Production equipment and methods for producing products

Abstract

The present application relates to a production facility (10) for producing a product (20), particularly a biological product (20), and / or a method for producing a product (20), particularly a biological product (20).

Description

[Technical field]

[0001] FIELD OF THEINVENTION The present invention relates to a production facility and a method for producing a product. In particular, the present invention relates to a production facility for producing a biologic product and a method for producing a biologic product. [Background technology]

[0002] Conventional production systems, especially in the field of personalized therapeutics, have a high proportion of manual intervention, which, although it does indeed make it possible to produce such therapeutics at a high level of personalization or in a highly personalized form, entails high costs for such individual and / or minimum scale production and results in high quality variations and thus in a large amount of production waste and / or rejects being recorded. Furthermore, there is no possibility for large-scale application and / or industrial production of individual and / or minimum batch sizes. Summary of the Invention [Problem to be solved by the invention]

[0003] The problem underlying the present invention is to solve the aforementioned problems and to make it possible to produce individual and / or minimum batch sizes of products, in particular in the pharmaceutical field, efficiently and in particular with a quality that remains unchanged. [Means for solving the problem]

[0004] This problem is solved according to the invention by the features of claim 1. Advantageous further configurations of the invention are set out in the dependent claims. Effect of the Invention

[0005] The production plant according to the invention, in particular for the production of biological products, advantageously comprises: - particularly suitable clean room areas, - a locking device for feeding and / or removing objects from the surroundings of the production facility into and / or from a particularly preferred clean room area, - a handling device for moving objects within the cleanroom area; - a storage device disposed within the cleanroom area, the storage device including a plurality of storage locations for receiving a plurality of objects; Includes.

[0006] The objects, in particular objects from the surroundings of the production facility for feeding into the clean room area and / or objects for removing from the clean room area, are: - 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 extract-contacting and / or product-contacting tool units, and / or in particular extract-non-contacting and / or product-contacting tools or extract-non-contacting and / or product-contacting 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 the following:

[0007] It should be understood that the foregoing list is illustrative and not exhaustive.

[0008] Alternatively or additionally, the object may include one or more of the above listed elements and / or combinations thereof.

[0009] The extract may comprise cells and / or biological materials other than cells.

[0010] The extract may be at least partially liquid and / or at least partially semi-solid and / or at least partially solid.

[0011] Alternatively, the extract may be entirely liquid, or entirely semi-solid, or entirely semi-solid.

[0012] The cells of the extract are particularly as a cell suspension, e.g. cells in suspension culture, or - as adherent cells, for example cells on the culture surface, in particular of a container or extract container, for example of a culture container and / or pouch, It may be present, for example formed.

[0013] The cells may be at least partially fresh and / or at least partially frozen, such that to some extent the extract may be present in, for example, a liquid, semi-solid, and / or solid state.

[0014] The extract may be arranged in a container or extract container, in particular a vessel, such as a culture vessel, cell culture vessel, bottle, vial, pouch, cassette (e.g. a cassette made of a particularly biocompatible hard plastic), and / or titer plate (e.g. a microtiter plate). The container or extract container, including the above examples, may be appropriate in each case, in particular biocompatible, partially or completely coated, and / or partially or completely uncoated.

[0015] The volume of the container for containing and processing the extract may be between 1 μl and 1000 ml, in particular between 1 μl and 500 ml, more in particular between 1 μl and 1000 μl. The volume may be, for example, 250 ml or 750 ml. Furthermore, the volume may be smaller than 1 μl and / or larger than 1000 ml.

[0016] The product may be a biologic product for personalized therapy.

[0017] In effect, the biologic product may be a personalized therapeutic.

[0018] The or said personalization may be present for one patient or for a group of patients, in other words for one or more patients.

[0019] The biologic product can be, for example, a cellular therapy, such as an autologous and / or allogeneic cellular therapy, or a genetic therapy, such as an autologous gene and / or an allogeneic gene therapy.

[0020] The clean room area can define a sterile production area. The clean room area can have at least one clean room classification CNC (i.e., controlled but not compartmentalized) based on Good Manufacturing Practice (GMP) for pharmaceutical products.

[0021] It is contemplated that the clean room area may include at least one of clean room areas D, C, B, or A that are Good Manufacturing Practice (GMP) based for pharmaceutical products.

[0022] The clean room area may have a positive pressure, in particular to protect the extract and / or product in terms of sterility, and may also have a negative pressure, in particular in areas of the clean room area separated from the positive pressure area, in order to protect workers or users from the extract and / or product.

[0023] The production facility may have a system for adjusting ambient properties of a cleanroom area.

[0024] The system for adjusting the ambient properties of the cleanroom area can in particular comprise a pneumatic device, by means of which the air pressure, in particular the positive and / or negative pressure in the cleanroom area, can be adjusted.

[0025] Additionally or alternatively, the air device can also regulate the air circulation, including the air introduction and / or air discharge into or from the clean room area and / or the air return guidance inside the clean room area, in particular via one or more filter devices of a system for regulating the ambient properties.

[0026] In effect, the positive pressure area within the production facility may define and / or be a clean room area.

[0027] The production facility may have a housing for separating / dividing cleanroom areas, in particular towards the periphery 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.

[0028] The housing may enclose virtually the entire production facility.

[0029] The locking device may be configured for feeding objects from the periphery of the production facility via or through the housing into the cleanroom area and / or for removing objects from the cleanroom area via or through the housing. In effect, the locking device may serve as at least one interface of the housing surrounding at least the cleanroom area towards the periphery of the production facility, for example as at least one inlet and / or as at least one outlet.

[0030] Additionally or alternatively, the locking device may have at least one inlet lock and at least one outlet lock, in other words, the locking device may have one or more inlet locks and one or more outlet locks, which may be useful in particular for directional object guidance or for directional object flow.

[0031] Additionally or alternatively, the inlet and outlet locks can be classified with respect to the objects to be passed by them and can be provided accordingly as part of the locking device, for example, one inlet and one outlet lock each for extractives and / or consumable materials and / or tools or tool units and / or waste, or any combination thereof.

[0032] For example, the entrance lock and / or the exit lock may serve as the interface of the clean room area to the perimeter of the production facility.

[0033] The locking device may comprise one or more maintenance locks, via which the cleanroom area can be accessed from the periphery of the production facility, in particular by personnel or users.

[0034] Additionally or alternatively, the maintenance lock or locks may be configured as a respective device of the production installation, separate from the locking device.

[0035] Additionally or alternatively, the clean room area may comprise a number of clean room sub-areas.

[0036] In other words, the clean room area may be divided into multiple clean room sub-areas.

[0037] For example, it is conceivable that the handling device and the storage device are arranged in one common cleanroom sub-area or in different cleanroom sub-areas.

[0038] The cleanroom sub-areas can have the same cleanroom classification or different cleanroom classifications.

[0039] One or more cleanroom sub-areas may have different positive pressures.

[0040] In other words, one or more clean room sub-areas may have a pressure difference with respect to the positive pressure.

[0041] The clean room classification is based on the Good Manufacturing Practice (GMP) for pharmaceutical products, namely: Cleanroom Classification CNC, Clean room classification D, Clean room classification C, Clean room classification B, Cleanroom Class A It may be one of:

[0042] Each clean room part area may be assigned a respective part area housing, in particular for separating / dividing the respective clean room part area and for obtaining its clean room classification.

[0043] Additionally or alternatively, cleanroom part areas with the same cleanroom classification may be assigned one common part area housing.

[0044] The respective part area housing and / or the common part area housing can each be configured as a part of the housing of the production facility.

[0045] Additionally or alternatively, the individual part area housings and / or the common part area housing can be designed separately, in particular independently.

[0046] At least one partial area locking device may be assigned to each partial area housing, which may be formed as part of such a partial area housing.

[0047] Additionally or alternatively, the at least one partial area locking device can be designed separately, in particular independently.

[0048] Each part-area locking device may be designed for feeding objects from one clean room part-area into another clean room part-area and / or for removing objects from one clean room part-area into another clean room part-area.

[0049] A cleanroom sub-area may be divided into several sub-cleanroom sub-areas, see the description of the cleanroom sub-areas for possible structures and / or configurations of the sub-cleanroom sub-areas.

[0050] One or more cleanroom part areas with cleanroom classification A may be arranged in particular for processes and / or procedures for processing and / or transport and / or storage and / or analysis and / or packaging and / or unpacking, in which contact of extracts, intermediate products and / or products may occur or in which there may be a specific theoretical possibility of such contact by one or more objects which may lead to contamination, e.g. by one or more tools and / or one or more consumable materials and / or one or more devices of a production facility.

[0051] One or more clean room part areas with clean room classification B may be arranged in relation to the locking devices, storage devices, in particular storage locations of the storage devices, handling devices and / or cleaning devices of the production facility. Additionally or alternatively, one or more clean room part areas with clean room classification A may also be arranged in relation to this.

[0052] One or more clean room sub-areas with clean room classification C or D may be arranged with respect to the storage and transport device of the storage device.

[0053] One or more clean room part areas with clean room classification CNC may be arranged with respect to one or more spatial remaining areas of the production facility, in particular such one or more spatial remaining areas may be provided for technical crews and machines required for the general operation of the production facility and / or the production facility part.

[0054] The production facility may have one or more current sources and / or one or more interfaces that can be connected to one or more current sources. The current sources are arranged in the cleanroom area, in particular inside the housing, and are designed to supply current to at least one of the components contained by the production facility or to a component part of the production facility. The component or part is assigned to one or more current sources, for example via one or more interfaces.

[0055] Additionally or alternatively, one or more current sources may be arranged within the periphery of the production equipment and / or may be spatially separated or isolated, and the current sources may be connectable or connected to the production equipment.

[0056] The production facility may have one or more control units, which are arranged in the cleanroom area, in particular inside the housing, or in the production facility and are configured and programmed to regulate and / or control at least one of the components contained by the production facility or parts of the production facility, the components or parts being assigned to one or more control units.

[0057] Additionally or alternatively, the one or more control units may be arranged within the periphery of the production facility and / or may be arranged spatially separated or isolated and may be connectable or connected to the production facility, in particular wirelessly and / or via wires, for example via one or more communication interfaces of the production facility.

[0058] The one or more control units may be connectable to one or more data processing systems and / or computer systems, in particular external, i.e. not included by the production facility, e.g. via one or more communication interfaces of the production facility, in particular wirelessly or via wires.

[0059] Additionally or alternatively, the 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.

[0060] The production facility may include a number of workpiece supports, which serve to accommodate objects, in particular extractables and / or tools and / or consumable materials.

[0061] One or more clean room sub-areas having clean room classification A may be arranged with respect to the workpiece support.

[0062] Additionally or alternatively, one or more clean room part areas with clean room classification B may be arranged relative to the workpiece support.

[0063] The workpiece support may be located only within and / or between one or more cleanroom sub-areas having the same and / or homogenous cleanroom classification.

[0064] Each workpiece support may have fastening means, in particular positive and / or frictional and / or magnetic fastening means, for receiving 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.

[0065] The workpiece support may remain permanently within the clean room area, in particular over one or more complete production runs.

[0066] The production facility can include a plurality of types of workpiece supports, which differ from one another with respect to the shape and size of the receiving area of ​​the respective workpiece supports. One type of workpiece support can serve to receive a container for containing an extract, for example a culture vessel.

[0067] One type of workpiece support may serve to receive 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.

[0068] One type of workpiece support can serve to receive consumable material, for delivering the consumable material to the extract and / or for performing a processing process on the extract.

[0069] The one or more workpiece supports may each include one or more action units for performing an action on the extractor and / or tool.

[0070] The action unit or units may be formed as a processing unit, for example a tool unit, for carrying out a processing step on the extract.

[0071] The processing unit, e.g. a tool unit, may be designed to perform up-down movements and / or tilting movements and / or shaking movements and / or rotational movements, in particular by means of at least one appropriately assigned actuator unit or actuator device unit, so that movements of this type, e.g. a combination of these types of movements, can be transmitted to the extract.

[0072] The processing unit, for example a tool unit or a component of a tool unit, may be designed for temperature regulation, in particular heating and / or cooling, of the workpiece support.

[0073] The one or more action units may be formed as sensor units for determining actual 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.

[0074] The parameters may in particular be one of the following: temperature of the workpiece support and / or the object received by the workpiece support, air humidity, ambient pressure, gas mixture composition, position, e.g. angular position, vibration, occupancy, in particular occupancy state, e.g. storage occupancy state, and positioning, e.g. captured or uncaptured positioning, and / or current position positioning.

[0075] It should be understood that the foregoing list is illustrative and not exhaustive.

[0076] Alternatively or additionally, the parameters may be a combination of the aforementioned enumerated elements.

[0077] One or more of the workpiece supports may include a storage device for storing energy and / or one or more consumable materials.

[0078] The workpiece support may be reusable multiple times, and in particular the storage device may be rechargeable and / or replenished with consumable materials.

[0079] 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.

[0080] The production facility may include a charging station located within the clean room area for charging the storage devices, and / or a refill station located within the clean room area for filling the storage devices.

[0081] The refilling station can be configured as a stationary refilling station, to which expendable material can be supplied via a locking device in order to fill the refilling station.

[0082] The refilling station is configured as a mobile refilling station, which can in particular be supplied, when filled with consumable material, from the surroundings of the production facility via the locking device into the clean room area, and can in particular be removed from the clean room area via the locking device, when empty of consumable material.

[0083] The refill station may in particular be positionable, for example positioned, on a storage location of the storage device.

[0084] The refilling station may, for example, comprise a container for a liquid or may be formed as a container for a liquid.

[0085] The volume of the container for liquid of the refilling station may be, for example, between 1 ml and 100 l, preferably between 50 ml and 50 l. The container may have an interface for withdrawal and / or for filling of the liquid.

[0086] The workpiece support or supports can have one or more coupling devices, by means of which two or more, in particular two or more, workpiece supports can be connected to one another.

[0087] The storage device may include a storage transport device for transporting objects to and / or away from the storage location.

[0088] The handling device can 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 can be configured as a lock-transport device or as part of the lock-transport device and can be assigned to such.

[0089] The storage and transport device may be a device different from the handling device.

[0090] The storage and transport device may include a rail-guided transport system and / or one or more free-running transport vehicles.

[0091] The storage and transport device may include one or more rail-guided storage and transport units, by means of which one or more storage shelves of the storage device may be accessed, in particular for storage and removal processes, as well as for processing and / or maintenance processes.

[0092] The storage and transport apparatus may include one or more storage and transport units formed as a portal conveyor.

[0093] Additionally or alternatively, the storage and transport device may include a storage and transport unit configured as a pick-and-place robot or as a wire robot.

[0094] By means of one or more portal conveyors, one or more storage location faces of the storage device may be accessible for storage and removal processes, as well as for processing and / or maintenance processes.

[0095] The storage-transport device, in particular the rail-guided transport system, the free-running transport vehicle(s), the rail-guided storage-transport unit(s) and / or the portal conveyor(s) may be induction-loop guided, magnetically guided, in particular permanently magnetically 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.

[0096] The storage and transport device, in particular the rail-guided transport system, one or more free-running transport vehicles, one or more rail-guided storage and transport units and / or one or more portal conveyors may be configured, for example, to run through at least two clean room partial areas having different clean room classifications.

[0097] The storage-transport device, in particular the rail-guided transport system, the free-running transport vehicle(s), the rail-guided storage-transport unit(s) and / or the portal conveyor(s) can be configured to be at least partially encapsulated, so that, for example in the case of an encapsulated actuator system of the storage-transport device, liberation of contaminants, which may occur in particular due to particle wear of the actuator device, can be avoided or at least reduced.

[0098] 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 removal processes, as well as for processing and / or maintenance processes.

[0099] The handling device may be or may include a multi-axis robotic arm.

[0100] 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 arranged on a planar carrier.

[0101] Additionally or alternatively, the rail-guided transport system of the storage-transport device and / or the one or more free-running transport vehicles may each include at least one multi-axis robotic arm.

[0102] The storage and transport devices and / or handling devices may be assigned an exchange device 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.

[0103] The exchange device can have at least one adapter device and / or at least one matrix device, which are respectively designed corresponding to the gripping unit and / or the support unit, so that these units can be gripped in a particularly form-fitting manner and can be attached to one or more storage-transport units of the storage-transport device and / or to one or more handling units of the handling device.

[0104] The storage-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-transport units of the storage-transport device and / or at least one gripping unit and / or carrier unit of one or more handling units of the handling device can be cleaned, in particular after carrying out a storage, transport, handling, maintenance and / or processing step. The cleaning device may be arranged in particular for cleaning while applying irradiation and / or gas treatment.

[0105] A cleaning device of a production facility assigned to the storage / transport device and / or the handling device may be arranged within the clean room area, in particular in or at the locking device or, for example, directly adjacent to the locking device. A cleaning device of a production facility assigned to the storage / transport device and / or the handling device may be spatially separated from the locking device within the clean room area.

[0106] By means of the handling device, one or more objects, for example as mentioned above, can be transferred from a locking location of the locking device to the storage-transport device, in particular to one or more storage-transport units of the storage-transport device.

[0107] The locking device may include an entrance lock, through which a lock location, in particular the entrance lock location, is accessible from the periphery and which is configured to feed objects into the cleanroom area from the periphery of the production facility, and an exit lock, through which a lock location, in particular the exit lock location, is accessible from the periphery and which is configured to remove objects from the cleanroom area.

[0108] 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 handover lock location, and / or from a lock location, in particular a handover lock location, to a further lock location, in particular an exit lock location.

[0109] 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.

[0110] 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 also be provided in the locking device.

[0111] The entrance locking location may be assigned an unpacking location, arranged adjacently or spatially separated. Additionally or alternatively, the entrance locking location may be the unpacking location.

[0112] The exit locking location may be assigned a packing location, arranged adjacently or spatially separated. Additionally or alternatively, the exit locking location may be a packing location.

[0113] The storage and transport device and / or the handling device may each include one or more workpiece support receivers for receiving and transporting one or more workpiece supports, in particular one or more of the aforementioned workpiece supports.

[0114] 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 a 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 receiving portions.

[0115] In other words, one or more workpiece support exchanges may be possible, for example be performed, by the handling device.

[0116] The locking device may include a cleaning device for cleaning the workpiece support(s) and / or for cleaning the workpiece support(s) receiver(s).

[0117] The production facility may include a cleaning device to which the workpiece supports may be fed for cleaning themselves, in particular after a transport of an object by the respective workpiece support has taken place.

[0118] The cleaning device assigned to the storage / transport device and / or the 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.

[0119] Any of the respective cleaning devices may be at least partially or completely formed separately from one another, in particular so as to form independent devices.

[0120] A storage device may include one or more storage shelves and / or one or more storage location surfaces, each having a plurality of storage locations.

[0121] The individual storage locations can have different clean room sub-areas, in this connection reference should be made additionally to the corresponding descriptive parts regarding the clean room classification.

[0122] Each storage location may serve as a decoupling area and / or space to areas and / or spaces serving for the performance of a treatment process.

[0123] The storage locations can be thermostatable, in particular individually thermostatable, in particular by means of respectively assigned thermostats of the storage devices.

[0124] The storage locations may be thermally decoupled from one another by thermal isolation materials and / or may be decouplable, so that the storage locations can be thermoregulated independently and / or differently from one another by the respective assigned thermoregulation devices, e.g. heated or cooled.

[0125] It is also conceivable that the thermal decoupling of the at least two storage locations is effected by means of a further storage location arranged between the at least two storage locations, for example a storage location, which may not be temperature regulated, in particular for tools.

[0126] A plurality of storage location surfaces, in particular two or more storage location surfaces, may be arranged one above the other, in particular in the height direction.

[0127] In effect, multiple storage locations may be arranged in a stack.

[0128] 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 one another or may be connected to one another via a storage transport device, in particular via one or more lift devices of the storage transport device.

[0129] By means of the storage and transport device, the extracts and / or the tools and / or the consumable materials may be able to be stored in a storage location or may be able to be withdrawn from a storage location.

[0130] In particular, by means of a storage transport device of the storage device, the extract and / or the workpiece support and / or the tool and / or the consumable material may be storeable into the storage location or may be withdrawable from the storage location.

[0131] One or more storage locations may be accessible from multiple directions and / or by multiple storage and transport units of a storage and transport apparatus, for example, a storage shelf may be arranged between, for example, two storage and transport units, thereby ensuring accessibility to the intermediate storage shelf from each storage and transport unit, or, for example, both of the two storage and transport units may have access to the intermediate storage shelf.

[0132] It is conceivable, for example, that a further storage shelf is arranged on each of the two storage-transport units on different sides.

[0133] In effect, there may be a storage shelf-storage and transport unit-storage shelf-storage and transport unit-storage shelf-arrangement.

[0134] It is conceivable that in the intermediate or middle storage shelf, in particular tools and / or consumable materials can be stored, and in the respective outer storage shelves, extracts can be stored.

[0135] Such an exemplary arrangement may, for example, allow for a short distance from the tool and / or consumable material in particular to the extractable material.

[0136] Comparable advantages in terms of short distances or distance optimization can be achieved in addition to such an alternating arrangement of the storage shelves, for example, by a star-shaped arrangement of the storage shelves, which can in this case also or alternatively be provided.

[0137] The storage locations may be accessible by the storage transport device vertically from above or horizontally from the side. A plurality of rows of storage locations oriented substantially horizontally may be arranged vertically above one another.

[0138] In effect, the storage locations may be arranged in rows and columns.

[0139] Some of the storage locations, and in particular the entire storage location, may be shelf locations of one or more storage shelves.

[0140] The storage system may include a number of different types of storage locations for accommodating different types of workpiece supports.

[0141] The various types of storage locations may differ from one another with regard to their shape and / or size.

[0142] The various types of storage locations may differ from one another with regard to their functionality and / or configuration.

[0143] The various types of storage locations may be arranged on storage location shelves and / or in storage location planes of the storage device, distributed in a regular pattern.

[0144] This makes it possible to ensure rapid access to the tools required, for example, for processing the extract.

[0145] The various types of storage locations may be arranged on the storage location shelves and / or storage location surfaces of the storage device based on an optimized, in particular minimal, distance to the objects to be stored or stored in the storage locations.

[0146] This makes it possible, for example, to ensure rapid access of tools required for processing the extract.

[0147] The storage device may have multiple areas for receiving different types of workpiece supports.

[0148] The storage device may include a number of storage locations forming processing stations for processing the extract.

[0149] The storage device may include a number of storage locations forming tool stations for storing, maintaining, cleaning, replacing, charging, and / or controlling tools.

[0150] The storage device may include a number of storage locations with one or more interfaces, in particular for current supply and / or signal transmission, such as control and / or regulating 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 workpiece support, for example a storage box.

[0151] The workpiece carrier already mentioned can in particular be designed as a receiving box for receiving the extract.

[0152] Additionally or alternatively, the production facility may include a number of storage boxes for storing one or more workpiece supports, respectively, together with the extract placed thereon and / or received thereon.

[0153] In effect, the production facility can include a plurality of workpiece supports formed as storage boxes for storing the extract, or a plurality of storage boxes for storing one or more workpiece supports, respectively, together with the extract arranged and / or received therein.

[0154] The containment box may define a process cell, in particular a sterile process cell, or a process unit, in particular a sterile process unit.

[0155] In effect, the containment box may be a process cell, in particular a sterile process cell, or a process unit, in particular a sterile process unit.

[0156] One or more cleanroom part areas with cleanroom classification A may be arranged relative to the or to one respective storage box.

[0157] The main function of the containment box may be to provide a climatically compatible pharmaceutical processing room or a climatically compatible pharmaceutical processing environment, in particular while observing the highest cleanroom requirements, in particular while observing cleanroom classification A.

[0158] The receiving box may in particular be designed for incubation, the receiving box in particular having an interface to one or more tool units, in particular for gassing and / or temperature regulation.

[0159] The storage box can be constructed and shaped to have a hygienic conformity structure, in particular to meet hygienic design criteria, for example with respect to a minimized number of undercuts, which optimizes the cleanability of the storage box.

[0160] For the hygiene-compatible construction of the storage box, such a storage box can be equipped with magnetic fastening means, by which in particular the extract can be reliably held under optimized hygiene conditions. For example, the magnetic fastening means can be designed to cooperate with an at least partially magnetic corresponding element of a vessel for receiving the extract or of an extract container.

[0161] Additionally or alternatively, for this purpose the storage box may be provided with means for positively and / or frictionally fastening.

[0162] The storage boxes may in particular be capable of being stored in the storage locations of the storage device fully automatically, for example by means of a storage transport device of the storage device already described.

[0163] One or more of the containment boxes may enclose a closable interior space.

[0164] The closable interior space may define a clean room sub-area and / or a sterile production area.

[0165] In effect, the closable interior space may be a clean room sub-area and / or a sterile production area.

[0166] The cleanroom sub-area definable by the closable interior space may have a cleanroom classification A.

[0167] The containment box for introducing the extract and / or for withdrawing the product produced from the extract may be openable and / or closeable automatically and / or by a handling device.

[0168] One or more of the containment boxes may comprise a conditioning unit which is integrated into or is or can be releasably arranged in the containment box, and by means of the conditioning unit the temperature and / or pressure and / or humidity and / or gas composition in the interior space of the respective containment box may be influenced, in particular controlled and / or regulated.

[0169] 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 storage boxes as required, in particular fully automatically, for example by the storage and transport device of the storage device as described above and / or by a handling device.

[0170] Additionally or alternatively, one or more of the conditioning units may be tool units of a tool system of the production facility, the tool units being capable of being placed in or removed from their respective storage boxes as required, in particular independently, by means of their own actuator devices and / or with the aid of actuator devices in or arranged in the respective storage boxes.

[0171] The storage box may comprise one or more connection elements which are connectable to corresponding connection elements of one or more processing locations, in particular in order to supply the respective storage box with electrical energy and / or consumables, in particular liquids and / or gases, and / or to couple the respective storage box, in particular in terms of signal technology, with a higher-level control device, for example one or more control units.

[0172] The storage device may include a storage location with a connection element, so that one or more process steps for processing the extract can be carried out in the storage location of the storage device, which serves as a processing location.

[0173] The storage location and / or the storage box of the storage device may comprise a fastening element, The storage box can be positioned and fixed in the storage location by means of the fastening element.

[0174] The storage boxes may each include one or more tool receiving portions for receiving and fixing one or more tools, in particular in the interior space of the respective storage box.

[0175] The one or more tool receiving portions may each comprise one or more connection elements which can be connected to corresponding connection elements of the tool to be received, in particular in order to supply the respective tool with electrical energy and / or consumables, in particular liquid and / or gas, and / or to couple the respective tool in signal terms with a receiving box and / or in particular with a higher-level control device.

[0176] The storage boxes may also be (respectively) storeable in a storage location when not in use for the production of a product, in particular after cleaning, for example by the cleaning device of the production facility already mentioned.

[0177] The storage boxes that are not stored in the storage location in a state where they are not utilized for the production of the product may be fully automatically removable from the storage location, in particular by a storage transport device of the storage device, for storing or introducing the extract.

[0178] Additionally or alternatively, the storage box may include one or more connection elements that are connectable with corresponding connection elements of a further storage box, thereby providing a single integrated storage box.

[0179] For possible structures and / or configurations of the assembled containment box, please refer to the description of the containment box.

[0180] One or more storage locations can be configured as storage locations for grouped storage boxes.

[0181] Additionally or alternatively, one or more, in particular all, storage boxes may be configured to accommodate one or more workpiece supports, respectively, with tools and / or consumable materials arranged and / or received therein. Additionally or alternatively, the workpiece supports may be configured as tool supports and / or as consumable material supports. The production facility may include an unpacking device for unpacking the objects to be supplied to the cleanroom area.

[0182] The unpacking device may be integrated into the locking device or may form an integral part of the locking device.

[0183] Additionally or alternatively, the unpacking device is connected to the handling device and / or the storage device, in particular via an autoclave device, for example a hatch autoclave device, by means of which the unpacked and / or partially unpacked objects can in particular be automatically received in each case, sterilized and dried and subsequently fed to the handling device and / or the storage device.

[0184] The locking device may include an entry lock location that is accessible from the periphery of the production facility and at which the packaged objects may be placed, in particular manually and / or automatically.

[0185] The packaged objects can be transported from the entrance lock location by a lock transport device of the production facility to, for example, the unpacking location already mentioned and can be automatically unpacked at the unpacking location, or the packaged objects can be automatically unpacked at the entrance lock location.

[0186] The locking device can comprise, for example, a cleaning device as already mentioned, for cleaning the packaging material of the packaged object.

[0187] By means of the cleaning device of the locking device, the objects can be cleaned and / or sterilized in the packaged state, in particular by irradiation and / or gas treatment.

[0188] Cleaning of the locking device by means of a cleaning device may in particular be possible at the entrance locking location, at the unpacking location and / or at a cleaning location provided within the locking device.

[0189] The unpacking apparatus may include a number of unpacking units for unpacking different types of objects and / or packaging material, in particular for removing different types of packaging material from the objects.

[0190] One or more unpacking units for unpacking the extracts and one or more further unpacking units for unpacking the tools and / or consumable materials may be provided.

[0191] The packaging material of the packaged objects, in particular the packaged extract, may be able to be led out in a sterile state by one or more unpacking units 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.

[0192] The objects, in particular the extract, may be deliverable after unpacking of the handling device, in particular by means of a lock transport device.

[0193] The unpacking location within the locking device may be located spatially separated from the remainder of the locking device.

[0194] Unpacking may be possible fully automatically by one or more unpacking units.

[0195] Additionally or alternatively, unpacking may be performed manually and / or partially automatically, for example automatically whilst using at least one manual action.

[0196] The locking device, in particular one of the locking locations provided in the locking device, for example the unpacking location, may be capable of being cleaned by a cleaning device of the locking device before, during and / or after unpacking, in particular by irradiation and / or gas treatment.

[0197] Cleaning during unpacking may for example be possible between individual unpacking steps.

[0198] The unpacking device may include sensing and control devices that may determine the type of object to be unpacked and / or the type of packaging material to be removed.

[0199] An unpacking unit of the unpacking device may be selectable and controllable by the control device to perform the unpacking process, the unpacking unit may be one of a plurality of unpacking units for performing different unpacking processes, and the selected unpacking unit may be assigned to a determined type of object to be unpacked and / or type of packaging material to be removed.

[0200] Additionally or alternatively, unpacking may be possible manually, for example at an entrance lock location.

[0201] The production facility may include a packaging device for packaging objects, such as manufactured products, to be removed from the cleanroom area.

[0202] The packaging device may be integrated into or form an integral part of the locking device.

[0203] Additionally or alternatively, the packaging device is connected to the handling device and / or the storage device, in particular via an autoclave device, for example a hatch autoclave device, by means of which the objects can in particular be automatically received in each case, sterilized and dried and subsequently released from the lock.

[0204] The locking device may include an exit locking location, which is accessible from the periphery of the production facility and into which the packaged objects can be extracted, in particular manually and / or automatically.

[0205] The objects to be packaged can be transported by a 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.

[0206] The packaging apparatus may include a number of packaging units for packaging different types of objects and / or packaging materials, in particular for packaging objects with different types of packaging materials.

[0207] One or more packaging units for packaging the manufactured products and one or more further unpacking units for packaging the used tools to be removed and / or the used consumable materials to be removed may be formed.

[0208] The objects to be packaged, in particular the manufactured products, may be movable, in particular handleable or transportable, before, during and / or after packaging, by means of the handling device and / or the locking transport device.

[0209] The packaging location within the locking device may be located spatially separated from the remainder of the locking device.

[0210] Packaging may be carried out fully automatically by one or several packaging units.

[0211] Additionally or alternatively, packaging may be performed manually and / or partially automatically, for example automatically while using at least one manual action.

[0212] The locking device, in particular one of the locking locations provided in the locking device, for example the packaging location, may be capable of being cleaned by a cleaning device of the locking device before, during and / or after packaging, in particular by irradiation and / or gas treatment.

[0213] The packaging device may include sensing and control devices that may determine the type of object to be packaged and / or the type of packaging material to be used.

[0214] A packaging unit of the packaging device can be selected and controlled by the control device to perform a packaging process, and the packaging unit may be one of a plurality of packaging units for performing different packaging processes, and the selected packaging unit may be assigned to a determined type of object to be packaged and to a type of packaging material used.

[0215] The packing device and the unpacking device may be formed in one common device for unpacking and / or packing.

[0216] As already explained in connection with the conditioning unit of the storage box, the production facility may include a tool system.

[0217] In particular, the production facility may include tooling systems that may enable handling and / or maintenance processes on the extract within the clean room area.

[0218] The tool system may comprise a number of, in particular fully automatic, tool units for carrying out different treatment and / or maintenance procedures.

[0219] The tool units described herein may be the tools described herein and / or the tools described herein may be the tool units described herein.

[0220] The tool system may include one or more tool units configured as supply units for supplying consumable materials to the extract.

[0221] The consumable material may include at least one liquid, and / or at least one gas and / or gas mixture.

[0222] Additionally or alternatively, the consumable material may include at least a solid, such as at least one freeze-dried solid.

[0223] The tooling system may include one or more tooling units configured as a withdrawal unit for withdrawing a sample from an extract.

[0224] 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.

[0225] The tool system may include a preparation unit by means of which a single-use component of the tool unit may be removed after its use, in particular discarded, and replaced with one or more new single-use components.

[0226] A single-use component may in particular be a component that cannot be used again after one, in particular first, use.

[0227] A multi-use component may be a component that can be used at least one further time, especially after a single, especially initial, use.

[0228] The single use components and multi-use components can be, for example, elements and / or systems, respectively.

[0229] Optionally, such elements and / or such systems may comprise at least one of the following: tubes, needles, syringes, containers, in particular vessels or pouches, e.g. vessels for extracts, valves, microfluidic units, probes, cartridges, vials, and / or flasks, in particular for reagents.

[0230] It should be understood that the foregoing list is illustrative and not exhaustive.

[0231] Alternatively or additionally, the elements may include a combination of the above listed elements. The multi-use components may be cleanable and / or sterilizable. The preparation unit may be located entirely within a clean room area.

[0232] 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.

[0233] The preparation process, in particular the de-equipping and / or fitting steps of the preparation process, may be possible to be carried out in one or several, in particular different, cleanroom sub-areas of the cleanroom area.

[0234] The preparation unit may include or may be assigned a cleaning unit, by means of which multiple components of one or more tool units can be cleaned, in particular sterilized, after their use.

[0235] Additionally or alternatively, the cleaning unit can be formed as an independent or separate tool unit.

[0236] The cleaning can be carried out by a cleaning unit before the de-installation and installation processes, during the execution of these processes, in particular between the de-installation and installation processes and / or after the preparation process.

[0237] The tool system may include a number of portable tool units which may be delivered to a processing location for processing the extract, in particular a processing location which is simultaneously a storage location for storing the extract, in order to carry out the processing step, and which may be temporarily stored there.

[0238] 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 by one or more storage and transport units.

[0239] One or more tool units may be formed and arranged by a handling device for carrying out processing and maintenance steps.

[0240] The tool unit or units may in particular be configured and arranged independently of the handling device for carrying out the treatment and / or maintenance steps.

[0241] The tool units may be single use or reusable.

[0242] 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.

[0243] The tool unit may be a mechanical tool.

[0244] The tool unit may be movable and / or suitable for use by a robotic arm, for example a multi-axis robotic arm.

[0245] 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 predetermined amount of liquid, in particular for taking a sample for analysis.

[0246] 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 a pump for circulation.

[0247] 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 in particular arranged and in particular contained in a tool support, in particular in a containment box, thereby in particular changing the environment of the extract, in particular the environment of the cells of the extract, thereby in particular changing the extract itself, in particular the cells of the extract itself, in particular in terms of cell growth and / or cell surface, e.g. cell membrane surface, and / or cell metabolism.

[0248] 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.

[0249] Additionally or alternatively, at least one auxiliary material, such as magnetic particles, may be used to concentrate and / or separate the liquid.

[0250] 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 number, 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 metabolic product.

[0251] It should be understood that the foregoing list is illustrative and not exhaustive.

[0252] The tool system includes a recycling unit and / or a reconditioning unit by means of which the cleaning and / or reconditioning process can be carried out in a cleanroom area, in particular in at least one of the following: - can be carried out in the cleanroom area itself, e.g. in a cleanroom sub-area of ​​the cleanroom area itself, in order to maintain the cleanroom characteristics of the unit, e.g. its cleanroom classification characteristics, - can be implemented in a storage-transport device, in particular in a storage-transport unit of the storage-transport device, in order to maintain the cleanroom properties, e.g. the cleanroom classification properties, of a cleanroom area, e.g. a cleanroom part area, in which the storage-transport device or its storage-transport unit is arranged and / or movable, - can be carried out on consumable materials; - can be implemented in a tool or a tool unit; It can be implemented in a workpiece support.

[0253] It should be understood that the foregoing list is illustrative and not exhaustive.

[0254] The recycling unit and / or the reconditioning unit may comprise sensor devices by means of which the success, and in particular the quality, of the cleaning and / or reconditioning process can be determined.

[0255] For example, at least one of the aforementioned listed elements, cleaned and reconditioned by a recycling unit and / or a reconditioning unit, may be prepared for a subsequent process, in particular in or at a storage location, after the cleaning and / or reconditioning process.

[0256] Defective and / or redundant tool units can be removed from the production facility via the locking device, in particular defective and / or redundant tool units can be extracted from a storage location and automatically transported to the locking device for withdrawal of the tool units from the production facility.

[0257] The tool system may in particular be arranged fully automatically.

[0258] In fact, the production facility may include, in particular, a fully automatic tool system, which includes one or more tool units for carrying out processing steps on the extract, and which tool system is arranged inside a clean room area, for example inside a clean room sub-area, for example inside a storage box as a clean room sub-area.

[0259] The tool system may include one or more tool units formed as a fluid conveying device, by means of which the fluid can be conveyed adjustably in terms of volumetric flow.

[0260] The volume flow that can be delivered by the fluid delivery device may be, for example, 500 ml / min or more. There may be a tolerance of ±5%.

[0261] The fluid transport device may have a directional element, which may produce a directed volumetric flow.

[0262] The fluid transport device may include a thermal isolation material that allows the temperature of the fluid to be kept constant during transport.

[0263] Additionally or alternatively, the fluid transport device may have a heat source and / or a cooling unit and / or may be assigned a heat source and / or a cooling unit, by means of which the temperature of the fluid may be kept constant and / or adjustable during transport.

[0264] The fluid transport device may have at least one sensor device to monitor and / or control and / or regulate the fluid transport and / or to analyze and / or detect components in the transported fluid, such as particles and / or turbidity and / or air bubbles and / or fluorescently marked components.

[0265] The fluid transport device may comprise a fluid directing device, which allows the fluid to be transported with little foaming.

[0266] The fluid transport device may be dead-volume optimized.

[0267] The tool system may include one or more tool units formed as a microfluidic transport device, by means of which fluid is transported in an adjustable manner, in particular with regard to volumetric flow, in particular for aliquoting.

[0268] The volumetric flows that can be delivered by the microfluidic delivery device may for example be less than 500 ml / min, advantageously greater than or equal to 100 ml / min and less than 500 ml / min. A tolerance of ±5% may be present.

[0269] The fluid transport device may have a directional element, which may produce a directed volumetric flow.

[0270] The fluid transport device may comprise a thermal isolation material, by means of which the temperature of the fluid can be kept constant during transport. Additionally or alternatively, the fluid transport device may comprise a heat source and / or a cooling unit, and / or may be assigned a heat source and / or a cooling unit, by means of which the temperature of the fluid can be kept constant and / or adjustable during transport.

[0271] The microfluidic transport device may comprise at least one sensor device to monitor and / or control and / or regulate fluid transport and / or to analyse and / or detect components in the transported fluid, such as particles and / or turbidity and / or air bubbles and / or fluorescently marked components.

[0272] The microfluidic transport device may have a fluid directing device, by means of which the fluid can be transported with little foaming.The microfluidic transport device may be dead-volume optimized.

[0273] The tool system may include one or more tool units formed as a device for dividing a fluid, by means of which the fluid is conveyed in an adjustable manner in terms of volume flow and by means of which the fluid is divided, in particular adjustably, into at least two, in particular 2 to 12 fluid portions.

[0274] The fluid portion, in particular the associated volume flow, may for example be less than 500 ml / min, preferably greater than or equal to 100 ml / min and less than 500 ml / min. A tolerance of ±5% may be present.

[0275] The divided fluid, in particular at least one fluid portion of the divided fluid, may be capable of being released by the fluid dividing device into at least one assigned container, in particular a vessel, a workpiece support and / or a storage box, and / or into and / or onto a sensor.

[0276] The fluid dividing device may have a directional element, by means of which at least one directed volumetric flow, in particular at least two directed volumetric flows, can be generated.

[0277] The fluid dividing device may comprise a thermal separator, which allows the temperature of the fluid to be kept constant during conveyance and / or division.

[0278] Additionally or alternatively, the fluid dividing device may comprise a heat source and / or a cooling unit and / or may be assigned a heat source and / or a cooling unit by means of which the temperature of the fluid may be kept constant and / or adjustable during transport.

[0279] The fluid dividing device may have a fluid guiding device for the fluid to be divided and / or for the divided fluid, in particular for the respective fluid portions, by means of which the fluid and / or fluid portions can be transported and / or divided with little foaming.

[0280] The flow divider may be dead-volume optimized.

[0281] The tool system may include one or more tool units configured as a fluid mixer, by means of which the fluids are mixable.

[0282] The fluid mixing device can have a mixing unit, in particular a mechanical mixing unit and / or a geometric mixing unit, which has a defined fluid guiding device for mixing, in particular for mixing with little foaming.

[0283] The fluids may be mixable by the mixing unit of the fluid mixing apparatus at defined shear forces, in particular at low shear forces, in particular with little foaming.

[0284] Additionally or alternatively, the fluid mixing apparatus may comprise a heat source and / or a cooling unit and / or the fluid mixing apparatus may be assigned a heat source and / or a cooling unit by means of which the temperature of the fluids may be kept constant and / or adjustable during mixing.

[0285] The tool system may include one or more tool units formed as a mixing device, by means of which at least two components can be mixed with one another, in particular one of the at least two components being a fluid.

[0286] The mixing device can be substantially similar to a fluid mixing device, in particular the mixing device can be similar to a fluid mixing device or can be formed as a fluid mixing device. In fact, the fluid mixing device can be formed as a mixing device.

[0287] The tool system may include one or more tool units configured as measuring devices, by means of which at least one property of the fluid and / or the extract can be measured.

[0288] The measuring device may be configured for measuring a pH value, and / or a gas value or a gas mixture value, such as an oxygen value, a cell density, and / or a turbidity, in particular a turbidity in a fluid.

[0289] The tool system may comprise one or more tool units configured as a material separation device, by means of which a starting component can be separated into at least two components.

[0290] The material separation device comprises means for tangential flow filtration, for example for centrifugation at 200-300 g, for affinity chromatography and / or for magnetic separation, by which the starting components can be separated into at least two components.

[0291] Additionally or alternatively, the material separation apparatus may comprise and / or be assigned a temperature adjustment element by means of which the temperature of the starting components to be separated and / or the separated starting components can be kept constant before, during and / or after the separation and / or can be adjusted to a temperature of, for example, 5 to 10°C.

[0292] The tool system may include one or more tool units formed as heating devices, by means of which the fluid can be temperature regulated, in particular the fluid can be heated or cooled, for example to a temperature below 37°C.

[0293] The heating device may be formed as a separate device, the heat sources and / or the temperature adjustment elements of the aforementioned devices of the tool system may be formed as part of the heating device and / or may be assigned to the heating device.

[0294] The heating device may be arranged and / or configured to generate a homogeneous temperature field, in particular in spatial and / or temporal terms.

[0295] The tool system may include one or more tool units formed as a device for supplying and / or delivering a gas, in particular a gas mixture, by means of which the gas, in particular a gas mixture, can be supplied and / or delivered in a particularly homogeneous manner.

[0296] By means of the device for supplying and / or delivering a gas, for example oxygen, carbon dioxide and / or hydrogen peroxide may be able to be supplied and / or delivered.

[0297] The fluid transport devices, microfluid transport devices, fluid division devices, fluid mixing devices, mixing devices, measuring devices, substance separation devices, heating devices and devices for supplying and / or extracting gases may be formed in any combination with one another as one or more devices, for example within just one common device.

[0298] The tool system may include one or more tool units formed as a manipulator by means of which cell membranes, in particular cell membranes of the cells of the extract, can be manipulated, in particular by at least one of the following, electric fields, addition of chemicals, receptor-mediated transfection, microinjection, gene guns, magnet-assisted transfection, sonoporation, optical transfection, microfluidic channels, e.g. collapsing of the microfluidic channels, or any combination thereof.

[0299] Additionally or alternatively, the manipulator may enable the introduction of genetic material, in particular foreign genetic material, such as DNA, e.g. foreign DNA, and / or RNA, e.g. foreign RNA, into the cell through the cell membrane.

[0300] Additionally or alternatively, the manipulator may enable the delivery of viruses to cells, and the manipulator may perform native manipulations on the cells.

[0301] The tool system may include one or more tool units formed as a radiation source and / or a light emitting device, the radiation source being configured to emit an ionizing beam, in particular towards the target object, e.g. towards the extract, and the light emitting device being configured to emit light having a predetermined wavelength, in particular towards the target object, e.g. towards the extract.

[0302] Additionally or alternatively, the tool system may include one or more tool units configured as a flow cell-sequencing device and / or as a next-generation sequencing device.

[0303] The tool system may include one or more tool units formed as cleaning devices, in particular as the cleaning devices already described and / or as the cleaning units already described, by means of which the places where processing steps can be carried out on an extract by means of said one or more tool units are cleanable and / or sterilizable.

[0304] The tooling system may have a supply device assigned to it for supplying the consumable material thereto.

[0305] In effect, the production equipment may include, for example, the tooling system described above, and a supply device for supplying consumable materials to the tooling system.

[0306] The supply system may include or utilize one or more storage locations of a storage system located within the clean room area for storing consumable materials.

[0307] In effect, a supply device may be assigned a storage location in a storage device.

[0308] The locking device may form part of or cooperate with the supply device, and may allow the consumable material to be introduced into the cleanroom area.

[0309] Consumable materials to be used in the process may be provided in the locking device, in particular on the exit locking location of the locking device, in particular prior to its use, and may optionally be ready for use, in particular unpackable and / or temperature adjustable.

[0310] The storage device may form an integral part of the supply device or may cooperate with this integral part.

[0311] By means of the storage and transport device of the storage device, in particular by means of one or more storage and transport units of the storage and transport device of the storage device, consumable materials supplied from the surroundings of the production facility, in particular through a locking device, may be able to be supplied to one or more storage locations of the storage device.

[0312] By means of a storage and transport device of the storage device, in particular by means of one or more storage and transport units of the storage and transport device of the storage device, consumable materials may be able to be supplied to the tool system, in particular to one or more tool units of the tool system, for example consumables and / or tool consumables to one or more tool units of the tool system.

[0313] The consumables and / or tool consumables may each include one or more multi-use components and / or one or more single-use components.

[0314] Consumable materials to be used in the process may be provided in a storage location, in particular prior to their use, and may optionally be ready for use, in particular temperature adjustable.

[0315] The supply device may include one or more disposal units by means of which especially used, worn out and / or soiled consumables and / or tool consumables can be removed from the cleanroom area.

[0316] One or more waste units may be assigned to an equipment unit of the tool system and may in particular be handleable by the equipment unit and / or may form an integral part of the equipment unit of the tool system.

[0317] The supply device may include a replenishment device arranged within the clean room area, by means of which consumables, particularly those present in liquid form, may be supplied to one or more storage devices of one or more workpiece supports and / or one or more storage locations.

[0318] Additionally or alternatively, the refilling device may be configured as and / or assigned to the aforementioned refilling station. The storage device may in particular be configured to store energy and / or one or more consumable materials, in particular the storage device may be electrically rechargeable and / or refillable with consumable materials.

[0319] A storage device may provide energy and / or one or more consumable materials to carry out a process.

[0320] The storage device may include at least one interface for replenishing and / or providing energy and / or consumable materials, and in particular the interface may be configured to be coupleable to a tool / tool ​​unit, in particular for said provision.

[0321] The supply device may comprise a water facility, in particular an ultrapure water facility, for providing water, in particular ultrapure water, as at least one consumable material.

[0322] The water facility may be connectable, for example via an interface provided in the production facility, to a water source, in particular an ultrapure water source, which may be arranged around the production facility. As mentioned above, one or more probes, sensors, sensor units and / or homogeneous measuring elements may be provided in the production facility.

[0323] In effect, the production facility may comprise one or more sensor units for determining one or more values ​​of one or more parameters of one or more extracts, and / or one or more workpiece supports, and / or one or more tools. The production facility may comprise one or more sensor units for determining one or more values ​​of one or more parameters of one or more consumable materials.

[0324] The determination can be performed at least partially automatically, in particular fully automatically, by one or more sensor units. By means of the one or more sensor units, the occupancy state of one or more storage locations of a storage device of the production facility can be determined, in particular monitored.

[0325] By means of one or more sensor units, the local temperature and / or the local humidity and / or the local lighting or illumination intensity of or within one or more storage locations of a storage device of a production facility may be determined, in particular monitored.

[0326] 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.

[0327] The production facility may comprise one or more sensor units for determining the processing progress of the extract during processing or between two processing steps based on at least one fluid of the extract.

[0328] The sensor unit or units for determining the processing progress may be a microscopic device for visually capturing the microscopic components of the extract.

[0329] The microscope equipment includes: - Automated microscopy equipment, and / or - Lensless microscope equipment, and / or - a microscope device of the optical microscope type, and / or - Microscope equipment for fluorescence and / or luminescence testing The device may have and / or be configured as such.

[0330] The microscope apparatus may comprise a data and / or image processing unit configured and programmed to ascertain and / or determine at least one processing progress status and / or one or more values ​​of one or more parameters of one or more extracts.

[0331] By means of the data and / or image processing unit of the microscope device, the morphology and / or concentration and / or motility and / or functionality of the cells of each of the one or more extracts can be known and / or determined.

[0332] In one or more storage locations for receiving the extract or in the storage locations, respectively, one or more sensor units for determining the processing progress are arranged, which may in particular be integrated in the storage locations.

[0333] The production equipment, in particular one or more tools for carrying out one or more process steps, may be controllable and adjustable depending on one or more determined values, in particular one or more process parameters may be changed, in particular modifiable, depending on the determined process progress.

[0334] The production facility may include one or more sensor units for monitoring the amount of consumable material stored within the clean room area.

[0335] 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 the production facility may provide information, in particular to a user and / or a computing system, that a prescribed amount of consumable material is being fallen below the prescribed amount.

[0336] The sensor unit or units may be configured as a device for a polymerase chain reaction analysis (PCR-analysis) and / or for an endotoxin test and / or for a mycoplasma test.

[0337] The one or more sensor units may enable protein analysis, in particular protein quantification, and / or enzymatic activity tests, and / or immunological tests, and / or amino acid analysis, and / or protein sequence analysis to be performed on the extract and / or parts, in particular constituent parts, of the extract.

[0338] Additionally or alternatively, one or more sensor units may enable spectroscopy, and / or light microscopy, and / or chromatography, and / or electrophoresis, and / or mass spectrometry to be carried out on the extract and / or parts, in particular constituent parts, of the extract.

[0339] The one or more sensor units may enable 3D structure elucidation, in particular magnetic resonance spectroscopy, and / or electron microscopy, and / or scanning electron microscopy, and / or X-ray analysis to be carried out on the extract and / or parts, in particular constituent parts, of the extract.

[0340] The one or more sensor units may enable peptide and / or carbohydrate analyses, in particular high performance liquid chromatography and / or electrophoresis and / or mass spectrometry and / or magnetic resonance spectroscopy, and / or lipid analyses, in particular solid phase extraction and / or chromatography and / or chromatography and / or mass spectrometry and / or immunoassay tests, and / or phosphorylation and acetylation analyses, in particular for at least one protein, and / or metabolite tests and / or metabolite monitoring, in particular for glucose, lactate, oxygen, carbon dioxide, ammonium, phosphate and / or derivatives thereof, to be performed on the extract and / or parts, in particular components of the extract. The one or more sensor units may enable nucleic acid analyses to be performed on the extract and / or parts, in particular components of the extract.

[0341] A production facility, in particular for nucleic acid analysis, may comprise extraction devices, and / or gel filtration devices, and / or precipitation devices, and / or concentration devices, and / or centrifugation devices, and / or isolation devices, and / or PCR analysis devices, and / or magnetic bead handling devices for separating coupled materials and fluids by means of magnetic beads, such devices being assignable and / or assigned to one or more sensor units, in particular for nucleic acid analysis.

[0342] For example, by means of one or more sensor units, in particular for nucleic acid analysis, absorption measurements, and / or gel electrophoresis methods, in particular for the separation and / or cleanup of RNA and / or DNA and / or proteins, and / or gel documentation, in particular on RNA and / or DNA and / or protein gels and / or Western blots, and / or RNA analysis and / or DNA analysis and / or sequence analysis, in particular for RNA- / DNA- / protein quantification, and / or chip analysis, and / or DNA mapping and / or protein-DNA interaction analysis, and / or genotyping, and / or epigenetic analysis, and / or proteomic analysis, and / or metabolomic-fingerprinting, -profiling, -targeted analysis may be possible on the extract and / or parts, in particular constituent parts, of the extract.

[0343] The production facility may comprise, in particular for cell analysis, morphology determination devices, and / or metabolite testing devices, and / or receptor binding testing devices, and / or signal transduction testing devices, and / or cell differentiation testing devices, and / or viscosity testing devices, and / or DNA- / RNA- / protein expression testing devices, and / or chip / microfluidic testing devices, such devices may be and / or be assigned to one or more sensor units, in particular for cell analysis.

[0344] Additionally or alternatively, by means of one or more sensor units, expression analyses, in particular for gene and / or protein expression, and / or transfection analyses, and / or flow cytometry, and / or ELISA tests, and / or luciferase tests, and / or kinase tests may be performed on the extract and / or parts, in particular constituent parts, of the extract.

[0345] By means of one or more sensor units, osmolality tests and / or freezing point depression measurements and / or turbidity measurements, in particular optical density measurements, and / or particle measurements, in particular particle density measurements, and / or pH measurements and / or viscosity measurements may be possible on the extract and / or parts, in particular constituent parts, of the extract.

[0346] In other words, the production facility includes one or more sensor device units, and the sensor device units are used to control one or more substantially all process steps, In particular one or more, substantially all of the process steps and / or one or more, substantially all of the process states, in particular one or more, substantially all of the process states, can be monitored and, in particular, if necessary, adjusted, in particular post-adjusted and / or controlled, in particular post-controlled.

[0347] 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 the product-suspension, e.g. at least one light absorption based on liquid turbidity, in particular in the extract-suspension and / or the 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.

[0348] The aforementioned sensor device unit or the aforementioned sensor unit may be arranged in a production facility as required, in particular in a clean room area with respect to one or more objects, such as extracts and / or tools and / or storage areas and / or consumable materials.

[0349] In particular, the sensor unit(s) or the sensor device unit(s) may be and / or may be arranged in-line, thereby enabling continuous automated measurements and / or enabling real-time monitoring, in particular with respect to the extract(s).

[0350] In particular, in addition or instead, the sensor unit or units or the sensor device unit or units may be positionable and / or arranged online, thereby allowing continuous automatic measurements, in particular with respect to one or more extracts, and the positioning of the sensor unit or the sensor device unit takes place in particular not in the direct processing environment of the extract, but in a branch line leading away from the processing environment arranged for this, for example in a bypass, in which a sample of the test substance, in particular of the extract, can be drawn off, in particular automatically, and optionally a reagent, for example for a color change, can be added in the branch line.

[0351] In particular, in addition or instead, one or more sensor units or one or more sensor device units may be and / or may be arranged atline, such that an extract sample drawn from the extract processing environment can be tested separately, in particular spatially separated, from the processing environment, and optionally an isolated sample preparation can be performed.

[0352] The at-line arranged sensor device unit or units can be and / or may be arranged in a clean room area adjacent, in particular in the immediate vicinity of, the processing environment of the extract.

[0353] Additionally or alternatively, one or more sensor device units arranged in line can be and / or may be arranged adjacent to, in particular in close proximity to, the production facility, within the perimeter of the production facility.

[0354] In particular, in addition to or instead of this, the sensor unit(s) or the sensor device unit(s) may be and / or may be arranged offline, in particular in a clean room area and / or outside the production facility, for example in an external laboratory.

[0355] As already mentioned above, the production facility may include one or more cleaning devices.

[0356] The cleaning device may be formed as a separate device in the cleanroom area and / or may be a component part of a tool system, in particular a tool or a tool unit and / or a locking device and / or a storage device.

[0357] The cleaning device may include one or more interfaces by which the cleaning device can be connected, in particular to pharmaceutical cleaning systems, for cleaning in place (Cleaning in Place, abbreviated as CIP), for washing in place (Washing in Place, abbreviated as WIP) and / or for sterilization in place (Sterilization in Place, abbreviated as SIP).

[0358] The cleaning-in-place, cleaning-in-place and / or sterilization-in-place can in particular be carried out in a storage location and / or on a workpiece support, in particular in a storage box.

[0359] The cleaning apparatus may include one or more interfaces by means of which a gas and / or gas mixture and / or liquid, for example hydrogen peroxide in gaseous and / or liquid form, may be supplied to the cleaning apparatus, thereby cleaning, in particular decontaminating and / or sterilizing one or more objects within the cleanroom area and / or the cleanroom area, in particular a part, in particular all, of at least one cleanroom area.

[0360] The cleaning device may include one or more drying devices by means of which one or more objects inside the cleanroom area, in particular tools and / or workpiece supports, e.g. storage boxes, and / or the cleanroom area, in particular parts of at least one cleanroom area, in particular all of it, can be dried, in particular after cleaning has been carried out.

[0361] Additionally or alternatively, the cleaning apparatus may include one or more autoclave apparatuses that may sterilize one or more objects within the clean room area.

[0362] The one or more autoclave devices may be embodied as an autoclave device as described in connection with the unpacking device and / or the packing device.

[0363] The cleaning device may include one or more interfaces by means of which waste water, in particular contaminated liquids, can be conducted away from the cleanroom area.

[0364] The cleaning device may have one or more distribution elements, such as nozzles and / or sprinklers, which are connected to a source of cleaning agent within the cleanroom area and / or can be connected to a source of cleaning agent within the perimeter of the production facility, and by which the distribution elements can decompose the source of cleaning agent, such as water vapor and / or hydrogen peroxide, for cleaning.

[0365] By means of the cleaning device, objects, in particular tools and / or consumable materials, which in particular come into direct contact with the extract, can be cleaned, in particular sterilized, in particular by irradiation.

[0366] By means of the cleaning device, objects which in particular do not come into direct contact with the extract can be cleaned, in particular by gas treatment, and in particular sterilized.

[0367] The cleaning device may in particular comprise a stationary cleaning station, by means of which at least one workpiece support, in particular at least one storage box, may be cleanable, in particular disinfectable and / or sterilizable.

[0368] The workpiece supports may be deliverable to the cleaning station by a storage transport device and / or a handling device. The cleaning station may include a washer and / or an autoclave device.

[0369] The method according to the invention is described below.

[0370] The above-described system according to the invention, i.e. the production installation according to the invention, and all structural and functional features associated with embodiments of this system or installation may be included alone or in combination in the method according to the invention, and the associated properties, configurations and advantages may be included and achieved accordingly.

[0371] In addition, the production facility according to the present invention described above may be configured to carry out the method shown in FIG. 25, and the method according to the present invention described below may be configured to be executable by the production facility according to the present invention described above.

[0372] The method according to the invention for producing a product, in particular a biological product, by means of a production facility, in particular the aforementioned production facility (i.e. comprising in particular the following: a clean room area, a locking device for feeding objects into the clean room area from the periphery of the production facility and / or removing objects from the clean room area, a handling device for moving the objects inside the clean room area and a storage device arranged inside the clean room area, comprising a plurality of storage locations for receiving a plurality of objects) comprises the following: - selecting one of a plurality of production programs for producing a plurality of products producible by the production facility; - introducing the extract into a locking device of said production facility; - automatically transporting the extract into a clean room area of ​​the production facility; and - automatically carrying out one or more processing steps on the extract; This includes:

[0373] After completion of the treatment process, the product made from the extract may be automatically transported from the production facility.

[0374] The extracts may be patient-related or pooled extracts.

[0375] A pooled extract can be and / or may have been produced from multiple patient-related extracts, thereby serving to produce a product for a patient and / or patient group, or in other words, to produce a product for one or more patients.

[0376] The process can have a pool of two or more extracts to produce a pooled extract.

[0377] The processing steps comprise in particular the repeated pairing and / or combination of objects, in particular tools or tool units, extracts, consumable materials, etc., so that in particular biological manufacturing processes can be reproduced in their individual process steps.

[0378] Once the extract has been automatically transported into the clean room area of ​​the production facility, the extract may be stored in a storage location located within the clean room area of ​​a storage device of the production facility.

[0379] One or more processing steps can be carried out fully automatically until the product to be produced from the extract is completed.

[0380] Alternatively, one or more processing steps can be carried out fully automatically until the product to be produced from the extract is complete, taking into account in particular the quality analyses carried out or capable of being carried out by one or more sensor units or sensor devices.

[0381] One or more, in particular all, of the processing steps may be carried out at the storage site.

[0382] The product thus produced can be withdrawn from the storage location and automatically transported to a locking device for withdrawing the product from the production facility.

[0383] The product may be filled and / or packaged prior to withdrawal, in particular in a ready-to-use state. One or more containers, receptacles and / or tools utilized to manufacture the product may remain at least partially within the cleanroom area after completion of the product, be cleaned, sterilized and subsequently reused for the manufacture of further products.

[0384] Consumable materials, in particular consumables and / or tool consumables, required for producing a product and / or for producing a number of different products may be stored within the clean room area, in particular before a selection of the product to be produced is made.

[0385] The consumable materials may be automatically transported into the clean room area via the locking device and stored therein, in particular in one or more storage locations of the storage device.

[0386] The amount of consumable material stored within the clean room area may be monitored and if it falls below a specified minimum amount, the inventory may be increased by supplying the required consumable material, particularly via a suggestion or warning message on the operator unit.

[0387] Multiple products, particularly multiple different products, may be manufactured simultaneously within the clean room area.

[0388] In particular, one or more process steps that may be carried out by one or more tool units are: - 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 the 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 liquids, in particular by means of columns, for example separation columns, and / or centrifuges, - analyzing the extract and / or intermediate product and / or product, in particular by means of one or more sensor units, and storing, in particular storing and / or extracting one or more objects by means of a storage and transport device, - temperature regulation, in particular incubation, of one or more objects, in particular of one or more extracts, may have the following structure:

[0389] It should be understood that the foregoing list of process steps is exemplary and not exhaustive.

[0390] Alternatively or additionally, it may be possible to combine one or more process steps with one or more process steps in a single process step, and / or in any combination thereof.

[0391] The combination of processes may result from instructions for producing a product, in particular a prescription, in particular instructions for producing a personalized product based on patient-related information.

[0392] The processing step may comprise, for example, supplying a consumable material, in particular a liquid, to the extract, in particular after a workpiece support holding the consumable material, in particular the liquid, and a storage box holding in particular the extract and / or an extract container or vessel together with the extract are fluidly connected to one another, in particular by one or more tool units and / or handling devices, and then supplying the consumable material to the extract and transporting it in a defined manner, in particular directed to the extract.

[0393] The work-piece supports connected to one another may define a process cell, in particular a sterile process cell, or a process unit, in particular a sterile process unit, by which suspensions, in particular cell suspensions, for example from liquids and extracts, can be produced and / or modified in a defined manner.

[0394] Furthermore, after supply, in particular after transport, the workpiece supports may be separable from one another again by one or more tool units and / or handling devices. One or more tool units and / or handling devices may be cleaned and / or sterilized by a cleaning device before or after the processing step. After cleaning and / or sterilization have been carried out, the tool units may be stored again in the storage location by the storage and transport device.

[0395] Additionally or alternatively, the handling device can be newly equipped, in particular with one or more tool units, after cleaning and / or sterilization and / or can be equipped for a subsequent processing step.

[0396] The processing step may for example include extracting, for example of cells, particularly a part of the extract, particularly to a storage location.

[0397] Incubation may be performed after the supply of the consumable material in order to generate a cell suspension Incubation may be performed before the supply of the consumable material in order to modify, for example, the cell suspension, especially in a storage location.

[0398] The work piece support on which the cell suspension is disposed may be cleaned and sterilized by a cleaning device before incubation can or is performed.

[0399] During incubation, gassing and temperature regulation can be performed or can be performed by one or more tool units. During incubation, one or more functions, in particular heating, fixing and / or gassing, can be performed in particular in just one containment box.

[0400] In parallel or consecutive to the treatment process, in particular incubation, the workpiece support, in particular a workpiece support which holds or has held a consumable material, in particular a liquid, may be cleanable and / or sterilizable by a cleaning device.

[0401] In addition to this, the container in which the liquid is stored and which is held by the workpiece support may be removable or may be removed from the clean room area by the handling device via the locking device. Optionally, the workpiece support may be cleanable and / or sterilizable or may be cleaned and / or sterilized by a cleaning device. Optionally, the workpiece may also be re-equipped with, in particular consumable materials, in particular from a storage device and / or via the locking device by the storage transport device and / or handling device.

[0402] Each product to be manufactured may be assigned a series of process steps, which are performed by tools that are located inside the clean room area and remain there after the process steps have been performed.

[0403] The tool or tools may be cleaned, in particular sterilized, inside a clean room area after performing the process or processes.

[0404] The one or more tools may be equipped with tool consumables within the clean room area prior to performing the one or more process steps.

[0405] One or more tool consumables may be removed and / or discarded from one or more tools inside the clean room area after one or more process steps have been performed. A number of, in particular all, process steps may be assigned a process time value, which indicates the time that elapses from the start of the respective process step to its end, in particular - the time required to provide at least one tool required for the respective process step, in particular including one or more tool consumables, and / or - the time for the supply and / or placement and / or start-up of at least one tool in the extract to be treated, in particular in the storage location 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 - including the time required to remove at least one tool from the extraction, in particular from a storage location, -Preferably ○ cleaning of at least one tool, and / or ○ Removal and / or disposal of tool consumables, and / or ○ Return transportation of the tool to its departure point, specifically to the storage location assigned to it Includes.

[0406] In each production program, the process steps required for the production of a given product and the associated process time values ​​can be recorded or taken into account / can be recorded or taken into account.

[0407] At the start of a production program, the production course can be predicted and the tools required and / or specified for the execution of the process can be prepared in advance for the time slots resulting from the prediction.

[0408] One or more processing steps may each include - one or more cleaning processes for cleaning one or more tools and / or for cleaning one or more storage locations, and / or - one or more disposal processes for disposing of expendable materials; and / or - one or more preparatory steps for equipping one or more tools with consumable material; and / or - one or more control steps for controlling the processing result, may be assigned or may have been assigned, Depending on the forecast of the production process, time slots may be / can be pre-prepared in one or more devices required for the execution of one or more cleaning processes, one or more disposal processes, one or more preparation processes and / or one or more control processes.

[0409] After one or more processing steps, and in particular after each processing step, the production progress forecast can be tested and / or realized, in particular to check or correct time slots for tools and / or other equipment still required to complete the product.

[0410] At the desired start of a production program, it can be determined based on a prediction of the production course whether all necessary tools and / or other equipment are available within the required time slit to complete the product, and the production program can be started only if such determination provides a positive result.

[0411] Additionally or alternatively, at the start of the entire production program and / or part of a production program, it may also be determined based on a forecast of the production course whether all necessary tools and / or other equipment are available within the required time slots and / or production periods to complete the product and / or whether resource bottlenecks, in particular with regard to consumable materials, and / or other production risks exist, and the production program may be started only if such determination provides a positive result regarding availability and a negative result regarding resource bottlenecks and production risks.

[0412] Additionally or alternatively, at the desired start of a production program and / or part of a production program, it can also be determined based on a prediction of the production course whether all necessary tools and / or other equipment and / or objects and / or other materials are available within the required time slit and / or can be supplied, in particular by a user, within the required time slit to complete the product, e.g. whether there is a confirmation that can be entered by the user that the tools, equipment, objects and / or materials can be supplied within the required time slit, and the production program can be started only if such a determination delivers a positive result.

[0413] The production facility may include one or more control units, in particular the control units already mentioned, for controlling and / or regulating the production facility, in particular for controlling and / or regulating at least one of the components contained by the production facility or components of the production facility.

[0414] The production facility may have one or more storage units and / or may be assigned one or more distributed storage units, e.g. located in a cloud and / or on a server. At least one storage unit can store or has stored therein a computer program product. The computer program product comprises instructions, which, when executed by at least one control unit of the production facility, prompt said production facility to perform said method. The computer program product may additionally or instead be stored in a computer-readable (further) storage medium.

[0415] The one or more control units may enable the production of a product, in particular a biological product, by the production facility.

[0416] The control unit or units may be configured and programmed to specifically automatically classify one or more products to be manufactured within a production batch.

[0417] One or more control units may be configured and programmed to carry out order planning for one or more products and / or production batches, in particular in terms of time and / or taking into account resources located within the production facility, such as tools and / or consumable materials, and / or the actual workload of the production facility.

[0418] Additionally or alternatively, the order plan may be executable with respect to a given production strategy, for example with respect to quality, e.g. product quality, with respect to time course, and / or with respect to costs over time.

[0419] One or more control units may be configured and programmed to have access to, and to create and / or modify, information management units storable or stored in, one or more storage units.

[0420] The one or more control units may be configured and programmed to access and / or modify the calculation units storable or stored in the one or more memory units, thereby enabling automatic calculation and / or cost calculation of the product to be manufactured.

[0421] The one or more control units may be configured and programmed to encode and decode information that can be stored in the at least one memory unit, in particular patient-related information for manufacturing the product, for example in the information management unit.

[0422] Additionally or alternatively, the one or more control units may be configured and programmed to anonymize and / or pseudonymize information storable in the at least one storage unit, in particular patient-related information for producing the product, for example in the information management unit.

[0423] By means of the information management unit, information may be maintainable, in particular storable and / or modifiable and / or generateable, information including, for example, one or more prescriptions for one or more products and / or intermediate products, patient-related information, machine-related information regarding the production facility, actual working hours information regarding the production facility, information regarding material logistics and / or material requirements of the production facility.

[0424] The one or more storage units may be capable of storing instructions for producing a product, in particular instructions for producing a personalized product based on patient-related information.

[0425] The extract may be a patient-related extract.

[0426] Additionally or alternatively, the extract may be a pooled extract.

[0427] A pooled extract can be and / or may have been produced from multiple patient-related extracts, thereby serving to produce a product for a patient and / or patient group, or in other words, to produce a product for one or more patients.

[0428] The instructions for producing a product may define the course of one or more process steps.

[0429] In effect, the instructions may define a production program. The one or more production programs may be storable in one or more storage units and may be executable, in particular by one or more control units, to produce one of a number of products producible by the production facility. By means of the production facility, a product, in particular a patient-related product, may be produced from the at least one extract, in particular from the at least one patient-related extract, by instructions based on the patient-related information.

[0430] The control unit or units may be configured and programmed to communicate with one or more communication interfaces and / or one or more human-machine-interfaces, HMI-interfaces for short, of the production facility.

[0431] One or more control units 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.

[0432] In connection with the above description of the production installation according to the invention and the method according to the invention, the invention is further described below by describing exemplary sequences, in particular exemplary material flows, of one or more objects of the production installation and / or exemplary sequences, in particular exemplary material flows, of one or more objects which can be supplied to and / or removed from the production installation.

[0433] It is to be understood that the following exemplary processes and / or material flows may be modified, alone or in combination, with respect to all structural and functional features associated with the production installation according to the invention as described above and with respect to its embodiments, and also with respect to the method according to the invention as described above and with respect to its embodiments.

[0434] The following description relates specifically to the extract.

[0435] The extract may be located and / or contained within a container, in particular an extract container or vessel.

[0436] The extract container containing the extract may define a cleanroom subarea having a cleanroom classification A.

[0437] The extract container containing the extract may be packaged in a packaging material, which may be formed in the sense of a partial area housing for the extract container containing the extract.

[0438] 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.

[0439] 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.

[0440] Advantageously, the packaging material may be cleaned and / or sterilized before removal by a cleaning device of the locking device or a part of a cleaning device of the production facility assigned to the locking device.

[0441] The locking device may include a clean room sub-area having clean room classification B.

[0442] The entrance lock location and / or the unpacking location may include a cleanroom sub-area having a cleanroom classification A.

[0443] The extract container containing the extract may be movable within the locking device by means of a locking transport device and / or a handling device.

[0444] By means of the handling device, the extract container containing the extract may be transferable to a workpiece support, in particular a storage box, within the locking device or immediately adjacent to the locking device, or may be transferable to a workpiece support which is or is arranged within the storage box.

[0445] A containment box housing the extract container containing the extract may define a sterile process unit.

[0446] The storage box housing the extract container containing the extract may be housed by a storage transport device of the storage device in or at a storage location of the storage device.

[0447] Additionally or alternatively, such storage boxes can also be provided by the storage and transport device, in particular for one or more process steps with one or more tool units.

[0448] Additionally or alternatively, an extract container containing the extract can be delivered to a workpiece support in or immediately adjacent to the locking device by the handling device, which workpiece support may be transportable to a storage location by a storage transport device after delivery of the extract container, and after storage in the storage location the workpiece support can be delivered together with the extract container from the storage location to a storage box defining a sterile process unit, in particular having clean room classification A.

[0449] One or more workpiece supports holding and transporting one or more tool units from the storage device and / or one or more consumable materials from the storage device may be transportable to the storage box by the storage transport device, and optionally the workpiece supports may be disposed within the respective storage boxes.

[0450] The storage box and the one or more workpiece supports, or the storage box in which the respective workpiece supports are arranged, may be connectable / coupleable with each other or may be connected / coupled for one or more process steps in the extract arranged in the storage box, and for one or more process steps of the process one or more tool units and / or one or more consumable materials of the one or more workpiece supports may be required.

[0451] In other words, the storage box and one or more further storage boxes may be connectable / coupleable with each other or may be connected / coupled, each of said further storage boxes housing at least one workpiece support, by which one or more tool units and / or one or more types of consumable materials can be held or are held for one or more processing steps.

[0452] The process may enable the production of a product from the extract.

[0453] In effect, the extract container held within the containment box can now be called the product container.

[0454] Additionally or alternatively, a separate container, which may be allocated to consumable materials, may be provided by the workpiece support and / or may be provided, which container may serve as a product container, into which a product can be transferred by one or more tool units.

[0455] The product containers with the product 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 locking location of the locking device, in particular to a packaging location.

[0456] The product container comprising the product may be or may be packaged at the exit locking location, in particular a packaging location, in particular by one or more packaging units, so that it is or can be subsequently withdrawn from the locking device.

[0457] The following description relates specifically to workpiece supports or storage boxes.

[0458] The workpiece support can be especially functionally designed as a receiving box for receiving the extract, and can in fact have the function of a receiving box and be designed to fulfil this function.

[0459] Additionally or alternatively, the production facility may include a number of storage boxes for storing one or more workpiece supports, respectively, together with the extract placed thereon and / or received thereon.

[0460] The workpiece support or storage box may be capable of being fed into the clean room area via a locking device.

[0461] The workpiece support or the receiving box may be cleanable and / or sterilizable in the locking device by means of a cleaning device of the locking device or a part of a cleaning device of the production facility assigned to the locking device.

[0462] The workpiece support or storage box may be capable of being stored in a storage location of the storage device by a storage transport device of the storage device, and the workpiece support or storage box may be delivered to the storage transport device by a lock transport device and / or a handling device.

[0463] If necessary, the workpiece supports and / or storage boxes may be delivered from a storage location to a suitable application by a storage transport device and, optionally, a handling device and / or a locking transport device.

[0464] For example, the workpiece support may be or can be equipped, for example by a handling device, with one or more extractive substances and / or one or more tool units and / or one or more consumable materials, so that in particular the workpiece support can be or is stored in a storage device or can be supplied for one or more process steps. In particular, a plurality of workpiece supports may be provided in this way.

[0465] The workpiece supports may be positionable in the respective storage boxes, for example by a handling device, by which the workpiece supports are storeable and / or provideable.

[0466] Additionally or alternatively, the workpiece supports may be positionable in the respective storage boxes, for example by means of handling devices and / or actuator devices arranged in the respective storage boxes and / or on the respective workpiece supports, and the workpiece supports may be stored and / or provided by means of the handling devices and / or actuator devices.

[0467] A number of workpiece supports, in particular workpiece supports formed as storage boxes, and / or storage boxes may be connectable / coupleable to one another, thereby forming a sterile process unit for carrying out one or more processing steps.

[0468] for example, - a workpiece support formed as or arranged in a receiving box, which receives an extract container containing the extract; - a workpiece support configured as or arranged in a storage box, which stores consumable materials for one or more process steps; a workpiece support configured as or arranged in a storage box, which stores one or more tool units for one or more process steps; are connectable / coupleable to one another, in particular by storage / transport and / or handling devices, or are connected / coupled to one another, thereby forming a common sterile process unit, thereby allowing one or more treatment steps to be subsequently carried out.

[0469] After carrying out the treatment process, the workpiece support or the receiving box may again be detachable / decoupleable from one another or may be detached / decoupled.

[0470] The storage boxes containing the manufactured products are transported by the storage and transport device to the locking device as described above. The workpiece supports or storage boxes assigned to tool units and consumable materials can be delivered to a cleaning device of the production facility, by means of which the workpiece supports can be cleaned and / or sterilized.

[0471] The cleaned and / or sterilized workpiece supports or receiving boxes can be placed back into the storage location of the storage device and are free to be used again.

[0472] The following description relates in particular to tools or tool units and to consumable materials, which may be fed into the cleanroom area via a locking device.

[0473] The tool unit or the consumable material may be capable of being introduced into a locking device of a production installation, in particular into an entrance locking location of the locking device.

[0474] The tool units or consumable materials may be cleanable and / or sterilizable in the locking device by means of a cleaning device of the locking device or a part of a cleaning device of the production facility assigned to the locking device.

[0475] The tool unit or the consumable material may have packaging material, which may be removable from the tool unit or the consumable material, 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.

[0476] Advantageously, the packaging material may be cleaned and / or sterilized by a cleaning device of the locking device before removal.

[0477] The tool units or consumable materials may be stored in a storage location of the storage device by a storage and transport device of the storage device, and the tool units or consumable materials may be delivered to the storage and transport device by the locking and transport device and / or the handling device in a state where they are placed on a workpiece support by the handling device.

[0478] The tool units or consumable materials may be movable within the locking device by means of the locking transport device and / or the handling device.

[0479] By means of the handling device, the tool unit or consumable material may be transferable to a workpiece support, in particular a storage box, within the locking device or immediately adjacent to the locking device, or may be transferable to a workpiece support which is or is arranged within the storage box.

[0480] The workpiece supports or storage boxes containing the tool units or consumable materials may be storeable in or at a storage location of the storage device by a storage transport device of the storage device.

[0481] Such a workpiece support or storage box may be or may be provided by a storage and transport device, as already described in connection with the extract and the workpiece support or storage box, for one or more processing steps by the tool unit or using consumable materials.

[0482] After one or more processing steps have been carried out and the storage boxes have been detached / decoupled from one another again, the used tool units or used consumable materials may be capable of being supplied by a storage and transport device, and in particular single-use components may be removed as required from the tool units by a handling device, in particular prior to cleaning and / or sterilization by a cleaning device.

[0483] Furthermore, after one or more treatment steps have been carried out and the storage boxes have been detached / decoupled from one another again, the used tool units of the cleaning device can be delivered by the storage and transport device.

[0484] Additionally or alternatively, used consumable materials, in particular used liquid consumable materials, may be removable from the respective storage box and optionally from the production facility, in particular via a locking device, during one or more process steps.

[0485] Used and / or damaged tool units or used consumable materials may be removable by a handling device from the cleanroom area via a locking device.

[0486] The cleaned and / or sterilized tool units may be stored again in the storage location of the storage device and are free to be used again.

[0487] In relation to the preceding description, the present invention makes it possible to achieve a fully automated complete system for manufacturing biological pharmaceutical products for industrial production of individual batch sizes, in particular individual and / or minimum batch sizes, particularly having modularly formed and / or autonomously operating components.

[0488] According to the invention, in particular by means of the provided sensor device or the provided sensor unit, analytical functions can be integrated into automated processes, in particular into processing steps, so that the ambient and / or processing conditions required for the growth of cells outside the living organism can be finely adjusted and / or controlled and / or regulated, thereby ensuring efficient production of the product.

[0489] According to the invention, due to the flexible and modular structure of the production facility, which may be enabled in particular by a wide variety of devices, both the production of individual and / or minimum batch sizes of biological products as well as the mass production can be carried out automatically, in particular fully automatically, for example for producing autologous and / or allogeneic cell therapeutics, the starting materials of which, in particular the patient's own cells, react highly sensitively to the ambient conditions.

[0490] According to the invention, in particular by means of the cleaning and storage devices integrated in the clean room area, a fully automatic complete system for the production of biological products can be achieved, which can be equipped automatically and which can clean and sterilize the objects required for the processing steps in the extract and thus prepare them again for the sterile production area.

[0491] According to the invention, biological products, in particular personalized therapeutic agents, can be produced automatically, in particular fully automatically and flexibly, based on individually configurable process steps, in particular in a single process space, for example in a clean room area and / or a storage area and / or a storage box.

[0492] In contrast to the rigidly linked individual process steps that typically exist in conventional manufacturing processes for comparable biological products, an efficient system and method is achieved by the present invention.

[0493] The present invention makes it possible to achieve a system, i.e., a production facility and a method, in which an operator or user is no longer required within the direct process environment, which can, among other things, increase manufacturing efficiency and also reduce the probability of manual errors.

[0494] Additionally or alternatively, the production facility may require less space or construction space since workers or users only have to enter the cleanroom area of ​​the production facility during emergencies and / or maintenance.

[0495] This allows the costly building and spatial structures to be economically and technically reduced according to the extract to be directly processed, in other words according to the biological workpieces to be processed, which are to be converted into products.

[0496] The clean environments in which products are openly processed, especially clean rooms class A, can be reduced to a minimum.

[0497] 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 provided and / or processed within the production facility, in particular by one or more control units.

[0498] As the above description indicates, the present invention relates in particular to a production installation and method according to one of the following texts in which further specific embodiments of the invention are described.

[0499] 1. A production facility, in particular for the manufacture of biological products, said production facility being: - a clean room area; - a locking device for feeding and / or removing objects from the cleanroom area around the production facility; - a handling device for moving said objects inside said cleanroom area; a storage device disposed within the cleanroom area, the storage device including a plurality of storage locations for receiving a plurality of objects; Including, production facilities.

[0500] 2. A production facility as described in paragraph 1, characterized in that the storage device includes a storage and transport device for transporting objects in the direction toward the storage location and / or away from the storage location.

[0501] 3. The production facility described in paragraph 2, characterized in that the storage and transportation equipment is a device different from the handling equipment.

[0502] 4. A production facility as described in paragraphs 2 or 3, characterized in that the storage and transport device includes a rail-guided transport system and / or one or more free-running transport vehicles.

[0503] 5. A production facility according to one of the sentences 2 to 4, characterized in that the storage and transport device comprises one or more rail-guided storage and transport units by means of which one or more storage shelves of the storage device can be accessed for storage and removal processes as well as for processing and / or maintenance processes.

[0504] 6. A production facility according to one of sentences 2 to 5, characterized in that the storage and transport device comprises one or more storage and transport units formed as a portal conveyor.

[0505] 7. A production facility according to one of the preceding paragraphs 1 to 6, characterized in that the handling device is or includes a multi-axis robot arm.

[0506] 8. A production installation according to one of the documents 2 to 7, characterized in that the storage and transport device and / or the handling device are assigned an exchange device of the production installation, by means of which different gripping units and / or carrier 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 with the respective storage and transport units and / or handling units.

[0507] 9. A production installation according to one of sentences 2 to 8, characterized in that the storage and transport device and / or the handling device may be assigned a cleaning device for the production installation, by means of which at least one gripping unit and / or carrier unit of one or more storage and transport units of the storage and transport device and / or one or more handling units of the handling device can be cleaned, in particular after the performance of a storage process, a transport process, a handling process, a maintenance process and / or a processing process.

[0508] 10. A production installation according to one of sentences 2 to 9, characterized in that by means of the handling device one or more objects can be transferred from a locking location of the locking device to a storage and transport device, in particular to one or more storage and transport units of the storage and transport device.

[0509] 11. A production installation according to one of sentences 1 to 10, characterized in that the handling device can 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 handover lock location, and / or from a lock location, in particular a handover lock location, to a further lock location, in particular an exit lock location.

[0510] 12. A production facility according to one of sentences 2 to 11, characterized in that the storage and transport device and / or the handling device each include one or more workpiece support receiving sections for receiving and transporting one or more workpiece supports.

[0511] 13. A production installation according to one of sentences 1 to 12, characterized in that the locking device comprises a cleaning device for cleaning the workpiece support or support parts and / or for cleaning the workpiece support receptacle or receptacles.

[0512] 14. A production installation according to one of sentences 1 to 13, characterized in that it comprises a cleaning device to which the workpiece supports can be fed for cleaning themselves, in particular after transport of the objects by the respective workpiece supports has taken place.

[0513] 15. A production installation according to one of sentences 1 to 14, characterized in that the storage device comprises one or more storage shelves and / or one or more storage location surfaces, each having a plurality of storage locations, and that by means of the storage transport device, the extracts and / or tools and / or consumable materials can be stored in or removed from the storage locations.

[0514] 16. A production installation according to one of sentences 1 to 15, characterized in that the production installation comprises a plurality of workpiece supports, which serve to accommodate extractables and / or tools and / or consumable materials.

[0515] 17. A production installation according to sentence 16, characterized in that the workpiece support remains permanently within the clean room area, in particular over one or more complete production processes.

[0516] 18. A production installation according to one of sentences 1 to 17, characterized in that the production installation can include a plurality of types of workpiece supports, the workpiece supports differing from one another in terms of the shape and dimensions of the receiving areas of the respective workpiece supports.

[0517] 19. A production installation according to one of sentences 16 to 18, characterized in that one type of workpiece support serves for receiving a container for containing the extract.

[0518] 20. A production installation according to one of sentences 16 to 19, characterized in that one type of workpiece support serves to receive one or more tool units and / or tool consumables for carrying out processing processes in the extract and / or for carrying out maintenance processes inside the clean room area.

[0519] 21. A production installation according to one of sentences 16 to 20, characterized in that one type of workpiece support serves to receive consumable material for supplying it to the extract and / or for carrying out a treatment process in the extract.

[0520] 22. A production installation according to one of sentences 16 to 21, characterized in that one or more workpiece supports each comprise one or more action units for carrying out actions on the extractor and / or the tool.

[0521] 23. A production installation according to one of sentences 16 to 22, characterized in that one or more action units are formed as processing units for carrying out processing steps on the extract.

[0522] 24. A production installation according to one of sentences 16 to 23, characterized in that one or more action units are formed as sensor units for determining actual values ​​of parameters of the respective workpiece support and / or extractives arranged on the workpiece support and / or tools arranged on the workpiece support and / or consumable materials arranged on the workpiece support.

[0523] 25. A production installation according to one of sentences 16 to 24, characterized in that one or more workpiece supports comprise a storage device for storing energy and / or one or more consumable materials.

[0524] 26. A production installation according to one of sentences 16 to 25, characterized in that the workpiece support can be reused several times, in particular the storage device being rechargeable and / or capable of replenishing consumable materials.

[0525] 27. A production facility according to one of sentences 1 to 26, characterized in that the production facility includes a charging station for charging the storage device, arranged within the clean room area, and / or a refilling station for filling the storage device, arranged within the clean room area.

[0526] 28. A production installation according to one of sentences 1 to 27, characterized in that the production installation comprises a plurality of workpiece supports formed as storage boxes for storing the extract or a plurality of storage boxes for storing one or more workpiece supports, respectively, together with the extract arranged and / or received therein.

[0527] 29. A production facility according to claim 28, characterized in that the storage boxes can be stored in the storage location of the storage device, in particular fully automatically, by means of the storage and transport device of the storage device described above.

[0528] 30. A production facility as described in sentences 28 or 29, characterized in that one or more of the containment boxes enclose a closable internal space.

[0529] 31. A production installation according to one of sentences 28 to 30, characterized in that the containment boxes for introducing the extract and / or for withdrawing the product produced from the extract are openable and / or closable automatically and / or by means of a handling device.

[0530] 32. A production installation according to one of sentences 28 to 31, characterized in that one or more of the containment boxes comprises a conditioning unit which is integrated or which is or can be releasably arranged in the containment box, by means of which the temperature and / or pressure and / or humidity and / or gas composition in the internal space of each containment box can be influenced, in particular controlled and / or adjusted.

[0531] 33. A production installation according to sentence 32, characterized in that one or more of the conditioning units are tool units of a tool system of the production installation, the tool units being capable of being placed in or removed from the respective storage boxes as required, in particular by a storage and transport device of the storage device and / or fully automatically by a handling device.

[0532] 34. A production installation according to one of the sentences 28 to 33, characterized in that the receiving box comprises one or more connection elements which can be connected to corresponding connection elements of one or more process locations, in particular for supplying the respective receiving box with electrical energy and / or consumables, in particular liquids and / or gases, and / or for coupling the respective receiving box, in particular in terms of signal technology, with a higher-level control device.

[0533] 35. A production installation according to one of sentences 1 to 34, characterized in that the storage device comprises a storage location with a connecting element, so that one or more process steps for processing the extract can be carried out in the storage location of the storage device, which serves as a processing location.

[0534] 36. A production facility according to one of sentences 28 to 35, characterized in that the storage location and / or the storage box of the storage device may comprise a fastening element by means of which the storage box may be positioned and fixed in the storage location.

[0535] 37. A production installation according to one of sentences 28 to 36, characterized in that the storage boxes may each comprise one or more tool receiving portions for receiving and fixing one or more tools, in particular in the interior space of the respective storage box.

[0536] 38. A production installation according to sentence 37, characterized in that the one or more tool receiving parts can each comprise one or more connecting elements which can be connected to corresponding connecting elements of the tool to be received, in particular in order to supply the respective tool with electrical energy and / or consumables, in particular liquids and / or gases, and / or to couple the respective tool in terms of signal technology with a receiving box and / or in particular with a higher-level control device.

[0537] 39. A production installation according to one of sentences 1 to 38, characterized in that the storage device comprises one or more storage shelves and / or one or more storage location surfaces, each of which has a plurality of storage locations.

[0538] 40. A production installation according to one of sentences 1 to 39, characterized in that the extract and / or the workpiece support and / or the tools and / or the consumable materials can be stored in the storage location or can be withdrawn from the storage location by means of a storage and transport device of the storage device.

[0539] 41. A production facility according to sentence 40, characterized in that one or more storage locations are accessible from multiple directions and / or by multiple storage and transport units of a storage and transport device.

[0540] 42. A production facility according to sentence 40 or 41, characterized in that the storage location is accessible vertically from above or horizontally from the side by a storage transport device.

[0541] 43. A production facility according to one of sentences 1 to 42, characterized in that a number of rows of storage locations oriented approximately horizontally are arranged vertically one above the other.

[0542] 44. A production facility according to one of sentences 1 to 43, characterized in that some of the storage locations, in particular the entire storage location, are shelf locations of one or more storage shelves.

[0543] 45. A production installation according to one of sentences 1 to 44, characterized in that the storage device comprises a plurality of different types of storage locations for accommodating different types of workpiece supports.

[0544] 46. ​​A production facility according to sentence 45, characterized in that the various types of storage locations differ from one another in terms of their shape and / or dimensions.

[0545] 47. A production facility according to sentences 45 or 46, characterized in that the various types of storage locations differ from one another in terms of their function and / or configuration.

[0546] 48. A production installation according to one of sentences 45 to 47, characterized in that the various types of storage locations are arranged on the storage location shelves and / or in the storage location plane of the storage device in a distributed manner in a regular pattern.

[0547] 49. A production installation according to one of sentences 1 to 48, characterized in that the storage device has a plurality of areas for receiving different types of workpiece supports.

[0548] 50. A production installation according to one of sentences 1 to 49, characterized in that the storage device comprises a plurality of storage locations forming processing stations for processing the extract.

[0549] 51. A production facility according to one of sentences 1 to 50, characterized in that the storage device comprises a plurality of storage locations forming tool stations for storing, maintaining, cleaning, replacing, charging and / or controlling tools.

[0550] 52. A production facility according to one of sentences 1 to 51, characterized in that the production facility includes an unpacking device for unpacking objects to be supplied to the clean room area.

[0551] 53. A production installation according to sentence 52, characterized in that the unpacking device may be integrated into the locking device or form a constituent part of the locking device.

[0552] 54. A production facility according to one of sentences 1 to 53, characterized in that the locking device can include an entrance locking location, which is accessible from the periphery of the production facility and in which packaged objects can be placed, in particular manually and / or automatically.

[0553] 55. A production installation according to sentence 54, characterized in that the packaged objects can be transported from the entrance locking location to the unpacking location by a locking and transporting device of the production installation and can be automatically unpacked at the unpacking location or the packaged objects can be automatically unpacked at the entrance locking location and / or the production installation has an autoclave device which is loadable and / or unloadable from one side by the user, in particular manually, and from the other side automatically, in particular after sterilization and drying by the autoclave device, inside the cleanroom area, in particular by a handling device and / or a storage and transporting device, so that less packaged or partially packaged objects and / or unpackaged objects can be introduced and removed in a sterile manner into the cleanroom area.

[0554] 56. A production installation according to one of sentences 1 to 55, characterized in that the locking device has a cleaning device for cleaning the packaging material of the packaged objects.

[0555] 57. A production installation according to one of sentences 52 to 56, characterized in that the unpacking device comprises a plurality of unpacking units for unpacking different types of objects and / or packaging material, in particular for removing different types of packaging material from the objects.

[0556] 58. A production installation according to sentence 57, characterized in that it is formed with one or more unpacking units for unpacking extracts and one or more further unpacking units for unpacking tools and / or consumable materials.

[0557] 59. A production installation according to one of sentences 52 to 58, characterized in that the unpacking device can include a detection device and a control device, by means of which it is possible to determine the type of object to be unpacked and / or the type of packaging material to be removed.

[0558] 60. A production installation according to sentence 59, characterized in that by the control device an unpacking unit of the unpacking device is selectable and controllable to perform an unpacking process, the unpacking unit being one of a plurality of unpacking units for performing different unpacking processes, and the selected unpacking unit being assigned to a determined type of object to be unpacked and / or a type of packaging material to be removed.

[0559] 61. A production facility according to one of sentences 1 to 60, characterized in that the production facility comprises a tool system by means of which handling and / or maintenance processes on the extract can be carried out inside the clean room area.

[0560] 62. A production installation according to sentence 61, characterized in that the tool system comprises a plurality of, in particular fully automatic, tool units for carrying out various processing and / or maintenance processes.

[0561] 63. A production installation according to sentence 61 or 62, characterized in that the tool system comprises one or more tool units formed as supply units for supplying consumable materials to the extract.

[0562] 64. A production installation according to one of sentences 61 to 63, characterized in that the tool system comprises one or more tool units formed as withdrawal units for withdrawing samples from the extract.

[0563] 65. A production installation according to one of sentences 61 to 64, characterized in that one or more of the tool units of the tool system each comprise one or more multi-use components and / or one or more single-use components.

[0564] 66. A production installation according to one of sentences 61 to 65, characterized in that the tool system includes a preparation unit by means of which a single-use component of the tool unit can be removed after its use, in particular discarded, and replaced by one or more new single-use components.

[0565] 67. The production facility described in sentence 66, characterized in that the preparation unit is located entirely within the clean room area.

[0566] 68. A production installation according to sentence 66 or 67, characterized in that the preparation unit comprises a handling unit, in particular a multi-axis robot arm and / or a pick-and-place robot and / or a wire robot, and the preparation process can be carried out fully automatically by means of the handling unit.

[0567] 69. A production installation according to one of sentences 66 to 68, characterized in that the preparation unit comprises a cleaning unit or is assigned a cleaning unit by means of which multiple components of one or more tool units can be cleaned, in particular sterilized, after their use.

[0568] 70. A production installation according to one of sentences 61 to 69, characterized in that the tool system comprises a plurality of portable tool units, which can be supplied to a processing location for processing the extract, in particular a processing location which is simultaneously a storage location for storing the extract, in order to carry out the processing process, and can be temporarily stored at said location.

[0569] 71. A production facility according to sentence 70, characterized in that 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 means of a storage and transport device of the production facility, in particular by means of one or more storage and transport units.

[0570] 72. A production installation according to one of sentences 1 to 71, characterized in that one or more tool units are formed and arranged by handling devices for carrying out processing and maintenance processes.

[0571] 73. A production installation according to one of sentences 1 to 72, characterized in that one or more tool units are formed and arranged independently, in particular independently, of handling devices for carrying out processing and / or maintenance processes.

[0572] 74. A production installation according to one of sentences 1 to 73, characterized in that the production installation comprises in particular a fully automatic tool system, the tool unit comprising one or more tool units for carrying out processing steps on the extract, the tool being arranged inside a clean room area.

[0573] 75. A production installation according to one of sentences 61 to 74, characterized in that the tool system comprises one or more tool units formed as a fluid conveying device, by means of which the fluid can be conveyed adjustably in terms of the volumetric flow.

[0574] 76. A production installation according to one of sentences 61 to 75, characterized in that the tool system comprises one or more tool units formed as a microfluidic transport device, by means of which the fluid can be transported in an adjustable manner, in particular in terms of volumetric flow, in particular for aliquoting.

[0575] 77. A production installation according to one of sentences 61 to 76, characterized in that the tool system can comprise one or more tool units formed as a device for dividing a fluid, by means of which the fluid can be conveyed adjustably in terms of volumetric flow and by means of which the fluid can be divided, in particular adjustably, into at least two fluid portions.

[0576] 78. A production installation according to one of sentences 61 to 77, characterized in that the tool system can include one or more tool units formed as a fluid mixing device, by means of which the fluids are mixable.

[0577] 79. A production installation according to one of sentences 61 to 78, characterized in that the tool system comprises one or more tool units formed as a mixing device, by means of which at least two components can be mixed with one another, in particular one of the at least two components being a fluid.

[0578] 80. A production installation according to one of sentences 61 to 79, characterized in that the tool system can include one or more tool units formed as measuring devices, by means of which at least one characteristic of the fluid and / or the extract can be measured.

[0579] 81. A production installation according to one of sentences 61 to 80, characterized in that the tool system comprises one or more tool units formed as a material separation device, by means of which the starting components can be separated into at least two components.

[0580] 82. A production installation according to one of sentences 61 to 81, characterized in that the tool system comprises one or more tool units formed as heating devices, by means of which the temperature of the fluid can be regulated.

[0581] 83. A production installation according to one of sentences 61 to 82, characterized in that the tool system comprises one or more tool units formed as a device for supplying and / or delivering gas, by means of which gas can be supplied and / or delivered.

[0582] 84. A production installation according to one of sentences 61 to 83, characterized in that the tool system can comprise one or more tool units formed as a manipulator, by means of which the cell membrane can be manipulated, in particular by means of an electric field.

[0583] 85. A production installation according to one of sentences 61 to 84, characterized in that the tool system comprises one or more tool units formed as a radiation source and / or a light-emitting device, the radiation source being formed to emit an ionizing beam and the light-emitting device being formed to emit light having a predetermined wavelength.

[0584] 86. A production installation according to one of sentences 61 to 85, characterized in that the tool system comprises one or more tool units formed as cleaning devices, by means of which the places in which processing steps can be carried out on an extract by means of said one or more tool units are cleanable and / or sterilizable.

[0585] 87. A production facility according to one of sentences 1 to 86, characterized in that the tool system includes a tool system and a supply device for supplying consumable material to the tool system.

[0586] 88. A production facility as described in sentence 87, characterized in that the supply device includes or utilizes one or more storage locations of a storage device located within the clean room area for storing consumable materials.

[0587] 89. A production installation according to sentence 87 or 88, characterized in that the locking device forms a component of the supply device or cooperates with this component, and by means of the locking device the consumable material can be introduced into the clean room area.

[0588] 90. A production installation according to one of sentences 87 to 89, characterized in that the storage device forms a component part of the supply device or cooperates with this component part.

[0589] 91. A production installation according to one of sentences 87 to 90, characterized in that consumable materials supplied from the surroundings of the production installation can be supplied to one or more storage locations of the storage installation by means of a storage-transport device of the storage installation, in particular by means of one or more storage-transport units of the storage-transport device of the storage installation.

[0590] 92. A production installation according to one of sentences 61 to 91, characterized in that consumable materials can be supplied to the tool system, in particular to one or more tool units of the tool system, e.g. consumables and / or tool consumables to one or more tool units of the tool system, by means of a storage-transport device of the storage device, in particular by means of one or more storage-transport units of the storage-transport device of the storage device.

[0591] 93. A production installation according to one of sentences 87 to 92, characterized in that the supply device comprises one or more disposal units by means of which in particular used, worn-out and / or soiled consumables and / or tool consumables can be removed from the clean room area.

[0592] 94. A production installation according to one of sentences 87 to 93, characterized in that the supply device can include a replenishment device arranged inside the clean room area, by means of which consumables, in particular those present in liquid form, can be supplied to one or more storage devices of one or more workpiece supports and / or one or more storage locations.

[0593] 95. Production facilities are a) one or more extracts, and / or b) one or more workpiece supports; and / or c) one or more tools; and / or d) one or more storage boxes, in particular storage boxes configured as sterile process units; A production installation according to one of the documents 1 to 94, characterized in that it comprises one or more sensor units for determining one or more values ​​of one or more parameters.

[0594] 96. A production facility according to one of sentences 1 to 95, characterized in that by means of one or more sensor units the occupancy state of one or more storage locations of a storage device of the production facility can be determined, in particular monitored.

[0595] 97. A production installation according to one of sentences 1 to 96, characterized in that by means of one or more sensor units the local temperature and / or the local humidity and / or the local lighting or illumination intensity of or in one or more storage locations of a storage device of the production installation can be determined, in particular monitored.

[0596] 98. A production installation according to one of sentences 1 to 97, characterized in that the production installation comprises one or more sensor units for determining the processing progress during the processing of an extract or between two processing steps.

[0597] 99. A production installation according to one of the sentences 1 to 98, characterized in that one or more sensor units for determining the processing progress are microscopic devices for visually grasping the microscopic components of the extract.

[0598] 100. A production installation according to one of sentences 1 to 99, characterized in that in one or more storage locations for receiving the extract or in the storage locations, respectively, one or more sensor units for determining the processing progress are arranged, in particular integrated in the storage locations.

[0599] 101. A production installation according to one of sentences 1 to 100, characterized in that the production installation, in particular the one or more tools for carrying out one or more process steps, is controllable and adjustable depending on one or more determined values, in particular in that one or more process parameters are changed depending on the determined process progress.

[0600] 102. A production facility according to one of sentences 1 to 101, characterized in that the production facility includes one or more sensor units for monitoring the amount of consumable materials stored inside the clean room area.

[0601] 103. A method for producing a product, in particular a biological product, by means of a production facility, in particular a production facility according to one of the documents 1 to 102, said method comprising the steps of: - selecting one of a plurality of production programs for producing a plurality of products producible by the production facility; - introducing the extract into a locking device of said production facility; - automatically transporting said extract into a clean room area of ​​said production facility; - automatically carrying out one or more processing steps on said extract; A method for producing a product comprising:

[0602] 104. The method according to sentence 103, characterized in that when the extract is automatically transported into the clean room area of ​​the production facility, the extract is stored in a storage location of a storage device of the production facility located inside the clean room area.

[0603] 105. The method according to sentence 104, characterized in that one or more processing steps are carried out fully automatically until the product to be produced from the extract is completed.

[0604] 106. The method according to sentence 104 or 105, characterized in that one or more, in particular all, processing steps are carried out at the storage location.

[0605] 107. The method according to one of sentences 104 to 106, characterized in that the product thus produced is extracted from said storage location and automatically transported to said locking device for withdrawal of said product from said production facility.

[0606] 108. The method according to sentence 107, characterized in that the product is filled and / or packaged before withdrawal, in particular in a ready-to-use state.

[0607] 109. The method of any one of sentences 104 to 108, characterized in that one or more containers, receptacles and / or tools utilized to manufacture the product remain at least partially within the cleanroom area after completion of the product, are cleaned, sterilized, and subsequently reused for the manufacture of further products.

[0608] 110. The method according to one of sentences 104 to 109, characterized in that consumable materials, in particular consumables and / or tool consumables, necessary for producing the product and / or for producing a number of different products are stored inside the cleanroom area, in particular before a selection of the product to be produced is made.

[0609] 111. The method according to sentence 110, characterized in that the consumable material is automatically transported into the clean room area via the locking device and stored in the clean room area, in particular in one or more storage locations of the storage device.

[0610] 112. The method according to sentence 110 or 111, characterized in that the amount of consumable material stored inside the cleanroom area is monitored and, if it falls below a specified minimum amount, the inventory is increased by supplying the required consumable material, in particular via a suggestion or warning message of an operator unit.

[0611] 113. The method according to one of sentences 104 to 112, characterized in that several products, in particular several different products, are produced simultaneously inside the cleanroom area.

[0612] 114. The method according to sentence 103, characterized in that each product to be manufactured may be assigned a series of processing steps, which are carried out by tools arranged inside the cleanroom area and which remain in the cleanroom area after carrying out the processing steps.

[0613] 115. The method according to one of sentences 103 to 114, characterized in that the tool or tools are cleaned, in particular sterilized, inside a clean room area after carrying out the process or processes.

[0614] 116. The method according to one of sentences 103 to 115, characterized in that one or more tools are equipped with tool consumables inside the clean room area before carrying out one or more process steps.

[0615] 117. The method of one of sentences 116, characterized in that one or more tool consumables are removed and / or discarded from the one or more tools inside the clean room area after performing one or more processing steps.

[0616] 118. A number of, in particular all, processing steps may be assigned a processing time value, which indicates the time that elapses from the start of the respective processing step to its end, in particular - the time required to provide at least one tool required for the respective process step, in particular including one or more tool consumables, and / or - the time for the supply and / or placement and / or start-up of at least one tool in the extract to be treated, in particular in the storage location 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 - including the time required to remove at least one tool from the extraction, in particular from a storage location, -Preferably a) cleaning of at least one tool; and / or b) Removal and / or disposal of tool consumables; and / or c) Return transportation of the tools to the point of departure, in particular to the storage area assigned to them. The method according to one of sentences 103 to 117, comprising:

[0617] 119. The method according to one of sentences 103 to 118, characterized in that in each production program, the process steps required for the production of a given product as well as the associated process time values ​​can be / are recorded or taken into account.

[0618] 120. A method according to one of the statements 103 to 119, characterized in that at the start of a production program, the production course is predicted and the tools required and / or specified for the implementation of the process steps are prepared in advance for the time slots resulting from the prediction.

[0619] 121. One or more process steps may each include a) one or more cleaning processes for cleaning one or more tools and / or cleaning one or more storage locations; and / or b) one or more disposal processes for disposing of expendable materials; and / or c) one or more preparatory steps for equipping one or more tools with consumable material; and / or d) one or more control steps for controlling the processing result; is assigned or has been assigned, The method according to one of statements 103 to 120, characterized in that, depending on the forecast of the production process, time slots are reserved in advance in one or more devices required for the execution of one or more cleaning processes, one or more disposal processes, one or more preparation processes and / or one or more control processes.

[0620] 122. The method according to sentence 120 or 121, characterized in that after one or more processing steps, in particular after each processing step, a forecast of the production course is tested and / or realized, in particular to check or correct time slots for tools and / or other equipment still required to complete the product.

[0621] 123. A method according to one of sentences 103 to 122, characterized in that at the desired start of a production program, it is determined based on a forecast of the production course whether all necessary tools and / or other equipment are available within the required time slit to complete the product, and the production program is started only if such a determination provides a positive result.

[0622] Further advantageous features and / or advantages are the subject of the following description of exemplary embodiments and the drawings. [Brief description of the drawings]

[0623] [Figure 1] FIG. 1 is a schematic perspective view of a production facility in accordance with an example embodiment of the present invention. [Diagram 2] FIG. 2 is a perspective view that diagrammatically illustrates a portion of the production facility shown in FIG. [Diagram 3] FIG. 3 is a top view that diagrammatically illustrates a portion of the production facility shown in FIG. [Figure 4] FIG. 4 is a top view that diagrammatically illustrates a portion of the production facility shown in FIG. [Diagram 5] FIG. 5 is a top view that diagrammatically illustrates the production facility shown in FIG. [Figure 6] FIG. 6 is a top view that diagrammatically illustrates the production facility shown in FIG. [Figure 7] FIG. 7 is a top view that diagrammatically illustrates the production facility shown in FIG. [Figure 8] FIG. 8 is a top view that diagrammatically illustrates a portion of the production facility shown in FIG. [Figure 9]FIG. 9 is a perspective view that diagrammatically illustrates a portion of the production facility illustrated in FIG. [Figure 10] FIG. 10 is a top view that diagrammatically illustrates a portion of the production facility shown in FIG. [Figure 11] FIG. 11 is a top view that diagrammatically illustrates a portion of the production facility shown in FIG. [Figure 12] FIG. 12 is a schematic perspective view of a production facility according to a further exemplary embodiment of the present invention. [Figure 13] FIG. 13 is a perspective view that diagrammatically illustrates a portion of the production facility shown in FIG. [Figure 14] FIG. 14 is a top view that diagrammatically illustrates a portion of the production facility shown in FIG. [Figure 15] FIG. 15 is a top view that diagrammatically illustrates a portion of the production facility shown in FIG. [Figure 16] FIG. 16 is a top view that diagrammatically illustrates the production facility shown in FIG. [Figure 17] FIG. 17 is a top view that diagrammatically illustrates the production facility shown in FIG. [Figure 18] FIG. 18 is a top view that diagrammatically illustrates the production facility shown in FIG. [Figure 19] FIG. 19 is a top view that diagrammatically illustrates a portion of the production facility shown in FIG. [Figure 20] FIG. 20 is a perspective view that diagrammatically illustrates a portion of the production facility shown in FIG. [Figure 21] FIG. 21 is a top view that diagrammatically illustrates a portion of the production facility shown in FIG. [Figure 22] FIG. 22 is a top view that diagrammatically illustrates a portion of the production facility shown in FIG. [Diagram 23] FIG. 23 is a schematic perspective view of a production facility according to a further exemplary embodiment of the present invention. [Figure 24] FIG. 24 is a schematic perspective view of a production facility according to a further exemplary embodiment of the present invention. [Diagram 25]FIG. 25 illustrates a method according to an example embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0624] Identical or functionally equivalent elements have the same reference numbers in all figures.

[0625] FIG. 1 shows a schematic perspective view of a production facility 10 according to an example embodiment of the present invention.

[0626] With reference to FIG. 1, a production facility 10 may be configured to, among other things, manufacture a biological product 20, a clean room area 100; a locking device 200 for feeding objects into and / or removing objects from the cleanroom area 100 around the production facility 10; a handling device 300 for moving said objects inside said cleanroom 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.

[0627] The biological product 20 may be intended for personalized therapy and may thus be a personalized therapeutic agent, such as a personalized cellular therapy agent, such as an autologous and / or allogeneic cellular therapy agent, or a genetic therapy agent, such as an autologous gene and / or an allogeneic gene therapy agent.

[0628] The production facility 10 has a housing (not shown) for separating a clean room area 100 toward the periphery of the production facility 10 .

[0629] In effect, the housing encloses the entire production facility 10 .

[0630] The locking device 200 is thus 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.

[0631] The clean room area 100 can be or is loaded with positive pressure by a system (not shown) for adjusting the ambient characteristics of the clean room area 100 of the production facility 10, thereby ensuring predetermined clean room area characteristics of the clean room area 100 and in particular avoiding the ingress of contaminants.

[0632] Additionally, air is supplied into or drawn from the cleanroom area 100 by a system for adjusting the ambient characteristics of the cleanroom area 100 .

[0633] As can be seen in FIG. 1, storage system 400 includes a plurality of storage shelves 404, here three in this example, each having a plurality of storage locations 402.

[0634] In effect, storage location 402 is a shelf location for one or more, for example, three, storage shelves 404 .

[0635] The storage arrangement 400 further includes a storage transport arrangement 406 for transporting objects in a direction toward the storage location 402 , and in particular the storage shelves 404 , and / or away from the storage location 402 , and in particular the storage shelves 404 .

[0636] In particular, by means of a storage transport device of the storage device, the extract and / or the workpiece support and / or the tool and / or the consumable material may be storeable into the storage location or may be withdrawable from the storage location.

[0637] The storage and transport device 406 is a different device than the handling device 300 .

[0638] The storage and transport device 406 is a rail-guided transport system and includes one or more, here illustratively two, rail-guided storage and transport units 408. The storage and transport units allow access to the storage shelves 404 of the storage device 400 for storage and retrieval processes, as well as for processing and / or maintenance processes.

[0639] The storage shelves 404 are generally parallel to one another and spaced apart from one another within the clean room area 100 .

[0640] A storage transport device 406 is disposed within each space between the storage shelves 404. A storage transport device 408 is assigned to each space between the storage shelves 404.

[0641] In effect, there may be a storage shelf-storage and transport unit-storage shelf-storage and transport unit-storage shelf-arrangement.

[0642] Such an arrangement allows the storage locations 402 of at least the middle storage shelf 404 to be accessible from multiple directions and / or by both storage transport units 408 of the storage transport apparatus 406 .

[0643] Other configurations of storage shelves 404 and storage transport units 408 combinations are also contemplated herein.

[0644] The parallel arrangement described above can be extended or realized in any alternating manner, for example, as desired.

[0645] Additionally, a star-shaped arrangement of storage shelves 404 may be envisioned, for example.

[0646] The storage locations 402 of the storage shelves 404 are accessible horizontally and laterally by a storage transport device 406 .

[0647] A plurality of generally horizontally oriented rows of storage bays 402 are arranged vertically above one another within a storage shelf 404 .

[0648] In effect, the storage locations 402 within the storage shelves 404 are arranged in rows and columns. For example, shown in Figure 1 is a 4x13 (outer storage shelves 404) and 4x10 (middle shelves 404) matrix arrangement.

[0649] As previously mentioned, the storage locations 402 are configured to accommodate various types of objects. The storage locations 402 may differ from one another with respect to their shapes and / or sizes.

[0650] For simplified illustration, the storage locations 402 in FIG. 1 are illustrated merely in a uniform format, and in particular in a uniform shape and size.

[0651] The storage locations 402 may further differ from one another with respect to their functionality and / or configuration.

[0652] The various types of storage locations may be arranged on storage location shelves and / or in storage location planes of the storage device, distributed in a regular pattern.

[0653] The production facility 10 may further include a cleaning device 500. The cleaning device may enable one or more workpiece supports 30 and / or one or more tools or tool units 702 and / or one or more consumable materials 704 to be cleaned and / or sterilized.

[0654] The cleaning device 500 may be formed both as a separate device in a clean room area and as a component part of a tool system, in particular a tool or tool unit 702 .

[0655] The cleaning device 500 makes it possible to clean and / or sterilize, in particular by irradiation, objects that come into direct contact with the extract, in particular the tools 702 and / or the consumable materials 704.

[0656] The cleaning device 500 allows objects that do not come into direct contact with the extract to be cleaned and / or disinfected or sterilized, in particular by gas treatment.

[0657] The production facility 10 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, such as manufactured products 20, to be removed from the clean room area 100.

[0658] The unpacking device 212 and the packing device 214 are incorporated or added to the locking device 200, and in particular, are incorporated or added in a lateral arrangement here.

[0659] 1 and 2, the locking device 200 comprises an entrance lock 202 through which a lock location 206, in particular the entrance lock location 206, is accessible from the periphery and which is configured to feed objects from the periphery of the production facility 10 into the clean room area 100.

[0660] 1 and 2, the locking device 200 has an exit lock 204. Through the exit lock 204, a lock location 208, in particular 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.

[0661] The entrance lock 202 and the exit lock 204 further comprise means for spatially isolating the lock locations 206, 208 (not shown) specifically assigned to the entrance lock 202 and the exit lock 204, respectively.

[0662] Isolation is selectively performed in each case by the isolating means of the entrance lock 202 and the exit lock 204 towards the periphery of the production facility 10 and / or towards parts of the locking device 200 which are different from the locking locations 206, 208, respectively.

[0663] Furthermore, the production facility 10 may have a number 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, in particular for maintenance work inside the clean room area 100.

[0664] The production facility 10 comprises one or more control units that are located within a control system 600 located within a switchboard within the cleanroom area 100 and that are configured and programmed to regulate and / or control at least one of the components contained by the production facility or parts of the production facility, the components or parts being assigned to one or more control units.

[0665] It is conceivable that one or more control units form a higher-level control device.

[0666] The one or more control units are 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-interfaces 602 are illustrated in the drawings) of the production facility 10.

[0667] A communication interface not shown may, for example, serve 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.

[0668] The one or more control units 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 regarding the production status of the product 20 and / or information regarding the storage status of the storage device 400.

[0669] Additionally, the production of the biologic product 20 by the production facility 10 may be effectuated by one or more control units.

[0670] By means of one or more control units, said product production can be carried out according to one or more production programs.

[0671] Each product 20 to be manufactured may be assigned a series of processing steps, which may be performed by tool units 702 located within the clean room area 100 and remaining within the clean room area after the processing steps have been performed.

[0672] 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.

[0673] The production equipment 10 further includes one or more sensor units for determining one or more values ​​of one or more parameters of the one or more extractives 40, and / or the one or more workpiece supports 30, and / or the one or more tools or tool units 702, and / or the one or more consumable materials 704.

[0674] The sensor unit is connectable to or connected to a control unit.

[0675] The sensor unit is particularly useful for determining the processing progress of an extract during processing or between two processing steps.

[0676] The sensor device is particularly useful for controlling and / or adjusting one or more tool units 702 for performing 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.

[0677] The sensor unit serves in particular to monitor the storage conditions and / or storage amounts in the storage device 400 , for example in the storage location 402 .

[0678] The production facility 10 is further connected to at least one current source (not shown) arranged around the production facility for the purpose of supplying it with electric current.

[0679] 2, there is shown an enlarged view of the locking device 200 of FIG.

[0680] 2 and 3, the handling device 300 includes a multi-axis robotic arm 320 arranged adjacent to the lock device 200 and a lock transport device 304. By means of the lock transport device one or more objects can be transported from a lock location, in particular the entry lock location 206, to a further lock location, in particular the handover lock location 216, and / or from a lock location, in particular the handover lock location, to a further lock location, in particular the exit lock location 208.

[0681] It is also conceivable that the handling device 300 has a first multi-axis robot arm and a second multi-axis robot arm (not shown), the first multi-axis robot arm being assigned to an inlet material flow into the production facility and the second multi-axis robot arm being assigned to an outlet material flow from the production facility. It is also conceivable that the handling device 300 can in fact be divided into a first handling device and a second handling device, the first handling device and the second handling device being respectively assigned to an inlet material flow into the production facility and an outlet material flow from the production facility.

[0682] In the entry lock 202, the workpiece support 30 of the production facility 10 is arranged on an entry lock location 206, and the extract 40 contained in an extract container 42. The extract container 42 is arranged on the workpiece support 30.

[0683] The workpiece support 30 is disposed on a lock transport device 304 .

[0684] The extract 40 comprises cells and medium, the cells and medium forming a cell suspension.

[0685] The cell suspension has a volume ranging from 1 μl to 1000 ml.

[0686] Besides the workpiece support 30, the production facility 10 has one or more further workpiece supports 30. The further workpiece supports can be or are housed, for example, in a storage location 402.

[0687] The workpiece support 30 serves to receive the extractables and / or the tools or tool units and / or the consumable materials.

[0688] The workpiece support 30 has fastening means (not shown), in particular fastening means for receiving extractables and / or tools and / or consumable materials, respectively, in particular positively and / or frictionally and / or magnetically fastening means.

[0689] The fastening means can in particular comprise at least one adapter device and / or at least one form-nesting device, so that a particularly secure receiving connection between the workpiece support and the extract container can be achieved.

[0690] The fastening means can in particular be individually designed corresponding to the object to be received, for example the extract container.

[0691] The workpiece support 30 shown in FIGS. 1 and 2 receives an extract 40 , here disposed in an extract container 42 .

[0692] The production facility 10 includes a plurality of types of workpiece supports 30 that differ from one another with respect to the shape and size of the receiving area of ​​each workpiece support 30 .

[0693] As illustrated in FIGS. 1 and 2, one type of workpiece support 30 serves to receive an extract container 42 .

[0694] Another type of workpiece support 30 serves to receive one or more tool units 702 and / or tool consumables 704 for performing processing steps in the extract 40 or for performing maintenance steps within the clean room area 100.

[0695] Another type of workpiece support 30 serves to receive consumable material 704 for supplying the consumable material 704 to the extract 40 and / or for carrying out a process in the extract 40 .

[0696] The workpiece support or supports 30 each include one or more action units (not shown) for carrying out an action on the extract 40 and / or the tool 702. The action unit or units are formed as processing units, e.g. tool unit 702, for carrying out a processing step on the extract and / or the action unit or units are formed as sensor units for determining actual values ​​of parameters of the respective workpiece support 30 and / or extract 40 arranged on the workpiece support and / or tool 702 arranged on the workpiece support and / or consumable material 704 arranged on the workpiece support. This allows in particular the functions of an independent tool system (see below) to be taken over in the functional units, here in the workpiece support 30.

[0697] One or more of the workpiece supports 30 include a storage device (not shown) for storing energy and / or one or more consumable materials 704. The workpiece supports 30 may be reused multiple times, and in particular the storage device may be rechargeable and / or the consumable materials 704 may be replenished.

[0698] The workpiece support 30 has one or more coupling devices (not shown) by means of which several, in particular two or more, workpiece supports 30 can be coupled to one another.

[0699] The workpiece support 30, shown in Figures 1 and 2, disposed on a lock transport device 304, is fed to the entrance lock location 206 for receiving the extract container 42 in a process not shown.

[0700] In this case, the user first produces the desired product 20 from the extract 40 by selecting a production program for the production facility 10 via, for example, the HMI interface 602 .

[0701] Subsequently, the user places the extract container 42 together with the extract 40 disposed in the extract container on a workpiece support 30 provided at the entrance lock location 206. The workpiece support is already provided at the entrance lock location 206 for receiving an object. Alternatively, the workpiece support 30 stored in a storage location 402 on one of the storage shelves 404 has been retrieved from the storage location 402 by a storage transport unit 408 of the storage transport device 406 and transported to the lock device 200, so that the workpiece support 30 can be supplied to the entrance lock location 206 by the multi-axis robot arm 302 and the lock transport device 304.

[0702] As soon as the workpiece support 30 is provided at the entrance lock location 206 for receiving the extract 40, the extract container 42 together with the extract 40 disposed therein is manually delivered by the user to the workpiece support 30 and fixed to the workpiece support by a fixing means.

[0703] The extract container 42 typically further comprises packaging materials to maintain the sterility of the extract 30 .

[0704] The entrance lock 202 can now transition to a closed state or is now closed.

[0705] The cleaning and sterilization processes are now carried out in the packaged extract container 42 at the entry lock location 260 by gassing and / or irradiation by a gassing source and / or irradiation source (not shown) positioned accordingly at the entry lock location 206.

[0706] The packaged extract container 42 is then moved onto the workpiece support 30 by the rock transport device 304 into range of the multi-axis robotic arm 302 .

[0707] The multi-axis robotic arm 302 separates the packaged extract container 42 from the workpiece support 30 and transfers the extract container 42 to the unpacking device 212. In the unpacking device, the packaging material of the extract container 42 can be / is removed by one or more unpacking units of the unpacking device 212.

[0708] Here, the entrance lock location 208 shown in FIGS. 2 and 3 serves as an unpacking location 206 , which is accessible by one or more unpacking units of the unpacking device 212 .

[0709] It is further conceivable that the packaging material of the extract container 42 can be removed by one or more unpacking units by the multi-axis robotic arm 302.

[0710] After the delivery of the packed extract container 42 to the unpacking device 212, the workpiece support 30 is again returned to the entrance lock location 206 by the lock transport device 304 for new reception of objects, as shown in particular in FIG.

[0711] After unpacking by the unpacking device 212, the unpacked extract container 42 is transferred by the multi-axis robotic arm 302 to another, in particular a sterile, workpiece support 30 (see FIG. 4) provided on a lock transport device 304 at one or more transfer lock locations 216.

[0712] This alternative workpiece support 30 has previously been removed from storage location 402 on storage shelf 404 and is accordingly serviced by storage transport unit 408, multi-axis robotic arm 302, and lock transport device 304 as shown in FIG.

[0713] The lock transport device 304 and / or the multi-axis robot arm 302 move the workpiece support 30 together with the extract container 42 disposed on the workpiece support into a storage box 50 (the left storage box 50 shown in Figures 3-5), to which the storage box 50 has been provided to the lock transport device 304 by a storage-transport unit 408 (see Figures 3-5).

[0714] Furthermore, a further storage box 50 is provided for storing objects (the right storage box 50 shown in Figures 3-5).

[0715] The production facility 10 includes a number of storage boxes 50 for storing one or more workpiece supports 30, respectively, together with the extract 40 disposed thereon and / or received therein. The extract is disposed in an extract container 42.

[0716] Additionally or alternatively, it is also conceivable for the aforementioned tool support 30 to be formed as a storage box 50 .

[0717] As shown in FIG. 1, the storage box 50 may be capable of being stored in a storage location 402 of a storage device 400 fully automatically, in particular by a storage transport unit 408 .

[0718] One or more of the containment boxes 50 can enclose a closable interior space. The interior space can define a sterile process environment.

[0719] In effect, containment box 50 may define a process unit, particularly a sterile process unit.

[0720] The containment box 50 may be openable and / or closeable automatically and / or by a handling device 300 to introduce the extract 40 and / or to withdraw the product 20 produced from the extract 40.

[0721] The containment boxes 50 may each include one or more integrated or releasably arranged in the containment box or may be releasably arranged in the containment box (not shown) conditioning units, by means of which the temperature and / or pressure and / or humidity and / or gas composition in the interior space of the respective containment box 50 may be influenced, in particular controlled and / or regulated.

[0722] One or more of the conditioning units are tool units 702 of a tool system of the production installation 10. The tool units can be placed in or removed from the respective storage boxes 50, in particular fully automatically, by the storage and transport device 406, in particular the storage and transport unit 408 of the storage and transport device 406, and / or by the handling device 300, in particular the multi-axis robot arm 302 of the handling device 300, as required.

[0723] The storage box 50 comprises one or more connection elements which can be connected to corresponding connection elements of one or more processing locations 402, in particular to supply the respective storage box 50 with electrical energy and / or consumables 704, in particular liquids and / or gases, and / or to couple the respective storage box 50 in terms of signal technology with a higher-level control device, in particular with one or more control units serving as higher-level control devices, in particular with the production installation 10.

[0724] The storage location 402 is provided with connection elements thereto so that one or more process steps for processing the extract 40 can be carried out in the storage device 400 at the storage location 402 serving as a processing location.

[0725] The storage location 402 of the storage device 400 and / or the storage box 50 may include fastening elements by which the storage box 50 may be positioned and secured in the storage location 402 .

[0726] The storage boxes 50 may each include one or more tool receiving portions for receiving and fixing one or more tools or tool units 702 , particularly in the interior space of the respective storage box 50 .

[0727] The one or more tool receiving portions may each include one or more connection elements which are connectable to corresponding connection elements of the tool 702 to be received, in particular for supplying the respective tool 702 with electrical energy and / or consumables, in particular liquid and / or gas, and / or for signal-technically coupling the respective tool 702 with the receiving box 50 and / or with a higher-level control device.

[0728] It is also contemplated that the storage box 50 may include one or more connection elements that may be connected to corresponding connection elements of a further storage box 50, thereby providing a single integrated storage box 50.

[0729] 4 and 5, the workpiece support 30, together with the extract container 42 disposed on the workpiece support, is moved into the storage box 50 (left) by the lock transport device 304 and / or the multi-axis robotic arm 302.

[0730] The storage box 50 can now be stored in the left or middle storage shelf 404 shown in FIG. 5 by the left storage and transport unit 408 shown in FIG.

[0731] By means of the left storage and transport unit 408, the storage box 50 is transported to the middle storage shelf 404 and stored there. Depending on the production program of the production installation 10 selected by the user, i.e. according to which the production installation 10 can produce the desired product 20 from the extract 40, the storage and transport unit 408 can transport or transports one or more objects, in particular tools or tool units 702 and / or consumable materials, stored in the storage location 402 of the storage device 400, to the storage box 50 stored together with the extract container 42 in the middle storage shelf 404 in a defined sequence and at defined times, also defined by the selected production program.

[0732] As illustrated by the arrows in FIG. 6 , in order to perform one or more processing steps, for example, the tool unit 702 is extracted from the left storage shelf 404 by the storage transport unit 408 and fed into the storage box 50 containing the extract container 42, thereby performing one or more processing steps on the extract 40 in the extract container 42 by the tool unit 702.

[0733] The illustrated arrows may represent a tool path 706 of a tool unit 702 within the clean room area 100 .

[0734] The extracted tool unit 702 is now placed on the workpiece support 30 and / or in the storage box 50 .

[0735] The tool unit 702 is part of a tool system of the production facility 10. The tool system allows handling and / or maintenance processes on the extract to be carried out inside the clean room area 100.

[0736] The tool system comprises a number of, in particular fully automatic, tool units 702 for carrying out different processing and / or maintenance procedures.

[0737] The tool system includes one or more tool units 702 configured as supply units for supplying consumable materials to the extractor 40 .

[0738] The tooling system includes one or more tooling units 702 formed as extraction units for extracting samples from the extract 40 .

[0739] One or more of the tool units 702 of the tool system each include one or more multi-use components and / or one or more single-use components.

[0740] After carrying out one or more processing steps on the extract 40, the previously supplied, now used tool unit 702 is again led out of the storage box 50 containing the extract 40 by the storage and transport unit 408, in particular removed from the storage box 50 and sent out.

[0741] This is done inside the containment box 50.

[0742] As shown by the arrow in FIG. 7, the storage-transport unit 408 transports the used tool unit 702 in such a storage box 50 to the handling device 300, where it is extracted from the storage box 50 by the handling device 300 (see FIG. 8).

[0743] The illustrated arrows can represent a tool path 706 of a used tool unit 702 inside the clean room area 100. The tool path can be understood in the sense of a material flow, whereby in this production facility a basically directional material flow is preferred, in particular from the clean side to the dirty side.

[0744] By means of the handling device 300, in particular the multi-axis robotic arm 302 of the handling device 300, the used tool unit 702 is separated from the single-use components, e.g. tubes, cannulas and / or other disposable elements, that have been used during one or more process steps and are placed in the tool unit 702. The removed single-use components can be or are removed from the cleanroom area 100 via the locking device 200.

[0745] As shown in figure 8, this is done in particular by a multi-axis robot arm 302 via a waste lock 218 of the locking device 200. It is conceivable that the waste lock 218 is formed as a separate device from the handling device 300, with a cleanroom-technical separation between these devices, thus ensuring a directional material flow from the clean side to the dirty side.

[0746] 9, the used tool unit 702 is put back into the storage box 50 again and is subsequently delivered together with the storage box 50 to a cleaning device 500 of the production facility 10, in particular by the storage transport unit 408 and / or the handling device 300. By means of the cleaning device, the used tool unit 702 and its storage box 50 can be cleaned and sterilized or are cleaned and sterilized.

[0747] As shown diagrammatically in FIG. 10, the tool units 702 cleaned and sterilized by the cleaning device 500 are fed back to the handling device 300 .

[0748] Furthermore, the handling device 300 is supplied with consumable materials 704, in particular one or more new sterile single-use components, from the storage shelves 404 by the storage transport unit 408 on the workpiece support 30 and / or in a further storage box 50 (the right storage box 50 shown in Figure 10).

[0749] The handling device 300, in particular the multi-axis robot arm 302, allows the tool unit 702 to be fitted with new consumable material 704, i.e. a new single-use component, so that it can be used again for one or more process steps.

[0750] The tool unit 702 thus reconditioned can be stored again in the storage location 402, on the workpiece support 30 and / or in a storage box 50 which has also been reconditioned, by means of the storage and transport unit 408, in particular until a new use.

[0751] Such aforementioned exemplary processes may be performed repeatedly until all processing steps specified and required by the production program have been performed on the extract 40 and from the extract 40 the product 20 to be manufactured has been produced.

[0752] The extract container 42 can now be referred to as the product container 22 in which the product 20 made from the extract 40 resides.

[0753] The storage box 50 in which the product container 22 is located is transported by the storage and transport unit 408 to the handling device 300 .

[0754] There, the product container 22 is extracted from the storage box 50 by the handling device 300 and placed on the workpiece support 30. The workpiece support receives the product container 22 and transports it to the packaging device 214.

[0755] A multi-axis robotic arm 302 allows the product container 22 to be delivered to a packaging device for aseptic packaging.

[0756] The multi-axis robotic arm 302 separates the product container 22 from the workpiece support 30 and delivers the product container 22 to the packaging apparatus 214. Within the packaging apparatus 214, the product container 22, and thus the product 20, can be packaged in sterile packaging material and packaged or surrounded by one or more packaging units of the packaging apparatus 214.

[0757] 11 serves as a packaging location and is accessible by one or more packaging units of the packaging apparatus 214. It is further contemplated that the product containers 42 can be aseptically packaged with packaging material by the multi-axis robotic arm 302 and by one or more packaging units.

[0758] After packaging by the packaging device 214, the packaged product container 22 is again transferred by the multi-axis robot arm 302 to the workpiece support 30 (see FIG. 11) and delivered by the lock transport device 304 to the exit lock location 208. At this location, the packaged product container 22 containing the product 20 can be retrieved by a user.

[0759] The workpiece support 30 on which the product container 22 is disposed, as well as the storage box 50 in which the product container 22 is disposed, are fed to the cleaning device 500 of the production facility 10 as described above, and subsequently cleaned and sterilized, before being stored again in their respective storage locations 402 for subsequent use.

[0760] FIG. 12 shows a schematic perspective view of a production facility 10 according to a further exemplary embodiment of the present invention.

[0761] The production plant 10 according to a further exemplary embodiment of the present invention shown in FIG. 12 has substantially the same structural and functional features as the exemplary embodiment of the production plant 10 according to the present invention shown in FIG. 1, so only the differences in structural and functional features will be presented below.

[0762] The storage and transport system 406 , shown diagrammatically in FIG. 12, includes one or more transport vehicles 410 that are free-running within the cleanroom area 100 .

[0763] In other words, a transport vehicle running freely within the clean room area 100 is a transport vehicle that is controllable and capable of running freely as required within the clean room area 100, so that when appropriately controlled by at least one of the control units, the transport vehicle becomes free-running each time as required.

[0764] By means of the transport vehicle 410, the storage shelves 404 of the storage device 400 can be accessed, inter alia, for storage and retrieval processes, as well as for processing and / or maintenance processes.

[0765] The storage shelves 404, and in particular the storage locations 402 of the storage shelves 404, can be accessed by a transport vehicle 410 for storage and retrieval processes, as well as for processing and / or maintenance processes, via one or more storage shelf-locks 412 (see FIG. 20).

[0766] It is also conceivable that the storage locations 402 of the storage shelf 404 are arranged on various storage location planes within the storage shelf 404, which storage location planes are arranged, for example, one above the other, and each storage location plane of one storage shelf 404 can be accessed by the transport vehicle 410 via a particularly common displacement unit within the respective storage shelf 404.

[0767] The use of free-running transport vehicles 410 additionally allows for any arrangement of storage shelves 404 .

[0768] The generally parallel arrangement of storage shelves 404 shown in FIG. 12 and in the drawings relating to FIG. 12 is shown purely by way of example for purposes of illustration.

[0769] With reference to FIG. 13, a workpiece support 30 on which / to be held an extract 40 disposed in an extract container 42 is positioned at an entrance lock location 206 on a free-running transport vehicle 410 .

[0770] The workpiece support 30, shown in Figures 13 and 14, disposed on a transport vehicle 410, is delivered by the transport vehicle 410 to the entrance lock location 206 to receive the extract container 42 in a process not shown.

[0771] In this case, the user first produces the desired product 20 from the extract 40 by selecting a production program for the production facility 10 via, for example, the HMI interface 602 .

[0772] The user then places the extract container 42 together with the extract 40 disposed therein onto a workpiece support 30 provided at the entry lock location 206. The workpiece support is already provided on a transport vehicle 410 at the entry lock location 206 for receiving the object.

[0773] Alternatively, the workpiece support 30 stored in a storage location 402 on one of the storage shelves 404 is withdrawn from the storage location 402 by a transport vehicle 410 of the storage transport device 406 and transported to the locking device 200. As soon as the workpiece support 30 is provided at the entrance locking location 206 for receiving the extract 40, the extract container 42 together with the extract 40 disposed therein is manually delivered by the user to the workpiece support 30 disposed on the transport vehicle 410 and fixed to the workpiece support by a fixing means.

[0774] As shown diagrammatically in FIG. 15, the packaged extract container 42 is then moved by the transport vehicle 410 on the workpiece support 30 into range of the multi-axis robotic arm 302 .

[0775] The multi-axis robotic arm 302 separates the packaged extract container 42 from the workpiece support 30 and transfers the extract container 42 to the unpacking device 212. In the unpacking device, the packaging material of the extract container 42 can be / is removed by one or more unpacking units of the unpacking device 212.

[0776] After the packaged extract container 42 has been handed over to the unpacking device 212, the workpiece support 30 is returned again by the transport vehicle 410 to the entrance lock location 206 for new receipt of objects, so that a situation substantially as shown in FIG. 14 may exist.

[0777] After unpacking by the unpacking device 212, the unpacked extract container 42 is transferred by the multi-axis robot arm 302 to another, in particular sterile, workpiece support 30 (see FIG. 15) placed in a storage box 50 and provided in a storage box 50 on another sterile transport vehicle 410 at the transfer lock location 216.

[0778] This other workpiece support 30 has previously been removed together with the storage box 50 from the storage location 402 of the storage shelf 404 and transported by a separate transport vehicle 410 to the delivery lock location 216 .

[0779] 15 and 16, the storage box 50, together with the workpiece support 30 disposed within the storage box, with the extract container 42 disposed on the workpiece support, can be moved or is moved and stored to the storage location 402 within the storage shelf 404 by the transport vehicle 410.

[0780] As illustrated by the arrows (tool path 706) in FIG. 17, in order to perform one or more processing steps, for example, the tool unit 702 is extracted from the left storage shelf 404 by the transport vehicle 410 and delivered to a storage box 50 containing the extract container 42 stored in the middle storage shelf 404, thereby performing one or more processing steps on the extract 40 in the extract container 42 by the tool unit 702.

[0781] After carrying out one or more processing steps on the extract 40, the previously supplied, now used tool unit 702 is again led out by the transport vehicle 410 from the storage box 50 containing the extract 40, in particular removed from the storage box 50 and sent away.

[0782] As shown by the arrow in FIG. 18, the transport vehicle 410 transports the used tool unit 702 in its storage box 50 to the handling device 300 where it is pulled out of the storage box 50 by the handling device 300, thereby removing the single-use components located in the tool unit 702 (see FIG. 19).

[0783] 19 and 20, the used tool unit 702 is returned again into the storage box 50 by the handling device 300 and then delivered together with the storage box 50 to the cleaning device 500 of the production facility 10 by the transport vehicle 410. By the cleaning device, the used tool unit 702 and its storage box 50 can be cleaned and sterilized or are cleaned and sterilized.

[0784] As shown diagrammatically in Fig. 21, the tool unit 702 cleaned and sterilized by the cleaning device 500 is again delivered by a transport vehicle 410 to the handling device 300, whereby the handling device 300 is equipped with consumable materials 704, in particular one or more new sterile single-use components, from the storage shelves 404. The single-use components have been provided to the handling device 300 by another transport vehicle 410, for example during cleaning of the used tool unit 702.

[0785] In parallel or successively thereto, the manufactured product 20 disposed in the product container 22 is removed from the storage shelf 404 by a further transport vehicle 410 and transported to a delivery lock location 216 for packaging by a packaging device 214.

[0786] After packaging by the packaging device 214, the packaged product container 22 is again transferred by the multi-axis robotic arm 302 to the workpiece support 30 (see FIG. 22) and delivered by the transport vehicle 410 to the exit lock location 208. At this location, the packaged product container 22 containing the product 20 can be retrieved by the user.

[0787] FIG. 23 shows a schematic perspective view of a production facility 10 according to a further exemplary embodiment of the present invention.

[0788] The production plant 10 according to a further exemplary embodiment of the present invention shown in FIG. 23 has substantially the same structural and functional features as the exemplary embodiment of the production plant 10 according to the present invention shown in FIG. 1, so only the differences in structural and functional features are presented below.

[0789] The storage and transport device 406 includes one or more free-running transport vehicles 410, as previously described in connection with the exemplary embodiment of the production facility 10 according to the present invention shown in FIG.

[0790] The storage device 400 includes a plurality of storage location planes 414, here four, each having a plurality of storage locations 402.

[0791] The storage locations 414 are arranged one above the other, in particular one above the other in the height direction.

[0792] In effect, the storage locations 414 are arranged in a stack, as shown diagrammatically in FIG.

[0793] Disposed on the storage surface 414 are different types of storage locations 402 for storing different types of objects.

[0794] As shown diagrammatically in FIG. 23, the various types of storage locations 402 are distributed in a regular pattern.

[0795] For example, a plurality, particularly all, of the storage boxes 50, a plurality, particularly all, of the tools 702 arranged on each of the workpiece supports 30, and a plurality, particularly all, of the consumable materials 704 arranged on each of the workpiece supports 30, are spatially adjacent to each other in the pattern.

[0796] The storage transport device 406 further includes one or more lift devices 416. The lift devices allow access to the storage location surface 414 of the storage device 400, among other things, for storage and retrieval processes, as well as processing and / or maintenance processes.

[0797] A lift device 416 allows the transport vehicle 410 to be moved to an individual storage location surface 414 .

[0798] Additionally or alternatively, it is contemplated that the lift device 416 may effect a handover process of a transported object from a transport vehicle 410 located on a storage location surface 414 to another transport vehicle 410 located on another storage location surface 414. In effect, such a handover process may be effected from one transport vehicle to another transport vehicle 410 via the lift device 416.

[0799] FIG. 24 shows a schematic perspective view of a production facility 10 according to a further exemplary embodiment of the present invention.

[0800] The production equipment 10 according to a further exemplary embodiment of the present invention shown in FIG. 24 has substantially the same structural and functional features as the exemplary embodiment of the production equipment 10 according to the present invention shown in FIG. 1, so only the differences in structural and functional features will be presented below.

[0801] Storage device 400 includes a storage location surface 414. The storage location surface has a plurality of storage locations 402.

[0802] Disposed on the storage surface 414 are different types of storage locations 402 for storing different types of objects.

[0803] As shown diagrammatically in FIG. 24, the various types of storage locations 402 are distributed in a regular pattern.

[0804] For example, a plurality of, particularly all of, the tools 702 arranged on each of the workpiece supports 30 and a plurality of, particularly all of, the consumable materials 704 arranged on each of the workpiece supports 30 are spatially adjacent to each other in the pattern.

[0805] The storage and transport device 406 can include a storage and transport unit 408 formed as a portal conveyor 418. By means of the portal conveyor 418, the storage location surface 414 can be accessed, in particular for storage and removal processes, as well as for processing and / or maintenance processes.

[0806] FIG. 25 illustrates a method according to an example embodiment of the present invention.

[0807] The method for producing a biological product 20 by a production facility, in particular the aforementioned production facility 10, comprises the steps of: - selecting (S1) one of a plurality of production programs for producing a plurality of products 20 that can be produced by the production facility 10; - introducing the extract 40 into the locking device 200 of the production facility 10 (S2); - automatically transporting said extract 40 into the clean room area 100 of said production facility 10, optionally storing said extract 40 in a storage location 402 of a storage device 400 of said production facility 10, said storage location 402 being located inside said clean room area 100 (S4); - automatically carrying out one or more processing steps on said extract 40 (S4); This includes:

[0808] In S4, one or more processing steps are carried out fully automatically until the product 20 to be produced from the extract 40 is completed.

[0809] At S4, one or more, particularly all, of the processing steps may be performed at the repository 402.

[0810] In S4, the producible or produced product 20 is removed from the storage location 402 and automatically transported to the locking device 200 for withdrawal from the production facility 10.

[0811] In a step following S4, the product 20 is filled and / or packaged prior to withdrawal, in particular in a ready-to-use state.

[0812] One or more containers, receptacles and / or tools utilized to produce the product 20 remain at least partially within the cleanroom area 100 after completion of the product 20, are cleaned, and subsequently reused for the production of additional products 20.

[0813] In order to manufacture the product 20 and / or to manufacture a number of different products 20, the necessary consumable materials 704, in particular consumables and / or tool consumables, are / are stored inside the cleanroom area 100, in particular before selection of the product 20 to be manufactured is made.

[0814] The consumable materials 704 are automatically transported through the locking device 200 into the clean room area 100 and stored within the clean room area, specifically within one or more storage locations 402 of the storage device 400 .

[0815] The amount of the consumable material 704 stored within the cleanroom area 100 is monitored and if it falls below a specified minimum amount, the inventory is increased by supplying the required consumable material 704, particularly via a suggestion or warning message on an operator unit, for example via the HMI interface 602.

[0816] Multiple products 20 , particularly multiple different products 20 , can be produced simultaneously within the clean room area 100 .

[0817] In fact, the methods may be carried out or performed one or more times, simultaneously, in parallel and / or staggered in time.

[0818] In particular, one or more process steps that may be performed by one or more tool units 702 include: - 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 the 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 liquids, in particular by means of columns, for example separation columns, and / or centrifuges, - analyzing the extract and / or intermediate products and / or products, in particular by means of one or more sensor units, and storing, in particular storing and / or extracting one or more objects by means of a storage and transport device 406; - temperature regulation, in particular incubation, of one or more objects, in particular of one or more extracts 40; has.

[0819] It should be understood that the foregoing list of process steps is exemplary and not exhaustive.

[0820] Alternatively or additionally, one or more process steps may be combined with one or more process steps in a single process step, and / or in any combination thereof.

[0821] Each product to be manufactured is assigned a series of process steps which are performed by tools 702 located inside the cleanroom area 100 and which remain there after the process steps are performed.

[0822] After the tool(s) 702 have undergone one or more process steps, they are cleaned, particularly sterilized, within a clean room area.

[0823] One or more tools 702 are equipped with tool consumables, particularly single-use components, within the clean room area 100 prior to performing one or more process steps.

[0824] The tool consumable(s) are removed and / or discarded from the tool(s) within the clean room area after undergoing the processing step(s).

[0825] A number of, in particular all, processing steps are assigned a processing time value, which indicates the time that elapses from the start of the respective processing step to its end, in particular the time required to provide at least one tool 702 required for the respective process step, in particular including one or more tool consumables, and / or the time for the supply and / or placement and / or start-up of at least one tool 702 at the extract 40 to be treated, in particular at the storage location 402 in which the extract 40 is located, and / or - the time for which the extract 40 is allowed to act in order to achieve the desired treatment result, and / or - Time to remove at least one tool from the extraction, especially from the storage area Including, -Preferably cleaning of at least one tool 702, and / or ○ Removal and / or disposal of tool consumables, and / or Return transportation of the tool 702 to the starting location, in particular to the storage location 402 assigned to the tool 702 Includes.

[0826] 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 / are recorded or taken into account.

[0827] At the start of a production program, the production course is predicted and the tools 702 required and / or specified for the execution of the processes are prepared in advance for the time slots resulting from the prediction.

[0828] One or more processing steps may each include one or more cleaning processes for cleaning one or more tools 702 and / or cleaning one or more storage locations 402; and / or - one or more disposal processes for disposing of consumable materials 704; and / or - one or more preparatory steps for equipping one or more tools 702 with consumable material 704; and / or - one or more control steps for controlling the processing result, is assigned or has been assigned, Depending on the forecast of the production course, time slots are / are pre-prepared in one or more devices required for the execution of one or more cleaning processes, one or more disposal processes, one or more preparation processes and / or one or more control processes.

[0829] After one or more processing steps, and in particular after each processing step, the production progress predictions are tested and / or realized, in particular to confirm or correct time slots for tools 702 and / or other equipment still required to complete the product 20.

[0830] At the desired start of a production program, it is determined whether all necessary tools 702 and / or other equipment are available within the required time slit to complete the product 20 based on a prediction of the production course, and the production program can be started only if such determination delivers a positive result.

[0831] With respect to the method shown in Fig. 25, it is to be understood that all structural and functional features associated with the production facility according to the invention, and in particular with the above-described embodiment of the production facility 10, may also be included in the method according to the invention, either alone or in combination, and the associated properties, configurations and advantages may be included and achieved accordingly. The above-described production facility 10 is configured to perform the method shown in Fig. 25, and the method shown in Fig. 25 is further configured to be executable by the above-described production facility 10.

Claims

1. A method for manufacturing a product, particularly a biological product (20), by means of a production facility (10), in particular the following: a clean room area (100); a lock device (200) for supplying an object from the surroundings of the production facility (10) into the clean room area (100) and / or removing an object from the clean room area (100); a handling device (300) for moving the object inside the clean room area (100); and a storage device (400) arranged inside the clean room area (100) and including a plurality of storage locations (402) for accommodating a plurality of objects, the method comprising the following steps: - Selecting one of a plurality of production programs for manufacturing a plurality of products (20) that can be manufactured by the production facility (10); - Introducing an extract (40) into the lock device (200) of the production facility (10); - Automatically transporting the extract (40) into the clean room area (100) of the production facility (10), the extract (40) being stored in a storage location (402) located inside the clean room area (100) of the storage device (400) of the production facility (10); - Automatically performing one or more processing steps on the extract (40); A method for manufacturing a product, comprising the above steps.

2. The method according to claim 1, characterized in that one or more processing steps are performed fully automatically until the product (20) to be manufactured from the extract (40) is completed.

3. The method according to claim 1, characterized in that one or more, particularly all, processing steps are performed in the storage location (402).

4. The method according to claim 1, characterized in that the product (20) thus manufactured is withdrawn from the storage location (402) and automatically transported to the lock device (200) in order to withdraw the product from the production facility (10).

5. The method according to claim 4, characterized in that the product (20) is filled and / or packaged before being withdrawn, particularly filled and / or packaged in a ready-to-use state.

6. One or more containers, receptacles and / or tools (702) used to produce the product (20) remain at least partially inside the cleanroom area (100) after completion of the product (20), are cleaned, sterilized and subsequently reused for the production of further product (20), the method according to claim 1.

7. Consumables (704), in particular consumables (704) and / or tool consumables (704), required to produce the product (20) and / or to produce a plurality of different products (20) are stored inside the cleanroom area (100), in particular before the selection of the product (20) to be produced is made, the method according to claim 1.

8. The consumables (704) are automatically transported into the cleanroom area via the locking device (200) and stored within the cleanroom area, in particular in one or more storage locations (402) of the storage device (400), the method according to claim 7.

9. The amount of the consumables (704) stored inside the cleanroom area is monitored and, when it falls below a defined minimum amount, the storage amount is increased by supplying the required consumables (704), in particular via a suggestion or warning message of the operator unit, the method according to claim 7.

10. A plurality of products (20), in particular a plurality of different products (20), are produced simultaneously inside the cleanroom area (100), the method according to any one of claims 1 to 9.

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