4A (Functional element inserted into the functional module and media pipelines connected) Perspective view;

[0044] Figure 6 - Figure 1A Transparent side view of the containment (with the second version of the functional module installed in the transfer unit, the assembly consisting of an element carrier, functional elements, and media pipelines, in the initial retracted position, placed in a container);

[0045] Figure 7A - Figure 6 Perspective view of the functional module (in the initial retracted position);

[0046] Figure 7B - Figure 7A (In the extended working position) Perspective view;

[0047] Figure 7C - Figure 6 Perspective exploded view of the functional module;

[0048] Figure 8A - Figure 6 Transparent view of the enlarged part of the functional module;

[0049] Figure 8B - According to Figure 8A , view of the functional module in the removed working position; and

[0050] Figure 8C - Figure 8B View of the enlarged detail X1 in Detailed implementation mode

[0051] Referring to the attached drawings, the following is a detailed description of the functional module in two different versions according to the present invention, its assembly process, and the method of establishing the operation preparation and applying the functional module.

[0052] The following provisions apply throughout the further description: If reference numerals are included in the figures for clarity of the drawing but are not explained in the directly relevant description text, reference is made to the relevant discussions in the foregoing or subsequent figure descriptions.

[0053] Figure 1A and 1B

[0054] To explain the partitioning of the internal space, the existing walls and equipment, the containment 9 enclosed by the housing 90 (standing in the installation area 8 in the form of an isolator here) shows its basic structure. A transparent pane 911 is usually arranged in the front wall 910, and the exchange unit 95 is inserted into the rear wall 912. The housing 90 also includes an upper top surface 91, a lower bottom surface 92, a rear outer wall 900 equipped with a transfer connection 903, and first and second side surfaces 916, 918, which, together with the front and rear walls 910, 912, separate the containment 9 from the outside world. The first side surface 916 has an inlet side channel 917, while the second side surface 918 has an outlet side channel 919. From the lower part of the front wall 910 below the pane 911, a projection 913 extends to the installation area 8 and the inclined, downward intermediate floor 914 to the lowermost area of the rear wall 912. In addition, a horizontal space partition 915 extends from the upper part of the front wall 910 to the rear wall 912 and thus extends horizontally to the upper unit wall 901 and the lower unit wall 902 to the rear outer wall 900 accordingly.

[0055] The front area 94 and the rear area 99 are thus formed by the housing 90 and the existing walls. The front area 94 is configured as a roof area 98 partitioned above the partition 915, a floor area 97 below the intermediate floor 914, and a processing area 93 located between the roof area 98 and the floor area 97. A transfer unit 96 is formed between the upper unit wall 901 and the lower unit wall 902 in the rear area 99. The transfer connection 903 in the rear outer wall 900 is advantageously designed as a rapid transfer port (RTP) for the protected introduction of pre-sterilized components into the transfer unit 96. In addition, glove ports 905 are provided in the outer wall 900, usually configured in pairs, for activities in the transfer unit 96 while maintaining a sterile atmosphere.

[0056] The equipment of the containment 9 includes a batching station 3 arranged in the processing area 93, and the functional module 2 - this is the first version - is moved from the transfer unit 96 to the working position through the transfer port 260. The first version of the functional module 2 is Figure 1A to Figure 5The subject matter, after its detailed description, the actual assembly procedure and application of the device are explained. The flange joint 20 installed in the groove of the switching unit 95 has a transmission port 260. The functional module 2 is installed on the flange joint 20 in a fixed but extendable manner. The basic component of the functional module 2 is the component carrier 23. To move to the dosing station 3, the robot 1 has a manipulation element 12 guided by its pivotable arm 11, for example in the form of a gripper. The robot 1 can advantageously be anchored with its feet 10 on the rear wall 912 below the switching unit 95.

[0057] Figure 2A and 2B

[0058] The basic components of the functional module 2 are described by this set of figures. These include:

[0059] a) The flange joint 20, which consists of a first seal 21, a second seal 2T with a smaller diameter, a third seal 27, a cover ring 22 and a molded part 26 with a transmission port 260;

[0060] b) The front piece 24 and the handle 240 fixed thereto;

[0061] c) The end piece 25 and the handle 250 fixed thereto; and

[0062] d) The component carrier 23, which is used to mount the functional element 230.

[0063] Figure 3A and 3B

[0064] For the sake of clarity only, this is not the case during the actual assembly process. This set of figures shows the assembled functional module 2 that has not yet been equipped with the functional element 230 and the media line 231 has not yet been connected, which has been moved out of the transmission port 260 into the dosing station 3 in the processing area 93. In the shown working position, the front piece 24 fixed on the component carrier 23 moves forward in the processing area 93, and the end piece 25 fills the transmission port 260, sealing it at least partially. The cover ring 22 of the flange joint 20 installed in the switching unit 95 abuts against the switching unit 95 from the side of the processing area 93.

[0065] Figure 4A and 4B

[0066] Again in the working position, for the sake of clarity and still not in line with the actual assembly process, it is now visible that the assembled functional module 2 has been equipped with the functional element 230, but the media line 231 has still not been connected.

[0067] Figure 5

[0068] When the functional module 2 equipped with the functional component 230 is assembled, the medium pipeline 231 is now also connected to the functional element, that is, directly connected to the opening of the functional component 230 in each case. The functional module 2 is in the actual working position (as in practice), that is, moved out of the transfer port 260 and forward into the dosing station 3 in the processing area 93, and the end piece 25 stands in the transfer port 260, at least sealing the transfer port partially.

[0069] Assembly process and application of the first version of the functional module

[0070] The preparation work and the start of production are carried out in the following steps:

[0071] 1. The unassembled component carrier 23, that is, the functional element 230 has not been inserted and the medium pipeline 231 has not been connected yet, is moved from the retracted initial position to the intermediate position, where the partially open transfer port 260 allows gas to pass between the processing area 93 and the transfer unit 96.

[0072] 2. During the intermediate position, the processing area 93 is decontaminated, and this decontamination extends to the transfer unit 96 through the partially open transfer port 260, so that the component carrier 23 can be thoroughly cleaned.

[0073] 3. After the decontamination of the processing area 93, the component carrier 23 and the transfer unit 96, the pre-sterilized functional element 230 and the medium pipeline 231 are introduced into the transfer unit 96 while maintaining the clean area state. The safe introduction of the pre-sterilized components into the transfer unit 96 is achieved through the transfer joint 903.

[0074] 4. The component carrier 23 returns to the retracted initial position, that is, it is located in the transfer unit 96. Now, the assembly of the component carrier 23 and the functional element 230, and the connection of the medium pipeline 231 to the functional element 230 are carried out. This assembly work is performed by the operator, and the aseptic atmosphere in the transfer unit 96 is maintained through the glove port 905.

[0075] 5. After processing and assembly, the fully assembled component carrier 23 can now be pushed forward out of the transfer unit 96 and into the processing area 93 until the dosing station 3.

[0076] 6. Advantageously, the actuating element 12 of the robot 1 transports the container to be filled (especially filled with a liquid medicine), preferably a top-open vial, to the dosing station 3.

[0077] 7. During the filling process, the liquid is supplied through the medium pipeline 231 immersed in the container and the cannula-shaped functional element 230.

[0078] Assembly process and application of the second version of the functional module

[0079] Figure 6

[0080] Compared with Group Figure 1A +1B, the internal space division, existing walls and equipment of the containment 9 shown are basically unchanged in principle, so they can be referred to. However, the second version of the functional module 2 is now used, which is processed by group Figure 6 to 8C In addition, instead of the transfer joint 903 installed in the rear outer wall 900, the transfer unit 96 can now be accessed through a simple wall opening 904, or at least the wall part along the transfer unit 96 is completely open.

[0081] Different from the first version, according to the second version of the functional module 2 - currently in the retracted initial position - is not permanently installed on the flange joint 20, but is pushed through the wall opening 904 and then docks with the flange joint 20 through its open transfer port 260. The functional module 2 has a container 28 sealed from the outside world. In the sterile inner chamber 29 of this container, the pre-sterilized and fully assembled component carrier 23 is accommodated in the retracted initial position. A channel 280 (which is quasi-automatically closed in the initial position) is provided in the container 28, and the assembled component carrier 23 can be moved out through this channel to the extended working position.

[0082] Figure 7A to 7C

[0083] The basic components of the second version of the functional module 2 are described in this group of figures. They include:

[0084] a) An airtight container 28, which has external assembly elements 282, a sterile inner chamber 29 and a closable channel 280 surrounded by a front window 281;

[0085] b) A component carrier 23 and functional elements 230 inserted therein, a front piece 24 and a rear piece 25, and a medium pipeline 231 (not visible here) (see Figure 8A - 8C );

[0086] c) A cover 285 for closing the rear part of the container 28; and

[0087] d) A feed component 286, for example, designed as a spindle, and an actuator 287, which is in the form of a rotary wheel here.

[0088] Figure 8A

[0089] In the retracted initial position, the component carrier 23 with the functional element 230 is located in the container 28 and thus not at the dosing station 3. The front piece 24 closes the channel 280 in an airtight manner. The excess length of the medium line 231 connected to the functional element 230 lies in the inner chamber 29 of the container 28 and leads to the connection piece 232. As an example of the structure of the medium line 231, the medium line 231 leading from the connection piece 232 can advantageously be branched and distributed to the individual functional elements 230. However, it is preferred that each functional element 230 is equipped with an independent medium line 231 with an excess length, which can extend to the respective connection piece 232.

[0090] Before starting production, i.e., when the functional module 2 is still in the retracted initial position, it is necessary to purify the processing area 93 and at the same time purify the outer surface of the front piece 24, which currently seals the inner chamber 29 in an airtight manner.

[0091] Figure 8B and 8C

[0092] When the actuator 287 is actuated, the feed component 286 is driven, causing the front piece 24 to successively move away from the channel 280. At the same time, the component carrier 23 together with its equipment is removed from the container 28 and into the processing area 93 until the extended working position of the dosing station 3. In the front area inside the container 28, the end piece 25 produces an impact. When the component carrier 23 is extended, the excess length of the previously existing medium line 231 is stretched. During production, the liquid to be processed located at the dosing station 3 is supplied from the outside to the connection piece 232, conveyed through the medium line 231, and thereby enters the functional element 230.

[0093] When using the first version ( Figure 1A - 5 ) and the second version ( Figure 6 - 8C ) of the functional module 2, it is preferred to transport the container to be filled, such as a reservoir containing four vials, to the dosing station 3 by means of the actuating element 12 of the robot 1. The vials are filled, for example with a medicinal solution, by means of the functional element 230 held by the component carrier 23, which is also located at the dosing station 3 at this time. During filling, the cannula-shaped functional element 230 is immersed in the top-open vials. When processing oxygen-sensitive liquids, a protective gas (such as nitrogen) must be superimposed for filling.

Claims

1. A containment (9) which is provided in an installation area (8) for positioning purposes and has: a) a housing (90) surrounding a processing area (93); b) a batching station (3) provided in the processing area (93) for aseptically injecting liquid into containers; c) a transfer port (260) leading to the processing area (93); and d) a functional module (2) with an element carrier (23) that can be moved to the batching station (3), the element carrier (23) being equipped with functional elements (230) and media pipelines (231) connected to the functional elements, characterized in that: The functional module (2), having the element carrier (23), the functional elements (230) accommodated by the element carrier, and the media pipelines (231) connected to the functional elements can be moved from outside the processing area (93) to the working position of the batching station (3) through the transfer port (260).

2. The containment (9) according to claim 1, characterized in that: a) The functional module (2) is used for aseptically filling liquid medicine or venom into a plurality of containers, and these containers are combined in a reservoir; and b) When processing oxygen-sensitive liquids, a protective gas must be superimposed.

3. The containment (9) according to claim 1, characterized in that: a) The housing (90) of the containment (9) has a rear wall (912) surrounding the processing area (93); and b) The transfer port (260) is formed by an opening in a membrane member (26) mounted on a flange joint (20) of the rear wall (912).

4. The containment (9) according to any one of claims 1 to 3, characterized in that: a) The element carrier (23) has a front piece (24) fixedly provided at the foremost part and an end piece (25) fixedly provided at the rear part; wherein: b) The front piece (24) stays in the initial position in the transfer port (260); and c) The end piece (25) is used to impact the transfer port (260) when reaching the working position and form a channel for accessing the media pipelines (231) of the functional module (2).

5. The containment (9) according to any one of claims 1 to 3, characterized in that: a) The functional module (2) mounted on the transfer port (260) extends into a transfer unit (96) adjacent to the processing area (93) in the initial position; and b) The transfer port (260) forms an interface between the processing area (93) and the transfer unit (96).

6. The containment vessel (9) according to claim 5, characterized in that: In the outer wall (900) of the housing (90) belonging to the containment (9) and surrounding the transfer unit (96) facing the installation area (8), there is: a) a transfer joint (903) for protected introduction of the pre-sterilized functional elements (230) and media pipelines (231) into the transfer unit (96); and b) A glove port (905) for operating while maintaining a sterile atmosphere in the transfer unit (96), i.e., equipping the element carrier (23) with the functional element (230) and the media line (231) connected to this functional element.

7. The containment vessel (9) according to claim 6, characterized in that: The transfer connector (903) is designed as a quick transfer port.

8. The enclosure (9) according to any one of claims 1 to 3, characterized in that: a) The functional module (2) has: aa) An airtight container (28) with a sterilized inner chamber (29); and ab) An assembled and sterilized assembly in the container (28), which includes the element carrier (23), the functional element (230) accommodated by this element carrier, the media line (231) connected to this functional element and leading to one or more external connectors (232), and a front piece (24) fixed to the foremost part of the element carrier (23); where: b) The assembly is retracted to the initial position inside the container (28), and the front piece (24) hermetically seals the passage (280) on the container (28); and c) To reach the working position, the assembly can first be moved out of the container (28) through the front piece (24) and enter the dosing station (3) in the processing area (93) through the transfer port (260).

9. The containment vessel (9) according to claim 8, characterized in that: It has: a) One or more of the connectors (232) outside the container (28), which are connected to the media line (231) from inside the container (28), and one or more of the connectors (232) are intended to connect at least one supply line; and b) An actuator (287) outside the container (28) for moving the assembly, which includes the element carrier (23) with the front piece (24), the functional element (230) accommodated by the element carrier (23), and the media line (231) connected to this functional element.

10. The enclosure (9) according to claim 8, characterized in that: a) The functional module (2) is installed in the transfer port (260) in such a way that the functional module (2) extends into the transfer unit (96) adjacent to the processing area (93) and can extend to the installation area (8), or the functional module (2) can extend completely freely into the installation area (8) as a whole; and b) One or more of the external connectors (232) and the actuator (287) for moving the assembly are accessible from the installation area (8), and the assembly includes the element carrier (23) with the front piece (24), the functional element (230) accommodated by this element carrier, and the media line (231) connected to this functional element; where c) The transfer unit (96) can be opened to the installation area (8).

11. A method for operating a containment (9) as claimed in any one of claims 1 to 7, characterized in that The order of method steps: a) Outside the processing area (93), provide the element carrier (23) equipped with the functional element (230) and the media line (231) connected to this functional element; and b) An assembled component in a decontaminated or sterilized state, including the element carrier (23), the functional element (230) accommodated in the element carrier, and the medium pipeline (231) connected to the functional element, is moved from the initial position to the extended working position of the batching station (3) through a sealed transfer port (260) provided on the rear wall (912) surrounding the processing area (93).

12. The method according to claim 11, characterized in that: The provision and assembly of the element carrier (23) having the functional element (230) and the medium pipeline (231) are carried out under sterile conditions in an airtight transfer unit (96) adjacent to the processing area (93) and facing the installation area (8).

13. The method according to claim 11, wherein: a) When the element carrier (23) partially extends into the processing area (93), the front piece (24) firmly mounted at the foremost part of the element carrier (23) opens the transfer port (260) between the processing area (93) and the transfer unit (96), and the processing area (93), the transfer unit (96), and the element carrier (23) are purified by introducing a decontaminant; then b) The pre-sterilized functional element (230) and the medium pipeline (231) are introduced into the transfer unit (96) under sterile conditions through a transfer joint (903); finally c) Under the condition of maintaining a sterile atmosphere in the transfer unit (96), the element carrier (23) is fitted with the functional element (230) and the medium pipeline (231) connected to the functional element by using a glove port (905).

14. The method according to claim 13, characterized in that: The processing area (93), the transfer unit (96), and the element carrier (23) are purified by introducing a decontaminant simultaneously from one side of the processing area (93) and one side of the transfer unit (96).

15. The method according to claim 11, wherein: a) In the initial position, an assembled component including the element carrier (23), the functional element (230) accommodated in the element carrier, and the medium pipeline (231) connected to the functional element is in the transfer unit (96), and the front piece (24) at the foremost part of the element carrier (23) is located in the transfer port (260); at this time b) To reach the working position, the assembled component is moved out of the transfer unit (96) to the batching station (3).

16. The method according to claim 11, wherein: a) To reach the working position, an assembled component including the element carrier (23) with a front piece (24), the functional element (230) accommodated in the element carrier (23), and the medium pipeline (231) connected to the functional element is guided or supported in a trolley manner and moved out of the transfer unit (96) until the end piece (25) located at the rear of the element carrier (23) hits the transfer port (260); wherein b) The component is extended to the working position by pushing the component out from one side of the transfer unit (96) or pulling it out from one side of the processing area (93).

17. A method for operating a containment (9) as claimed in any one of claims 1 to 3 and 7 to 10, characterized in that Order of method steps: a) Provide the functional module (2), comprising: aa) An airtight container (28) having a sterilized inner chamber (29); and ab) An assembled and sterilized component in the container (28), which includes the element carrier (23) having a front piece (24), the functional element (230) received by the element carrier (23), and the medium pipeline (231) connected to the functional element, the medium pipeline leading to a common external connection (232) or respective corresponding connections (232), wherein: ac) The component retracts to an initial position within the container (28), so that the front piece (24) hermetically seals the passage (280) on the container (28); and ad) To reach the working position, the component is first guided in a trolley manner through the front piece (24), removed from the container (28) and extended to the dosing station (3); b) Mount the functional module (2) at an initial position sealed at the transfer port (260), with the outer surface of the front piece (24) facing the processing area (93); c) Purify the processing area (93) while purifying the outer surface of the front piece (24); d) Advance the component to the dosing station (3) to reach the working position; finally e) Connect the supply pipeline to one or more external connections (232), wherein f) Method step e) may alternatively occur between method steps c) and d) or between method steps b) and c).

18. The method according to claim 17, characterized in that: a) The functional module (2) is mounted on the transfer port (260) such that the functional module (2) extends into the transfer unit (96) adjacent to the processing area (93) and can extend to the installation area (8) or the functional module (2) can extend entirely freely into the installation area (8); and b) The one or more external connections (232) and the actuator (287) for moving the component are accessible from the installation area (8) and / or the transfer unit (96), the component including the element carrier (23) having the front piece (24), the functional element (230) received by the element carrier, and the medium pipeline (231) connected to the functional element.

Images