Production facilities for manufacturing the product

Abstract

The present application relates to a production facility (10) for producing a product (20), particularly a biologic product (20), the production facility having a plurality of process units (30, 50, 702, 704) for containing and / or processing an extract (40), and / or a method thereof.

Description

[Technical Field]

[0001] The present invention relates to a production facility (production system) for producing a product, and more particularly to a production facility for producing a biological product. [Background technology]

[0002] Conventional production systems, specifically in the field of personalized therapeutics, involve a high degree of manual intervention. While this does allow for the manufacture of such therapeutics at a high level of personalization or in a highly personalized manner, such individual and / or minimum-scale production is associated with high costs and results in high variations in quality and thus in a large amount of production waste and / or rejects. Furthermore, large-scale application and / or industrial production of individual and / or minimum batch sizes is not possible.

[0003] Furthermore, due to the high costs associated with such pharmaceutical products and / or therapeutics, particularly with respect to the manufacturing itself and / or the intellectual property associated therewith, and due to maintaining high quality levels, the production of such products and / or therapeutics needs to be carried out in a secure and / or tamper-proof manner. Summary of the Invention [Problem to be solved by the invention]

[0004] The problem underlying the present invention is therefore to solve the aforementioned problems and to enable individual and / or minimum batch sizes of products, in particular in the pharmaceutical field, to be produced efficiently and in particular reliably and / or tamper-proof. [Means for solving the problem]

[0005] This problem is solved according to the invention by a production plant for producing a product, in particular a biological product, having the features of claim 1.

[0006] Advantageous further configurations of the invention are set forth in the dependent claims. [Effects of the Invention]

[0007] According to this, the production facility comprises a plurality of process units for receiving and / or processing the extract, each process unit comprising at least one calculation unit.

[0008] For example, the process unit may be configured as a patient box, in particular for storing and / or transporting the extract, and / or as a tool box, in particular for processing the extract, and / or as a tool unit, in particular for processing the extract, and / or as a sensor unit, in particular for analyzing the extract. The above list is exemplary and not exhaustive. In particular, the process units are described in more detail below.

[0009] The production facilities are - in particular a suitable clean room area, - a locking device for feeding and / or removing objects from the surroundings of the production facility, in particular into a suitable clean room area; - a handling device for moving objects within the clean room area; a storage device located within the cleanroom area, the storage device including a plurality of storage locations for storing a plurality of objects; The invention may further include:

[0010] One or more process units may be configured as handling devices.

[0011] One or more process units may be formed as part of the storage device.

[0012] The objects, in particular the objects from the surroundings of the production facility for feeding into the clean room area and / or for removing from the clean room area, may be: extracts, in particular cell-containing materials, such as cell-containing starting materials and / or biological materials and / or biological workpieces, - intermediate products, in particular cell-containing intermediate products and / or biological intermediate products, tools or tool units, in particular extract-contacting and / or product-contacting tools or tool units, and / or in particular extract-non-contacting and / or product-non-contacting tools or tool units, - one or more consumable materials, - for example a product to be produced, in particular a biological product, e.g. a biological product to be produced, It may include at least one of:

[0013] It should be understood that the foregoing list is exemplary and not exhaustive, and that instead or in addition, an object may include one or more of the foregoing listed elements, and / or combinations thereof.

[0014] The extract may comprise cells and / or biological materials other than cells.

[0015] The extract may be a patient-related or pooled extract.

[0016] The extract may be at least partially liquid and / or at least partially semi-solid and / or at least partially solid. Alternatively, the extract may be completely liquid, completely semi-solid, or completely semi-solid. For example, the cells of the extract may be present, e.g., formed, as a cell suspension, e.g., cells in a suspension culture, or as adherent cells, e.g., cells on the culture surface of a container or extract container, e.g., a culture container and / or pouch.

[0017] The cells may be at least partially fresh and / or at least partially frozen, so that to some extent the extract may be present in, for example, a liquid, semi-solid, and / or solid state.

[0018] The extract may be disposed in a container or extract container, particularly a vessel such as a culture vessel, cell culture vessel, bottle, vial, pouch, cassette (e.g., particularly a cassette made of a biocompatible hard plastic), and / or titer plate (e.g., a microtiter plate). The container or extract container, including the above examples, is in each case appropriate, particularly biocompatible, and may be partially or completely coated and / or partially or completely uncoated.

[0019] The product may be a biologic product for personalized therapy. In effect, the biologic product may be a personalized therapeutic. The personalization or said personalization may be for one patient or a group of patients, in other words, for one or more patients. The biologic product may be, for example, a cellular therapy, such as an autologous and / or allogeneic cellular therapy, or a gene therapy, such as an autologous and / or allogeneic gene therapy.

[0020] The clean room area may define a sterile production area.

[0021] In particular, the cleanroom area may be configured and / or compartmentalized as described in German patent application DE 102021 207 738.2, which is incorporated herein by reference.

[0022] The production facility can include a system for adjusting the ambient characteristics of the clean room area. For example, the system for adjusting the ambient characteristics of the clean room area can specifically include a pneumatic device. The pneumatic device can adjust the air pressure, specifically positive and / or negative pressure, in the clean room area.

[0023] One or more process units may be configured as a system for adjusting the ambient properties of the clean room area and / or specifically as a pneumatic device.

[0024] The production facility may have a housing, in particular for separating / dividing the cleanroom area relative to the surroundings of the production facility and for obtaining its cleanroom classification. The housing surrounds the cleanroom area, in particular the cleanroom area and the locking device.

[0025] The housing may enclose virtually the entire production facility.

[0026] The locking device may be configured to feed objects from the surroundings of the production facility into the clean room area via or through the housing and / or to remove objects from the clean room area via or through the housing.

[0027] The locking device may have at least one entrance lock and at least one exit lock, which may serve, in particular, for directional object guidance or directional object flow. Additionally or alternatively, the entrance lock and the exit lock may be classified according to the objects to be passed through them and may be provided accordingly as part of the locking device. Optionally, the locking device may have one or more maintenance locks, via which the cleanroom area may be accessed from the periphery of the production facility, in particular by workers or users.

[0028] Additionally or alternatively, the clean room area may have several clean room sub-areas, i.e., may be divided into several clean room sub-areas, for example, it is conceivable that the handling device and the storage device are arranged in one common clean room sub-area or in different clean room sub-areas.

[0029] In particular, the cleanroom area may be configured and / or compartmentalized as described in German patent application DE 102021 207 738.2, which is incorporated herein by reference.

[0030] The production facility may have one or more current sources and / or one or more interfaces connectable to one or more current sources. The current sources are arranged in the cleanroom area, in particular inside the housing, and are configured to supply current to at least one of the components contained by the production facility or to a part of the production facility. The part or parts are connected to one or more current sources, for example via one or more interfaces.

[0031] One or more of the process units may be configured as a workpiece support, which serves to accommodate objects, in particular extractables and / or tools and / or consumable materials.

[0032] In particular, it is conceivable that the workpiece support is formed as the patient box and / or the tool. Additionally or alternatively, the production facility may include a plurality of patient boxes and / or a plurality of tool boxes for accommodating one or more workpiece supports, respectively, on which the extract is arranged and / or housed.

[0033] Each workpiece support may have fixing means, in particular positive and / or frictional and / or magnetic fixing means, for accommodating the extractable material and / or the tool and / or the consumable material, respectively, so that the extractable material and / or the tool and / or the consumable material are held reliably.

[0034] The workpiece support may remain within the clean room area permanently, specifically over one or more complete production runs.

[0035] A production facility may include multiple types of workpiece supports, which differ from one another with respect to the shape and size of the receiving area of ​​each workpiece support.

[0036] One type of workpiece support can serve to house a vessel for containing an extract, such as a culture vessel.

[0037] This may in particular be a workpiece support formed as a patient box, in effect a patient box.

[0038] One type of workpiece support can serve to house one or more tool units and / or tool consumables for performing processing steps on the extract and / or for performing maintenance steps inside the clean room area.

[0039] This may be a workpiece support formed as a tool box, in effect a tool box.

[0040] One type of workpiece support can serve to contain consumable materials for feeding the consumable materials to the extract and / or for performing processing steps on the extract.

[0041] This may be a workpiece support formed as a tool box, in effect a tool box.

[0042] The one or more workpiece supports may each include one or more action units for performing an action on the extractor and / or tool.

[0043] This may be a workpiece support formed as a patient box and / or a tool box, in effect a patient box and / or a tool box.

[0044] One or more action units may be formed as processing units, for example tool units, for carrying out processing steps on the extract.

[0045] The process unit may be configured as an actuator unit and / or a processing unit and / or a tool unit, so that in fact one process unit can optionally have one process unit, in particular one further process unit.

[0046] The processing unit, e.g., the tool unit, may be configured to perform up-and-down movements and / or tilting movements and / or shaking movements and / or rotational movements, in particular by means of at least one correspondingly assigned actuator unit or actuator device unit, so that such types of movements, e.g., combinations of such types of movements, can be transmitted to the extract.

[0047] The processing unit, for example a tool unit or a component of a tool unit, may be configured to temperature-regulate, in particular heat and / or cool, the workpiece support.

[0048] One or more action units may be formed as sensor units for determining current values ​​of parameters of the respective workpiece support and / or extractant arranged on the workpiece support and / or tool arranged on the workpiece support and / or consumable material arranged on the workpiece support.

[0049] The parameter may specifically be one of the following: temperature of the workpiece support and / or the object housed by the workpiece support, air humidity, ambient pressure, gas mixture composition, position, e.g., angular position, vibration, occupancy, specifically occupancy state, e.g., storage occupancy state, and positioning, e.g., captured or uncaught positioning, and / or current location positioning. It should be understood that the foregoing list is exemplary and not exhaustive. Alternatively or additionally, the parameter may be a combination of the foregoing listed elements.

[0050] One or more of the workpiece supports may include a storage device for storing energy and / or one or more consumable materials.

[0051] The workpiece support may be reusable multiple times, in particular the storage device may be rechargeable and / or replenished with consumable materials.

[0052] The workpiece support may have at least one interface by means of which electrical energy and / or consumable materials can be charged or replenished and (re)discharged.

[0053] The production facility may include a charging station located within the clean room area for charging the storage device, and / or a refill station located within the clean room area for filling the storage device.

[0054] The refilling station may be configured as a stationary refilling station, into which the consumable material can be supplied via the locking device in order to fill it, and / or as a mobile refilling station, which can be supplied, in particular filled with consumable material, from the periphery of the production facility into the clean room area via the locking device and can be removed, in particular empty of consumable material, from the clean room area via the locking device. Furthermore, the refilling station may be, in particular arrangeable, for example arranged, on a storage location of the storage device.

[0055] One or more workpiece supports may have one or more coupling devices by means of which multiple, in particular two or more, workpiece supports may be coupled to one another.

[0056] In other words, one or more process units may have said coupling device for coupling the process units.

[0057] The storage device may include a storage transport device for transporting objects toward and / or away from the storage location.

[0058] One or more process units may be configured as a storage and transport device.

[0059] The handling device may have a distribution unit, via which the objects to be transported can be supplied to and / or received from the storage-transport device. Optionally, the distribution unit may be configured as or part of the locked transport device or may be assigned to such.

[0060] The distribution unit can be configured as a process unit separate from the handling device.

[0061] In other words, one or more process units may be configured as handling devices and at least one further process unit may be configured as a distribution unit.

[0062] The storage and transport device may be a device different from the handling device.

[0063] The storage and transport device may include a rail-guided transport system and / or one or more free-running transport vehicles.

[0064] One or more process units may be configured as rail-guided transport systems and / or the process units may be configured as free-running transport vehicles.

[0065] The storage and transport device may include one or more rail-guided storage and transport units that allow access to one or more storage shelves of the storage device, particularly for storage and retrieval processes, as well as for processing and / or maintenance processes.

[0066] The storage and transport device may comprise one or more storage and transport units formed as portal conveyors, by means of which one or more storage location faces of the storage device are accessible, in particular for storage and removal processes, as well as for processing and / or maintenance processes.

[0067] The storage and transport device, in particular the rail-guided transport system, the one or more free-running transport vehicles, the one or more rail-guided storage and transport units, and / or the one or more portal conveyors may be induction loop guided, magnetically guided, in particular permanent magnet guided, and / or solenoid guided. Additionally or alternatively, sensor-based guidance, in particular camera-based guidance, and / or radar / LIDAR-based guidance may be provided.

[0068] Additionally or alternatively, the storage and transport device may include one or more lift devices that allow access to one or more storage location surfaces of the storage device for storage and retrieval processes, as well as for processing and / or maintenance processes.

[0069] The handling device may be or include a multi-axis robotic arm. Additionally or alternatively, the handling device may be or include a pick-and-place robot or a wire robot, and / or the handling device may be or include a suitable slider actuator device disposed on a planar vehicle. Additionally or alternatively, the rail-guided transport system of the storage and transport device and / or one or more free-running transport vehicles may each include at least one multi-axis robotic arm.

[0070] The storage and transport devices and / or handling devices may be assigned exchange devices of the production facility, by means of which different gripping units and / or support units can be assembled to one or more storage and transport units of the storage and transport device and / or to one or more handling units of the handling device, in particular in order to carry out different storage, transport, handling, maintenance and / or processing processes using the respective storage and transport units and / or handling units.

[0071] A process unit may be configured as the exchange device.

[0072] The storage and transport device and / or the handling device may be assigned a cleaning device of the production facility, by means of which one or more storage and transport units of the storage and transport device and / or at least one gripping unit and / or support unit of one or more handling units of the handling device can be cleaned, in particular after carrying out a storage process, a transport process, a handling process, a maintenance process and / or a processing process.

[0073] A process unit may be configured as the cleaning device.

[0074] The cleaning device may in particular be arranged for cleaning whilst applying irradiation and / or gas treatment.

[0075] The cleaning device of the production facility, which is assigned to the storage, transport and / or handling device, may be arranged within the clean room area, in particular within or at the locking device or, for example, directly adjacent to the locking device.

[0076] The cleaning devices of the production facility, which are assigned to the storage and transport devices and / or handling devices, may be spatially separated from the locking devices within the clean room area.

[0077] By means of the handling device, one or more objects, such as those mentioned above, can be transferred from a locking location of the locking device to the storage and transport device, specifically to one or more storage and transport units of the storage and transport device.

[0078] The locking device may include an entrance lock, where a lock location, specifically the entrance lock location, is accessible from the periphery via the entrance lock and the entrance lock is configured to supply objects from the periphery of the production facility into the clean room area, and an exit lock, where a lock location, specifically the exit lock location, is accessible from the periphery via the exit lock and the exit lock is configured to remove objects from the clean room area.

[0079] The handling device may include a lock transport device by means of which one or more objects can be transported from a lock location, in particular an entrance lock location, to a further lock location, in particular a delivery lock location, and / or from a lock location, in particular a delivery lock location, to a further lock location, in particular an exit lock location.

[0080] The handling device, in particular the lock transport device, may comprise a displacement unit, by means of which one or more objects can be moved between the various lock locations.

[0081] One or more process units may be configured as a locking device, in particular as a locking transport device, and / or at least one process unit may be configured as the displacement unit.

[0082] In addition to or instead of at least one locking location, in particular an entrance locking location and / or an exit locking location, an unpacking location and / or a packing location may be provided in the locking device, and optionally the entrance locking location may be assigned an unpacking location arranged adjacently or spatially separated, or the entrance locking location may be an unpacking location, and / or the exit locking location may be assigned a packing location arranged adjacently or spatially separated, or the exit locking location may be a packing location.

[0083] The storage and transport device and / or handling device may each include one or more workpiece support receiving sections for receiving and transporting one or more workpiece supports, in particular one or more of the aforementioned workpiece supports.

[0084] The handling device may be capable of transferring one or more workpiece supports, in particular one or more equipped workpiece supports (e.g. equipped with an extractant), from a locking location of the locking device to the storage and transport device, in particular to one or more storage and transport units of the storage and transport device via one or more workpiece support receptacles.

[0085] The locking device may include a cleaning device for cleaning one or more workpiece supports and / or for cleaning one or more workpiece support receptacles.

[0086] The production facility may include a cleaning device to which the workpiece supports may be fed for cleaning themselves, in particular after the transport of an object by the respective workpiece support has taken place.

[0087] The cleaning device assigned to the storage and transport device and / or handling device, the cleaning device of the locking device and the cleaning device of the production facility may be arranged to form one common cleaning device of the production facility.

[0088] Any of the cleaning devices may be formed at least partially or completely separately from one another, in particular to form independent devices, and each of these cleaning devices may be formed as or by a process unit.

[0089] The storage device may include one or more storage shelves and / or one or more storage location surfaces, each having multiple storage locations.

[0090] The storage locations can be temperature-controllable, in particular individually temperature-controllable, in particular by means of respectively assigned temperature control devices of the storage devices. Optionally, one or more process units can be configured as temperature control devices.

[0091] A plurality of storage locations, in particular two or more storage locations, may be arranged one above the other, in particular in the vertical direction. In effect, the plurality of storage locations may be arranged in a stack.

[0092] A plurality of storage location surfaces, in particular two or more storage location surfaces, for example two or more storage location surfaces arranged one above the other, may be connectable to or connected to one another via a storage transport device, in particular via one or more lift devices of the storage transport device.

[0093] The storage and transport device may allow the extracts and / or tools and / or consumable materials to be stored in or withdrawn from a storage location.

[0094] In particular, the extract and / or workpiece support and / or tool and / or consumable material may be stored in or withdrawn from the storage location by means of a storage transport device of the storage device.

[0095] One or more storage locations may be accessible from multiple directions and / or by multiple storage transport units of a storage transport apparatus.

[0096] The storage location may be accessible vertically from above or horizontally from the side by the storage transport device.

[0097] A plurality of rows of generally horizontally oriented storage locations may be arranged vertically one above the other, effectively forming a matrix of storage locations.

[0098] Some of the storage locations, particularly the entire storage location, may be a shelf location on one or more storage shelves.

[0099] The storage device may include a plurality of different types of storage locations for accommodating different types of workpiece supports, and optionally the different types of storage locations may differ from one another in terms of their shape and / or size and / or in terms of their function and / or configuration.

[0100] The storage device may include a plurality of storage locations forming processing stations for processing the extract.

[0101] The process unit may also be configured as a storage location.

[0102] The storage device may include multiple storage locations forming tool stations for storing, maintaining, cleaning, changing, charging, and / or controlling tools.

[0103] The storage device may include a number of storage locations with one or more interfaces, in particular for current supply and / or signal transmission, e.g., control and / or regulation signal transmission, which interfaces are connectable with one or more corresponding interfaces of an object that can be accommodated in the storage location, in particular a process unit, in particular a workpiece support, preferably a patient box or a tool box.

[0104] The workpiece support already mentioned can in particular be configured as a process unit, for example as a patient box or tool box for containing and / or processing the extract.

[0105] It should be understood that the features relating to the workpiece support may also be incorporated into the patient box and / or tool box.

[0106] The patient box and / or tool box may define a process cell, in particular a sterile process cell. In fact, a process unit formed as a patient box and / or tool box may be a process cell, in particular a sterile process cell.

[0107] The patient box and / or the tool box, in particular the tool box, may have an interface to one or more tool units, in particular for gassing and / or temperature regulation.

[0108] Additionally or alternatively, for this purpose the patient box and / or the tool box, in particular the tool box, may be provided with means for positive and / or frictional fastening.

[0109] The patient box and / or the tool box may in particular be storeable in the storage location of the storage device, for example fully automatically by means of the storage transport device of the storage device already described.

[0110] One or more of the patient box and / or tool box can enclose a closable interior space. Optionally, the closable interior space can specifically define a sterile production area. In effect, the closable interior space can be a sterile production area.

[0111] The patient box and / or the tool box may be openable and / or closable automatically and / or by a handling device, in particular for introducing the extract and / or for withdrawing the product produced from the extract and / or for carrying out the processing steps.

[0112] One or more of the patient boxes and / or tool boxes may include a conditioning unit that is integrated into or releasably disposed in the storage box or that can be releasably disposed in the storage box, and that can influence, in particular control and / or regulate, the temperature and / or pressure and / or humidity and / or gas composition within the interior space of the respective box.

[0113] One or more of the conditioning units may be tool units of a tool system of the production facility, which tool units can be placed in or removed from the respective patient boxes and / or respective tool boxes as needed, for example by the storage and transport device of the storage device, as already mentioned, and / or by a handling device, in particular fully automatically.

[0114] Additionally or alternatively, one or more of the conditioning units may be tool units of a tool system of the production facility, and the tool units may be capable of being placed in or removed from their respective patient boxes and / or tool boxes as required, in particular independently, by means of their own actuator devices and / or by means of actuator devices located in or in the storage boxes of the respective patient boxes and / or tool boxes.

[0115] The patient box and / or tool box may include one or more connection elements that are connectable with corresponding connection elements of one or more processing locations, in particular to supply electrical energy and / or consumables, in particular liquids and / or gases, to the respective patient box and / or respective tool box.

[0116] The storage device may include a storage location with a connecting element, so that one or more processing steps for processing the extract can be carried out in the storage location of the storage device, which serves as a processing location.

[0117] The storage location and / or the patient box and / or the tool box of the storage device may include a fastening element by means of which the patient box and / or the tool box may be positioned and fastened in the storage location.

[0118] The patient box and / or the tool box, in particular the tool box, may each comprise one or more tool storage compartments for storing and fixing one or more tools, in particular in the interior space of the respective box, in particular the one or more tool storage compartments may each comprise one or more connection elements which are connectable with corresponding connection elements of the tools to be stored, in particular for supplying the respective tools with electrical energy and / or consumables, in particular liquids and / or gases, and / or for signal-technically coupling the respective tools with the respective box.

[0119] The patient box and / or tool box (respectively) may be stored in a storage location when not being utilized for product manufacturing, particularly after cleaning, for example, by the cleaning equipment of the production facility described above.

[0120] Patient boxes and / or tool boxes that are not stored in a storage location and are not used for product production may be fully automatically removable from the storage location, in particular by a storage transport device of the storage device, to accommodate or introduce the extract.

[0121] Additionally or alternatively, the patient box and / or tool box may include one or more connection elements that are connectable with corresponding connection elements of further patient boxes and / or tool boxes, thereby providing a single integrated patient box and / or a single integrated tool box and / or combinations thereof.

[0122] For possible configurations and / or forms of the grouped box, please refer to the remaining description of the patient box and / or tool box. It should be understood that one or more storage locations may be configured as storage locations for the grouped box.

[0123] The production facility comprises: an unpacking device for unpacking the objects to be delivered to the clean room area; and / or packaging equipment for packaging objects to be removed from the cleanroom area, such as manufactured products.

[0124] The unpacking device and / or the packing device may be integrated into or form an integral part of the locking device.

[0125] The unpacking device and / or the packing device may be configured as or formed by a process unit.

[0126] The locking device may include an entry lock location accessible from the periphery of the production facility, into which packaged objects may be placed, particularly by a person and / or automatically, and / or an exit lock location accessible from the periphery of the production facility, into which packaged objects may be removed, particularly by a person and / or automatically.

[0127] The packaged objects can be transported by the lock transport device of the production facility from the entrance lock location to, for example, the unpacking location already mentioned and automatically unpacked at the unpacking location, or the packaged objects can be automatically unpacked at the entrance lock location, and the objects to be packaged can be transported by the lock transport device of the production facility from the delivery lock location to the unpacking location and automatically unpacked at the unpacking location, or the objects to be packaged can be automatically packaged at the exit lock location.

[0128] The locking device may include a cleaning device, for example as already described, for cleaning the packaging material of the packaged and / or unpackaged objects.

[0129] The packaged objects, in particular the packaging material of the packaged extract, may be able to be led out in a sterile state by the unpacking device after unpacking, for example via an outlet lock location and / or via a waste lock location of a separately formed waste lock of the unpacking device or locking device, so that the unpacked objects, in particular the unpacked extract, do not come into contact with the packaging material.

[0130] The packing device and the unpacking device may be formed in one common device for unpacking and / or packing.

[0131] As already explained in connection with the patient box and / or tool box conditioning units, the production facility may include a tooling system that may enable handling and / or maintenance processes on the extract to be carried out within the clean room area.

[0132] The tooling system may include a number of, in particular fully automatic, tooling units for carrying out different processing and / or maintenance procedures.

[0133] The process units may be configured as tool units, one or more of which may additionally or alternatively be assigned to and / or contained in a tool box.

[0134] The tool units described herein may be the tools described herein and / or the tools described herein may be the tool units described herein.

[0135] The tooling system may include one or more tooling units configured as supply units for supplying consumable materials to the extract, and / or one or more tooling units configured as withdrawal units for withdrawing samples from the extract.

[0136] One or more of the tool units of the tool system may each include one or more multi-use components and / or one or more single-use components.

[0137] The tool system may include a preparation unit that allows the single-use components of the tool unit to be removed, particularly discarded, after their use and replaced with one or more new single-use components.

[0138] The preparation unit may include a handling unit, in particular a multi-axis robot arm, by means of which the preparation process can be carried out fully automatically.

[0139] The cleaning can be carried out by a cleaning unit of the preparation unit before the un-equipping and equipping steps, during these steps, in particular between the un-equipping and equipping steps, and / or after the preparation step.

[0140] The tooling system may include a plurality of portable tooling units, which may be capable of being supplied to a processing location for processing the extract, in particular a processing location that is simultaneously a storage location for storing the extract, in order to carry out the processing process, and may be capable of temporary intermediate storage at that location.

[0141] One or more portable tool units of the tool system can be supplied to a tool storage location, and / or to a processing location, and / or to a preparation location by a storage and transport device of the production facility, in particular one or more storage and transport units.

[0142] One or more tool units may be formed and arranged by a handling device for carrying out processing and maintenance processes.

[0143] The one or more tool units may be formed and arranged independently, in particular independently, of the handling device for carrying out the treatment and / or maintenance steps.

[0144] The tool units may be installable in a storage location, capable of intermediate storage, storable and / or connectable to an assigned interface within the storage location.

[0145] The tool unit may be a tool for supplying and / or drawing off a liquid, for example a tool for sucking up a liquid, in particular a tool for pumping a liquid, for example a pump tool, and the tool unit may be configured to supply and / or draw off a specified amount of liquid, in particular for taking a sample for analysis.

[0146] The tool unit may 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 may be a pump for circulation.

[0147] The tool unit may be a means for biochemical manipulation of cells, by which at least one substance can be supplied to the extract and / or the temperature of the extract can be changed and / or the ambient pressure of the extract can be changed, the extract being particularly arranged and particularly contained in a tool support, particularly in a containment box, thereby particularly changing the environment of the extract, particularly the environment of the cells of the extract, thereby particularly changing the extract itself, particularly the cells of the extract itself, particularly in terms of cell growth and / or cell surface, for example cell membrane surface, and / or cell metabolism.

[0148] The tool unit may in particular be a means for concentrating and / or separating liquids by means of a column, for example a separation column, and / or a centrifuge.

[0149] The tool unit may be a means for analyzing program parameters by means of probes and / or sensors, the probes and / or sensors being configured to grasp, detect and / or determine, for example, at least one of the following: at least one temperature, at least one particle, e.g., at least one particle concentration, at least one vibration, at least one acceleration, at least one cell count, at least one cell density, at least one turbidity, e.g., at least one light absorption based on liquid turbidity, at least one gas composition, at least one gas, e.g., CO2, and / or at least one chemical, in particular at least one biochemical, e.g., a metabolite.

[0150] It should be understood that the foregoing list is illustrative and not exhaustive.

[0151] The tool system may in particular be arranged fully automatically.

[0152] In fact, the production facility may in particular comprise a fully automatic tool system, the tool unit comprising one or more tool units for carrying out processing steps on the extract, the tool system being arranged inside a clean room area, for example inside a clean room subarea, for example inside a patient box and / or a tool box as clean room subarea.

[0153] A supply device may be assigned to the tooling system for supplying the tooling system with consumable materials. A production facility, such as the tooling system described above, may include a supply device for supplying the tooling system with consumable materials. Specifically, the supply device may include or utilize one or more storage locations of a storage device located within the clean room area for storing the consumable materials.

[0154] Consumable materials to be used in the process may be provided in the locking device, in particular on an exit locking location of the locking device, in particular prior to its use, and may optionally be prepared for use, in particular temperature adjustable.

[0155] The supply device may include one or more disposal units, which may specifically remove used, worn-out, and / or soiled consumables and / or tool consumables from the cleanroom area.

[0156] One or more disposal units may be assigned to an equipment unit of the tool system, may in particular be handleable by the equipment unit, and / or may form a constituent part of the equipment unit of the tool system.

[0157] The supply device may include a replenishment device located within the clean room area, which may supply consumables, particularly those present in liquid form, to one or more storage devices of one or more workpiece supports and / or one or more storage locations.

[0158] Additionally or alternatively, the replenishment device may be configured as the aforementioned replenishment station and / or may be assigned to such a replenishment station.

[0159] As already mentioned, one or more sensor units, in particular probes, sensors and / or homogeneous measuring elements, may be included in the production facility.

[0160] In effect, the production facility may include one or more sensor units for determining one or more values ​​of one or more parameters of one or more extractants, and / or one or more workpiece supports, and / or one or more tools, and / or one or more consumable materials.

[0161] The determination may be performed at least partly automatically, in particular fully automatically, by one or more sensor units.

[0162] By means of one or more sensor units, the occupancy status of one or more storage locations of a storage device of a production facility may be determined, in particular monitored.

[0163] The one or more sensor units may be capable of determining, and in particular monitoring, the local temperature, and / or local humidity, and / or local lighting or illumination intensity at or within one or more storage locations of a storage device of a production facility.

[0164] The production facility may include one or more sensor units for determining the processing progress of the extract during processing or between two processing steps, for example based on at least one fluid of the extract.

[0165] One or more process units, in particular the patient box and / or tool box and / or storage location, may each have one or more sensor units arranged therein, in particular integrated within the storage location, for determining the processing progress.

[0166] In particular, the sensor unit may be configured and / or formed as described in German Patent Application No. DE 10 2021 207 738.2, which is incorporated herein by reference.

[0167] In other words, in summary, the production facility includes one or more sensor units, which can monitor one or more, substantially all process steps, in particular one or more, substantially all processing steps, and / or one or more, substantially all process states, in particular one or more, substantially all processing states, and in particular can adjust, in particular post-adjust, and / or control, in particular post-control, if necessary.

[0168] The sensor device unit may specifically address at least one temperature, at least one particle, e.g. 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 the turbidity of the extract-suspension and / or product-suspension, e.g. at least one light absorption based on liquid turbidity, in particular in the extract-suspension and / or product-suspension, at least one gas composition, at least one gas, e.g. CO2, and / or at least one chemical, in particular at least one biochemical, e.g. at least one metabolic product, e.g. glucose.

[0169] The aforementioned sensor device units may be arranged in the production facility as needed, in particular in the clean room area, with respect to one or more objects, such as extracts and / or tools and / or storage locations and / or consumable materials and / or process units, such as patient boxes and / or tool boxes.

[0170] As already mentioned above, the production facility may include one or more cleaning devices.

[0171] The cleaning device may be formed as a separate device in the clean room area and / or may be a component part of a tool system, in particular a tool or tool unit, and / or a locking device and / or a storage device.

[0172] Additionally or alternatively, the cleaning apparatus may include one or more autoclave apparatuses that are capable of sterilizing one or more objects within the clean room area.

[0173] The one or more autoclave devices may be embodied as the autoclave devices described in connection with the unpacking device and / or the packing device.

[0174] The cleaning device may in particular include a stationary cleaning station, by means of which at least one process unit, in particular at least one workpiece support, in particular at least one patient box and / or at least one tool box, may be cleanable, in particular disinfectable and / or sterilizable.

[0175] The cleaning station may include a washer and / or an autoclave device.

[0176] The production facility has at least one control unit by means of and / or via which the production facility can be operated, in particular adjusted and / or controllable.

[0177] In effect, the production facility comprises at least one control unit, which may be configured and programmed to regulate and / or control the production facility at least partially or completely.

[0178] Additionally or alternatively, at least one control unit may be configured and programmed to regulate and / or control at least one of the components contained by the production facility or a part of the production facility, and the (component) or (part) may be assigned to at least one control unit.

[0179] The at least one control unit may be formed by one or more, in particular all, computing units of the process units.

[0180] In fact, one or more, in particular all, of the computing units of the process units may form at least one control unit.

[0181] Additionally or alternatively, the at least one control unit may be configured and programmed as an intermediate unit between a computer system assigned or assignable to the production facility and the production facility itself, said computer system being configured and programmed to at least partially or completely regulate and / or control the production facility.

[0182] The computer system assigned or assignable to the production facility may be arranged within the periphery of the production facility and / or may be arranged spatially separated or separately and may be connectable or connected to the production facility, in particular to at least one control unit formed as an intermediate unit, in particular wirelessly and / or by wire, for example by one or more communication interfaces of the production facility.

[0183] A production facility may have a computer system that is assigned or assignable to the production facility.

[0184] Additionally or alternatively, the computer system assigned or assignable to the production facility may be a control computer system, in particular a cloud-based control computer system and / or a control server.

[0185] Additionally or alternatively, the at least one control unit may be formed as at least one independent control unit.

[0186] The at least one independent control unit may be arranged within the periphery of the production facility and / or may be spatially separated or arranged separately and may be connectable or connected to the rest of the production facility, in particular wirelessly and / or by wire, for example by one or more communication interfaces of the production facility.

[0187] Additionally or alternatively, the at least one independent control unit may be located in a clean room area, in particular inside a housing, or in a production facility.

[0188] In effect, the production facility may be operable, in particular regulated and / or controllable by said computing units of the process units and / or by at least one, in particular independent control unit and / or by said computer system assigned or assignable to the production facility. It should be understood that said components may be configured for the operation, in particular for the regulation and / or for the control of the production facility, alone or in any combination thereof.

[0189] Additionally or alternatively, the at least one control unit may be programmed and configured to identify, code and / or assign one or more objects in the production facility by an ID assigned to each object. Optionally, the ID may be assigned to each object, in particular by RFID and / or barcode means and / or as unique information, in particular a digital fingerprint.

[0190] The production facility may include one or more communication interfaces and / or one or more human-machine interfaces, or HMI-interfaces for short, by means of which one or more pieces of information about the production facility and / or at least one component of the production facility and / or at least part of the production facility can be provided to at least one user and / or one or more computer systems, in particular in relation to, for example, the fact that a consumable material in the production facility is below a specified level.

[0191] At least one control unit may be configured and programmed to communicate with one or more communication interfaces and / or one or more human-machine-interfaces, or HMI-interfaces for short, of the production facility.

[0192] At least one control unit may be configured and programmed to provide information to an operator or user via the communication interface and / or via the HMI interface, such as fault information and / or information about the production status of the product and / or information about the storage status of the storage device.

[0193] The at least one control unit may be configured and programmed to allocate the extract to one or more process units based on one of a plurality of production programs for producing one of a plurality of products producible by the production facility.

[0194] In other words, the production facility may have a plurality of process units for containing and / or processing the extract, the process units configured as described above and / or below and each having at least one computing unit, and the production facility may further have at least one control unit configured and programmed to allocate the extract to one or more process units based on one of a plurality of production programs for producing one of a plurality of products producible by the production facility.

[0195] The production program may include multiple, particularly encrypted, production program packets, each of which includes at least one piece of information that references other production program packets and / or includes instructions for storing and / or processing the extract.

[0196] A production program can represent a prescription for manufacturing a product, specifically a personalized product based on patient-related information.

[0197] A defined sequence of a plurality of production program packets can form a production program for producing a product producible by the production facility.

[0198] In particular, the complete order may only be determinable from all references relating to other production program packets.

[0199] For example, it is contemplated that the defined sequence may be definable by the production facility, in particular by at least one control unit of the production facility, and / or by a computer system assigned or assignable to the production facility, in particular may be dynamically definable.

[0200] Taking into account the quality analysis carried out or capable of being carried out by the one or more sensor units, one or more production program packets may be carried out, in particular fully automatically, until the product to be produced from the extract is completed.

[0201] The product thus produced may be transportable or may be transported from the production facility to the locking device automatically, which may be included, for example, as instructions in the production program packet.

[0202] The product may be filled and / or packaged prior to its withdrawal, particularly in a ready-to-use state, which may be included, for example, as instructions by the production program packet.

[0203] Specifically, a production program packet contains instructions for one or more processes, e.g., - supplying liquids and / or gases, in particular gas mixtures, - delivery, in particular pumping, of liquids and / or gases, in particular gas mixtures, - delivering, in particular pumping, a portion of a liquid and / or gas, in particular a gas mixture, for analysis by one or more sensor units; - mixing one or more components, in particular at least one liquid, with a further component, for example a further liquid, - concentrating and / or separating the liquid, in particular by means of a column, for example a separation column, and / or a centrifuge, - analyzing the extract and / or intermediate product and / or product, in particular by means of one or more sensor units, - storing, particularly storing and / or retrieving, one or more objects, particularly by means of a storage and transport device; - temperature-conditioning, in particular incubating, one or more objects, in particular one or more extracts; It has instructions for:

[0204] It should be understood that the foregoing list of process steps or instructions in the production program packet thereof is exemplary and not exhaustive. Alternatively or additionally, it may be possible to combine one or more process steps with one or more other process steps in a single process step, and / or in any combination thereof.

[0205] One or more, in particular all, production program packets may be encrypted and / or may be provided in an encrypted state, in particular to one or more of the process units.

[0206] The process unit, in particular its at least one computing unit, may be configured and programmed to carry out, in particular to decode and then execute, instructions of at least one production program packet.

[0207] Some of the process units may form a process unit group, underlying the sequential ordering of the process units relative to one another, with reference to a production program packet, and by which a product can be produced.

[0208] It should be understood that the composition of the group may only arise from reference to the entire production program packet, and thus the complete group may only become fully apparent upon completion of production of the product.

[0209] Additionally or alternatively, some of the process units may form a process unit group that executes, specifically decodes, and then executes a production program packet, specifically a single production program packet, to ensure the success and / or fail-safety of the processing steps contained in the production program packet.

[0210] One or more, in particular all, of the production program packets may be provided to each one of the process units, in particular to at least one of the computing units thereof, and / or may be transferable to each one of the process units, in particular to at least one of the computing units thereof, in particular by at least one control unit and / or by a computer system assigned or assignable to the production facility.

[0211] It should be understood that one or more, particularly all, of the production program packets may be storable in a dynamically manageable and / or modifiable storage pool, which may be operable and / or stored by a computer system, particularly assigned or assignable to at least one control unit and / or production equipment, so that new production program packets, particularly can be dynamically supplemented and / or modified locally, and particularly new recipes for manufacturing products may be efficiently and quickly prepared.

[0212] A production facility may have a computer system that is assigned or assignable to the production facility.

[0213] Additionally or alternatively, the computer systems allocated or allocable to the production facility may be cloud-based computer systems and / or servers.

[0214] Each process unit, in particular each computing unit of a process unit, may include at least one storage unit for providing and / or storing data, in particular one or more production program packets, and / or one or more pieces of information, and / or one or more encryption keys, and / or in particular a distributed database.

[0215] It should be understood that a production facility, in particular its components, such as the aforementioned process units, may have multiple storage units and / or may be assigned one or more storage units, in particular distributed, for example located in the cloud and / or on servers, on at least one of which a computer program product can be stored, the computer program product comprising instructions that, when executed, can cause one or at least one of the aforementioned control units of the production facility to operate the production facility as described herein. The computer program product may additionally or alternatively be stored on a computer-readable (further) storage medium.

[0216] The plurality of, particularly encrypted, production program packets may include a start packet and one or more follow packets, each packet containing at least one piece of information, which may reference the follow packets and / or contain instructions for containing and / or processing the extract.

[0217] In effect, each defined sequence of a plurality of production program packets forming a production program for producing a product producible by the production facility can begin with a start packet.

[0218] The extract may be assignable only to a process unit to which a start packet has been assigned and / or to which the start packet is associated and / or on which the start packet is stored, or to which a start packet can be provided after or together with the assignment of the extract.

[0219] It should be understood that at least one of the follow packets may be specifically formed as the last follow packet and / or as a completion packet, which packet contains at least one piece of information, the information including instructions for delivering and / or completing the processing of the extract and / or for completing the product made from the extract.

[0220] It should be understood that a production program packet may contain two or more pieces of information, each of which may reference other production program packets, e.g., two or more production program packets, and / or may contain instructions for storing and / or processing the extract.

[0221] The process unit, in particular at least one of its computing units, may be configured and programmed to store one or more encryption keys by means of which the production program packets of the production program can respectively be decrypted.

[0222] Such an encryption key may be specifically a private encryption key, specifically for public key encryption.

[0223] In other words, the encryption key may be uniquely assigned to the production program packet.

[0224] Specifically, an encryption key may be stored by at least one of the process units, by which the production program packet can be decrypted and / or activated for initiation of the production program.

[0225] In other words, an encrypted start key for decrypting the start packets may be storable in at least one of the process units, thereby allowing the production of a product to begin according to the defined sequence of each of the multiple production program packets.

[0226] One or more production program packets may be decipherable locally within the process unit by a computational unit of the process unit.

[0227] Additionally or alternatively, one or more production program packets may be decipherable outside the process unit by at least one control unit and / or by a computer system assigned or assignable to the production facility.

[0228] One or more encryption keys may be assignable to the process units by at least one control unit and / or by a computer system assigned or assignable to the production facility.

[0229] Additionally or alternatively, one or more encryption keys may be inseparably embedded within a processing unit, in particular within at least one computational unit thereof.

[0230] The process unit may have a security module, in particular a Trusted-Platform-Module, for providing one or more encryption keys, in particular the security module being capable of storing one or more encryption keys for decrypting individual production program packets of the production program.

[0231] Such an encryption key may be specifically a private encryption key, specifically for public key encryption.

[0232] The processing unit, in particular at least one of its computing units, may be configured and programmed to receive release information for the use and / or provision of one or more encryption keys, and / or the one or more encryption keys may only be available and / or provideable by the processing unit in a time-limited manner.

[0233] In other words, one or more encryption keys can be used and / or provided by a process unit in an unlimited manner, or in a time-limited manner, as long as the process unit is provided with the appropriate release information, as detailed in the description below.

[0234] The extract can only be assigned to a process unit and / or processing of the extract can be carried out by the process unit if the unambiguous information relating to the process unit, which can be provided by the process unit itself, and the further unambiguous information relating to the process unit, which can be detected by the at least one control unit, match and, in particular, if this indicates the integrity of the process unit in question.

[0235] In other words, an extract can only be assigned to a process unit and / or processing of the extract can only be performed by a process unit insofar as the process unit in question has been configured and / or identified.

[0236] Such integrity may include matching a target state of a process unit with an actual state of the process unit, particularly the target state relative to a starting state of the process unit, such that it is possible to determine whether the process unit has been tampered with and / or unintendedly altered.

[0237] At least one process unit may be configured to feed the extract into the production facility and / or to withdraw the extract, the at least partially processed extract, and / or the product from the production facility, in particular via a locking device.

[0238] In other words, at least one process unit may be configured as a lock box for lock entry and / or lock exit of objects to the production facility. For example, the lock box may be a lock entry box, a lock exit box, and / or a combined lock entry-lock exit box.

[0239] In particular, such a process unit, preferably configured as a lockbox, can be configured and programmed to execute the start of a production program, in particular a start packet.

[0240] The patient box and / or tool box (respectively) may be lock boxes and / or may be usable as such.

[0241] The production facility may be configured to provide one or more process units for containing and / or processing the extract.

[0242] The production facility may be configured to execute such a production program packet based on an encrypted production program packet, in particular of a production program, that precedes the production program packet, in particular by determining an encrypted production program packet of the production program for producing a product that can be produced by the production facility and one of the process units.

[0243] The production facility may be configured to decode the determined production program packet by activating the determined production program packet on the determined process unit, and subsequently control the process unit to perform one or more processing steps on the extract based on the decoded production program packet.

[0244] The production facility may be configured to execute such subsequent production program packets based on the decrypted production program packets by determining the encrypted production program packets and subsequent process units that follow the decrypted production program packets, specifically the encrypted production program packets of the production program.

[0245] In other words, the production facility may be configured to operate in a subsequent step, and / or in further words, a method can be provided for partially controlling a production facility for producing a product, in particular a biological product, the production facility being configured as described above and / or below, and the method comprising: - providing one or more process units for containing and / or processing the extract, - executing such a production program packet based on the encrypted production program packet of the production program preceding it, specifically by determining an encrypted production program packet of the production program for producing a product producible by the production facility and one of the process units; - decoding the determined production program packet by activating the determined production program packet on the determined process unit, and subsequently controlling the process unit to perform one or more processing steps on the extract based on the decoded production program packet; and - determining the encrypted production program packets and subsequent process units that follow the decrypted production program packets, specifically the production program, and executing such subsequent production program packets based on the decrypted production program packets; This includes:

[0246] It is to be understood that all structural and / or functional features associated with the system according to the invention, i.e. the inventive production installation, and its embodiments described above and / or below, may also be included in the method, either alone or in combination, and that the associated properties, configurations and advantages may be included and achieved accordingly.

[0247] The context for the stated completeness of the process units is detailed below.

[0248] In particular, the production facility may have at least one control unit as described above, which may be configured and programmed to determine the integrity of each process unit before an extract can be received and / or processed by the process unit in accordance with one of a plurality of production programs for producing one of a plurality of products producible by the production facility.

[0249] The purpose of the integrity determination may be to be able to prove alterations in particular to the process unit, in particular to the patient box and / or the tool box, for example, to detect whether espionage means, such as cameras and / or other equivalent hardware, have been attached to the process unit by unauthorized persons so that the manufacture of the product can be inferred.

[0250] The computing unit of the process unit may be configured and programmed to provide unambiguous information relating to the process unit, and further unambiguous information relating to such process unit may be detected by the at least one control unit, and the integrity of such process unit may be determined by the at least one control unit based on a comparison of both such unambiguous information, and may be set and / or confirmed, in particular, when both such unambiguous information match.

[0251] The setting and / or checking of the integrity may in particular take place in the respective calculation unit and / or in at least one control unit.

[0252] In particular, the unambiguous information that can be provided on the part of the calculation unit can represent a target state and / or a starting state of the process unit, based on which deviations for the process unit can be determined.

[0253] The process unit may have a security module, in particular a trusted platform module, for providing unique information about the process unit, in particular fingerprint information, and the computing unit of the process unit is configured and programmed to provide unique information of at least one control unit for determining integrity.

[0254] In particular, unique information or fingerprint information may refer to digital fingerprint information, for example information that has a unique and / or unambiguous signature.

[0255] The production facility may have one or more sensor units by means of which the process units can be detected, in particular visually, and based on such detection, unique information about each process unit can be provided by at least one control unit for determining its integrity.

[0256] In particular, the one or more sensor units may include one or more camera units, which may visually detect characteristic landmarks on the face, in particular the surface, and / or geometry of the process unit.

[0257] In other words, the unambiguous information may be based on characteristic landmarks of the face, in particular the surface, and / or geometry of the process unit.

[0258] The geometry may be a two-dimensional and / or a three-dimensional geometry.

[0259] Additionally or alternatively, the production installation may have one or more actuator units by means of which one or more process units may be excited, in particular mechanically, in order to generate mechanical vibrations, which vibrations may be detected by one or more sensor units, and based on the vibrations, unique information may be provided by at least one control unit regarding the respective process units for determining their integrity.

[0260] In other words, the unambiguous information can be based on a characteristic response of the process unit in question to a mechanical excitation, and in particular if an unauthorized change has been made to the process unit in question, this can be inferred from the deviation of the characteristic response from a recorded characteristic response.

[0261] At least one of the one or more actuator units is configured to generate mechanical vibrations, and such actuator unit may be located on or within one of the one or more process units and / or may be engageable with one of the one or more process units so as to generate mechanical vibrations in that process unit.

[0262] For example, the actuator unit can be configured as a motor, in particular a vibration motor, by means of which a definable frequency range can be generated and / or driven.

[0263] Vibrations can be detected by at least one of the sensor units and a characteristic curve of the vibrations specific to the process unit can now be provided as a characteristic response and / or as unambiguous information, thereby making it possible to detect structural changes in or at the process unit in particular.

[0264] In particular, the vibrations may include a frequency range of 10 Hz or more and 100 Hz or less, and / or the vibrations may include one or more specifically different frequency ranges that may each be 10 Hz or more and 100 Hz or less, and / or the vibrations may include one or more specifically different frequency ranges that may follow each other in a predetermined order.

[0265] Additionally or alternatively, at least one of the one or more actuator units may be configured to generate acoustic vibrations, in particular sound waves, and such actuator unit may be located on one of the one or more process units and / or may be engageable with one of the one or more process units so as to generate mechanical vibrations, in particular sound waves, for that process unit.

[0266] For example, the actuator unit may be formed as an acoustic transducer, in particular a loudspeaker, by means of which a definable frequency range can be generated and / or driven.

[0267] At least one of the sensor units may be able to detect sound or sound frequencies and may now be able to provide a characteristic curve specific to the process unit of the sound or sound frequencies as a characteristic response and / or as unambiguous information, thereby making it possible to detect, in particular, structural changes within or in the process unit.

[0268] In particular, the (acoustic) vibrations may include a frequency range of 30 Hz or more and 10,000 Hz or less, and / or the (acoustic) vibrations may include one or more, in particular various frequency ranges, each of 30 Hz or more and 10,000 Hz or less, and / or the (acoustic) vibrations may include one or more, in particular various frequency ranges, which may follow each other in a predetermined order.

[0269] Additionally or alternatively, one or more, particularly all, process units may have at least one storage chamber, particularly surrounded by sides, for storing one or more objects, particularly an extract, and / or one or more objects for processing the extract, and the integrity includes internal integrity with respect to the storage chamber and / or external integrity with respect to the outside of the storage chamber.

[0270] It should be understood that the described sensor units and / or the described actuators may be configured with internal integrity and / or external integrity.

[0271] In particular, a patient box and / or a tool box may be a process unit, in particular having a storage chamber surrounded by sides.

[0272] The process unit may be configured and programmed to execute, in particular to decode and then execute, instructions based on at least one production program, in particular instructions of a production program packet, as long as its integrity has been established and / or verified.

[0273] In other words, one or more, particularly all, of the production program packets are each provided on one process unit and are executable, particularly decipherable and executable, only to the extent that the integrity of the process unit in question has been configured and / or verified.

[0274] Additionally or alternatively, one or more, in particular all, of the production program packets may be transmittable to each one of the process units, in particular by at least one control unit and / or by a computer system assigned or assignable to the production facility, only insofar as the integrity of the process unit in question has been set and / or verified.

[0275] The process unit may be configured and programmed to block the execution and / or interpretation of instructions according to at least one production program unless its integrity is configurable and / or verifiable.

[0276] In particular, the process unit may be configured and programmed to provide a message, in particular a warning message, to at least one control unit and / or at least one computer system assigned or assignable to the production facility, unless its integrity is configurable and / or verifiable.

[0277] Additionally or alternatively, the at least one computing unit may be configured and programmed to determine the integrity of a respective process unit before an extract can be received and / or processed by such process unit, in particular according to one of a plurality of production programs for producing one of a plurality of products producible by the production facility.

[0278] In other words, each process unit may be configured as a self-checking process unit, which is configured to determine its own integrity or, more specifically, to be able to determine unauthorized modifications by itself.

[0279] In particular, the integrity may be determinable by at least one control unit and / or by each computing unit of the process unit in question.

[0280] In effect, in other words, the production facility may have at least one or at least one control unit as described above, the control unit configured and programmed to determine the integrity of each process unit, and each calculation unit of the process units configured and programmed to determine the integrity of the respective process unit, and optionally each integrity result may be compared with a plausibility check, specifically by the at least one control unit and / or the respective calculation unit.

[0281] The computation unit of the process unit may be configured and programmed to store and / or provide unambiguous information regarding such process unit and to detect further unambiguous information regarding such process unit, and the integrity of such process unit may be determined by the computation unit based on a comparison of both such unambiguous information and is specifically settable and / or confirmed when both such unambiguous information match.

[0282] Specifically, the unique information may include a starting state of the process unit in question and a starting timestamp assignable to the starting state, and the further unique information includes a further state of the process unit in question and a further timestamp assignable to the further state, the further timestamp being different from the starting timestamp.

[0283] As already mentioned, the starting state can correspond to a target state of the process unit.

[0284] The respective time stamp allows an unambiguous chronological assignment and / or classification of the respective state of the process unit.

[0285] In particular, the process unit formed as a patient box and / or as a tool box has at least one storage chamber, in particular surrounded by sides, for storing one or more objects, in particular an extract and / or one or more objects for processing the extract, in particular integrity including internal integrity with respect to the storage chamber and / or external integrity with respect to the outside relative to said storage chamber.

[0286] The process units, in particular the patient box and / or the tool box, have one or more sensor units by means of which unambiguous information and / or further unambiguous information about the process unit in question can be detected in order to determine its integrity, in particular its internal integrity.

[0287] In particular, at least one sensor unit can detect brightness values ​​in and / or of the process unit in question, and unambiguous information and / or further unambiguous information about the process unit in question can be provided for determining its integrity, in particular its internal integrity, based on the detectable brightness values.

[0288] Additionally or alternatively, the brightness value may be detectable continuously, particularly over the entire processing process, to determine the integrity of each process unit while the extract is received by such process unit and / or processed according to one of a plurality of production programs for producing a plurality of products producible by the production facility.

[0289] In particular, the at least one receiving chamber surrounded by the side surface may be configured as a closed chamber during operation of the corresponding process unit, so that when light is detected, the integrity is not configurable and / or verifiable, in other words, there may be manipulation and / or attacks on the corresponding process unit.

[0290] Additionally or alternatively, the process unit may have one or more actuator units by which the process unit in question can be excited, in particular mechanically, to generate mechanical vibrations, which vibrations can be detected by one or more sensor units, and based on said vibrations unambiguous information about the process unit in question and / or further unambiguous information can be provided for determining its integrity.

[0291] In other words, the actuator units useful for the integrity determination may be contained within the respective process unit itself and / or may be contained within the production facility, specifically outside the respective process unit.

[0292] For example, the actuator unit can be configured as a motor, in particular a vibration motor, by means of which a definable frequency range can be generated and / or driven.

[0293] The vibrations may include a frequency range of 10 Hz or more and 100 Hz or less, and / or the vibrations include one or more, particularly various frequency ranges, each of which is 10 Hz or more and 100 Hz or less, and / or the vibrations include one or more, particularly various frequency ranges, which may be successive to one another in a predetermined order, and in particular at least one of the one or more actuators is formed as a vibration motor, which is fixed in and / or to the process unit in question to generate mechanical vibrations.

[0294] Additionally or alternatively, at least one of the one or more actuator units may be configured to generate acoustic vibrations, in particular sound waves, and may be fixed within and / or to a corresponding process unit to generate mechanical vibrations, in particular sound waves, for the corresponding process unit.

[0295] In particular, the vibrations may include a frequency range of 30 Hz or more and 10,000 Hz or less, and / or the vibrations include one or more, specifically various frequency ranges, each of 30 Hz or more and 10,000 Hz or less, and / or the vibrations include one or more, specifically various frequency ranges, which may follow each other in a predetermined order.

[0296] The actuator units for determining the integrity described with respect to the process unit may be configured substantially like and / or functionally equivalent to the actuator units for determining the integrity described with respect to the production facility.

[0297] Additionally or alternatively, the process unit may have one or more conductive lead elements, which are arranged in and / or within the process unit and / or within a side wall of the process unit and may specifically form an independent current circuit, and one or more sensor units may detect whether the current circuit has been altered relative to its original state and / or whether it has been interrupted, and based on the detection of the current circuit, unambiguous information and / or further unambiguous information about the process unit in question may be provided for determining its integrity.

[0298] In other words, the process unit may be provided with a wire mesh netting, in particular with one or more insulated wires, and / or may be covered in an inner, outer and / or intermediate layer thereto, and the wire mesh netting or wires may be tested for integrity by a current source, so that tampering and / or attacks may be determined and / or proven in the absence of current.

[0299] Additionally or alternatively, at least one sensor unit is formed as an inertial measurement unit, by means of which at least one acceleration value, in particular an acceleration vector, and / or at least one rotational speed value, in particular a rotational speed vector, related to the process unit in question can be detected, and unambiguous information and / or further unambiguous information related to the process unit in question can be provided for determining its integrity based on the detectable acceleration values ​​and / or rotational speed values.

[0300] In particular, the process unit may be movable or can be made to move in a predefined pattern, for example a forward-backward-rotation-up-down pattern, by an external excitation or force, and the resulting acceleration and / or rotation speed values ​​of the process unit may be determinable by the inertial measurement unit to provide unambiguous information and / or further unambiguous information for comparison, such that manipulation and / or attacks can be determined and / or proven when deviations occur in the unambiguous information or when the resulting acceleration and / or rotation speed values ​​are different.

[0301] In particular, the production facility has handling devices for moving objects within the production facility and / or one or more actuator units by means of which the process unit in question can be mechanically excited, in particular to generate a defined movement, which movement can be detected by an inertial measurement unit, and based on which unambiguous information and / or further unambiguous information about the process unit in question can be provided for determining its integrity.

[0302] The handling device may in particular be or include the multi-axis robotic arm already described.

[0303] Additionally or alternatively, the acceleration and / or rotational speed values ​​may be detectable, in particular continuously, by the inertial measurement unit during operation of the process unit in question, thereby providing unambiguous information, in particular continuously, for process units of the same type, in particular structural type and / or configuration, in particular for continuous integrity determination. For example, the acceleration and / or rotational speed values ​​of a process unit, in particular a patient box and / or a tool box, may be detectable during transport to a or the aforementioned cleaning device and / or storage location, and changes, in particular determinable from this, in terms of mass and / or mass distribution may be determined, whereby manipulation and / or attacks may be determined and / or proven.

[0304] Additionally or alternatively, at least one sensor unit can detect temperature values ​​in and / or of the process unit in question, and can provide unambiguous information and / or further unambiguous information about the process unit in question for determining its integrity based on the detectable temperature values.

[0305] Additionally or alternatively, the process unit in question can be at least partially visually detected by at least one sensor unit, and unambiguous information and / or further unambiguous information about the process unit in question can be provided for determining its completeness based on visual detection, in particular the at least one sensor unit includes a camera unit, and characteristic landmarks and / or geometry of the process unit in question can be visually detected by the camera unit.

[0306] It should be understood that any combination of the components described for completeness, in particular actuator units and / or sensor units, is conceivable for each process unit.

[0307] Thus, by detecting sensor data or sensor information or sensor values ​​for initiating use and / or operation within a production facility, unique information or a digital fingerprint of the process unit in question may be generated. At any time when the process unit in question has not been filled with contents, such as tools, extracts, etc., it may be possible to test whether integrity or the absence of manipulation and / or attacks exists, in other words whether the unique information still remains unchanged.

[0308] In particular, individual sensor units, for example brightness sensors, are available for integrity determination during operation, in particular continuously, thereby enabling potential attacks to be demonstrated.

[0309] As mentioned above, the plurality of process units serve to contain and / or process the extract, each process unit may have at least one calculation unit, and the extract may be containable and / or processable by the process units according to one of a plurality of production programs for producing one of a plurality of products producible by the production facility.

[0310] In this case, at least a part of the production program may in particular serve exclusively to imitate and / or suggest one or more production program steps, in particular one or more production program steps for the manufacture of a product.

[0311] This may specifically result in the true or actual manufacturing process or manufacturing program process being hidden or obscured, specifically requiring a potential attacker to conduct further investigation to be able to recover the manufacturing of the product.

[0312] A production program process may specifically relate to the actual execution of instructions in a production program packet.

[0313] Specifically, this portion of the production program may include one or more process steps that are additional and / or ineffective in relation to the actual manufacture of the product, specifically to mimic and / or suggest one or more production program steps only.

[0314] As previously mentioned, the production program may include a plurality of, particularly encrypted, production program packets, each of which contains at least one piece of information that references other production program packets and / or contains instructions for storing and / or processing an extract, and specifically, a defined sequence of the plurality of production program packets forms a production program for producing a product producible by the production equipment.

[0315] In this case, the production program may specifically include one or more, specifically encrypted, dummy production program packets, each dummy production program packet including at least one piece of information that references the production program packet or other dummy production program packets and / or includes dummy instructions for imitating and / or suggesting the storage and / or processing of the extract.

[0316] For example, a dummy production program packet, specifically a dummy instruction, may have no content, specifically in production terms.

[0317] The production facility may have at least one random module, which may be executable by one or more computing units of the process unit, by one or at least one control unit of the production facility, and / or by a computer system assigned or assignable to the production facility, and by the random module, one or more dummy production program packets may be randomly incorporated into the production program, in particular, one or more dummy instructions may be randomly assigned to each dummy production program packet by the at least one random module.

[0318] The process unit is configured and programmed to execute, in particular decode and then execute, any instructions, in particular real and / or dummy instructions for containing and / or processing the extract, based on the production program.

[0319] In particular, the process unit may be configured and programmed to contain and / or process a dummy extract to mimic and / or suggest the containing and / or processing of an actual extract while using the dummy extract.

[0320] For example, the dummy extract may be an empty container that is not visible from the outside and is designated for the actual extract, and / or may contain materials similar to the actual extract.

[0321] Additionally or alternatively, the production facility may have one or more concealment chambers for housing one or more process units, the interior of each concealment chamber being optically isolated and / or at least sufficiently invisible from the exterior of the concealment chamber, and in particular at least one process unit may be prompted to be housed inside a corresponding concealment chamber by at least part of a production program for mimicking and / or suggesting the production of a product.

[0322] For example, the concealment chamber may be substantially or completely invisible to anyone standing outside the production facility, particularly the clean room area.

[0323] For example, optical isolation can relate to wavelength ranges that are visually perceptible to humans and / or wavelength ranges that are not visually perceptible to humans, such as the infrared range.

[0324] The storage location of the storage device can be configured as a hidden chamber. Additionally or alternatively, the hidden chamber can be arranged in the clean room area as a separate device.

[0325] At least one concealed chamber has one or more exchange units by which objects contained in and / or by the process units, in particular the patient box and / or the tool box, can be exchanged between the corresponding process units located inside the concealed chamber.

[0326] Additionally or alternatively, at least one concealment chamber may have one or more storage locations on which one or more process units can be accommodated at random times.

[0327] At least one concealed chamber may be configured solely to mimic and / or suggest processing of an extract, or alternatively, at least one concealed chamber may be configured to (actually) process an extract and / or to mimic and / or suggest processing of an extract.

[0328] At least one concealment chamber may have one or more sensor units for monitoring optical separation of the interior from the exterior of the concealment chamber, in particular, a brightness value inside the concealment chamber can be detected by at least one sensor unit of the concealment chamber.

[0329] At least one dummy production program packet may include one or more dummy instructions that prompt placing one or more process units in one of the concealed chambers.

[0330] In other words, the process unit may be capable of being housed or instructed to be housed in one of the concealed chambers by at least one dummy production program packet.

[0331] At least one dummy production program packet may include one or more dummy instructions that prompt objects contained in and / or by the process units, specifically the patient box and / or tool box, to be transposed between corresponding process units located within the concealment chamber.

[0332] Additionally or alternatively, the production facility may have one or at least one control unit as described above, the control unit being configured and programmed to at least partially store and operate a database and / or exchange information with the database, the database being at least partially stored and / or operated on a computer system assigned or assignable to the production facility, the database containing one or more, in particular unique, release information for allowing the storage and / or processing of the extract by one of the plurality of process units, the database being modifiable by retrieving at least one of the release information for one of the plurality of process units, such that such release information is subsequently no longer available for retrieval in its original form.

[0333] Specifically, unique release information may refer to information that is unique and / or has a unique identifier.

[0334] A production facility may have a computer system that is assigned or assignable to the production facility.

[0335] Additionally or alternatively, the computer system allocated or allocable to the production facility may be a release computer system, in particular a cloud-based release computer system and / or a release server.

[0336] The database may be configured and programmed to receive and store one or more new release information items solely outside the production facility, for example, one or more new release information items on the part of a database access authorizer, specifically a prescription rights holder represented by a production program, may be communicated to the database via a computer system, for example, via a cloud and / or server.

[0337] Additionally or alternatively, the database may be configured and programmed to be storable and / or operable on a computer system exclusively assigned or assignable to the production facility, or to be synchronized with a parallel database storable and / or operable on a computer system exclusively assigned or assignable to the production facility.

[0338] Each computing unit of each process unit may be configured and programmed to receive and store one or more pieces of release information, and each piece of release information received by the computing unit may be compared with each piece of release information already stored on the computing unit to avoid duplicate use of the received release information in the production facility.

[0339] In particular, each computing unit may be configured and programmed to at least partially or completely store and operate a distributed database, in particular an encrypted distributed ledger, advantageously in particular an encrypted distributed ledger, by which one or more receivable or received release information can be stored. The use of a distributed database in particular provides an anti-tampering technical solution to avoid double use of received release information in a production facility. The distributed database is explained in more detail below.

[0340] As previously mentioned, the production facility may be capable of producing one of a plurality of products according to one of a plurality of production programs, and the production program may include a plurality of production program packets, each of which may include at least one piece of information, the information including instructions for containing and / or processing the extract.

[0341] In this case, at least one of the release information may be uniquely assigned to each production program packet to allow such a production program packet to be executed specifically once by at least one process unit, thereby ensuring that the execution of the production program packet is not possible beyond the release limit or the number of release executions.

[0342] Specifically, each production program may be initialized and / or startable by the production equipment only to the extent that the overall production program packet of the production program and / or the overall release information assigned to the production program packet can or has been provided.

[0343] The one or more release information can be received and stored by at least one process unit, in particular its calculation unit, for delayed authorization and execution of the containment and / or processing of the extract, and / or the one or more release information can be received in real time by at least one process unit, in particular its calculation unit, for direct authorization and execution of the containment and / or processing of the extract.

[0344] Said authorization and / or execution of storing and / or processing the extract may specifically relate to authorization of execution of, and correspondingly actual execution of, instructions for storing and / or processing the extract in the production program packet.

[0345] The database may be or may have been encrypted, and / or each release information in the database may be or may have been encrypted.

[0346] For example, at least a portion of the database and / or at least one release information may be decryptable by at least one encryption key, which may be provided by and / or stored by and / or at the processing unit.

[0347] The encryption key for the release may be different from the encryption key for the production program packets.

[0348] Additionally or alternatively, such an encryption key may be a specifically private encryption key specifically for public key encryption.

[0349] As mentioned above, the production facility may be capable of producing one of a plurality of products according to one of a plurality of production programs, at least a portion of which may serve specifically and exclusively to simulate and / or suggest the production of the product, where such at least a portion of which may be enabled for execution by one or more release information.

[0350] In other words, each production program may be initialized and / or startable by the production equipment only to the extent that an overall production program packet, including a dummy production program packet of the production program, and / or overall release information assigned to the production program packet, including the dummy production program packet, is available or has been provided.

[0351] One or more release information items can be read from the database, in particular by one or more process units, and / or can be provided by the database as collective release information for authorizing the entire process for producing the product, which can simplify the release process, since each individual release information item on the part of the database access authorizer, in particular the right holder of the prescription represented by the production program, does not have to be released separately, in particular the entire production program can be released at once.

[0352] Additionally or alternatively, release information for each individual production program packet may be readable from the database individually, in particular by a process unit, and / or may be provided by the database, and / or multiple release information for allocable production program packets may be readable together from the database, in particular by one or more process units, and / or may be provided by the database.

[0353] The database may be configured and programmed to assign respective consent information to one or more, in particular to all, release information, which consent information can be stored in the database for each release information, in particular by a database access authorizer, and each release information can only be provided as long as the assigned consent information is stored.

[0354] Additionally or alternatively, the database may be configured and programmed to contain and provide information on various types of releases, in particular releases of a given type corresponding to a given type of process unit and / or part of a given type for manufacturing a product, in particular a production program packet, a production program.

[0355] For example, certain types of release information may relate only to patient boxes and / or only to tool boxes, or certain types of release information may relate to certain types of processing, such as temperature regulation and / or storage in a storage device.

[0356] Each release information may include an information stamp, specifically a mode information stamp, by means of which the respective release information can be assigned to a production mode of the production facility for manufacturing the product and / or a simulation mode of the production facility for simulating the operation of the production facility and / or specifically the manufacturing of the product.

[0357] In other words, depending on the information stamp of the release information, the production program packet may be executable by the process unit to actually contain and / or process the extract, or may be executable only for its simulation with respect to the process unit in question.

[0358] Additionally or alternatively, each release information may comprise an information stamp, in particular a numerical information stamp, by means of which the in particular maximum repeatability of the containment and / or processing of the extract permitted by the release information in question can be determined, which should be understood to include in particular the maximum repeatability of the operation of the production equipment and / or in particular the simulation of the production of the product.

[0359] At least one control unit may be connectable or configured and programmed to exchange data with a computer system assigned or assignable to the production facility, thereby determining the presence of such a data connection, such that the production facility and / or one or more, particularly all, process units can be reversibly transitioned to a normal state for unrestricted operation, a reserved state for temporally and / or functionally restricted operation, and / or a hibernation state for quiescent operation, depending on the data connection. For example, such a computer system may be configured as a heartbeat computer system, which will be described in more detail below. Specifically, the production facility may have such a computer system, specifically a heartbeat computer system, assigned or assignable to the production facility. Additionally or alternatively, such a computer system assigned or assignable to the production facility may be a cloud-based computer system and / or a server.

[0360] Each computing unit may be configured and programmed to at least partially or completely store and operate a particularly encrypted distributed database, advantageously a particularly encrypted distributed ledger, each distributed database being a redundant copy of each of the other distributed databases, each computing unit being configured and programmed to verify the operation of each distributed database on each of the other computing units and to realise a unique distributed database in response to the verification, each distributed database being configured and programmed to contain one or more, particularly unique, information relating to the receipt and / or processing of the extract by each process unit.

[0361] Specifically, unique release information may refer to information that is unique and / or has a unique identifier.

[0362] As mentioned above, each process unit, in particular the computing unit of each process unit, may have a security module, in particular a Trusted-Platform-Module, for providing one or more encryption keys.

[0363] Such an encryption key may be specifically a private encryption key, specifically for public key encryption.

[0364] Each distributed database may be or may be encrypted by an encryption key that may be assigned and / or provided specifically to only the process unit on which the distributed database may be or is stored, thereby ensuring that a distributed database may only be stored once on a process unit.

[0365] As mentioned above, the production facility may be capable of producing one of a plurality of products according to one of a plurality of production programs, and the production programs may include a plurality of production program packets, each of which may include at least one piece of information, the information including instructions for containing and / or processing an extract, the instructions being executable by at least one process unit, wherein each computing unit may be configured and programmed to store the execution of each of the production program packets in a distributed database, in particular in response to verification by the remaining computing units.

[0366] Each computing unit may be configured and programmed to execute a production program packet only to the extent that such production program packet is not stored in the distributed database as having already been executed.

[0367] In particular, each computing unit may be configured and programmed to receive one or more, in particular unique, release information for authorizing the storage and / or processing of the extract by one or at least one of the aforementioned control units of the production facility and / or by a computer system, in particular a release computer system, assigned or assignable to the production facility, and to store the one or more release information in a unique distributed database.

[0368] Optionally, each computing unit may be configured and programmed to compare each received release information with each release information already stored in the distributed database, particularly in response to verification by the remaining computing units, in order to avoid duplicate use of the received release information in the production facility.

[0369] Each release information may include an information stamp, in particular a number information stamp, which determines in particular the maximum repeatability of the containment and / or processing of the extract permitted by the corresponding release information, and the in particular information stamp, in particular the number information stamp, of each release information in the distributed database can be realized according to the permitted execution of the containment and / or processing of the extract.

[0370] As mentioned above, each production program packet may be uniquely assigned at least one of the release information in order to authorize such production program packet with at least one process unit.

[0371] In particular, each computing unit may be configured and programmed to execute the instructions of a production program packet only insofar as release information belonging to such a production program packet has been provided to the computing unit and in particular such production program packet and / or the release information is stored in the distributed database as not having been executed yet.

[0372] Additionally or alternatively, each computing unit may be configured and programmed to execute the instructions of a production program packet only to the extent that the maximum repeatability of execution of that production program packet based on the release information in the distributed database has not yet been reached.

[0373] In other words, the release information mechanism may grant authorization for the execution of a production program packet, which may be specifically stored in a distributed database, and specifically, at the time of each execution of a production program packet, it may be checked whether the number of previous executions is less than the authorized number of executions of the production program packet, and specifically, it may be stored in the distributed database that the production program packet has been executed, is being executed, or may be executed, so that the available number of executions can be reduced by 1 at the time of actual execution, thereby ensuring that the production program packet cannot be executed beyond the release limit.

[0374] The production facility may have and / or be connectable or connected to one or more further computer systems, each of the further computer systems being located differently in location relative to the rest of the production facility, each of the further computer systems having a respective distributed database stored and operated on it, and each of the further computer systems being configured and programmed to verify the operation of the respective distributed database on the other and / or each of the computing units and to implement a unique distributed database in response to the verification.

[0375] For example, such further computer systems may in particular be cloud-based computer systems and / or servers.

[0376] As mentioned above, the production facility may have one or at least one control unit as mentioned above, which is connectable or connected for data exchange with a computer system assigned or assignable to the production facility, in particular the heartbeat computer system as mentioned above, and is configured and programmed to thereby determine the existence of such a data connection.

[0377] Such computer systems, and specifically the Heartbeat Computer System, are described in further detail below.

[0378] In particular, such a computer system can serve to allow the production facility to operate without a data connection only for a certain period of time, i.e., the production facility can only produce if there is a connection to said computer system, in particular a heartbeat computer system, in addition to or instead of the requirement for release information as described above.

[0379] The production equipment, and / or one or more, in particular all, process units may be reversibly transferable, depending on the data connection, to a normal state for unrestricted operation, to a reserved state for temporally and / or functionally restricted operation, and / or to a rest state for stationary operation.

[0380] The pending state may in particular be a transition state between the normal state and the dormant state, through which the normal state transitions to the dormant state, in particular the transition from the dormant state to the normal state does not need to go through the pending state, and / or advantageously the transition from the dormant state to the normal state may be made directly.

[0381] In particular, one or more of the at least one control unit and / or computing units, in particular each, may be configured and programmed to determine the existence of a data connection with the computer system, in particular continuously or at regular time intervals.

[0382] Only when a data connection is present can the production facility for producing the product, in particular the process unit for containing and / or processing the extract, be operated in an unrestricted state, which may be in a normal state and / or be assigned to a normal state.

[0383] Additionally or alternatively, when there is no data connection, the production facility for producing the product, in particular the process unit for storing and / or processing the extract, may be able to be transferred to a reserved state, in which the production of the product, in particular the storing and / or processing of the extract, is limited in time and / or functionality.

[0384] One or more of the at least one control unit and / or computing units, in particular each, may be configured and programmed to store an information stamp, in particular a time stamp, upon transition to a reserved state, and to stop unrestricted operation of the production equipment and / or one or more, in particular all, process units after a predefined time from such information stamp, in particular the time stamp, and in particular to transition the production equipment and / or the process units in question to a resting state.

[0385] In particular, one or more of the at least one control unit and / or computing units, in particular each, may be configured and programmed to still execute a predefined part of the production program for producing the product when transitioning to the hold state. This can serve, for example, to ensure progress in the production or processing of the extract and / or to bridge possible short-term interruptions in the data connection. In particular, when the hold state transitions or moves back to the normal state and said predefined part of the production program has not yet been completely executed, the production program can continue normally.

[0386] Additionally or alternatively, one or more of the at least one control unit and / or computing units, in particular each, may be configured and programmed to amend and / or supplement with one or more production program packets a production program for producing a product to contain the extract and / or at least partially processed extract and / or product upon transition to a resting state, in particular as long as the resting state exists.

[0387] The storage may specifically take place in at least one of the storage locations of the storage device.

[0388] The modification and / or supplementation may for example comprise the purposeful temperature regulation, for example freezing, of the extract and / or at least partially processed extract and / or product, thereby ensuring the progress of the production or processing.

[0389] The computer system, in particular the heartbeat computer system, may be arranged spatially differently with respect to the rest of the production facility, in particular the computer system comprises a server, with which at least one control unit is connectable or connected for data exchange.

[0390] The production facility may be configured to operate in a subsequent step and / or in other words a method can be provided for partially controlling a production facility for producing a product, in particular a biological product, the production facility being configured as described above and / or below and the method comprising: - providing one or more process units for containing and / or processing the extract, - providing data connections of a computer system assigned or assignable to the production facility and / or to one or more, in particular all, of the process units; - determining by at least one control unit of the production facility and / or at least one computing unit of at least one process unit whether a data connection exists; and -Controlling production equipment and / or one or more, in particular all, process units according to a data connection This includes:

[0391] The control may include reversibly transitioning the production equipment and / or one or more, in particular all, process units, in particular based on the presence of a data connection, to a normal state for unrestricted operation, to a reserved state for temporally and / or functionally restricted operation, and / or to a rest state for stationary operation.

[0392] One or more of the at least one control unit and / or one or more of the calculation units, in particular each, may be configured to store an information stamp, in particular a time stamp, upon transition to the reserved state and, after a predefined time from such information stamp, in particular the time stamp, stop unrestricted operation of the production equipment and / or one or more, in particular all, process units and in particular transition the production equipment and / or the process units in question to a hibernation state.

[0393] One or more, in particular each, of the at least one control unit and / or computing unit may still be adapted to execute a predefined part of the production program for manufacturing the product upon transition to the reserved state.

[0394] One or more, in particular each, of the at least one control unit and / or computing units may be adapted to amend and / or supplement a production program for producing a product with one or more production program packets to accommodate the extract and / or the at least partially processed extract and / or product upon transition to the resting state, in particular as long as the resting state exists.

[0395] It is to be understood that all structural and / or functional features relating to the system according to the invention, i.e. the production installation according to the invention, and to the embodiments thereof described above and / or below, may also be included, alone or in combination, in the above, in particular in the above-described method, and that the associated properties, configurations and advantages may also be included and achieved accordingly.

[0396] The production facility may have a simulation device configured and programmed to simulate the operation of the production facility and / or specifically the production of a product based on at least one production program and to provide corresponding simulation results, the simulation device being partially or completely formed by one or more, specifically all, computing units of each process unit.

[0397] In particular, since the characteristics of the production facility, i.e., its facility-specific and / or tool-specific features, can play a major role in relation to the phasing and / or performance of the production facility, the simulation of the production facility can include a software-based and / or hardware-based simulation. In other words, the simulation cannot be performed purely on a software basis, for example, by means of a digital production facility twin, but can be performed at the production facility itself. This can in particular include the fact that each component of the production facility can be configured and programmed to participate in and / or perform part of the simulation.

[0398] For example, to avoid disclosing prescriptions or production program progress or other information to unauthorized persons through the simulation, the difference between the simulation mode and the production mode, or between the simulation and the actual execution of the production program, may be only with respect to the performance of actual physical movements, which are advantageously not performed during the simulation in this case. The previously mentioned processes regarding release, encryption / decryption, protected communications (see in particular below), etc., may be performed in the simulation.

[0399] For example, the simulation device may be configured and programmed to simulate parts of the associated production program that have not yet been executed during the production of a product and to provide corresponding simulation results. This may specifically mean that at least a part of the production facility, specifically one or more process units of the production facility, may be dynamically switchable back and forth between a production mode and a simulation mode, specifically depending on the simulation requirements. In other words, starting from a current state of the production facility, specifically a production state, further simulations may be performed based on the at least one production program, for example, to optimize subsequent production steps and / or processes and / or to determine which further and / or additional processes and / or production programs can be initiated.

[0400] The simulation device may be configured and programmed to detect equipment parameters of the production equipment during the production of a product, and / or detect storage process measurements and / or treatment process measurements of the process units, specifically, operation parameters of the process units, and store them as simulation information and save them for performing a simulation; specifically, a simulation of the operation of the production equipment and / or the production of the product based on such simulation information can be performed by the simulation device.

[0401] In other words, the simulation device process-specific parameters and / or measurements, e.g., the sequence of treatments or process steps, and / or - Equipment-specific parameters and / or measurements of, for example, process units and / or location parameters of the production equipment, such as external temperature, air humidity, air pressure, and / or - Patient-specific parameters and / or measurements, e.g., drug treatment history, and / or - tool-specific parameters and / or measurements, for example of a tool unit, in particular of a tool box, and / or -Detecting material-specific parameters and / or measurements, e.g., of consumable materials, and storing simulation information and saving it for performing the simulation. The device may be configured and programmed as follows:

[0402] As mentioned above, the production facility may have one or more sensor units, which are at least partially assigned to and / or form part of the process units, and the simulation device is configured and programmed to perform a simulation based on simulation information detectable or detected by such sensor units.

[0403] In particular, the sensor unit may be configured and / or formed as described in German Patent Application No. DE 10 2021 207 738.2, which is incorporated herein by reference.

[0404] In particular, the simulation information may include at least one of the following: time parameters and / or time measurements of the production equipment, in particular of the process units; climate parameters and / or climate measurements in and / or around the production equipment, in particular of the process units; and operational parameters and / or operational measurements of the production equipment, in particular of the process units.

[0405] For example, the time parameters and / or time measurements may include pumping time of a process unit formed as a pumping device, and / or transport time of a process unit, and / or sterilization time of a process unit formed as a sterilization device, and / or cleaning time of a process unit formed as a cleaning device, and / or waiting time inside a production facility, and / or unpacking / packing time of a process unit formed as an unpacking / packing device, and / or loading and / or unloading time of a process unit, and / or setup time of a process unit formed as a tool unit.

[0406] Additionally or alternatively, the time parameters and / or time measurements may comprise processing time values ​​of processing steps that can be performed by the process unit.

[0407] In particular, a plurality of, in particular the entire processing steps may include the processing time value, which indicates the time elapsed from the start of each processing step to its end, in particular: - the time required to provide at least one tool required for the respective process, in particular including one or more tool consumables; and / or - the time for supplying and / or placing and / or starting up at least one tool and / or tool box in the extract to be processed, in particular in the patient box in which the extract is located, and / or - the time for which the extract is allowed to act in order to achieve the desired treatment result, and / or - Time to remove at least one tool from the extract, specifically from the patient box Including, - Preferably o Cleaning of the process units involved, in particular the patient box and / or tool box, and / or o Removal and / or disposal of patient boxes and / or tool boxes, and / or o Return transport of the process units, in particular the patient box and / or tool box, to the point of departure, in particular the respectively assigned storage location Includes.

[0408] For example, the climate parameters and climate measurements may comprise temperature values ​​and / or air humidity values ​​and / or gas composition values.

[0409] For example, the operating parameters and / or operating measurements may comprise temperature parameters of a process unit configured as a temperature control device and / or a fill level of a storage device.

[0410] In particular, a part of a production program to be executed by an associated process unit for producing a product may be simulated by a computing unit forming a simulation device, in particular the production program may comprise a plurality of, in particular encrypted, production program packets, each production program packet comprising at least one piece of information, the information comprising instructions for storing and / or processing an extract, the instructions being executable by at least one process unit, and one or more production program packets forming the part of the production program to be simulated.

[0411] In other words, each process unit may be configured and programmed to simulate at least the portion of the production program that the process unit in question would have to execute and / or would execute to actually produce the product.

[0412] As mentioned above, the production program may include a plurality of, particularly encrypted, production program packets, and each production program packet may include at least one piece of information, the information including instructions for storing and / or processing an extract, the instructions being executable by at least one process unit, and wherein the simulation is executable based on one or more production program packets, particularly the one or more production program packets being configured and programmed to manufacture a product and to simulate the operation of a production facility and / or the manufacture of the product.

[0413] In other words, each process unit may be configured and programmed to simulate at least one production program packet that the process unit must and / or would execute to receive and / or process the extract during the actual production of the product.

[0414] The process unit is configured and programmed to store one or more encryption keys by which the production program packets of the production program can be respectively decrypted for simulation.

[0415] Such an encryption key may be specifically a private encryption key, specifically for public key encryption.

[0416] Specifically, the encryption key for the simulation may be the same encryption key that is uniquely assigned to the production program packets, or the key may be different and assignable to the simulation and the actual production, respectively.

[0417] Each production program packet may be releasable for execution by release information receivable by a process unit to simulate operation of a production facility and / or manufacturing of a product.

[0418] Specifically, each release information includes an information stamp, specifically a mode information stamp, by means of which the respective release information and / or the respective production program packet can be assigned to a production mode of a production facility for manufacturing a product and / or a simulation mode of a production facility for simulating the operation of the production facility and / or the manufacturing of the product.

[0419] Each process unit may be configured and programmed in a production mode of the production facility to manufacture the product and / or in a simulation mode of the production facility to simulate the operation of the production facility and / or the manufacture of the product.

[0420] The production mode and the simulation mode can be differentiated by the process unit, specifically on the basis of the information stamp, so that the process unit is in the corresponding operating state.

[0421] One or more process units may be configured and programmed to simultaneously simulate one or more production program packets for at least one process unit in a production mode, and specifically to generate simulation information in doing so.

[0422] For example, during the actual production of a product by one or more process units, any parameters and / or measurement values ​​detectable by one or more sensor units may be stored in the simulation device, in particular by the corresponding calculation units of the process units involved in the actual production of the product.

[0423] As mentioned above, each production program packet contains at least one piece of information that references other production program packets and / or contains instructions for storing and / or processing the extract, in particular a defined sequence of a plurality of production program packets can form a production program for producing a product that can be produced by a production facility, in which case each reference to other production program packets can contain an information stamp, in particular a mode information stamp, by means of which each other production program packet can be assigned to a production mode of the production facility for producing the product and / or a simulation mode of the production facility for simulating the operation of the production facility and / or the production of the product in particular.

[0424] The production facility may comprise one or at least one control unit as already mentioned, by means of which the utilization and / or occupancy, in particular the logistics, of the production facility can be provided based on the simulation results.

[0425] Additionally or alternatively, the production facility may have one or at least one control unit as described above, by means of which the time course of one or more production programs can be predicted based on the simulation results, and / or based on the simulation results, the process units required and / or intended for the execution of the processing steps and / or the consumable materials to be provided in the production facility can be allocated in time and / or space.

[0426] Specifically, by simulating the process over various run times, a statistically optimal entry point or start for producing new or additional products may be determined, and this can be done reliably and with great accuracy by hardware-like simulation of actual production.

[0427] As already mentioned above, the simulation may require at least partial or complete release by one or more release information. In essence, the release of the simulation may be performed similarly to the release of an actual product production. Simulation is described in more detail below.

[0428] As mentioned above, a production facility can have the simulation device mentioned above, in which case the production facility can include one or at least one control unit as mentioned above, which is configured and programmed to at least partially store and operate one or more of the databases as mentioned above and / or to exchange information with the databases, which databases are at least partially stored and / or run on a computer system assigned or assignable to the production facility, which databases can in particular additionally or alternatively contain one or more, in particular unique, release information for allowing the simulation of the storage and / or processing of an extract by one of the process units, and which databases can be modified by reading out at least one of the release information for the simulation by one of the process units, so that such release information is subsequently no longer available for reading in its original form.

[0429] Specifically, unique release information may refer to information that is unique and / or has a unique identifier.

[0430] A production facility may have a computer system that is assigned or assignable to the production facility.

[0431] Additionally or alternatively, the computer system allocated or allocable to the production facility may be a release computer system, in particular a cloud-based release computer system and / or a release server.

[0432] The database may be configured and programmed to receive and store one or more new release information for permitting simulations, exclusively outside the production facility, for example, one or more new release information on the part of a database access authorizer, specifically a prescription rights holder represented by a production program, may be communicated to the database via a computer system, for example, via a cloud and / or server.

[0433] The database may be configured and programmed to be storable and / or operable on a computer system exclusively assigned or assignable to the production facility and / or to be synchronized with a parallel database storable and / or operable on a computer system exclusively assigned or assignable to the production facility.

[0434] Each computing unit of each process unit may be configured and programmed to receive and store one or more pieces of release information, and each piece of release information received by the computing unit may be compared with each piece of release information already stored on the computing unit to avoid duplicate use of the received release information in the production facility.

[0435] In particular, each computing unit may be configured and programmed to at least partially or completely store and operate a distributed database, in particular an encrypted distributed ledger, advantageously in particular an encrypted distributed ledger, by which one or more receivable or received release information can be stored. The use of a distributed database in particular provides an anti-tampering technical solution to avoid double use of received release information in a production facility. The distributed database is explained in more detail below.

[0436] As previously mentioned, the production facility may be capable of producing one of a plurality of products according to one of a plurality of production programs, and the production program may include a plurality of production program packets, each of which may include at least one piece of information, the information including instructions for containing and / or processing the extract.

[0437] In this case, at least one of the release information may be uniquely assigned to each production program packet to allow such production program packet to be specifically simulated and / or specifically executed once by at least one process unit, thereby ensuring that the simulation of the production program packet is not possible beyond the release limit or number of release runs.

[0438] Specifically, the simulation may be initialized and / or started by the simulation device only to the extent that the overall production program packets of the production program and / or the overall release information assigned to the production program packets are available.

[0439] The one or more release information can be received and stored by at least one process unit to allow and execute a time-delayed simulation of receiving and / or processing the extract, and / or the one or more release information can be received in real time by at least one process unit to allow and execute a direct simulation of receiving and / or processing the extract.

[0440] The database may be or may have been encrypted, and / or each release information in the database may be or may have been encrypted.

[0441] For example, at least a portion of the database and / or at least one release information may be decryptable by at least one encryption key, which may be provided by and / or stored by and / or at the processing unit.

[0442] The encryption key for the release may be different from the encryption key for the production program packets.

[0443] Additionally or alternatively, such an encryption key may be a specifically private encryption key specifically for public key encryption.

[0444] As mentioned above, the production facility may be capable of producing one of a plurality of products according to one of a plurality of production programs, at least a portion of which may serve specifically and exclusively to simulate and / or suggest the production of the product, where such at least a portion of which may be enabled for simulation and / or execution by one or more release information.

[0445] In other words, the simulation may be initialized and / or startable by the simulation device only to the extent that an overall production program packet including a dummy production program packet of the production program and / or overall release information assigned to the production program packet including the dummy production program packet can be provided or has been provided.

[0446] One or more release information items can be read from the database, in particular by one or more process units, and / or provided by the database, as collective release information for permitting a simulation of the operation of the entire production facility and / or the entire process for producing a product, which simplifies the release process, since each individual release information item on the part of the database access authorizer, in particular the right holder of the prescription represented by the production program, does not have to be released separately, and in particular a complete simulation of the entire production program can be released at once.

[0447] Additionally or alternatively, release information for each individual production program packet may be readable from the database individually, in particular by a process unit, and / or may be provided by the database, and / or multiple release information for allocable production program packets may be readable together from the database, in particular by one or more process units, and / or may be provided by the database.

[0448] The database may be configured and programmed to assign respective consent information to one or more, in particular all, release information, and the consent information may be stored in the database for each release information, in particular by a database access authorizer, and each release information may be provided only as long as the assigned consent information is stored.

[0449] Additionally or alternatively, the database may be configured and programmed to contain and provide various types of release information, in particular where a given type of release corresponds to a given type of process unit and / or to a given type of portion of a production program for manufacturing a product, in particular a production program packet.

[0450] For example, certain types of release information may relate only to patient boxes and / or only to tool boxes, or certain types of release information may relate to certain types of processing, such as temperature regulation and / or storage in a storage device.

[0451] As mentioned above, each release information includes an information stamp, specifically a mode information stamp, by means of which each release information can be assigned to a production mode of a production facility for producing a product and / or a simulation mode of a production facility for simulating the operation of the production facility and / or the production of the product.

[0452] Additionally or alternatively, each release information may include an information stamp, in particular a numerical information stamp, by means of which it is possible to determine in particular the maximum repeatability of the simulation of the containment and / or processing of the extract permitted by the corresponding release information.

[0453] Furthermore, the production facility may be switchable to different states depending on the existence of a data connection with a computer system, such as a heartbeat computer system, that is assigned or assignable to the production facility, as described above, in which case the simulation may be enabled or disabled depending on the respective state.

[0454] As mentioned above, each process unit may have one or more sensor units, each of which may be configured to detect and provide at least one measurement value related to the storage and / or processing of the extract and / or related to the process unit itself to a computing unit for transmission in encrypted and abstracted form to one or more eligible recipient units.

[0455] This allows the measured values ​​and / or information to be made unidentifiable on the process unit side, so that information leakage to unauthorized persons, for example by tampering with the tapping, can be avoided.

[0456] In other words, at least one measurement value detectable by one or more sensor units may / can first be made indistinguishable before such measurement value can be communicated to one or more eligible receiving units.

[0457] The one or more eligible recipient units may include one or more other process units, and / or at least one higher level control unit of the production facility, and / or a computer system assigned or assignable to the production facility.

[0458] The information representing the at least one detectable measurement value may be modifiable by the sensor unit itself, and one or more eligible receiving units may be configured and programmed to interpret the modified information.

[0459] Additionally or alternatively, the information representing the at least one detectable measurement value may be modifiable by the computing unit, and one or more eligible receiving units may be configured and programmed to interpret the modified information.

[0460] Additionally or alternatively, the information may be modifiable in an encrypted and / or abstracted state, and the information may be decipherable and / or embodiable by one or more eligible recipient units.

[0461] In other words, the modifications may include encryption and / or abstraction.

[0462] As mentioned above, here too encryption may specifically relate to public key encryption.

[0463] Abstraction may involve, as a simple, non-limiting example, the omission of specific physical units: First, one or more eligible units can interpret the pure numerical value and / or reassign it to the correct specific physical unit.

[0464] Thus, the information depth or information content of the at least one measurement may be able to be preserved, in other words, there is no information loss.

[0465] Each computing unit may be configured and programmed to provide information only or exclusively as modified information for transmission to one or more eligible recipient units.

[0466] Additionally or alternatively, each computing unit may be configured and programmed to evaluate at least one detectable measurement value according to parameter ranges storable or stored within the computing unit, and subsequently provide only the results of the evaluation of the at least one detectable measurement value for transmission to one or more eligible receiving units.

[0467] For example, the at least one detectable measurement value may be evaluated by a calculation unit with a scalar value between 1 and 100, and only the determined scalar value may be provided to one or more eligible units. The scalar value may be assignable to an acceptable or good condition, and / or an unacceptable or bad condition, and / or some transitional condition.

[0468] The transmitted information may be configured to be stored in one or more eligible units, in particular for process optimization of the production facility, for example, such information may serve as and / or form simulation information.

[0469] Additionally or alternatively, the transmitted information may be configured to be stored in one or more eligible units according to different data categories.

[0470] Additionally or alternatively, the transmitted information may be provided with an information stamp, in particular a release stamp, and / or a timestamp and / or a location stamp, depending on the data category, in order to restrict access to such information.

[0471] Each computing unit has at least one communication module, in particular a Bluetooth® module, preferably a Bluetooth® low energy module, and / or a Wi-Fi module, and each computing unit is configured and programmed to form a network with each other computing unit for information transmission via the at least one communication module.

[0472] It should be understood that the communication module may be configured in other ways, for example, the communication module may be based on ZigBee technology, 6LoWPAN technology, LoRaWAN technology, NB-IoT technology, LTE technology, 5G technology, Wi-Fi technology, etc.

[0473] One or more of the computing units may be configured and programmed as a network node and / or hub to communicate information from the processing unit to one or more eligible recipient units via at least one communication module.

[0474] One or more of the computing units may be configured and programmed as a gateway to communicate information from the process unit to one or more eligible units by means of at least one communication module.

[0475] The production facility may have a zero-trust architecture and / or be operated and / or be capable of operating according to a zero-trust architecture. This may and / or can increase the production security of the products to be produced, particularly biologic products, such as cell culture products and / or cell therapy products. For example, it can eliminate the risk of external, e.g., malicious, intervention in the system or production facility resulting in the substitution of cell cultures and / or the leakage of personal data. In particular, it can minimize the attack surface and / or the effects of a cyber-attack on the production facility.

[0476] The processing unit, and in particular its computing unit, may be part of the zero-trust architecture and / or may be or be assigned to the zero-trust architecture.

[0477] The process units, and in particular the computing units thereof, may advantageously be configured and programmed to allow only authorized access persons to perform defined operations based on the production programs and / or production program packets. The authorizations of users and / or devices and / or units, e.g., process units, of the production facility may be restricted and / or limited to the minimum level required to perform their respective tasks within the production facility. This may advantageously prevent a potential attacker from exploiting, for example, over-privileged accounts and / or devices and / or process units, for example, for fraudulent operations.

[0478] The process units, and in particular the computing units thereof, may be configured and programmed to continuously and / or discontinuously monitor and / or test, for example during continuous operation, the respective identities and / or respective statuses of users and / or devices and / or units, e.g., process units, of the production facility, which may advantageously ensure that unauthorized and / or invasive actors are unable to gain and / or retain access to the production facility, in particular the network.

[0479] Additionally or alternatively, the at least one control unit and / or one or more of the separate control units of the production facility may be configured and programmed to continuously and / or discontinuously monitor and / or test, for example during continuous operation, the respective identities and / or respective statuses of users and / or devices and / or units, e.g., process units, of the production facility. This may advantageously ensure that unauthorized and / or invasive parties are unable to gain and / or retain access to the production facilities, and in particular the network.

[0480] A production facility, in particular a process unit, may be segmented into multiple network areas. In other words, the network may have multiple network areas. The network areas may be preferably partially or completely isolated from one another. For example, data traffic or information exchange between network areas may be strictly controlled, and / or a predetermined type of data traffic or information exchange may be predefined so that any deviations therefrom may be detectable. This may reduce the number of potential entry points for an attacker and / or ensure that the spread of threats within the network is limited.

[0481] Access to resources located within the production facility, such as process units and / or tools and / or consumable materials and / or computational output, may advantageously be based on strict authentication and / or authorization. Advantageously, each access attempt to said resources may be tested before this can be guaranteed. For example, this may be based on unique information, in particular fingerprint information, and / or production program packets, as already described herein. This may advantageously prevent potential attackers from accessing, for example, confidential and / or critical data, information, and / or systems, such as process units and / or tools.

[0482] Advantageously, a Zero Trust architecture can meet and / or satisfy high security, quality, and / or compliance requirements, particularly in biological product production environments that are considered highly regulated and / or sensitive. Applying a Zero Trust architecture can advantageously improve the security posture of, and / or reliably protect, business objectives related to, particularly in biological product production environments.

[0483] The following description relates specifically to extracts.

[0484] The extract may be located and / or contained within a container, particularly an extract container or vessel.

[0485] The extract container containing the extract may be packaged in a packaging material.

[0486] The extract container containing the extract may be introduceable into a locking device of the production facility, in particular into an entrance locking location of the locking device.

[0487] At least one control unit allocates extract containers containing extracts to process units, in particular patient boxes.

[0488] The packaging material of the extract container may be removable, in particular at an entrance locking location in the locking device and / or at a separate unpacking location, in particular by one or more unpacking units. Such a process may be included in the instructions of the production program packet.

[0489] Advantageously, the packaging material may be cleaned and / or sterilized before removal by a cleaning device of the locking device or a part of the cleaning device of the production facility assigned to the locking device, and such a procedure may be included in the instructions of the production program packet.

[0490] The extract container containing the extract may be movable within the locking device by the locking transport and / or handling device, optionally already within the patient box. Such a process may be included in the instructions of the production program packet.

[0491] By means of the handling device, the extract container containing the extract may be delivered to the patient box within or immediately adjacent to the locking device and / or to a workpiece support that may be or is located within the patient box, and such a process may be included in the instructions of the production program packet.

[0492] A containment box containing the extract container containing the extract may define an aseptic process unit.

[0493] The storage box containing the extract container containing the extract may be stored in or at a storage location of the storage device by a storage transport device of the storage device. Such a process may be included in the instructions of the production program packet.

[0494] Additionally or alternatively, such storage boxes may be provided by the storage and transport device specifically for one or more processing steps with one or more tool units, which steps may be included in the instructions of the production program packet.

[0495] The patient box and the tool box may be connectable / coupleable to each other or may be connected / coupled to each other for one or more process steps in the extract placed in the storage box, and one or more of the process steps may require one or more tool units and / or one or more consumable materials that may be specifically placed and / or contained in the tool box. Such processes may be included in the instructions of at least one production program packet. Specifically, each individual process step may be included in the instructions of at least one individual production program packet.

[0496] The process may enable the production of a product from the extract, specifically according to the sequence of a production program packet.

[0497] In effect, the extract container held within the patient box can now be called the product container.

[0498] The product containers containing the products arranged in the storage boxes can be moved by the storage transport device and / or the lock transport device and / or the handling device to an exit lock location of the lock device, specifically to a packaging location, and such a process can be included in the instructions of at least one production program packet.

[0499] The product container containing the product may be packable or packed at an exit locking location, particularly a packing location, particularly by one or more packing units, so that it can be subsequently withdrawn or removed from the locking device, and such a process may be included in the instructions of at least one production program packet.

[0500] It should be understood that for each of the aforementioned steps, the corresponding release information is processed by the involved process unit and a corresponding decoding is performed by the involved process unit.

[0501] Furthermore, it should be understood that the production facility is in a normal state, i.e. there is a data connection with a computer system that is assigned or can be assigned to the production facility.

[0502] The process unit configured as a patient box and / or as a tool box will once again be mentioned below.

[0503] One or more patient boxes and / or tool boxes may be accessible to the clean room area via a locking device.

[0504] One or more patient boxes and / or tool boxes may be cleanable and / or sterilizable within the locking device by a cleaning device of the locking device or a part of the cleaning device of the production facility assigned to the locking device.

[0505] One or more patient boxes and / or tool boxes may be stored in a storage location of the storage device by a storage transport device of the storage device, to which the corresponding boxes can be delivered by a locking transport device and / or handling device.

[0506] If necessary, one or more patient boxes and / or tool boxes may be delivered from a storage location to a prescribed appropriate use by a storage transport device, and optionally a handling device and / or a locking transport device.

[0507] For example, the patient box and / or tool box may be or can be equipped with one or more extractives and / or one or more tool units and / or one or more consumable materials, for example by a handling device, so that in particular the patient box and / or tool box can be or is stored in a storage device or can be supplied for one or more processing steps, in particular a plurality of patient boxes and / or tool boxes may be provided in this way.

[0508] One or more workpiece supports may be positionable within each patient box and / or tool box, for example by a handling device, by which the workpiece supports can be stored and / or provided.

[0509] Multiple patient boxes and / or tool boxes may be connectable / coupleable to one another to form a sterile process unit for performing one or more processing steps according to instructions in one or more production program packets.

[0510] for example, - a patient box containing an extract container containing the extract; - a tool box containing consumable materials for one or more process steps; - a tool box containing one or more tool units for one or more process steps; are connectable / coupleable to or connected / coupled with one another, in particular by storage, transport and / or handling devices, thereby forming a common sterile process unit, thereby enabling one or more processing steps to be subsequently carried out according to the instructions of one or more production program packets. It should be understood that objects may already be contained in the boxes in question according to the instructions of one or more production program packets.

[0511] After the processing step has been carried out, the boxes may again be dissociable / decoupleable from each other or may be dissociated / decoupled.

[0512] The patient boxes containing the manufactured products are transported by the storage and transport device to the locking device as previously described.

[0513] The tool box may be capable of being fed to a cleaning device in the production facility, by means of which the workpiece support can be cleaned and / or sterilized.

[0514] The cleaned and / or sterilized tool box may be placed back into the storage location of the storage device and is free to be used again.

[0515] In relation to the preceding description, the present invention makes it possible to achieve a fully automated overall system for manufacturing biological pharmaceutical products for industrial production of individual batch sizes, particularly individual and / or minimum batch sizes, particularly having modularly formed and / or autonomously operating components.

[0516] The present invention provides a fully automated overall system for manufacturing biological pharmaceutical products, which provides enhanced security with respect to tampering and / or industrial espionage.

[0517] In contrast to the rigidly linked individual process steps typically present in conventional manufacturing processes for comparable biologic products, the present invention provides an efficient system and method, in particular, by using an individual release process, whereby individual process steps can be releasable by the rights holder in a tailor-made manner.

[0518] The present invention provides a system, i.e., a production facility, and a method, using which an operator or user is no longer required in the direct process environment, thereby specifically increasing manufacturing efficiency and reducing the probability of manual errors. Furthermore, production optimization can be performed based on the simulation results, further increasing manufacturing efficiency.

[0519] Particularly advantageously, in the present invention, all required systems and / or devices for autonomous operation, and the associated equipment and / or consumable materials, can be provided within the production facility, and furthermore, all necessary information for autonomous operation can be stored and / or processed within the production facility, in particular by one or more control units, which can be formed by the computing units of the process units.

[0520] As the above description indicates, the present invention specifically relates to a production facility and method according to one of the following texts in which more specific embodiments of the present invention are described.

[0521] 1. A production facility for manufacturing a product, in particular a biological product, having a plurality of process units for containing and / or processing an extract, each process unit having at least one computational unit.

[0522] 2. The production facility according to sentence 1, characterized in that the production facility has at least one control unit, and the control unit is configured and programmed to allocate the extract to one or more process units based on one of a plurality of production programs for producing one of a plurality of products that can be produced by the production facility.

[0523] 3. A production facility as described in sentence 2, characterized in that the production program includes a plurality of, specifically encrypted, production program packets, each of which includes at least one piece of information, the information referencing other production program packets and / or including instructions for storing and / or processing the extract.

[0524] 4. A production facility as described in sentence 3, characterized in that the defined sequence of the plurality of production program packets forms a production program for producing a product that can be produced by the production facility, and specifically, the complete sequence can only be determined from all references related to other production program packets.

[0525] 5. A production installation according to sentence 3 or 4, characterized in that the process unit is configured and programmed to carry out, in particular to decode and then execute, the instructions of at least one production program packet.

[0526] 6. A production facility according to one of sentences 3 to 5, characterized in that one or more, in particular all, of the production program packets are provided to one process unit each and / or can be transmitted to one process unit each by at least one control unit and / or by a computer system assigned or assignable to the production facility.

[0527] 7. A production facility according to one of sentences 3 to 6, characterized in that the plurality of, in particular encrypted, production program packets include a start packet and one or more follow packets, each packet containing at least one piece of information, the information referencing the follow packet and / or including instructions for storing and / or processing the extract.

[0528] 8. A production installation according to sentence 7, characterized in that the extract can only be assigned to a process unit to which a start packet has been assigned and / or to which the start packet is associated and / or on which the start packet is stored, or to which a start packet can be provided after or together with the assignment of the extract.

[0529] 9. A production facility according to one of sentences 1 to 8, characterized in that the process unit is configured and programmed to store one or more encryption keys and to enable the decryption of each production program packet of the production program by means of the encryption keys.

[0530] 10. A production facility according to sentence 9, characterized in that an encryption key is stored by at least one of the process units, by means of which the production program packet can be decrypted and / or activated for the start of the production program.

[0531] 11. A production facility according to one of sentences 3 to 10, characterized in that one or more production program packets are decodable locally within the process unit by a computing unit of the process unit and / or one or more production program packets are decodable outside the process unit by at least one control unit and / or by a computer system assigned or assignable to the production facility.

[0532] 12. A production facility according to one of sentences 9 to 11, characterized in that one or more encryption keys can be allocated to the process units by at least one control unit and / or by a computer system that is assigned or can be assigned to the production facility, and / or one or more encryption keys are inseparably integrated in the process units.

[0533] 13. A production facility according to one of sentences 9 to 12, characterized in that the process unit has a security module, in particular a Trusted Platform Module, for providing one or more encryption keys, in particular the security module being capable of storing one or more encryption keys for decrypting individual production program packets of the production program.

[0534] 14. A production facility according to one of sentences 9 to 13, characterized in that the process unit is configured and programmed to receive release information for the use and / or provision of one or more encryption keys, and / or the one or more encryption keys can only be used and / or provided by the process unit in a time-limited manner.

[0535] 15. A production installation according to one of sentences 2 to 14, characterized in that an extract can be assigned to a process unit and / or processing of the extract can be carried out by a process unit only if unambiguous information relating to the process unit, which can be provided by the process unit itself, coincides with further unambiguous information relating to the process unit, which can be detected by at least one control unit.

[0536] 16. A production facility according to one of sentences 1 to 15, characterized in that the plurality of process units comprise one or more patient boxes for storing and / or transporting the extract, and / or one or more tool boxes for processing the extract, and / or one or more tool units for processing the extract, and / or one or more sensor units for analyzing the extract.

[0537] 17. A production facility according to one of sentences 2 to 16, characterized in that at least one process unit is configured to feed extract into the production facility and / or withdraw extract, at least partially processed extract and / or product from the production facility, in particular such process unit is configured and programmed to execute the start of a production program, in particular a start packet.

[0538] 18. A production facility according to one of sentences 1 to 17, characterized in that the production facility has at least one control unit, in particular at least one control unit, which is configured and programmed to determine the completeness of each process unit before an extract can be received and / or processed by the process unit according to one of a plurality of production programs for producing one of a plurality of products producible by the production facility.

[0539] 19. A production installation according to sentence 18, characterized in that the calculation unit of the process unit may be configured and programmed to provide unambiguous information relating to the process unit, and further unambiguous information relating to the process unit may be detected by at least one control unit, and the integrity of such a process unit may be determined by the at least one control unit based on a comparison of both such unambiguous information, and in particular may be settable and / or confirmed when both such unambiguous information coincide.

[0540] 20. A production facility according to sentences 18 or 19, characterized in that the process unit has a security module, in particular a trusted platform module, for providing unambiguous information about the process unit, in particular fingerprint information, and the computing unit of the process unit is configured and programmed to provide unambiguous information of at least one control unit for determining its integrity.

[0541] 21. A production installation according to one of sentences 18 to 20, characterized in that the production installation can have one or more sensor units by means of which the process units can be detected, in particular visually, and based on such detection, unambiguous information can be provided by at least one control unit about each process unit for determining its integrity.

[0542] 22. A production installation according to sentence 21, characterized in that the one or more sensor units may include one or more camera units, by means of which characteristic landmarks of the faces, in particular surfaces, and / or geometry of the process units can be visually detected.

[0543] 23. A production installation according to sentences 21 or 22, characterized in that the production installation has one or more actuator units, by which one or more process units can be excited, in particular mechanically, in order to generate mechanical vibrations, the vibrations being detectable by one or more sensor units, and based on the vibrations, unambiguous information about each process unit can be provided by at least one control unit for determining its integrity.

[0544] 24. A production facility according to sentence 23, characterized in that at least one of the one or more actuator units is configured to generate mechanical vibrations, and such actuator unit may be located on or in one of the one or more process units and / or be engageable with one of the one or more process units so as to generate mechanical vibrations in the process unit in question.

[0545] 25. A production facility according to sentence 23 or 24, characterized in that the vibrations can include a frequency range of 10 Hz or more and 100 Hz or less, and / or the vibrations include one or more specifically various frequency ranges, each of which may be 10 Hz or more and 100 Hz or less, and / or the vibrations include one or more specifically various frequency ranges, which may be successive to one another in a predetermined order.

[0546] 26. A production installation according to one of sentences 23 to 25, characterized in that at least one of the one or more actuator units may be configured to generate acoustic vibrations, in particular sound waves, and such actuator unit is arranged in one of the one or more process units and / or is capable of engaging with one of the one or more process units so as to generate mechanical vibrations, in particular sound waves, for the process unit in question.

[0547] 27. A production facility according to sentence 26, characterized in that the vibrations include a frequency range of 30 Hz or more and 10,000 Hz or less, and / or the vibrations include one or more, specifically various frequency ranges, each of which is 30 Hz or more and 10,000 Hz or less, and / or the vibrations include one or more, specifically various frequency ranges, which may be successive to one another in a predetermined order.

[0548] 28. A production installation according to one of sentences 18 to 27, characterized in that one or more, in particular all, process units have at least one accommodation chamber, in particular surrounded by sides, for accommodating one or more objects, in particular an extract and / or one or more objects for processing the extract, and the integrity comprises internal integrity with respect to the accommodation chamber and / or external integrity with respect to the outside with respect to said accommodation chamber.

[0549] 29. A production installation according to one of sentences 18 to 28, characterized in that the process units are configured and programmed to execute, in particular to decode and then execute, instructions according to at least one production program, insofar as its integrity has been set and / or verified.

[0550] 30. A production facility according to sentence 29, characterized in that the production program comprises a plurality of, in particular encrypted, production program packets, each of which contains at least one piece of information that references other production program packets and / or contains instructions for storing and / or processing extracts, and (a) one or more, in particular all, of the production program packets are provided on one process unit each and are executable, in particular decryptable and executable, only insofar as the integrity of the process unit in question has been set and / or verified, and / or (b) one or more, in particular all, of the production program packets are communicable to one process unit each, in particular by at least one control unit and / or by a computer system assigned or assignable to the production facility, only insofar as the integrity of the process unit in question has been set and / or verified.

[0551] 31. A production installation according to one of sentences 18 to 30, characterized in that the process units are configured and programmed to block the execution and / or decoding of instructions according to at least one production program unless their integrity is configurable and / or verifiable.

[0552] 32. A production facility according to one of sentences 18 to 31, characterized in that the process unit is configured and programmed to provide a message, in particular a warning message, insofar as its integrity is not configurable and / or verifiable, in particular to at least one control unit and / or at least one computer system assigned or assignable to the production facility.

[0553] 33. A production facility according to one of sentences 1 to 32, characterized in that the at least one calculation unit is specifically configured and programmed to determine the completeness of each process unit before an extract can be received and / or processed by such process unit according to one of a plurality of production programs for producing one of a plurality of products producible by the production facility.

[0554] 34. A production installation according to sentence 33, characterized in that the calculation unit of the process unit is configured and programmed to store and / or provide unambiguous information about such process unit and to detect further unambiguous information about such process unit, and the integrity of such process unit can be determined by the calculation unit based on a comparison of both such unambiguous information and is specifically settable and / or confirmed when said both unambiguous information match.

[0555] 35. A production facility as described in sentence 34, characterized in that the unique information includes a starting state of the process unit in question and a starting timestamp assignable to the starting state, and the further unique information includes a further state of the process unit in question and a further timestamp assignable to the further state, the further timestamp being different from the starting timestamp.

[0556] 36. A production installation according to one of sentences 33 to 35, characterized in that one or more, in particular all, process units have at least one accommodation chamber, in particular surrounded by sides, for accommodating one or more objects, in particular an extract and / or one or more objects for processing the extract, and the integrity comprises internal integrity with respect to the accommodation chamber and / or external integrity with respect to the outside with respect to said accommodation chamber.

[0557] 37. A production installation according to one of sentences 33 to 36, characterized in that the process unit has one or more sensor units by means of which unambiguous information and / or further unambiguous information about the process unit in question can be detected in order to determine its integrity, in particular its internal integrity.

[0558] 38. A production installation according to sentence 37, characterized in that by means of at least one sensor unit brightness values ​​in and / or of the process unit in question can be detected, and unambiguous information and / or further unambiguous information about the process unit in question can be provided for determining its integrity, in particular its internal integrity, based on the detectable brightness values.

[0559] 39. A production installation according to sentences 37 or 38, characterized in that the process unit has one or more actuator units by means of which the process unit in question can be excited, in particular mechanically, in order to generate mechanical vibrations, the vibrations being detectable by one or more sensor units, and based on the vibrations unambiguous information about the process unit in question and / or further unambiguous information can be provided for determining its integrity.

[0560] 40. A production facility according to sentence 39, characterized in that the vibrations can include a frequency range of 10 Hz or more and 100 Hz or less, and / or the vibrations include one or more, specifically various frequency ranges, each of which is 10 Hz or more and 100 Hz or less, and / or the vibrations include one or more, specifically various frequency ranges, which may be successive to one another in a predetermined order, and in particular that at least one of the one or more actuators is formed as a vibration motor, which is fixed in and / or to the process unit in question to generate mechanical vibrations.

[0561] 41. A production installation according to sentences 39 or 40, characterized in that at least one of the one or more actuator units is configured to generate acoustic vibrations, in particular sound waves, and is fixed within and / or to the process unit in question in order to generate mechanical vibrations, in particular sound waves, for the process unit in question, in particular the vibrations can include a frequency range of 30 Hz or more and / or the vibrations include one or more, in particular various frequency ranges, each of 30 Hz or more and / or various frequency ranges, which can be successive to one another in a predetermined order.

[0562] 42. A production installation according to one of sentences 37 to 41, characterized in that the process unit has one or more electrically conductive conductor elements, which are arranged at and / or within the process unit and / or inside the side walls of the process unit and in particular form an independent current circuit, and by means of one or more sensor units it is possible to detect whether the current circuit has been altered relative to its original state and / or whether it has been interrupted, and based on the detection of the current circuit, unambiguous information about the process unit in question and / or further unambiguous information can be provided for determining its integrity.

[0563] 43. A production installation according to one of sentences 37 to 42, characterized in that at least one sensor unit is formed as an inertial measurement unit, by means of which at least one acceleration value, in particular an acceleration vector, and / or at least one rotational speed value, in particular a rotational speed vector, related to the process unit in question can be detected, and unambiguous information and / or further unambiguous information related to the process unit in question can be provided for determining its integrity based on the detectable acceleration values ​​and / or rotational speed values.

[0564] 44. A production installation according to sentence 43, characterized in that the production installation has handling devices for moving objects inside the production installation and / or one or more actuator units by means of which the process unit in question can be mechanically excited to generate a specifically defined movement, which movement can be detected by the inertial measurement unit and, based on said movement, can provide unambiguous information about the process unit in question and / or further unambiguous information for determining its integrity.

[0565] 45. A production installation according to one of sentences 37 to 44, characterized in that by means of at least one sensor unit, temperature values ​​in and / or of the process unit in question can be detected and unambiguous information and / or further unambiguous information about the process unit in question can be provided for determining its integrity based on the detectable temperature values.

[0566] 46. ​​A production installation according to one of sentences 37 to 44, characterized in that by means of at least one sensor unit the process unit in question is at least partially visually detectable and unambiguous information and / or further unambiguous information about the process unit in question can be provided for determining its completeness based on visual detection, in particular in that at least one sensor unit includes a camera unit by means of which characteristic landmarks and / or geometry of the process unit in question are visually detectable.

[0567] 47. A production facility according to one of sentences 33 to 46, characterized in that the production facility has at least one control unit, which is configured and programmed in particular to determine the completeness of each process unit before an extract can be received and / or processed by the process unit according to one of a plurality of production programs for producing one of a plurality of products producible by the production facility, in particular a calculation unit of the process unit being further configured and programmed to provide univocal information about the process unit, and further univocal information about the process unit can be detected by the at least one control unit, and the completeness of such process unit can be determined by the at least one calculation unit based on a comparison of both such univocal information, in particular settable and / or confirmed when both such univocal information match.

[0568] 48. A production facility according to one of sentences 1 to 47, characterized in that the extract can be accommodated and / or processed by the process unit according to one of a plurality of production programs for producing one of a plurality of products producible by the production facility, and at least part of the production program serves in particular exclusively to imitate and / or suggest one or more production program steps, in particular one or more production program steps for the production of the product.

[0569] 49. A production facility according to sentence 48, characterized in that the production program comprises a plurality of, in particular encrypted, production program packets, each production program packet comprising at least one piece of information, the information referencing other production program packets and / or comprising instructions for containing and / or processing an extract, in particular a defined sequence of the plurality of production program packets forming a production program for producing a product producible by the production facility.

[0570] 50. A production facility according to sentence 48 or 49, characterized in that the production program includes one or more, in particular encrypted, dummy production program packets, each dummy production program packet including at least one piece of information, which information references a production program packet or another dummy production program packet and / or includes dummy instructions for imitating and / or suggesting the storage and / or processing of the extract.

[0571] 51. A production facility according to sentence 50, characterized in that the production facility has at least one random module, which may be executable by one or more calculation units of the process units, by at least one control unit of the production facility, and / or by a computer system assigned or assignable to the production facility, and in that the random module allows one or more dummy production program packets to be randomly incorporated into the production program, in particular one or more dummy instructions to be randomly assigned to each dummy production program packet by the at least one random module.

[0572] 52. A production installation according to one of sentences 48 to 51, characterized in that the process unit is configured and programmed to carry out, in particular to decode and then execute, any instructions based on the production program.

[0573] 53. A production installation according to one of sentences 48 to 52, characterized in that the process unit is configured and programmed to contain and / or process a dummy extract in order to mimic and / or suggest the containment and / or processing of a real extract while using the dummy extract.

[0574] 54. A production facility according to one of sentences 48 to 53, characterised in that the production facility may have one or more concealment chambers for housing one or more process units, the interior of each concealment chamber being optically isolated from the exterior of the concealment chamber and / or at least sufficiently invisible, in particular at least one process unit being induced to be housed inside the respective concealment chamber by at least part of a production program for imitating and / or suggesting the production of a product.

[0575] 55. A production installation according to sentence 54, characterized in that at least one concealment chamber has one or more exchange units by means of which process units, in particular patient boxes and / or objects contained in and / or by these process units, can be exchanged between the corresponding process units located inside the concealment chamber.

[0576] 56. A production facility according to sentence 54 or 55, characterized in that at least one concealment chamber has one or more storage locations, on which one or more process units can be accommodated at random times.

[0577] 57. A production installation according to one of sentences 54 to 56, characterized in that at least one concealment chamber is formed so as to imitate and / or suggest exclusively the processing of extracts.

[0578] 58. A production installation according to one of sentences 54 to 57, characterized in that at least one concealment chamber may have one or more sensor units for monitoring the optical separation of the interior from the exterior of the concealment chamber, in particular, by means of at least one sensor unit of the concealment chamber, a brightness value inside the concealment chamber can be detected.

[0579] 59. A production facility according to one of sentences 54 to 58 in combination with sentence 50, wherein at least one dummy production program packet may include one or more dummy instructions, the dummy instructions prompting the placement of one or more process units in one of the concealed chambers.

[0580] 60. A production facility as described in sentence 59, characterized in that at least one dummy production program packet may include one or more dummy instructions, the dummy instructions prompting the displacement of objects contained in and / or by the process units between corresponding process units located within the concealment chamber.

[0581] 61. A production facility according to one of sentences 1 to 60, characterized in that the production facility has at least one control unit, which is configured and programmed to at least partially store and operate a database and / or exchange information with the database, the database being at least partially stored and / or operated on a computer system assigned or assignable to the production facility, the database containing one or more, in particular unique, release information for allowing the receiving and / or processing of an extract by one of the plurality of process units, and the database is modifiable by reading out at least one of the release information for one of the plurality of process units, so that such release information is subsequently no longer available for reading out in its original form.

[0582] 62. A production facility according to sentence 61, characterized in that the database is configured and programmed to receive and store one or more pieces of new release information exclusively outside the production facility.

[0583] 63. A production facility according to sentence 61 or 62, characterized in that the database is configured and programmed so as to be storable and / or operable on a computer system exclusively assigned or assignable to the production facility, or so as to be synchronizable with a parallel database storable and / or operable on a computer system exclusively assigned or assignable to the production facility.

[0584] 64. A production facility according to one of sentences 61 to 63, characterized in that each computing unit of each process unit is configured and programmed to receive and store one or more pieces of release information, and each piece of release information received by the computing unit can be compared with each piece of release information already stored on the computing unit in order to avoid double use of the received release information in the production facility, and in particular each computing unit may be configured and programmed to at least partially or completely store and operate a particularly encrypted distributed database, advantageously a particularly encrypted distributed ledger, whereby one or more pieces of receivable or received release information can be stored.

[0585] 65. A production facility according to one of sentences 61 to 64, characterized in that by the production facility one of a plurality of products can be manufactured according to one of a plurality of production programs, the production programs can include a plurality of production program packets, each production program packet can include at least one piece of information, the information including instructions for containing and / or processing an extract, and in that at least one piece of release information can be uniquely assigned to each production program packet to allow such production program packet to be executed specifically once by at least one process unit, and in particular each production program can be initialized and / or started by the production facility only insofar as the overall production program packet of the production program and / or the overall release information assigned to the production program packet is or is available.

[0586] 66. A production facility according to one of sentences 61 to 65, characterized in that one or more release information can be received and stored by at least one process unit for time-delayed authorization and execution of the containment and / or processing of the extract, and / or one or more release information can be received in real time by at least one process unit for direct authorization and execution of the containment and / or processing of the extract.

[0587] 67. A production facility according to one of sentences 61 to 66, characterized in that the database can be or has been encrypted, and / or each release information in the database can be or has been encrypted.

[0588] 68. A production facility according to one of sentences 61 to 67, characterized in that by means of the production facility one of a plurality of products may be produced according to one of a plurality of production programs, at least a part of the production program serves specifically, in particular exclusively, to imitate and / or suggest the production of the product, and that such at least a part of the production program is authorizable for execution by one or more release information.

[0589] 69. A production facility according to one of sentences 61 to 68, characterized in that one or more release information items can be read from a database, in particular by one or more process units, and / or can be provided by the database, as collective release information (Buendelfreigabeinformation) for authorizing the entire process for producing the product.

[0590] 70. A production installation according to one of statements 61 to 64 or 66 to 69 in combination with statement 65, characterized in that release information for each individual production program packet can be read individually from the database, in particular by a process unit, and / or can be provided by the database, and / or release information for multiple allocable production program packets can be read together from the database, in particular by one or more process units, and / or can be provided by the database.

[0591] 71. A production facility according to one of sentences 61 to 70, characterized in that the database may be configured and programmed to assign respective consent information to one or more, in particular to all, release information, the consent information being storable in the database for each release information, in particular by a database access authorizer, and each release information being available only insofar as the assigned consent information is stored.

[0592] 72. A production facility according to one of sentences 61 to 71, characterized in that the database is configured and programmed to contain and provide various types of release information, in particular that a given type of release corresponds to a given type of process unit and / or to a given type of part of a production program for manufacturing a product, in particular a production program packet.

[0593] 73. A production facility 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 mode information stamp each release information can be assigned to a production mode of the production facility for producing a product and / or to a simulation mode of the production facility for simulating the operation of the production facility and / or in particular the production of a product.

[0594] 74. A production facility according to sentence 72 or 73, characterized in that each release information may comprise an information stamp, in particular a numerical information stamp, by means of which it is possible to determine in particular the maximum repeatability of the containment and / or processing of the extract permitted by the corresponding release information.

[0595] 75. A production installation according to one of sentences 61 to 74, characterized in that at least one control unit is connectable or connected for data exchange with a computer system assigned or assignable to the production installation, and is configured and programmed to thereby determine the existence of such a data connection, and that the production installation and / or one or more, in particular all, process units are reversibly transferable, depending on the data connection, to a normal state for unrestricted operation, to a reserved state for temporally and / or functionally restricted operation and / or to a rest state for stationary operation.

[0596] 76. A production facility according to one of sentences 1 to 75, characterized in that each computing unit is configured and programmed to at least partially or completely store and operate a distributed database, preferably an encrypted distributed ledger, each distributed database being a redundant copy of each of the other distributed databases, each computing unit is configured and programmed to verify the operation of each distributed database in each of the other computing units and to realize a unique distributed database in response to the verification, and each distributed database is configured and programmed to contain one or more, particularly unique, information regarding the storage and / or processing of extracts by each process unit.

[0597] 77. A production facility 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 encryption keys.

[0598] 78. A production facility according to sentence 76 or 77, characterized in that each distributed database can be encrypted or may be encrypted by an encryption key, and the encryption key can be assigned and / or provided specifically only to the process unit in which the distributed database can be stored or is stored.

[0599] 79. A production facility according to one of sentences 76 to 78, characterized in that by the production facility one of a plurality of products can be produced according to one of a plurality of production programs, the production programs include a plurality of production program packets, each production program packet including at least one piece of information, the information including instructions for containing and / or processing an extract, the instructions being executable by at least one process unit.

[0600] 80. A production facility according to sentence 79, characterized in that each computing unit is configured and programmed to store the execution of each of the production program packets in a distributed database, specifically in response to verification by the remaining computing units.

[0601] 81. A production facility according to sentence 79 or 80, characterized in that each computing unit is configured and programmed to execute a production program packet only to the extent that such production program packet is not stored in the distributed database as having already been executed.

[0602] 82. A production facility according to one of sentences 76 to 81, characterized in that each calculation unit is configured and programmed to receive one or more, in particular unique, release information for allowing the storage and / or processing of the extract by at least one control unit of the production facility and / or a computer system assigned or assignable to the production facility, and to store the one or more release information in a unique distributed database.

[0603] 83. A production facility according to sentence 82, characterized in that each calculation unit is configured and programmed to compare each received release information with each release information already stored in the distributed database, specifically in response to verification by the remaining calculation units, in order to avoid double use of the received release information in the production facility.

[0604] 84. A production facility according to sentence 82 or 83, characterized in that each release information comprises an information stamp, in particular a numerical information stamp, by means of which the maximum repeatability, in particular of the containment and / or processing of the extract permitted by the corresponding release information, can be determined, and the information stamp, in particular the numerical information stamp, of each release information in the distributed database can be realized depending on the permitted execution of the containment and / or processing of the extract.

[0605] 85. A production facility according to one of statements 79 to 81 in combination with one of statements 82 to 84, characterized in that at least one of the release information can be uniquely assigned to each production program packet in order to authorize such a production program packet by at least one process unit.

[0606] 86. A production installation according to sentence 85, characterized in that each computing unit is configured and programmed to execute the instructions of a production program packet only insofar as release information belonging to such a production program packet has been provided to the computing unit and, in particular, such a production program packet and / or such release information has been stored in a distributed database as not having been executed yet.

[0607] 87. A production facility according to sentence 85 or 86, characterized in that each computing unit is configured and programmed to execute the instructions of a production program packet only to the extent that the maximum repeatability of the execution of said production program packet based on release information in the distributed database has not yet been reached.

[0608] 88. A production facility according to one of sentences 76 to 87, characterized in that the production facility has one or more further computer systems and / or is connectable or connected to such, each of the further computer systems being arranged in a different location relative to the rest of the production facility, in each of the further computer systems a respective distributed database being stored and operated, and each of the further computer systems being configured and programmed to verify the operation of the respective distributed database in the other computing units and / or in each of the computing units and to implement a unique distributed database in response to the verification.

[0609] 89. A production facility according to one of sentences 1 to 88, characterized in that the production facility has at least one control unit, which is connectable or connected for data exchange with a computer system assigned or assignable to the production facility, and is thereby configured and programmed to determine the existence of such a data connection.

[0610] 90. A production installation according to sentence 89, characterized in that the production installation and / or 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 reserved state for temporally and / or functionally restricted operation and / or into a rest state for stationary operation.

[0611] 91. A production installation according to sentence 89 or 90, characterized in that one or more of the at least one control unit and / or calculation units, in particular each, is configured and programmed to determine the presence of a data connection with a computer system, in particular continuously or at regular time intervals.

[0612] 92. A production installation according to one of sentences 89 to 91, characterized in that the production installation for producing a product, in particular the process unit for containing and / or processing an extract, can be operated in an unrestricted manner only when a data connection is present.

[0613] 93. A production installation according to one of sentences 89 to 92, characterized in that when there is no data connection, the production installation for producing a product, in particular the process unit for receiving and / or processing an extract, can be transferred to a reserved state, in which the production of the product, in particular the receiving and / or processing of the extract, is limited in time and / or functionality.

[0614] 94. A production installation according to one of sentences 90 to 93, characterized in that one or more of the at least one control unit and / or one or more of the calculation units, in particular each, are configured and programmed to store an information stamp, in particular a time stamp, when transitioning to a reserved state, and to stop the unrestricted operation of the production installation and / or one or more, in particular all, process units after a predefined time from such information stamp, in particular the time stamp, and to transition the production installation and / or the process unit in question to a resting state.

[0615] 95. A production installation according to one of sentences 90 to 94, characterized in that one or more of the at least one control unit and / or calculation units, in particular each, is configured and programmed to still execute a predefined part of the production program for manufacturing the product when transitioning to the reserve state.

[0616] 96. A production installation according to one of sentences 90 to 95, characterized in that at least one control unit and / or one or more of the calculation units, in particular each, are configured and programmed to amend and / or supplement with one or more production program packets a production program for producing a product, in order to accommodate the extract and / or at least partially processed extract and / or product, upon transition to a resting state, in particular as long as the resting state exists.

[0617] 97. A production facility according to one of sentences 89 to 96, characterized in that the production facility has a computer system, which may be arranged spatially differently with respect to the rest of the production facility, in particular the computer system comprises a server, with which at least one control unit is connectable or connected for data exchange.

[0618] 98. A production facility according to one of sentences 1 to 97, characterized in that a plurality of process units serve to receive and / or process an extract according to one of a plurality of production programs for producing one of a plurality of products producible by the production facility, and the production facility has a simulation device, which is configured and programmed to simulate the operation of the production facility and / or specifically the production of the product according to at least one production program and to provide corresponding simulation results, and the simulation device is partially or completely formed by one or more, specifically all, calculation units of the respective process units.

[0619] 99. A production facility according to sentence 98, characterized in that the simulation device is configured and programmed to detect equipment parameters of the production facility during the production of a product, and / or detect the storage process measurements and / or treatment process measurements of the process units, specifically the operating parameters of the process units, and store them as simulation information and save them for the implementation of a simulation, and specifically, a simulation of the operation of the production facility and / or the production of a product based on such simulation information can be implemented by the simulation device.

[0620] 100. A production installation according to sentence 98 or 99, characterized in that the production installation has one or more sensor units, which are at least partially assigned to and / or form part of the process units, and the simulation device is configured and programmed to perform a simulation based on simulation information detectable or detected by such sensor units.

[0621] 101. The simulation information comprises at least one of the following: time parameters and / or time measurements of the production equipment, in particular of the process units; climatic parameters and / or climatic measurements in and / or around the production equipment, in particular in and / or around the process units; operational parameters and / or operational measurements of the production equipment, in particular of the process units, in particular, where the time parameters and / or time measurements comprise pumping times of process units formed as pumping devices, and / or transport times of process units, and / or sterilization times of process units formed as sterilization devices, and / or cleaning times of process units formed as cleaning devices, and / or waiting times inside the production equipment, and / or unpacking / packing times of process units formed as unpacking / packing devices, and / or loading and / or unloading times of process units, and / or setup times of process units formed as tool units; and / or (b): the climatic parameters and climatic measurements comprise temperature values ​​and / or air humidity values ​​and / or gas composition values; and / or (c) A production facility according to sentence 99 or 100, characterized in that the operating parameters and / or operating measurements include temperature parameters of a process unit configured as a temperature control device and / or a filling level of a storage device.

[0622] 102. A production installation according to one of sentences 98 to 101, characterized in that a part of a production program to be executed by an associated process unit for producing a product can be simulated by a computing unit forming a simulation device, in particular the production program comprises a plurality of, in particular encrypted, production program packets, each production program packet containing at least one piece of information, the information containing instructions for containing and / or processing an extract, the instructions being executable by at least one process unit, and one or more production program packets forming the part of the production program to be simulated.

[0623] 103. A production facility according to one of sentences 98 to 102, characterized in that the production program comprises a plurality of, in particular encrypted, production program packets, and each production program packet comprises at least one piece of information, the information comprising instructions for containing and / or processing an extract, the instructions being executable by at least one process unit, and the simulation being executable based on one or more production program packets, in particular the one or more production program packets being configured and programmed to manufacture a product and to simulate the operation of the production facility and / or the manufacture of the product.

[0624] 104. A production facility according to sentence 102 or 103, characterized in that the process unit is configured and programmed to store one or more encryption keys by means of which the production program packets of the production program can be decrypted for simulation, respectively.

[0625] 105. A production facility according to one of sentences 102 to 104, characterized in that each production program packet is releasable for execution by release information receivable by a process unit to simulate the operation of the production facility and / or the production of a product, and in particular each release information includes an information stamp, in particular a mode information stamp, and by means of the mode information stamp each release information and / or each production program packet is assignable to a production mode of the production facility for producing a product and / or to a simulation mode of the production facility for simulating the operation of the production facility and / or the production of a product.

[0626] 106. A production facility according to one of sentences 98 to 105, characterized in that each process unit is configured and programmed in a production mode of the production facility for manufacturing a product and / or in a simulation mode of the production facility for simulating the operation of the production facility and / or the manufacturing of a product.

[0627] 107. A production facility according to sentence 106, characterized in that one or more process units are configured and programmed to simultaneously simulate one or more production program packets for at least one process unit in a production mode, and specifically to generate simulation information in doing so.

[0628] 108. A production facility according to one of sentences 102 to 107, characterized in that each production program packet contains at least one piece of information, the information referring to other production program packets and / or containing instructions for containing and / or processing an extract, in particular, a defined sequence of a plurality of production program packets forming a production program for producing a product producible by the production facility.

[0629] 109. A production facility according to sentence 108, characterized in that each reference to another production program packet comprises an information stamp, in particular a mode information stamp, by means of which each other production program packet can be assigned to a production mode of the production facility for manufacturing a product and / or to a simulation mode of the production facility for simulating the operation of the production facility and / or in particular the manufacture of a product.

[0630] 110. A production facility according to one of sentences 98 to 109, characterized in that the production facility has at least one control unit, by means of which the utilization and / or occupancy, in particular the logistics, of the production facility can be provided based on the simulation results.

[0631] 111. A production installation according to one of sentences 98 to 110, characterized in that the production installation has one or at least one control unit as already described, by means of which the time course of the production of one or more production programs can be predicted based on simulation results, and / or based on the simulation results, the process units required and / or intended for the implementation of the process steps and / or the consumable materials to be provided in the production installation can be allocated in time and / or space.

[0632] 112. A production facility in which a plurality of process units serve to receive and / or process an extract according to one of a plurality of production programs for producing one of a plurality of products producible by the production facility, and the production facility has a simulation device configured and programmed to simulate the operation of the production facility and / or specifically the production of the product according to at least one production program and to provide corresponding simulation results, the simulation device being partially or completely formed by one or more, specifically all, computing units of the respective process units, and the production facility further has at least one control unit, the control unit at least partially storing and operating a database. 112. A production facility according to claim 1, wherein the production facility is configured and programmed to read out and / or exchange information with a database, the database being at least partially stored and / or running on a computer system assigned or assignable to the production facility, the database containing one or more, in particular unique, release information for allowing the simulation of the storage and / or processing of the extract by one or more process units, the database being modifiable by reading out at least one of the release information for the simulation by one of the process units, such that the release information is subsequently no longer available for reading out in its original form.

[0633] 113. A production facility according to sentence 112, characterized in that the database is configured and programmed to receive and store, exclusively outside the production facility, one or more new release information for permitting simulation.

[0634] 114. A production facility according to sentences 112 or 113, characterized in that the database is configured and programmed so as to be storable and / or operable on a computer system exclusively assigned or assignable to the production facility, or so as to be synchronizable with a parallel database storable and / or operable on a computer system exclusively assigned or assignable to the production facility.

[0635] 115. A production facility according to one of sentences 112 to 114, characterized in that each computing unit of each process unit is configured and programmed to receive and store one or more pieces of release information, and each piece of release information received by the computing unit can be compared with release information already stored on the computing unit in order to avoid double use of the received release information in the production facility, and in particular each computing unit may be configured and programmed to at least partially or completely store and operate a particularly encrypted distributed database, advantageously a particularly encrypted distributed ledger, by means of which one or more pieces of receivable or received release information can be stored.

[0636] 116. A production facility according to one of statements 112 to 115, characterized in that the production program comprises a plurality of production program packets, each production program packet comprising at least one piece of information, the information comprising instructions for containing and / or processing an extract, and each production program packet being uniquely assignable with at least one piece of release information to allow such production program packet to be specifically simulated once and / or specifically executed once by at least one process unit, and in particular each production program being initialized and / or startable by the production facility only insofar as the overall production program packet of the production program and / or the overall release information assigned to the production program packet is available.

[0637] 117. A production facility according to one of sentences 112 to 116, characterized in that one or more release information can be received and stored by at least one process unit in order to allow and execute a simulation of the receipt and / or processing of the extract in a time-delayed manner, and / or one or more release information can be received in real time by at least one process unit in order to allow and execute a simulation of the receipt and / or processing of the extract directly.

[0638] 118. A production facility according to one of sentences 112 to 117, characterized in that the database can be or has been encrypted, and / or each release information in the database can be or has been encrypted.

[0639] 119. A production facility according to one of sentences 112 to 118, characterized in that by means of the production facility one of a plurality of products can be produced according to one of a plurality of production programs, at least a part of the production program serves specifically, in particular exclusively, to imitate and / or suggest the production of the product, and such at least a part of the production program can be authorized for simulation and / or for execution by one or more release information.

[0640] 120. A production facility according to one of sentences 112 to 119, characterized in that one or more pieces of release information can be read from a database, in particular by one or more process units, and / or can be provided by the database, as collective release information (Buendelfreigabeinformation) for allowing a simulation of the operation of the entire production facility and / or a simulation of the entire process for producing a product.

[0641] 121. A production facility according to one of statements 112 to 115 or 117 to 120 in combination with statement 116, characterized in that release information for each individual production program packet is readable individually from the database, in particular by a process unit, and / or can be provided by the database, and / or release information for multiple allocable production program packets is readable together from the database, in particular by one or more process units, and / or can be provided by the database.

[0642] 122. A production facility according to one of sentences 112 to 121, characterized in that the database may be configured and programmed to assign respective consent information to one or more, in particular to all, release information, the consent information being storable in the database for each release information, in particular by a database access authorizer, and each release information being available only insofar as the assigned consent information is stored.

[0643] 123. A production facility according to one of sentences 112 to 122, characterized in that the database is configured and programmed to contain and provide various types of release information, in particular that a given type of release corresponds to a given type of process unit and / or to a given type of part of a production program for manufacturing a product, in particular a production program packet.

[0644] 124. A production facility according to sentence 123, characterized in that each release information comprises an information stamp, in particular a mode information stamp, by means of which each release information can be assigned to a production mode of the production facility for producing a product and / or a simulation mode of the production facility for simulating the operation of the production facility and / or the production of the product.

[0645] 125. A production facility according to sentence 123 or 124, characterized in that each release information contains an information stamp, in particular a numerical information stamp, by means of which it is possible to determine in particular the maximum repeatability of the simulation of the containment and / or processing of the extract permitted by the corresponding release information.

[0646] 126. A production installation according to one of sentences 112 to 125, characterized in that at least one control unit is connectable or connected for data exchange with a computer system assigned or assignable to the production installation, and is configured and programmed to thereby determine the existence of such a data connection, and that the production installation and / or 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 reserved state for temporally and / or functionally restricted operation, and / or into a rest state for stationary operation, in particular a simulation is possible depending on the respective state.

[0647] 127. A production facility according to one of sentences 1 to 126, characterized in that a plurality of process units serve to receive and / or process an extract according to one of a plurality of production programs for producing one of a plurality of products producible by the production facility, and each process unit has one or more sensor units, each sensor unit being configured to detect and provide to a computing unit at least one measured value relating to the receiving and / or processing of the extract and / or relating to the process unit itself for transmission in encrypted and abstracted form to one or more receiving-eligible units.

[0648] 128. A production facility according to sentence 127, characterized in that one or more eligible recipient units comprise one or more other process units, and / or at least one higher-level control unit of the production facility, and / or a computer system assigned or assignable to the production facility.

[0649] 129. A production installation according to sentence 127 or 128, characterized in that the information representing at least one detectable measurement value is modifiable by the sensor unit itself, and one or more eligible receiving units are configured and programmed to interpret the modified information.

[0650] 130. A production installation according to one of sentences 127 to 129, characterized in that the information representing at least one detectable measurement value is modifiable by a calculation unit, and one or more eligible receiving units are configured and programmed to interpret the modified information.

[0651] 131. A production facility according to sentence 129 or 130, characterized in that the information is modifiable in an encrypted and / or abstracted state and is decipherable and / or tangible by one or more eligible receiving units.

[0652] 132. A production facility according to one of sentences 129 to 131, characterized in that each calculation unit is configured and programmed to provide information only as modified information for transmission to one or more eligible recipient units.

[0653] 133. A production installation according to one of sentences 127 to 132, characterized in that each calculation unit is configured and programmed to evaluate at least one detectable measurement value according to a parameter range storable or stored in the calculation unit and subsequently to provide only the result of the evaluation of the at least one detectable measurement value for transmission to one or more eligible recipient units.

[0654] 134. A production facility according to one of sentences 127 to 133, characterized in that the transmitted information is configured to be stored in one or more eligible receiving units, in particular for process optimization of the production facility.

[0655] 135. A production facility according to one of sentences 127 to 134, characterized in that the transmitted information is formed in such a way that it is stored in one or more eligible receiving units according to various data categories.

[0656] 136. A production facility 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 said information.

[0657] 137. A production installation 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 Wi-Fi module, and each computing unit is configured and programmed to form a network together with each other computing unit for information transmission by means of the at least one communication module.

[0658] 138. A production installation according to one of sentences 137, characterized in that one or more of the computing units are configured and programmed as network nodes and / or hubs to transmit information from the process units to one or more eligible units by means of at least one communication module.

[0659] 139. A production facility according to sentence 137 or 138, characterized in that one or more of the computing units are configured and programmed as a gateway to transmit information from the process unit to one or more eligible recipient units by means of at least one communication module.

[0660] 140. A method for controlling a production facility for producing a product, in particular a biological product, in particular a production facility according to any one of sentences 1 to 139, wherein the method comprises at least the following: - providing one or more process units for containing and / or processing the extract; A method comprising:

[0661] 141. The method further comprises: - executing such a production program packet based on the encrypted production program packet of the production program preceding it, specifically by determining an encrypted production program packet of the production program for producing a product producible by the production facility and one of the process units; - decoding the determined production program packet by activating the determined production program packet on the determined process unit, and subsequently controlling the process unit to perform one or more processing steps on the extract based on the decoded production program packet; and - determining the encrypted production program packets and subsequent process units that follow the decrypted production program packets, specifically the production program, and executing such subsequent production program packets based on the decrypted production program packets; 141. The method of claim 140, comprising:

[0662] 142. The method further comprises: - providing data connections of a computer system assigned or assignable to the production facility and / or to one or more, in particular all, of the process units; - determining by at least one control unit of the production facility and / or at least one computing unit of at least one process unit whether a data connection exists; and -Controlling production equipment and / or one or more, in particular all, process units according to a data connection 142. The method of claim 140 or 141, comprising:

[0663] 143. The method according to sentence 142, characterized in that the control comprises reversibly transferring the production equipment and / or one or more, in particular all, process units, in particular based on the presence of a data connection, to a normal state for unrestricted operation, to a reserved state for temporally and / or functionally restricted operation, and / or to a rest state for stationary operation.

[0664] 144. A method according to sentence 143, characterized in that one or more of the at least one control unit and / or one or more of the calculation units, in particular each, stores an information stamp, in particular a time stamp, when transitioning to a reserved state, and after a predefined time from such information stamp, in particular the time stamp, stops the unrestricted operation of the production equipment and / or one or more, in particular all, process units and in particular transitions the production equipment and / or the process units in question to a resting state.

[0665] 145. A method according to sentence 143 or 144, characterized in that one or more of the at least one control unit and / or computing units, in particular each, still executes a predefined part of the production program for manufacturing the product upon transition to the reserved state.

[0666] 146. The method according to one of sentences 143 to 145, characterized in that at least one control unit and / or one or more of the calculation units, in particular each, amends and / or supplements the production program for producing the product with one or more production program packets for storing the extract and / or the at least partially processed extract and / or product upon transition to the resting state, in particular as long as the resting state exists.

[0667] Further advantageous features and / or benefits are the subject of the following description and drawings of exemplary embodiments. [Brief explanation of the drawings]

[0668] [Figure 1] FIG. 1 is a schematic perspective view of a production facility in accordance with an example embodiment of the present invention. [Figure 2] FIG. 2 is a perspective view that schematically illustrates a part of the production facility shown in FIG. [Figure 3] FIG. 3 is a top view that schematically illustrates a portion of the production facility shown in FIG. [Figure 4]FIG. 4 is a top view that schematically illustrates a portion of the production facility shown in FIG. [Figure 5] FIG. 5 is a top view schematically showing the production facility shown in FIG. [Figure 6] FIG. 6 is a top view schematically showing the production facility shown in FIG. [Figure 7] FIG. 7 is a top view schematically showing the production facility shown in FIG. [Figure 8] FIG. 8 is a top view that schematically illustrates a portion of the production facility shown in FIG. [Figure 9] FIG. 9 is a perspective view that schematically illustrates a part of the production facility shown in FIG. [Figure 10] FIG. 10 is a top view that schematically illustrates a portion of the production facility shown in FIG. [Figure 11] FIG. 11 is a top view that schematically illustrates a portion of the production facility shown in FIG. [Figure 12] FIG. 12 is a perspective view that schematically illustrates a production facility according to a further exemplary embodiment of the present invention. [Figure 13] FIG. 13 is a perspective view that schematically illustrates a production facility according to a further exemplary embodiment of the present invention. [Figure 14] FIG. 14 is a schematic perspective view of a production facility according to a further exemplary embodiment of the present invention. [Figure 15] FIG. 15 illustrates a method according to an example embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0669] Identical or functionally equivalent elements have the same reference numerals in all figures.

[0670] FIG. 1 shows a schematic perspective view of a production facility 10 according to an example embodiment of the present invention.

[0671] With reference to FIG. 1, production facility 10 includes multiple process units for containing and / or processing extract 40 , specifically to produce biologic product 20 .

[0672] In this embodiment, the process units are configured as workpiece supports 30 for containing and / or transporting the extract 40, specifically as workpiece supports 30 formed as patient boxes 50, and / or specifically as patient boxes 50 for containing and / or transporting the extract 40. In other words, the workpiece supports 30 formed as patient boxes 50 may be patient boxes 30,50.

[0673] Furthermore, in this embodiment, a number of process units are formed, in particular as toolboxes 702, 704 for processing the extract 40.

[0674] Tool boxes 702, 704 described herein specifically in the context of tool units are designated by the numeral 702, and tool boxes 702, 704 described herein specifically in the context of consumables and / or consumable materials are designated by the numeral 704. It should be understood that tool boxes 702, 704 may be described in terms of tool units or in terms of consumables and / or consumable materials and may be designated by both numerals 702, 704.

[0675] Each process unit has a calculation unit.

[0676] That is, specifically, each patient box 30, 50 and each tool box 702, 704 has its own computing unit.

[0677] Furthermore, the production facility 10 shown in FIG. - a clean room area 100; a locking device 200 for feeding and / or removing objects from the clean room area 100 around the production facility 10; a handling device 300 for moving said objects inside said clean room area 100; a storage device 400 located within said clean room area, said storage device 400 including a plurality of storage locations 402 for storing a plurality of objects; Includes.

[0678] In this embodiment, specifically, the handling device 300 is formed as a process unit, or the process unit forms the handling device 300, and the storage location 402 is formed as a process unit, or the process unit forms the storage location 402.

[0679] The biologic product 20 may be intended for personalized therapy and may thus be a personalized therapeutic drug.

[0680] The production facility 10 has a housing (not shown) for separating a clean room area 100 around the periphery of the production facility 10 .

[0681] The locking device 200 is therefore configured for supplying objects from the surroundings of the production facility 10 into the clean room area 100 via or through the housing, and / or for removing objects from the clean room area 100 via or through the housing.

[0682] The clean room area 100 may be configured and / or compartmentalized as described in German patent application DE 102021 207 738.2, which is incorporated herein by reference.

[0683] The production facility 10 is further connected to at least one current source (not shown) arranged around the production facility 10 for supplying it with electric current.

[0684] As can be seen in FIG. 1, storage device 400 includes a plurality of, here three, storage shelves 404 each having a plurality of storage locations 402 .

[0685] The storage device 400 further includes a storage transport device 406 for transporting objects toward the storage location 402, specifically the storage shelves 404, and / or away from the storage location 402, specifically the storage shelves 404.

[0686] Specifically, by the storage transport device 406 of the storage device 400, extracts and / or workpiece supports and / or tool units and / or consumable materials and / or process units, such as patient boxes 30, 50 and / or tool boxes 702, 704, may be stored in or withdrawn from storage locations 402 of the storage shelves 404.

[0687] The storage and transport device 406 is a different device from the handling device 300 .

[0688] In this embodiment, specifically, the storage and transport device 406 is formed as a process unit, or multiple process units form the storage and transport device 406 .

[0689] 1 includes one or more transport vehicles 410 that run freely within the clean room area 100. In other words, the transport vehicles 410 that run freely within the clean room area 100 may be transport vehicles that are controllable and free-running as needed within the clean room area 100, so that when controlled accordingly by at least one of the control units, the transport vehicles run freely whenever needed.

[0690] In this embodiment, specifically, the transport vehicle 410 is configured as a process unit, or the process unit forms the transport vehicle 410 .

[0691] The transport vehicle 410 provides access to the storage shelves 404 of the storage device 400, particularly for storage and retrieval processes, as well as for processing and / or maintenance processes.

[0692] The storage shelves 404, and more specifically the storage locations 402 of the storage shelves 404, can be accessed by a transport vehicle 410 via one or more storage shelf-locks 412 for storage and retrieval processes, as well as for processing and / or maintenance processes (see FIG. 9).

[0693] The use of free-running transport vehicles 410 allows for any arrangement of storage shelves 404. The generally parallel arrangement of storage shelves 404 shown in Figure 1 and in the accompanying drawings is shown purely by way of example for purposes of illustration.

[0694] The production facility 10 may further include a cleaning device 500, which may clean and / or sterilize 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 consumable materials by irradiation and / or gas treatment.

[0695] The production facility 10 further includes an unpacking device 212 for unpacking objects to be supplied to the clean room area 100, and a packaging device 214 for packaging objects to be removed from the clean room area 100, such as manufactured products 20.

[0696] The unpacking device 212 and the packing device 214 are incorporated into or added to the locking device 200, specifically, in this case, they are incorporated into or added in a state where they are arranged laterally.

[0697] 1 and 2, the locking device 200 includes an entrance lock 202 through which a lock location 206, specifically the entrance lock location 206, is accessible from the periphery, and the entrance lock 202 is configured to feed objects from the periphery of the production facility 10 into the clean room area 100.

[0698] 1 and 2, the locking device 200 includes an exit lock 204 through which a lock location 208, specifically the exit lock location 208, is accessible from the surroundings, and the exit lock 204 is configured to remove objects from the clean room area 100.

[0699] The entry lock 202 and the exit lock 204 further include means for spatially isolating the lock locations 206, 208 (not shown), specifically those assigned to the entry lock 202 and the exit lock 204, respectively.

[0700] Isolation can be selectively performed towards the periphery of the production facility 10 and / or towards parts of the locking device 200 different from the locking locations 206, 208 respectively by means of the respective isolating means of the entrance lock 202 and the exit lock 204 in each case.

[0701] Furthermore, the production facility 10 may have a plurality of maintenance locks 210. Via the maintenance locks 210, the clean room area 100 may be accessed from the periphery of the production facility 10, for example, by users, specifically for maintenance work inside the clean room area 100.

[0702] The production facility 10 comprises a control unit by and / or via which the production facility 10 is operable, in particular adjustable and / or controllable.

[0703] The control device is / is formed by all the computing units of the process units, i.e., in particular the control unit is formed by the computing units of the patient boxes 30, 50, the tool boxes 702, 704, the handling device 300, the storage and transport device 406, the transport vehicle 410, etc.

[0704] In effect, the control unit is a distributed control unit, which is based on a group, in particular a cluster, of individual computing units of the process units of the production installation 10 .

[0705] The control unit may be connectable or connected to a control supplementation system 600 located, for example, in a distribution panel, which control supplementation system may be specifically configured and programmed to supplementally regulate and / or control at least one of the components contained by the production facility or a component part of the production facility.

[0706] The control supplementation system 600 is configured, for example, specifically to perform supplementary and / or subordinate and / or obvious processes that the control unit does not execute and that are not security-critical to the production facility 10.

[0707] The control unit is configured and programmed to communicate with one or more communication interfaces (not shown) and / or one or more human-machine interfaces, or HMI interfaces for short, 602 (HMI interface 602 is shown in the drawings as an example) of the production facility 10.

[0708] A communication interface not shown may serve, for example, to ensure data exchange with a higher-level guidance system and / or data management system of an assigned cloud system, thereby enabling, for example, data evaluation and / or data optimization via artificial intelligence and / or deep learning.

[0709] The control unit may further be configured and programmed to provide information to a user via the communication interface and / or via the HMI-interface 602, such as fault information and / or information about the production status of the product 20 and / or information about the storage status of the storage device 400.

[0710] Furthermore, the control unit may implement the production of the biological product 20 by the production facility 10 .

[0711] A control unit allows the production of said products to be carried out according to one or more production programs.

[0712] Specifically, the control unit is configured and programmed to allocate the extract 40 to one of the process units 30, 50, 702, 704 based on one of a plurality of production programs for producing one of a plurality of products 20 producible by the production facility.

[0713] As shown in FIG. 1, the production facility 10 has a first computer system 800 assigned to the production facility 10 for exchanging data with the production facility 10, and a second computer system 900 assigned to the production facility 10 for providing release information.

[0714] The first and second computer systems 800, 900 are typically spatially separated or distinct from one another and from the rest of the production facility.

[0715] The first and second computer systems 800 and 900 are configured as servers, respectively. Specifically, 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.

[0716] The heartbeat server 800 and the release server 900 can be connected and / or are connected to the production facility 10, in particular to the control units, preferably to the computing units of the process units, in particular via the control supplementation system 600. The control supplementation system can be configured or present as a communication medium. Additionally or alternatively, the heartbeat server 800 and the release server 900 can be connected and / or are connected to the production facility 10, in particular to the control units, preferably to the computing units of the process units, in particular directly or indirectly via, for example, internet-based and / or wireless-based technologies, as commonly known in the art.

[0717] Each product 20 to be manufactured is assigned a series of processing steps that can be performed by process units, such as tool units and / or tool boxes 702, 704, located within the clean room area 100 and that remain within the clean room area after the processing steps are performed.

[0718] In each production program, the process steps required for the production of a given product 20 and the associated process time values ​​are recorded or taken into account.

[0719] Specifically, the production program includes a plurality of encrypted production program packets.

[0720] The process units, specifically the patient boxes 30, 50 and / or tool boxes 702, 704, are configured and programmed to store one or more encryption keys by which the production program packets of the production program can be decrypted, specifically locally on the respective process units.

[0721] One or more encryption keys are inseparably embedded in the process unit, for which purpose each process unit has a security module, in particular a Trusted-Platform-Module.

[0722] Each production program packet contains at least one piece of information that references other production program packets and contains instructions for storing and / or processing the extract 40 .

[0723] In other words, a production program packet contains instructions for one or more process steps.

[0724] A defined sequence of a plurality of production program packets forms a production program for producing a product 20 producible by the production facility 10. Such a sequence represents the sequence of processing steps described above.

[0725] In particular, the complete order can only be determined from all references to other production program packets, since none of the production program packets allow a complete overview across the entire production program.

[0726] A production program packet includes a start packet and one or more follow packets, i.e., the start packet indicates the beginning of the production program.

[0727] The process units, specifically the patient boxes 30, 50 and / or tool boxes 702, 704, are configured and programmed to carry out, specifically to decode and then execute, the instructions of at least one production program packet.

[0728] All production program packets are provided to one process unit each and / or can be transmitted to one process unit each by a computer system, such as the release server 900, that is assigned or assignable to the production facility 10 in particular.

[0729] The production facility 10 is configured to be operable according to various conditions, and such operation is dependent on the existence of a data connection with the heartbeat server 800, as will be explained in more detail below.

[0730] Specifically, as can be seen from FIG. 1, the heartbeat server 800 is connectable to or connected to the production equipment 10 (see dashed lines).

[0731] The control unit is configured and programmed to be connectable or connected for data exchange with the heartbeat server 800 described above, and thereby continuously determines the existence of such a data connection.

[0732] Specifically, such a heartbeat server 800 can serve to allow the production facility 10 to operate without a data connection only for a predetermined period of time, i.e., the production facility 10 can only produce if there is a connection with the heartbeat computer system 800.

[0733] The production equipment and process units, specifically the patient boxes 30, 50 and / or tool boxes 702, 704, can be connected to the data connection. - to normal state for unrestricted operation, - into a reserved state for time- and / or functionally limited operations, and / or -To hibernation for still operation, It is reversibly transferable.

[0734] The pending state may specifically be a transition state between the normal state and the dormant state, through which the normal state transitions to the dormant state, specifically the transition from the dormant state to the normal state does not need to go through the pending state, and advantageously the transition from the dormant state to the normal state may be made directly.

[0735] Only when a data connection is present can the production facility 10 for manufacturing the product 20, or specifically the patient boxes 30, 50 and / or tool boxes 702, 704 for containing and / or processing the extract 40, operate in an unrestricted state. This is the normal state.

[0736] In the absence of a data connection, the production facility 10, in particular the patient boxes 30, 50 and / or tool boxes 702, 704 for storing and / or processing the extract 40, may be able to transition to a reserved state, in which the production of the product 20, or in particular the storage and / or processing of the extract 40, is limited in time and / or functionality.

[0737] The control unit and / or the computing unit of the process unit in question stores an information stamp, in particular a time stamp, upon transition to a reserved state, and after a predefined time from such information stamp, in particular a time stamp, stops unrestricted operation of the production facility 10 or in particular the patient box 30, 50 and / or the tool box 702, 704 and transitions the production facility 10 or the process unit in question to a resting state.

[0738] Upon transition to the hold state, a predefined part of the production program for producing the product 20 is still executed, which serves, for example, to ensure the progress of the production or processing of the extract 40 and / or to bridge possible short-term interruptions in the data connection.

[0739] Upon transition to the pause state, the continuous production program is modified and / or supplemented (in particular by the control unit) with one or more production program packets to accommodate the extract 40 and / or at least partially processed extract 40 and / or product 20 for as long as the pause state exists.

[0740] In other words, at least one production program is modified and / or supplemented by one or more production program packets, which contain instructions for storage.

[0741] The storage may specifically occur in at least one of the storage locations 402 of the storage device 400 .

[0742] The modification and / or supplementation may include, for example, purposeful temperature control, e.g., freezing, of the extract 40 and / or the at least partially processed extract 40, and / or the product 20, to ensure the progress of the production or process. This may be done in the storage location 402.

[0743] In effect, determining the existence of a data connection can be considered a security mechanism for the production facility 10 .

[0744] The production facility 10 may be further configured to include one or more additional security mechanisms.

[0745] Further specific details of the aforementioned security mechanisms are described below.

[0746] Specifically, the production facility 10 is configured to determine the integrity of each process unit, specifically the patient boxes 30, 50 and / or tool boxes 702, 704.

[0747] With respect to the process unit in question, such an integrity determination can be performed on the one hand outside the process unit in question, or on the other hand by the process unit in question itself, both of which possibilities can be implemented in the production facility 10, either alone or in combination.

[0748] On the one hand, the control unit is configured 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.

[0749] On the other hand, each calculation unit is configured and programmed to determine the integrity of each process unit, ie in particular the patient box 30, 50 and / or the tool box 702, 704.

[0750] This occurs before the extract 40 can be received and / or processed by the process unit or appropriate box 30, 50, 702, 704 according to one or more production program packets.

[0751] The purpose of the integrity determination is to be able to prove alterations to the process unit, in particular the patient box 30, 50 and / or the tool box 702, 704. For example, this makes it possible to detect whether an unauthorized person has attached espionage means, such as a camera and / or other equivalent hardware, to the process unit in order to be able to infer the manufacture of the product 20.

[0752] For this purpose, the calculation unit of the process unit or the box in question is configured and programmed to provide unique information relating to the process unit or the box in question 30, 50, 702, 704.

[0753] The control unit can detect further unambiguous information relating to the process unit or box 30, 50, 702, 704 in question, which relates to determining the integrity of the process unit or box 30, 50, 702, 704 from the outside.

[0754] The integrity of such a process unit or box 30, 50, 702, 704 can be determined by at least one control unit based on comparing both such unambiguous information.

[0755] If both such unambiguous information match, the integrity can be set and / or verified, which may in particular take place in the respective computing unit and / or in the at least one control unit.

[0756] The unambiguous information available on the part of the calculation unit represents the target and / or starting state of the process unit or box 30, 50, 702, 704, based on which deviations for the process unit or box 30, 50, 702, 704 can be determined.

[0757] The unique information is stored on the aforementioned security module of each process unit or box 30, 50, 702, 704 and can be provided for the integrity determination.

[0758] In particular, unique information or fingerprint information may refer to digital fingerprint information, for example information that has a unique and / or unambiguous signature.

[0759] The process units or boxes 30, 50, 702, 704 are configured and programmed to execute, i.e., decode and then execute, the instructions of the production program packet only as long as its integrity has been established and / or verified.

[0760] In other words, the process is carried out by boxes 30, 50, 702, 704 only insofar as boxes 30, 50, 702, 704 are specifically intact with respect to damage and / or tampering.

[0761] Unless the integrity of the relevant box 30, 50, 702, 704 is configurable and / or verifiable, execution and / or decryption of instructions is blocked.

[0762] Furthermore, the process units or boxes 30, 50, 702, 704 are configured and programmed to provide messages, in particular warning messages, for example via the HMI interface 602, unless their integrity is configurable and / or verifiable.

[0763] The production facility 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.

[0764] Based on such detection, unique information about each process unit or box 30, 50, 702, 704 can be provided by the control unit for determining its integrity.

[0765] The one or more sensor units may include one or more camera units that can visually detect characteristic landmarks on the faces, particularly surfaces, and / or geometry of the process unit or box 30, 50, 702, 704.

[0766] In other words, the unambiguous information is based on characteristic landmarks of the face, in particular the surface, and / or the geometry of the process unit, which may be a two-dimensional and / or a three-dimensional geometry.

[0767] Numerous further possibilities for unambiguous information are conceivable in addition or instead of this, for example: the production installation 10 comprises 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 mechanical vibrations, the vibrations being detectable by one or more sensor units, and on the basis of the vibrations unambiguous information can be provided about each process unit or box 30, 50, 702, 704 for determining its integrity, in particular one of the one or more actuator units is configured to generate mechanical vibrations, and such actuator unit is located on or in one of the one or more process units or boxes 30, 50, 702, 704 and / or is engageable with one of the one or more process units or boxes 30, 50, 702, 704 so as to generate mechanical vibrations in the process unit or box 30, 50, 702, 704, and optionally the actuator unit is configured as a motor, in particular a vibration motor, by means of which a definable frequency range can be generated and / or driven; and / or the vibrations include a frequency range of 10 Hz or more and 100 Hz or less, and / or the vibrations include one or more specifically different frequency ranges, each of which is 10 Hz or more and 100 Hz or less, and / or the vibrations include one or more specifically different frequency ranges that are successive to one another in a predetermined order, and / or one of the one or more actuator units is configured to generate acoustic vibrations, in particular sound waves, and such actuator unit may be located on one of the one or more process units or boxes 30, 50, 702, 704 and / or be engageable with one of the one or more process units or boxes 30, 50, 702, 704 so as to generate mechanical vibrations, in particular sound waves, for that process unit or box 30, 50, 702, 704; and optionally the actuator unit may be configured as an acoustic transducer, in particular as a loudspeaker, by means of which a definable frequency range can be generated and / or driven; and / or The (acoustic) vibrations include a frequency range of 30 Hz to 10,000 Hz, and / or the (acoustic) vibrations include one or more, in particular different frequency ranges, each of 30 Hz to 10,000 Hz, and / or the (acoustic) vibrations include one or more, in particular different frequency ranges, which may follow each other in a predetermined order.

[0768] It should be understood that the foregoing list of completeness determining means is exemplary and not exhaustive.

[0769] It should also be understood that any combination of the components described for completeness, particularly actuator units and / or sensor units, is conceivable for each process unit or box 30, 50, 702.

[0770] As previously mentioned, each computing unit is further configured and programmed to determine the integrity of its respective processing unit, specifically the patient box 30, 50 and / or the tool box 702, 704.

[0771] This concerns the integrity determination by the process unit or box 30, 50, 702, 704 in question itself.

[0772] In other words, each process unit or box 30, 50, 702, 704 may be configured as a self-checking process unit that is configured to determine its own inherent integrity or, more specifically, to be able to determine unauthorized modifications by itself.

[0773] Also here, although the calculation unit provides unambiguous information about such process units or boxes 30, 50, 702, 704, further unambiguous information about such process units or boxes 30, 50, 702, 704 can be detected by the calculation unit itself.

[0774] The integrity of the relevant process unit or box 30, 50, 702, 704 can be determined by the respective calculation unit based on a comparison of both such unambiguous information.

[0775] The process units, in particular the patient box 30, 50 and / or the tool box 702, 704, have one or more sensor units by which unique and / or further unique information about the process unit or box 30, 50, 702, 704 in question can be detected to determine its integrity.

[0776] At least one sensor unit can detect brightness values ​​within the respective process unit or box 30, 50, 702, 704, and unique information about the respective process unit or box 30, 50, 702, 704 can be provided for determining the integrity based on the detectable brightness values. For example, detection of light can indicate tampering and / or attacks on the respective process unit or box 30, 50, 702, 704, and if dark, the respective process unit or box 30, 50, 702, 704 is intact, i.e., integrity is confirmed.

[0777] Additionally, at least one sensor unit may be at least partially visually detectable for the process unit or box 30, 50, 702, 704 in question and provide unambiguous and / or further unambiguous information about the process unit or box 30, 50, 702, 704 in question for determining its integrity based on visual detection, and the at least one sensor unit may include a camera unit by means of which characteristic landmarks and / or geometry of the process unit or box 30, 50, 702, 704 in question can be visually detected. Such sensors may in particular be located inside and / or outside the process unit or box 30, 50, 702, 704.

[0778] Numerous further possibilities for unambiguous information are conceivable in addition or instead of this, for example: - the 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, in order to generate mechanical vibrations, which vibrations can be detected by one or more sensor units, and on the basis of which unambiguous information and / or further unambiguous information about the process unit or box 30, 50, 702, 704 in question can be provided for determining the integrity, optionally the vibrations comprise a frequency range of ≧10 Hz and ≦100 Hz, and / or the vibrations comprise one or more, in particular various, frequency ranges, each of ≧10 Hz and ≦100 Hz, and / or the vibrations comprise one or more, in particular various, frequency ranges that follow one another in a predetermined order, in particular at least one of the one or more actuators being formed as a vibration motor, which is fixed in and / or to the process unit in question in order to generate mechanical vibrations; and / or at least one of the one or more actuator units is configured to generate acoustic vibrations, in particular sound waves, and is fixed in or to the process unit or box 30, 50, 702, 704 in question, for generating mechanical vibrations, in particular sound waves, relative to the process unit or box 30, 50, 702, 704 in question, and optionally the vibrations include a frequency range of ≧30 Hz and ≦10,000 Hz, and / or the vibrations include one or more, in particular different frequency ranges, each of ≧30 Hz and ≦10,000 Hz, and / or the vibrations include one or more, in particular different frequency ranges, which may follow one another in a predetermined sequence, and / or - the process unit or box 30, 50, 702, 704 has one or more electrically conductive conductor elements arranged on and / or within the process unit or box 30, 50, 702, 704 and / or within a side wall of the process unit or box 30, 50, 702, 704 and in particular forming an independent current circuit, and one or more sensor units are able to detect whether the current circuit has been altered relative to its original state and / or whether it has been interrupted, and based on the detection of the current circuit, unambiguous information about the process unit or box 30, 50, 702, 704 and / or further unambiguous information can be provided to determine its integrity; and / or - at least one sensor unit is configured as an inertial measurement unit, by means of which at least one acceleration value, in particular an acceleration vector, and / or at least one rotational speed value, in particular a rotational speed vector, for the process unit or box 30, 50, 702, 704 in question can be detected, and unambiguous information and / or further unambiguous information for the process unit or box 30, 50, 702, 704 in question can be provided for determining the integrity based on the detectable acceleration value and / or rotational speed value; and / or - By means of at least one sensor unit, temperature values ​​in and / or of the process unit in question can be detected and unambiguous information and / or further unambiguous information about the process unit in question can be provided for determining its integrity based on the detectable temperature values.

[0779] It should be understood that the foregoing list of completeness determining means is exemplary and not exhaustive.

[0780] It should also be understood that any combination of the components described for completeness, particularly actuator units and / or sensor units, is conceivable for each process unit or box 30, 50, 702.

[0781] Further specific details of the aforementioned security mechanisms are described below.

[0782] In this case, at least a part of the production program serves, in particular exclusively, to imitate and / or suggest one or more production program steps, in particular one or more process steps.

[0783] This may specifically result in the true or actual production process or production program step or process being hidden or obscured, specifically requiring a potential attacker to conduct further investigation to be able to recover the production of product 20.

[0784] For purposes of imitation and / or suggestion, the production program includes one or more encrypted dummy production program packets.

[0785] Each dummy production program packet contains at least one piece of information that references a (correct) production program packet or another dummy production program packet and / or contains dummy instructions for imitating and / or suggesting the storage and / or processing of the extract 40. For example, the dummy production program packets, and in particular the dummy instructions, may be empty of content in production terms.

[0786] The production facility 10 has a random module which can be executed by a computing unit and by which one or more dummy production program packets can be randomly inserted into the production program.

[0787] The process units or boxes 30, 50, 702, 704 are configured and programmed to execute, in particular decode and then execute, any instructions, in particular real instructions and / or dummy instructions.

[0788] Additionally, the process units or boxes 30, 50, 702, 704 are configured and programmed to contain and / or process a dummy extract to mimic and / or suggest the containing and / or processing of an actual extract 40 while using the dummy extract.

[0789] For example, the dummy extract may be an empty container 42 that is not visible from the outside and is designated for the actual extract 40 and / or may contain materials similar to the actual extract 40.

[0790] Additionally, the production facility 10 includes one or more concealed chambers for housing one or more process units, the interior of each concealed chamber being optically isolated and / or at least sufficiently invisible from the exterior of the concealed chamber.

[0791] The process units or boxes 30, 50, 702, 704 are prompted by at least part of the production program to imitate and / or suggest that they be housed within the respective concealment chambers.

[0792] For example, the concealment chamber may be formed by one or more storage locations 402. Additionally or alternatively, the concealment chamber may be located within the clean room area 100 as a separate device.

[0793] 1 and 9, the concealment chambers are accessible via storage shelf-lock 412 to correspond to process units formed as boxes 30, 50, 702, 704.

[0794] As can be seen from Figures 1 and 9, the concealment chamber is substantially or completely invisible to those standing outside the production facility 10, specifically the clean room area 100, and also to those standing outside.

[0795] For example, optical isolation may relate to wavelength ranges that are visually perceptible to humans and / or wavelength ranges that are not visually perceptible to humans, such as the infrared range.

[0796] The concealment chamber contains one or more replacement units (not shown) that allow objects contained in and / or by the process units, particularly patient boxes 30, 50 and / or tool boxes 702, 704, to be interchanged between the appropriate process units located within the concealment chamber, with corresponding instructions being included in the dummy production program packet.

[0797] In other words, the concealment chambers or their exchange units may allow objects to be exchanged between the respective process units in a shell-game-like manner.

[0798] The concealment chamber may have one or more sensor units for monitoring optical separation of the interior from the exterior of the concealment chamber, specifically, a brightness value inside the concealment chamber can be detected by at least one sensor unit of the concealment chamber.

[0799] Further of the aforementioned security mechanisms are specifically described below.

[0800] Such a security mechanism is based in particular on the fact that a process unit, specifically a box 30, 50, 702, 704, can execute a process only insofar as the process unit or box 30, 50, 702, 704 has been provided with release input or permission by the release server 900 as described above.

[0801] The release server 900 is configured and programmed to at least partially store and operate a database.

[0802] The control unit is also configured and programmed to exchange information with this database.

[0803] Specifically, as can be seen from FIG. 1, the release server 900 is connectable to or connected to the production facility 10 (see dashed line).

[0804] The database contains multiple, particularly unique, release information for authorizing the storage and / or processing or treatment of the extract 40 by the process units, particularly boxes 30, 50, 702, 704.

[0805] The database can be modified by reading out at least one of the release information for one of the process units or boxes 30, 50, 702, 704, so that such release information can subsequently no longer be provided for reading in its original form.

[0806] In particular, since it is recorded in the database that the release information has already been transmitted and / or used, such release information can no longer be provided for retrieval in its original form.

[0807] Specifically, unique release information may refer to information that is unique and / or has a unique identifier.

[0808] The database is configured and programmed to receive and store information about one or more new releases entirely outside the production facility.

[0809] In other words, the database can be supplied with one or more new releases exclusively from outside the production facility.

[0810] For example, one or more new release information on the part of the database access authorizer 1000, specifically the prescription rights holder represented by the production program, can be communicated to the database via a separate computer system 1000, for example via a cloud and / or server. Optionally, such computer system 1000 may be part of the production facility 10.

[0811] The database may be configured and programmed to be storable and / or operable exclusively on the release server 900, or to be synchronized with a parallel database that may be storable and / or operable, for example, by the control unit and / or a separate computer system 1000.

[0812] Each processing unit, in particular each computing unit of each box 30, 50, 702, 704, is configured and programmed to receive and store one or more pieces of release information.

[0813] Specifically, each release information received by the computing unit can be compared with each release information already stored on the computing unit to avoid duplicate use of the received release information in the production facility 10.

[0814] In other words, all the computing units are networked together so as to compare the received release information in this way, specifically to avoid double usage.

[0815] To this end, each computing unit is configured and programmed to store and operate a particularly encrypted distributed database, advantageously a particularly encrypted distributed ledger, thereby storing one or more receivable or received release information.

[0816] The use of a distributed database can specifically provide an anti-tampering technical solution to avoid duplicate use of the received release information in the production facility 10. The distributed database will be described in more detail below.

[0817] Each production program packet can be uniquely assigned one of the release information to allow such a production program packet to be executed specifically once by a process unit, specifically boxes 30, 50, 702, and 704. This can ensure that the execution of the production program packet is not possible beyond the release limit or number of release executions.

[0818] Specifically, each production program can be initialized and / or started by the production equipment only to the extent that the overall production program packet of the production program and / or the overall release information assigned to the production program packet can be or has been provided on the corresponding process unit or box 30, 50, 702, 704.

[0819] In particular for this purpose, the release information can be received and stored by the computing unit.

[0820] This may be done for a time-delayed authorization and execution of the receiving and / or processing of the extract 40 and / or for an immediate authorization and execution of the receiving and / or processing of the extract 40 .

[0821] Each release information in the database can be encrypted or is encrypted and can be decrypted by at least one encryption key, which can be provided by and / or stored by and / or stored at the respective computing unit, in particular its security module.

[0822] It should be understood that the embodiments relating to release information also relate to the previously mentioned dummy production program packet of a production program.

[0823] In other words, the dummy production program packet can also be released by one or more pieces of release information in the release server 900 .

[0824] It is conceivable that one or more release information pieces can be read from the database, in particular by one or more process units, as collective release information for authorizing the entire process for producing the product 20. Additionally or alternatively, the release information pieces for each individual production program packet can be read from the database individually, in particular by the process units.

[0825] The database may be configured and programmed to assign respective consent information to one or more, particularly all, release information, and the consent information may be stored in the database for each release information, particularly by the database access authorizer 1000, and each release information may be provided only as long as the assigned consent information is stored.

[0826] In other words, the database access authorizer 1000 can consent to the use of individual or multiple release information on the release server 900. For example, this may enable a separate, in particular automated, computing system for the product to be manufactured and / or the rights regarding the manufacturing of the product 20 may remain with the rights holder.

[0827] Each release information may include an information stamp, specifically a number information stamp, which is considered to be capable of determining the specific maximum repeatability of the containment and / or processing or treatment of the extract 40 permitted by the corresponding release information.

[0828] Furthermore, it should be understood that the possibility of processing authorization by release information depends on the existence of a data connection to the heartbeat server 800 of the production facility 10, i.e., normal, pending, and / or dormant.

[0829] As mentioned above, on the side of the process units, specifically boxes 30, 50, 702, 704, the execution of the process, specifically the execution of the production program packets, and / or the use of the release information can be monitored by a distributed database, which is operated by the process units or respective computing units of boxes 30, 50, 702, 704.

[0830] Each computing unit is configured and programmed to store and operate an encrypted distributed database, advantageously a Distributed Ledger.

[0831] Each distributed database is a redundant copy of each of the other distributed databases, the copies being stored on the computing units.

[0832] Each computing unit is configured and programmed to verify the operation of its respective distributed database on each of the other computing units and to implement a unique distributed database in response to the verification.

[0833] Each distributed database is configured and programmed to contain one or more, particularly unique, information relating to the receiving and / or processing of the extract 40 by each process unit, particularly each box 30, 50, 702, 704.

[0834] Specifically, the unique release information may refer to information that is unique and / or has a unique identifier, and the unique information specifically includes one or more pieces of release information, one or more pieces of information about executed and / or unexecuted production program packets, etc.

[0835] Each distributed database may be or may have been encrypted by an encryption key that may be specifically assigned and / or provided only to the process unit in which the distributed database may or is stored, and the encryption key is in particular stored in the security module mentioned above.

[0836] Each computing unit is configured and programmed to store the execution of each of the production program packets in a distributed database, subject to verification by the remaining computing units.

[0837] Each computing unit is further configured and programmed to execute a production program packet only to the extent that such production program packet is not stored in the distributed database as having already been executed.

[0838] Each computing unit is further configured and programmed to store one or more pieces of release information in its own distributed database, and to compare each received release information with each release information already stored in the distributed database, upon verification by the remaining computing units, to avoid duplicate use of the received release information in the production facility.

[0839] The instructions of a production program packet are executed by a processing unit or box 30, 50, 702, 704 only to the extent that release information belonging to such a production program packet has been provided to the computing unit and such production program packet and such release information are stored in the distributed database as not already executed.

[0840] In other words, the release information mechanism may grant authorization for the execution of a production program packet, which may be specifically stored in a distributed database, and specifically, at the time of each execution of a production program packet, it may be checked whether the number of previous executions is less than the authorized number of executions of the production program packet, and specifically, it may be stored in the distributed database that the production program packet has been executed, is being executed, or may be executed, so that the available number of executions can be reduced by 1 at the time of actual execution, thereby ensuring that the production program packet cannot be executed beyond the release limit.

[0841] It is contemplated that production facility 10 may have and / or be connectable to or connected to one or more additional computer systems, each of which may be spatially distinct from the rest of production facility 10, each of which may have a respective distributed database stored and operated on it, and each of which may be configured and programmed to verify the operation of the respective distributed database on the other and / or on each of the computing units, and to implement a unique distributed database in response to the verification. Such computer systems may in particular be formed by heartbeat server 800 and / or release server 900 and / or auxiliary computer system 1000.

[0842] Specifically, for the purpose of data evaluation and / or data optimization of deep learning of the production facility 10, the production facility 10 is configured to perform a simulation of its specific operation and / or specifically of the process.

[0843] This allows for example an optimization of the distance of the boxes 30, 50, 702, 704 and / or the transport vehicle 410 and / or the multi-axis robotic arm 302 or allows a corresponding optimization of the distance.

[0844] Additionally, the production progress predictions can be tested and / or realized to confirm or correct time slots corresponding to resources for completing the product 20.

[0845] Furthermore, order planning for one or more products 20 and / or production batches can be performed, specifically in terms of time and / or taking into account resources located within the production facility 10, such as boxes 30, 50, 702, 704 and / or tools and / or consumable materials, and / or the actual workload of the production facility 10.

[0846] For this purpose, the production facility 10 has a simulation device that is configured and programmed to simulate the operation of the production facility 10 and / or specifically the production of the product 20 based on at least one production program and to provide corresponding simulation results.

[0847] Like the control unit, the simulation device is also formed by all the calculation units of the respective process unit, and it is conceivable that the control unit in this embodiment functions as the simulation device and / or performs or implements the functions thereof.

[0848] The simulation device is configured and programmed to detect equipment parameters of the production facility 10 during the production of the product 20, and / or detect the storage process measurements and / or treatment process measurements of the process units, specifically the operating parameters of the process units, and store them as simulation information and save them for performing the simulation.

[0849] In other words, the simulation device - process-specific parameters and / or measurements, e.g., the sequence of treatments or process steps, and / or - equipment-specific parameters and / or measurements of the process units, in particular the process units 30, 50 and / or boxes 702, 704, and / or location parameters of the production facility 10, such as external temperature, air humidity, air pressure, and / or - patient-specific parameters and / or measurements, e.g., drug treatment history, and / or - tool-specific parameters and / or measurements of, for example, the tool units, in particular the tool boxes 702, 704; and / or - detecting material-specific parameters and / or measurements, e.g., of consumable materials, and storing simulation information and performing simulations; It is formed and programmed as follows.

[0850] As already mentioned, the production facility 10 comprises one or more sensor units, which are at least partially assigned to and / or form part of the process units.

[0851] The simulation device is configured and programmed to perform a simulation based on simulation information detectable or detected by such sensor units.

[0852] In particular, the sensor unit may be configured and / or formed as described in German Patent Application No. DE 10 2021 207 738.2, which is incorporated herein by reference.

[0853] In particular, the computing units forming the simulation device can simulate the parts of a production program that are to be executed by the associated process units.

[0854] In other words, each process unit, and more specifically each box 30, 50, 702, 704, is configured and programmed to simulate at least the portion of the production program that the corresponding process unit or 30, 50, 702, 704 must execute and / or would execute to actually produce product 20.

[0855] In further words, each process unit, specifically each box 30, 50, 702, 704, is configured and programmed to simulate at least one production program packet that the corresponding process unit or box 30, 50, 702, 704 must execute and / or would execute to contain and / or process the extract 40 when actually producing the product 20.

[0856] In the case of simulation, too, each production program packet to be simulated must be decoded by the respective computing unit, as has already been explained in connection with the (actual) execution of a production program packet.

[0857] Furthermore, simulations also require release by the release server 900. This was already explained in connection with the (actual) execution of production program packets.

[0858] That is, the execution of the simulation can be released by release information that can be received by the process unit.

[0859] That is, each release information is configured to allow either actual execution of the production program packet or only its simulation.

[0860] For this purpose, each release information includes 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 facility 10 for producing the product 20, or to a simulation mode of the production facility 10 for simulating the operation of the production facility 10 and / or the production of the product 20, in particular one or more production program packets or processing steps.

[0861] In other words, depending on the information stamp of the release information, the production program packet can be executed by the process unit, specifically boxes 30, 50, 702, 704, to actually contain and / or process the extract 40, or can be executed only for its simulation with respect to the process unit in question, specifically boxes 30, 50, 702, 704.

[0862] As already mentioned above, a simulation may also require release, at least partially or completely, by one or more release information. In essence, the release of a simulation may be performed similarly to the release of an actual production of product 20. This is explained in more detail below with respect to simulation.

[0863] The database of the release server 900 further contains release information for authorizing the simulation, and the database can be modified by reading out at least one of the release information for the simulation, so that such release information can subsequently no longer be provided for reading in its original form.

[0864] The database is configured and programmed to receive and store one or more new release information for authorizing a simulation solely outside of the production facility 10. For example, new release information for a simulation on the part of the database access authorizer 1000 may also be communicated to the database.

[0865] Specifically, to allow a single simulation, each production program packet can be uniquely assigned at least one of the release information.

[0866] In particular, the simulation can be initialized and / or started by the simulation device only to the extent that the overall production program packets of the production program and / or the overall release information assigned to the production program packets are available.

[0867] The one or more release information can be received and stored by at least one process unit, in particular boxes 30, 50, 702, 704, to allow and execute a time-delayed simulation of the containment and / or processing of the extract 40, and / or can be received in real time to allow and execute a direct simulation of the containment and / or processing of the extract 40.

[0868] It should be understood that the simulation by the simulation device also relates to dummy production program packets.

[0869] Furthermore, the simulation can specifically be initialized and / or started only to the extent that overall production program packets, including dummy production program packets of the production program, and / or overall release information assigned to the production program packets, including the dummy production program packets, can be provided or has been provided.

[0870] Furthermore, the production facility 10 may be able to switch to different states depending on the existence of a data connection with the heartbeat server 800, as previously described. In this case, the simulation may be enabled or disabled depending on the respective state.

[0871] As described above, the production facility 10 has a plurality of, specifically a large number of, sensor units.

[0872] The sensor unit may be configured as described in German patent application DE 102021 207 738.2, which is incorporated herein by reference.

[0873] Specifically, the production facility 10 includes one or more sensor units for determining one or more values ​​of one or more parameters of one or more extracts 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 consumable materials.

[0874] The sensor unit serves in particular to determine the processing progress of the extract 40 during processing or between two processing steps.

[0875] The sensor device in particular serves to control and / or adjust one or more tool units for carrying out one or more processing steps depending on one or more determined values, in particular one or more processing parameters are changed or can be modified depending on the determined processing progress.

[0876] The sensor unit serves to monitor the storage conditions and / or storage amounts in particular in the storage device 400 , for example in the storage location 402 .

[0877] Additionally, as previously mentioned, at least some of the sensor units of the production facility 10 are located and / or contained within the process units, specifically the patient boxes 30, 50 and / or tool boxes 702, 704.

[0878] In this case, each sensor unit, or at least each sensor unit of the process unit, in particular the patient box 30, 50 and / or the tool box 702, 704, is configured to detect and provide to a respective computing unit at least one measurement value related to the containment and / or processing of the extract 40 and / or related to the process unit itself, for transmission in encrypted and abstracted form to one or more eligible receiving units.

[0879] This allows the measured values ​​and / or information to be made unidentifiable on the process unit side, so that information leakage to unauthorized persons, for example by tampering with the tapping, can be avoided.

[0880] In other words, at least one measurement value detectable by one or more sensor units is / is first made unidentifiable before such measurement value can be communicated to one or more eligible receiving units.

[0881] In this embodiment, the one or more eligible units are one or more other process units and / or control units of production facility 10 .

[0882] Information representative of the at least one detectable measurement value is modifiable by the computing unit, and one or more eligible recipient units are configured and programmed to interpret the modified information.

[0883] The information may be amendable in an encrypted and / or abstracted state, and may be decipherable and / or embodied by one or more eligible recipient units.

[0884] In other words, the modification includes encryption and / or abstraction.

[0885] As mentioned above, again encryption specifically relates to public key encryption.

[0886] Abstraction may involve, as a simple, non-limiting example, the omission of specific physical units: First, one or more eligible units can interpret the pure numerical value and / or reassign it to the correct specific physical unit.

[0887] Thus, the information depth or information content of the at least one measurement may be able to be preserved, in other words, there is no information loss.

[0888] Each computing unit is configured and programmed to provide information, either solely or exclusively as modified information, for transmission to one or more eligible recipient units.

[0889] The transmitted information is stored in one or more eligible units, in particular for process optimization of the production facility 10. In particular, such information serves as or forms described simulation information.

[0890] Each computing unit further comprises a communication module, in particular a Bluetooth module, advantageously a Bluetooth Low Energy module, and / or a Wi-Fi module.

[0891] Each computing unit is further configured and programmed to form a network with each other computing unit for communication by at least one communication module.

[0892] It should be understood that the communication module may be configured in other ways, for example, the communication module may be based on ZigBee technology, 6LoWPAN technology, LoRaWAN technology, NB-IoT technology, LTE technology, 5G technology, Wi-Fi technology, etc.

[0893] Specifically, see below for reference to Figures 2 to 11.

[0894] 2, an enlarged view of the locking device 200 of FIG. 1 is shown in particular.

[0895] Here, the handling device 300 includes a multi-axis robotic arm 302 positioned adjacent to the locking device 200 .

[0896] One of the free-running transport vehicles 410 can move objects within the locking device 200, and can transport one or more objects from a locking location, specifically the entry locking location 206, to a further locking location, specifically the delivery locking location 216, and / or from a locking location, specifically the delivery locking location, to a further locking location, specifically the exit locking location 208.

[0897] Further, with reference to FIG. 2 , a patient box 30 containing and holding an extract 40 disposed within an extract container 42 is positioned on a free-running transport vehicle 410 at the entrance lock location 206.

[0898] The patient boxes 30, 50 shown in Figures 2 and 3, which are placed on a transport vehicle 410, are delivered by the transport vehicle 410 to the entrance lock location 206 to receive the extract container 42 in a process not shown.

[0899] In this case, the user first selects a production program for the production facility 10 via, for example, the HMI interface 602 to produce the desired product 20 from the extract 40 .

[0900] As soon as all release information from the release server 900 and all production program packets for the selected production program are present, the production program can start.

[0901] It should be understood that before each execution of a production program packet, the integrity of the process unit in question is determined, and only to the extent that integrity exists is the production program packet executed.

[0902] The control unit performs the allocation of the extracts 40 to be processed to the patient boxes 30, 50. The patient boxes are assigned and / or have stored thereon the start packets of the selected production programs.

[0903] After such allocation, the patient box 30, 50 is delivered to the entrance lock location 206 on the transport vehicle 410. This process may also be performed based on a follow-up packet of the start packet, in which case the transport vehicle 410 is the execution processing unit of said follow-up packet.

[0904] As previously mentioned, each step, particularly a processing step, and / or each production program packet, particularly a start packet and a follow packet, requires release information.

[0905] Furthermore, it should be understood that each decryption on a processing unit is performed in each case by means of the key recorded therein.

[0906] In other words, for each process, specifically the processing steps, the production program packet, the release information, and one or more encryption keys are collected in the corresponding process unit.

[0907] As a result, the user places the extract container 42 with the extract 40 placed therein into the patient box 30, 50 provided at the entrance lock location 206, i.e., into the patient box 30, 50 assigned to contain the extract 40 based on the production program by the control unit.

[0908] It is assumed that a patient box 30, 50 stored in a storage location 402 on one of the storage shelves 404 is removed from the stora...

Claims

1. A production facility (10) for producing a product (20), in particular a biological product (20), comprising: a plurality of process units (30, 50, 702, 704) for containing and / or processing the extract (40), each process unit (30, 50, 702, 704) having at least one calculation unit; The production facility (10) is configured and programmed with at least one computing unit to determine the integrity of a corresponding process unit (30, 50, 702, 704) before an extract (40) can be received and / or processed by the process unit (30, 50, 702, 704) in accordance with one of a plurality of production programs for producing one of a plurality of products (20) producible by the production facility (10).

2. the computing unit of the process unit (30, 50, 702, 704) is configured and programmed to store and / or provide univocal information related to the process unit (30, 50, 702, 704) and to detect further univocal information related to the process unit (30, 50, 702, 704), the integrity of the process unit (30, 50, 702, 704) being determinable by the computing unit based on a comparison of the two univocal pieces of information, and in particular being settable and / or confirmed when the two univocal pieces of information match; Advantageously, the unique information comprises a starting state of the process unit (30, 50, 702, 704) in question and a starting timestamp assignable to the starting state, and the further unique information comprises a further state of the process unit (30, 50, 702, 704) in question and a further timestamp assignable to the further state, the further timestamp being different from the starting timestamp.

3. 3. The production installation (10) according to claim 1 or 2, characterized in that one or more, in particular all, process units (30, 50, 702, 704) have at least one accommodation chamber, in particular surrounded by sides, for accommodating one or more objects, in particular the extract (40) and / or one or more objects for processing said extract (40), and said integrity comprises an internal integrity with respect to said accommodation chamber and / or an external integrity with respect to the outside of said accommodation chamber.

4. the process unit (30, 50, 702, 704) has one or more sensor units by means of which unambiguous information and / or further unambiguous information about the process unit (30, 50, 702, 704) in question can be detected in order to determine the integrity, in particular the internal integrity, Advantageously, the production installation (10) according to any one of claims 1 to 3 is characterized in that at least one sensor unit is capable of detecting brightness values ​​in and / or of the process unit (30, 50, 702, 704) in question and is capable of providing the unambiguous information and / or the further unambiguous information about the process unit (30, 50, 702, 704) in question for determining the integrity, in particular the internal integrity, based on the detectable brightness values.

5. a process unit (30, 50, 702, 704) has one or more actuator units by which the process unit (30, 50, 702, 704) in question can be excited, in particular mechanically, in order to generate mechanical vibrations, the vibrations being detectable by one or more sensor units, and based on the vibrations the unambiguous information and / or the further unambiguous information about the process unit (30, 50, 702, 704) in question can be provided for determining the integrity, Advantageously, the vibrations comprise a frequency range of 10 Hz to 100 Hz, and / or the vibrations comprise one or more, in particular various, frequency ranges, each of 10 Hz to 100 Hz, and / or the vibrations comprise one or more, in particular various, frequency ranges that follow one another in a predetermined order, and wherein at least one of the one or more actuator units is formed as a vibration motor, the vibration motor being fixed in and / or to the process unit (30, 50, 702, 704) in question for generating the mechanical vibrations.

6. at least one of the one or more actuator units is configured to generate acoustic vibrations, particularly sound waves, and is fixed within and / or to the corresponding process unit (30, 50, 702, 704) to generate the mechanical vibrations, particularly sound waves, for the corresponding process unit (30, 50, 702, 704); in particular, 6. The production installation (10) according to claim 5, characterized in that the vibrations comprise a frequency range of 30 Hz or more and 10,000 Hz or less, and / or the vibrations comprise one or more, in particular various, frequency ranges, each of 30 Hz or more and 10,000 Hz or less, and / or the vibrations comprise one or more, in particular various, frequency ranges that follow each other in a predetermined order.

7. 7. The production installation (10) according to claim 4, wherein the process unit (30, 50, 702, 704) has one or more electrically conductive conductor elements arranged at and / or within the process unit (30, 50, 702, 704) and / or arranged inside a side wall of the process unit (30, 50, 702, 704) and specifically forming an independent current circuit, wherein one or more sensor units are able to detect whether the current circuit has been altered relative to its original state and / or whether it has been interrupted, and wherein, based on the detection of the current circuit, the unambiguous information and / or the further unambiguous information about the process unit (30, 50, 702, 704) in question can be provided for determining the integrity.

8. at least one sensor unit is configured as an inertial measurement unit by which at least one acceleration value, in particular an acceleration vector, and / or at least one rotational speed value, in particular a rotational speed vector, for the process unit (30, 50, 702, 704) in question can be detected, and the unambiguous information and / or the further unambiguous information for the process unit (30, 50, 702, 704) in question can be provided for determining the integrity based on the detectable acceleration value and / or rotational speed value, Preferably, the production facility (10) comprises a handling device for moving objects within the production facility (10) and / or one or more actuator units by means of which the process unit (30, 50, 702, 704) in question can be mechanically excited to generate a specifically defined movement, which movement can be detected by the inertial measurement unit, and based on which the unambiguous information and / or the further unambiguous information about the process unit (30, 50, 702, 704) in question can be provided for determining the integrity.

9. 9. The production installation (10) according to claim 4, wherein at least one sensor unit is capable of detecting temperature values ​​in and / or at the process unit (30, 50, 702, 704) in question, and the unambiguous information and / or the further unambiguous information about the process unit (30, 50, 702, 704) in question can be provided for determining the integrity based on the detectable temperature values.

10. 10. The production installation (10) according to claim 4, wherein at least one sensor unit is capable of at least partially visually detecting the process unit (30, 50, 702, 704) in question, and the unambiguous information and / or the further unambiguous information regarding the process unit (30, 50, 702, 704) in question can be provided for determining the completeness based on the visual detection, in particular, the at least one sensor unit includes a camera unit by means of which characteristic landmarks and / or geometry of the process unit (30, 50, 702, 704) in question can be visually detected.

11. The production facility (10) has at least one control unit, the control unit being configured and programmed to determine the integrity of each process unit (30, 50, 702, 704) before the extract (40) can be received and / or processed by the process unit (30, 50, 702, 704) according to one of a plurality of production programs for producing one of a plurality of products (20) producible by the production facility (10), in particular, the calculation unit of the process unit (30, 50, 702, 704) determining the integrity of the process unit (30, 50, 702, 704) before the extract (40) can be received and / or processed by the process unit (30, 50, 702, 704) according to one of a plurality of production programs for producing one of a plurality of products (20) producible by the production facility (10), in particular 11. The production installation (10) according to claim 1, further configured and programmed to provide unambiguous information about the process unit (30, 50, 702, 704), and wherein the at least one control unit can detect further unambiguous information about the process unit (30, 50, 702, 704), and the integrity of the process unit (30, 50, 702, 704) can be determined by the at least one control unit based on a comparison of the two unambiguous pieces of information, and is settable and / or confirmed when the two unambiguous pieces of information match.

12. each process unit (30, 50, 702, 704) has one or more sensor units, each sensor unit configured to detect and provide to said computing unit at least one measurement value related to the storage and / or processing of said extract (40) and / or related to said process unit (30, 50, 702, 704) itself for transmission in encrypted and abstracted form to one or more eligible recipient units, Advantageously, the one or more eligible recipient units include one or more other process units (30, 50, 702, 704), and / or at least one higher-level control unit of the production facility (10), and / or a computer system assigned or assignable to the production facility (10).

13. the information representative of the at least one detectable measurement value is modifiable by the sensor unit itself, and the one or more eligible recipient units are configured and programmed to interpret the modified information; and / or 13. The production installation (10) of claim 12, characterized in that the information representative of the at least one detectable measurement value is modifiable by the computing unit, and the one or more eligible receiving units are configured and programmed to interpret the modified information.

14. 14. The production facility (10) according to claim 13, characterized in that the information is modifiable in an encrypted and / or abstracted state and is decipherable and / or tangible by the one or more eligible recipient units, and / or each computing unit is configured and programmed to provide the information for transmission to the one or more eligible recipient units only as modified information.

15. 15. The production installation (10) according to any one of claims 12 to 14, characterized in that each calculation unit is configured and programmed to evaluate the at least one detectable measurement value according to parameter ranges storable or stored in the calculation unit, and subsequently to provide only the result of the evaluation of the at least one detectable measurement value for transmission to one or more eligible recipient units.

16. the transmitted information is configured to be stored in the one or more eligible units, in particular for process optimization of the production facility (10); and / or 16. A production installation (10) according to any one of claims 12 to 15, characterized in that the transmitted information is configured to be stored in the one or more eligible units according to different data categories, and advantageously 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 the information.

17. each computing unit has at least one communication module, in particular a Bluetooth module, preferably a Bluetooth Low Energy module and / or a Wi-Fi module, and each computing unit is configured and programmed to form a network with each other computing unit for information transmission by said at least one communication module, Advantageously, a) one or more of the computing units are configured and programmed as a network node and / or hub to communicate information from the processing unit (30, 50, 702, 704) to the one or more eligible recipient units by means of the at least one communication module; and / or b) one or more of said computing units are configured and programmed as a gateway to communicate from said processing unit (30, 50, 702, 704) to said one or more eligible units by means of said at least one communication module; 17. A production installation (10) according to any one of claims 12 to 16, characterized in that:

Images