Production system for producing a product

Abstract

The present invention relates to a production system (10) for producing a product (20), in particular a biological-pharmaceutical product, the system having a plurality of processing units (30, 50, 702, 704) for holding and / or treating a starting material (40), and / or to a corresponding process.

Description

[0001] Production facility for manufacturing a product

[0002] The present invention relates to a production plant for manufacturing a product. In particular, the present invention relates to a production plant for manufacturing a biological-pharmaceutical product.

[0003] Conventional production systems, particularly in the pharmaceutical sector for personalized therapeutics, involve a high degree of manual intervention. While this allows these therapeutics to be manufactured at a highly personalized level, such customized and / or micro-production processes are associated with high costs and high quality fluctuations, as well as high production waste and / or defective parts. Furthermore, there is no possibility for large-scale application and / or industrial production of customized and / or micro-batch sizes.

[0004] Furthermore, due to the high costs associated with such pharmaceutical products and / or therapeutics, in particular with regard to the manufacturing itself and / or the associated intellectual property, as well as due to the maintenance of a high level of quality, there is a need to carry out the production of such products and / or therapeutics in a secure and / or tamper-proof manner.

[0005] The present invention is therefore based on the object of solving the aforementioned problems, in particular of being able to produce individual and / or very small batch sizes of products in the pharmaceutical sector efficiently and in particular in a safe and / or tamper-proof manner.

[0006] This object is achieved according to the invention by a production plant for producing a product, in particular a biological-pharmaceutical product, having the features of claim 1.

[0007] Advantageous developments of the invention are described in the dependent claims.

[0008] According to this, it is provided that the production plant in particular has a plurality of process units for receiving and / or treating a reactant, wherein each process unit has at least one computing unit. For example, it can be provided that a process unit is designed as a patient box, in particular for receiving and / or transporting a reactant, and / or as a tool box, in particular for treating a reactant, and / or as a tool unit, in particular for treating a reactant, and / or as a sensor unit, in particular for analyzing a reactant. It should be understood that the above list is exemplary and not exhaustive. The process units are described in more detail, in particular in the following description.

[0009] The production facility may further comprise: a particularly suitable cleanroom area; a lock device for supplying an object from an environment of the production facility into the particularly suitable cleanroom area and / or for removing an object from the cleanroom area; a handling device for moving the object within the cleanroom area; and a storage device arranged within the cleanroom area, which comprises a plurality of storage locations for accommodating a plurality of objects.

[0010] It can be provided that one or more process units are designed as the handling device.

[0011] It can be provided that one or more process units are formed as part of the storage device.

[0012] An object, in particular the object from the environment of the production plant for feeding into the clean room area and / or the object for removal from the clean room area, can comprise at least one of the following: a reactant, in particular a material containing cells, for example a starting material containing cells, and / or a biological-pharmaceutical material and / or a biological-pharmaceutical workpiece, an intermediate product, in particular an intermediate product containing cells and / or a biological-pharmaceutical intermediate product, a tool or a tool unit, in particular a tool or tool unit that comes into contact with the reactant and / or the product and / or in particular a tool or tool unit that does not come into contact with the reactant and / or the product.Tool unit, one or more consumables, a product, for example the product to be manufactured, in particular a biological pharmaceutical product, for example the biological-pharmaceutical product to be manufactured.

[0013] It should be understood that the above list is exemplary and not exhaustive. Alternatively or additionally, the object may include one or more and / or a combination of the previously described enumeration elements.

[0014] The reactant may comprise cells and / or a biological material that differs from cells.

[0015] A reactant can be a patient-related reactant and / or a pooled reactant from several patient-related reactants.

[0016] The reactant can be at least partially liquid, and / or at least partially semi-solid, and / or at least partially solid. Alternatively, the reactant can be completely liquid, or completely semi-solid, or completely solid. For example, the cells of the reactant can be present, for example, in particular as a cell suspension, for example as cells in a suspension culture, or as adherent cells, for example as cells on a culture surface, in particular of a container or reactant container, for example a culture vessel and / or a bag.

[0017] The cells may be at least partially fresh and / or at least partially in a frozen state, whereby the reactant may, for example, be in a liquid, a semi-solid and / or a solid state.

[0018] It can be provided that the reactant is arranged in a container or reactant container, in particular a vessel, for example a culture vessel, a cell culture vessel, a bottle, a vial, a bag, a cassette (e.g., a cassette made of a particularly biocompatible, hard plastic) and / or a titer plate (e.g., a microtiter plate). It can be provided that the container or reactant container, including the aforementioned examples, is in each case suitably, in particular biocompatible, partially or completely coated and / or partially or completely uncoated.

[0019] The product can be a biological-pharmaceutical product for personalized therapy. In a sense, the biological-pharmaceutical product can be a personalized therapeutic. It can be intended that personalization is intended for a patient or a group of patients, in other words, for one or more patients. The biological-pharmaceutical product can be, for example, a cell therapy, for example, an autologous and / or allogeneic cell therapy, or a gene therapy, for example, an autologous and / or allogeneic gene therapy.

[0020] The cleanroom area can define an aseptic production area.

[0021] In particular, the clean room area can be designed and / or classified as described in the application DE 102021 207 738.2, to which reference is hereby made.

[0022] The production plant can have a system for adjusting the environmental properties of the clean room area, wherein, for example, the system for adjusting the environmental properties of the clean room area can in particular have an air device by means of which an air pressure, in particular an overpressure and / or a negative pressure, can be adjusted in the clean room area.

[0023] It can be provided that one or more process units are designed as the system for adjusting the environmental properties of the clean room area and / or in particular as the air device.

[0024] The production facility may have an enclosure, in particular for separating / delimiting the cleanroom area from the environment of the production facility and for maintaining its cleanroom class, wherein the enclosure surrounds the cleanroom area, in particular the cleanroom area and the airlock device.

[0025] The enclosure may be designed to surround the entire production facility. The airlock device may be configured to transport an object from the surroundings of the production facility via or through the enclosure into the cleanroom area and / or to remove an object from the cleanroom area via or through the enclosure.

[0026] It can be provided that the airlock device has at least one entrance airlock and at least one exit airlock. This can serve, in particular, for directed object guidance or a directed object flow. Additionally or alternatively, it can be provided that the entrance airlocks and the exit airlocks can be categorized with respect to an object to be airlocked through them and can be provided accordingly as part of the airlock device. Optionally, the airlock device can have one or more maintenance airlocks, via which the clean room area is accessible from the surroundings of the production facility, in particular for human operators or users.

[0027] Additionally or alternatively, the cleanroom area may comprise multiple cleanroom sub-areas. In other words, the cleanroom area may be divided into multiple cleanroom sub-areas. For example, it may be conceivable for the handling device and the storage device to be arranged in a common cleanroom sub-area or in different cleanroom sub-areas.

[0028] In particular, the clean room sub-areas can be designed and / or classified as described in the application DE 102021 207 738.2, to which reference is hereby made.

[0029] The production plant can have one or more (electrical) power sources and / or one or more interfaces connectable to one or more (electrical) power sources, which are arranged within the clean room area, in particular the enclosure, and which are configured to supply at least one of the components comprised by the production plant or a part of the production plant with electrical power, which (component) or (part) is assigned to the one or more power sources, for example via the one or more interfaces.

[0030] It can be provided that one or more of the process units are designed as workpiece carriers, which serve to hold objects, including reactants and / or tools and / or consumables. In particular, it is conceivable that a workpiece carrier is designed as the said patient box and / or the said tool box. Additionally or alternatively, it can be provided that the production system comprises several patient boxes and / or several tool boxes, each for holding one or more workpiece carriers, including the reactants arranged and / or held thereon.

[0031] It can be provided that each workpiece carrier has a means for fixing, in particular a means for a positive and / or a non-positive and / or a magnetic fixing, for a respective receiving of reactants and / or tools and / or consumables, whereby the reactants and / or the tools and / or the consumables are held reliably.

[0032] The workpiece carriers can remain permanently within the clean room area, in particular throughout one or more complete production processes.

[0033] The production system can comprise several types of workpiece carriers, which differ from one another with regard to the shape and / or dimensions of a receiving area of ​​the respective workpiece carrier.

[0034] One type of workpiece carrier can be used to hold a vessel, for example a culture vessel, for holding a reactant.

[0035] This can in particular be the workpiece carrier configured as a patient box, in a sense the patient box.

[0036] One type of workpiece carrier can be used to hold one or more tool units and / or tool consumables for carrying out a treatment process on a reactant and / or for carrying out a maintenance process within the clean room area.

[0037] This can, in particular, be the workpiece carrier configured as a toolbox, the toolbox in a sense. One type of workpiece carrier can be used to hold consumables for feeding them to a reactant and / or for performing a treatment process on a reactant.

[0038] This can in particular be the workpiece carrier configured as a tool box, in a sense the tool box.

[0039] One or more workpiece carriers can each comprise one or more action units for carrying out an action on a reactant and / or on a tool.

[0040] This can in particular be the workpiece carrier configured as a patient box and / or tool box, in a sense the patient box and / or tool box.

[0041] One or more action units can be designed as a treatment unit, for example as a tool unit, for carrying out a treatment process on the reactant.

[0042] It can be provided that a process unit is designed as an action unit and / or treatment unit and / or tool unit. Thus, to a certain extent, a process unit can optionally comprise a process unit, in particular a further process unit.

[0043] It can be provided that a treatment unit, for example a tool unit, is configured to carry out a rocking and / or tilting and / or shaking and / or rotating movement, in particular by means of at least one correspondingly assigned actuator unit or actuator unit, so that this type of movement, for example this type of movement combination, can be transferred to the reactant.

[0044] It can be provided that a treatment unit, for example a tool unit or a component of a tool unit, is configured to temper the workpiece carrier, in particular to heat and / or cool it.

[0045] One or more action units can be designed as a sensor unit for determining a current value of a parameter of the respective workpiece carrier and / or of a reactant arranged thereon and / or of a tool arranged thereon and / or of consumables arranged thereon.

[0046] A parameter can be, in particular, one of the following: a temperature, a humidity, an ambient pressure, a gas mixture composition, a position, for example an angular position, a vibration, an occupancy, in particular an occupancy state, for example a storage occupancy state, and a positioning, for example a locked positioning or a non-locked positioning and / or a location positioning, of the workpiece carrier and / or of an object picked up by the workpiece carrier. It should be understood that the preceding list is exemplary and not exhaustive. Alternatively or additionally, the parameter can be a combination of the previously described enumeration elements.

[0047] One or more workpiece carriers may include a storage device for storing energy and / or one or more consumables.

[0048] The workpiece carriers can be reusable multiple times; in particular, the storage device can be electrically rechargeable and / or refillable with consumables.

[0049] The workpiece carriers can have at least one interface by means of which the electrical energy and / or the consumable material can be charged or refilled and (re)released.

[0050] The production facility may comprise a charging station arranged within the clean room area for charging the storage device and / or a refilling station arranged within the clean room area for filling the storage device.

[0051] It can be provided that the refill station is designed as a stationary refill station, to which consumables can be supplied via the lock device in order to refill them, and / or that the refill station is designed as a locally mobile refill station, which, in particular, can be supplied from an area surrounding the production facility into the cleanroom area via the lock device when filled with consumables and, in particular, can be removed from the cleanroom area via the lock device when emptied of consumables. It can further be provided that the refill station can be arranged, for example, is arranged, in particular, on a storage location of the storage device.

[0052] One or more workpiece carriers can have one or more coupling devices by means of which several, in particular two or more, workpiece carriers can be connected to one another.

[0053] In other words, one or more process units may comprise said coupling devices for connecting process units.

[0054] The storage device may comprise a storage transport device for transporting objects to and / or away from the storage locations.

[0055] It can be provided that one or more process units are designed as the storage transport device.

[0056] The handling device can have a distribution unit, via which objects to be transported can be fed to and / or received from the storage transport device. Optionally, the distribution unit can be designed as or part of a lock transport device, or can be assigned to such a device.

[0057] It can be provided that the distribution unit is designed as a process unit separate from the handling device.

[0058] In other words, one or more process units can be designed as the handling device and at least one further process unit can be designed as the distribution unit.

[0059] The storage transport device may be a device different from the handling device.

[0060] The warehouse transport device can comprise a rail-guided transport system and / or one or more freely moving transport vehicles. It can be provided that one or more process units are configured as the rail-guided transport system and / or that a process unit is configured as a freely moving transport vehicle.

[0061] The storage transport device can comprise one or more rail-guided storage transport units, by means of which one or more storage racks of the storage device are accessible, in particular for storage and retrieval operations as well as for treatment operations and / or maintenance operations.

[0062] The storage transport device can comprise one or more storage transport units designed as portal conveyors, wherein in particular by means of the one or more portal conveyors one or more storage area areas of the storage device are accessible in particular for storage and retrieval operations as well as for treatment operations and / or maintenance operations.

[0063] The warehouse transport device, in particular the rail-guided transport system, the one or more freely moving transport vehicles, the one or more rail-guided warehouse transport units, and / or the one or more gantry conveyors, can be induction loop-guided and / or magnetically guided, in particular permanent magnet guided and / or magnetic coil guided. Additionally or alternatively, sensor-based guidance, in particular camera-based guidance and / or radar / LIDAR-based guidance, can be provided.

[0064] Additionally or alternatively, it can be provided that the storage transport device comprises one or more elevator devices by means of which one or more storage area areas of the storage device are accessible, in particular for storage and retrieval operations as well as for treatment operations and / or maintenance operations.

[0065] The handling device can be or comprise a multi-axis robot arm. Additionally or alternatively, the handling device can be or comprise a pick-and-place robot or a cable robot, and / or the handling device can be or comprise a suitable gripper actuator mounted on a planar runner. Additionally or alternatively, the rail-guided transport system and / or the one or more freely moving transport vehicles of the warehouse transport device can each comprise at least one multi-axis robot arm.

[0066] The storage transport device and / or the handling device can be assigned a changing device of the production plant, by means of which different gripping units and / or carrier units can be mounted on one or more storage transport units of the storage transport device and / or on one or more handling units of the handling device, in particular for carrying out different storage processes, transport processes, handling processes, maintenance processes and / or treatment processes by means of the respective storage transport unit and / or handling unit.

[0067] It can be provided that a process unit is designed as the said changing device.

[0068] The storage transport device and / or the handling device can be assigned a cleaning device of the production plant, by means of which at least one gripping unit and / or carrier unit of one or more storage transport units of the storage transport device and / or one or more handling units of the handling device can be cleaned, in particular after carrying out a storage process, transport process, handling process, maintenance process and / or treatment process.

[0069] It can be provided that a process unit is designed as the said cleaning device.

[0070] It can be provided that the cleaning device is designed for cleaning, in particular by using irradiation and / or gassing.

[0071] The cleaning device of the production facility associated with the storage transport device and / or the handling device can be arranged in particular in or on the airlock device or, for example, directly adjacent to the airlock device within the cleanroom area. It can be provided that the cleaning device of the production facility associated with the storage transport device and / or the handling device is spatially separated from the airlock device within the cleanroom area.

[0072] By means of the handling device, one or more objects, for example as described above, can be transferred from a lock location of the lock device to a storage transport device, in particular to one or more storage transport units of a storage transport device.

[0073] The lock device can comprise an entrance lock, via which a lock location, in particular an entrance lock location, is accessible from the environment and which is configured to feed an object from an environment of the production plant into the clean room area, and an exit lock, via which a lock location, in particular an exit lock location, is accessible from the environment and which is configured to remove an object from the clean room area.

[0074] The handling device may comprise a lock transport device, by means of which one or more objects are transported from one lock location, in particular an entrance lock location, to another lock location, in particular a

[0075] Transfer lock location, and / or from a lock location, in particular a

[0076] Transfer lock area, to another lock area, in particular a

[0077] Exit lock area, are transportable.

[0078] It can be provided that the handling device, in particular the lock transport device, comprises a displacement unit by means of which one or more objects can be moved between the different lock locations.

[0079] It can be provided that one or more process units are designed as the lock device, in particular the lock transport device, and / or at least one process unit is designed as the said displacement unit.

[0080] In addition to or alternatively to at least one lock station, in particular the entry lock station and / or the exit lock station, an unpacking station and / or a packaging station can be provided in the lock device, wherein optionally: the entry lock station can be assigned to the unpacking station, arranged adjacently or spatially separately, or the entry lock station can be the unpacking station, and / or the exit lock station can be assigned to the packaging station, arranged adjacently or spatially separately, or the exit lock station can be the packaging station.

[0081] The storage transport device and / or the handling device can each comprise one or more workpiece carrier receptacles for receiving and transporting one or more workpiece carriers, in particular one or more of the previously described workpiece carriers.

[0082] It can be provided that, by means of the handling device, one or more workpiece carriers, in particular one or more loaded workpiece carriers (for example loaded with a reactant), can be transferred from a lock location of the lock device to the storage transport device, in particular to the one or more storage transport units of the storage transport device, in particular via the one or more workpiece carrier receptacles.

[0083] The lock device may comprise a cleaning device for cleaning one or more workpiece carriers and / or for cleaning one or more workpiece carrier receptacles.

[0084] The production plant can comprise a cleaning device to which workpiece carriers can be fed for cleaning the same, in particular after an object has been transported by means of the respective workpiece carrier.

[0085] It can be provided that the cleaning device assigned to the storage transport device and / or the handling device, the cleaning device of the lock device and the cleaning device of the production plant form a common cleaning device of the production plant.

[0086] It can be provided that each of the respective cleaning devices is designed at least partially or completely separately from one another, in particular forming independent devices. Each of these cleaning devices can be designed as a process unit or be formed by such a unit. The storage device can comprise one or more storage racks and / or one or more storage area areas, each of which has several storage locations.

[0087] It can be provided that the storage locations can be temperature-controlled, in particular individually temperature-controlled, by means of a respective temperature-control device of the storage device, wherein optionally one or more process units can be designed as the temperature-control device.

[0088] It can be provided that several storage areas, in particular two or more storage areas, are arranged one above the other, in particular in a vertical direction. To a certain extent, the several storage areas can be arranged in a stack-like manner.

[0089] It can be provided that several storage area areas, in particular two or more storage area areas, for example two or more storage area areas arranged one above the other, can be or are connected to one another via the storage transport device, in particular via one or more lifting devices of the storage transport device.

[0090] By means of the storage transport device, reactants and / or tools and / or consumables can be stored in the storage locations or removed from them.

[0091] In particular, reactants and / or workpiece carriers and / or tools and / or consumables can be stored in and / or removed from the storage locations by means of the storage transport device of the storage device.

[0092] One or more storage locations can be accessible from several directions and / or by means of several storage transport units of the storage transport device.

[0093] The storage locations can be accessible vertically from above or horizontally from the side using the storage transport device.

[0094] Several essentially horizontally aligned rows of storage locations can be arranged vertically one above the other. The storage locations can be arranged in a matrix-like manner. Several of the storage locations, in particular all of the storage locations, can be shelf locations of one or more storage racks.

[0095] The storage device can comprise a plurality of different types of storage locations for accommodating different types of workpiece carriers, wherein the different types of storage locations can optionally differ from one another in terms of their shape and / or dimensions and / or in terms of their function and / or equipment.

[0096] The storage device can comprise several storage locations, which form treatment stations for the treatment of reactants.

[0097] It can be provided that a process unit is designed as a storage location.

[0098] The storage device may comprise a plurality of storage locations which form tool stations for storing, maintaining, cleaning, changing, electrically charging and / or checking tools.

[0099] The storage device can comprise a plurality of storage locations which have one or more interfaces, in particular for an (electrical) power supply and / or for a signal transmission, for example a control and / or regulating signal transmission, which can be connected to one or more corresponding interfaces of an object which can be accommodated in the storage locations, in particular process units, for example workpiece carriers, preferably patient boxes or tool boxes.

[0100] The workpiece carriers already described can be designed in particular as process units, for example as patient boxes or tool boxes, for receiving and / or treating a reactant.

[0101] It should be understood that the statements relating to workpiece carriers may also refer to patient boxes and / or tool boxes.

[0102] A patient box and / or a tool box can define a process cell, in particular an aseptic process cell. To a certain extent, a process unit configured as a patient box and / or a tool box can be a process cell, in particular an aseptic process cell. A patient box and / or a tool box, in particular the tool box, can have interfaces for one or more tool units, in particular for gassing and / or temperature control.

[0103] Additionally or alternatively, for this purpose, it can be provided that a patient box and / or a tool box, in particular the tool box, is equipped with a means for positive and / or non-positive fixation.

[0104] The patient boxes and / or the tool boxes can be stored in storage locations of the storage device, in particular fully automatically by means of a storage transport device of the storage device, for example the one already described.

[0105] One or more of the patient boxes and / or tool boxes can enclose a lockable interior, whereby the lockable interior can optionally define, in particular, an aseptic production area. To a certain extent, it can be provided that the lockable interior is an aseptic production area.

[0106] The patient boxes and / or the tool boxes can be opened and / or closed automatically and / or by means of the handling device, in particular for introducing a reactant and / or for removing a product made from a reactant and / or for carrying out a treatment procedure.

[0107] One or more of the patient boxes and / or the tool boxes can each comprise one or more conditioning units integrated therein or detachably arranged thereon or detachably arrangeable thereon, by means of which a temperature and / or a pressure and / or a humidity and / or a gas composition in the interior of the respective box can be influenced, in particular controlled and / or regulated.

[0108] One or more of the conditioning units can be tool units of a tool system of the production plant, which can be arranged on or removed from the respective patient box and / or the respective tool box as required, in particular fully automatically by means of a storage transport device of the storage device, for example the one already described, and / or by means of the handling device. Additionally or alternatively, it can be provided that one or more of the conditioning units are tool units of a tool system of the production plant, which can be arranged on or removed from the respective patient box and / or the respective tool box as required, in particular independently by means of their own actuators and / or using actuators installed in or on the respective patient box and / or the respective tool box.

[0109] The patient boxes and / or the tool boxes can comprise one or more connection elements which can be connected to corresponding connection elements at one or more treatment stations, in particular in order to supply the respective patient box and / or the respective tool box with electrical energy and / or consumables, in particular liquids and / or gases.

[0110] The storage device can comprise storage locations provided with connecting elements, so that one or more treatment processes for treating the reactants can be carried out at storage locations of the storage device serving as treatment locations.

[0111] The storage locations of the storage device and / or the patient boxes and / or the tool boxes can comprise fixing elements by means of which the patient boxes and / or the tool boxes can be positioned and / or fixed at the storage locations.

[0112] The patient boxes and / or the tool boxes, in particular the tool boxes, can each comprise one or more tool receptacles for receiving and securing one or more tools, in particular in the interior of the respective box, wherein in particular the one or more tool receptacles can each comprise one or more connection elements which can be connected to corresponding connection elements on the respective tool to be received, in particular in order to supply the respective tool with electrical energy and / or consumables, in particular liquids and / or gases, and / or in order to establish a signal-technical coupling of the respective tool to the respective box.

[0113] The patient boxes and / or the tool boxes can also be stored in storage locations (respectively) in a state not used for product production, in particular after cleaning by means of a cleaning device of the production plant, for example the one already described.

[0114] The patient boxes and / or tool boxes stored in storage locations in a state not used for product production can be removed from the storage locations for receiving or introducing educts, in particular fully automatically by means of the storage transport device of the storage device.

[0115] Additionally or alternatively, it can be provided that a patient box and / or a tool box comprise one or more connection elements which can be connected to corresponding connection elements on another patient box and / or tool box, whereby a composite patient box and / or a composite tool box and / or a combination thereof can be provided.

[0116] For possible design and / or configuration of the composite boxes, please refer to the remaining description regarding the patient boxes and / or the tool boxes. It should be understood that one or more storage locations can be configured as storage locations for composite boxes.

[0117] The production plant may comprise an unpacking device for unpacking objects to be supplied to the clean room area and / or a packaging device for packaging the objects to be removed from the clean room area, for example the manufactured product.

[0118] The unpacking device and / or the packaging device can be integrated into the lock device or form a component thereof.

[0119] The unpacking device and / or the packaging device can be designed as or formed by process units.

[0120] The lock device can comprise an entry lock location, which is accessible from the surroundings of the production plant and at which a packaged object can be arranged, in particular by a person and / or automatically, and / or an exit lock location, which is accessible from the surroundings of the production plant and at which a packaged object can be removed, in particular by a person and / or automatically.

[0121] The packaged object can be transported by means of a lock transport device of the production plant from the input lock station to an unpacking station, for example the one already described, and can be unpacked automatically at the unpacking station, or the packaged object can be unpacked automatically at the input lock station, and / or the object to be packaged can be transported by means of a lock transport device of the production plant from a transfer lock station to a packaging station and can be packaged automatically at the packaging station, or the object to be packaged can be packaged automatically at the exit lock station.

[0122] The lock device may comprise a cleaning device, for example the one already described, for cleaning a packaging of the packaged object and / or the unpacked object.

[0123] The packaging of the packaged object, in particular of the packaged reactant, can be removed in a sterile manner by means of the unpacking device after unpacking, for example via the exit lock location and / or via a waste lock location of a separately formed waste lock of the unpacking device or the lock device, whereby the unpacked object, in particular the unpacked reactant, cannot come into contact with the packaging.

[0124] It can be provided that the packaging device and the unpacking device are formed in a common device for unpacking and / or packaging.

[0125] As already described in connection with the conditioning units of the patient boxes and / or the tool boxes, the production plant can comprise a tool system by means of which, in particular, treatment processes on reactants and / or maintenance processes can be carried out within the clean room area.

[0126] The tool system can comprise a plurality of, in particular fully automated, tool units for performing different treatment and / or maintenance processes. It can be provided that a process unit is designed as a tool unit. Additionally or alternatively, one or more of the tool units can be assigned to a tool box and / or be enclosed by such a tool box.

[0127] It may be provided that a tool unit described herein is a tool described herein and / or a tool described herein is a tool unit described herein.

[0128] The tool system may comprise one or more tool units designed as feed units for supplying consumables to the reactants and / or one or more tool units designed as removal units for taking a sample from a reactant.

[0129] One or more of the tool units of the tool system may each comprise one or more multi-use components and / or one or more single-use components.

[0130] The tool system may comprise a setup unit by means of which one or more single-use components of a tool unit can be removed, in particular disposed of, fully automatically after use and replaced by one or more new single-use components.

[0131] The setup unit can comprise a handling unit, in particular a multi-axis robot arm, by means of which a fully automatic setup process can be carried out.

[0132] It can be provided that cleaning can be carried out before, during, in particular between a dismantling process and a setup process, and / or after the setup process by means of a cleaning unit of the setup unit.

[0133] The tool system can comprise a plurality of portable tool units, which can be fed to a treatment station for treating a reactant, which can in particular also be a storage location for storing the reactant, and can be temporarily stored there for carrying out a treatment process. One or more portable tool units of the tool system can be fed to a tool storage location and / or to a treatment station and / or to a setup location by means of a storage transport device, in particular one or more storage transport units, of the production plant.

[0134] One or more tool units can be designed and configured by means of the handling device to carry out a treatment process and / or a maintenance process.

[0135] One or more tool units can be designed and configured independently of the handling device, in particular automatically, to carry out a treatment process and / or a maintenance process.

[0136] A tool unit can be placed in a storage location, stored temporarily, stored and / or connected to assigned interfaces in the storage location.

[0137] A tool unit can be a tool for supplying and / or removing, for example, aspirating a liquid, in particular a tool for pumping a liquid, for example a pumping tool, wherein the tool unit can be configured in particular to supply and / or remove a predetermined amount of liquid, in particular for taking a sample for analysis.

[0138] A tool unit can be a tool for mixing at least one liquid, in particular at least one liquid with at least one liquid, gaseous, and / or solid substance. For example, the tool unit can be a circulation pump.

[0139] A tool unit can be a means for the biochemical manipulation of cells, by means of which at least one substance can be supplied to a reactant, and / or a temperature of a reactant can be changed, and / or an ambient pressure of a reactant can be changed, wherein the reactant is arranged, in particular accommodated, in a tool carrier, in particular in a receiving box. As a result, in particular the environment of the reactant, in particular the cells of the reactant, can be changed in order to thereby change the reactant itself, in particular the cells of the reactant itself, in particular with regard to cell growth and / or a cell surface, for example a cell membrane surface, and / or cell metabolism.

[0140] A tool unit can be a means for concentrating and / or separating liquids, in particular by means of a column, for example a separation column, and / or a centrifuge.

[0141] A tool unit can be a means for analyzing process parameters by means of a probe and / or a sensor, wherein the probe and / or the sensor is configured, for example, to capture, detect and / or determine at least one of the following: at least one temperature, at least one particle, for example at least one particle concentration, at least one vibration, at least one acceleration, at least one cell number, at least one cell density, at least one turbidity, for example at least one light absorption due to liquid turbidity, at least one gas composition, at least one gas, for example CO2, and / or at least one chemical substance, in particular at least one biochemical substance, for example at least one metabolite.

[0142] It should be understood that the above list is exemplary and not exhaustive.

[0143] It may be provided that the tool system is set up in particular to be fully automated.

[0144] In a certain sense, the production plant can comprise a particularly fully automated tool system which comprises one or more tool units for carrying out treatment processes on a reactant, wherein the tool system is arranged within the cleanroom area, for example within a cleanroom sub-area, for example within a patient box and / or a tool box as a cleanroom sub-area.

[0145] It can be provided that a supply device for supplying the tool system with consumables is assigned to the tool system. To a certain extent, the production facility can comprise a tool system, for example the one described above, and a supply device for supplying the tool system with consumables. In particular, the supply device for storing consumables can comprise or utilize one or more storage locations of the storage device arranged within the clean room area.

[0146] The consumables to be used in a treatment process can be made available in the storage locations, in particular before their use, and, optionally, can be prepared for use, in particular temperature-controlled.

[0147] The supply device may comprise one or more disposal units by means of which, in particular, used, consumed and / or contaminated consumables and / or tool consumables can be removed from the clean room area.

[0148] One or more disposal units can be assigned to the setup unit of the tool system, in particular can be handled by it, and / or form a component of the setup unit of the tool system.

[0149] The supply device can comprise a refilling device arranged within the clean room area, by means of which consumables, in particular in liquid form, can be fed to one or more storage devices of one or more workpiece carriers and / or one or more storage locations.

[0150] Additionally or alternatively, the refilling device can be designed as the refilling station described above and / or be associated with it.

[0151] As already described, the production plant may include one or more sensor units, in particular probes, sensors, and / or essentially identical measuring elements.

[0152] In a certain sense, the production plant may comprise one or more sensor units for determining one or more values ​​of one or more parameters of one or more reactants, and / or one or more workpiece carriers, and / or one or more tools, and / or one or more consumables.

[0153] The determination can be carried out at least partially automated, in particular fully automated, using one or more sensor units. Using one or more sensor units, the occupancy status of one or more storage locations of a storage device in the production facility can be determined, in particular monitored.

[0154] By means of one or more sensor units, a local temperature and / or a local humidity and / or a local illumination or irradiance at or in one or more storage locations of the storage device of the production plant can be determined, in particular monitored.

[0155] The production plant can comprise one or more sensor units for determining a treatment progress during the treatment of a reactant or between two treatment processes, for example based on at least one fluid of the reactant.

[0156] On or in one or more process units, in particular patient boxes and / or tool boxes and / or storage areas, one or more sensor units for determining the treatment progress can be arranged, in particular integrated, for receiving reactants.

[0157] In particular, the sensor units can be designed and / or configured as described in the application DE 10 2021 207 738.2, to which reference is hereby made.

[0158] In other words, it can be summarized that the production plant comprises one or more sensor units by means of which one or more, essentially all, process steps, in particular one or more, essentially all, treatment processes, and / or one or more, essentially all, process states, in particular one or more, essentially all, treatment states can be monitored and, in particular, if necessary, regulated, in particular readjustable, and / or controlled, in particular readjustable.

[0159] The sensor units can in particular address: at least one temperature, at least one particle, for example at least one particle concentration, at least one vibration, at least one acceleration, at least one cell number, at least one cell density, at least one turbidity, in particular a turbidity of a reactant and / or product suspension, for example at least one light absorption due to a liquid turbidity, in particular in a reactant and / or product suspension, at least one gas composition, at least one gas, for example CO2, and / or at least one chemical substance, in particular at least one biochemical substance, for example at least one metabolite, for example glucose.

[0160] The sensor units described above can be arranged in the production plant as required, in particular with respect to one or more objects, for example reactants and / or tools and / or storage locations and / or consumables and / or process units, such as patient boxes and / or tool boxes, in the clean room area.

[0161] As previously described, the production facility may include one or more cleaning devices.

[0162] The cleaning device can be designed as a separate device in the clean room area and / or be a component of the tool system, in particular a tool or a tool unit, and / or the lock device and / or the storage device.

[0163] Additionally or alternatively, the cleaning device may comprise one or more autoclaving devices by means of which one or more objects within the clean room area can be sterilized.

[0164] It can be provided that the one or more autoclaving devices are implemented as an autoclaving device described in connection with the unpacking device and / or with the packaging device.

[0165] The cleaning device can comprise a particularly stationary cleaning station, by means of which at least one process unit, in particular at least one workpiece carrier, in particular at least one patient box and / or at least one tool box, can be cleaned, in particular disinfected and / or sterilized.

[0166] The cleaning station can comprise a washing machine and / or an autoclaving device. It can be provided that the production facility has at least one control unit by means of which and / or via which the production facility can be operated, in particular regulated and / or controlled.

[0167] In a certain sense, it can be provided that the production plant has at least one control unit which is designed and programmed to regulate and / or control the production plant at least partially or completely.

[0168] Additionally or alternatively, it can be provided that the at least one control unit is designed and programmed to regulate and / or control at least one of the components comprised by the production plant or a part of the production plant, which (component) or (part) is / are assigned to the at least one control unit.

[0169] It can be provided that the at least one control unit is formed by one or more, in particular all, computing units of the process units.

[0170] In a sense, one or more, in particular all, computing units of the process units can form at least one control unit.

[0171] Additionally or alternatively, it can be provided that the at least one control unit is designed and programmed as an intermediary unit between a computer system assigned or assignable to the production plant and the production plant itself, wherein said computer system is designed and programmed to at least partially or completely regulate and / or control the production plant.

[0172] The computer system assigned or assignable to the production plant can be arranged in the environment of the production plant and / or arranged spatially separated or separately and can be connected or connected to the production plant, in particular to the at least one control unit designed as an intermediary unit, in particular wirelessly and / or by cable, for example by means of one or more communication interfaces of the production plant.

[0173] It can be provided that the production plant has the computer system assigned or assignable to the production plant. Additionally or alternatively, it can be provided that the computer system assigned or assignable to the production plant is a control computer system, in particular a cloud-based control computer system and / or a control server.

[0174] Additionally or alternatively, it can be provided that the at least one control unit is designed as at least one independent control unit.

[0175] The at least one independent control unit can be arranged in the environment of the production plant and / or spatially separated or arranged separately and can be connected or connected to the rest of the production plant, in particular wirelessly and / or by cable, for example by means of one or more communication interfaces of the production plant.

[0176] Additionally or alternatively, the at least one independent control unit can be arranged within the clean room area, in particular the enclosure, or on the production plant.

[0177] To a certain extent, it can be provided that the production plant can be operated, in particular regulated and / or controlled, by means of said computing units of the process units and / or by means of at least one, in particular independent, control unit and / or by means of said computer system assigned or assignable to the production plant. It should be understood that said components can be configured alone or in any combination thereof for operating, in particular for regulating and / or controlling, the production plant.

[0178] Additionally or alternatively, it can be provided that the at least one control unit is programmed and designed to identify, code and / or assign one or more objects in the production plant, in particular by means of an ID assigned to a respective object, wherein, optionally, the ID can be assigned to a respective object in particular by means of RFID means and / or barcode means and / or as unique information, in particular a digital fingerprint.

[0179] The production plant can comprise one or more communication interfaces and / or one or more human-machine interfaces, in short: HMI interfaces, by means of which one or more items of information about the production plant and / or at least one component of the production plant and / or at least a part of the production plant can be provided, in particular to at least one user and / or one or more computer systems, for example with regard to a fall below a predetermined quantity of consumables from the production plant.

[0180] The at least one control unit can be designed and programmed to be able to communicate with one or more communication interfaces and / or one or more human-machine interfaces, in short: HMI interfaces, of the production plant.

[0181] The at least one control unit can be designed and programmed to provide information to a human operator or user via the communication interfaces and / or via the HMI interfaces, for example fault information and / or information about a state of production of a product and / or information about stock levels of the storage device.

[0182] It can be provided that the at least one control unit is designed and programmed to assign a or the reactant to one of the several process units on the basis of one of several production programs for producing one of several products that can be produced by means of the production plant.

[0183] In other words, the production plant can have the plurality of process units for receiving and / or treating a reactant, which are configured as described above and / or below and which each have at least one computing unit, and the production plant can further have the at least one control unit which is designed and programmed to assign the reactant to one of the plurality of process units on the basis of one of a plurality of production programs for producing one of a plurality of products that can be produced by means of the production plant.

[0184] A production program can comprise multiple, particularly encrypted, production program packages, wherein each production program package contains at least one piece of information that refers to another production program package and / or includes instructions for the intake and / or treatment of a reactant. A production program can represent a recipe for producing a product, particularly a personalized product based on patient-related information.

[0185] A defined sequence of the several production program packages can form the production program for the manufacture of a product that can be manufactured by the production plant.

[0186] In particular, it may be provided that the complete sequence can only be determined from all references to the other production program packages.

[0187] It may, for example, be conceivable that said defined sequence can be defined, in particular dynamically defined, by the production plant, in particular by the at least one control unit of the production plant and / or a computer system assigned or assignable to the production plant.

[0188] One or more production program packages can be executed or can be executed fully automatically, in particular, until a product to be manufactured from the reactant is completed, in particular taking into account a quality analysis that has been carried out or can be carried out, in particular by means of one or more sensor units.

[0189] The product thus manufactured can be automatically transported to the lock device for removal from the production facility. This can, for example, be included as an instruction in a production program package.

[0190] The product may be filled and / or packaged before removal, in particular filled and / or packaged ready for use. This may, for example, be included as an instruction in a production program package.

[0191] In particular, a production program package may contain instructions for one or more treatment operations, for example instructions for:

[0192] Supplying a liquid and / or a gas, in particular a gas mixture,

[0193] Discharging, in particular pumping out, a liquid and / or a gas, in particular a gas mixture, Discharging, in particular pumping out, a part of a liquid and / or a gas, in particular a gas mixture, for analysis by means of one or more sensor units,

[0194] Mixing one or more components, in particular at least one liquid with at least one further component, for example another liquid,

[0195] Concentrating and / or separating a liquid, in particular by means of a column, for example a separation column, and / or a centrifuge,

[0196] Analyzing a reactant and / or an intermediate and / or a product, in particular by means of one or more sensor units,

[0197] Storage, in particular storing and / or retrieving, of one or more objects, in particular by means of the storage transport device,

[0198] Tempering, in particular incubating, one or more objects, in particular one or more reactants.

[0199] It should be understood that the above list of processing operations and their instructions from production program packages is exemplary and not exhaustive. Alternatively or additionally, it may be provided that one or more processing operations can be combined with one or more processing operations in a single processing operation and / or in any combination thereof.

[0200] It can be provided that one or more, in particular all, production program packages are encrypted and / or can be provided in encrypted form, in particular to one or more of the process units.

[0201] A processing unit, in particular its at least one computing unit, can be designed and programmed to execute instructions of at least one production program package, in particular to decrypt them and then execute them.

[0202] Several of the process units can form a group of process units, which (group) is based on a sequential order of the process units among each other with regard to the references of the production program packages and by means of which (group) a product can be manufactured.

[0203] It should be understood that the composition of the said group can only be determined from all the references of the production program packages and therefore a complete group can only be fully clear upon completion of the manufacture of a product.

[0204] Additionally or alternatively, it can be provided that several of the process units can form a group of process units which executes, in particular decrypts and then executes, a production program package, in particular only one production program package, in order to ensure the success of a treatment process contained in the production program package and / or to ensure reliability.

[0205] It can be provided that one or more, in particular all, of the production program packages are provided on a respective process unit, in particular on its at least one computing unit, and / or are transmittable to a respective process unit, in particular on its at least one computing unit, in particular by means of the at least one control unit and / or by means of a computer system assigned or assignable to the production plant.

[0206] It should be understood that one or more, in particular all, of the production program packages can be kept in a dynamically manageable and / or changeable memory pool, which can be operated and / or kept in particular by the at least one control unit and / or a computer system assigned or assignable to the production plant, whereby new production program packages can be dynamically supplemented and / or changed, in particular there, and in particular new recipes for manufacturing a product can be created efficiently and quickly.

[0207] It may be provided that the production facility has the computer system assigned or assignable to the production facility.

[0208] Additionally or alternatively, it may be provided that the computer system assigned or assignable to the production plant is a cloud-based computer system and / or a server.

[0209] Each process unit, in particular each computing unit of a process unit, can comprise at least one storage unit for providing and / or storing data, in particular one or more production program packages and / or one or more items of information and / or one or more cryptographic keys and / or a particularly decentralized database.

[0210] It should be understood that the production plant, in particular its components, for example the aforementioned process units, can have a plurality of storage units and / or the production plant can be assigned one or more, in particular decentralized, for example located in a cloud and / or on a server, storage units, wherein a computer program product can be stored or is stored on at least one storage unit, which comprises instructions which, when the computer program product is executed by a or the already described at least one control unit of the production plant, causes the previously described production plant to be operable as described in this description. The computer program product can additionally or alternatively be stored on a computer-readable (further) storage medium.

[0211] It can be provided that the plurality of, in particular encrypted, production program packages comprise a start package and one or more follow-up packages, wherein each package contains at least one piece of information which refers to a follow-up package and / or comprises instructions for receiving and / or treating a reactant.

[0212] In a sense, any defined sequence of the several production program packages that form the production program for manufacturing a product that can be manufactured by the production facility can begin with a starter package.

[0213] It can be provided that the reactant can only be assigned to a process unit to which the start package is assigned and / or which refers to the start package and / or on which the start package is stored, or can be assigned to a process unit to which the start package can be provided after or with an assignment of the reactant.

[0214] It should be understood that at least one of the follow-up packages can be configured as, in particular, the last follow-up package and / or as a final package, which contains at least one piece of information comprising instructions for dispensing and / or completing a treatment of a reactant and / or for completing a product produced from the reactant. It should be understood that a production program package can also contain two or more pieces of information, each of which refers to another production program package, for example, two or more production program packages, and / or comprises instructions for receiving and / or treating a reactant.

[0215] A process unit, in particular its at least one computing unit, can be designed and programmed to hold one or more cryptographic keys by means of which production program packages of the production program can be decrypted.

[0216] Such a cryptographic key can in particular be a private cryptographic key, in particular for public key encryption.

[0217] In other words, a cryptographic key can be uniquely assigned to a production program package.

[0218] In particular, a cryptographic key can be stored by means of at least one of the process units, by means of which a production program package can be decrypted and / or activated to start the production program.

[0219] In other words, a cryptographic start key for decrypting the start package can be stored on at least one of the process units, so that production of a product can be started according to the respective defined sequence of the plurality of production program packages.

[0220] One or more production program packages can be locally decrypted in a process unit by means of the processing unit's computing unit.

[0221] Additionally or alternatively, one or more production program packages can be decrypted outside the process units by means of the at least one control unit and / or by means of a computer system assigned or assignable to the production plant. The one or more cryptographic keys can be assigned to the process unit by means of the at least one control unit and / or by means of a computer system assigned or assignable to the production plant.

[0222] Additionally or alternatively, the one or more cryptographic keys can be inseparably integrated into the processing unit, in particular its at least one computing unit.

[0223] It can be provided that a process unit has a security module, in particular a trusted platform module, for providing one or more cryptographic keys, wherein in particular by means of the security module one or more cryptographic keys for decrypting individual production program packages of the production program can be stored.

[0224] Such a cryptographic key can in particular be a private cryptographic key, in particular for public key encryption.

[0225] It can be provided that a process unit, in particular its at least one computing unit, is designed and programmed to receive release information for using and / or providing the one or more cryptographic keys, and / or that the one or more cryptographic keys can only be used and / or provided by the process unit for a limited period of time.

[0226] In other words, one or more cryptographic keys can only be used and / or provided by the process unit without restriction or, in particular, for a limited period of time, provided that corresponding release information, which is described in more detail in the following description, is provided to the process unit.

[0227] It can be provided that the reactant can only be assigned to a process unit and / or that treatment of the reactant by means of a process unit can only be carried out if unique information relating to the process unit, which can be provided by the process unit itself, and further unique information relating to the process unit, which can be detected by means of the at least one control unit, match and, in particular, therefore, the integrity of the process unit in question is present. In other words, the reactant can only be assigned to a process unit and / or that treatment of the reactant by means of a process unit can only be carried out if the integrity of the process unit in question has been set and / or confirmed.

[0228] Such integrity may include a match between a target state of a process unit and an actual state of the process unit, wherein the target state may, in particular, refer to an initial state of the process unit. For example, it may thus be possible to determine whether a process unit has been tampered with and / or an unintended change has been made.

[0229] It can be provided that at least one process unit is configured for supplying a reactant into the production plant and / or for removing a reactant, an at least partially treated reactant and / or a product from the production plant, in particular via the lock device.

[0230] In other words, at least one process unit can be designed as a lock box for transferring an object into and / or out of the production facility. For example, the lock box can be an infeed box, an outfeed box, and / or a combined infeed-outfeed box.

[0231] In particular, this process unit, preferably the process unit configured as a lock box, can be designed and programmed to execute a start, in particular a start package, of a production program.

[0232] It may be provided that a patient box and / or a tool box (each) is a lock box and / or can be used as such.

[0233] It may be provided that the production plant is configured to provide one or more process units for receiving and / or treating a reactant.

[0234] The production plant can be configured to determine a production program package, in particular an encrypted production program package, of a production program, in particular for producing a product that can be produced by means of the production plant, and one of the process units to execute this production program package, based on a production program package, in particular an encrypted production program package, of the production program that is arranged upstream of the production program package.

[0235] The production plant can be configured to activate the determined production program package on the determined process unit, to decode the determined production program package and to subsequently control the process unit to carry out one or more treatment steps on the reactant based on the decode production program package.

[0236] The production plant can be configured to determine a production program package subsequent to the decrypted production program package, in particular an encrypted production program package, of the production program and a subsequent process unit to execute this subsequent production program package based on the decrypted production program package.

[0237] In other words, the production plant can be configured to be operable in particular with the following steps, and / or in still other words, a method can be provided for the in particular partial control of a or the production plant for producing a product, in particular a biological pharmaceutical product, wherein the production plant is configured as described above and / or below and wherein the method comprises the following:

[0238] Providing one or more process units for receiving and / or treating a reactant;

[0239] Determining a production program package, in particular an encrypted production program package, of a production program, in particular for producing a product that can be produced by means of the production plant, and one of the process units in order to execute this production program package, based on a production program package of the production program that is arranged upstream of the production program package and is in particular encrypted;

[0240] - activating the determined production program package on the determined process unit in order to decrypt the determined production program package and to subsequently control the process unit to carry out one or more treatment steps on the reactant based on the decrypted production program package; and determining a production program package of the production program following the decrypted production program package, in particular an encrypted production program package, and a subsequent process unit to execute this subsequent production program package based on the decrypted production program package.

[0241] It should be understood that all structural and / or functional features associated with the above and / or below described system according to the invention, ie the production plant according to the invention, and its embodiments, can also be included in the said method, either alone or in combination, and the associated properties, configurations and advantages can also be included and achieved accordingly.

[0242] The context of the already described integrity of a process unit is described in more detail below.

[0243] In particular, the production plant can have one or the already described at least one control unit, which can be designed and programmed to determine one or the integrity of each process unit, in particular before a reactant can be received and / or treated by means of a process unit according to one of several production programs for producing one of several products that can be produced by means of the production plant.

[0244] One goal of integrity assessment can be to detect changes to the process units, especially the patient boxes and / or tool boxes. For example, it can be determined whether unauthorized spyware such as cameras and / or other similar hardware has been installed in or on the process units to draw conclusions about the product's manufacture.

[0245] It can be provided that the computing unit of a process unit is designed and programmed to provide unique information relating to this process unit, and by means of the at least one control unit a further unique information relating to this process unit can be acquired, wherein the integrity of this process unit can be determined based on a comparison of these two unique information items, in particular by means of the at least one control unit, and can be set and / or confirmed in particular if these two unique information items match.

[0246] Setting and / or confirming the integrity can take place in particular in a respective computing unit and / or the at least one control unit.

[0247] In particular, the unique information provided by the computing unit can represent a target state and / or an initial state of the process unit, on the basis of which a deviation with respect to the process unit can be determined.

[0248] A process unit may have a security module, in particular a trusted platform module, for providing unique information, in particular fingerprint information about the process unit, wherein the computing unit of the process unit is designed and programmed to provide the unique information to the at least one control unit for determining the integrity.

[0249] In particular, unique information or fingerprint information can be understood as digital fingerprint information, for example information that is unique and / or has a unique identification.

[0250] The production plant can have one or more sensor units by means of which the process units can be detected, in particular visually, and on the basis of this detection, information which is unique with regard to the respective process units can be provided by means of the at least one control unit in order to determine the integrity.

[0251] In particular, the one or more sensor units may comprise one or more camera units by means of which characteristic landmarks of an area, in particular a surface, and / or a geometry of the process units can be visually captured.

[0252] In other words, the unique information may be based on characteristic landmarks of an area, in particular a surface, and / or a geometry of the process units.

[0253] The geometry can be a two-dimensional and / or a three-dimensional geometry. Additionally or alternatively, the production plant can have one or more actuator units, by means of which one or more process units can be mechanically excited to generate a vibration, in particular a mechanical vibration, which can be detected by the one or more sensor units and on the basis of which unique information regarding the respective process units can be provided by the at least one control unit to determine the integrity.

[0254] In other words, the unique information can be based on a characteristic response of the relevant process unit with respect to the mechanical excitation. In the case of an unauthorized modification to the relevant process unit, in particular, this can be determined from a deviation of the characteristic response with respect to a stored characteristic response.

[0255] It can be provided that at least one of the one or more actuator units is configured to generate a mechanical vibration, and this actuator unit can be arranged on or in one of the one or more process units and / or can be engaged with one of the one or more process units to generate the mechanical vibration at the relevant process unit.

[0256] For example, an actuator unit can be designed as a motor, in particular a vibration motor, by means of which predeterminable frequency ranges can be generated and / or traveled.

[0257] The vibrations can be detected by means of at least one of the sensor units and a vibration profile specific to a process unit can now be provided as a characteristic response and / or as unambiguous information, whereby in particular structural changes in or on the process unit can be detected.

[0258] In particular, the oscillation can comprise a frequency range of greater than or equal to 10 Hz and less than or equal to 100 Hz, and / or the oscillation can comprise one or more, in particular, different frequency ranges, which can each be greater than or equal to 10 Hz and less than or equal to 100 Hz, and / or the oscillation can comprise one or more, in particular, different frequency ranges, which can follow one another in a specific order. Additionally or alternatively, at least one of the one or more actuator units can be configured to generate an acoustic oscillation, in particular a sound wave, and this actuator unit can be arranged on or in one of the one or more process units and / or can be engageable with one of the one or more process units to generate the mechanical oscillation, in particular the sound wave, with respect to the relevant process unit.

[0259] For example, an actuator unit can be designed as a sound transducer, in particular a loudspeaker, by means of which predeterminable frequency ranges can be generated and / or traveled.

[0260] The sound or the sound frequencies can be detected by means of at least one of the sensor units and a course of the sound or the sound frequencies specific to a process unit can now be provided as a characteristic response and / or as unambiguous information, whereby in particular structural changes in or on the process unit can be detected.

[0261] In particular, the (acoustic) vibration can comprise a frequency range of greater than or equal to 30 Hz and less than or equal to 10,000 Hz, and / or the (acoustic) vibration can comprise one or more, in particular, different frequency ranges, which can each be greater than or equal to 30 Hz and less than or equal to 10,000 Hz, and / or the (acoustic) vibration can comprise one or more, in particular, different frequency ranges, which can follow one another in a specific order.

[0262] Additionally or alternatively, it can be provided that one or more, in particular all, process units have at least one receiving space, in particular enclosed by a lateral surface, for receiving one or more objects, in particular a reactant and / or one or more objects for treating the reactant, wherein the integrity comprises an internal integrity relating to the receiving space and / or an external integrity relating to an exterior with respect to the receiving space.

[0263] It should be understood that the described sensor units and / or actuator units can be configured with respect to internal integrity and / or external integrity. In particular, the patient boxes and / or tool boxes can be such processing units that have the receiving space enclosed, in particular, by a lateral surface.

[0264] It can be provided that a process unit is designed and programmed to execute instructions according to at least one production program, in particular a production program package, in particular to decrypt them and then execute them, provided that their integrity is set and / or confirmed.

[0265] In other words, it can be provided that one or more, in particular all, of the production program packages are provided on a respective process unit and are only executable, in particular decryptable and executable, if the integrity of the respective process unit is set and / or confirmed.

[0266] Additionally or alternatively, one or more, in particular all, of the production program packages can be transmitted to a respective process unit, in particular by means of the at least one control unit and / or by means of a computer system assigned or assignable to the production plant, provided that the integrity of the relevant process unit is set and / or confirmed.

[0267] It can be provided that a process unit is designed and programmed to block execution and / or decryption of instructions according to at least one production program if their integrity cannot be set and / or confirmed.

[0268] In particular, a process unit can be designed and programmed to provide a message, in particular an alarm message, in particular to the at least one control unit and / or a computer system assigned or assignable to the production plant, if its integrity cannot be set and / or confirmed.

[0269] Additionally or alternatively, the at least one computing unit may be designed and programmed to determine an integrity of the respective process unit, in particular before a reactant can be received and / or treated by means of this process unit according to one of several production programs for producing one of several products that can be produced by means of the production plant.

[0270] In other words, each process unit can be designed as a self-checking process unit, which is configured to determine its own integrity or, in particular, to be able to detect unauthorized changes to itself.

[0271] In particular, it can be provided that the integrity can be determined by means of the at least one control unit and / or by means of each computing unit of the relevant process unit.

[0272] In other words, the production plant can have at least one or the already described at least one control unit, which is designed and programmed to determine an integrity of each process unit, and each computing unit of a process unit can be designed and programmed to determine an integrity of the respective process unit, wherein the respective integrity result can optionally be compared for plausibility checking, in particular by means of the at least one control unit and / or the respective computing unit.

[0273] It can be provided that the computing unit of a process unit is designed and programmed to store and / or provide one or more unique pieces of information relating to this process unit and to record one or more further unique pieces of information relating to this process unit, wherein the integrity of this process unit can be determined by means of the computing unit based on a comparison of these two unique pieces of information and, in particular, can be set and / or confirmed if these two unique pieces of information match.

[0274] In particular, the unique information may comprise an initial state of the relevant process unit and an initial time stamp assignable to the initial state, and the further unique information may comprise a further state of the relevant process unit and a further time stamp assignable to the further state, which is different from the initial time stamp.

[0275] As already described, the initial state can correspond to a target state of the process unit. Using the respective timestamp, a clear temporal assignment and / or classification of the respective states of the process unit can be achieved.

[0276] Process units configured in particular as patient boxes and / or as tool boxes can have at least one receiving space, in particular enclosed by a lateral surface, for receiving one or more objects, in particular a reactant and / or one or more objects for treating the reactant, wherein in particular the integrity comprises an internal integrity relating to the receiving space and / or an external integrity relating to an exterior with respect to the receiving space.

[0277] A process unit, in particular a patient box and / or a tool box, can have one or more sensor units by means of which one or more unique pieces of information and / or one or more further unique pieces of information about the process unit in question can be recorded in order to determine the integrity, in particular an internal integrity.

[0278] In particular, a brightness value in and / or on the relevant process unit can be detected by means of at least one sensor unit and the unique information and / or the further unique information about the relevant process unit can be provided based on the detectable brightness value in order to determine the integrity, in particular an internal integrity.

[0279] Additionally or alternatively, the brightness value can be recorded continuously, in particular over an entire treatment process, in order to determine an integrity of the respective process unit while a reactant is received by means of this process unit and / or treated according to one of several production programs for producing one of several products that can be produced by means of the production plant.

[0280] The at least one receiving space, enclosed in particular by a lateral surface, can be configured as a closed space during operation of the relevant process unit, so that integrity cannot be set and / or confirmed when light is detected. In other words, manipulation and / or an attack on the relevant process unit can occur. Additionally or alternatively, it can be provided that a process unit has one or more actuator units, by means of which the relevant process unit can be excited, in particular mechanically, to generate a vibration, in particular a mechanical vibration, which can be detected by one or more sensor units and on the basis of which the unique information and / or the further unique information about the relevant process unit can be provided to determine the integrity.

[0281] In other words, actuator units used for integrity determination can be included in the respective process units themselves and / or in the production plant, in particular outside the respective process units.

[0282] For example, an actuator unit can be designed as a motor, in particular a vibration motor, by means of which predeterminable frequency ranges can be generated and / or traveled.

[0283] It can be provided that the oscillation comprises a frequency range of greater than or equal to 10 Hz and less than or equal to 100 Hz, and / or the oscillation comprises one or more, in particular, different frequency ranges, which are each greater than or equal to 10 Hz and less than or equal to 100 Hz, and / or the oscillation comprises one or more, in particular, different frequency ranges, which follow one another in a specific order, wherein in particular at least one of the one or more actuator units is designed as a vibration motor, which is fixed in and / or on the relevant process unit for generating the mechanical oscillation.

[0284] Additionally or alternatively, it can be provided that at least one of the one or more actuator units is configured to generate an acoustic vibration, in particular a sound wave, and is fixed in and / or on the relevant process unit to generate the mechanical vibration, in particular the sound wave, with respect to the relevant process unit.

[0285] In particular, it can be provided that the vibration comprises a frequency range of greater than or equal to 30 Hz and less than or equal to 10,000 Hz, and / or the vibration comprises one or more, in particular, different frequency ranges, which are each greater than or equal to 30 Hz and less than or equal to 10,000 Hz, and / or the vibration comprises one or more, in particular, different frequency ranges, which follow one another in a specific order. The actuator units for determining the integrity described with regard to the process units can be substantially configured like and / or functionally equivalent to the actuator units for determining the integrity described with regard to the production plant.

[0286] Additionally or alternatively, a process unit can have one or more electrically conductive line elements which are arranged on and / or in the process unit and / or are arranged within a lateral surface wall of the process unit and which form a particularly independent electrical circuit, wherein it can be detected by means of one or more sensor units whether the electrical circuit has been changed with respect to its original state and / or is interrupted, and wherein, on the basis of the circuit detection, the unique information and / or the further unique information about the process unit in question can be provided for determining the integrity.

[0287] In other words, a process unit can be provided with a wire mesh network, in particular with one or more insulated wires, and / or coated, in particular in an interior, an exterior and / or in a related intermediate layer, wherein an integrity of the wire mesh network or the wires can be checked by means of a power source, so that in the absence of the electrical current, manipulation and / or attack can be determined and / or detected.

[0288] Additionally or alternatively, at least one sensor unit can be designed as an inertial measuring unit, by means of which at least one acceleration value, in particular an acceleration vector, and / or at least one rotation rate value, in particular a rotation rate vector, can be detected with respect to the relevant process unit, and the unique information and / or the further unique information about the relevant process unit can be provided based on the detectable acceleration and / or rotation rate values ​​in order to determine the integrity.

[0289] In particular, a process unit can be movable or moved by means of an external excitation or force in a predefined pattern, for example forward-backward-rotate-up-down, and the resulting acceleration and / or rotation rate values ​​of the process unit can be recorded by means of the inertial measuring unit in order to provide the unique information and / or the further unique information for comparison, so that in the event of a deviation of the unique information or in the event of different resulting acceleration and / or rotation rate values, a manipulation and / or an attack can be determined and / or detected.

[0290] In particular, the production plant can have a handling device or the handling device already described for moving an object within the production plant and / or one or more actuator units, by means of which the process unit in question can be mechanically excited to generate a particularly defined movement which can be detected by means of the inertial measuring unit and on the basis of which the unique information and / or the further unique information about the process unit in question can be provided to determine the integrity.

[0291] The handling device can in particular be the multi-axis robot arm already described or comprise one or more of these.

[0292] Additionally or alternatively, the said acceleration and / or yaw rate values ​​can be continuously recorded by means of the inertial measuring unit during operation of the relevant process unit, so that, in particular for process units of the same type, in particular design and / or configuration, the unambiguous information can be continuously provided, in particular for continuous integrity determination. For example, the said acceleration and / or yaw rate values ​​of a process unit, in particular of a patient box and / or a tool box, can be recorded during transport to a cleaning device or the one already described and / or to storage locations, and in particular a change in mass and / or mass distribution that can be determined therefrom can be determined, so that manipulation and / or an attack can be determined and / or detected.

[0293] It can additionally or alternatively be provided that a temperature value in and / or on the relevant process unit can be detected by means of at least one sensor unit and the unique information and / or the further unique information about the relevant process unit can be provided based on the detectable temperature value in order to determine the integrity.

[0294] It can additionally or alternatively be provided that the process unit in question can be at least partially visually detected by means of at least one sensor unit and the unique information and / or the further unique information about the process unit in question can be provided based on the visual detection in order to determine the integrity, wherein in particular the at least one sensor unit comprises a camera unit by means of which characteristic landmarks and / or geometries of the process unit in question can be visually detected.

[0295] It should be understood that any combination of the components described with regard to integrity, in particular actuator units and / or sensor units, may be conceivable with respect to the respective process units.

[0296] In other words, by capturing sensor data, information, or values ​​at the beginning of use and / or operation in the production plant, unique information or a digital fingerprint of the relevant process units can be generated. At any point in time when a relevant process unit is not filled with content, e.g., tools, reactants, etc., it can be verified whether its integrity is present or whether there has been no manipulation and / or attack—in other words, whether the unique information remains unchanged.

[0297] In particular, individual sensor units, such as brightness sensors, can be used continuously during operation to determine integrity in order to detect potential attacks.

[0298] As already described, the plurality of process units can serve to receive and / or treat a reactant, wherein each process unit can have at least one processing unit and wherein a reactant can be received and / or treated by means of a process unit according to one of several production programs for producing one of several products that can be produced by means of the production plant.

[0299] In this case, it can be provided in particular that at least a part of one or the production program serves in particular exclusively to imitate and / or indicate one or more production program processes, in particular one or more production program processes of manufacturing a product.

[0300] In particular, this can result in real or actual production steps or production program processes being concealed, so that potential attackers in particular would have to conduct further investigations in order to be able to trace the manufacture of a product.

[0301] A production program operation may in particular refer to an actual execution of instructions of a production program package.

[0302] In particular, the part of a or the production program may comprise one or more process operations which are additional and / or useless with regard to the actual manufacture of a product, in particular exclusively for imitating and / or suggesting one or more production program operations.

[0303] As already described, it can be provided that a production program comprises a plurality of, in particular encrypted, production program packages, wherein each production program package contains at least one piece of information which refers to another production program package and / or comprises instructions for receiving and / or treating a reactant, wherein in particular a defined sequence of the plurality of production program packages forms the production program for producing a product which can be produced by means of the production plant.

[0304] In this case, it can be provided in particular that a production program comprises one or more, in particular encrypted, dummy production program packages, wherein each dummy production program package contains at least one piece of information which refers to a production program package or another dummy production program package and / or which comprises dummy instructions for imitating and / or indicating an intake and / or a treatment of a reactant.

[0305] For example, a dummy production program package, in particular a dummy instruction, may be empty of content, particularly from a production-technical perspective.

[0306] It can be provided that the production plant has at least one random module which can be executed by means of one or more computing units of the process units, by means of one or the at least one control unit of the production plant already described and / or by means of a computer system assigned or assignable to the production plant and by means of which one or more dummy production program packages can be integrated into a production program in a random manner, wherein in particular one or more dummy instructions can be assigned to each dummy production program package in a random manner by means of the at least one random module.

[0307] A process unit is designed and programmed to execute, in particular to decode and then execute, any instructions, in particular actual instructions for receiving and / or treating a reactant and / or dummy instructions, according to a production program.

[0308] In particular, a process unit for receiving and / or treating a dummy reactant can be designed and programmed to simulate and / or indicate receiving and / or treating an actual reactant using the dummy reactant.

[0309] For example, a dummy reactant may be an empty container intended for an actual reactant, which is not visible from the outside, and / or may comprise a material that resembles an actual reactant.

[0310] Additionally or alternatively, it can be provided that the production plant has one or more concealment rooms for accommodating one or more process units, wherein an interior of each concealment room is optically separated from the outside of the concealment room and / or at least largely invisible, wherein in particular at least one process unit can be caused by means of the at least part of a production program for imitating and / or indicating a manufacture of a product in order to be accommodated in the interior of a respective concealment room.

[0311] For example, a concealment room may be largely or completely invisible to persons standing outside the production facility, particularly the clean room area.

[0312] For example, optical separation can refer to a wavelength range visually perceptible to humans and / or to a wavelength range not visually perceptible to humans, e.g., an infrared range. A storage location of the storage device can be configured as a concealment room. Additionally or alternatively, a concealment room can be arranged as a separate facility within the clean room area.

[0313] It can be provided that at least one concealment room has one or more exchange units by means of which objects which are accommodated in and / or by process units, in particular patient boxes and / or tool boxes, can be relocated between the relevant process units which are located within the concealment room.

[0314] Additionally or alternatively, it can be provided that at least one concealment room has one or more storage locations on which one or more process units can be accommodated for a random period of time.

[0315] At least one concealment space can be configured exclusively to simulate and / or indicate a treatment of a reactant. Alternatively, at least one concealment space can be configured for the (actual) treatment of a reactant and / or to simulate and / or indicate a treatment of a reactant.

[0316] It can be provided that at least one concealment space has one or more sensor units for monitoring the optical separation of the interior from the exterior of the concealment space, wherein in particular a brightness value within the concealment space can be detected by means of at least one sensor unit of the concealment space.

[0317] It may be provided that at least one dummy production program package comprises one or more dummy instructions that cause one or more process units to be recorded in one of the concealment rooms.

[0318] In other words, a process unit can be instructed by means of at least one dummy production program package to be or be accommodated in one of the concealment rooms.

[0319] It can be provided that at least one dummy production program package comprises one or more dummy instructions which cause a relocation of objects which are accommodated in and / or by process units, in particular patient boxes and / or tool boxes, between the respective process units which are located within the concealment space.

[0320] Additionally or alternatively, it can be provided that the production plant has a control unit or the one already described, which is designed and programmed to at least partially store and operate a database and / or to exchange information with a database which is at least partially stored and / or operated on a computer system assigned or assignable to the production plant, wherein the database contains one or more, in particular unique, release information items for authorizing the intake and / or treatment of a reactant by means of one of the plurality of process units, wherein the database can be changed by retrieving at least one of the release information items for one of the plurality of process units, so that this release information can subsequently no longer be made available for retrieval in its original form.

[0321] In particular, the unique release information can be understood as information that is unique and / or has a unique identification.

[0322] It may be provided that the production facility has the computer system assigned or assignable to the production facility.

[0323] Additionally or alternatively, it can be provided that the computer system assigned or assignable to the production plant is a release computer system, in particular a cloud-based release computer system and / or a release server.

[0324] The database can be configured and programmed to receive and store one or more new release information items exclusively from outside the production facility. For example, one or more new release information items can be transmitted to the database by a person authorized to access the database, in particular by a rights holder to a recipe represented by a production program, in particular via a computer system, for example via a cloud and / or a server.

[0325] Additionally or alternatively, the database may be configured and programmed to be stored and / or operated exclusively on the computer system assigned or attributable to the production facility, or to be synchronized with a parallel database that is stored and / or operated exclusively on the computer system assigned or attributable to the production facility.

[0326] It can be provided that each computing unit of each process unit is set up and programmed to receive and store one or more release information items, wherein each release information item received by a computing unit can be compared with each release information item already stored on a computing unit in order to avoid double use of the received release information in the production plant.

[0327] In particular, each computing unit can be designed and programmed to at least partially or completely store and operate a particularly encrypted decentralized database, preferably a particularly encrypted distributed ledger, in order to store the one or more receivable or received release information items. The use of the decentralized database can, in particular, provide a tamper-proof technical solution to prevent duplicate use of the received release information in the production facility. The decentralized database is described in more detail in the following description.

[0328] As already described, one of several products can be produced by means of the production plant according to one of several production programs, wherein a production program can comprise several production program packages and each production program package can contain at least one piece of information which comprises instructions for receiving and / or treating a reactant.

[0329] In this case, it can be provided that at least one piece of release information can be uniquely assigned to each production program package to authorize, in particular, a one-time execution of this production program package by at least one process unit. This can ensure that the execution of production program packages is not possible beyond an approved limit or an approved number of executions. In particular, each production program can only be initialized and / or started by the production system if all production program packages of the production program and / or all release information assigned to the production program packages can be provided or is provided.

[0330] It can be provided that one or more release information items can be received and stored by means of at least one process unit, in particular its computing unit, for a time-delayed authorization and execution of a recording and / or a treatment of a reactant and / or one or more release information items can be received in real time by means of at least one process unit, in particular its computing unit, for an immediate authorization and execution of a recording and / or a treatment of a reactant.

[0331] The said authorization and execution of a receiving and / or processing of a reactant may in particular refer to an authorization of an execution of instructions for receiving and / or processing a reactant of a production program package and to the corresponding actual execution.

[0332] The database may be encryptable or encrypted and / or any sharing information in the database may be encryptable or encrypted.

[0333] For example, at least a part of the database and / or at least one piece of release information can be decrypted by means of at least one cryptographic key, which can be provided and / or stored by means of a process unit and / or is stored there.

[0334] A cryptographic key relating to a release may be different from a cryptographic key relating to a production program package.

[0335] Additionally or alternatively, such cryptographic keys may in particular be private cryptographic keys, in particular for public key encryption.

[0336] As already described, one of several products can be manufactured by means of the production facility according to one of several production programs, wherein at least one part of a production program can serve, in particular, exclusively to imitate and / or indicate the manufacture of a product. In this case, it can be provided that this at least one part of a production program can be authorized for execution by means of one or more release information items.

[0337] In other words, each production program can only be initialized and / or started by means of the production facility if all production program packages, including the dummy production program packages of the production program, and / or all release information associated with the production program packages, including the dummy production program packages, can be provided or is provided.

[0338] One or more pieces of release information can be retrieved from the database as bundled release information to authorize an entire process for manufacturing a product, in particular by means of one or more process units and / or made available via the database. This can simplify a release process, since not every individual piece of release information needs to be released separately by a person authorized to access the database, in particular by a rights holder to a recipe represented by a production program, but rather entire production programs can be released at once.

[0339] Additionally or alternatively, it can be provided that release information for each individual production program package can be retrieved individually from the database, in particular by means of a process unit and / or can be provided by means of the database, and / or several release information items for assignable production program packages can be retrieved together from the database, in particular by means of one or more process units and / or can be provided by means of the database.

[0340] The database can be set up and programmed to assign a respective consent information to one or more, in particular all, release information, which can be stored in the database for each release information, in particular by a person authorized to access the database, wherein each release information can only be provided if an assigned consent information is stored.

[0341] Additionally or alternatively, the database may be configured and programmed to contain and provide various types of release information, wherein in particular a type of release corresponds to a type of process unit and / or to a type of part, in particular a production program package, of a production program for manufacturing a product.

[0342] For example, a type of release information may relate only to patient boxes and / or only to tool boxes, or a type of release information may relate to a type of treatment process, for example a tempering process and / or a storage process in the storage device.

[0343] It can be provided that each release information comprises an information stamp, in particular a mode information stamp, by means of which the respective release information can be assigned to a production mode of the production plant for manufacturing a product and / or to a simulation mode of the production plant for simulating the operation of the production plant and / or in particular the manufacturing of a product.

[0344] In other words, depending on the information stamp of the release information, a production program package can be executed by means of a process unit for actually receiving and / or treating a reactant or merely for simulating it with respect to the process unit in question.

[0345] Additionally or alternatively, each release information item can comprise an information stamp, in particular a number information stamp, by means of which a maximum repeatability of a receiving and / or treatment of a reactant can be determined, which can be authorized by means of the respective release information. It should be understood that this can include a maximum repeatability of a simulation of the operation of the production plant and / or, in particular, the manufacture of a product.

[0346] It can be provided that the at least one control unit is designed and programmed to be connectable or connected to the computer system assigned or assignable to the production plant for data exchange in order to determine the existence of this data connection, wherein the production plant and / or the one or more, in particular all, process units can be reversibly transferred, depending on the data connection, into a normal state for unrestricted operation, into a reserve state for temporally and / or functionally restricted operation, and / or into a pause state for idle operation. For example, this computer system can be configured as a heartbeat computer system, which will be described in more detail in the following description.In particular, it can be provided that the production facility has this computer system assigned or assignable to the production facility, in particular a heartbeat computer system. Additionally or alternatively, it can be provided that this computer system assigned or assignable to the production facility is a cloud-based computer system and / or a server.

[0347] It can be provided that each computing unit is designed and programmed to at least partially or completely store and operate a particularly encrypted decentralized database, preferably a particularly encrypted distributed ledger, wherein each decentralized database is a redundant copy of each of the other decentralized databases, wherein each computing unit is designed and programmed to validate an operation of the respective decentralized databases on each of the other computing units and to update its own decentralized database in response to a validation, wherein each decentralized database is designed and programmed to include one or more, in particular unique, pieces of information about an intake and / or a treatment of a reactant from each process unit.

[0348] In particular, unambiguous information may be understood as information that is unique and / or has a unique identifier.

[0349] As already described, each process unit, in particular the computing unit of each process unit, can have a security module, in particular a trusted platform module, for providing one or more cryptographic keys.

[0350] Such a cryptographic key can in particular be a private cryptographic key, in particular for public key encryption.

[0351] Each decentralized database can be encrypted or can be encrypted using a cryptographic key that can only be specifically assigned and / or made available to the process unit on which the decentralized database can be stored or is stored. This can ensure that the decentralized database can only be stored once on the process unit. As already described, one of several products can be manufactured by means of the production plant according to one of several production programs, wherein a production program can comprise several production program packages and each production program package can contain at least one piece of information comprising instructions for receiving and / or treating a reactant, which can be executed by at least one process unit.It can be provided that each computing unit is set up and programmed to store each execution of a production program package in the decentralized database, in particular depending on the validation by the other computing units.

[0352] It may be provided that each processing unit is set up and programmed to execute a production program package only if this production program package is not stored in the decentralized database as already executed.

[0353] In particular, each computing unit can be configured and programmed to receive one or more, in particular unique, release information for authorizing the intake and / or treatment of a reactant from one or more of the already described at least one control units of the production plant and / or a computer system assigned or assignable to the production plant, in particular one or more release computer systems, and to store the one or more release information in its own decentralized database.

[0354] Optionally, each processing unit can be set up and programmed to compare each received release information with each release information already stored in the decentralized database in order to avoid double use of the received release information in the production plant, in particular depending on the validation by the other processing units.

[0355] It can be provided that each piece of release information comprises an information stamp, in particular a quantity information stamp, by means of which a maximum repeatability of a recording and / or treatment of a reactant can be determined, which can be authorized by means of the respective release information, wherein in particular the information stamp, in particular the quantity information stamp, of each piece of release information in the decentralized database can be updated depending on an authorized execution of a recording and / or treatment of a reactant. At least one piece of release information can be uniquely assigned to each production program package to authorize execution of this production program package by at least one process unit, as already described above.

[0356] In particular, each computing unit can be designed and programmed to execute the instructions of a production program package only if release information associated with this production program package is provided to the computing unit and, in particular, this production program package and / or this release information is stored in the decentralized database as not yet executed.

[0357] Additionally or alternatively, each computing unit can be designed and programmed to execute the instructions of a production program package only if a maximum repeatability of an execution of this production program package is stored in the decentralized database as not yet reached according to the release information.

[0358] In other words, by means of the described release information mechanism, permission to execute a production program package can be granted, which can be stored in particular in the decentralized database. In particular, with each execution of a production program package, it can be checked whether the number of previous executions is less than the permitted number of executions of the production program package. In particular, it can be stored in the decentralized database that a production program package is being executed, is being executed, or may be executed, whereby the said number of available executions can be reduced by 1 (one) during actual execution. This ensures that the execution of production program packages is not possible beyond the authorized limit.

[0359] It can be provided that the production plant has one or more further computer systems and / or can be connected or is connectable to such, wherein each of the further computer systems is arranged differently in relation to a remainder of the production plant, wherein the decentralized database is stored and operated on each of the further computer systems, and wherein each of the further computer systems is designed and programmed to validate an operation of the respective decentralized databases on each of the other computer systems and / or computing units and to update its own decentralized database in response to a validation.

[0360] For example, these additional computer systems may in particular be cloud-based computer systems and / or servers.

[0361] As already described, the production plant can have a control unit or the control unit already described, which is designed and programmed to be connectable or connected to a computer system assigned or assignable to the production plant, in particular the heartbeat computer system already described, for data exchange in order to determine the existence of this data connection.

[0362] This computer system, especially the heartbeat computer system, will be described in more detail below.

[0363] In particular, this computer system can be used to ensure that the production facility can only operate without a data connection for a specific period of time. In other words, in addition to or as an alternative to the requirement of the release information already described, the production facility can only produce if there is a connection to the said computer system, in particular the heartbeat computer system.

[0364] It can be provided that the production plant and / or the one or more, in particular all, process units can be reversibly transferred, depending on the data connection, into a normal state for unrestricted operation, into a reserve state for temporally and / or functionally restricted operation and / or into a pause state for idle operation.

[0365] The reserve state can in particular be a transition state between the normal state and the pause state, via which the normal state transitions into the pause state, wherein in particular a transition from the pause state to the normal state does not have to take place via the reserve state and / or preferably a transition from the pause state to the normal state can take place directly.

[0366] In particular, the at least one control unit and / or one or more, in particular each, of the computing units can be designed and programmed to determine the existence of the data connection to the computer system, in particular continuously or at regular intervals.

[0367] It may be stipulated that the production facility for manufacturing a product, in particular the process units for receiving and / or treating a reactant, can only be fully operational when the data connection is established. This may be the normal state and / or be assigned to the normal state.

[0368] Additionally or alternatively, it can be provided that if the data connection does not exist, the production plant for manufacturing a product, in particular the process units for receiving and / or treating a reactant, can be transferred to a reserve state in which the production of a product, in particular the receiving and / or treating of a reactant, is limited in time and / or function.

[0369] The at least one control unit and / or one or more, in particular each, of the computing units can be designed and programmed to store an information stamp, in particular a time stamp, when transferred to the reserve state and to stop unrestricted operation of the production plant and / or the one or more, in particular all, process units after a predefined period of time from this information stamp, in particular this time stamp, and in particular to transfer the production plant and / or the relevant process units to the pause state.

[0370] In particular, the at least one control unit and / or one or more, in particular each, of the computing units can be designed and programmed to execute only a predefined part of a production program for manufacturing a product upon transfer to the standby state. This can serve, for example, to ensure the progress of production or treatment of a reactant and / or to bridge a possible brief interruption in the data connection. In particular, if the standby state returns to a normal state and the said predefined part of the production program has not yet been fully executed, the production program can continue as normal.

[0371] Additionally or alternatively, the at least one control unit and / or one or more, in particular each, of the computing units can be designed and programmed to modify and / or supplement a production program for manufacturing a product with one or more production program packages when transferred to the pause state for storing a reactant and / or an at least partially treated reactant and / or a product, in particular as long as the pause state exists.

[0372] Storage can take place in particular in at least one of the storage locations of the storage facility.

[0373] A modification and / or an addition may, for example, comprise a targeted tempering, for example freezing, of a reactant and / or of an at least partially treated reactant and / or of a product in order to ensure production or treatment progress.

[0374] The computer system, in particular the heartbeat computer system, can be arranged differently in relation to the rest of the production plant, wherein in particular the computer system comprises a server to which the at least one control unit can be connected or is connected for data exchange.

[0375] It can be provided that the production plant is configured to be operable in particular with the following steps, and / or in other words, a method can be provided for the in particular partial control of a or the production plant for producing a product, in particular a biological-pharmaceutical product, wherein the production plant is configured as described above and / or below and wherein the method comprises the following:

[0376] Providing one or more process units for receiving and / or treating a reactant;

[0377] Providing a data connection from a computer system assigned or assignable to the production plant to the production plant and / or one or more, in particular all, process units;

[0378] Determining whether the data connection exists by means of at least one control unit of the production plant and / or at least one computing unit of at least one process unit; and

[0379] Controlling the production plant and / or the one or more, in particular all, process units depending on the data connection. It can be provided that the control comprises a reversible transfer of the production plant and / or the one or more, in particular all, process units into a normal state for unrestricted operation, into a reserve state for temporally and / or functionally restricted operation, and / or into a pause state for idle operation, in particular based on the existence of the data connection.

[0380] It can be provided that the at least one control unit and / or one or more, in particular each, of the computing units store an information stamp, in particular a time stamp, when transferred to the reserve state and stop unrestricted operation of the production plant and / or the one or more, in particular all, process units after a predefined period of time from this information stamp, in particular this time stamp, and in particular transfer the production plant and / or the relevant process units to the pause state.

[0381] It can be provided that the at least one control unit and / or one or more, in particular each, of the computing units only execute a predefined part of a production program for manufacturing a product when transferred to the reserve state.

[0382] It can be provided that the at least one control unit and / or one or more, in particular each, of the computing units, when transferred to the pause state, modifies and / or supplements a production program for manufacturing a product with one or more production program packages in order to store a reactant and / or an at least partially treated reactant and / or a product, in particular as long as the pause state exists.

[0383] It should be understood that all structural and / or functional features associated with the system according to the invention described above and / or below, ie the production plant according to the invention, and its embodiments, can also be included in the said method, in particular described above, either alone or in combination, and the associated properties, configurations and advantages can also be included and achieved accordingly.It can be provided that the production plant has a simulation device which is designed and programmed to simulate the operation of the production plant and / or in particular the manufacture of a product based on at least one production program and to provide a simulation result corresponding thereto, wherein the simulation device is formed partially or completely by one or more, in particular all, computing units of the respective process units.

[0384] In particular, since the properties of the production plant, e.g., plant-specific and / or tool-specific characteristics, can play a major role in phasing the production plant and / or its capacity, said simulation of the production plant can comprise a software-based and / or a hardware-based simulation. In other words, the simulation may not be purely software-based, e.g., using a digital production plant twin, but rather be carried out under the production plant itself. This may, in particular, include the possibility that each component of the production plant can be configured and programmed to participate in the simulation and / or to carry out part of it.

[0385] For example, to avoid revealing recipes, production program sequences, or other information to unauthorized persons through a simulation, a distinction can be made between simulation mode and production mode, or between a simulation and the actual execution of a production program, only with regard to the execution of actual physical movements, which preferably do not occur in the simulation. The processes already described regarding approvals, encryption / decryption, secure communication (see especially the description below), etc., can take place in the simulation.

[0386] For example, it can be provided that the simulation device can be designed and programmed to simulate a not yet executed part of the associated production program during the manufacture of a product and to provide a corresponding simulation result. This can be understood, in particular, to mean that at least a part of the production plant, in particular one or more process units of the production plant, can be dynamically switched back and / or forth between a production mode and a simulation mode, in particular depending on the simulation requirements.In other words, starting from a current state, in particular production state, of the production plant, further simulation can be carried out based on the at least one production program, for example to optimize subsequent production steps and / or treatment processes and / or to determine which further and / or additional treatment processes and / or production programs can be initiated.

[0387] The simulation device can be designed and programmed to record plant parameters of the production plant during manufacture of a product and / or to record recording process measured values ​​and / or treatment process measured values ​​of the process units, in particular operating parameters of the process units, and to store them as simulation information and to keep them available for carrying out a simulation, wherein in particular the simulation of an operation of the production plant and / or a manufacture of a product can be carried out on the basis of this simulation information by means of the simulation device.

[0388] In other words, the simulation device can be designed and programmed to:

[0389] - process-specific parameters and / or measured values, e.g. a sequence of treatment processes or process steps, and / or

[0390] - plant-specific parameters and / or measured values, e.g. of process units and / or location parameters of the production plant such as outside temperature, humidity, air pressure, and / or patient-specific parameters and / or measured values, e.g. a medical treatment history, and / or

[0391] - tool-specific parameters and / or measured values, e.g. of tool units, especially tool boxes, and / or

[0392] - to record material-specific parameters and / or measured values, e.g. of consumables, and to save them as simulation information and to keep them available for carrying out a simulation.

[0393] As already described, the production plant can have one or more sensor units. It can be provided that these are at least partially assigned to the process units and / or form part of the process units, wherein the simulation device is designed and programmed to perform the simulation based on simulation information that can be acquired or acquired by these sensor units. In particular, the sensor units can be designed and / or configured as described in the application DE 10 2021 207 738.2, which is hereby incorporated by reference.

[0394] In particular, simulation information may comprise at least one of the following: time parameters and / or time measured values ​​of the production plant, in particular of the process units, climate parameters and / or climate measured values ​​in and / or around the production plant, in particular in and / or around the process units, and / or operating parameters and / or operating measured values ​​of the production plant, in particular of the process units.

[0395] For example, time parameters and / or time measurements can include: pumping times of process units configured as pumping devices and / or transport times of process units and / or sterilization times of process units configured as sterilization devices and / or cleaning times of process units configured as cleaning devices and / or waiting times within the production plant and / or unpacking / packing times of process units configured as unpacking / packing devices and / or loading / unloading times of process units and / or setup times of process units configured as tool units.

[0396] Additionally or alternatively, time parameters and / or time measurement values ​​may include treatment time values ​​of treatment processes that can be carried out by means of process units.

[0397] In particular, several, in particular all, treatment processes can comprise said treatment time values, which indicate the period of time that elapses from the start of the respective treatment process to its end, in particular including: a time period for the provision of the at least one tool and / or tool box required for the respective treatment process, in particular including its / their equipping with one or more tool consumables, and / or a time period for the supply and / or arrangement and / or commissioning of the at least one tool and / or tool box on the reactant to be treated, in particular in a patient box in which the reactant is arranged, and / or a time period for the action on the reactant to achieve a desired treatment result, and / or a time period for the removal of the at least one tool and / or tool box from the reactant,in particular from the patient box; preferably including: o cleaning the process units involved, in particular patient boxes and / or tool boxes, and / or o removing and / or disposing of tool consumables, and / or o returning the process units involved, in particular patient boxes and / or tool boxes, to a starting location, in particular a respective assigned storage location.

[0398] For example, climate parameters and / or climate measurements can include:

[0399] Temperature values ​​and / or humidity values ​​and / or gas composition values

[0400] For example, operating parameters and / or operating measurements can include:

[0401] Temperature parameters of process units configured as temperature control devices and / or fill levels of storage devices.

[0402] In particular, the part of a production program which is to be executed by means of the associated process units for producing a product can be simulated by means of the computing units forming the simulation device, wherein in particular a production program comprises several, in particular encrypted, production program packages and each production program package contains at least one piece of information which comprises instructions for receiving and / or treating a reactant, which instructions can be executed by means of at least one process unit, and one or more production program packages form the said part of the production program to be simulated.

[0403] In other words, each process unit can be designed and programmed to simulate at least that part of a production program which the process unit in question must and / or would execute to actually manufacture a product.

[0404] As already described, a production program can comprise a plurality of, in particular encrypted, production program packages, and each production program package can contain at least one piece of information which comprises instructions for receiving and / or treating a reactant, which can be executed by means of at least one process unit, wherein it can be provided here that the simulation can be executed based on one or more production program packages, wherein in particular the one or more production program packages are designed and programmed both for the manufacture of a product and for the simulation of the operation of the production plant and / or the manufacture of the product.

[0405] In other words, each process unit can be designed and programmed to simulate at least one production program package that the process unit in question must and / or would execute to receive and / or treat a reactant during actual production of a product.

[0406] A process unit can be designed and programmed to hold one or more cryptographic keys by means of which production program packages of the production program for the simulation can be decrypted.

[0407] Such a cryptographic key can in particular be a private cryptographic key, in particular for public key encryption.

[0408] In particular, a cryptographic key for the simulation can be the same cryptographic key that is uniquely assigned to a production program package. Alternatively, the keys can be different and can be assigned to the simulation and the actual production, respectively.

[0409] Each production program package can be released for execution by means of release information received from the process unit for simulating the operation of the production plant and / or the manufacture of a product.

[0410] In particular, each piece of release information can comprise an information stamp, in particular a mode information stamp, by means of which the respective release information and / or the respective production program package can be assigned to a production mode of the production plant for manufacturing a product and / or a simulation mode of the production plant for simulating the operation of the production plant and / or the manufacture of a product. Each process unit can be designed and programmed to be operable in a production mode of the production plant for manufacturing a product and / or a simulation mode of the production plant for simulating the operation of the production plant and / or the manufacture of a product.

[0411] A differentiation between the production mode and the simulation mode can be made, in particular, based on the information stamp by the process unit in order to be in a corresponding operation.

[0412] One or more process units can be designed and programmed to simultaneously simulate one or more production program packages for at least one process unit in the production mode and, in particular, to generate simulation information in the process.

[0413] For example, during an actual manufacture of a product by means of one or more process units, any parameters and / or measured values ​​that can be detected by means of the one or more sensor units can be stored as simulation information, in particular by means of the simulation device, for example the relevant computing units of the process units involved in the actual manufacture of a product.

[0414] As already described, each production program package can contain at least one piece of information that refers to another production program package and / or includes instructions for receiving and / or treating a reactant, wherein, in particular, a defined sequence of the multiple production program packages can form the production program for producing a product that can be produced by the production plant. It can be provided that each reference to another production program package includes an information stamp, in particular an information stamp, by means of which the respective other production program package can be assigned to a production mode of the production plant for producing a product and / or to a simulation mode of the production plant for simulating the operation of the production plant and / or the production of a product.

[0415] The production plant can have one or the already described at least one control unit, by means of which a particularly logistical utilization and / or occupancy of the production plant can be provided based on the simulation result.

[0416] Additionally or alternatively, the production plant can have one or the already described at least one control unit, by means of which a prediction of a temporal production sequence of one or more production programs can be created based on the simulation result and / or based on the simulation result, the process units required and / or intended for carrying out the treatment processes and / or the consumables to be provided in the production plant can be assigned in terms of time and / or location.

[0417] In particular, by simulating treatment processes over various runtimes, a statistically optimal entry point or starting point for the production of a new or additional product can be determined. This can be done reliably and very accurately by simulating actual production, particularly at a hardware-level.

[0418] As previously described, a simulation may also require at least partial or complete approval using one or more pieces of release information. Essentially, the approval of a simulation can be analogous to the approval of the actual production of a product. This will be described in more detail below with regard to a simulation.

[0419] As already described, the production plant can have the simulation device already described. In this case, it can be provided that the production plant further comprises one or the at least one control unit already described, which is designed and programmed to at least partially store and operate one or the already described database, and / or to exchange information with one or morethe database already described, which is at least partially stored and / or operated on a computer system assigned or assignable to the production plant, wherein the database can contain one or more, in particular unique, release information for authorizing a simulation of an intake and / or a treatment of a reactant by means of one of the plurality of process units, in particular additionally or alternatively, wherein the database can be changed by retrieving at least one of the release information for a simulation by means of one of the plurality of process units, so that this release information can subsequently no longer be made available for retrieval in the original form.

[0420] In particular, the unique release information can be understood as information that is unique and / or has a unique identification.

[0421] It may be provided that the production facility has the computer system assigned or assignable to the production facility.

[0422] Additionally or alternatively, it can be provided that the computer system assigned or assignable to the production plant is a or the release computer system, in particular a or the cloud-based release computer system and / or a or the release server.

[0423] The database can be configured and programmed to receive and store one or more new release information items for authorizing a simulation exclusively from outside the production facility. For example, one or more new release information items can be transmitted to the database by a database access user, in particular a rights holder to a recipe represented by a production program, in particular via a computer system, for example, via a cloud and / or a server.

[0424] It can be provided that the database is set up and programmed to be stored and / or operated exclusively on the computer system assigned or assignable to the production plant, or to be synchronized with a parallel database which is stored and / or operated exclusively on the computer system assigned or assignable to the production plant.

[0425] It can be provided that each processing unit is configured and programmed to receive and store one or more pieces of release information, wherein each piece of release information received by a processing unit can be compared with each piece of release information already stored on a processing unit to prevent duplicate use of the received release information in the production plant. In particular, each processing unit can be configured and programmed to at least partially or completely store and operate a decentralized database, preferably an encrypted distributed ledger, in particular, in order to store the one or more pieces of release information that can be received or have been received.By using the decentralized database, a tamper-proof technical solution can be provided, preventing duplicate use of the received release information in the production facility. The decentralized database is described in more detail below.

[0426] As already described, one of several products can be produced by means of the production plant according to one of several production programs, wherein a production program can comprise several production program packages and each production program package can contain at least one piece of information which comprises instructions for receiving and / or treating a reactant.

[0427] In this case, it can be provided that at least one piece of release information can be uniquely assigned to each production program package to authorize a one-time simulation and / or a one-time execution of this production program package by at least one process unit. This can ensure that the simulation of production program packages is not possible beyond an approved limit or an approved number of executions.

[0428] In particular, a simulation can only be initialized and / or started by means of the simulation device if all production program packages of the production program and / or all release information associated with the production program packages can be provided.

[0429] It can be provided that one or more pieces of release information can be received and stored by at least one process unit for a time-delayed authorization and execution of a simulation of an intake and / or a treatment of a reactant, and / or one or more pieces of release information can be received in real time by at least one process unit for an immediate authorization and execution of a simulation of an intake and / or a treatment of a reactant. It can be provided that the database is encryptable or encrypted, and / or each piece of release information in the database is encryptable or encrypted.

[0430] For example, at least a part of the database and / or at least one piece of release information can be decrypted by means of at least one cryptographic key, which can be provided and / or stored by means of a process unit and / or is stored there.

[0431] A cryptographic key relating to a release may be different from a cryptographic key relating to a production program package.

[0432] Additionally or alternatively, such cryptographic keys may in particular be private cryptographic keys, in particular for public key encryption.

[0433] As already described, one of several products can be manufactured by means of the production facility according to one of several production programs, wherein at least one part of a production program can serve, in particular, exclusively to simulate and / or indicate the manufacture of a product. In this case, it can be provided that this at least one part of a production program can be authorized for simulation and / or execution by means of one or more release information items.

[0434] In other words, a simulation can only be initialized and / or started by means of the simulation device if all production program packages, including the dummy production program packages of the production program, and / or all release information associated with the production program packages, including the dummy production program packages, can be provided or is provided.

[0435] It can be provided that one or more pieces of release information can be retrieved from the database as bundled release information to authorize a simulation of the operation of the entire production plant and / or a simulation of an entire process for manufacturing a product, in particular by means of one or more process units and / or by means of the database. This can simplify a release process because not every individual piece of release information needs to be released separately by a person authorized to access the database, in particular by a rights holder to a recipe represented by a production program, but rather, in particular, a complete simulation of an entire production program can be released at once.

[0436] Additionally or alternatively, it can be provided that release information for each individual production program package can be retrieved individually from the database, in particular by means of a process unit and / or can be provided by means of the database, and / or several release information items for assignable production program packages can be retrieved together from the database, in particular by means of one or more process units and / or can be provided by means of the database.

[0437] It can be provided that the database is set up and programmed to assign a respective consent information to one or more, in particular all, release information items, which can be stored in the database for each release information item, in particular by a person authorized to access the database, wherein each release information item can only be provided if an assigned consent information item is stored.

[0438] Additionally or alternatively, it can be provided that the database is set up and programmed to contain and provide different types of release information, wherein in particular a type of release corresponds to a type of process unit and / or to a type of part, in particular a production program package, of a production program for manufacturing a product.

[0439] For example, a type of release information may relate only to patient boxes and / or only to tool boxes, or a type of release information may relate to a type of treatment process, for example a tempering process and / or a storage process in the storage device.

[0440] As already described, it can be provided that each piece of release information comprises an information stamp, in particular a mode information stamp, by means of which the respective piece of release information can be assigned to a production mode of the production plant for manufacturing a product and / or a simulation mode of the production plant for simulating the operation of the production plant and / or the manufacturing of a product. Additionally or alternatively, it can be provided that each piece of release information comprises an information stamp, in particular an information stamp, in particular a number information stamp, by means of which a maximum repeatability of a simulation of an intake and / or a treatment of a reactant can be determined, which can be authorized by means of the relevant release information.

[0441] Furthermore, it can be provided that the production plant can be switched to a different state depending on the existence of a data connection to the computer system assigned or assignable to the production plant, in particular the heartbeat computer system, as already described. In this case, it can be provided that a simulation can be carried out or not depending on the respective state.

[0442] As already described, each process unit can have one or more sensor units. In this case, each sensor unit can be configured to record at least one measured value relating to the intake and / or treatment of the reactant and / or relating to the process unit itself and to provide it to the processing unit for transmission to one or more authorized units in encrypted and / or abstracted form.

[0443] In this way, measured values ​​and / or information can be made unrecognizable on the process unit side, so that a leak of information to an unauthorized person, e.g. by means of manipulative tapping, can be avoided.

[0444] In other words, at least one measured value which can be detected by means of the one or more sensor units can first be made unrecognizable before it can be transmitted to one or more authorized receiving units.

[0445] It can be provided that the one or more units authorized to receive comprise one or more other process units and / or at least one higher-level control unit of the production plant and / or a computer system assigned or assignable to the production plant.

[0446] It can be provided that information representing the at least one detectable measured value can be modified by means of the sensor unit itself and the one or more receiving units are designed and programmed to interpret the modified information.

[0447] Additionally or alternatively, it can be provided that information representing the at least one detectable measured value can be modified by means of the computing unit and the one or more units authorized to receive it are designed and programmed to interpret the modified information.

[0448] Additionally or alternatively, it may be provided that the information can be modified in an encrypted manner and / or an abstracted manner and that the information can be decrypted and / or concretized by means of the one or more units authorized to receive it.

[0449] In other words, modifying may include encrypting and / or abstracting.

[0450] As already described, encryption here can also refer to public key encryption.

[0451] As a simple, non-limiting example, abstraction can include, in particular, the omission of physical units. Only the one or more authorized receiving units can interpret the pure numerical value and / or assign the correct, particularly physical, unit to it.

[0452] The information depth or information content of at least one measured value can thus be maintained. In other words, no loss of information can occur.

[0453] It may be provided that each computing unit is set up and programmed to provide the information only or exclusively as modified information for transmission to the one or more units authorized to receive it.

[0454] Additionally or alternatively, it can be provided that each computing unit is set up and programmed to evaluate the at least one detectable measured value according to parameter ranges that can be stored or are stored in the computing unit and to subsequently provide only one result of the evaluation of the at least one detectable measured value for transmission to one or more units authorized to receive it.

[0455] For example, the at least one detectable measured value can be evaluated on a scale from 1 to 100 by the computing unit, and only the determined scale value can be provided to the one or more authorized receiving units. A scale value can be assigned to an accentuated or good state and / or a non-accentuated or bad state and / or any transitional state.

[0456] It may be provided that the transmitted information is designed for storage in one or more authorized receiving units, particularly for process optimization of the production plant. For example, this information can serve as and / or form simulation information.

[0457] Additionally or alternatively, it may be provided that the transmitted information is designed for storage in one or more authorized receiving units according to different data categories.

[0458] Additionally or alternatively, it may be provided that the transmitted information, depending on the data category, is provided with an information stamp, in particular a release stamp and / or a time stamp and / or a location stamp, in order to restrict access to this information.

[0459] It can be provided that each computing unit has at least one communication module, in particular a Bluetooth module, preferably a Bluetooth Low Energy module, and / or a WiFi module, and each computing unit is set up and programmed to form a network with each other computing unit for transmitting information by means of the at least one communication module.

[0460] It should be understood that the communication module can be configured in alternative ways. For example, the communication module can be based on: ZigBee technology, 6LoWPAN technology, LoRaWAN technology, NB-iOT technology, LTE technology, 5G technology, Wi-Fi technology, etc. It can be provided that one or more of the computing units are configured and programmed as network nodes and / or hubs to transmit information from the processing units to the one or more authorized receiving units via the at least one communication module.

[0461] It can be provided that one or more of the computing units are set up and programmed as a gateway for transmitting information from the processing units to the one or more authorized receiving units by means of the at least one communication module.

[0462] It can be provided that the production facility has a zero-trust architecture and / or is operated and / or operable according to a zero-trust architecture. This can increase and / or increase the production security of the products to be manufactured, in particular biological pharmaceutical products, for example, cell culture and / or cell therapy products. For example, this can prevent cell cultures from being swapped and / or personal data from being leaked due to external, for example malicious, interference with the system or production facility. In particular, the attack surface and / or the impact of cyberattacks on the production facility can be minimized.

[0463] It may be provided that the process units and in particular their computing units are part of the Zero Trust architecture and / or can be assigned to it or are assigned to it.

[0464] It can be provided that the process units, and in particular their computing units, are configured and programmed to permit access authorizations only to execute a predetermined operation, preferably based on a production program and / or a production program package. The authorizations of users and / or devices and / or units, e.g., process units, of the production plant can be restricted and / or limited to a minimum required level in order to be able to fulfill their respective tasks within the production plant. This can preferably prevent any attackers from exploiting, for example, overprivileged accounts and / or devices and / or process units, for example for manipulation.It can be provided that the process units, and in particular their computing units, are configured and programmed to continuously and / or discontinuously monitor and / or verify the respective identity and / or status of users and / or devices and / or units, e.g., process units, of the production facility, for example, even during ongoing operations. This can preferably ensure that no unauthorized and / or compromised actors can gain and / or retain access to the production facility, in particular the network.

[0465] Additionally or alternatively, it may be provided that the at least one control unit and / or one or more separate control units of the production plant are configured and programmed to continuously and / or discontinuously monitor and / or check the respective identity and / or status of users and / or devices and / or units, e.g., process units, of the production plant, for example, even during ongoing operations. This can preferably ensure that no unauthorized and / or compromised actors can obtain and / or retain access to the production plant, in particular the network.

[0466] It can be provided that the production plant, in particular the process units, is (are) segmented into several network areas. In other words, said network can have several network areas. The network areas can preferably be partially or completely isolated from one another. Between network areas, for example, data traffic or information exchange can be strictly controlled and / or a type of data traffic or information exchange can be predefined so that any deviations from it can be detected. This can preferably ensure that the number of potential entry points for attackers is reduced and / or the spread of threats within the network is limited.

[0467] It can be provided that access to resources located within the production facility, for example process units and / or tools and / or consumables and / or computing power, can be based on preferably strict authentication and / or authorization. Preferably, each access attempt to said resources can be checked before it can be granted. For example, this can be done on the basis of a unique piece of information, in particular a fingerprint piece of information, and / or a production program package, as already described herein. This can preferably prevent potential attackers from accessing, for example, sensitive and / or critical data, information and / or systems, e.g., process units and / or tools, etc.

[0468] Advantageously, the Zero-Trust architecture can be used to meet and / or fulfill high security, quality, and / or compliance requirements, particularly in a biological-pharmaceutical production environment that is considered highly regulated and / or sensitive. By applying the Zero-Trust architecture, the security posture of the biological-pharmaceutical production environment can be improved and / or related business objectives can be reliably protected.

[0469] The following description refers in particular to a reactant:

[0470] A reactant can be arranged and / or accommodated in a container, in particular a reactant container or a vessel.

[0471] The reactant container with the reactant can be wrapped using packaging.

[0472] The reactant container with the reactant can be introduced into the lock device of the production plant, in particular into an entrance lock position of the lock device.

[0473] The at least one control unit assigns the reactant container to the reactant processing unit, in particular a patient box.

[0474] The packaging of the reactant container can be removed from the reactant container, particularly at the entry lock station and / or at a separate unpacking station in the lock device, particularly by means of one or more unpacking units. This process can be included in an instruction of a production program package.

[0475] Preferably, it can be provided that the packaging is cleaned and / or sterilized before removal by means of a cleaning device of the lock device or a part of the cleaning device of the production system assigned to the lock device. This process can be included in an instruction of a production program package. It can be provided that the reactant container with the reactant is movable within the lock device by means of a lock transport device and / or the handling device. Optionally, this can already take place in the patient box. This process can be included in an instruction of a production program package.

[0476] By means of the handling device, the reactant container with the reactant can be transferred to the patient box in or immediately adjacent to the lock device and / or to a workpiece carrier that can be or is arranged in the patient box. This process can be included in an instruction of a production program package.

[0477] The patient box, which contains the educt container with the educt, can define an aseptic process unit.

[0478] The patient box, which contains the reactant container with the reactant, can be stored in or at a storage location of the storage device using a storage transport device of the storage device. This process can be included in an instruction of a production program package.

[0479] Additionally or alternatively, this patient box can be prepared for one or more treatment processes, in particular by means of one or more tool units, in particular by means of a tool box, using the storage transport device. This process can be included in an instruction of a production program package.

[0480] The patient box and the tool box can be connectable / coupled to one another or can be connected / coupled for one or more treatment processes on the reactant arranged in the receiving box, wherein one or more tool units and / or one or more consumables may be required for one or more treatment processes, which may in particular be arranged and / or contained in the tool box. This process can be included in an instruction of at least one production program package. In particular, each individual treatment process can be included in an instruction of at least one individual production program package. By means of the treatment processes, a product can be generated from the reactant, in particular according to the sequence of the production program packages.

[0481] In a sense, the reactant container held in the patient box can now be referred to as a product container.

[0482] The product container containing the product, which is arranged in the patient box, can be moved by means of the storage transport device and / or the lock transport device and / or handling device to an exit lock location, in particular to a packaging location, of the lock device. This process can be included in an instruction of at least one production program package.

[0483] The product container containing the product can be packaged or packaged at the exit lock station, in particular at the packaging station, in particular using one or more packaging units, in order to subsequently be removable or removed from the lock device. This process can be included in an instruction of at least one production program package.

[0484] It should be understood that for each process described above, corresponding release information was processed by the involved process units and corresponding decryption was performed by the involved process units.

[0485] Furthermore, it should be understood that the production plant was in a normal state, i.e. a data connection to the computer system assigned or assignable to the production plant existed.

[0486] In the following, we will again discuss process units designed as patient boxes and / or tool boxes:

[0487] One or more patient boxes and / or tool boxes can be connected via the

[0488] Lock device must be able to be fed into the clean room area.

[0489] One or more patient boxes and / or tool boxes can be placed in the

[0490] The lock device must be able to be cleaned and / or sterilized by means of a cleaning device of the lock device or a part of the cleaning device of the production plant assigned to the lock device.

[0491] One or more patient boxes and / or tool boxes can be stored at a storage location of the storage device by means of a storage transport device of the storage device, to which the boxes in question can be transferred by means of a lock transport device and / or the handling device.

[0492] If required, one or more patient boxes and / or tool boxes can be transported from the storage location to their intended use by means of the storage transport device and, optionally, the handling device and / or the lock transport device.

[0493] For example, a patient box and / or a tool box can be equipped or can be equipped with one or more reactants and / or one or more tool units and / or one or more consumables, for example by means of the handling device, in particular in order to subsequently be stored or can be stored in the storage device or to be made available for one or more treatment processes, wherein in particular several patient boxes and / or tool boxes can be made available in this way.

[0494] One or more workpiece carriers can be arranged in respective patient boxes and / or tool boxes, for example by means of the handling device by means of which the workpiece carriers can be stored and / or made available.

[0495] Several patient boxes and / or tool boxes can be connected / coupled to form an aseptic process unit for performing one or more treatment procedures according to the instructions of one or more production program packages.

[0496] For example, a patient box containing a reactant container, a tool box containing consumables for one or more treatment processes, and a tool box containing one or more tool units for one or more treatment processes can be connected / coupled to one another, or can be connected / coupled, in particular by means of the storage transport device and / or the handling device, in order to form a common aseptic process unit, in order to subsequently enable one or more treatment processes to be carried out in accordance with the instructions of one or more production program packages. It should be understood that the objects in the boxes in question can already be accommodated in accordance with the instructions of one or more production program packages.

[0497] After the treatment processes have been carried out, the boxes can be detached / uncoupled from each other or detached / uncoupled.

[0498] The patient box with the manufactured product is transported to the lock device as previously described using the storage transport device.

[0499] The tool boxes can be fed into a cleaning device of the production plant, by means of which the workpiece carriers can be cleaned and / or sterilized.

[0500] The cleaned and / or sterilized tool boxes can be stored again in storage locations of the storage facility and can be available for reuse.

[0501] With reference to the preceding description, the present invention can provide a fully automated overall system for the production of biological-pharmaceutical products for the industrial production of individual batch sizes, in particular individual and / or very small batch sizes, in particular with modularly configured and / or autonomously acting components.

[0502] With the present invention, in particular, a fully automated overall system for the production of biological-pharmaceutical products can be created which has increased security, in particular with regard to manipulation and / or industrial espionage.

[0503] Compared to the tightly interlinked individual process steps typically found in conventional production processes for comparable biological and pharmaceutical products, the present invention creates a more efficient system and method. In particular, individual release processes allow individual process steps to be released in a tailored manner by a rights holder.

[0504] The present invention provides a system, ie, the production plant, and a method by which a human operator or user is no longer required in the immediate process environment, thereby increasing production efficiency and reducing the likelihood of manual errors. Furthermore, production optimization can be achieved based on simulation results, thus further increasing production efficiency.

[0505] It may be particularly advantageous that, in the present invention, all necessary systems and / or devices for autonomous operation and associated equipment and / or consumables can be present within the production plant and, furthermore, all necessary information for autonomous operation within the production plant can be stored and / or processed, in particular by means of the at least one control unit, which can preferably be formed by means of the computing units of the process units.

[0506] As the above description shows, the invention relates in particular to a production plant and a method according to one of the following sentences, in which particular embodiments of the invention are further described:

[0507] 1. Production plant for producing a product, in particular a biological pharmaceutical product, which has a plurality of process units for receiving and / or treating a reactant, wherein each process unit has at least one computing unit.

[0508] 2. Production plant according to sentence 1, characterized in that the production plant has at least one control unit which is designed and programmed to assign the reactant to one of the plurality of process units on the basis of one of a plurality of production programs for producing one of a plurality of products producible by means of the production plant. 3. Production plant according to sentence 2, characterized in that a production program comprises a plurality of, in particular encrypted, production program packages, wherein each production program package contains at least one piece of information which refers to another production program package and / or comprises instructions for receiving and / or processing a reactant.

[0509] 4. Production plant according to sentence 3, characterized in that a defined sequence of the several production program packages forms the production program for the manufacture of a product that can be manufactured by means of the production plant, wherein in particular the complete sequence can only be determined from all references to the other production program packages.

[0510] 5. Production plant according to sentence 3 or 4, characterized in that a process unit is designed and programmed to execute instructions of at least one production program package, in particular to decrypt and then execute them.

[0511] 6. Production plant according to one of sentences 3 to 5, characterized in that one or more, in particular all, of the production program packages are provided on a respective process unit and / or can be transmitted to a respective process unit, in particular by means of the at least one control unit and / or by means of a computer system assigned or assignable to the production plant.

[0512] 7. Production plant according to one of sentences 3 to 6, characterized in that the plurality of, in particular encrypted, production program packages comprise a start package and one or more follow-up packages, each package containing at least one piece of information which refers to a follow-up package and / or comprises instructions for receiving and / or treating a reactant.

[0513] 8. Production plant according to sentence 7, characterized in that the reactant can only be assigned to a process unit to which the starter package is assigned and / or which refers to the starter package and / or on which the starter package is stored, or can be assigned to a process unit to which the starter package can be provided after or with an assignment of the reactant. 9. Production plant according to one of sentences 1 to 8, characterized in that a process unit is designed and programmed to hold one or more cryptographic keys by means of which production program packages of the production program can be decrypted.

[0514] 10. Production plant according to sentence 9, characterized in that a cryptographic key is stored by means of at least one of the process units, by means of which a production program package can be decrypted and / or activated to start the production program.

[0515] 11. Production plant according to one of sentences 3 to 10, characterized in that one or more production program packages in a process unit can be decoded locally by means of the computing unit of the process unit, and / or one or more production program packages can be decoded by means of the at least one control unit and / or by means of a computer system assigned or assignable to the production plant outside the process units.

[0516] 12. Production plant according to one of sentences 9 to 11, characterized in that the one or more cryptographic keys can be assigned to the process unit by means of the at least one control unit and / or by means of a computer system assigned or assignable to the production plant, and / or the one or more cryptographic keys are inseparably integrated in the process unit.

[0517] 13. Production plant according to one of sentences 9 to 12, characterized in that a process unit has a security module, in particular a trusted platform module, for providing one or more cryptographic keys, wherein in particular by means of the security module one or more cryptographic keys for decrypting individual production program packages of the production program can be stored.

[0518] 14. Production plant according to one of sentences 9 to 13, characterized in that a process unit is designed and programmed to receive release information for the use and / or provision of the one or more cryptographic keys, and / or the one or more cryptographic keys can only be used and / or provided by the process unit for a limited time. 15. Production plant according to one of sentences 2 to 14, characterized in that the reactant can only be assigned to a process unit and / or treatment of the reactant by means of a process unit can only be carried out if unique information relating to the process unit, which can be provided by the process unit itself, and further unique information relating to the process unit, which can be detected by means of the at least one control unit, match.

[0519] 16. Production plant according to one of sentences 1 to 15, characterized in that the plurality of process units comprise: one or more patient boxes for receiving and / or transporting a reactant; and / or one or more tool boxes for treating a reactant; and / or one or more tool units for treating a reactant; and / or one or more sensor units for analyzing a reactant.

[0520] 17. Production plant according to one of sentences 2 to 16, characterized in that at least one process unit is configured for supplying a reactant into the production plant and / or for removing a reactant, an at least partially treated reactant and / or a product from the production plant, wherein in particular this process unit is designed and programmed to carry out a start, in particular a start package, of a production program.

[0521] 18. Production plant according to one of sentences 1 to 17, characterized in that the production plant has at least one control unit, in particular the at least one control unit, which is designed and programmed to determine an integrity of each process unit, in particular before a reactant can be received and / or treated by means of a process unit according to one of several production programs for producing one of several products that can be produced by means of the production plant.

[0522] 19. Production plant according to sentence 18, characterized in that the computing unit of a process unit is designed and programmed to provide unique information relating to this process unit, and further unique information relating to this process unit can be acquired by means of the at least one control unit, wherein the integrity of this process unit can be determined based on a comparison of these two unique pieces of information, in particular by means of the at least one control unit, and can be set and / or confirmed, in particular if these two unique pieces of information match. 20.Production plant according to sentence 18 or 19, characterized in that a process unit has a security module, in particular a trusted platform module, for providing unique information, in particular fingerprint information about the process unit, wherein the computing unit of the process unit is designed and programmed to provide the unique information to the at least one control unit for determining the integrity.

[0523] 21. Production plant according to one of sentences 18 to 20, characterized in that the production plant has one or more sensor units by means of which the process units can be detected, in particular visually, and on the basis of this detection, information which is unique with regard to the respective process units can be provided by means of the at least one control unit in order to determine the integrity.

[0524] 22. Production plant according to sentence 21, characterized in that the one or more sensor units comprise one or more camera units by means of which characteristic landmarks of an area, in particular a surface, and / or a geometry of the process units can be visually recorded.

[0525] 23. Production plant according to sentence 21 or 22, characterized in that the production plant has one or more actuator units, by means of which one or more process units can be excited, in particular mechanically, to generate a vibration, in particular a mechanical vibration, which can be detected by means of the one or more sensor units and on the basis of which information which is unique with regard to the respective process units can be provided by means of the at least one control unit in order to determine the integrity.

[0526] 24. Production plant according to sentence 23, characterized in that at least one of the one or more actuator units is configured to generate a mechanical oscillation, and this actuator unit is arranged on or in one of the one or more process units and / or can be brought into engagement with one of the one or more process units to generate the mechanical oscillation on the relevant process unit. 25. Production plant according to sentence 23 or 24, characterized in that the oscillation comprises a frequency range of greater than or equal to 10 Hz and less than or equal to 100 Hz, and / or the oscillation comprises one or more, in particular, different frequency ranges, which are each greater than or equal to 10 Hz and less than or equal to 100 Hz, and / or the oscillation comprises one or more, in particular, different frequency ranges, which follow one another in a specific order.

[0527] 26. Production plant according to one of sentences 23 to 25, characterized in that at least one of the one or more actuator units is configured to generate an acoustic vibration, in particular a sound wave, and this actuator unit is arranged on or in one of the one or more process units and / or can be brought into engagement with one of the one or more process units to generate the mechanical vibration, in particular the sound wave, with respect to the relevant process unit.

[0528] 27. Production plant according to sentence 26, characterized in that the oscillation comprises a frequency range of greater than or equal to 30 Hz and less than or equal to 10,000 Hz, and / or the oscillation comprises one or more, in particular, different frequency ranges, which are each greater than or equal to 30 Hz and less than or equal to 10,000 Hz, and / or the oscillation comprises one or more, in particular, different frequency ranges, which follow one another in a specific order.

[0529] 28. Production plant according to one of sentences 18 to 27, characterized in that one or more, in particular all, process units have at least one receiving space, in particular enclosed by a lateral surface, for receiving one or more objects, in particular a reactant and / or one or more objects for treating the reactant, wherein the integrity comprises an internal integrity relating to the receiving space and / or an external integrity relating to an exterior with respect to the receiving space.

[0530] 29. Production plant according to one of sentences 18 to 28, characterized in that a process unit is designed and programmed to execute instructions according to at least one production program, in particular to decrypt them and then execute them, provided their integrity is set and / or confirmed. 30. Production plant according to sentence 29, characterized in that a production program comprises several, in particular encrypted, production program packages, wherein each production program package contains at least one piece of information which refers to another production program package and / or comprises instructions for receiving and / or treating a reactant, wherein: (a) one or more, in particular all, of the production program packages are provided on a respective process unit and are only executable, in particular decryptable and executable, provided the integrity of the relevant process unit is set and / or confirmed;and / or (b) one or more, in particular all, of the production program packages can be transmitted to a respective process unit, in particular by means of the at least one control unit and / or by means of a computer system assigned or assignable to the production plant, provided that the integrity of the relevant process unit is set and / or confirmed;

[0531] 31. Production plant according to one of sentences 18 to 30, characterized in that a process unit is designed and programmed to block an execution and / or a decryption of instructions according to at least one production program, if their integrity cannot be set and / or confirmed.

[0532] 32. Production plant according to one of sentences 18 to 31, characterized in that a process unit is designed and programmed to provide a message, in particular an alarm message, in particular to the at least one control unit and / or a computer system assigned or assignable to the production plant, if its integrity cannot be set and / or confirmed.

[0533] 33. Production plant according to one of sentences 1 to 32, characterized in that the at least one computing unit is designed and programmed to determine an integrity of the respective process unit, in particular before a reactant can be received and / or treated by means of this process unit according to one of several production programs for producing one of several products that can be produced by means of the production plant.

[0534] 34. Production plant according to sentence 33, characterized in that the computing unit of a process unit is designed and programmed to store and / or provide unique information relating to this process unit and to record further unique information relating to this process unit, wherein the integrity of this process unit can be determined by means of the computing unit based on a comparison of these two unique pieces of information and, in particular, can be set and / or confirmed if these two unique pieces of information match.

[0535] 35. Production plant according to sentence 34, characterized in that the unique information comprises an initial state of the process unit in question and an initial time stamp assignable to the initial state, and the further unique information comprises a further state of the process unit in question and a further time stamp assignable to the further state, which is different from the initial time stamp.

[0536] 36. Production plant according to one of sentences 33 to 35, characterized in that one or more, in particular all, process units have at least one receiving space, in particular enclosed by a lateral surface, for receiving one or more objects, in particular a reactant and / or one or more objects for treating the reactant, wherein the integrity comprises an internal integrity relating to the receiving space and / or an external integrity relating to an exterior with respect to the receiving space.

[0537] 37. Production plant according to one of sentences 33 to 36, characterized in that a process unit has one or more sensor units by means of which unique information and / or further unique information about the process unit in question can be detected in order to determine the integrity, in particular an internal integrity.

[0538] 38. Production plant according to sentence 37, characterized in that a brightness value in and / or on the relevant process unit can be detected by means of at least one sensor unit and the unique information and / or the further unique information about the relevant process unit can be provided based on the detectable brightness value in order to determine the integrity, in particular an internal integrity.

[0539] 39. Production plant according to sentence 37 or 38, characterized in that a process unit has one or more actuator units, by means of which the process unit in question can be excited, in particular mechanically, to generate a vibration, in particular a mechanical vibration, which can be detected by means of one or more sensor units and on the basis of which the unique information and / or the further unique information about the process unit in question can be provided to determine the integrity.

[0540] 40. Production plant according to sentence 39, characterized in that the vibration comprises a frequency range of greater than or equal to 10 Hz and less than or equal to 100 Hz, and / or the vibration comprises one or more, in particular, different frequency ranges, which are each greater than or equal to 10 Hz and less than or equal to 100 Hz, and / or the vibration comprises one or more, in particular, different frequency ranges, which follow one another in a specific order, wherein in particular at least one of the one or more actuator units is designed as a vibration motor, which is fixed in and / or on the relevant process unit for generating the mechanical vibration.

[0541] 41. Production plant according to sentence 39 or 40, characterized in that at least one of the one or more actuator units is configured to generate an acoustic oscillation, in particular a sound wave, and is fixed in and / or on the relevant process unit to generate the mechanical oscillation, in particular the sound wave, with respect to the relevant process unit, wherein in particular: the oscillation comprises a frequency range of greater than or equal to 30 Hz and less than or equal to 10,000 Hz, and / or the oscillation comprises one or more, in particular different, frequency ranges which are each greater than or equal to 30 Hz and less than or equal to 10,000 Hz, and / or the oscillation comprises one or more, in particular different, frequency ranges which follow one another in a specific order.

[0542] 42. Production plant according to one of sentences 37 to 41, characterized in that a process unit has one or more electrically conductive line elements which are arranged on and / or in the process unit and / or are arranged within a lateral surface wall of the process unit and which form a particularly independent electrical circuit, wherein it can be detected by means of one or more sensor units whether the electrical circuit has been changed with respect to its original state and / or is interrupted, and wherein on the basis of the circuit detection the unique information and / or the further unique information about the process unit in question can be provided for determining the integrity.

[0543] 43. Production plant according to one of sentences 37 to 42, characterized in that at least one sensor unit is designed as an inertial measuring unit, by means of which at least one acceleration value, in particular an acceleration vector, and / or at least one rotation rate value, in particular a rotation rate vector, can be detected with respect to the relevant process unit, and the unique information and / or the further unique information about the relevant process unit can be provided based on the detectable acceleration and / or rotation rate values ​​in order to determine the integrity.

[0544] 44. Production plant according to sentence 43, characterized in that the production plant has a handling device for moving an object within the production plant and / or one or more actuator units by means of which the process unit in question can be mechanically excited to generate a particularly defined movement which can be detected by means of the inertial measuring unit and on the basis of which the unique information and / or the further unique information about the process unit in question can be provided to determine the integrity.

[0545] 45. Production plant according to one of sentences 37 to 44, characterized in that a temperature value in and / or on the relevant process unit can be detected by means of at least one sensor unit and the unique information and / or the further unique information about the relevant process unit can be provided based on the detectable temperature value in order to determine the integrity.

[0546] 46. ​​Production plant according to one of sentences 37 to 44, characterized in that the process unit in question can be at least partially visually detected by means of at least one sensor unit and the unique information and / or the further unique information about the process unit in question can be provided based on the visual detection in order to determine the integrity, wherein in particular the at least one sensor unit comprises a camera unit by means of which characteristic landmarks and / or geometries of the process unit in question can be visually detected.

[0547] 47. Production plant according to one of sentences 33 to 46, characterized in that the production plant has at least one control unit which is designed and programmed to determine the integrity of each process unit, in particular before a reactant can be received and / or treated by means of a process unit according to one of several production programs for producing one of several products that can be produced by means of the production plant, wherein in particular the computing unit of a process unit is further designed and programmed to provide unique information relating to this process unit, and by means of the at least one control unit, further unique information relating to this process unit can be acquired,wherein the integrity of this process unit can be determined based on a comparison of these two unique pieces of information by means of the at least one control unit and, in particular, can be set and / or confirmed if these two unique pieces of information match.

[0548] 48. Production plant according to one of sentences 1 to 47, characterized in that a reactant can be received and / or treated by means of a process unit according to one of several production programs for producing one of several products that can be produced by means of the production plant, wherein at least a part of a production program serves in particular exclusively to imitate and / or indicate one or more production program processes, in particular one or more production program processes for producing a product.

[0549] 49. Production plant according to sentence 48, characterized in that a production program comprises several, in particular encrypted, production program packages, wherein each production program package contains at least one piece of information which refers to another production program package and / or comprises instructions for receiving and / or treating a reactant, wherein in particular a defined sequence of the several production program packages forms the production program for producing a product which can be produced by means of the production plant.

[0550] 50. Production plant according to sentence 48 or 49, characterized in that a production program comprises one or more, in particular encrypted, dummy production program packages, wherein each dummy production program package contains at least one piece of information which refers to a production program package or another dummy production program package and / or which comprises dummy instructions for imitating and / or indicating an intake and / or a treatment of a reactant.

[0551] 51. Production plant according to sentence 50, characterized in that the production plant has at least one random module which can be executed by means of one or more computing units of the process units, by means of at least one control unit of the production plant and / or by means of a computer system assigned or assignable to the production plant and by means of which one or more dummy production program packages can be integrated into a production program in a random manner, wherein in particular one or more dummy instructions can be assigned to each dummy production program package in a random manner by means of the at least one random module.

[0552] 52. Production plant according to one of sentences 48 to 51, characterized in that a process unit is designed and programmed to execute any instructions according to a production program, in particular to decrypt and then execute them.

[0553] 53. Production plant according to one of sentences 48 to 52, characterized in that a process unit for receiving and / or treating a dummy reactant is designed and programmed to simulate and / or indicate receiving and / or treating an actual reactant using the dummy reactant.

[0554] 54. Production plant according to one of sentences 48 to 53, characterized in that the production plant has one or more concealment rooms for accommodating one or more process units, wherein an interior of each concealment room is optically separated from the outside of the concealment room and / or at least largely invisible, wherein in particular at least one process unit can be caused by means of the at least part of a production program for imitating and / or indicating a manufacture of a product in order to be accommodated in the interior of a respective concealment room.

[0555] 55. Production plant according to sentence 54, characterized in that at least one concealment room has one or more exchange units by means of which objects which are accommodated in and / or by process units can be relocated between the relevant process units which are located within the concealment room.

[0556] 56. A production facility according to clause 54 or 55, characterized in that at least one concealment room has one or more storage locations in which one or more process units can be accommodated for a random period of time. 57. A production facility according to one of clauses 54 to 56, characterized in that at least one concealment room is configured exclusively for simulating and / or indicating a treatment of a reactant.

[0557] 58. Production plant according to one of sentences 54 to 57, characterized in that at least one concealment room has one or more sensor units for monitoring the optical separation of the interior from the exterior of the concealment room, wherein in particular a brightness value within the concealment room can be detected by means of at least one sensor unit of the concealment room.

[0558] 59. Production plant according to one of sentences 54 to 58 in combination with sentence 50, characterized in that at least one dummy production program package comprises one or more dummy instructions which cause one or more process units to be recorded in one of the concealment rooms.

[0559] 60. Production plant according to sentence 59, characterized in that at least one dummy production program package comprises one or more dummy instructions which cause a relocation of objects which are accommodated in and / or by process units between the respective process units which are located within the concealment space.

[0560] 61. Production plant according to one of sentences 1 to 60, characterized in that the production plant has at least one control unit which is designed and programmed to at least partially store and operate a database and / or to exchange information with a database which is at least partially stored and / or operated on a computer system assigned or assignable to the production plant, wherein the database contains one or more, in particular unique, release information items for authorizing the intake and / or treatment of a reactant by means of one of the plurality of process units, wherein the database is modifiable by retrieving at least one of the release information items for one of the plurality of process units, so that this release information can subsequently no longer be made available for retrieval in its original form. 62.Production plant according to sentence 61, characterized in that the database is set up and programmed to receive and store one or more new release information items exclusively from outside the production plant.

[0561] 63. Production plant according to sentence 61 or 62, characterized in that the database is set up and programmed to be storable and / or operable exclusively on the computer system assigned or assignable to the production plant, or to be synchronizable with a parallel database which is storable and / or operable exclusively on the computer system assigned or assignable to the production plant.

[0562] 64. Production plant according to one of sentences 61 to 63, characterized in that each computing unit of each process unit is set up and programmed to receive and store one or more pieces of release information, wherein each piece of release information received by a computing unit can be compared with each piece of release information already stored on a computing unit in order to avoid double use of the received release information in the production plant, wherein in particular each computing unit is designed and programmed to at least partially or completely store and operate a decentralized database, preferably an encrypted distributed ledger, in particular, in order to store the one or more pieces of release information that can be received or have been received.

[0563] 65. Production plant according to one of sentences 61 to 64, characterized in that one of several products can be manufactured according to one of several production programs by means of the production plant, wherein a production program comprises several production program packages and each production program package contains at least one piece of information which comprises instructions for receiving and / or treating a reactant, wherein at least one piece of release information can be uniquely assigned to each production program package to authorize a particularly one-time execution of this production program package by means of at least one process unit, wherein in particular each production program can only be initialized and / or started by means of the production plant if all production program packages of the production program and / or all release information assigned to the production program packages can be provided or are provided. 66.Production plant according to one of sentences 61 to 65, characterized in that one or more release information items can be received and stored by at least one process unit for a time-delayed authorization and execution of a recording and / or a treatment of a reactant and / or one or more release information items can be received in real time by at least one process unit for an immediate authorization and execution of a recording and / or a treatment of a reactant.

[0564] 67. Production plant according to one of sentences 61 to 66, characterized in that the database is encryptable or encrypted and / or each release information in the database is encryptable or encrypted.

[0565] 68. Production plant according to one of sentences 61 to 67, characterized in that by means of the production plant one of several products can be produced according to one of several production programs, wherein at least one part of a production program serves in particular exclusively to imitate and / or indicate the manufacture of a product and this at least one part of a production program can be authorized for execution by means of one or more release information.

[0566] 69. Production plant according to one of sentences 61 to 68, characterized in that one or more release information items can be retrieved from the database as bundle release information for authorizing an overall process for manufacturing a product, in particular by means of one or more process units and / or can be provided by means of the database.

[0567] 70. Production plant according to one of sentences 61 to 64 or 66 to 69 in combination with sentence 65, characterized in that release information for each individual production program package can be retrieved individually from the database, in particular by means of a process unit and / or can be provided by means of the database, and / or several release information items for assignable production program packages can be retrieved together from the database, in particular by means of one or more process units and / or can be provided by means of the database.

[0568] 71. Production plant according to one of sentences 61 to 70, characterized in that the database is set up and programmed to assign one or more, in particular all, pieces of release information a respective consent information, which can be stored in the database for each piece of release information, in particular by a person authorized to access the database, wherein each piece of release information can only be provided if an assigned consent information is stored.

[0569] 72. Production plant according to one of sentences 61 to 71, characterized in that the database is set up and programmed to contain and provide different types of release information, wherein in particular a type of release corresponds to a type of process unit and / or to a type of part, in particular a production program package, of a production program for manufacturing a product.

[0570] 73. Production plant according to sentence 72, characterized in that each release information comprises an information stamp, in particular a mode information stamp, by means of which the respective release information can be assigned to a production mode of the production plant for manufacturing a product and / or a simulation mode of the production plant for simulating the operation of the production plant and / or in particular the manufacturing of a product.

[0571] 74. Production plant according to sentence 72 or 73, characterized in that each release information comprises an information stamp, in particular a number information stamp, by means of which a particular maximum repeatability of a recording and / or a treatment of a reactant can be determined, which can be authorized by means of the relevant release information.

[0572] 75. Production plant according to one of sentences 61 to 74, characterized in that the at least one control unit is designed and programmed to be connectable or to be connected to the computer system assigned or assignable to the production plant for data exchange in order to determine the existence of this data connection, wherein the production plant and / or the one or more, in particular all, process units are reversibly transferable, depending on the data connection, into a normal state for unrestricted operation, into a reserve state for temporally and / or functionally restricted operation, and / or into a pause state for inactive operation. 76.Production plant according to one of sentences 1 to 75, characterized in that each computing unit is designed and programmed to at least partially or completely store and operate a particularly encrypted decentralized database, preferably a particularly encrypted distributed ledger, wherein each decentralized database is a redundant copy of each of the other decentralized databases, wherein each computing unit is designed and programmed to validate an operation of the respective decentralized databases on each of the other computing units and to update its own decentralized database in response to a validation, wherein each decentralized database is designed and programmed to comprise one or more, in particular unique, items of information about an intake and / or a treatment of a reactant from each process unit.

[0573] 77. Production plant according to sentence 76, characterized in that each process unit, in particular the computing unit of each process unit, has a security module, in particular a trusted platform module, for providing one or more cryptographic keys.

[0574] 78. Production plant according to sentence 76 or 77, characterized in that each decentralized database can be encrypted or is encrypted by means of a cryptographic key which can be specifically assigned and / or made available only to the process unit on which the decentralized database can be stored or is stored.

[0575] 79. Production plant according to one of sentences 76 to 78, characterized in that by means of the production plant one of several products can be produced according to one of several production programs, wherein a production program comprises several production program packages and each production program package contains at least one piece of information which comprises instructions for receiving and / or treating a reactant, which can be executed by means of at least one process unit.

[0576] 80. Production plant according to sentence 79, characterized in that each processing unit is configured and programmed to store each execution of a production program package in the decentralized database, in particular depending on the validation by the other processing units. 81. Production plant according to sentence 79 or 80, characterized in that each processing unit is configured and programmed to execute a production program package only if this production program package is not stored in the decentralized database as already executed.

[0577] 82. Production plant according to one of the sentences 76 to 81, characterized in that each computing unit is set up and programmed to receive one or more, in particular unique, release information for authorizing the intake and / or treatment of a reactant from at least one control unit of the production plant and / or a computer system assigned or assignable to the production plant and to store the one or more release information in its own decentralized database.

[0578] 83. Production plant according to sentence 82, characterized in that each processing unit is set up and programmed to compare each received release information with each release information already stored in the decentralized database in order to avoid double use of the received release information in the production plant, in particular depending on the validation by the other processing units.

[0579] 84. Production plant according to sentence 82 or 83, characterized in that each release information comprises an information stamp, in particular a number information stamp, by means of which a particular maximum repeatability of a recording and / or a treatment of a reactant can be determined, which can be authorized by means of the relevant release information, wherein in particular the information stamp, in particular the number information stamp, of each release information in the decentralized database can be updated depending on an authorized execution of a recording and / or a treatment of a reactant.

[0580] 85. Production plant according to one of sentences 79 to 81 in combination with one of sentences 82 to 84, characterized in that at least one piece of release information can be uniquely assigned to each production program package to authorize execution of this production program package by at least one process unit. 86. Production plant according to sentence 85, characterized in that each processing unit is designed and programmed to execute the instructions of a production program package only if release information associated with this production program package is provided to the processing unit and, in particular, this production program package and / or this release information is stored in the decentralized database as not yet executed.

[0581] 87. Production plant according to sentence 85 or 86, characterized in that each computing unit is designed and programmed to execute the instructions of a production program package only if a maximum repeatability of an execution of this production program package is stored in the decentralized database as not yet reached according to the release information.

[0582] 88. Production plant according to one of sentences 76 to 87, characterized in that the production plant has one or more further computer systems and / or can be connected or is connectable to such, wherein each of the further computer systems is arranged differently in terms of location with respect to a remainder of the production plant, wherein the decentralized database is stored and operated on each of the further computer systems, and wherein each of the further computer systems is designed and programmed to validate an operation of the respective decentralized databases on each of the other computer systems and / or computing units and to update its own decentralized database in response to a validation.

[0583] 89. Production plant according to one of sentences 1 to 88, characterized in that the production plant has at least one control unit which is designed and programmed to be connectable or connected to a computer system assigned or assignable to the production plant for data exchange in order to determine the existence of this data connection.

[0584] 90. Production plant according to sentence 89, characterized in that the production plant and / or the one or more, in particular all, process units can be reversibly transferred, depending on the data connection, into a normal state for unrestricted operation, into a reserve state for temporally and / or functionally restricted operation, and / or into a pause state for idle operation. 91. Production plant according to sentence 89 or 90, characterized in that the at least one control unit and / or one or more, in particular each, of the computing units are designed and programmed to determine the existence of the data connection to the computer system, in particular continuously or at regular intervals.

[0585] 92. Production plant according to one of the sentences 89 to 91, characterized in that the production plant for manufacturing a product, in particular the process units for receiving and / or treating a reactant, can only be operated without restriction if the data connection exists.

[0586] 93. Production plant according to one of sentences 89 to 92, characterized in that if the data connection does not exist, the production plant for producing a product, in particular the process units for receiving and / or treating a reactant, can be transferred into a reserve state in which the production of a product, in particular the receiving and / or treating of a reactant, is limited in time and / or function.

[0587] 94. Production plant according to one of sentences 90 to 93, characterized in that the at least one control unit and / or one or more, in particular each, of the computing units are designed and programmed to store an information stamp, in particular a time stamp, when transferred to the reserve state and to stop unrestricted operation of the production plant and / or the one or more, in particular all, process units after a predefined period of time from this information stamp, in particular this time stamp, and in particular to transfer the production plant and / or the relevant process units to the pause state.

[0588] 95. Production plant according to one of sentences 90 to 94, characterized in that the at least one control unit and / or one or more, in particular each, of the computing units are designed and programmed to execute only a predefined part of a production program for manufacturing a product upon transfer to the reserve state. 96. Production plant according to one of sentences 90 to 95, characterized in that the at least one control unit and / or one or more, in particular each, of the computing units are designed and programmed to modify and / or supplement a production program for manufacturing a product with one or more production program packages upon transfer to the pause state for storing a reactant and / or an at least partially treated reactant and / or a product, in particular as long as the pause state exists.

[0589] 97. Production plant according to one of sentences 89 to 96, characterized in that the production plant has the computer system, wherein the computer system is arranged spatially differently with respect to a remainder of the production plant, wherein in particular the computer system comprises a server to which the at least one control unit is or can be connected for data exchange.

[0590] 98. Production plant according to one of sentences 1 to 97, characterized in that the plurality of process units serve to receive and / or treat a reactant according to one of a plurality of production programs for producing one of a plurality of products that can be produced by means of the production plant, and in that the production plant has a simulation device that is designed and programmed to simulate the operation of the production plant and / or in particular the production of a product based on at least one production program and to provide a simulation result corresponding thereto, wherein the simulation device is formed partially or completely by one or more, in particular all, computing units of the respective process units.

[0591] 99. Production plant according to sentence 98, characterized in that the simulation device is designed and programmed to record plant parameters of the production plant during the manufacture of a product and / or to record recording process measured values ​​and / or treatment process measured values ​​of the process units, in particular operating parameters of the process units, and to store them as simulation information and to keep them available for carrying out a simulation, wherein in particular the simulation of an operation of the production plant and / or a manufacture of a product can be carried out on the basis of this simulation information by means of the simulation device. 100.Production plant according to sentence 98 or 99, characterized in that the production plant has one or more sensor units which are at least partially assigned to the process units and / or form part of the process units, wherein the simulation device is designed and programmed to carry out the simulation on the basis of simulation information which can be detected or is detected by means of these sensor units.

[0592] 101. Production plant according to sentence 99 or 100, characterized in that a simulation information comprises at least one of the following: time parameters and / or time measurements of the production plant, in particular of the process units, climate parameters and / or climate measurements in and / or around the production plant, in particular in and / or around the process units, and / or operating parameters and / or operating measurements of the production plant, in particular of the process units, wherein in particular: (a) time parameters and / or time measurements comprise: pumping times of process units configured as pumping devices and / or transport times of process units and / or sterilization times of process units configured as sterilization devices and / or cleaning times of process units configured as cleaning devices and / or waiting times within the production plant and / or unpacking / packaging times of unpacking / packaging devicesconfigured process units and / or loading / unloading times of process units and / or setup times of process units configured as tool units; and / or (b) climate parameters and / or climate measured values: temperature values ​​and / or air humidity values ​​and / or gas composition values; and / or (c) operating parameters and / or operating measured values: temperature parameters of process units configured as temperature control devices and / or fill levels of storage devices.

[0593] 102. Production plant according to one of sentences 98 to 101, characterized in that the part of a production program that is to be executed by means of the associated process units for manufacturing a product can be simulated by means of the computing units forming the simulation device, wherein in particular a production program comprises several, in particular encrypted, production program packages, and each production program package contains at least one piece of information that comprises instructions for receiving and / or treating a reactant, which instructions can be executed by means of at least one process unit, and one or more production program packages form the said part of the production program to be simulated. 103.Production plant according to one of sentences 98 to 102, characterized in that a production program comprises a plurality of, in particular encrypted, production program packages and each production program package contains at least one piece of information which comprises instructions for receiving and / or treating a reactant, which instructions can be executed by means of at least one process unit, and the simulation can be executed based on one or more production program packages, wherein in particular the one or more production program packages are designed and programmed both for the production of a product and for the simulation of the operation of the production plant and / or the production of the product.

[0594] 104. Production plant according to sentence 102 or 103, characterized in that a process unit is designed and programmed to hold one or more cryptographic keys by means of which production program packages of the production program for the simulation can be decrypted.

[0595] 105. Production plant according to one of sentences 102 to 104, characterized in that each production program package can be released for execution by means of release information receivable from the process unit for simulating the operation of the production plant and / or the manufacture of a product, wherein in particular each release information comprises an information stamp, in particular a mode information stamp, by means of which the respective release information and / or the respective production program package can be assigned to a production mode of the production plant for manufacturing a product and / or a simulation mode of the production plant for simulating the operation of the production plant and / or the manufacture of a product.

[0596] 106. Production plant according to one of sentences 98 to 105, characterized in that each process unit is designed and programmed to be operable in a production mode of the production plant for producing a product and / or a simulation mode of the production plant for simulating the operation of the production plant and / or the production of a product.

[0597] 107. Production plant according to sentence 106, characterized in that one or more process units are designed and programmed to simultaneously simulate one or more production program packages for at least one process unit in the production mode and in particular to generate simulation information in the process.

[0598] 108. Production plant according to one of sentences 102 to 107, characterized in that each production program package contains at least one piece of information which refers to another production program package and / or comprises instructions for receiving and / or treating a reactant, wherein in particular a defined sequence of the plurality of production program packages forms the production program for producing a product which can be produced by means of the production plant.

[0599] 109. Production plant according to sentence 108, characterized in that each reference to another production program package comprises an information stamp, in particular a mode information stamp, by means of which the respective other production program package can be assigned to a production mode of the production plant for manufacturing a product and / or a simulation mode of the production plant for simulating the operation of the production plant and / or the manufacturing of a product.

[0600] 110. Production plant according to one of sentences 98 to 109, characterized in that the production plant has at least one control unit by means of which a particularly logistical capacity utilization and / or occupancy of the production plant can be provided based on the simulation result.

[0601] 111. Production plant according to one of sentences 98 to 110, characterized in that the production plant has at least one control unit by means of which, based on the simulation result, a prediction of a temporal production sequence of one or more production programs can be created and / or, based on the simulation result, the process units required and / or intended for carrying out the treatment processes and / or the consumables to be provided in the production plant can be assigned in terms of time and / or location.

[0602] 112. Production plant according to one of sentences 1 to 111, characterized in that the plurality of process units serve to receive and / or treat a reactant according to one of a plurality of production programs for producing one of a plurality of products that can be produced by means of the production plant, and in that the production plant has a simulation device that is designed and programmed to simulate the operation of the production plant and / or in particular the production of a product based on at least one production program and to provide a simulation result corresponding thereto, wherein the simulation device is formed partially or completely by one or more, in particular all, computing units of the respective process units, and in that the production plant further has at least one control unit that is designed and programmed to at least partially store and operate a database,and / or to exchange information with a database which is at least partially stored and / or operated on a computer system assigned or assignable to the production plant, wherein the database contains one or more, in particular unique, release information for authorizing a simulation of an intake and / or treatment of a reactant by means of one of the plurality of process units, wherein the database can be changed by retrieving at least one of the release information for a simulation by means of one of the plurality of process units, so that this release information can subsequently no longer be made available for retrieval in its original form.

[0603] 113. Production plant according to sentence 112, characterized in that the database is set up and programmed to receive and store one or more new release information for authorizing a simulation exclusively from outside the production plant.

[0604] 114. Production plant according to sentence 112 or 113, characterized in that the database is set up and programmed to be storable and / or operable exclusively on the computer system assigned or assignable to the production plant, or to be synchronized with a parallel database which is storable and / or operable exclusively on the computer system assigned or assignable to the production plant.

[0605] 115. Production plant according to one of sentences 112 to 114, characterized in that each computing unit of each process unit is set up and programmed to receive and store one or more pieces of release information, wherein each piece of release information received by a computing unit can be compared with each piece of release information already stored on a computing unit in order to avoid double use of the received release information in the production plant, wherein in particular each computing unit is designed and programmed to at least partially or completely store and operate a decentralized database, preferably an encrypted distributed ledger, in particular, in order to store the one or more pieces of release information that can be received or have been received.

[0606] 116. Production plant according to one of sentences 112 to 115, characterized in that a production program comprises a plurality of production program packages and each production program package contains at least one piece of information which comprises instructions for receiving and / or treating a reactant, wherein at least one piece of release information can be uniquely assigned to each production program package for authorizing a particularly one-time simulation and / or a particularly one-time execution of this production program package by means of at least one process unit, wherein in particular a simulation can only be initialized and / or started by means of the simulation device if all production program packages of the production program and / or all release information assigned to the production program packages can be provided.

[0607] 117. Production plant according to one of sentences 112 to 116, characterized in that one or more release information items can be received and stored by at least one process unit for a time-delayed authorization and execution of a simulation of a reception and / or a treatment of a reactant and / or one or more release information items can be received in real time by at least one process unit for an immediate authorization and execution of a simulation of a reception and / or a treatment of a reactant.

[0608] 118. Production plant according to one of sentences 112 to 117, characterized in that the database is encryptable or encrypted and / or each release information in the database is encryptable or encrypted.

[0609] 119. Production plant according to one of sentences 112 to 118, characterized in that by means of the production plant one of several products can be produced according to one of several production programs, wherein at least one part of a production program serves in particular exclusively to imitate and / or indicate a production of a product and this at least one part of a production program can be authorized by means of one or more release information for simulation and / or execution.

[0610] 120. Production plant according to one of sentences 112 to 119, characterized in that one or more release information items can be retrieved from the database as bundle release information for authorizing a simulation of the operation of the entire production plant and / or a simulation of an overall process for manufacturing a product, in particular by means of one or more process units and / or by means of the database.

[0611] 121. Production plant according to one of sentences 112 to 115 or 117 to 120 in combination with sentence 116, characterized in that release information for each individual production program package can be retrieved individually from the database, in particular by means of a process unit and / or can be provided by means of the database, and / or several release information items for assignable production program packages can be retrieved together from the database, in particular by means of one or more process units and / or can be provided by means of the database.

[0612] 122. Production plant according to one of sentences 112 to 121, characterized in that the database is set up and programmed to assign one or more, in particular all, pieces of release information a respective consent information, which can be stored in the database for each piece of release information, in particular by a person authorized to access the database, wherein each piece of release information can only be provided if an assigned consent information is stored.

[0613] 123. Production plant according to one of sentences 112 to 122, characterized in that the database is set up and programmed to contain and provide different types of release information, wherein in particular a type of release corresponds to a type of process unit and / or to a type of part, in particular a production program package, of a production program for manufacturing a product.

[0614] 124. Production plant according to sentence 123, characterized in that each release information comprises an information stamp, in particular a mode information stamp, by means of which the respective release information can be assigned to a production mode of the production plant for manufacturing a product and / or a simulation mode of the production plant for simulating the operation of the production plant and / or the manufacturing of a product.

[0615] 125. Production plant according to sentence 123 or 124, characterized in that each release information comprises an information stamp, in particular a number information stamp, by means of which a particular maximum repeatability of a simulation of an intake and / or a treatment of a reactant can be determined, which can be authorized by means of the relevant release information.

[0616] 126. Production plant according to one of sentences 112 to 125, characterized in that the at least one control unit is designed and programmed to be connectable or connected to the computer system assigned or assignable to the production plant for data exchange in order to determine the existence of this data connection, wherein the production plant and / or the one or more, in particular all, process units are reversibly transferable, depending on the data connection, into a normal state for unrestricted operation, into a reserve state for temporally and / or functionally restricted operation and / or into a pause state for dormant operation, wherein in particular a simulation is able to be carried out depending on the respective state.

[0617] 127. Production plant according to one of sentences 1 to 126, characterized in that the plurality of process units serve for receiving and / or treating a reactant according to one of a plurality of production programs for producing one of a plurality of products that can be produced by means of the production plant and each process unit has one or more sensor units, wherein each sensor unit is configured to record at least one measured value relating to the receiving and / or treatment of the reactant and / or relating to the process unit itself and to provide it to the computing unit for transmission to one or more authorised units in encrypted and / or abstracted form.

[0618] 128. Production plant according to sentence 127, characterized in that the one or more authorized receiving units comprise one or more other process units and / or at least one higher-level control unit of the production plant and / or a computer system assigned or assignable to the production plant. 129. Production plant according to sentence 127 or 128, characterized in that information representing the at least one detectable measured value can be modified by the sensor unit itself, and the one or more authorized receiving units are designed and programmed to interpret the modified information.

[0619] 130. Production plant according to one of sentences 127 to 129, characterized in that information representing the at least one detectable measured value can be modified by means of the computing unit and the one or more receiving units are designed and programmed to interpret the modified information.

[0620] 131. Production plant according to sentence 129 or 130, characterized in that the information can be modified in an encrypted manner and / or an abstracted manner and the information can be decrypted and / or concretized by means of the one or more authorised receiving units.

[0621] 132. Production plant according to one of sentences 129 to 131, characterized in that each computing unit is configured and programmed to provide the information only as modified information for transmission to the one or more units authorized to receive it.

[0622] 133. Production plant according to one of sentences 127 to 132, characterized in that each computing unit is set up and programmed to evaluate the at least one detectable measured value according to parameter ranges that can be stored or are stored in the computing unit and to subsequently provide only one result of the evaluation of the at least one detectable measured value for transmission to one or more units authorized to receive it.

[0623] 134. Production plant according to one of sentences 127 to 133, characterized in that the transmitted information is designed for storage in one or more authorized receiving units, in particular for process optimization of the production plant. 135. Production plant according to one of sentences 127 to 134, characterized in that the transmitted information is designed for storage in one or more authorized receiving units according to different data categories.

[0624] 136. Production plant according to sentence 135, characterized in that the transmitted information is provided with an information stamp, in particular a release stamp, depending on the data category, in order to restrict access to this information.

[0625] 137. Production plant according to one of sentences 127 to 136, characterized in that each computing unit has at least one communication module, in particular a Bluetooth module, preferably a Bluetooth Low Energy module, and / or a WiFi module, and each computing unit is set up and programmed to form a network with each other computing unit for transmitting information by means of the at least one communication module.

[0626] 138. Production plant according to sentence 137, characterized in that one or more of the computing units are set up and programmed as network nodes and / or hubs for transmitting information from the processing units to the one or more authorised receiving units by means of the at least one communication module.

[0627] 139. Production plant according to sentence 137 or 138, characterized in that one or more of the computing units are set up and programmed as a gateway for transmitting information from the process units to the one or more authorised receiving units by means of the at least one communication module.

[0628] 140. Method for controlling a production plant for producing a product, in particular a biological-pharmaceutical product, in particular a production plant according to one of sentences 1 to 139, wherein the method comprises at least the following:

[0629] Providing one or more process units for receiving and / or treating a reactant.

[0630] 141. Method according to sentence 140, characterized in that the method further comprises the following: determining a production program package, in particular an encrypted production program package, of a production program, in particular for producing a product that can be produced by means of the production plant, and one of the process units in order to execute this production program package, based on a production program package of the production program that is arranged upstream of the production program package and is in particular encrypted;

[0631] Activating the determined production program package on the determined process unit in order to decrypt the determined production program package and subsequently control the process unit to carry out one or more treatment steps on the reactant based on the decrypted production program package; and determining a production program package of the production program following the decrypted production program package, in particular an encrypted production program package, and a subsequent process unit to execute this subsequent production program package based on the decrypted production program package.

[0632] 142. Method according to sentence 140 or 141, characterized in that the method further comprises the following:

[0633] Providing a data connection from a computer system assigned or assignable to the production plant to the production plant and / or one or more, in particular all, process units;

[0634] Determining whether the data connection exists by means of at least one control unit of the production plant and / or at least one computing unit of at least one process unit; and

[0635] Controlling the production plant and / or one or more, in particular all, process units depending on the data connection.

[0636] 143. Method according to sentence 142, characterized in that controlling comprises a reversible transfer of the production plant and / or the one or more, in particular all, process units into a normal state for unrestricted operation, into a reserve state for temporally and / or functionally restricted operation and / or into a pause state for dormant operation, in particular based on the existence of the data connection.

[0637] 144. Method according to sentence 143, characterized in that the at least one control unit and / or one or more, in particular each, of the computing units store an information stamp, in particular a time stamp, when transferred to the reserve state and stop unrestricted operation of the production plant and / or the one or more, in particular all, process units after a predefined period of time from this information stamp, in particular this time stamp, and in particular transfer the production plant and / or the relevant process units to the pause state.

[0638] 145. Method according to sentence 143 or 144, characterized in that the at least one control unit and / or one or more, in particular each, of the computing units, when transferred to the reserve state, only execute a predefined part of a production program for manufacturing a product.

[0639] 146. Method according to one of sentences 143 to 145, characterized in that the at least one control unit and / or one or more, in particular each, of the computing units, when transferred to the pause state, modifies and / or supplements a production program for manufacturing a product with one or more production program packages in order to store a reactant and / or an at least partially treated reactant and / or a product, in particular as long as the pause state exists.

[0640] Further preferred features and / or advantages of the present invention are the subject of the following description and the drawings of exemplary embodiments.

[0641] The figures show:

[0642] Fig. 1 is a schematic perspective view of a production plant according to an exemplary embodiment of the present invention,

[0643] Fig. 2 is a schematic perspective view of part of the production plant shown in Fig. 1,

[0644] Fig. 3 is a schematic plan view of part of the production plant shown in Fig. 1,

[0645] Fig. 4 is a schematic plan view of a part of the production plant shown in Fig. 1, Fig. 5 is a schematic plan view of the production plant shown in Fig. 1,

[0646] Fig. 6 is a schematic plan view of the production plant shown in Fig. 1,

[0647] Fig. 7 is a schematic plan view of the production plant shown in Fig. 1,

[0648] Fig. 8 is a schematic plan view of part of the production plant shown in Fig. 1,

[0649] Fig. 9 is a schematic perspective view of part of the production plant shown in Fig. 1,

[0650] Fig. 10 is a schematic plan view of part of the production plant shown in Fig. 1,

[0651] Fig. 11 is a schematic plan view of part of the production plant shown in Fig. 1,

[0652] Fig. 12 is a schematic perspective view of a production plant according to another exemplary embodiment of the present invention,

[0653] Fig. 13 is a schematic perspective view of a production plant according to another exemplary embodiment of the present invention,

[0654] Fig. 14 is a schematic perspective view of a production plant according to another exemplary embodiment of the present invention, and

[0655] Fig. 15 shows a method according to an exemplary embodiment of the present invention. Identical or functionally equivalent elements are provided with the same reference numerals throughout the figures.

[0656] Fig. 1 shows a schematic perspective view of a production plant 10 according to an exemplary embodiment of the present invention.

[0657] Referring to Fig. 1, a production plant 10, in particular for the production of biological-pharmaceutical products 20, comprises several process units for receiving and / or treating a reactant 40.

[0658] In the present exemplary embodiment, several process units are designed as workpiece carriers 30, in particular workpiece carriers 30 configured as patient boxes 50, for receiving and / or transporting a reactant 40 and / or as patient boxes 50, in particular for receiving and / or transporting a reactant 40. In other words, workpiece carriers 30 configured as patient boxes 50 can be patient boxes 30, 50.

[0659] Furthermore, in the present embodiment, several process units are designed as tool boxes 702, 704, in particular for treating a reactant 40.

[0660] A toolbox 702, 704, which is described in the present description particularly in connection with tool units, is designated by the reference numeral 702, and a toolbox 702, 704, which is described in the present description particularly in connection with consumables and / or consumable materials, is designated by the reference numeral 704. It should be understood that a toolbox 702, 704 can be described both with regard to tool units and with regard to consumables and / or consumable materials and can be designated by both reference numerals 702, 704.

[0661] Each process unit has a computing unit.

[0662] This means that in particular each patient box 30, 50 and each tool box 702, 704 has a respective computing unit.

[0663] Furthermore, the production facility 10 shown in Fig. 1 comprises: a cleanroom area 100; a lock device 200 for supplying an object from an environment of the production facility 10 into the cleanroom area 100 and / or for removing an object from the cleanroom area 100; a handling device 300 for moving the object within the cleanroom area 100; and a storage device 400 arranged within the cleanroom area, which storage device comprises a plurality of storage locations 402 for receiving a plurality of objects.

[0664] In the present exemplary embodiment, it is provided in particular that the handling device 300 is designed as a process unit or a process unit forms the handling device 300, and that a storage location 402 is designed as a process unit or a process unit forms a storage location 402.

[0665] The biological-pharmaceutical product 20 may be intended for personalized therapy and may therefore be a personalized therapeutic.

[0666] The production plant 10 has an enclosure, not shown in the figures, for separating the clean room area 100 from the surroundings of the production plant 10.

[0667] Therefore, the lock device 200 is configured to feed an object from the environment of the production plant 10 via or through the enclosure into the clean room area 100 and / or to remove an object from the clean room area 100 via or through the enclosure.

[0668] The clean room area 100 is designed and / or classified as described in the application DE 10 2021 207 738.2, which is hereby incorporated by reference.

[0669] The production plant 10 is further connected to at least one electrical power source (not shown in the figures) arranged in the vicinity of the production plant 10 for a power supply.

[0670] As can be seen in Fig. 1, the storage device 400 comprises a plurality of, here by way of example three, storage racks 404, each having a plurality of storage locations 402. The storage device 400 further comprises a storage transport device 406 for transporting objects to the storage locations 402, in particular the storage racks 404, and / or away from the storage locations 402, in particular the storage racks 404.

[0671] In particular, by means of the storage transport device 406 of the storage device 400, reactants and / or workpiece carriers and / or tool units and / or consumables and / or process units, for example patient boxes 30, 50 and / or tool boxes 702, 704, can be stored in the storage locations 402 of the storage racks 404 and / or removed therefrom.

[0672] The storage transport device 406 is a different device from the handling device 300.

[0673] In the present exemplary embodiment, it is provided in particular that the storage transport device 406 is designed as process units or that several process units form the storage transport device 406.

[0674] The storage transport device 406 schematically shown in Fig. 1 comprises one or more transport vehicles 410 that move freely in the clean room area 100. In other words, it can be provided that the transport vehicles 410 that move freely in the clean room area 100 are transport vehicles that can be controlled and moved freely in the clean room area 100 as needed, so that when controlled accordingly, they can move freely as needed.

[0675] In the present embodiment, it is provided in particular that a transport vehicle 410 is designed as a process unit or a process unit forms a transport vehicle 410

[0676] By means of the transport vehicles 410, the storage racks 404 of the storage device 400 are accessible in particular for storage and retrieval operations as well as for treatment operations and / or maintenance operations.

[0677] The storage racks 404, in particular the storage locations 402 of the storage racks 404, are accessible via one or more storage rack locks 412 for storage and retrieval operations as well as for treatment operations and / or maintenance operations by the transport vehicles 410 (see Fig. 9).

[0678] By using the freely moving transport vehicle 410, any arrangement of the storage racks 404 is possible. The essentially parallel arrangement of the storage racks 404 shown in Fig. 1 and the related figures is shown purely as an example for explanatory purposes.

[0679] The production plant 10 further comprises a cleaning device 500, by means of which one or more patient boxes 30, 50 and / or one or more tool boxes 702, 704 and / or one or more tools or tool units and / or one or more consumables can be cleaned and / or sterilized, in particular by means of irradiation and / or gassing.

[0680] The production plant 10 also comprises an unpacking device 212 for unpacking objects to be supplied to the clean room area 100 and a packaging device 214 for packaging the objects to be removed from the clean room area 100, for example for packaging the manufactured product 20.

[0681] The unpacking device 212 and the packaging device 214 are integrated or attached to the lock device 200, in particular in the present case arranged laterally.

[0682] As shown in Figs. 1 and 2, the lock device 200 has an entrance lock 202, via which a lock location 206, in particular an entrance lock location 206, is accessible from the environment and which is configured to feed an object from an environment of the production plant 10 into the clean room area 100.

[0683] As further shown in Figs. 1 and 2, the lock device 200 comprises an exit lock 204, via which a lock location 208, in particular an exit lock location 208, is accessible from the environment and which is configured to remove an object from the clean room area 100. The entrance lock 202 and the exit lock 204 further comprise means for, in particular, spatially isolating the lock locations 206, 208 (not shown in the figures) associated with the entrance lock 202 and the exit lock 204, respectively.

[0684] Isolation can be carried out selectively towards the environment of the production plant 10 and / or towards a respective part of the lock device 200 different from the lock locations 206, 208, in each case by means of the respective means for isolating the entrance lock 202 and the exit lock 204.

[0685] Furthermore, the production plant 10 has a plurality of maintenance locks 210, via which the clean room area 100 is accessible from an environment of the production plant 10, for example, to users, in particular for maintenance work within the clean room area 100.

[0686] The production plant 10 has a control unit by means of which and / or via which the production plant 10 can be operated, in particular regulated and / or controlled.

[0687] The control unit is / is formed by all processing units of the process units. In particular, the control unit is formed by the respective processing units of the patient boxes 30, 50, the tool boxes 702, 704, the handling device 300, the storage transport device 406, the transport vehicles 410, etc.

[0688] In a sense, the control unit is a distributed control unit which is based on a group, in particular a swarm, of individual computing units of the process units of the production plant 10.

[0689] The control unit can, for example, be connectable or connected to a supplementary control system 600 arranged in control cabinets, which can in particular be designed and programmed to additionally regulate and / or control at least one component included in the production plant or a part of the production plant.

[0690] The control supplementary system 600 is configured, for example, to carry out, in particular, supplementary and / or subordinate and / or trivial processes which the control unit does not execute and which are not safety-relevant for the production plant 10.

[0691] The control unit is designed and programmed to be able to communicate with one or more communication interfaces (not shown in the figures) and / or one or more human-machine interfaces, in short: HMI interfaces, 602 of the production plant 10 (an HMI interface 602 is shown as an example in the figures).

[0692] The communication interfaces not shown in the figures can, for example, serve to ensure data exchange with a higher-level control system and / or data management system, for example an associated cloud system, in order to enable, for example, data evaluation and / or data optimization via artificial intelligence and / or deep learning.

[0693] The control unit is further configured and programmed to provide information to a user via the communication interfaces and / or via the HMI interfaces 602, for example, fault information and / or information about a state of manufacture of a product 20 and / or information about inventory levels of the storage device 400.

[0694] Furthermore, the production of the biological-pharmaceutical product 20 can be carried out by means of the production plant 10 by means of the control unit.

[0695] By means of the control unit, the said product production can be carried out according to one or more production programs.

[0696] In particular, the control unit is designed and programmed to assign a or the reactant 40 to one of the multiple process units 30, 50, 702, 704 on the basis of one of multiple production programs for producing one of multiple products 20 that can be produced by means of the production plant.

[0697] As shown in Fig. 1, the production plant 10 further comprises a first computer system 800 assigned to the production plant 10 for exchanging data with the production plant 10 and a second computer system 900 assigned to the production plant 10 for providing release information.

[0698] The first and second computer systems 800, 900 are in particular spatially separated or arranged separately with respect to a remainder of the production plant and with respect to each other.

[0699] The first and second computer systems 800, 900 are each configured as servers. In particular, the first computer system 800 is configured as a heartbeat server 800, and the second computer system 900 is configured as a release server 900.

[0700] The heartbeat server 800 and the release server 900 are connectable and / or connected to the production plant 10, in particular to the control unit, preferably to the computing units of the process units, in particular via the control supplementary system 600, which can be configured or is present as a communications intermediary. Additionally or alternatively, the heartbeat server 800 and the release server 900 can be connectable and / or connected to the production plant 10, in particular to the control unit, preferably to the computing units of the process units, in particular directly or indirectly, as is generally known in the art, such as via an internet-based and / or radio-based technology.

[0701] Each product 20 to be manufactured is assigned a sequence of treatment processes which can be carried out by means of process units arranged within the clean room area 100 and remaining in the clean room area after the treatment processes have been carried out, such as tool units and / or tool boxes 702, 704.

[0702] In each production program, the 20 treatment processes required for the manufacture of a specific product as well as the associated treatment time values ​​are stored or taken into account as instructions.

[0703] In particular, a production program comprises several encrypted production program packages.

[0704] The process units, in particular the patient boxes 30, 50 and / or the tool boxes 702, 704, are designed and programmed to hold one or more cryptographic keys by means of which the production program packages of the production program can be decrypted, in particular locally on the respective process unit.

[0705] The one or more cryptographic keys are inseparably integrated into the process units. For this purpose, each process unit has a security module, in particular a Trusted Platform module.

[0706] Each production program package contains at least one piece of information which refers to another production program package and comprises instructions for receiving and / or treating a reactant 40.

[0707] In other words, a production program package contains the instructions for one or more treatment processes.

[0708] A defined sequence of the several production program packages forms the production program for manufacturing a product 20 that can be manufactured by means of the production plant 10. This sequence represents the previously mentioned sequence of treatment processes.

[0709] In particular, the complete sequence can only be determined from all references to the other production program packages, since none of the production program packages provides a complete overview of the entire production program.

[0710] The production program packages include, in particular, a starter package and one or more follow-up packages. This means that a starter package marks the beginning of a production program.

[0711] The process units, in particular the patient boxes 30, 50 and / or the tool boxes 702, 704, are designed and programmed to execute instructions of at least one production program package, in particular to decode and then execute them.

[0712] All production program packages are provided on a respective process unit and / or can be transmitted to a respective process unit, in particular by means of a computer system assigned or assignable to the production plant 10, for example the release server 900.

[0713] The production plant 10 is configured to be operable according to various states that depend on the existence of a data connection with the heartbeat server 800. This will be described in detail below.

[0714] As can be seen in particular in Fig. 1, the heartbeat server 800 is connectable or connected to the production plant 10 (see dashed line).

[0715] The control unit is designed and programmed to be connectable or connected to the previously described heartbeat server 800 for data exchange, in particular to continuously determine the existence of this data connection.

[0716] In particular, this heartbeat server 800 serves to ensure that the production plant 10 can only operate without a data connection for a certain period of time. In other words, the production plant 10 can only produce if a connection to the heartbeat server 800 exists.

[0717] The production plant and the process units, ie in particular the patient boxes 30, 50 and / or the tool boxes 702, 704, can be reversibly transferred, depending on the data connection, into a normal state for unrestricted operation, into a reserve state for temporally and / or functionally restricted operation and / or into a pause state for idle operation.

[0718] The reserve state is a transitional state between the normal state and the paused state, via which the normal state transitions into the paused state, whereby in particular a transition from the paused state to the normal state does not have to occur via the reserve state and preferably a transition from the paused state to the normal state can occur directly.

[0719] Only when the data connection exists can the production facility 10 for manufacturing a product 20, or in particular the patient boxes 30, 50 and / or the tool boxes 702, 704 for receiving and / or treating a reactant 40, be fully operational. This is the normal state.

[0720] If the data connection does not exist, the production plant 10 or in particular the patient boxes 30, 50 and / or the tool boxes 702, 704 for receiving and / or treating a reactant 40 can be transferred into a reserve state in which the production of a product 20 or in particular the receiving and / or treating of a reactant 40 is limited in time and / or function.

[0721] The control unit and / or the computing units of the respective process units store an information stamp, in particular a time stamp, upon transfer to the reserve state and stop unrestricted operation of the production system 10 or in particular of the patient boxes 30, 50 and / or the tool boxes 702, 704 after a predefined period of time from this information stamp, in particular time stamp, and transfer the production system 10 or the respective boxes to the pause state.

[0722] When transferred to the standby state, only a predefined part of a production program for manufacturing a product 20 is executed. This serves, for example, to ensure production or treatment progress on a reactant 40 and / or to bridge a possible short-term interruption in the data connection.

[0723] When transferred to the pause state, the running production programs are modified and / or supplemented with one or more production program packages (in particular by means of the control unit) for storing the reactants 40 and / or an at least partially treated reactant 40 and / or a product 20 as long as the pause state exists.

[0724] In other words, at least one production program is modified and / or supplemented with one or more production program packages, wherein the production program packages include instructions for storage.

[0725] Storage takes place in particular in or at at least one of the storage locations 402 of the storage device 400. A modification and / or addition may, for example, comprise targeted tempering, for example freezing, of a reactant 40 and / or an at least partially treated reactant 40 and / or a product 20 in order to ensure production or treatment progress. This can take place at a storage location 402.

[0726] In a sense, the determination of the existence of the data connection can be regarded as a security mechanism of the production plant 10.

[0727] The production plant 10 is further configured to have one or more additional security mechanisms.

[0728] Another previously mentioned security mechanism will be described in particular below:

[0729] In particular, the production plant 10 is configured to determine an integrity of each process unit, ie in particular the patient boxes 30, 50 and / or the tool boxes 702, 704.

[0730] With regard to the relevant process units, this integrity determination can be performed either from outside the relevant process units or by the relevant process units themselves. These two options can be provided individually or in combination in the production plant 10.

[0731] On the one hand, the control unit is designed and programmed to determine the integrity of each process unit, ie in particular the patient boxes 30, 50 and / or the tool boxes 702, 704.

[0732] On the other hand, each computing unit is designed and programmed to determine the integrity of the respective process unit, ie in particular patient box 30, 50 and / or tool box 702, 704.

[0733] This occurs before a reactant 40 can be received and / or treated by the process unit or the respective box 30, 50, 702, 704 according to one or more production program packages. One goal of the integrity determination is, in particular, to be able to detect changes to the process units, in particular the patient boxes 30, 50 and the tool boxes 702, 704. For example, it can thus be determined whether unauthorized spyware such as cameras and / or other comparable hardware has been installed in or on the process units in order to draw conclusions about the production of the product 20.

[0734] For this purpose, the computing unit of a process unit or a respective box 30, 50, 702, 704 is designed and programmed to provide unique information relating to this process unit or box.

[0735] Using the control unit, further unique information related to this process unit or box 30, 50, 702, 704 can be captured. This refers to the integrity determination from outside the respective process units or boxes 30, 50, 702, 704.

[0736] The integrity of this process unit or box 30, 50, 702, 704 can be determined by the control unit based on a comparison of these two unique pieces of information.

[0737] If these two unique pieces of information match, the integrity can be set and / or confirmed. Setting and / or confirming the integrity can occur, in particular, in a respective processing unit and / or the at least one control unit.

[0738] The unique information that can be provided by the computing unit represents a target state and / or an initial state of the process unit or box 30, 50, 702, 704, on the basis of which a deviation with regard to the process unit or box 30, 50, 702, 704 can be determined.

[0739] The unique information is stored on the previously described security module of the respective process unit or box 30, 50, 702, 704 and is available for integrity determination.

[0740] In particular, unique information is understood to mean digital fingerprint information, for example, information that is unique and / or has a unique identifier. A processing unit or box 30, 50, 702, 704 is designed and programmed to execute instructions from a production program package, i.e., to decrypt and then execute them, only if their integrity is set and / or confirmed.

[0741] In other words, treatment operations are only carried out using the boxes 30, 50, 702, 704 if these boxes 30, 50, 702, 704 are intact, in particular with regard to damage and / or manipulation.

[0742] Execution and / or decryption of instructions are blocked if the integrity of the respective boxes 30, 50, 702, 704 cannot be set and / or confirmed.

[0743] Furthermore, a process unit or box 30, 50, 702, 704 is designed and programmed to provide a message, in particular an alarm message, for example via the HMI interface 602, if its integrity cannot be set and / or confirmed.

[0744] The production plant has one or more sensor units for determining the integrity, by means of which the process units or boxes 30, 50, 702, 704 can be detected, in particular visually.

[0745] Based on this recording, unique information regarding the respective process units or boxes 30, 50, 702, 704 can be provided by the control unit to determine the integrity.

[0746] The one or more sensor units comprise one or more camera units, by means of which characteristic landmarks of an area, in particular a surface, and / or a geometry of the process units or boxes 30, 50, 702, 704 can be visually detected.

[0747] In other words, the unique information is based on characteristic landmarks of a surface, in particular a surface, and / or a geometry of the process units. The geometry can be two-dimensional and / or three-dimensional.

[0748] It should be understood that numerous further possibilities with regard to the unique information are additionally or alternatively conceivable, such as, for example, that: the production plant 10 has one or more actuator units, by means of which one or more process units or boxes 30, 50, 702, 704 can be excited, in particular mechanically, to generate a vibration, in particular a mechanical vibration, which can be detected by means of the one or more sensor units and on the basis of which information which is unique with regard to the respective process units or boxes 30, 50, 702, 704 can be provided by means of the control unit in order to determine the integrity; wherein in particular: o one of the one or more actuator units is configured to generate a mechanical vibration and this actuator unit is arranged on or in one of the one or more process units or boxes 30, 50, 702, 704 and / or is connected to one of the one or more process units orBoxes 30, 50, 702, 704 can be brought into engagement to generate the mechanical vibration at the respective process unit or boxes 30, 50, 702, 704; where optionally:.

[0749] ■ an actuator unit is designed as a motor, in particular a vibration motor, by means of which predeterminable frequency ranges can be generated and / or travelled; and / or

[0750] ■ the vibration comprises a frequency range of greater than or equal to 10 Hz and less than or equal to 100 Hz, and / or the vibration comprises one or more, in particular, different frequency ranges, which are each greater than or equal to 10 Hz and less than or equal to 100 Hz, and / or the vibration comprises one or more, in particular, different frequency ranges, which follow one another in a specific order; and / or o one of the one or more actuator units is configured to generate an acoustic vibration, in particular a sound wave, and this actuator unit is arranged on or in one of the one or more process units or boxes 30, 50, 702, 704 and / or can be engaged with one of the one or more process units or boxes 30, 50, 702, 704 to generate the mechanical vibration, in particular the sound wave, with respect to the relevant process unit or box 30, 50, 702, 704; optionally wherein:

[0751] ■ an actuator unit is designed as a sound transducer, in particular a loudspeaker, by means of which predeterminable frequency ranges can be generated and / or travelled; and / or

[0752] ■ the (acoustic) vibration comprises a frequency range of greater than or equal to 30 Hz and less than or equal to 10,000 Hz, and / or the (acoustic) vibration comprises one or more, in particular, different frequency ranges, which are each greater than or equal to 30 Hz and less than or equal to 10,000 Hz, and / or the (acoustic) vibration comprises one or more, in particular, different frequency ranges, which follow one another in a specific order.

[0753] It should be understood that the preceding list of means for determining integrity is exemplary and not exhaustive.

[0754] It should also be understood that any combination of the components described with regard to the integrity, in particular actuator units and / or sensor units, may be conceivable with respect to the respective process units or boxes 30, 50, 702.

[0755] As already described, each computing unit is further designed and programmed to determine the integrity of the respective process unit, ie in particular patient box 30, 50 and / or tool box 702, 704.

[0756] This refers to the integrity determination by the relevant process units or Box 30, 50, 702, 704 themselves.

[0757] In other words, each process unit or box 30, 50, 702, 704 can be designed as a self-checking process unit, which is configured to determine its own integrity or, in particular, to be able to detect unauthorized changes to itself.

[0758] Here too, the computing unit provides one or more unique pieces of information relating to this process unit or box 30, 50, 702, 704, but one or more unique pieces of information relating to this process unit or box 30, 50, 702, 704 can be captured by the computing unit itself.

[0759] The integrity of the respective process unit or box 30, 50, 702, 704 can be determined based on a comparison of these two unique pieces of information by means of the respective computing unit.

[0760] A process unit, in particular a patient box 30, 50 and / or a tool box 702, 704, can have one or more sensor units by means of which one or the unique information and / or one or the further unique information about the relevant process unit or box 30, 50, 702, 704 can be detected in order to determine the integrity.

[0761] Using at least one sensor unit, a brightness value can be detected in the relevant process unit or box 30, 50, 702, 704, and the unique information and / or further unique information about the relevant process unit or box 30, 50, 702, 704 can be provided based on the detectable brightness value to determine integrity. For example, the detection of light can indicate tampering and / or an attack on the relevant process unit or box 30, 50, 702, 704, and when it is dark, the relevant process unit or box 30, 50, 702, 704 is intact, thus the integrity is confirmed.

[0762] In addition, the relevant process unit or box 30, 50, 702, 704 can be at least partially visually detected by means of at least one sensor unit, and the unique information and / or the further unique information about the relevant process unit or box 30, 50, 702, 704 can be provided based on the visual detection to determine the integrity, wherein the at least one sensor unit comprises a camera unit by means of which characteristic landmarks and / or geometries of the relevant process unit or box 30, 50, 702, 704 can be visually detected. This sensor unit is arranged in particular inside and / or on an outside of the process unit or box 30, 50, 702, 704.

[0763] It should be understood that numerous further possibilities with regard to the unique information are additionally or alternatively conceivable, such as, for example, that: a process unit or box 30, 50, 702, 704 has one or more actuator units, by means of which the process unit in question can be excited, in particular mechanically, to generate a vibration, in particular a mechanical vibration, which can be detected by means of one or more sensor units and on the basis of which the unique information and / or the further unique information about the process unit in question orBox 30, 50, 702, 704 can be provided for determining the integrity, wherein optionally: o the vibration comprises a frequency range of greater than or equal to 10 Hz and less than or equal to 100 Hz, and / or the vibration comprises one or more, in particular, different frequency ranges, which are each greater than or equal to 10 Hz and less than or equal to 100 Hz, and / or the vibration comprises one or more, in particular, different frequency ranges, which follow one another in a specific order, wherein in particular at least one of the one or more actuator units is designed as a vibration motor, which is fixed in and / or on the relevant process unit for generating the mechanical vibration; and / or at least one of the one or more actuator units is configured to generate an acoustic vibration, in particular a sound wave, and is fixed in and / or on the relevant process unit orBox 30, 50, 702, 704 is fixed to generate the mechanical vibration, in particular the sound wave, with respect to the relevant process unit or box 30, 50, 702, 704, wherein optionally: o the vibration comprises a frequency range of greater than or equal to 30 Hz and less than or equal to 10,000 Hz, and / or the vibration comprises one or more, in particular, different frequency ranges, which are each greater than or equal to 30 Hz and less than or equal to 10,000 Hz, and / or the vibration comprises one or more, in particular, different frequency ranges, which follow one another in a specific order; and / or a process unit or box 30, 50, 702, 704 has one or more electrically conductive line elements, which are arranged on and / or in the process unit or box 30, 50, 702, 704 and / or within a lateral surface wall of the process unit orBox 30, 50, 702, 704 are arranged and which form a particularly independent electrical circuit, wherein one or more sensor units can be used to detect whether the electrical circuit has been changed and / or interrupted with respect to its original state, and wherein, on the basis of the circuit detection, the unique information and / or the further unique information about the relevant process unit or Box 30, 50, 702, 704 can be provided to determine the integrity; and / or at least one sensor unit is designed as an inertial measuring unit, by means of which at least one acceleration value, in particular an acceleration vector, and / or at least one yaw rate value, in particular a yaw rate vector, can be detected with respect to the relevant process unit or Box 30, 50, 702, 704, and the unique information and / or the further unique information about the relevant process unit orBox 30, 50, 702, 704 can be provided based on the detectable acceleration and / or rotation rate values ​​to determine the integrity; and / or a temperature value in and / or on the relevant process unit can be detected by means of at least one sensor unit and the unique information and / or the further unique information about the relevant process unit can be provided based on the detectable temperature value to determine the integrity.

[0764] It should be understood that the preceding list of means for determining integrity is exemplary and not exhaustive.

[0765] It should also be understood that any combination of the components described with regard to the integrity, in particular actuator units and / or sensor units, may be conceivable with respect to the respective process units or boxes 30, 50, 702.

[0766] Another previously mentioned security mechanism will be described in particular below:

[0767] In this case, at least a part of one or more production programs serves exclusively to imitate and / or indicate one or more production program processes, in particular one or more treatment processes.

[0768] This makes it possible to conceal real or actual production steps or production program processes or treatment processes, so that potential attackers in particular would have to carry out further investigations in order to be able to trace the manufacture of a product 20.

[0769] For imitation and / or hinting purposes, a production program includes one or more encrypted dummy production program packages.

[0770] Each dummy production program package contains at least one piece of information that refers to a (correct) production program package or another dummy production program package and that includes dummy instructions for simulating and / or indicating the intake and / or treatment of a reactant 40. For example, a dummy production program package, in particular a dummy instruction, can be devoid of production-related content. The production plant 10 has a random module that can be executed by the computing units and by means of which one or more dummy production program packages can be randomly integrated into a production program.

[0771] A processing unit or box 30, 50, 702, 704 is designed and programmed to execute any instructions, in particular actual / correct instructions and / or dummy instructions, in particular to decrypt them and then execute them.

[0772] Furthermore, a process unit or box 30, 50, 702, 704 is designed and programmed to receive and / or treat a dummy reactant in order to simulate and / or indicate receiving and / or treating an actual reactant 40 using the dummy reactant.

[0773] For example, a dummy reactant may be an empty container 42 intended for an actual reactant 40, which is not visible from the outside, and / or may comprise a material that resembles an actual reactant 40.

[0774] In addition, the production plant 10 has one or more concealment rooms for accommodating one or more process units, wherein an interior of each concealment room is optically separated from the outside of the concealment room and / or at least largely invisible.

[0775] A process unit or box 30, 50, 702, 704 can be caused by the part of the production program to be imitated and / or indicated in order to be accommodated in the interior of a respective concealment room.

[0776] For example, the concealment room can be formed by one or more storage spaces 402. Additionally or alternatively, a concealment room can be arranged as an independent facility in the clean room area 100.

[0777] Referring to Figs. 1 and 9, the concealment room is accessible via the storage rack lock 412 for the process units configured as boxes 30, 50, 702, 704. As can be seen in Figs. 1 and 9, the concealment room is largely or completely invisible to persons standing outside as well as inside the production facility 10, in particular the clean room area 100.

[0778] For example, it can also be provided that an optical separation relates to a wavelength range that is visually perceptible to humans and / or to a wavelength range that is not visually perceptible to humans, e.g. an infrared range.

[0779] The concealment room has one or more exchange units (not shown in the figures) by means of which objects accommodated in and / or by process units, in particular patient boxes 30, 50 and / or tool boxes 702, 704, can be transferred between the respective process units located within the concealment room. Corresponding instructions are included in dummy production program packages.

[0780] In other words, by means of the obfuscation space or its exchange units, objects can be exchanged between the respective process units in a shell game manner.

[0781] The concealment space further comprises one or more sensor units for monitoring the optical separation of the interior from the exterior of the concealment space, wherein in particular a brightness value within the concealment space can be detected by means of at least one sensor unit of the concealment space.

[0782] Another previously mentioned security mechanism will be described in particular below:

[0783] This security mechanism is based in particular on the fact that production program packages from a respective process unit, in particular Box 30, 50, 702, 704, can only be executed if the respective process unit or Box 30, 50, 702, 704, has been provided with a separate release input or release authorization by the release server 900 already described. The release server 900 is designed and programmed to at least partially store and operate a database.

[0784] The control unit is in turn designed and programmed to exchange information with this database.

[0785] As can be seen in particular in Fig. 1, the release server 900 is connectable or connected to the production plant 10 (see dashed line).

[0786] The database contains several unique release information items for authorizing the intake and / or treatment of a reactant 40 or a treatment process by means of the process units, in particular the boxes 30, 50, 702, 704.

[0787] The database can be changed by retrieving at least one of the release information for one of the multiple process units or boxes 30, 50, 702, 704, so that this release information can subsequently no longer be made available for retrieval in its original form.

[0788] In particular, the database records that the release information has already been transmitted and / or used, so that it can no longer be retrieved in its original form.

[0789] In particular, the unique release information is understood to mean information that is unique and / or has a clear identification.

[0790] The database is set up and programmed to receive and store one or more new release information exclusively from outside the production facility.

[0791] In other words, the database can only be supplied with one or more new release information from outside the production facility.

[0792] For example, one or more new release information items can be transmitted to the database by a database access authorized party 1000, in particular a rights holder to a recipe represented by a production program, in particular via a separate computer system 1000, for example via a cloud and / or a server. Optionally, this computer system 1000 can be part of the production facility 10.

[0793] It is conceivable that the database is set up and programmed to be storable and / or operable exclusively on the release server 900, or to be synchronizable with a parallel database, which is storable and / or operable, for example, by means of the control unit and / or the separate computer system 1000.

[0794] Each computing unit of each processing unit, in particular each box 30, 50, 702, 704, is set up and programmed to receive and store one or more release information.

[0795] In particular, each release information received by a computing unit can be compared with each release information already stored on a computing unit in order to avoid double use of the received release information in the production plant 10.

[0796] In other words, all computing units are networked with each other, in particular for the aforementioned comparison of the received release information in order to avoid double use.

[0797] For this purpose, each computing unit is designed and programmed to store and operate an encrypted decentralized database, preferably an encrypted distributed ledger, in order to store the one or more receivable or received release information.

[0798] By using the decentralized database, a tamper-proof technical solution can be provided to prevent duplicate use of the received release information in the production facility 10. The decentralized database is described in more detail in the following description.

[0799] Each production program package can be uniquely assigned one piece of release information to authorize a one-time execution of this production program package by means of a process unit, in particular a box 30, 50, 702, 704. This ensures that the execution of production program packages is not possible beyond an approved limit or an approved number of executions.

[0800] In particular, each production program can only be initialized and / or started by means of the production system if all production program packages of the production program and all release information assigned to the production program packages can be provided or are provided on the relevant process units or boxes 30, 50, 702, 704.

[0801] In particular, the release information can be received and stored by means of the computing units.

[0802] This can be done in particular for a time-delayed authorization and execution of a recording and / or a treatment of a reactant 40 and / or for an immediate authorization and execution of a recording and / or a treatment of a reactant 40.

[0803] Each release information in the database is encryptable or encrypted and can be decrypted by means of at least one cryptographic key, which can be provided and / or stored by means of a respective computing unit, in particular its security module, and / or is stored there.

[0804] It should be understood that the statements regarding the release information also refer to the dummy production program packages of the production program already described.

[0805] In other words, the dummy production program packages are also releasable by means of one or more release information of the release server 900.

[0806] It is conceivable that one or more pieces of release information can be retrieved from the database as bundle release information for authorizing an entire process for manufacturing a product 20, in particular by means of one or more process units. Additionally or alternatively, it can be provided that release information for each individual production program package can be retrieved individually from the database, in particular by means of a process unit. The database is further configured and programmed to assign one or more, in particular all, pieces of release information a respective consent information, which can be stored in the database for each piece of release information, in particular by a person authorized to access the database 1000, wherein each piece of release information can only be provided if associated consent information is stored.

[0807] In other words, the authorized database access user 1000 can consent to the use of individual or multiple pieces of release information on the release server 900. For example, this can enable the implementation of a separate, particularly automated, billing system for products to be manufactured, and / or the rights holder can retain control over the production of a product 20.

[0808] It is conceivable that each release information comprises an information stamp, in particular a number information stamp, by means of which a particular maximum repeatability of a recording and / or a treatment of a reactant 40 or a treatment process can be determined, which can be authorized by means of the respective release information.

[0809] It should also be understood that the possibility of authorizing treatment processes by means of the release information depends on the existence of the data connection of the production plant 10 to the heartbeat server 800, i.e. the normal state, reserve state and / or pause state.

[0810] As already described, the execution of treatment processes, in particular the execution of production program packages and / or the use of release information, can be monitored by a process unit, in particular a box 30, 50, 702, 704, by means of a decentralized database which is operated by the respective computing unit of a process unit or box 30, 50, 702, 704.

[0811] Each computing unit is designed and programmed to store and operate an encrypted decentralized database, preferably an encrypted distributed ledger. Each decentralized database is a redundant copy of each of the other decentralized databases stored on the computing units.

[0812] Each computing unit is trained and programmed to validate the operation of the respective decentralized databases on each of the other computing units and to update its own decentralized database in response to a validation.

[0813] Each decentralized database is further configured and programmed to include one or more, in particular unique, pieces of information about a receiving and / or treatment of a reactant 40 from each process unit, in particular each box 30, 50, 702, 704.

[0814] In particular, unique information is understood to mean information that is unique and / or has a unique identifier. The unique information includes, in particular, one or more pieces of release information, one or more pieces of information about executed and / or unexecuted production program packages, etc.

[0815] Each decentralized database can be encrypted or encrypted using a cryptographic key that can be specifically assigned and / or made available only to the process unit on which the decentralized database can be stored or is stored. The cryptographic key is stored, in particular, in the security module described above.

[0816] Each processing unit is configured and programmed to store each execution of a production program package in the decentralized database, subject to validation by the other processing units.

[0817] Each processing unit is further configured and programmed to execute a production program package only if this production program package is not stored in the decentralized database as already executed.

[0818] Each processing unit is further configured and programmed to store the release information in its own decentralized database and to compare each received release information with each release information already stored in the decentralized database in order to avoid duplicate use of the received release information in the production plant, depending on the validation by the other processing units.

[0819] The instructions of a production program package are only executed by a processing unit or box 30, 50, 702, 704 if release information associated with this production program package is provided to the processing unit and this production program package and this release information are stored in the decentralized database as not yet executed.

[0820] In other words, by means of the described release information mechanism, permission to execute a production program package can be granted, which can be stored in particular in the decentralized database. In particular, with each execution of a production program package, it can be checked whether the number of previous executions is less than the permitted number of executions of the production program package. In particular, it can be stored in the decentralized database that a production program package is being executed, is being executed, or may be executed, whereby the said number of available executions can be reduced by 1 (one) during actual execution. This ensures that the execution of production program packages is not possible beyond the authorized limit.

[0821] It is conceivable that the production plant 10 has one or more additional computer systems and / or can be connected to such systems, wherein each of the additional computer systems is arranged at a different location relative to the rest of the production plant 10, wherein the decentralized database is stored and operated on each of the additional computer systems, and wherein each of the additional computer systems is configured and programmed to validate the operation of the respective decentralized databases on each of the other computer systems and / or computing units and to update its own decentralized database in response to a validation. Such a computer system can be formed, in particular, by the heartbeat server 800 and / or the release server 900 and / or the affiliated computer system 1000.

[0822] In particular, for the purpose of data evaluation and / or data optimization and / or deep learning of the production plant 10, the production plant 10 is configured to perform a simulation of its own operation and / or, in particular, of treatment processes. This allows, for example, the paths of the boxes 30, 50, 702, 704 and / or the transport vehicles 410 and / or the multi-axis robot arm 302 to be optimized, or a corresponding path optimization is possible.

[0823] Furthermore, a prediction of the production process can be checked and / or updated, in particular to confirm or correct time slots for resources to complete the product 20.

[0824] In addition, order planning of one or more products 20 and / or production batches can be carried out, in particular in terms of time and / or with regard to resources located within the production facility 10, for example boxes 30, 50, 702, 704 and / or tools and / or consumables, and / or a current capacity utilization of the production facility 10.

[0825] For this purpose, the production plant 10 has a simulation device which is designed and programmed to simulate the operation of the production plant 10 and / or in particular the manufacture of a product 20 based on at least one production program and to provide a simulation result corresponding thereto.

[0826] Like the control unit, the simulation device is formed by all the computing units of the respective process units. It is conceivable that the control unit in the present embodiment functions as the simulation device and / or executes or performs its function.

[0827] The simulation device is designed and programmed to record system parameters of the production system 10 during the manufacture of a product 20 and / or to record recording process measured values ​​and / or treatment process measured values ​​of the process units, in particular operating parameters of the process units, and to store them as simulation information and to keep them available for carrying out a simulation.

[0828] In other words, the simulation device is designed and programmed to:

[0829] - process-specific parameters and / or measured values, e.g. a sequence of treatment processes or process steps, and / or - plant-specific parameters and / or measured values, e.g. of process units, in particular of patient boxes 30, 50 and / or tool boxes 702, 704, and / or location parameters of the production plant 10 such as outside temperature, humidity, air pressure, and / or patient-specific parameters and / or measured values, e.g. a medical treatment history, and / or

[0830] - tool-specific parameters and / or measured values, e.g. of tool units, in particular tool boxes 702, 704, and / or

[0831] - to record material-specific parameters and / or measured values, e.g. of consumables, and to save them as simulation information and to keep them available for carrying out a simulation.

[0832] As already described, the production plant 10 has one or more sensor units. These are at least partially assigned to the process units and / or form part of the process units.

[0833] The simulation device is designed and programmed to carry out the simulation on the basis of simulation information that can be detected or is detected by means of these sensor units.

[0834] In particular, the sensor units can be designed and / or configured as described in the application DE 10 2021 207 738.2, to which reference is hereby made.

[0835] In particular, the part of a production program which is to be executed by means of the associated process units can be simulated by means of the computing units forming the simulation device.

[0836] In other words, each process unit, in particular each box 30, 50, 702, 704, is designed and programmed to simulate at least that part of a production program which the respective process unit or box 30, 50, 702, 704 must and / or would execute for the actual manufacture of a product 20.

[0837] In other words, each process unit, in particular each box 30, 50, 702, 704, is designed and programmed to simulate at least one production program package which the respective process unit or box 30, 50, 702, 704 must and / or would execute for receiving and / or treating a reactant 40 during the actual manufacture of a product 20.

[0838] During simulation, it is also intended that the respective production program packages to be simulated are to be decrypted by the respective computing units, which has already been described in connection with the (actual) execution of the production program packages.

[0839] Furthermore, the simulation also requires approval by means of the approval server 900, which has already been described in connection with the (actual) execution of the production program packages.

[0840] This means that the execution of a simulation can be released by means of release information received from the process unit.

[0841] This means that each release information is designed to authorize either an actual execution of a production program package or merely its simulation.

[0842] For this purpose, each release information comprises an information stamp, in particular a mode information stamp, by means of which the respective release information can be assigned to a production mode of the production plant 10 for producing a product 20 or to a simulation mode of the production plant 10 for simulating the operation of the production plant 10 and / or the production of a product 20, in particular one or more production program packages or treatment processes.

[0843] In other words, depending on the information stamp of the release information, a production program package can be executed by means of a process unit, in particular boxes 30, 50, 702, 704, for the actual reception and / or treatment of a reactant 40 or merely for its simulation with respect to the relevant process unit, in particular boxes 30, 50, 702, 704.

[0844] As previously described, a simulation may also require at least partial or complete approval using one or more pieces of approval information. Essentially, approval of a simulation can be carried out analogously to approval of the actual production of a product 20. This will be described in more detail below with regard to a simulation:

[0845] The database of the release server 900 further contains release information for authorizing a simulation, wherein the database can be changed by retrieving at least one of the release information for a simulation, so that this release information can subsequently no longer be made available for retrieval in its original form.

[0846] The database is further configured and programmed to receive and store one or more new release information for authorizing a simulation exclusively from outside the production facility 10. For example, the new release information for a simulation can also be transmitted to the database by the authorized user 1000.

[0847] At least one piece of release information can be uniquely assigned to each production program package to authorize a particularly one-time simulation.

[0848] In particular, a simulation can only be initialized and / or started by means of the simulation device if all production program packages of the production program and / or all release information assigned to the production program packages can be provided.

[0849] One or more release information items can be received and stored by a process unit, in particular box 30, 50, 702, 704, for a time-delayed authorization and execution of a simulation of an intake and / or a treatment of a reactant 40, and / or can be received in real time for an immediate authorization and execution of a simulation of an intake and / or a treatment of a reactant 40.

[0850] It should be understood that simulation by means of the simulation device also refers to dummy production program packages.

[0851] In particular, a simulation can only be initialized and / or started if all production program packages, including the dummy production program packages of the production program, and / or all release information assigned to the production program packages, including the dummy production program packages, can be made available or has been made available.

[0852] Furthermore, it can be provided that the production system 10 can be switched to a different state depending on the existence of a data connection to the heartbeat server 800, as already described. In this case, it can be provided that a simulation can be carried out or not depending on the respective state.

[0853] As already described, the production plant 10 has several, in particular a large number of, sensor units.

[0854] In particular, the sensor units can be designed and / or configured as described in the application DE 10 2021 207 738.2, to which reference is hereby made.

[0855] In particular, the production plant 10 comprises one or more sensor units for determining one or more values ​​of one or more parameters of one or more reactants 40, and / or one or more patient boxes 30, 50, and / or one or more tool boxes 702, 704, and / or one or more tools or tool units and / or one or more consumables.

[0856] The sensor units are used in particular to determine treatment progress during the treatment of a reactant 40 or between two treatment processes.

[0857] The sensor units are used in particular for controlling and / or regulating one or more tool units to carry out one or more treatment processes depending on the one or more determined values, wherein one or more treatment parameters are varied or can be changed, in particular depending on a determined treatment progress.

[0858] The sensor units are used in particular to monitor the storage device 400, for example storage conditions and / or storage quantities at the storage locations 402.

[0859] Furthermore, as already described, at least some of the sensor units of the production plant 10 are arranged and / or contained in the process units, in particular the patient boxes 30, 50, and / or the tool boxes 702, 704. Each sensor unit or at least each sensor unit of a process unit, in particular the patient boxes 30, 50, and / or the tool boxes 702, 704, is configured to record at least one measured value relating to the intake and / or treatment of the reactant 40 and / or relating to the process unit itself and to provide it to the respective computing unit for transmission to one or more authorized receiving units in encrypted and / or abstracted form.

[0860] In this way, measured values ​​and / or information can be made unrecognizable on the process unit side, so that a leak of information to an unauthorized person, e.g. by means of manipulative tapping, can be avoided.

[0861] In other words, at least one measured value which can be recorded by means of the one or more sensor units is / will be made unrecognizable before it can be transmitted to one or more authorized receiving units.

[0862] In the present embodiment, it is provided that the one or more authorized receiving units is one or more other proces...

Claims

Patent claims Production plant (10) for producing a product (20), in particular a biological-pharmaceutical product (20), comprising: a plurality of process units (30, 50, 702, 704) for receiving and / or treating a reactant (40), wherein each process unit (30, 50, 702, 704) has at least one computing unit, wherein each computing unit is designed and programmed to at least partially or completely store and operate a particularly encrypted decentralized database, preferably a particularly encrypted distributed ledger, wherein each decentralized database is a redundant copy of each of the other decentralized databases, wherein each computing unit is designed and programmed to validate an operation of the respective decentralized databases on each of the other computing units and to update its own decentralized database in response to a validation,wherein each decentralized database is designed and programmed to include one or more, in particular unique, items of information about the intake and / or treatment of a reactant (40) by each process unit (30, 50, 702, 704). Production plant (10) according to claim 1, characterized in that each process unit (30, 50, 702, 704), in particular the computing unit of each process unit (30, 50, 702, 704), has a security module, in particular a trusted platform module, for providing one or more cryptographic keys. Production plant (10) according to claim 1 or 2, characterized in that each decentralized database is or can be encrypted by means of a cryptographic key that can be specifically assigned to and / or provided only by that process unit (30, 50, 702, 704) on which the decentralized database is or can be stored. Production plant (10) according to one of claims 1 to 3, characterized in that, by means of the production plant (10), one of several products (20) can be manufactured according to one of several production programs, wherein a production program comprises several production program packages, and each production program package contains at least one piece of information comprising instructions for receiving and / or treating a reactant (40), which instructions can be executed by at least one process unit (30, 50, 702, 704). Production plant (10) according to claim 4, characterized in that each computing unit is configured and programmed to store each execution of a production program package in the decentralized database, in particular depending on the validation by the other computing units.Production plant (10) according to claim 4 or 5, characterized in that each computing unit is configured and programmed to execute a production program package only if this production program package is not stored in the decentralized database as already executed. Production plant (10) according to one of claims 1 to 6, characterized in that each computing unit is configured and programmed to receive one or more, in particular unique, release information items for authorizing the intake and / or treatment of a reactant (40) from at least one control unit of the production plant (10) and / or a computer system (900) assigned or assignable to the production plant (10), and to store the one or more release information items in its own decentralized database.Production plant (10) according to claim 7, characterized in that each computing unit is set up and programmed to compare each received release information with each release information already stored in the decentralized database in order to avoid double use of the received information. Release information in the production plant (10) is to be compared, in particular depending on the validation by the other computing units. Production plant (10) according to claim 7 or 8, characterized in that each piece of release information comprises an information stamp, in particular a number information stamp, by means of which a particular maximum repeatability of a recording and / or a treatment of a reactant (40) can be determined, which can be authorized by means of the respective release information, wherein in particular the information stamp, in particular the number information stamp, of each piece of release information in the decentralized database can be updated depending on an authorized execution of a recording and / or a treatment of a reactant (40).Production plant (10) according to one of claims 4 to 6 in combination with one of claims 7 to 9, characterized in that at least one piece of release information can be uniquely assigned to each production program package to authorize execution of this production program package by at least one process unit (30, 50, 702, 704). Production plant (10) according to claim 10, characterized in that each processing unit is designed and programmed to execute the instructions of a production program package only if release information associated with this production program package is provided to the processing unit and, in particular, this production program package and / or this release information is stored in the decentralized database as not yet executed.Production plant (10) according to claim 10 or 11, characterized in that each computing unit is designed and programmed to execute the instructions of a production program package only if maximum repeatability is achieved. an execution of this production program package according to the release information is stored in the decentralized database as not yet achieved. Production plant (10) according to one of claims 1 to 12, characterized in that the production plant (10) has one or more further computer systems and / or is connectable or connectable to such, wherein each of the further computer systems is arranged differently in relation to a remainder of the production plant (10), wherein the respective decentralized database is stored and operated on each of the further computer systems, and wherein each of the further computer systems is designed and programmed to validate operation of the respective decentralized databases on each of the other computer systems and / or computing units and to update its own decentralized database in response to a validation.

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