System for processing pharmaceutical containers and method for operating such a system

Abstract

The present invention relates to a system for processing pharmaceutical containers. The system comprises at least one production plant for filling and closing the containers in at least one processing space, and at least one preparation facility which is arranged or can be arranged spatially distant from the at least one production plant. Furthermore, at least one transportable container device is provided which can be docked onto the production plant for the purpose of introducing pharmaceutical production material which comprises the containers and closure elements. The container device can be docked onto the preparation facility in order to receive the production material. A metering device can be docked onto the production plant in order to introduce a filling needle and a fluid line. The invention further relates to a method for operating such a system.

Description

[0001] System for processing pharmaceutical containers and method for operating such a system

[0002] The present invention relates to a system for processing pharmaceutical containers, comprising a production plant for filling and closing the containers in a processing room, wherein the production plant comprises a filling station for filling the containers with a pharmaceutical product and a closing station for closing the containers with closure elements.

[0003] Furthermore, the present invention relates to a method for operating such a system.

[0004] In a production facility of the type described above, pharmaceutical containers are filled with a liquid product, for example. These containers can be vials, syringes, cartridges, or ampoules. The containers can be stable and stand independently on a support surface. Alternatively, they can be non-stable containers that require support by means of a holding device.

[0005] A high-quality cleanroom is typically required in the production facility, especially for small and very small batches, particularly in the so-called high-potency and / or toxic product range. A GMP A (Good Manufacturing Practice) cleanroom is desirable.

[0006] Before actual production, conventional systems require extensive preparatory steps, including, for example, the following: cleaning the system, installing components that do not come into contact with the product to be filled and that do not require sterilization, closing the system, decontamination, particularly with H2O2 vapor, to create a sufficient cleanroom class (e.g., Class A) required for production, and, in parallel, sterilizing components that come into contact with the product. These components are then introduced into the processing room by a user wearing gloves (aseptic setup). After preparation is complete, the product is filled. After filling, the system must be cleaned again before any closures are opened, for example, in the case of toxic production.

[0007] In conventional production systems, the above-mentioned steps not only require a significant amount of time, but the production system is also subject to the risk of potential unwanted contamination. For example, certain components of the production system are difficult to sterilize and / or, due to their size, are difficult to integrate into the production system. These include, for example, sorting devices with pots for closure elements and their sorting tracks. Consequently, with a large number of components, the entire production cycle is determined by the risk of contamination from the weakest link in the chain. Any malfunctions must be resolved manually by the user wearing gloves. Production must then be released; failure to do so could result in the entire batch being discarded.

[0008] The object of the present invention is to provide a system for processing pharmaceutical containers and a method for operating such a system in which hygienic requirements for production can be met in a more reliable manner.

[0009] This object is achieved by a system according to the invention for processing pharmaceutical containers, comprising: at least one production system for filling and closing the containers, which comprises, in at least one processing space, a filling station for filling the containers with a pharmaceutical product and a closing station for closing the containers with closure elements, wherein the at least one production system comprises a controllable robotic handling device which is arranged in at least one processing space, designed to handle pharmaceutical production material which comprises containers and / or closure elements which are received in a predefined arrangement in receiving bodies, and which comprises or forms at least one connection device for docking an external transportable container device and / or an external transportable dosing device;at least one preparation device which is or can be arranged spatially remote from the at least one production plant and comprises or forms at least one working space and at least one connection device for docking the container device, wherein pharmaceutical production material can be introduced into the at least one working space, which production material comprises containers and / or closure elements to be processed, wherein the containers and / or the closure elements can be inserted in the at least one working space in a predefined arrangement in the receiving body;At least one transportable container device, via which the containers received in the receiving body and / or the closure elements received in the receiving body can be transported directly or indirectly from the at least one preparation device to the at least one production facility and, when the container device is docked to the at least one production facility, can be introduced into the at least one processing space by means of the handling device; At least one dosing device, which comprises pharmaceutical dosing material in a receiving space, which comprises a fluid line and a filling needle arranged thereon, which can be introduced into the at least one processing space by means of the handling device when the dosing device is docked to the at least one production facility.

[0010] The present invention incorporates the consideration that risks and / or disturbances during production can be reduced and / or preferably largely avoided if the at least one production facility, which carries out the "core of production," can be decoupled from preparatory actions. For filling the product and at least one closure of a container via the closure element, preferably a pharmaceutical closure, the production facility comprises a filling station and a closing station in the at least one processing room. Containers and closure elements can preferably be fed via respective receiving bodies and handled by the robotic handling device.For this purpose, the handling device can be provided with information about the position of a respective receiving body at which a respective container or a respective closure element is arranged, as well as how these are to be moved in the processing space. Preparatory activities during production can be carried out in the at least one preparation device. Preferably, there is in particular the possibility of transferring the containers and / or the closure elements into respective receiving bodies in the defined arrangement required for processing in the production plant. The transfer takes place via the at least one container device, which is first docked to the preparation device in order to receive containers or closure elements, whereupon the container device can subsequently be docked to the at least one production plant for removing the containers or closure elements.According to the invention, a portable dosing device is further provided, which can contain dosing material in a working chamber, which can in particular comprise a fluid line and a filling needle arranged thereon. When the dosing device is docked to the production system, the filling needle and the fluid line, the latter at least partially, can be introduced into the processing chamber and inserted into the filling station.

[0011] It can be provided that a holding part of the dosing device, on which the filling needle and / or the fluid line are held and which is transferred from the receiving space of the docked dosing device into the processing space, forms part of the filling station.

[0012] Based on the above, it can be seen that, according to the present invention, hygiene requirements can be met in a simpler and more reliable manner by decoupling the actual production process from preparatory steps. Preparatory actions such as decontamination and / or sterilization can be performed externally to the at least one production facility and thus optimized with regard to the preparatory process. Accordingly, the actual production process can be optimized with regard to its implementation in the at least one production facility. In this way, the filling and closing of containers can be carried out with a lower risk of disruption in the production facility itself, in particular through the use of the robotically controllable handling device.Preferably, the number of components in the processing space can be reduced, which reduces the risk of disruption and thereby reduces the risk of undesirably open but already filled containers.

[0013] The at least one container device and the at least one dosing device can be docked to at least one connection device of the production system. In the present case, this can be understood in particular to mean that the system comprises a connection system in which components of the container device and the dosing device interact with components of the production system. For example, corresponding ports are used. The use of a so-called RTP (Rapid Transfer Port) is particularly conceivable. In this case, the connection device can comprise an insertion opening of the production system and a closing element arranged thereon for selectively opening and closing the insertion opening. A respective removal opening can be arranged on the container device or the dosing device, as well as a corresponding closing element with which the removal opening can be opened or closed.When the container device or dosing device is docked, the removal opening and the insertion opening can communicate with each other, allowing the contents of the container device or dosing device to be introduced into the processing chamber. If an RTP is provided, an alpha port can be provided on the production system, and a beta port can be provided on the container device or dosing device.

[0014] The at least one connection device can, for example, be arranged directly on a wall of the at least one processing chamber, to which the container device or the dosing device can be docked. The production material and / or the filling line and the filling needle can be introduced directly into the processing chamber by means of the handling device.

[0015] The production system can optionally include an injection cell, which has at least one connection device for the container device and / or for the dosing device. The production material and / or the filling line and the filling needle can be introduced into the processing chamber through the injection cell, for example, by means of the handling device.

[0016] According to the above, it can be provided that production material and / or dosing material can be introduced directly or indirectly, through the optional coupling cell, into the at least one processing chamber.

[0017] Typically, each receiving body will accommodate a plurality of containers or a plurality of closure elements. However, the invention is not limited to this. It can be provided that each receiving body accommodates only one container or only one closure element.

[0018] Containers and closure elements are accommodated, for example, in separate receiving bodies. However, it can be provided that at least one container and at least one closure element are accommodated in one receiving body.

[0019] The receiving bodies can be transferred via the handling device, for example, together with containers or closure elements, into the at least one processing chamber. Alternatively, it is conceivable for the receiving bodies to remain in the container device and only the containers or closure elements to be transferred into the processing chamber.

[0020] Conveniently, the system comprises at least one control device for controlling the at least one production system and / or the at least one preparation device. Each production system and / or each preparation device may comprise an independent control device. Two or more control devices may be linked to one another via information technology. The control device of the production system is intended, in particular, to control the robotic handling device, the filling station, and / or the closing station.

[0021] The system may comprise at least one data processing device for controlling and / or regulating the system. The data processing device may be located locally at the system location or remotely. The data processing device may be implemented as one or more servers located, for example, in a cloud.

[0022] The data processing device may comprise or form the at least one control device, or vice versa.

[0023] Preferably, the system is characterized by a cleanliness class of at least one processing room according to GMP Type A. If the containers in the production facility have been pharmaceutically sealed in one processing room, a subsequent processing room can have a lower cleanliness class, for example, according to GMP Type C.

[0024] If the production facility has a uniform cleanliness class throughout, particularly of type GMP A, in at least one processing room and, if available, an optional coupling cell and / or coupling cell, it is particularly possible to implement a truly closed isolator facility in the production facility, as described in Annex 1, "Manufacture of Sterile Medicinal Products" of August 2022, to the EU Guidelines for Good Manufacturing Practice (Annex 1, "Manufacture of Sterile Medicinal Products," to the "Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use"). Accordingly, the production facility preferably includes or forms a closed isolator facility in accordance with Annex 1, "Manufacture of Sterile Medicinal Products," to the EU Guidelines for Good Manufacturing Practice of August 2022.

[0025] Advantageously, the system is characterized by a cleanliness class of at least one workspace according to GMP Type C or better. For example, it can be provided that a workspace has a cleanliness class of GMP A. This is, for example, the workspace from which the production material is transferred to the container device that is docked to the preparation device. Advantageously, the system is characterized by a cleanliness class of GMP A for the receiving space of the dosing device. The same applies to the interior of the container device when docked to the at least one production system.

[0026] It may be advantageous if the system comprises a separate sterilization device, which is arranged, for example, spatially separate from the at least one production facility and the at least one preparation device. The sterilization device can in particular be an autoclave device. The sterilization device is preferably designed to sterilize objects held in the at least one container device and / or the at least one dosing device. This offers, for example, the possibility of carrying out terminal sterilization after filling the at least one container device and / or the at least one dosing device. This proves to be advantageous, for example, in the case in which the preparation device and thus the objects do not (yet) have the required level of purity when introduced into the container device and / or the dosing device.Terminal sterilization allows the container device and / or the dosing device to be upgraded to a higher purity class, for example type GMP A.

[0027] The at least one preparation device can, for example, comprise an insertion opening through which the production material can be introduced into the work area. For example, closure elements are inserted into bags, which are sorted in the production device and transferred into the receiving bodies. Alternatively or additionally, secondary packaging materials with the containers, which represent primary packaging materials, are inserted into the preparation device through the insertion opening, unpacked therein, and the containers are removed from the secondary packaging materials.

[0028] The at least one preparation device comprises, for example, a removal opening of the connection device, via which the production material can be transferred into the container device. In a manner corresponding to that already explained in connection with the at least one production system, a connection system is preferably formed via the preparation device and the container device and / or the dosing device, with closing elements at the removal opening of the preparation device and at the container device and / or the dosing device. Advantageously, an RTP is used with an alpha port on the preparation device and a beta port on the container device and / or at the dosing device. The at least one production device can comprise a disposal opening for waste. Furthermore, a disposal station can be provided in the work space, for example, via which waste can be disposed of during preparatory actions.

[0029] With regard to required and / or desired purity levels, it may be advantageous if the at least one preparation device comprises or forms at least one of the following: a pharmaceutical isolator device, with which a GMP A purity class can be advantageously provided in the work space; a decontamination device for providing a defined decontamination atmosphere in the at least one work space, in particular using H2O2, and / or a connection element for connecting an external decontamination device to the preparation device. For example, non-product-contact components that are to be transferred to the production facility can be decontaminated using the H2O2 atmosphere.

[0030] The system may comprise two or more preparation devices. The preparation devices may be identical or different.

[0031] The system can be provided with a preparation device for preparing the containers and a separate preparation device for preparing closure elements. It is understood that, for example, the containers or the closure elements can be picked up and transported to at least one production facility via different container devices.

[0032] The system can, for example, comprise a preparation device for providing culture media for introduction into the at least one production facility via the at least one container device, wherein the production facility is preferably separate from a production device for providing containers and / or closure elements. Culture media carriers are used in the production facility, for example, to monitor sterility. Using a suitable production device, culture media carriers are introduced into the work area in bags and, arranged in receiving bodies, are introduced into the container device, via which the culture media carriers are transported to the at least one production facility.The system can, for example, comprise a preparation device for preparing format parts and / or machine parts for introduction into the at least one production facility via the at least one container device, wherein the preparation device is preferably separate from a production facility for preparing containers and / or closure elements. Format parts, which are in particular designed to be container-specific or closure-element-specific, can also be prepared in this way outside the processing space of the production facility and subsequently transported to the at least one production facility via the at least one container device. Sterilization and / or decontamination of format parts and machine parts can take place in the production facility or in a separate sterilization facility.

[0033] It has already been mentioned that the at least one dosing device can be docked to a production device. Accordingly, it can be advantageous if the system comprises a preparation device for providing the dosing material in the work space, wherein the at least one dosing device can be docked to the preparation device and the dosing material can be transferred into the receiving space. The dosing material, in particular a filling line and a filling needle, can be prepared externally to the at least one production system in this way. In this case, sterilization and / or decontamination in the preparation device or a separate sterilization device is conceivable. The dosing material can comprise, for example, a fluid line, a filling needle, a dosing unit, a container for receiving the product and / or a filter element that is connected to the fluid line for introduction into the dosing device.

[0034] It can be provided that the at least one preparation device comprises two separate working spaces which are connected to each other via a transfer opening.

[0035] The transfer opening can be permanently open, for example, if both work spaces have the same purity class. If the work spaces have different purity classes, an open transfer opening can be provided if a gas flow is present from the work space with the higher purity class to the work space with the lower purity class. Such a gas flow is preferred if a closing element is present at the transfer opening that is only temporarily open for the transfer. A lock device can be provided at the transfer opening, which can preferably be decontaminated via an H2O2 cycle. In one of the two work spaces, for example, production material is prepared, in particular unpacked and / or decontaminated, wherein the production material is introduced into the second work space via the transfer opening, and wherein the container device can be docked in the region of the second work space.

[0036] The preparation of production material, which in particular includes containers, closure elements, culture media, and / or format parts, can be carried out in two stages with such a preparation device. For example, the production material is introduced into the first workspace, where it can be unpacked, for example, and subsequently sterilized and / or decontaminated. For this purpose, a glove port for a user is provided in the first workspace. The production material prepared in this way can be inserted in the second workspace, for example, in receiving bodies for transfer to the production facility. The second workspace can provide a glove port for the user and / or a robotically controllable handling device.

[0037] According to the above, it may be advantageous if the at least one preparation device comprises a controllable robotic handling device for moving the production material in the at least one work space and / or if the at least one preparation device has at least one glove opening for a user in the at least one work space.

[0038] It can be provided that the system comprises a storage device, spatially separate from the at least one production facility and the at least one preparation device, for temporarily storing filled container devices and / or dosing devices after filling at the at least one preparation device and before use at the at least one production facility. The container devices and / or dosing devices can be temporarily stored via the storage device so that production cycles can be processed efficiently. The time of preparation of the container devices and / or dosing devices can, for example, be decoupled from the time of production. Advantageously, a sterile status of a respective container device and / or dosing device is monitored in this case.This is achieved, for example, by pressurizing the container device and / or the dosing device and monitoring the positive pressure difference or by a pressure recorder. The container device and / or dosing device can be transported to the production facility in a timely manner, and production can begin. The at least one dosing device can comprise at least one of the following, preferably in the receiving space: the fluid line and the filling needle; a container for receiving the product to be filled; a dosing unit for conveying the product through the fluid line, for example, designed as a pump unit; and a filter element connected to the fluid line, for example, a sterile filter.

[0039] The system may comprise two or more production plants, which may be identical or different.

[0040] The at least one production system can, for example, comprise two connection devices, which are preferably designed differently from one another. Depending on the connection device, different types of devices can be docked. For example, the at least one container device can be docked to one connection device and the at least one dosing device can be docked to the other connection device. The different types of connection devices differ, for example, in terms of their size, but are otherwise functionally identical. For example, RTPs of different sizes are used. By using different types of connection devices, handling can be simplified and incorrect operation can be avoided, for example, by ensuring that a device can only be docked to the correct connection device.

[0041] The filling station and the closing station can be arranged in the same processing area of ​​the at least one production system. Such a configuration can be used, for example, for processing syringes or cartridges that are considered pharmaceutically sealed with only one closure element.

[0042] In one exemplary embodiment, the at least one production system comprises a further processing chamber and a further closing station arranged in the further processing chamber, wherein the processing chambers are connected to one another via a transfer opening. Such a production system accordingly comprises two closing stations. In particular, it can be provided that the filling station and the closing station are positioned in one processing chamber, and the further closing station is positioned in the further processing chamber. Such a production system is used, for example, for processing vials, which must first be closed with stoppers and then with crimp caps in order to be considered pharmaceutically sealed.

[0043] The transfer opening can be permanently open, for example, if both processing chambers have the same purity class. If the processing chambers have different purity classes, an open transfer opening can be provided if a gas flow is present from the processing chamber with the higher purity class to the processing chamber with the lower purity class. Such a gas flow is preferred if a closing element is present at the transfer opening that is only temporarily open for the transfer. A lock device can be provided at the transfer opening, which can preferably be decontaminated via an H2O2 cycle.

[0044] In an exemplary embodiment, the at least one production facility can comprise an additional processing chamber with a cleaning station, which is preferably connected to the at least one processing chamber via a transfer opening. Such a production facility is used, for example, in the processing of toxic products that require external cleaning after filling and sealing. The above-mentioned statement applies to the transfer opening. The processing chamber can have a GMP Type C cleanliness class.

[0045] In an exemplary embodiment, the at least one production facility can comprise a further processing chamber with a freeze-drying station, which is preferably connected to the at least one processing chamber via a transfer opening. Such a processing chamber is located, for example, downstream of a processing chamber with a filling station and closing station, in which vials are filled and sealed with stoppers, and upstream of another processing chamber in which the vials are provided with crimp caps. The above-mentioned applies to the transfer opening.

[0046] In a preferred embodiment of the invention, the at least one production system is designed without a glove opening for the user. All manipulation and / or handling processes can advantageously be carried out via the handling device in the at least one processing room. It is conceivable that the at least one container device and / or the at least one dosing device are transported and, in particular, carried by a user.

[0047] The at least one container device and / or the at least one dosing device can be designed to be portable for transport.

[0048] However, it is advantageous if the system comprises at least one transport device by which the container device is received or detachably received, and / or if the system comprises at least one transport device by which the dosing device is received or detachably received, wherein the at least one transport device comprises a chassis for moving on a support surface. This facilitates the handling of the container device and the dosing device.

[0049] Container devices and / or dosing devices can be transported via the at least one transport device, in particular from the preparation device to the production facility, if necessary to the sterilization device and / or the storage device. After filling and sealing, the container devices can be picked up via the at least one transport device and forwarded for further processing, for example, inspection, labeling, and / or further packaging.

[0050] In a preferred embodiment of the invention, the at least one transport device is designed to be self-propelled and self-steering for autonomous transport of the at least one container device or the at least one dosing device. This enables the system to be highly automated. For example, transport devices are provided that can be controlled by means of the aforementioned data processing device. The transport devices include, for example, a map of the surrounding area in a storage unit, based on which transport paths can be planned, managed, and / or processed.

[0051] Identification devices can be provided by means of which transport devices can identify the container devices, dosing devices, production devices and / or production systems in order to ensure that production can proceed as intended in such a way that the respective container device or dosing device is transported to the production system in good time and ready for the start of production and / or is picked up from the preparation device after setup.

[0052] The system advantageously comprises a data processing device with a storage unit in which a production plan is stored, wherein at least one of the following can be controlled by the data processing device directly or indirectly based on the production plan: the at least one production plant, the at least one preparation device, the at least one transport device.

[0053] As mentioned above, the present invention also relates to a method. A method according to the invention for operating a system of the type described above comprises:

[0054] - Docking of at least one container device to the at least one production plant;

[0055] Introducing a receiving body, which receives at least one container to be filled in a predefined arrangement, into the processing space by means of the at least one handling device;

[0056] Introducing a receiving body, which receives at least one closure element in a predefined arrangement, into the at least one processing space by means of the handling device;

[0057] - Docking of at least one dosing device to the at least one production plant, introducing the filling needle and, at least partially, the filling line into the at least one processing chamber; and

[0058] Filling and closing at least one container.

[0059] The container device and the dosing device can be docked simultaneously or one after the other, with the container device being docked before the dosing device or vice versa.

[0060] The advantages already described in connection with the explanation of the system according to the invention can also be achieved by implementing the method. Reference is made to the above explanations in this regard. Advantageous embodiments of the method according to the invention result from advantageous embodiments of the system according to the invention. Reference is made to the above explanations.

[0061] The following description of preferred embodiments of the invention, taken in conjunction with the drawings, serves to explain the invention in more detail. They show:

[0062] Figure 1: a schematic representation of the system according to the invention in a preferred

[0063] embodiment;

[0064] Figure 2: the system from Figure 1 in a schematic representation with an exemplary

[0065] Layout of the arrangement of the components of the system;

[0066] Figure 3: a production plant of the system as marked "A" in Figure 2 in an enlarged, more detailed view;

[0067] Figure 4: another production plant of the system as marked "B" in Figure 2 in an enlarged, more detailed view;

[0068] Figure 5: another production plant of the system as marked "C" in Figure 2 in an enlarged, more detailed view;

[0069] Figure 6: another production plant of the system as marked "D" in Figure 2 in an enlarged, more detailed view;

[0070] Figure 7: a preparation device of the system according to the marking "E" in Figure 2 in an enlarged, more detailed view;

[0071] Figure 8: another preparation device of the system according to the marking "F" in Figure 2 in an enlarged, more detailed view;

[0072] Figure 9: another preparation device of the system according to the marking "G" in Figure 2 in an enlarged, more detailed view;

[0073] Figure 10: another preparation device of the system according to the marking "H" of the

[0074] System from Figure 2 in an enlarged view of the detail top left in Figure 2;

[0075] Figure 11: a schematic representation of a container device of the system;

[0076] Figure 12: a schematic representation of a receiving body with containers;

[0077] Figure 13: a schematic representation of a receiving body with closure elements;

[0078] Figure 14: a schematic representation of a dosing device of the system in a plan view in an open view; and

[0079] Figure 15: A schematic representation of a transport device of the system. In the drawing, reference numeral 100 denotes a system according to the invention for processing pharmaceutical containers, which are designated by reference numeral 102. The containers can be, for example, vials, syringes, cartridges, and / or ampoules. The containers 102 can be stable or non-stable.

[0080] System 100 is a preferred embodiment of the system according to the invention and enables the implementation of a preferred embodiment of the method according to the invention. Features of preferred embodiments of the method result from features of preferred embodiments of the system.

[0081] The system 100 is used to fill the containers 102 with a pharmaceutical product and then seal them. Production takes place according to a production plan, which includes specifications for the containers to be used, the product to be filled, the type of processing in production facilities, and the hygiene requirements to be observed. Furthermore, the production plan can store information, in particular, regarding preparation for production.

[0082] While Figure 1 illustrates the system 100 in a schematic block diagram by way of example, Figure 2 shows the system 100 in a layout in an environment 104 defined by a building 106. Other layouts of the system 100 are conceivable. The following description is not limiting in this regard.

[0083] In the present example, the system 100 comprises several production systems 108 for filling and closing the containers 102. In the present example, two identically designed production systems 108 are provided, each labeled with the letter "A." Three additional production systems 108, which differ from the production system 108A ("108+A") and from each other, are labeled "B," "C," and "D" and are designated by the reference symbols 108B, 108C, and 108D. Unless reference is made to a specific production system below, it is generally designated by the reference symbol 108.

[0084] Accordingly, the system 100 comprises at least one preparation device 110. In the present case, several preparation devices are provided, which are labeled "E", "F", "G", and "H" and are designated by the reference numerals 110E, 110F, 110G, and 110H. Where reference is made to only one preparation device in general below, this is designated by the reference numeral 110. In the present exemplary embodiment, the environment 104 comprises several rooms 114 separated from one another by walls. The production systems 108 are each located in their own rooms 114. The preparation devices 110 are arranged in the same room 114. The environment 104 may comprise a corridor 116 or the like, to which the rooms 114 are adjacent.

[0085] Overall, it may be advantageous if the preparation devices 110 are spatially separated from the production systems 108. More than one production system 108 may be arranged in a room 114, and / or more than one preparation device 110 may be arranged in a room 114.

[0086] The system 100 preferably further comprises a sterilization device 118, which is positioned separately from the production devices 108 and the preparation devices 110.

[0087] Furthermore, the system 100 may include a storage device 120 positioned separately from the production equipment 108 and the preparation equipment 110.

[0088] Furthermore, the system 100 may include at least one system 122 for further processing filled and sealed containers 102. The systems 122 may include, for example, an inspection system 124, a labeling system 126, and / or a processing system 128 for further processing filled and sealed syringes.

[0089] The system 100 further comprises at least one container device 130, wherein in the present case a plurality of container devices 130 are provided.

[0090] Furthermore, the system 100 comprises at least one dosing device 132, in this case a plurality of dosing devices 132.

[0091] Furthermore, the system 100 comprises at least one transport device 134, in this case advantageously a plurality of transport devices 134.

[0092] The system 100 further comprises a control device 136 associated with a respective production facility 108. The control device 136 is arranged, for example, at the location of the production facility 108 and encompassed by it. The control devices 136 can be coupled to one another for the exchange of data. A control device 136 can also be arranged on one or more preparation devices 110 or encompassed by them.

[0093] Furthermore, the system 100 can include a data processing device 138 that can communicate with the control devices 136. The data processing device 138 can be formed by one or more servers and, for example, can be implemented via a cloud 140.

[0094] The data processing device 138 comprises a storage unit 142 in which, for example, the aforementioned production plan 144 is stored.

[0095] The data processing device 138 may comprise or form the control device(s) 136, or vice versa.

[0096] A respective production facility comprises a processing space 146. It is understood that the production facility 108 may comprise at least one chamber 148 with a wall 150 that encloses a processing space 146.

[0097] A filling station 152 is arranged in each processing chamber 146, where the containers 102 are filled with the pharmaceutical product. Furthermore, a closing station 154 is arranged in each processing chamber 146. The containers 102 are closed via the closing station 154 using a closure element 156 provided for this purpose.

[0098] A controllable robotic handling device 158 is arranged in the processing chamber 146. The handling device 158 can, in particular, handle the containers 102 and the closure elements 156. It is understood that more than one handling device 158 can be arranged in each processing chamber 146.

[0099] Upstream of the processing space 146, a production system 108 can optionally comprise a coupling cell 160, which can be connected to the processing space 146 via a transfer opening 162. In the present example, this applies to the production systems 108A, 108B, and 108C, but not to the production system 108D, which in the present example does not comprise a coupling cell 160.

[0100] The production system 108 comprises, at the processing chamber 146 and / or at the coupling cell 160, a connection device 164 for docking a respective container device 130 and a connection device 166 for docking a respective dosing device 132. Containers 102 and closure elements 154 can be fed to the processing chamber 146 directly or optionally indirectly via the coupling cell 160, in both cases via the handling device 158.

[0101] In the present example, the connection devices 164, 166 are designed differently. This ensures that the container device 130 and the dosing device 132 are docked at the correct position on the production system 108. The connection devices 164, 166 differ from one another, for example, in their size, but are otherwise functionally identical.

[0102] The connection devices 164, 166 are part of a respective connection system 168, whereby in this case, an RTP (Rapid Transfer Port) is used. For this purpose, the connection devices 164, 166 each comprise a closing element 170 for selectively opening or closing an insertion opening 172. This forms the alpha port of the RTP. The closing elements are shown schematically in an open position in the drawing.

[0103] A closing element 174 is arranged on the respective container devices 130 or dosing devices 132 for selectively opening or closing a discharge opening 176. This forms the beta port of the RTP.

[0104] Other connection systems or locking systems are conceivable.

[0105] In Figure 2, a solid line 178 indicates a path 179, via which, in the present example, containers 102 and closure elements 156 can be fed to the production systems 108 by means of container devices 130. Furthermore, culture media carriers, format parts, and / or machine parts, for example, can be fed via path 179 for use or application in the production systems 108.

[0106] A dotted line 180 indicates a path 181. In the present example, the dosing devices 132 are transported to the production systems 108 via path 181.

[0107] The production system 108A is intended for processing vials and comprises a further processing chamber 182, which is connected to the processing chamber 146 via a transfer opening 162. In the processing chamber 146, the vials are filled and sealed with supplied stoppers and then transferred to the processing chamber 182, in which a further controllable robotic handling device 158 is arranged. Closure elements 156 in the form of crimp caps are supplied via a further connection device 164 for container devices 130. The vials sealed with stoppers are pharmaceutically sealed with the crimp caps in the processing chamber 182.

[0108] The production systems 108A and 108C comprise, in this case, an optional decoupling cell 184 downstream of the processing chamber 182, which is connected to the processing chamber 182 via a transfer opening 162. A connection device 164 for container devices 130 is provided on the decoupling cell 184. Sealed containers 102 can be fed to the decoupling cell from the processing chamber 146 via the handling device.

[0109] Filled and sealed containers 102 can be uncoupled via the uncoupling cell 184 and transferred to a container device 130. From there, the containers 102 can be fed for further processing along a path 186, symbolized by a dashed line 187. For example, they are first fed to the inspection system 124 and then to the labeling system 126, or in the case of syringes, to the processing system 128.

[0110] Used culture media, for example, are fed to an analysis station 188 and analyzed there.

[0111] The production facility 108B does not have an additional processing room 182. In the production facility 108B, syringes are processed that are pharmaceutically sealed by inserting the plunger stopper. The supply of production material occurs, for example, via the injection cell 160, which can also be used as an output cell 184 for the filled and sealed syringes.

[0112] In this case, the production system 108C is intended for processing vials containing a toxic product. In addition to the processing chambers 146, 182, a further processing chamber 190 is provided, which is located downstream of the processing chamber 182 and connected to it via a transfer opening 162. In this case, the decoupling cell 184 is connected to the processing chamber 190.

[0113] A cleaning station 192 for cleaning the exterior of the pharmaceutically sealed vials is arranged in the processing room 190. A handling device 158 is preferably also provided. Starting from the production system 108C, the container devices 130 filled with the filled containers 102 can be conveyed for further processing via a further room 114, which can be a washroom, for cleaning the exterior of the container devices 130.

[0114] The production facility 108D comprises a further processing chamber 194, which is arranged between the processing chambers 146 and 182 and is connected to each of them via a transfer opening 162. A freeze-drying station 196 is arranged in the processing chamber 194 for processing the containers 102 by means of freeze-drying.

[0115] Figures 3 to 6 schematically depict the processing process for a respective container 102 at the top of the respective processing room, with a respective arrow 197: In the production systems 108A, 108C, and 108D, the processing of the empty container 102 with filling and simple closure with caps is shown in processing room 146; in the processing room 182, the pharmaceutical closure with crimp caps is shown; these are not shown separately; for the sake of clarity, the drawing symbolically shows only one closure element 156. In the production system 108B, the filling and pharmaceutical closure in a processing room 146 are shown. In the production systems 108C and 108D, the external cleaning of the pharmaceutically sealed container is shown in processing room 190; in the production system 108D, the freeze-drying of the not yet pharmaceutically sealed container 102 is also shown.

[0116] Advantageously, the production systems 108 in the processing rooms 146, 182, and 194 and in the optional coupling cell 160, if present, each have a GMP A purity class. Accordingly, the production system 108 preferably has continuous insulation properties up to the processing room in which the containers are pharmaceutically sealed. In this case, the respective transfer openings 162 between Class A processing rooms or the Class A coupling cell 160 can, for example, be permanently open, as explained above.

[0117] A processing room adjoining the processing room 182 in which the containers are pharmaceutically sealed may have a lower purity class, for example, type GMP C. In the production systems 108C, 108D, this is the processing room 190. The same may apply to the optional coupling-out cell 184, unless, as in the production system 108B, it also serves as the coupling-in cell 160. In the case of the type C rooms, a closing element with gas flow from the type A processing room or a lock device, as explained above, is preferably arranged at the transfer openings 162.

[0118] However, it is conceivable that the processing chamber 190 and the optional coupling cell 184 also have a cleanliness class of type GMP A.

[0119] If a production facility 108 has a uniform cleanliness class throughout, in particular of type GMP A, in the processing room 146 and, if present, at least one further processing room and, if applicable, an optional coupling cell 160 and / or coupling cell 184, it is particularly possible to implement a truly closed isolator facility in the production facility 108, as described in Annex 1, "Manufacture of Sterile Medicinal Products" of August 2022, to the EU Guidelines for Good Manufacturing Practice (Annex 1, "Manufacture of Sterile Medicinal Products", to the "Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use").

[0120] Accordingly, the production facility 108 preferably comprises or forms a closed isolation facility in accordance with Annex 1, "Manufacture of sterile medicinal products", to the EU Guide to Good Manufacturing Practice of August 2022.

[0121] In particular, it is possible to supply production material and dosing material via Class A container devices 130 and Class A dosing devices 132, respectively, and to remove the filled and pharmaceutically sealed containers 102 via a Class A container device that is docked to the production system 108 and to supply them for further processing, for example in one of the systems 122.

[0122] In system 100, the actual production in one of the production facilities 108 and the preparation of production in one or more of the preparation facilities 110 are decoupled from each other and, in particular, spatially separated. This makes it possible to ensure the hygienic properties in the production facilities 108 that are specified by production and stored, for example, in the production plan 144.

[0123] The decoupling of preparation and production allows for the long-term maintenance of purity characteristics, as the likelihood of disruption during production is reduced. Downtimes of the production equipment 108 are minimized, thereby increasing production throughput. In particular, the system 100 proves advantageous for processing small or very small quantities, for example, when filling toxic products and / or in the high-potency range.

[0124] In this context, it also proves to be advantageous that the decoupling of preparation and production means that the production facilities 108 require less space than conventional production facilities and systems.

[0125] The decoupling of preparation and production also proves advantageous for scaling and / or expanding the system 100. Depending on the requirements, for example, the number of preparation devices 110 can be adapted to the needs of the production systems 108 without having to use complete units in which both preparation and production are carried out, as is the case with conventional systems.

[0126] With regard to reliable and preferably unmanned processing in the production systems 108, it is advantageous if the containers 102 are arranged in a predefined arrangement in receiving bodies 198. Figures 11 and 12 show, by way of example, such a receiving body 198 with a magazine-shaped design.

[0127] In a corresponding manner, the closure elements 156 in the present case are also arranged in a predefined arrangement in receiving bodies 200. This is shown schematically in Figure 13 with a receiving body 200 in a magazine-shaped configuration.

[0128] Although the drawing shows a plurality of containers 102 and closure elements 156 in the receiving body 198 or 200, it can be provided that only one container 102 or only one closure element 156 is received in a respective receiving body.

[0129] By means of the robotic handling devices 158, the receiving bodies 198, 200 supplied via the container devices 130 can be removed from the interior spaces 202 of the container devices 130 and transferred to the processing chamber 146, 182 or the coupling cell 160 for processing. Based on control data, the handling device 158 can feed the containers 102 to the filling station 152 and subsequently to the closing station 154. Based on control data, the handling device 158 can feed the closure elements 156 to the closing station 154. Required control data is stored, for example, in the production plan 144 and can be transmitted to the control device 136.

[0130] After filling and closing, the handling devices 158 can feed the receiving bodies 198, 200 back into the interior spaces 202 of docked container devices 130 for further processing.

[0131] The preparation devices 110 are provided for preparing production material.

[0132] A respective preparation device 110 comprises a working space 204. It is understood that the preparation device 110 may comprise a chamber 206 with a wall 208 that encloses the one working space.

[0133] A connection device 164 for docking a container device 130 or, depending on the function, a connection device 166 for docking a dosing device 132 is arranged on each preparation device 110. It is conceivable that both connection devices 164, 166 are provided.

[0134] In this case, the preparation device 110E serves to prepare the containers 102. For this purpose, an insertion opening 210 is provided through which secondary packaging materials, for example, tubs 218 with outer packaging 220, are inserted. Packaging can be removed by the user via a glove opening 212 and disposed of via a disposal opening 214. At least one manual or automated disposal station 216 can be provided.

[0135] The preparation device 110 comprises in the present case the working space 204, in which the tubs 218 are freed from the outer packaging, as well as a further working space 222, which is connected to the working space 204 via a transfer opening 162.

[0136] The unpacked tubs 218 are transferred into the workspace 222. This can be done manually by an operator or by a controllable robotic handling device 224 arranged in the workspace 222.

[0137] It can be provided that a controllable robotic handling device 224 is also arranged in the work space 204. For example, the containers 102, which can be nested in the tub 218, are removed in the work space 222. The nest as a receiving body 198 or a separate receiving body 198 can be inserted into a docked container device 130 via a removal opening 226 of the connection device 164. Packaging material, for example the empty tub 218 or a cover film 228 of the tub 218, can be removed via further disposal openings 214.

[0138] It is understood that the system 100 is not limited to processing containers supplied via tubs 218. However, the ability to process RTU (ready-to-use) production material generally proves advantageous.

[0139] The preparation device 110F is provided here to prepare closure elements 156. The closure elements 156, which are supplied loosely, for example, via a bag, are introduced into the work space 204 via the insertion opening 210. A work station 230 is preferably arranged in the work space 204. In the present example, the work station 230 comprises a sorting pot 232. In general, the work station 230 preferably comprises a device for ensuring a defined position and orientation of the closure elements. A handling device 224 is advantageously provided. A control station 234 may be provided, for example, for checking the roundness of crimp caps.

[0140] The closure elements 156 are inserted into the receiving body 200 in a defined position and orientation and placed into a docked container device 130 via the removal opening 226. Packaging can be disposed of via a disposal opening 214.

[0141] In the present example, the preparation device 110G is provided to provide culture medium carriers 236. For example, the culture medium carriers 236 are introduced into the work space 204 via a bag, another type of packaging, or loosely through the insertion opening 210. The preparation device 110G preferably includes at least one glove opening 212, since culture medium carriers 236 can only be handled robotically to a limited extent.

[0142] The culture medium carriers 236 can be placed loose or in a magazine through the removal opening 226 into a docked container device 130. The preparation device 110H is provided here to equip the dosing device 132. For this purpose, dosing material 240 can be introduced into the work space 204. A glove opening 212 and / or a handling device 224 can be provided.

[0143] The dosing material 240 comprises, for example, a container 242, for example in the form of a bag, for the product, a dosing unit 244 for conveying the product, a fluid line 246, a filling needle 248 arranged thereon and / or a filter element 250 in the form of a sterile filter in the fluid line 246. The dosing unit 244 can, for example, be a pump unit.

[0144] The dosing material 240 can be transferred into the receiving space 252 of the docked dosing device 132.

[0145] During production, the dosing device 132 can be docked to the connection device 166. Via the handling device 158, the fluid line 246, at least partially, and the filling needle 248 can be introduced into the processing chamber 146 and arranged at the filling station 152 for filling.

[0146] Alternatively or additionally, for example, a holding part on which the filling needle 248 and / or the fluid line 246 are held and which is transferred from the receiving space 252 of the dosing device 132 into the processing space 146 can form part of the filling station 152.

[0147] Figure 2 schematically illustrates a preparation station 254. At the preparation station 254, a dosing device 132 can be manually set up by a user 256 away from the preparation device 110H.

[0148] The respective preparation device 110 can have a required degree of cleanliness. For example, a respective workspace has a cleanliness class of type GMP C or better. In particular, a cleanliness class of type GMP A can be provided.

[0149] To achieve a specified purity class, the preparation facility 110 may include or form a pharmaceutical isolator device 258. For example, in the present example, the preparation facilities 110E (at the workspace 222), 110F, 110G, and 110H are isolator devices in which the purity class GMP A prevails. The isolator device may have ISO class 5. Correspondingly, the respective production facility 108 may include or form a pharmaceutical isolator device 258, in particular of isolator class 5.

[0150] Alternatively or additionally, a decontamination device 260 may be provided, in particular for providing a decontamination atmosphere, for example by means of H2O2.

[0151] In the preparation device 110, the working chamber 204 may, for example, have a lower cleanliness class than the second working chamber 222. Decontamination takes place, for example, in the isolator device 258 in the working chamber 222.

[0152] If necessary, a terminal sterilization of the container devices 130 and / or the dosing device 132 can be carried out after filling at the external sterilization device 118 in order to bring the respective contents of the devices 130, 132 to the intended purity class.

[0153] The storage facility 120 is provided for temporarily storing filled and sealed container devices 130 and / or dosing devices 132 after production and before use in the production plant 108. The required container devices 130 and / or dosing devices 132 can be picked up from the storage facility 120 as needed and transported to the respective production plant 108.

[0154] Figure 15 shows a schematic view of the transport device 134. This device has a chassis 264 for moving on the installation surface 262.

[0155] In principle, it is conceivable that the transport device 134 is user-guided and is used by the user 256 for the transfer of the container devices 130 and / or the dosing devices 132.

[0156] Alternatively or additionally, the transport device 134 can preferably be designed to be self-propelled and self-steering and can be moved autonomously across the installation surface 262. Accordingly, the transport device 134 is, in particular, a transfer robot, which can comprise a control device 266 and a drive unit 268 for the chassis 264 for movement. The control device 266 is connected, for example, to the data processing device 138 and / or the control devices 136. The transport device 134 can comprise a gripping element 270 with which the container device 130 and / or the dosing device 132 can be releasably picked up, for example, from the preparation device 110, the sterilization device 118, or the storage device 120, and with which they can be transferred to the production system 108.It is understood that after production, the further transport of the container device 130 can preferably be carried out via the transport device 134.

[0157] The dosing device 132 can, in turn, have a chassis 264, as shown in Figure 14, and is advantageously also designed robotically, as described in connection with the transport device 134. In this case, no separate transport device 134 is required to transport the dosing device 132.

[0158] List of reference symbols

[0159] System, 242 containers

[0160] Vicinity

[0161] Building

[0162] production facility

[0163] Preparation facility

[0164] Space

[0165] corridor

[0166] Sterilization facility

[0167] Storage facility

[0168] Attachment

[0169] Control system

[0170] Labeling system

[0171] processing plant

[0172] Container equipment

[0173] Dosing device

[0174] T ransport device, 266 control device

[0175] Data processing facility

[0176] Cloud

[0177] storage unit

[0178] Production plan, 182, 190, 194 Processing room, 206 Chamber, 208 Wall

[0179] filling station

[0180] Locking station

[0181] Closure element, 224 handling device

[0182] Coupling cell

[0183] Transfer opening, 166 connection device

[0184] Connection system , 174 Closing element , 210 Insertion opening , 226 Removal opening solid line , 181 , 186 Path dotted line

[0185] Output cell dashed line analysis station

[0186] Cleaning station freeze-drying station arrow, 200 holding bodies

[0187] Interior, 222 work space

[0188] chamber

[0189] Glove opening

[0190] Disposal opening disposal station tub

[0191] Outer packaging

[0192] Cover film

[0193] workstation

[0194] sorting pot

[0195] Control station

[0196] Culture media

[0197] Dosing material

[0198] Dosing unit

[0199] Fluid line

[0200] Filling needle

[0201] filter element

[0202] recording room

[0203] Preparation station user

[0204] Isolator device

[0205] Decontamination facility installation area

[0206] chassis

[0207] Drive unit 270 gripping element

Claims

PATENT CLAIMS 1. System (100) for processing pharmaceutical containers (102), comprising: at least one production system (108) for filling and closing the containers (102), which comprises, in at least one processing space (146, 182, 190, 194), a filling station (152) for filling the containers (102) with a pharmaceutical product and a closing station for closing the containers with closure elements (156), wherein the at least one production system (108) comprises a controllable robotic handling device (158) arranged in the at least one processing space (146, 182, 190, 194), designed for handling pharmaceutical production material, which comprises containers (102) and / or closure elements (156) received in a predefined arrangement in receiving bodies (198, 200), and the at least one connection device (164,166) for docking an external transportable container device (130) and / or an external transportable dosing device (132); at least one preparation device (110) which is or can be arranged spatially remote from the at least one production system (108) and comprises or forms at least one work space (204, 222) and at least one connection device (164) for docking the container device (130), wherein pharmaceutical production material can be introduced into the at least one work space (204, 222), which production material comprises containers (102) to be processed and / or closure elements (156), wherein the containers (102) and / or the closure elements (156) can be inserted into receiving bodies (198, 200) in a predefined arrangement in the at least one work space (204, 222); at least one transportable container device (130) via which the material contained in the receiving body (198,200) and / or the closure elements (156) accommodated in the receiving body (198, 200) can be brought from the at least one preparation device (110) directly or indirectly to at least one production plant (108) and, when the container device (130) is docked to the at least one production plant (108), can be introduced into the at least one processing space (146, 182, 190, 194) by means of the handling device (158); at least one transportable dosing device (132) which comprises pharmaceutical dosing material (240) in a receiving space (252), which, a fluid line (246) and a filling needle (248) arranged thereon, which can be introduced into the at least one processing space (146, 182, 190, 194) by means of the handling device (158) when the dosing device (132) is docked to the at least one production system (108).

2. System (100) according to claim 1, characterized in that the system (100) comprises at least one control device (136) for controlling the at least one production plant (108) and / or the at least one preparation device (110).

3. System (100) according to claim 1 or 2, characterized by a cleanliness class of the at least one processing space (146, 182, 190, 194) according to type GMP A and / or by a cleanliness class of the at least one working space (204, 222) according to type GMP C or better, for example according to type GMP A.

4. System (100) according to one of the preceding claims, characterized in that the system (100) comprises a separate sterilization device (118), in particular an autoclave device, for sterilizing objects received in the at least one container device (130) and / or the at least one dosing device (132).

5. System (100) according to one of the preceding claims, characterized in that the at least one preparation device (110) comprises an insertion opening (172, 210) through which the production material can be introduced into the working space (204, 222).

6. System (100) according to one of the preceding claims, characterized in that the at least one preparation device (110) comprises a removal opening (176, 226) of the connection device (164, 166), via which the production material can be transferred into the container device (130).

7. System (100) according to one of the preceding claims, characterized in that the at least one preparation device (110) comprises a disposal opening (214) for waste.

8. System (100) according to one of the preceding claims, characterized in that the at least one preparation device (110) comprises or forms a pharmaceutical isolator device (258).

9. System (100) according to one of the preceding claims, characterized in that the at least one preparation device (110) comprises or forms a decontamination device (260) for providing a defined decontamination atmosphere in the at least one working space (204, 222), in particular by means of H2O2, and / or a connection element for connecting an external decontamination device (260) to the preparation device (110).

10. System (100) according to one of the preceding claims, characterized in that the system (100) comprises two or more preparation devices (110).

11. System (100) according to one of the preceding claims, characterized in that the system (100) comprises a preparation device (110) for providing the containers (102, 242) and a preparation device (110) separate therefrom for providing closure elements (156).

12. System (100) according to one of the preceding claims, characterized in that the system (100) comprises a preparation device (110) for providing culture medium supports (236) for introduction into the at least one production plant (108) via the at least one container device (130), which is preferably separate from a production device for providing containers (102) and / or closure elements (156).

13. System (100) according to one of the preceding claims, characterized in that the system (100) comprises a preparation device (110) for providing format parts and / or machine parts for introduction into the at least one production plant (108) via the at least one container device (130), which is preferably separate from a production device for providing containers (102) and / or closure elements (156).

14. System (100) according to one of the preceding claims, characterized in that the system (100) comprises a preparation device (110) for providing the dosing material (240) in the working space (204, 222), wherein the at least one dosing device (132) can be docked to the preparation device (110) and the dosing material (240) can be transferred into the receiving space (252).

15. System (100) according to one of the preceding claims, characterized in that the at least one preparation device (110) comprises two separate working spaces (204, 222) which are connected to one another via a transfer opening (162), wherein in one working space (204, 222) production material is prepared, in particular unpacked, sterilized and / or decontaminated, which is introduced into the second working space (204, 222) via the transfer opening (162), wherein the at least one container device (130) is dockable in the region of the second working space (204, 222).

16. System (100) according to one of the preceding claims, characterized in that the at least one preparation device (110) comprises a controllable robotic handling device (224) in the at least one work space (204, 222) for moving the production material and / or that the at least one preparation device (110) has at least one glove opening (212) for a user (256) into the at least one work space (204, 222).

17. System (100) according to one of the preceding claims, characterized in that the system (100) comprises a storage device (120) spatially separated from the at least one production plant (108) and the at least one preparation device (110) for temporarily storing filled container- devices (130) and / or dosing devices (132) after filling at the at least one preparation device (110) and before use at the at least one production plant (108).

18. System (100) according to one of the preceding claims, characterized in that the at least one dosing device (132) comprises at least one of the following, preferably in the receiving space (252): the fluid line (246) and the filling needle (248); a container (102) for receiving the product to be filled; a dosing unit (244) for conveying the product through the fluid line (246); a filter element (250) connected in the fluid line (246).

19. System (100) according to one of the preceding claims, characterized in that the system (100) comprises two or more production plants (108).

20. System (100) according to one of the preceding claims, characterized in that the at least one production plant (108) comprises two connection devices (164, 166) which are preferably designed differently from one another, wherein the at least one container device (130) can be docked to one connection device (164, 166) and the at least one dosing device (132) can be docked to the other connection device (164, 166).

21. System (100) according to one of the preceding claims, characterized in that the filling station and the closing station are arranged in the same processing space (146, 182, 190, 194) of the at least one production plant (108).

22. System (100) according to one of the preceding claims, characterized in that the at least one production plant (108) comprises a further processing space (146, 182, 190, 194) and a further closing station (154) which is arranged in the further processing space (146, 182, 190, 194), wherein the Processing spaces (146, 182, 190, 194) are connected to one another via a transfer opening (162).

23. System (100) according to one of the preceding claims, characterized in that the at least one production plant (108) comprises a further processing space (146, 182, 190, 194) with a cleaning station (192), which are preferably connected to the at least one processing space (146, 182, 190, 194) via a transfer opening (162).

24. System (100) according to one of the preceding claims, characterized in that the at least one production plant (108) comprises a further processing room (146, 182, 190, 194) with a freeze-drying station (196), which is preferably connected to the at least one processing room (146, 182, 190, 194) via a transfer opening (162).

25. System (100) according to one of the preceding claims, characterized in that the at least one production system (108) is designed to be free of a glove grip for the user (256).

26. System (100) according to one of the preceding claims, characterized in that the system (100) comprises at least one transport device (134) by which the container device (130) is received or detachably receivable, and / or that the system (100) comprises at least one transport device (134) by which the dosing device (132) is received or detachably receivable, wherein the at least one transport device (134) comprises a chassis (264) for moving on a support surface (262).

27. System (100) according to claim 26, characterized in that the at least one transport device (134) is designed to be self-propelled and self-steering for autonomous transport of the at least one container device (130) or the at least one dosing device (132).

28. System (100) according to one of the preceding claims, characterized in that the system (100) comprises a data processing device (138) with a storage unit (142) in which a production plan (144) is stored, wherein at least one of the following can be controlled by the data processing device (138) indirectly or based on the production plan (144): the at least one production plant (108), the at least one preparation device (110), the at least one transport device (134).

29. A method for operating a system according to any one of the preceding claims, comprising: Docking at least one container device (130) to the at least one production plant (108); introducing a receiving body (198200) which receives at least one container (102) to be filled in a predefined arrangement into the processing space (146, 182, 190, 194) by means of the at least one handling device (158); introducing a receiving body (198, 200) which receives at least one closure element (156) in a predefined arrangement into the processing space (146, 182, 190, 194) by means of the at least one handling device (158); Docking at least one dosing device (132) to the at least one production plant (108); Inserting the filling needle (248) and, at least partially, the fluid line (246) into the at least one processing chamber (146, 182, 190, 194); Filling and closing the at least one container (102).

Images