METHOD FOR INTRODUCING ARTICLES FROM A CONTAINER INTO THE PROCESS CHAMBER OF A CONTAINMENT UNDER ASEPTIC CONDITIONS AND AIRLOCK ARRANGEMENT FOR THIS PUMP

Description

Field of application of the invention

[0001] The present invention relates to a method and a lock arrangement positioned in an installation space for the aseptic introduction of articles from serially fed containers into a process chamber of a containment enclosed by a housing. An entry station is located upstream of the process chamber. An individual container comprises a receptacle with an aseptic interior and an opening closed by a cover. The articles stored in the interior are to be treated in the process chamber after the cover is opened. The containers of the containers are in the form of trough-shaped tubs, and the articles are, for example, pharmaceutical phials, vials, or syringes, which are inserted into systematically arranged trough-shaped receiving contours of nests. State of the art

[0002] WO 2020 / 016 645 A2 discloses an arrangement for the contamination-free introduction of a sterile object from a container sealed with a semipermeable cover into a working chamber of a containment surrounded by a wall. The arrangement comprises a gate unit with an access flange arranged in the wall, which forms a passage from the outside into the working chamber, and a door that tightly closes the passage and can be moved into the open position into the working chamber. The arrangement also includes a container receptacle with a catch for holding a container inserted into the container receptacle, an opening for inserting the container into the catch, and a flange for interacting with the access flange.

[0003] A decontamination unit is designed to decontaminate an outer surface of the cover facing the door when the door is closed, the container holder is docked to the access flange, and the container is stored in the container holder. In the closed position, the door is sealed to the access flange from the working chamber side, and the access flange defines a gap located in the passageway. The cover of the container placed in the container holder is sealed between the flange and the access flange when the container holder is pivoted toward the access flange. The decontamination unit is installed directly on the door or to the side of the gate unit, which has the door and access flange, with its direction of action facing into the passageway. The decontamination unit is designed as a radiation source, e.g. UVC, UV, E-beam or pulsed light, or as a gassing device, e.g. for nebulizing an H 2 O 2 solution. Object of the invention

[0004] Given the limited productivity of existing devices and methods according to the prior art, the object of the invention is to propose a more efficient method for transferring articles from a container into the process chamber of a containment under aseptic conditions, as well as a suitable lock arrangement for this purpose. Key factors here are the highest possible degree of automation, the extensive avoidance of manual intervention, and ensuring high purity requirements. Furthermore, it is important to ensure that only those articles that are to be processed are transferred into the process chamber, while minimizing the time and equipment required for decontamination. Overview of the invention

[0005] The method according to the invention and the airlock arrangement according to the invention are designed for the aseptic introduction of articles from serially fed containers into a process chamber of a containment system enclosed by a housing, using an airlock arrangement positioned in an installation space. An entry station is located upstream of the process chamber. A single container comprises a container with an aseptic interior and an opening sealed with a cover. The articles stored in the interior are to be treated in the process chamber after the cover is opened.

[0006] In the production mode of the lock arrangement, the following process steps are carried out: For transferring the articles from the containers into the process chamber, at least two passages leading from the entry station into the process chamber are provided, and each of the passages is closed on the one hand by a lid brought into the process chamber and / or on the other hand by a container brought into the entry station with its cover facing the passage; when the container is brought to the passage, the surface of the cover facing the passage, including its surroundings, is decontaminated by means of a decontamination device; after decontaminating the surface of the cover facing the passage, including its surroundings, the cover is opened in order to transfer the articles from the container through its passage into the process chamber;and after emptying the container, the lid is first brought back to the relevant passage and then the container, emptied of articles, is removed from the passage; the lid is used alternately at the passages.

[0007] Special embodiments of the method according to the invention or of the lock arrangement are defined below: The decontamination device is integrated in the lid or arranged outside the lid, wherein the emission element of the decontamination device is located directly in the lid or outside the lid in a receptacle.

[0008] The enclosed environment includes the gas volume present therein and surfaces surrounded by the gas volume, namely surfaces: the lid; the optional holder; an optional seal; and optionally exposed wall surfaces.

[0009] The process chamber is equipped with a manipulator or additionally with a second manipulator, on whose pivoting arms a tool head equipped with tools is located, whereby: the tools are designed to open the cover and then to transfer the articles from the container through the exposed passage into the process chamber; and one manipulator with its tools is used alternately at the passages to open the cover and transfer the articles into the process chamber; or one manipulator and the second manipulator are each used only at one of the passages or the two manipulators are used alternately at the passages.

[0010] A cutting tool is a component of the tooling used to cut open the cover for opening. Preferably, at least a portion of the cover and the wrapper are made of a semipermeable nonwoven fabric, such as Tyvek®. The cover maintains a sterile condition inside the container before removal and is sealed, e.g., by gluing or welding, on a rim surrounding the container's opening.

[0011] The container contains a removable nest for accommodating a variety of articles, which is transferred to the process chamber along with the articles. After the nest is emptied of articles in the process chamber, this empty nest is removed from the process chamber into a nearby or the same empty container pressed against the relevant passage. Alternatively, the articles are transferred directly from the nest remaining in the container into the process chamber.

[0012] The decontamination device is preferably designed as a radiation source, e.g. UVC, UV, E-beam or pulsed light, or alternatively as a gassing device, e.g. for nebulizing an H 2 O 2 solution.

[0013] The entrance station, enclosed by a housing, has an access leading to an adjacent staging station, where: the input station is operated with a purified, rectified displacement flow, some of which exits through the access; at the supply station, the containers are delivered which, when delivered, are each surrounded by a wrapping in order to aseptically maintain the internal volume of the container and its contents; and at the supply station, an opening in the wrapping, which has been kept closed until now, is now opened on the side facing the displacement flow exiting the access in order to introduce the individual container into the input station; or at the supply station, the wrapping is cut open on the side facing the displacement flow exiting the access in order to introduce the individual container into the input station.

[0014] The container, which is initially still enclosed in the closed wrapping, is positioned on a support. A feed device is used to push the container out of the open wrapping, with a displacement flow flowing onto it. The wrapping is held by a gripper, preferably a suction cup.

[0015] The containers brought into the input station are conveyed to the passages by at least one conveyor system and removed again after processing. The at least one conveyor system is preferably based on the principle of magnetic levitation technology and allows conveyance on multiple tracks, even in opposite directions.

[0016] A first conveyor transports the containers within the entry station, while a second conveyor pivots the containers with their covers pressed against the respective passage. The second conveyor can also be used to remove processed containers from the respective passage. To position the containers at the respective passage, the second conveyor preferably includes a gimbal bearing.

[0017] The second funding facility consists of: an axle through which a first axis of rotation extends; two forks fixed side by side on the axle, each pivotable about a second axis of rotation extending perpendicular to the first axis of rotation; and a support suspended in the associated fork and pivotable about a third axis of rotation, wherein the first axis of rotation and the third axis of rotation extend parallel to one another and the supports are configured to grip the edges of the containers when pivoting towards or away from the passages.

[0018] Two adjacent cardanic bearings are each formed from a U-shaped support, which is connected in the third axis of rotation to a fork which is suspended in the second axis of rotation.

[0019] A seal is located in each passage, which, together with the cover of a temporarily pressed-on container and / or a temporarily pressed-on lid, creates a seal at the passages in the transition from the entry station to the process chamber. Instead of a conventional seal, a minimal gap can be provided or a labyrinth seal can be used. The lid is supported by a pivoting arm of a device positioned in the process chamber.

[0020] The at least one manipulator or the additional manipulator are preferably designed as a robot.

[0021] The containers are shaped like tubs. The items are, for example, vials, phials, or syringes, which are inserted into systematically arranged nests.

[0022] The essence of the inventions is based on independent method claim 1 and independent subject claim 18, respectively. Brief description of the attached drawings

[0023] They show: Figure 1A - a container with a closed wrapping to be processed with the method according to the invention in the associated lock arrangement; Figure 1B - the container according to Figure 1A without the casing in exploded view; Figure 2A - the second conveyor device as a component of the lock arrangement, consisting of the axle and two cardanic bearings fixed to it, in perspective view; Figure 2B - a cardanic bearing made of Figure 2A , in plan view;

[0024] Figures 3A to 15D : the entirety of a process run with four figures of the lock arrangement, namely its front section according to figures A, rear section according to figures B, in plan view according to figures C and as a basic side view according to figures D; Figures 3A to 3D - Process phase 1 (starting position) Figures 4A to 4D - Process phase 2 Figures 5A to 5D - Process phase 3 Figures 6A to 6D - Process phase 4 Figures 7A to 7D - Process phase 5 Figures 8A to 8D - Process phase 6 Figures 9A to 9D - Process phase 7 Figures 10A to 10D - Process phase 8 Figures 11A to 11D - Process phase 9 Figures 12A to 12D - Process phase 10 Figures 13A to 13D - Process phase 11 Figures 14A to 14D - Process phase 12 Figures 15A to 15D - Process phase 13 Figure 16A - an alternative arrangement with the decantation device outside the lid, sitting in a holder, container pressed against the passage by means of the raised second conveyor device, lid closed, Decantation device activated; and Figure 16B - the arrangement according to Figure 16A with the lid open and the decantation device inactive. Example

[0025] With reference to the accompanying drawings, the following is a detailed description of the inventive method and the inventive lock arrangement for transferring articles from a container into the process chamber of a containment under aseptic conditions. Like the accompanying drawings, the embodiment described below relates to the transfer of articles from containers into the process chamber through two passages leading from the entry station into the process chamber. Each of the passages can be alternately closed by a lid positioned within the process chamber, into which the emission element of a decontamination device can be integrated.

[0026] The following definition applies to the entire remainder of the description. If reference numbers are included in a figure for the purpose of graphic clarity, and it is clearly evident from the drawing that these are "recurring" components, but are not explained in the immediately corresponding description text, reference is made to their explanation in the preceding figure descriptions for the sake of brevity. Figures 1A and 1B

[0027] A single container 9 includes: a container 94 with an aseptic interior 940 and a passage 95, which has a cover 98 is locked; a 940 stored nest 96, in whose trough-shaped contours the articles 960 which after opening the cover 98 in the trial chamber 43 of containment 4 to be treated; optionally a between the cover98 and the nest 96, about the articles 960 inserted intermediate layer 97; as well as the entire container in the delivery state 9 surrounding, closed enclosure 99, the internal volume 90 keeps sterile.

[0028] The container 94 For example, a tub-shaped tub. The articles 960 are especially vials, phials or syringes. The cover 98 and the wrapping 99 preferably consist of at least a portion of a semi-permeable nonwoven fabric, such as Tyvek ®< . The cover 98 is typically on the passage 95 of the container 94 surrounding edge 941 sealed and thus preserves the interior 940 of the container 94 in sterile condition. Figures 2A and 2B

[0029] As part of the lock arrangement 1 are the front first zone 31and the rear second zone 32 the entrance station 3 each with a second conveyor 35 Such a conveyor system 35 consists of an axis 350 and two cardanic bearings fixed to it 351. Through the axis 350 a first axis of rotation extends D1. Two next to each other on the axle 350 fixed forks 352 are each rotated around a second axis D2 pivotable, which is perpendicular to the first axis of rotation D1 In each fork 352 is a third axis of rotation D3 pivoting carrier 353 suspended, with the first axis of rotation D1 and the third axis of rotation D3 run parallel to each other. The supports 353 are for gripping the edges 941 the containers 94 when swiveling towards or away from the entrance station 3into the trial chamber 43 leading passages 47,48 configured. Figures 3A to 3D Structure of the lock arrangement 1

[0030] The installation room A installed lock arrangement 1 is structured into an entrance station 3, one of these upstream staging stations 2 and which is located at the entrance station 3 subsequent containment 4 with its trial chamber 43. The staging station 2 has the edition 20, to create new, third containers 93 with initially sealed wrapping 99 to position. The feed means 22 serves to push out such third containers 93 from the opened wrapper 99 from the edition 20 through access 37 in the entrance station 3 surrounding housing 39 to the first funding institution 34in the front first zone 31 the entrance station 3. During the pushing out, the in the supply station 2 existing grippers 21 the wrapping 99 back to the first funding institution 34 the second funding facility closes 35 In the plenary session 36 the front first zone 31 the entrance station 3 are a supply air fan 360 and supply air filters 361 to generate a purified, downward laminar air flow LF arranged.

[0031] Between the front first zone 31 the entrance station 3 and the front first zone 41 the trial chamber 43 the partition wall extends 40, which is the first passage 47 between the zones 31,41 In the first passage 47 the seal sits 470.Also in the plenary session 46 the front first zone 41 of containment 4 sit a supply air fan 460 and an air supply filter 461 to generate a purified, downward laminar air flow LF. In the trial chamber 43 surrounding housing 49 There is an exhaust air filter on the side and / or alternatively in the bottom 431 and a waste opening in the floor 432 provided that a depot 433 leads.

[0032] In the front first zone 41 and the rear second zone 42 extending common trial chamber 43 is an apparatus 5 with the boom 50 and the lid held to it 51 stationed in which the decontamination device 7 is integrated. By swiveling the boom 50 the lid can 51via intermediate positions to the first passage 47 or the second passage 48 be introduced.

[0033] In the entrance station 3 lies behind the first zone 31 the rear second zone 32, and in containment 4 lies behind the first zone 41 the rear second zone 42. Equivalent to the first zone 31 is the second zone 32 also in their plenary session 36 with a supply air fan 360 and an air supply filter 361 to generate an air flow LF equipped. A first conveyor system is also available 34 and the subsequent second funding facility 35 Also equivalent to the first zone 41 has the second zone 42 the plenary session 46 with supply air fan 460 and supply air filter 461 to generate the air flow LF.

[0034] For smaller systems, a common supply air fan 360 and a common supply air filter 361 for the first zone 31 and the second zone 32 and a common supply air fan 460 and a common supply air filter 461 for the first zone 41 and the second zone 42 For larger systems, the zones 31,32 or 41,42 several supply air fans 360,460 or supply air filter 361,461 In the rear second zone 42 are also in the housing 49 side and / or alternatively in the bottom of the exhaust air filter 431 and in the ground which leads to a depot 433 leading waste opening 432 available.

[0035] Between the rear second zone 32 the entrance station 3 and the rear second zone 42 the trial chamber 43the partition wall extends again 40, which is now the second passage 48 between the zones 32,42 In this second passage 48 the seal sits 480. In the first and second zone 41,42 joint trial chamber 43 is a manipulator 6 with the boom 60 and the tool head attached to it 61 stationed. By swiveling the boom 60 the tool head can 61 via intermediate positions to the first passage 47 or the second passage 48 be introduced. Process phase 1 (start position)

[0036] In staging station 2: A new, third container 93, still with sealed packaging 99, is on the edition 20 delivered, is located in front of the entrance 37 and is influenced by the current flowing through it LF flowing in. In entrance station3, in their front first zone 31: A second container 92, already out of the wrapping 99 freed, is located on the first conveyor 34. From the first zone 31 is the first passage 47 virtually open. In entrance station 3, rear second zone 32: The second passage 48 into the trial chamber 43 of containment 4 is from the pressed first container 91 with its cover 98 sealed, but already decontaminated. In containment 4, front first zone 41: The first passage 47 into the trial chamber 43 is from the lid 51 with the integrated decontamination device 7 closed. The lid 51 was from the apparatus 5 with the swiveled boom 50 from the trial chamber 43In containment 4, rear second zone 42: With a tool that is attached to the tool head 61 a swiveled boom 60 of the trial chamber 43 stationed manipulator 6 is mounted, the cover 98 opened, e.g. cut open, and removed.

[0037] In the following description of the process in the further process phases 2 to 13 ( Figures 4A to 15D ), only the changes to the previous process phase are listed to avoid repetition. Process phase 2 (Figures 4A to 4D)

[0038] In entrance station 3, front first zone 31: The second container 92, without wrapping 99, still on the first conveyor 34 standing, is transported by the second conveyor 35 taken over. Process phase 3 (Figures 5A to 5D)

[0039] In staging station2: The previously sealed envelope 99 about the new, third container 93 is done using the tool 23 opened, e.g. cut open; the gripper holds 21 the wrapping 99. Alternatively, a previously attached to the casing 99 The cut that was initially clamped, for example, can now be released. In the entrance station 3, front first zone 31: From the second funding institution 35 the second container 92 to the second passage 48 which is now pressed on both sides by the second container 92 or attached lid 51 is locked. In containment 4, rear second zone 42: With a tool that is attached to the tool head 61 of the pivoting boom 60 of the manipulator 6 is installed, when the cover is open 98 the optional intermediate layer 97from the first container 91 taken. Process phase 4 (Figures 6A to 6D)

[0040] In staging station 2: The new, third container 93 is taken from the access side 37 open wrapping 99 from the moving feed means 22 gradually towards access 37 pushed out and thereby by the purified flow LF irradiated. This prevents the container from being flushed 93 with a lot of impure ambient air from the installation room A. From the gripper 21 the wrapping 99 In containment 4, front first zone 41: The decontamination device 7 is activated to prevent the air from entering the lid 51, cover 98 on first container 91, the first passage 47 surrounding seal 470 and possible exposed wall surfaces in the surrounding area 8to decontaminate the existing gas volume and all surfaces surrounded by it. In the containment 4, rear second zone 42: With a manipulator 6 The tool is brought in from the internal volume 90 from the container 94 of the first container 91 the nest 96, together with the items stored therein 960 or just the articles 960, into the trial chamber 43 transferred for further processing. Process phase 5 (Figures 7A to 7D)

[0041] In staging station 2 and entrance station 3, front first zone 31: The new, third container 93 is achieved by pushing movement of the feed means 22 from the wrapping 99 out, through access 37 in the housing 39 and against the purified flow LF, to the first funding institution 34 into the first zone 31the entrance station 3 pushed out. The pushing out of the third container 93 from the wrapping 99 happens directly on the first conveyor 34, to prevent contact between containers 93 and circulation 20 and thus prevent the transfer of contamination. The gripper 21 keeps the cover 99 for disposal. In containment 4, rear second zone 42: Into the container emptied in the previous process phase 94 a part from a previous or current production cycle is removed from the process chamber 43 originating nest 96 using the manipulator 6 into this container 94 returned. Process phase 6 (Figures 8A to 8D)

[0042] In staging station 2 and entrance station 3, front first zone 31: The new, third container 93is completely in the first zone 31 inserted and is fed by the first conveyor 34 worn. On the support 20 remain the gripper 21 Wrapping retained and intended for disposal 99 and the feed means moved back to its starting position 22. In containment 4, front first zone 41: The lid 51 integrated decontamination device 7 can be switched off; the treatment is complete. By swiveling the boom 50 the apparatus 5 the lid 51 from the first passage 47 At the same time, the tool head 61 of the manipulator 6 towards the first passage 47 moved. In containment 4, rear second zone 42: By swiveling the boom 50 the apparatus 5 the lid 51the second passage 48 approximated. Process phase 7 (Figures 9A to 9D)

[0043] In containment 4, front first zone 41: The lid 51 is from the first passage 47 removed and that of the manipulator 6 guided tool is the cover 98 of the second container 92 In containment 4, rear second zone 42 and entrance station 3, rear second zone 32: With further swiveling of the boom 50 the apparatus 5 the lid 51 with the integrated decontamination device 7 to the second passage 48. Then the second conveyor is swivelled 35 the container 94 of the first container processed 91 from the second passage 48 removed and onto the first conveyor 34for transport outside the lock arrangement 1 set up. Process phase 8 (Figures 10A to 10D)

[0044] In staging station 2: As in process phase 1 according to the starting position, a next new, third container 93, again with the wrapping still sealed 99 on the edition 20, before access 37, positioned. In containment 4, front first zone 41: With the tool head 61 of the manipulator 6 installed tool, the cover 98 of the second container 92, which at the first passage 47 is pressed down, e.g. opened by cutting and the resulting cutting waste removed, so that access to the passage 95 into the container 94 is created. In entrance station 3, rear second zone 32: A on the staging station 2 from the wrapping99 released, further first container 91 with intact cover 98 was placed across the first conveyor 34 and now also to the second funding institution 35 loaded. Process phase 9 (Figures 11A to 11D)

[0045] In staging station 2: As in process phase 3 according to Figure 5A is done using the tool 23 the previously sealed envelope 99 opened. In containment 4, front first zone 41: As in process phase 3 according to Figure 5B is connected to the manipulator 6 guided tool, with the cover open 98, the optional intermediate layer 97 from the second container 92, that at the first passage 47 is pressed down, removed. In the entrance station 3, rear second zone 32: By swiveling the second conveyor 35the further first, transversely transferred container 91 with the cover 98 to the second passage 48 pressed.

[0046] Thus, as already in process phase 3 according to Figure 5A , at the first passage 47 emerged, now at the second passage 48, one between lid 51, cover 98 of the second container 92, the second passage 48 surrounding seal 480 and possible exposed wall surfaces an environment 8 including the gas volume enclosed therein and to be decontaminated in the next process phase 10. Process phase 10 (Figures 12A to 12D)

[0047] In staging station 2: Here the situation of process phase 4 is repeated according to Figure 6A , but now with the next new, third container 93. In containment 4, front first zone 41:Here the situation of process phase 4 is repeated according to Figure 6B , but now with the second container 92, which is now at the first passage 47 is pressed. In entrance station 3, rear second zone 32, and containment 4, rear second zone 42: The previous process phase 9 according to Figure 11B educated environment 8 with enclosed gas volume is decontamination device activated 7 decontaminated. Process phase 11 (Figures 13A to 13D)

[0048] In staging station 2: Here the situation of process phase 5 is repeated according to Figure 7A , but now with the next new, third container 93. In containment 4, front first zone 41: Here the situation of process phase 5 is repeated according to Figure 7B , however, the container is now 94of the second container 92, which is now at the first passage 47 is pressed, an empty nest 96 from the trial chamber 43 returned. In the entrance station 3, rear second zone 32, and containment 4, rear second zone 42: Decontamination continues. Process phase 12 (Figures 14A to 14D)

[0049] In staging station 2: Here the situation of process phase 6 is repeated according to Figure 8A , but now with the next new, third container 93. In containment 4, front first zone 41: Here the situation of process phase 6 is repeated according to Figure 8B , but now with the second container 92 and at the first passage 47, which swings the boom 50 the apparatus 5 the lid 51 is approached. In entrance station 3,rear second zone 32, and containment 4, rear second zone 42: Decontamination in the surrounding area 8 at the second passage 48 with the first, transversely transferred container 91 is finished. The lid 51 with the decontamination device 7 have swung away and the manipulator 6 with the tool head 61 installed tools is connected to the second passage 48 swung closer. Process phase 13 (Figures 15A to 15D)

[0050] In entrance station 3, front first zone 31 and containment 4, front first zone 41 : First, the apparatus swings 5 the lid 51 to the first passage 47, closing it. The second conveyor is then swivelled 35 the container 94 of the processed second container 92with the returned nest 96 to the first funding institution 34 for transverse transport outside the lock arrangement 1 loaded. This prevents a collision with the next new, third container 93 which is already on the first conveyor 34 stands. In entrance station 3, rear second zone 32 and containment 4, rear second zone 42: Here the situation is repeated as in process phase 1 according to Figure 3B , with a tool on the manipulator 6 the cover 98 opened, but now the original across the first conveyor 34 transferred new first container 91. Figures 16A and 16B

[0051] In this alternative arrangement, the decontamination device 7 not, as before, in the lid 51integrated, but the emission element of the decontamination device 7, e.g. a nebulizing nozzle for introducing a H 2 O 2 aerosol, is not located in the lid 51, but outside in a holder 70. This bracket 70 can be achieved in the simplest form by bending the area between the entrance station 3 Containment 4 extending partition wall 40 be educated. The environment 8 facing surface of the holder 70 is then part of the enclosed gas volume and environment to be decontaminated in the production process 8. The lid remains unchanged 51 from a pivoting boom 50 one in the trial chamber 43 stationed equipment 5 worn.

Claims

1. Method for feeding articles (960) under aseptic conditions from serially supplied containers (9; 91, 92, 93) into a process chamber (43) of a containment (4) surrounded by a housing (49) by means of a sluice arrangement (1) positioned in an installation space (A), wherein: a) an input station (3) is positioned upstream of the process chamber (43); b) a single container (9; 91, 92, 93) comprises: ba) a receptacle (94) having an aseptic interior (940) and a passage (95) closed by a cover (98); and bb) the articles (960) stored in the interior (940), which are to be treated in the process chamber (43) after opening the cover (98), characterized by the successive method steps in the production mode of the sluice arrangement (1): c) at least two passages (47, 48) leading from the input station (3) into the process chamber (43) are provided for transferring the articles (960) from the containers (9; 91, 92, 93) into the process chamber (43), and each of the passages (47, 48) is closed on the one hand by a lid (51) brought up in the process chamber (43) and / or on the other hand by a container (9; 91, 92, 93) brought up in the input station (3) with its cover (98) facing the passage (47, 48); d) when the container (9; 91, 92, 93) is brought up to the passage (47, 48), the surface of the cover (98) facing the passage (47, 48) with enclosed environment (8) is decontaminated by means of a decontamination device (7); e) after decontamination of the surface of the cover (98) facing the passage (47, 48), including its environment (8), the cover (98) is opened to transfer the articles (960) from the receptacle (94) through its passage (95) into the process chamber (43); and f) after the receptacle (94) has been emptied, the lid (51) is first brought back to the passage (47, 48) in question in order to subsequently remove the receptacle (94) emptied of the articles (960) from the passage (47, 48); wherein g) the lid (51) is used alternately at the passages (47, 48).

2. Method according to claim 1, characterized in that a) the decontamination device (7) is integrated in the lid (51) or is arranged outside of the lid (51); and b) the emission element of the decontamination device (7) is arranged directly in the lid (51) or outside the lid (51) in a holder (70).

3. Method according to at least one of claims 1 and 2, characterized in that the enclosed environment (8) comprises the gas volume present therein and surfaces surrounded by the gas volume, namely surfaces: a) of the lid (51); b) of the optional holder (70); c) of an optional seal (470,480); and d) of optionally exposed wall surfaces.

4. Method according to at least one of claims 1 to 3, characterized in that a) the process chamber (43) is equipped with a manipulator (6) or additionally with a second manipulator (6), on each of whose pivotable cantilevers (60) a tool head (61) fitted with tools is mounted, wherein: b) the tools are adapted to open the cover (98) and subsequently transfer the articles (960) from the receptacle (94) through the exposed passage (95) into the process chamber (43); and c) the one manipulator (6) with its tools is used alternately at the passages (47, 48) for opening the cover (98) and transferring the articles (960) into the process chamber (43); or d) the one manipulator (6) and the second manipulator (6) are each used at only one of the passages (47, 48) or the two manipulators (6) are used alternately at the passages (47, 48).

5. Method according to at least one of claims 1 to 4, characterized in that a) a cutting tool is a component of the tools to cut the cover (98) for opening; wherein b) preferably at least surface portions of the cover (98) and the enclosure (99) consist of a semipermeable nonwoven fabric, such as Tyvek®, and the cover (98), before removal, preserves the interior (940) of the receptacle (94) in a sterile state and is sealed on an edge (941) surrounding the passage (95) of the receptacle (94).

6. Method according to at least one of claims 1 to 5, characterized in that a) a removable nest (96) is stored in the receptacle (94) for accommodating a plurality of articles (960) and is transferred to the process chamber (43) together with the articles (960); and b) after emptying the nest (96) of the articles (960) in the process chamber (43), this emptied nest (96) is disposed of from the process chamber (43) into a next or the same emptied receptacle (94) pressed against the respective passage (47, 48); or c) the articles (960) are transferred directly from the nest (96) remaining in the receptacle (94) into the process chamber (43).

7. Method according to at least one of claims 1 to 6, characterized in that the decontamination device is preferably designed as a radiation source, e.g. UVC, UV, e-beam or pulsed light, or alternatively as a fumigation device, e.g. for nebulizing an H2O2 solution.

8. Method according to at least one of claims 1 to 7, characterized in that the input station (3), which is surrounded by a housing (39) having an access (37) leading to an adjacent supply station (2), wherein: a) the inlet station (3) is operated with a purified, rectified displacement flow (LF), which partially exits through the access (37); b) the containers (9; 91, 92, 93) are delivered to the supply station (2), which in the delivery state are each surrounded by an enclosure (99) in order to aseptically maintain the internal volume (90) of the container (9; 91, 92, 93) with its contents; and c) at the supply station (2), an opening provided on the enclosure (99), which was previously kept closed, is now opened on the side facing the displacement flow (LF) emerging from the access (37) in order to introduce the individual container (9; 91, 92, 93) into the input station (3); or d) at the supply station (2), the enclosure (99) is separated on the side facing the displacement flow (LF) emerging from the access (37) in order to introduce the individual container (9; 91, 92, 93) into the input station (3).

9. Method according to claim 8, characterized in that a) the container (9; 91, 92, 93), which is still in the initially closed enclosure (99), is positioned on a support (20); b) an advancing means (22) is used for pushing the container (9; 91, 92, 93) out of the open enclosure (99) with a displacement flow (LF) flowing onto the container (9; 91, 92, 93); and c) the enclosure (99) is retained by a gripper (21), preferably designed as a suction cup.

10. Method according to at least one of claims 1 to 9, characterized in that a) the containers (9; 91, 92, 93) introduced into the input station (3) are fed to the passages (47, 48) by means of at least one conveying device (34, 35); and b) the at least one conveying device (34, 35) is preferably based on the principle of magnetic levitation.

11. Method according to claim 10, characterized in that a) the transport of the containers (9; 91, 92, 93) within the input station (3) takes place by means of a first conveying device (34); while b) a second conveying device (35) causes the containers (9; 91, 92, 93) with the cover (98) pressed against the respective passage (47, 48) to be swung towards it; and c) the second conveying device (35) can also be used to remove processed containers (9; 91, 92, 93) from the respective passage (47, 48).

12. Method according to claim 11, characterized in that the second conveying device (35) comprises a cardanic bearing (351) for positioning the containers (9; 91, 92, 93) at the respective passage (47, 48).

13. Method according to at least one of claims 11 and 12, characterized in that the second conveying device (35) consists of: a) an axle (350) through which a first axis of rotation (D1) extends; b) two forks (352) fixed side by side on the axle (350), each pivotable about a second axis of rotation (D2) extending at right angles to the first axis of rotation (D1); and c) in each case a carrier (353) suspended in the assigned fork (352) and pivotable about a third axis of rotation (D3), wherein the first axis of rotation (D1) and the third axis of rotation (D3) extend parallel to one another and the carriers (353) are configured for engaging under the edges (941) of the receptacles (94) when pivoting to and away from the passages (47, 48); wherein d) two adjacent cardanic bearings (351) are each formed from a U-shaped carrier (353) which is connected in the third axis of rotation (D3) in each case to a fork (352) which is suspended in the second axis of rotation (D2).

14. Method according to at least one of claims 1 to 13, characterized in that in each passage (47, 48) there is a seal (470, 480) which, together with the cover (98) of a temporarily pressed-on container (9; 91, 92, 93) and / or with a temporarily pressed-on lid (51), creates seals at the passages (47, 48) in the transition from the input station (3) to the process chamber (43).

15. Method according to at least one of claims 1 to 14, characterized in that the lid (51) is carried by a pivotable cantilever (50) of an apparatus (5) positioned in the process chamber (43).

16. Method according to at least one of claims 4 to 15, characterized in that the at least one manipulator (6) or also the additional manipulator (6) is designed as a robot.

17. Method according to at least one of claims 1 to 16, characterized in that the receptacles (94) of the containers (9; 91, 92, 93) have the shape of trough-shaped tubs and the articles (960), for example vials or syringes, are inserted in systematically arranged receiving contours of nests (96).

18. Sluice arrangement for transferring articles (960) under aseptic conditions from serially supplied containers (9; 91, 92, 93) into a process chamber (43) of a containment (4) surrounded by a housing (49) by means of a sluice arrangement (1) positioned in an installation space (A), wherein: a) an input station (3) is located upstream of the process chamber (43); b) a single container (9;91,92,93) comprises: ba) a receptacle (94) having an aseptic interior (940) and a passage (95) which is closed with a cover (98); and bb) the articles (960) stored in the interior (940), which are to be treated in the process chamber (43) after opening the cover (98), characterized in that: c) at least two passages (47, 48) leading from the input station (3) into the process chamber (43) are provided for transferring the articles (960) from the containers (9; 91, 92, 93) into the process chamber (43), and each of the passages (47, 48) can be closed on the one hand by a lid (51) brought up in the process chamber (43) and / or on the other hand by a container (9; 91, 92, 93) brought up in the input station (3) with its cover (98) facing the passage (47, 48); d) when the container (9; 91, 92, 93) is brought up to the passage (47, 48), the surface of the cover (98) facing the passage (47, 48) with enclosed environment (8) can be decontaminated by means of a decontamination device (7); e) after decontamination of the surface of the cover (98) facing the passage (47, 48), including its environment (8), the cover (98) can be opened and the articles (960) can be transferred from the receptacle (94) through its passage (95) into the process chamber (43); and f) the lid (51) can be reattached to the respective passage (47, 48) at which the emptied receptacle (94) abuts, and thus the empty receptacle (94) can be removed from the passage (47, 48); wherein g) the lid (51) is used alternately between the passages (47, 48).

19. Sluice arrangement according to claim 18, characterized in that a) the decontamination device (7) is integrated in the lid (51) or is arranged outside the lid (51); and b) the emission element of the decontamination device (7) is arranged directly in the lid (51) or outside the lid (51) in a holder (70).

20. Sluice arrangement according to at least one of claims 18 and 19, characterized in that the enclosed environment (8) comprises the gas volume present therein and surfaces surrounded by the gas volume, namely surfaces: a) of the lid (51); b) of the optional holder (70); c) an optional seal (470,480); and d) of optionally exposed wall surfaces.

21. Sluice arrangement according to at least one of claims 18 to 20, characterized in that a) the process chamber (43) is equipped with a manipulator (6) or additionally with a second manipulator (6), on each of whose pivotable cantilevers (60) a tool head (61) fitted with tools is mounted, wherein: b) the tools are adapted to open the cover (98) and subsequently transfer the articles (960) from the receptacle (94) through the exposed passage (95) into the process chamber (43); and c) the one manipulator (6) with its tools is used alternately at the passages (47, 48) for opening the cover (98) and transferring the articles (960) into the process chamber (43); or d) the one manipulator (6) and the second manipulator (6) are each used at only one of the passages (47, 48) or the two manipulators (6) are used alternately at the passages (47, 48).

22. Sluice arrangement according to at least one of claims 18 to 21, characterized in that a) the tools have a cutting tool as a component intended for opening the cover (98); wherein b) preferably at least surface portions of the cover (98) and the enclosure (99) consist of a semipermeable nonwoven fabric, such as Tyvek®, and the cover (98), before removal, preserves the interior (940) of the receptacle (94) in a sterile state and is sealed on an edge (941) surrounding the passage (95) of the receptacle (94).

23. Sluice arrangement according to at least one of claims 18 to 22, characterized in that a) the receptacle (94) for accommodating a plurality of articles (960) stores a removable nest (96) which is transferable to the process chamber (43) together with the articles (960); and b) the nest (96) emptied of articles (960) is disposable from the process chamber (43) into a next or the same emptied receptacle (94) docked at the respective passage (47, 48); or c) the articles (960) can be transferred directly from the nest (96) remaining in the receptacle (94) into the process chamber (43).

24. Sluice arrangement according to at least one of claims 18 to 23, characterized in that the decontamination device is preferably designed as a radiation source, e.g. UVC, UV, e-beam or pulsed light, or alternatively as a fumigation device, e.g. for nebulizing an H2O2 solution.

25. Sluice arrangement according to at least one of claims 18 to 24, characterized in that the input station (3), which is surrounded by a housing (39) having an access (37) leading to an adjacent supply station (2), wherein: a) the inlet station (3) can be operated with a purified, rectified displacement flow (LF), which partially exits through the access (37); b) the supply station (2) is intended for the delivery of the containers (9; 91, 92, 93), which in the delivery state are each surrounded by an enclosure (99) in order to aseptically maintain the internal volume (90) of the container (9; 91, 92, 93) with its contents; and c) at the supply station (2), an opening provided on the enclosure (99), which was previously kept closed by means of an attached tool, is now opened on the side facing the displacement flow (LF) emerging from the access (37) by releasing the tool, so that the individual container (9; 91, 92, 93) can be introduced into the input station (3); or d) at the supply station (2), the enclosure (99) can be separated by means of a tool on the side facing the displacement flow (LF) emerging from the access (37), so that the individual container (9; 91, 92, 93) can be introduced into the input station (3).

26. Sluice arrangement according to claim 25, characterized in that a) a support (20) is provided for positioning the container (9; 91, 92, 93) which is inserted in the initially still closed enclosure (99); b) an advancing means (22) is used for pushing the container (9; 91, 92, 93) out of the open enclosure (99) with a displacement flow (LF) flowing onto the container (9; 91, 92, 93); and c) a gripper (21), preferably designed as a suction cup, is used to retain the enclosure (99).

27. Sluice arrangement according to at least one of claims 18 to 26, characterized in that a) at least one conveying device (34, 35) is provided for feeding the containers (9; 91, 92, 93) introduced into the input station (3) to the passages (47, 48); and b) the at least one conveying device (34 35) is based on the principle of magnetic levitation.

28. Sluice arrangement according to claim 27, characterized in that a) a first conveying device (34) is used to transport the containers (9; 91, 92, 93) within the input station (3); while b) a second conveying device (35) is intended for pivoting the containers (9; 91, 92, 93) with the cover (98) pressed against the respective passage (47, 48); and c) the second conveying device (35) can also be used to remove processed containers (9; 91, 92, 93) from the respective passage (47, 48).

29. Sluice arrangement according to claim 28, characterized in that the second conveying device (35) comprises a cardanic bearing (351) for positioning the containers (9; 91, 92, 93) at the respective passage (47, 48).

30. Sluice arrangement according to at least one of claims 28 and 29, characterized in that the second conveying device (35) consists of: a) an axle (350) through which a first axis of rotation (D1) extends; b) two forks (352) fixed side by side on the axle (350), each pivotable about a second axis of rotation (D2) extending at right angles to the first axis of rotation (01); and c) in each case a carrier (353) suspended in the assigned fork (352) and pivotable about a third axis of rotation (D3), wherein the first axis of rotation (D1) and the third axis of rotation (D3) extend parallel to one another and the carriers (353) are configured for engaging under the edges (941) of the receptacles (94) when pivoting to and away from the passages (47, 48); wherein d) two adjacent cardanic bearings (351) are each formed from a U-shaped carrier (353) which is connected in the third axis of rotation (D3) in each case to a fork (352) which is suspended in the second axis of rotation (D2).

31. Sluice arrangement according to at least one of claims 18 to 30, characterized in that in each passage (47, 48) there is a seal (470, 480) which, together with the cover (98) of a temporarily pressed-on container (9; 91, 92, 93) and / or with a temporarily pressed-on lid (51), creates seals at the passages (47, 48) in the transition from the input station (3) to the process chamber (43).

32. Sluice arrangement according to at least one of claims 18 to 31, characterized in that a pivotable cantilever (50) of an apparatus (5) positioned in the process chamber (43) carries the lid (51).

33. Sluice arrangement according to at least one of claims 21 to 32, characterized in that the at least one manipulator (6) or also the additional manipulator (6) is designed as a robot.

34. Sluice arrangement according to at least one of claims 18 to 33, characterized in that the receptacles (94) of the containers (9; 91, 92, 93) have the shape of trough-shaped tubs and the articles (960), for example vials or syringes, are inserted in systematically arranged receiving contours of nests (96).