Pharmaceutical plant and method for operating pharmaceutical plant
By designing a reversiblely connected frame and cover, the problems of long purification time of existing pharmaceutical equipment and difficulty in cleaning the inflatable seals are solved, achieving a more flexible purification process and safer operating conditions.
Patent Information
- Application Number
- CN202411156817.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2023-08-24
- Filing Date
- 2024-08-22
- Publication Date
- 2025-02-25
AI Technical Summary
The existing pharmaceutical equipment needs to process two modules successively during the purification process, resulting in extended purification time and difficulty in cleaning the inflatable seal, especially when handling strong products, and the bending radius of the seal limits the geometric configuration of the cover.
A pharmaceutical device is designed, which includes two separate working chamber modules and a reversible connection frame and cover. The frame and cover can be purified, sterilized and autoclaved separately and are reversibly connected to the wall by simple means, allowing the two modules to be purified in time or simultaneously.
With this design, the purification process becomes more flexible, allowing the other module to be still running while one module is purified, or purified simultaneously, thereby reducing overall purification time and reducing operational risks and complexity of seal cleaning.
Smart Images
Figure CN119499097A_ABST
Abstract
Description
Technical Field
[0001] The invention relates to a pharmaceutical plant having the features of the preamble of claim 1 and to a method for operating a pharmaceutical plant having the features of claim 11 . Background Art
[0002] Pharmaceutical equipment must be cleaned regularly. The purpose of cleaning is, in particular, to kill microorganisms on all surfaces within the equipment. To this end, the cleaning agent needs to reach all surfaces. Pharmaceutical equipment with at least two modules usually has an interface that connects the two modules to each other via an opening.
[0003] The opening can be closed by means of a cover. The cover can have two inflatable seals for sealing the opening or the interface. The purification of the two modules usually takes place successively. In this case, the seal further away from the purified module is inflated accordingly, so that the purified module is sealed. Due to the sequential purification of the modules and the switching of the double seal, it can be ensured that the gap between the two seals or between the opening and the cover can be applied with a purification agent successively from both sides. In this way, it can be ensured that all surfaces of the cover and thus the interface are wetted.
[0004] The disadvantage here is that both modules must be cleaned successively. This results in longer preparation or cleaning times. In addition, the cover or the two inflatable seals are laborious to clean. This can lead to risks when handling the cover, especially when handling potent products. In addition, the cover has a round or oval shape due to the bending radius of the inflatable seals. This severely limits the geometric configuration of the cover. Summary of the invention
[0005] It is therefore an object of the present invention to provide a pharmaceutical plant and a method for operating a pharmaceutical plant in which the above-mentioned disadvantages are eliminated.
[0006] The above object is achieved by a pharmaceutical device having the features of claim 1. The pharmaceutical device can be provided for filling a medicament, in particular in a sterile manner. The pharmaceutical device can be designed as a filling device.
[0007] The pharmaceutical device comprises a first module. The first module has a first working chamber that is sealed relative to its surroundings. The pharmaceutical device comprises a second module. The second module has a second working chamber that is sealed relative to its surroundings. The pharmaceutical device, the first module and / or the second module can be configured as a clean room. The pharmaceutical device can include three or more modules.
[0008] A clean room in the current sense may be a barrier system such as a RABS (Reduced Access Barrier System), an isolator (e.g. a sterile or cytotoxic isolator) or even a biosafety cabinet (Biosafety cabinet). A clean room in this sense may be under overpressure in order to prevent the ingress of contamination or to minimize the risk of ingress. Alternatively, a clean room in this sense may also be operated under negative pressure in order to prevent the escape of any toxic or otherwise dangerous substances to be handled in the clean room.
[0009] The pharmaceutical device comprises at least one wall for spatially separating the working chambers of the two modules. The wall can be configured as a partition wall between the two modules. It is conceivable that the wall can be configured as a single-walled or multi-walled structure and can be arranged between the two modules.
[0010] The pharmaceutical device further comprises at least one interface having at least one opening arranged in the wall for (fluidically) connecting (or coupling) the first working chamber to the second working chamber (and vice versa). The two working chambers of the two modules can be fluidically connected via the opening. The opening can form a fluid connection or coupling between the two working chambers or the two modules. The opening can be used to deliver a package (in which a drug can be filled) from the first module through the opening to the second module and / or vice versa. The pharmaceutical device can comprise three or more modules, wherein at least one interface can be arranged between two adjacent modules, respectively.
[0011] At present, a fluid connection or fluid coupling means that a gas and / or a liquid (fluid) can flow between two fluidly connected elements or between two elements in a fluid connection. At present, a fluid can refer to a gas and / or a liquid.
[0012] The interface comprises a cover for closing and releasing the opening. The cover releases the opening in the open position. The cover closes the opening in the closed position. In particular, the cover can be moved (reciprocatingly) between the open position and the closed position. In particular, when the cover is arranged in the closed position, no fluid can be exchanged between the two working chambers. In other words, in the closed position, the cover seals the opening. In particular, when the cover is arranged in the open position, a fluid exchange between the two working chambers is possible.
[0013] The interface comprises a frame that can be releasably connected to the wall. The frame can be reversibly fixed (mounted) on the wall. The frame can be arranged on the wall or connected to the wall. The frame can be separated (loosened) from the wall or removed from the wall.
[0014] The cover may include a grip for manual operation. The grip may be shaped in an ergonomic manner. The frame and the cover may be configured such that the cover and the frame can be operated together by means of the grip.
[0015] The cover is designed to be fastened to the wall by means of a frame. The cover can be reversibly connected to the wall or reversibly fixed to the wall by means of the frame. The frame can be designed as a support (cover support) for the cover.
[0016] The cover and / or the frame can be configured to be autoclavable. The cover and / or the frame can comprise or be made of an autoclavable material. The parameters (dimensions and / or weight) of the cover and / or the frame can be determined such that they can be handled, in particular with one hand, by an operator. In particular, the cover and / or the frame can have a weight of less than 5 kg (kilograms), preferably less than 2.5 kg, preferably less than 1.5 kg.
[0017] As a result, the cover and the frame can be cleaned, disinfected and / or autoclaved separately. This can be done in particular externally, outside the two modules, in particular outside the pharmaceutical plant. After cleaning or autoclaving, the cover can be fastened to the wall again with the frame. The two modules can then be cleaned independently of one another. This can take place in time one after the other, in particular in any order, or simultaneously.
[0018] Therefore, the purification of the pharmaceutical plant can be configured significantly more flexibly. For example, the first module can be purified while the second module is still being equipped. Both modules can be purified at the same time, so that the purification phase of the entire pharmaceutical plant can be shortened.
[0019] Hydrogen peroxide (H2O2) can be used as a cleaning agent.
[0020] According to one development, the frame can be configured to be (reversibly) connectable to the wall in a sealed manner by means of at least one first screw connection. Alternatively or additionally, the frame can be configured to be (reversibly) connectable to the wall in a sealed manner by means of at least one first clamping connection.
[0021] Thus, the reversible connection of the frame to the wall can be realized with simple means. In other words, the frame can be reversibly connected to the wall in a sealed or airtight manner with simple means.
[0022] At present, "reversibly connected" means that two elements can be releasably connected to each other. In other words, the connection between two elements reversibly connected to each other can be released and / or rebuilt.
[0023] At present, "sealing" or "tight" means that there is no fluid communication. In other words, a sealing or tight connection prevents the fluid exchange between the two elements.
[0024] According to a development, the cover can be configured to be connected to the frame in a sealing manner and / or can be detached from the frame. In other words, the cover can be configured to be reversibly connected to the frame in a sealing manner.
[0025] This ensures a tight connection between the cover and the frame. The cover can thus be switched into a (sealed) closed position, in which the two working chambers are fluidically separated. The cover can be switched into an open position, in which a fluid connection is achieved between the two working chambers (of the two modules).
[0026] According to one development, the cover can be designed to be sealably connected to the frame by means of at least one second screw connection. Alternatively or additionally, the cover can be designed to be sealably connected to the frame by means of at least one second clamping connection.
[0027] As a result, the cover can be connected to the frame in a sealing and reversible manner by simple means.
[0028] According to an extension, the cover can have at least one first contact surface and the frame can have at least one second contact surface. The cover and the frame can be configured such that when the cover is sealingly connected to the frame, the first contact surface is sealingly abutted (arranged) on the second contact surface. In other words, the first contact surface contacts the second contact surface, so that the cover is tightly connected to the frame. In particular, the first contact surface can completely abut on the second contact surface (and vice versa).
[0029] Thereby, a tight connection between the cover and the frame can be achieved by simple means.
[0030] According to an extended solution, the cover and the frame can be configured so that when the cover is loosened (separated) from the frame, the first contact surface and the second contact surface are exposed respectively. In other words, when the cover is separated from the frame, the first contact surface and the second contact surface are arranged spaced apart from each other (not in contact with each other).
[0031] This ensures that both the first contact surface and the second contact surface can be wetted or treated with the cleaning agent.
[0032] According to a further development, the first and / or second contact surface can be respectively designed to be annular or elliptical. Likewise, other geometrical designs of the first and / or second contact surface are also conceivable.
[0033] As a result, the contact surface can be minimized and at the same time flexibly configured. As a result, cleaning agents can be saved and the possible risk of leaks can be reduced.
[0034] According to an extension, the first contact surface, the first cross section of the first contact surface, the second contact surface and / or the second cross section of the second contact surface can be configured without bending. The first contact surface, its first cross section, the second contact surface and / or its second cross section can be configured to be inclined relative to the wall. In other words, the wall and the first contact surface, the first cross section, the second contact surface and / or the second cross section can each enclose or span an angle between 0° and 90°, in particular 45°.
[0035] At present, "no bend" means that there are no areas on the first and / or second contact surface where the slope / gradient of the corresponding surface changes abruptly. In particular, there are no edges and / or bends in the contact surface or its corresponding cross section. The two contact surfaces or their cross sections can be constructed to be flat at least in regions.
[0036] Thereby, possible risks of leakage points which may be caused by kinks in the contact surface can be reduced.The tightness and / or cleanability between cover and frame can be further optimized.
[0037] According to a further development, the cover can be designed to be circular or oval. It is also conceivable that the cover can have other geometric shapes (for example, circular, semicircular, rectangular, square, triangular, polygonal, etc.).
[0038] The shape of the cover can thereby be flexibly adapted to the respective given conditions and requirements.
[0039] The cover and the frame are configured to be removed from the first module or the second module. The cover and the frame can be configured to be removed from the pharmaceutical device. For this purpose, the parameters (size, shape and / or weight) of the cover and the frame can be determined accordingly.
[0040] As a result, the cover and the frame can be removed from the first module, the second module and / or the pharmaceutical system and can be cleaned or autoclaved externally (outside the first module, the second module and / or the pharmaceutical system).
[0041] According to an extension, the interface can include at least one partition having a through hole for the packaging to pass through. The through hole can be designed to be smaller than the opening arranged in the wall. The partition can be arranged on the frame. It is also conceivable that the partition can be arranged on the wall. The partition can be designed as a format piece. The partition can be fixedly connected to the frame and / or to the wall. It is also conceivable that the partition can be designed to be replaceable (reversibly releasable) connected to the frame and / or the wall or can be connected thereto.
[0042] Thus, when the cover is in the open position, the fluid exchange (gas exchange) through the opening or through the through-hole can be limited. When the cover is open, the fluid exchange that can occur, in particular due to different pressures in the first working chamber and the second working chamber, can be limited. By selecting the shape or parameters of the through-hole, the fluid exchange can be adjusted as required.
[0043] The above object is further achieved by a method for operating a pharmaceutical plant having the features of claim 11 .
[0044] The method comprises the following steps:
[0045] A pharmaceutical preparation device according to the above-described embodiments is provided.
[0046] Loosen the frame with cover from the wall.
[0047] The frame and the cover are purified, in particular autoclaved.
[0048] This can take place outside the module or the pharmaceutical device. It is also conceivable that the cleaning or autoclaving of the cover and the frame (for example in a film bag) can be carried out in the pharmaceutical device or in one of the modules. It is also conceivable that the pharmaceutical device includes a cleaning chamber in which the frame and the cover can be cleaned, in particular separately from one another (i.e., the cleaning takes place outside the module but in the pharmaceutical device).
[0049] With regard to the advantages that can be achieved with this method, reference is made to the statements made in this regard with respect to the pharmaceutical plant. The measures described in conjunction with the pharmaceutical plant and / or the measures still to be explained below can be used to further develop the method.
[0050] According to an extended solution, the method may include the following steps:
[0051] Prior to cleaning, the cover is released from the frame so that the first contact surface and the second contact surface are exposed and accessible to the cleaning agent.
[0052] After cleaning, the cover is connected to the frame so that the first contact surface and the second contact surface lie sealingly against one another.
[0053] This ensures that the first and second contact surfaces are completely wetted with the cleaning agent. Once the first and second contact surfaces are placed against each other in a sealed manner, contamination of the contact surfaces can no longer occur. Due to the tightness between the two contact surfaces, contamination is simply impossible.
[0054] According to an extended solution, the method may include the following steps:
[0055] Place the frame and cover into the film bag.
[0056] The frame and the cover are purified, in particular autoclaved, in the film bag.
[0057] After purification, the step of connecting the cover to the frame can be carried out in the membrane bag.
[0058] The cover and the frame can be cleaned or autoclaved in the film bag in a state loosened from each other. The cover and the frame can be (again) tightly connected to each other in the film bag after cleaning or autoclaving.
[0059] The cover can thus be connected to the frame in the still sterile environment of the film bag, thereby avoiding contamination, in particular of the contact surfaces.
[0060] Then, the frame together with the cover can be placed or arranged on the wall. Here, in particular, the contact surface between the frame and the cover remains sterile.
[0061] According to an extended solution, the method may include the following steps:
[0062] The frame and the cover are removed from the first module and / or the second module, in particular from the pharmaceutical plant.
[0063] Outside the first module and / or the second module, in particular outside the pharmaceutical plant, the frame and the cover are purified, in particular autoclaved.
[0064] Thus, the cleaning or autoclaving of the frame and the cover can be performed externally (independently of the first module, the second module and / or the pharmaceutical device). Thus, the flexibility of the cleaning of the entire pharmaceutical device can be increased. BRIEF DESCRIPTION OF THE DRAWINGS
[0065] Further features, details and advantages of the invention emerge from the text of the claims and from the following description of an exemplary embodiment based on the drawings.
[0066] Figure 1 is a schematic diagram of a pharmaceutical device having two modules and an interface;
[0067] Figure 2 is based on Figure 1 A schematic top view of an interface with a frame and a cover;
[0068] Figure 3 Is the basis of the interface Figure 2 A schematic cross-sectional view of section AA shown in ;
[0069] Figure 4 is based on Figure 3 A schematic cross-sectional view of an interface according to a second embodiment;
[0070] Figure 5 is a partial cross-sectional view of a frame and a cover according to a third embodiment;
[0071] Figure 6 is based on Figure 2 Schematic cross-sectional view of a frame and a cover during purification or autoclaving. DETAILED DESCRIPTION
[0072] In the following description and drawings, corresponding components and elements have the same reference numerals. For the sake of greater clarity, not all reference numerals are reproduced in all drawings.
[0073] Figure 1 A schematic diagram of a pharmaceutical device 10 is shown. In the present case, the pharmaceutical device 10 is provided for aseptic filling of a medicament.
[0074] The pharmaceutical device 10 comprises a first module 12 having a first working chamber 14 which is sealed from its surroundings. The pharmaceutical device 10 comprises a second module 16 having a second working chamber 18 which is sealed from its surroundings. The pharmaceutical device 10 comprises a wall 20 which spatially separates the two working chambers 14, 18.
[0075] The pharmaceutical device 10 comprises an interface 22. The interface 22 comprises an opening 24 arranged in the wall 20. By means of the opening 24, the two working chambers 14, 18 can be fluidically connected or coupled to one another.
[0076] The interface 22 comprises a cover 26 for closing and releasing the opening 24. The cover 26 releases the opening 24 in the open position and closes the opening 24 in the closed position. The cover 26 can be transferred from the open position to the closed position (and vice versa). In particular, the cover 26 seals or hermetically closes the opening 24 in the closed position. In other words, in the closed position, the cover 26 prevents fluid communication between the two working chambers 14, 18 through the opening 24 (the two working chambers 14, 18 are separated on the fluid). In the open position, the cover 26 releases the opening 24, so that the two working chambers 14, 18 are in fluid communication (the two working chambers 14, 18 are fluidically connected).
[0077] The interface 22 comprises a frame 28 which can be detachably connected to the wall 20. The frame can be placed sealingly or hermetically on the wall 20 or connected to the wall 20. The frame 28 is sealingly connected to the wall 20, in particular on the surface contacting the wall 20.
[0078] The cover 26 can be fastened to the wall 20 by means of the frame 28. In other words, the cover 26 is designed to be reversibly (and tightly) connectable to the wall by means of the frame 28.
[0079] In the present case, the cover 26 and the frame 28 are configured such that they can be removed from the first module, the second module and / or the pharmaceutical device 10 .
[0080] Figure 2 Show according to Figure 1 A schematic top view of the interface 22, and Figure 3 The interface 22 is shown according to Figure 2 Schematic cross-sectional view of section AA shown in .
[0081] The frame 28 is currently designed to be rectangular, in particular square. The frame 28 is currently designed to be sealably connectable to the wall 20 by means of a first screw connection 30. The first screw connection 30 currently comprises four screws 31, which are each arranged in a corner of the rectangular frame 28.
[0082] The cover 26 is configured to be sealably connected to the frame 28 (see Figure 2 as well as Figure 3 ) and / or can be released from the frame 28 (see Figure 6 ). In the present case, the cover 26 is designed to be oval.
[0083] In the present case, the cover 26 is designed to be sealably connectable to the frame 28 by means of a second screw connection 32. In the present case, the second screw connection 32 comprises four screws 33, which are arranged in pairs opposite one another.
[0084] It is conceivable that the screw 33 can be configured as a pin, which can keep the cover 26 and the frame 28 at a defined distance from each other. The pin can be configured so that the cover 26 can be locked at a plurality of defined distances from the frame 28. Therefore, the distance between the cover 26 and the frame 28 can be expanded in a controlled manner. As a result, the cover 26 can be prevented from opening suddenly. In this way, in particular when the cover 26 is opened, the fluid exchange through the interface 22 or through the opening 24 can be adjusted in a controlled manner. The cover 26 can be guided by means of the pin. In other words, the pin can form a guide for the cover 26 during the separation of the cover 26 from the frame 28 and during the connection of the cover 26 to the frame 28.
[0085] In the present case, the cover 26 comprises a grip 27. The cover can be operated by means of the grip. The cover 26 can be transferred from the closed position to the open position (and vice versa) by means of the grip 27, for example. The cover 26 can be operated together with the frame 28 (especially when the cover 26 is connected to the frame 28) by means of the grip 27.
[0086] In the present case, the cover 26 comprises a first contact surface 34 and the frame 28 comprises a second contact surface 36. When the cover 26 is connected to the frame 28 in a sealing manner, the first contact surface 34 and the second contact surface 36 lie against each other in a sealing or hermetically sealed manner.
[0087] In the present case, the first contact surface 34 and the second contact surface 36 are each designed to be elliptical (see Figure 2). In the present case, the first and second contact surfaces 34, 36 have a bend 35 (see Figure 3 ). Therefore, the first and second contact surfaces 34, 36 each have two non-bent sub-surfaces.
[0088] For greater clarity, the contact surfaces 34, 36 are Figure 3 When the contact surfaces 34 , 36 are placed tightly against each other, there is no distance between the contact surfaces 34 , 36 .
[0089] When the cover 26 is released from the frame 28, the two contact surfaces 34, 36 are each exposed (see Figure 6 ) so that the cleaning agent can completely wet the contact surfaces 34, 36.
[0090] Figure 4 Show according to Figure 3 Schematic cross-sectional view of an interface 22 according to a second exemplary embodiment. Figure 4 The embodiments shown in Figures 1 to 3 The difference between the embodiment shown in is that:
[0091] In the present case, the interface 22 comprises a partition 44. The partition 44 has a through hole 46. The partition 44 is used for passing packages (which may be filled with drugs) from the first module 12 or its working chamber 14 into the second module 16 or its working chamber 18 (and / or vice versa).
[0092] The through hole 46 is configured to be smaller than the opening 24. The through hole 46 can correspond to the shape of the package. In other words, the through hole 46 can have the contour of the package.
[0093] In the present case, the partition 44 is arranged on the frame 28 (between the cover 26 and the opening 24). The partition 44 can be arranged fixedly on the frame 28. The partition 44 can also be designed as a standard part (exchangeable). The partition 44 can be selected depending on the packaging used.
[0094] Figure 5 A portion of a cross-sectional view of a frame 28 and a cover 26 according to a third embodiment is shown. Figure 5 The embodiments shown in Figures 1 to 3 The exemplary embodiments shown in FIG. 1 differ in that the contact surfaces 34 , 36 are designed differently.
[0095] In the present case, the contact surfaces 34, 36 are designed without bends. The contact surfaces 34, 36 each have a cone segment shape. In other words, the contact surfaces 34, 36 each correspond to a part of the side surface of a cone or to a truncated cone.
[0096] In the present case, the first cross section 38 of the first contact surface 34 and the second cross section 40 of the second contact surface 36 are also designed without bends. In the present case, the two cross sections 38, 40 of the contact surfaces 34, 36 are oriented obliquely with respect to the wall 20. In the present case, there is an angle 39 between the first contact surface 34, the first cross section 38, the second contact surface 36, the second cross section 40 and the wall 20, which angle is 45° in the present case. In other words, the first cross section 38 (or the first contact surface 34) and the second cross section 40 (or the second contact surface 36) are designed in the present case to be oriented obliquely with respect to the wall 20 at 45°.
[0097] Below, refer to Figure 6 A method for operating a pharmaceutical plant 10 will be explained. Figure 6 Show according to Figure 2 Schematic sectional view of a frame 28 and a cover 26 during purification or autoclaving. In particular, the purification of the pharmaceutical device 10 is described below.
[0098] After the pharmaceutical device 10 has been provided, the frame 28 together with the cover 26 is first detached from the wall 20. The frame 28 and the cover 26 are then cleaned, in particular sterilized by autoclaving.
[0099] Before cleaning or autoclaving, the cover 26 is loosened or separated from the frame 28 so that the first contact surface 34 and the second contact surface 36 are exposed and accessible to the cleaning agent. Therefore, the cleaning agent can completely wet the two contact surfaces 34, 36.
[0100] After purification or autoclaving, the cover 26 is connected to the frame 28 so that the first contact surface 34 and the second contact surface 36 lie tightly against each other. As long as the two contact surfaces 34, 36 lie tightly against each other, contamination, in particular contamination of the contact surfaces 34, 36, can be ruled out. Such contamination can be avoided due to the tightness between the contact surfaces 34, 36. For the contact surfaces 34, 36 to be contaminated, they must be at least partially exposed.
[0101] In order to clean or autoclave the cover 26 and the frame 28, they are placed in a film bag 42 (see Figure 6 ). The frame 28 and the cover 26 are purified or autoclaved in the membrane bag 42. After purification or autoclaving, the cover 26 and the frame 28 are connected to each other again while still in the membrane bag 42. This is achieved, for example, by pressing the cover 26 onto the frame 28, for example by means of a gripper 27. For this purpose, a force can be applied to the cover 26 and / or the frame 28, for example, by an operator from outside the membrane bag 42 (through the membrane bag 42), so that the contact surfaces 34, 36 are in contact with each other (tightly) in the membrane bag 42.
[0102] The cover 26 and the frame 28 can then be removed from the film pocket 42 in the connected state and arranged (fixed) on the wall 20. In this case, the contact surfaces 34, 36 are not exposed and therefore remain clean or sterile.
[0103] After the frame 28 with the cover 26 is fixed to the wall 20, the two modules 12, 16 or their working chambers 14, 18 can be cleaned. This can be carried out successively or simultaneously. In both cases, the interface 22 is optimally cleaned, especially due to the sterile contact surfaces 34, 36.
[0104] The cleaning or autoclaving of the frame 28 and the cover 26 can take place outside the first module 12, the second module 16 and / or outside the pharmaceutical plant 10. For this purpose, first, the cover 26 and the frame 28 can be removed from the first module 12, the second module 16 and / or from the pharmaceutical plant 10. Subsequently, the cover 26 and the frame 28 can be cleaned or autoclaved, for example, in a film bag 42 (externally).
[0105] Before purification or autoclaving, the frame 28 and the cover 26 can be separated from each other so that the contact surfaces 34, 36 are exposed. This can take place in the film bag 42 or already before the frame 28 and the cover 26 are placed in the film bag 42.
Claims
1. A pharmaceutical device (10) for filling a drug, wherein the filling is in particular aseptic filling, the pharmaceutical device comprising: - a first module (12) having a first working chamber (14) which is sealed with respect to its surroundings, - a second module (16) having a second working chamber (18) which is sealed with respect to its surroundings, at least one wall (20) for spatially separating the working chambers (14, 18), at least one interface (22) having at least one opening (24) arranged in the wall (20) for connecting the first working chamber (14) to the second working chamber (18), wherein the interface (22) comprises a cover (26) for closing and releasing the opening (24), wherein the cover (26) releases the opening (24) in an open position and closes the opening (24) in a closed position, It is characterized in that The interface (22) comprises a frame (28) which can be releasably connected to the wall portion (20), wherein the cover (26) is configured to be fastened to the wall portion (20) by means of the frame (28), wherein the cover (26) and the frame (28) are configured to be removable from the first module (12) or from the second module (16), in particular from the pharmaceutical device (10).
2. The pharmaceutical equipment according to claim 1, characterized in that: The frame (28) is designed to be sealably connectable to the wall (20) by means of at least one first screw connection (30) and / or a first clamping connection.
3. Pharmaceutical device according to any one of the preceding claims, characterized in that The cover (26) is configured to be sealingly connectable to the frame (28) and / or detachable from the frame (28).
4. The pharmaceutical equipment according to claim 3, characterized in that: The cover (26) is designed to be sealably connectable to the frame (28) by means of at least one second screw connection (32) and / or a second clamping connection.
5. Pharmaceutical device according to any one of the preceding claims, characterized in that The cover (26) has at least one first contact surface (34), and the frame (28) has at least one second contact surface (36), wherein the cover (26) and the frame (28) are configured such that when the cover (26) is sealingly connected to the frame (28), the first contact surface (34) rests sealingly on the second contact surface (36).
6. The pharmaceutical device (10) according to claim 5, characterized in that The cover (26) and the frame (28) are configured such that when the cover (26) is released from the frame (28), the first contact surface (34) and the second contact surface (36) are each exposed.
7. The pharmaceutical device (10) according to claim 5 or 6, characterized in that: The first and / or the second contact surface (34, 36) is each designed to be annular or elliptical.
8. The pharmaceutical device (10) according to any one of claims 5 to 7, characterized in that The first contact surface (34), the first cross section (38) of the first contact surface (34), the second contact surface (36) and / or the second cross section (40) of the second contact surface (36) are designed without any bends, in particular inclined relative to the wall (20).
9. Pharmaceutical device (10) according to any one of the preceding claims, characterized in that The cover (26) is designed to be circular or oval.
10. The pharmaceutical device (10) according to any one of the preceding claims, the interface (22) comprising at least one partition (44) having a through hole (46) for the packages to pass through, wherein: The through-hole (46) is designed to be smaller than the opening (24), in particular wherein the partition (44) is arranged on the frame (28).
11. A method for operating a pharmaceutical plant (10), comprising the following steps: - providing a pharmaceutical device (10) according to any one of the preceding claims; - loosening the frame (28) together with the cover (26) from the wall (20); The frame (28) and the cover (26) are purified, in particular autoclaved.
12. The method according to claim 11, characterized in that: step: - before the decontamination, the cover (26) is loosened from the frame (28) so that the first contact surface (34) and the second contact surface (36) are exposed and accessible to the decontamination agent; After the cleaning, the cover (26) is connected to the frame (28) so that the first contact surface (34) and the second contact surface (36) lie in a sealing manner against one another.
13. The method according to claim 12, characterized in that: step: - placing the frame (28) and the cover (26) into a film bag (42); - cleaning, in particular autoclaving, the frame (28) and the cover (26) in the film bag (42), wherein, after purification, a step of connecting the cover (26) to the frame (28) is carried out in the membrane bag (42).
14. The method according to any one of claims 11 to 13, characterized in that step: - removing the frame (28) and the cover (26) from the first module (12), the second module (16) and / or from the pharmaceutical device (10); The frame (28) and the cover (26) are purified, in particular autoclaved, outside the first module (12), the second module (16) and / or outside the pharmaceutical plant (10).