Production plant for manufacturing a product

Abstract

Production plant (10) for the manufacture of biological pharmaceutical products (20), for example cell therapeutics or gene therapeutics, wherein the production plant (10) comprises the following: - a cleanroom area (100); - a lock device (200) for feeding an object from an environment of the production plant (10) into the cleanroom area (100) and / or for removing an object from the cleanroom area (100); - a handling device (300) for moving the object within the cleanroom area (100); - a storage device (400) arranged within the cleanroom area (100), which includes several storage places (402) for holding several objects, wherein the storage device (400) comprises several storage locations (402) which form treatment stations for the treatment of starting materials (40).

Description

[0001] The present invention relates to a production plant and a method for manufacturing a product. In particular, the present invention relates to a production plant for manufacturing biological pharmaceutical products and a method for manufacturing biological pharmaceutical products.

[0002] Conventional production systems, particularly in the pharmaceutical sector for personalized therapeutics, involve a high degree of manual intervention. While this allows for the production of these therapeutics at a high level of personalization, such individual and / or small-batch production is associated with high costs and significant fluctuations in quality, resulting in high production reject rates and / or defective parts. Furthermore, there is no possibility for large-scale application and / or industrial production of individual and / or very small batch sizes.

[0003] The present invention is based on the objective of solving the aforementioned problems, in particular being able to efficiently produce individual and / or very small batch sizes of products in the pharmaceutical field and especially in consistent quality.

[0004] This problem is solved according to the invention by the features of claim 1. Advantageous embodiments of the invention are described in the dependent claims.

[0005] A production plant according to the invention, in particular for the manufacture of biological-pharmaceutical products, preferably comprises: - a cleanroom area, especially a suitable one, - a lock device for feeding an object from the environment of the production plant into the, in particular suitable, cleanroom area and / or for removing an object from the cleanroom area, - a handling device for moving the object within the cleanroom area, and - a storage device located within the cleanroom area, which includes several storage locations for holding multiple objects.

[0006] An object, in particular the object from the vicinity of the production plant for feeding into the cleanroom area and / or the object for removal from the cleanroom area, may include at least one of the following: - a starting material, in particular a cell-containing material, for example a cell-containing precursor, and / or a biological-pharmaceutical material and / or a biological-pharmaceutical workpiece, - an intermediate, in particular a cell-containing intermediate and / or a biopharmaceutical intermediate, - a tool or tool unit, in particular a tool or tool unit that contacts the product and / or the material and / or the material and / or in particular a tool or tool unit that does not contact the product and / or the material, - one or more consumables, - a product, for example the product to be manufactured, in particular a biological-pharmaceutical product, for example the biological-pharmaceutical product to be manufactured.

[0007] It should be understood that the preceding list is exemplary and not exhaustive.

[0008] Alternatively or additionally, it may be stipulated that the object includes one or more and / or a combination of the enumeration items described above.

[0009] The starting material may consist of cells and / or a biological material that differs from cells.

[0010] The starting material can be at least partially liquid, and / or at least partially semi-solid, and / or at least partially solid.

[0011] Alternatively, the starting material can be completely liquid, or completely semi-solid, or completely solid.

[0012] The cells of the starting material can be used in particular as - a cell suspension, for example as cells in a suspension culture, or - adherent cells, for example as cells on a culture surface, in particular of a container or feed container, for example a culture vessel and / or a bag, They must be present, for example, trained.

[0013] The cells can be at least partially fresh and / or at least partially in a frozen state, which means that the starting material can be in a liquid, semi-solid and / or solid state, for example.

[0014] The starting material may be arranged in a container or starting material container, in particular a vessel, for example a culture vessel, a cell culture vessel, a bottle, a vial, a bag, a cassette (e.g., a cassette made of a hard plastic, in particular a biocompatible one), and / or a titrant (e.g., a microtiter plate). The container or starting material container, including the aforementioned examples, may be suitably, in particular biocompatible, partially or completely coated and / or partially or completely uncoated.

[0015] It may be provided that a container for receiving and processing a starting material has a volume between 1 µl and 1000 ml, in particular between 1 µl and 500 ml, and furthermore in particular between 1 µl and 1000 µl. The volume may, for example, be 250 ml or 750 ml. Furthermore, it may be provided that the volume is less than 1 µl and / or greater than 1000 ml.

[0016] The product could be a biological-pharmaceutical product for personalized therapy.

[0017] In a sense, the biological-pharmaceutical product can be a personalized therapeutic agent.

[0018] It may be intended that personalization is provided for a patient or a group of patients, in other words for one or more patients.

[0019] The biological-pharmaceutical product can be, for example, a cell therapy, such as an autologous and / or an allogeneic cell therapy, or a gene therapy, such as an autologous and / or an allogeneic gene therapy.

[0020] The cleanroom area can define an aseptic production area. The cleanroom area can have at least one CNC (Controlled but Not Classified) cleanroom class according to Good Manufacturing Practice (GMP).

[0021] It is conceivable that the cleanroom area has at least one of the cleanroom classes D, C, B or A according to Good Manufacturing Practice (GMP).

[0022] The cleanroom area may be pressurized, particularly to protect raw materials and / or products, especially with regard to sterility. Additionally, the cleanroom area may be pressurized in a separate section, distinct from the pressurized area, particularly to protect human operators or users from raw materials and / or products.

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

[0024] The system for adjusting the environmental properties of the cleanroom area may in particular include an air device by means of which an air pressure, in particular an overpressure and / or an underpressure, can be adjusted in the cleanroom area.

[0025] Additionally or alternatively, the air device can be used to adjust air supply and / or air extraction into or out of the cleanroom area and / or air circulation, in particular including air recirculation, within the cleanroom area, especially via one or more filter devices of the system for adjusting the environmental properties.

[0026] In a sense, an overpressure area in the production plant can define the cleanroom area and / or be the cleanroom area.

[0027] The production plant may have an enclosure, in particular for separating / demarcating the cleanroom area from the surroundings of the production plant and for maintaining its cleanroom class, wherein the enclosure surrounds the cleanroom area, in particular the cleanroom area and the airlock device.

[0028] It may be planned that the enclosure will, in a sense, surround the entire production facility.

[0029] The airlock device can be configured to introduce an object from the production plant environment into the cleanroom area via or through the enclosure, and / or to remove an object from the cleanroom area via or through the enclosure. In a sense, the airlock device can serve as at least one interface, for example, at least one inlet and / or at least one outlet, between the enclosure, which surrounds at least the cleanroom area, and the production plant environment.

[0030] Additionally or alternatively, the interlocking system may be provided with at least one inlet interlock and at least one outlet interlock. In other words, the interlocking system may have one or more inlet interlocks and one or more outlet interlocks. This may, in particular, serve to guide or direct the flow of objects.

[0031] Additionally or alternatively, the inlet and outlet locks may be categorized according to the object they are to be opened and are accordingly provided as part of the lock system. For example, one inlet lock and one outlet lock may each be provided for raw materials and / or for consumables and / or for tools or tool units and / or for waste, or for any combination thereof.

[0032] For example, it may be intended that the entrance airlock and / or the exit airlock serve as an interface between the cleanroom area and the environment of the production plant.

[0033] The airlock device can have one or more maintenance airlocks through which the cleanroom area is accessible from the production plant environment, particularly for human operators or users.

[0034] Additionally or alternatively, it may be provided that one or more maintenance locks are designed as separate devices of the production plant, distinct from the lock device.

[0035] Additionally or alternatively, it may be provided that the cleanroom area has several cleanroom sub-areas.

[0036] In other words, the cleanroom area can be divided into several cleanroom sub-areas.

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

[0038] The cleanroom sub-areas can have the same cleanroom class or different cleanroom classes.

[0039] It may be planned that one or more cleanroom sub-areas have different overpressures.

[0040] In other words, one or more cleanroom sub-areas can have pressure differences relative to each other in terms of overpressure.

[0041] A cleanroom class can be one of the following: - Cleanroom class CNC, - Cleanroom class D, - Cleanroom class C, - Cleanroom class B, - Cleanroom class A, Each in accordance with Good Manufacturing Practice (GMP).

[0042] Each cleanroom sub-area can be assigned a separate sub-area enclosure, particularly for the purpose of separating or demarcating the respective cleanroom sub-area and maintaining its respective cleanroom class.

[0043] Additionally or alternatively, cleanroom sub-areas that have the same cleanroom class can be assigned a common sub-area enclosure.

[0044] The respective sub-area enclosure and / or the common sub-area enclosure can each be configured as part of the enclosure of the production plant.

[0045] Additionally or alternatively, the respective sub-area enclosure and / or the common sub-area enclosure can be designed separately, in particular independently.

[0046] Each sub-area enclosure can be assigned at least one sub-area airlock device, which can be designed as part of this sub-area enclosure.

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

[0048] Each sub-area airlock device can be configured to feed an object from one cleanroom sub-area into another cleanroom sub-area and / or to remove an object from one cleanroom sub-area into another cleanroom sub-area.

[0049] It is possible for a cleanroom sub-area to be divided into several sub-cleanroom sub-areas. For possible designs and / or configurations of the sub-cleanroom sub-areas, please refer to the description of the cleanroom sub-areas.

[0050] It may be provided that one or more cleanroom sub-areas are set up with cleanroom class A with regard to processes and / or operations, in particular for treatment and / or transport and / or storage and / or analysis and / or packaging and / or unpacking, in which there is contact with reactants, intermediate products and / or products, or a particularly theoretical possibility of such contact may exist, for example by means of one or more objects that can lead to contamination, for example by means of one or more tools and / or one or more consumables and / or one or more devices of the production plant.

[0051] It may be provided that one or more cleanroom sub-areas are set up with cleanroom class B with regard to the airlock device, the storage device, in particular the storage locations of the storage device, the handling device and / or a cleaning device of the production plant. Additionally or alternatively, one or more cleanroom sub-areas may also be set up with cleanroom class A.

[0052] It may be provided that one or more cleanroom sub-areas are set up with cleanroom class C or D in relation to a storage transport device of the storage device.

[0053] It may be planned that one or more cleanroom sub-areas are equipped with CNC cleanroom class certification, in relation to one or more remaining spatial areas of the production plant. In particular, these one or more remaining spatial areas may be designated for technical equipment and / or machinery required for the general operation of the production plant and / or parts thereof.

[0054] The production plant may have one or more (electrical) power sources and / or one or more interfaces connectable to one or more (electrical) power sources, which are arranged within the cleanroom area, in particular the enclosure, and which are configured to supply at least one of the components or parts of the production plant with electrical power, which is assigned to the one or more power sources, for example via the one or more interfaces.

[0055] Additionally or alternatively, it may be provided that one or more (electrical) power sources are located in the vicinity of the production plant and / or are spatially separated or arranged separately, which can be connected to or are connected to the production plant.

[0056] The production plant may have one or more control units that are located within the cleanroom area, in particular the enclosure, or on the production plant and that are designed and programmed to regulate and / or control at least one of the components or parts of the production plant that are assigned to the one or more control units.

[0057] Additionally or alternatively, it may be provided that one or more control units are arranged in the vicinity of the production plant and / or are spatially separated or arranged separately and can be connected to the production plant, in particular wirelessly and / or via cables, for example by means of one or more communication interfaces of the production plant.

[0058] It may be provided that one or more control units can be connected to one or more, in particular external, i.e. not included in the production plant, data handling systems and / or computer systems, in particular wirelessly or via cables, for example by means of one or more communication interfaces of the production plant.

[0059] Additionally or alternatively, it may be provided that the control units are programmed and trained to identify, encode and / or assign one or more objects in the production plant, in particular by means of an ID assigned to each object, wherein, optionally, the ID can be assigned to a respective object, in particular by means of RFID and / or barcode means.

[0060] The production plant can include several workpiece carriers, which serve to hold objects, including raw materials and / or tools and / or consumables.

[0061] It may be planned that one or more cleanroom sub-areas are set up with cleanroom class A with regard to the workpiece carriers. For example, it may be planned that...

[0062] Additionally or alternatively, it may be provided that one or more cleanroom sub-areas are set up with cleanroom class B with regard to the workpiece carriers.

[0063] It may be stipulated that workpiece carriers only remain within and / or between one or more cleanroom sub-areas with the same and / or essentially identical cleanroom class.

[0064] It may be provided that each workpiece carrier has a means for fixing, in particular a means for a form-fit and / or force-fit and / or magnetic fixing, for a respective receiving of raw materials and / or tools and / or consumables, whereby the raw materials and / or tools and / or consumables are reliably held.

[0065] The workpiece carriers can remain permanently within the cleanroom area, particularly throughout one or more complete production processes.

[0066] The production plant can include several types of workpiece carriers, which differ in terms of the shape and / or dimensions of their receiving area. One type of workpiece carrier can be used to hold a vessel, for example, a culture vessel, to hold a starting material.

[0067] A type of workpiece carrier can serve to hold one or more tool units and / or tool consumables for carrying out a treatment process on a raw material and / or for carrying out a maintenance process within the cleanroom area.

[0068] One type of workpiece carrier can serve to hold consumables for feeding them to a raw material and / or for carrying out a treatment process on a raw material.

[0069] One or more workpiece carriers can each comprise one or more action units for performing an action on a raw material and / or on a tool.

[0070] One or more action units can be designed as a treatment unit, for example as a tool unit, to carry out a treatment process on the feedstock.

[0071] It may be provided that a treatment unit, for example a tool unit, is configured to perform a rocking and / or a tilting and / or a shaking and / or a rotating movement, in particular by means of at least one appropriately assigned actuator unit, so that this type of movement, for example this type of combination of movements, can be transferred to the feedstock.

[0072] It may be provided that a treatment unit, for example a tool unit or a component of a tool unit, is configured to temperature control the workpiece carrier, in particular to heat and / or cool it.

[0073] One or more action units can be designed as a sensor unit to determine a current value of a parameter of the respective workpiece carrier and / or an attached product and / or a tool and / or consumables.

[0074] A parameter can be, in particular, one of the following: a temperature, a humidity, an ambient pressure, a gas mixture composition, a position, for example an angular position, a vibration, an occupancy, in particular an occupancy state, for example a bearing occupancy state, and a positioning, for example a locked positioning or a non-locked positioning and / or a location positioning, of the workpiece carrier and / or an object received by means of the workpiece carrier.

[0075] It should be understood that the preceding list is exemplary and not exhaustive.

[0076] Alternatively or additionally, it may be provided that the parameter is a combination of the enumeration elements described above.

[0077] One or more workpiece carriers can include a storage device for storing energy and / or one or more consumables.

[0078] The workpiece carriers can be reusable multiple times; in particular, the storage device can be electrically rechargeable and / or refillable with consumables.

[0079] The workpiece carriers can have at least one interface by means of which the electrical energy and / or the consumables can be charged or refilled and (re)discharged.

[0080] The production facility may include a charging station located within the cleanroom area for charging the storage device and / or a refilling station located within the cleanroom area for refilling the storage device.

[0081] It may be provided that the refilling station is designed as a stationary refilling station, to which consumables can be supplied via the sluice device in order to refill it.

[0082] It may be provided that the refilling station is designed as a locally mobile refilling station, which, in particular, in a state filled with consumables, can be fed from an environment of the production plant into the cleanroom area via the airlock device and, in particular, in a state emptied of consumables, can be removed from the cleanroom area via the airlock device.

[0083] The refilling station can be arranged, for example, on a storage area of ​​the storage device.

[0084] The refill station can, for example, include a container for a liquid or be designed as a container for a liquid.

[0085] The refill station's container for a liquid can, for example, have a volume between 1 ml and 100 l, preferably between 50 ml and 50 l. The container can have an interface for dispensing and / or refilling the liquid.

[0086] One or more workpiece carriers can have one or more coupling devices by means of which several, in particular two or more, workpiece carriers can be connected to each other.

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

[0088] The handling device may include a distribution unit through which objects to be transported can be fed to and / or received by the storage transport device. Optionally, the distribution unit may be designed as one or part of a sluice transport device, or be associated with one.

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

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

[0091] The storage transport device can comprise one or more rail-guided storage transport units, by means of which one or more storage racks of the storage device are accessible, in particular for storage and retrieval operations as well as for treatment operations and / or maintenance operations.

[0092] The storage transport device can comprise one or more storage transport units designed as portal conveyors.

[0093] Additionally or alternatively, the storage transport device may include one or more storage transport units designed as pick-and-place robots or as rope robots.

[0094] It may be provided that one or more storage areas of the storage facility are accessible by means of one or more portal conveyors, particularly for storage and retrieval operations as well as for treatment operations and / or maintenance operations.

[0095] The storage transport device, in particular the rail-guided transport system, the one or more free-moving transport vehicles, the one or more rail-guided storage transport units, and / or the one or more gantry conveyors, can be guided by induction loops and / or magnetically, in particular by permanent magnets and / or magnetic coils. Additionally or alternatively, sensor-based guidance, in particular camera-based guidance and / or radar / LiDAR-based guidance, can be provided.

[0096] It may be provided that the storage transport device, in particular the rail-guided transport system, the one or more free-moving transport vehicles, the one or more rail-guided storage transport units and / or the one or more portal conveyors, is configured to be able to pass through at least two cleanroom sub-areas that have a different cleanroom class, for example.

[0097] The storage transport device, in particular the rail-guided transport system, the one or more free-moving transport vehicles, the one or more rail-guided storage transport units and / or the one or more portal conveyors, can be at least partially encapsulated, which, for example, in the case of encapsulated actuators of the storage transport device, can prevent or at least reduce the release of possible contaminants, in particular through particle abrasion of the actuators.

[0098] Additionally or alternatively, it may be provided that the storage transport device includes one or more lifting devices by means of which one or more storage areas of the storage device are accessible, in particular for storage and retrieval operations as well as for treatment operations and / or maintenance operations.

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

[0100] Additionally or alternatively, it may be provided that the handling device is or includes a pick-and-place robot or a rope robot, and / or that the handling device is or includes a suitable gripper actuator mounted on a planar runner.

[0101] Additionally or alternatively, it may be provided that the rail-guided transport system and / or the one or more free-moving transport vehicles of the warehouse transport device each include at least one multi-axis robot arm.

[0102] The storage transport device and / or the handling device may be assigned an interchangeable device of the production plant, by means of which different gripping units and / or carrier units can be mounted on one or more storage transport units of the storage transport device and / or on one or more handling units of the handling device, in particular for carrying out different storage operations, transport operations, handling operations, maintenance operations and / or treatment operations using the respective storage transport unit and / or handling unit.

[0103] The exchange device can have at least one adapter device and / or at least one die device, each designed to correspond to the gripping units and / or carrier units, in order to be able to grip them in a form-fitting manner and to be able to mount them on one or more storage transport units of the storage transport device and / or on one or more handling units of the handling device.

[0104] A cleaning device may be assigned to the storage transport device and / or the handling device of the production plant, by means of which at least one gripping unit and / or carrier unit of one or more storage transport units of the storage transport device and / or one or more handling units of the handling device can be cleaned, in particular after the execution of a storage operation, transport operation, handling operation, maintenance operation and / or treatment operation. The cleaning device may be designed for cleaning, in particular by means of irradiation and / or fumigation.

[0105] The cleaning device of the production plant, associated with the storage transport device and / or the handling device, may be located, in particular, in or on the airlock device or, for example, directly adjacent to the airlock device within the cleanroom area. It may be provided that the cleaning device of the production plant, associated with the storage transport device and / or the handling device, is spatially separated from the airlock device within the cleanroom area.

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

[0107] The airlock device can include an inlet airlock, through which an airlock station, in particular an inlet airlock station, is accessible from the environment and which is configured for feeding an object from an environment of the production plant into the cleanroom area, and an outlet airlock, through which an airlock station, in particular an outlet airlock station, is accessible from the environment and which is configured for removing an object from the cleanroom area.

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

[0109] It may be provided that the handling device, in particular the lock transport device, includes a shifting unit by means of which one or more objects can be moved between the different lock positions.

[0110] In addition to or as an alternative to at least one lock station, in particular the entrance lock station and / or the exit lock station, an unpacking station and / or a packaging station may be provided in the lock device.

[0111] The unpacking station can be assigned to the entry airlock station, either adjacent or spatially separated. Additionally or alternatively, the entry airlock station can also serve as the unpacking station.

[0112] The packaging area can be assigned to the exit airlock station, either adjacent or spatially separated. Additionally or alternatively, the packaging area can also be the exit airlock station.

[0113] The storage transport device and / or the handling device may each include one or more workpiece carrier receptacles for receiving and transporting one or more workpiece carriers, in particular one or more of the workpiece carriers described above.

[0114] It may be provided that, by means of the handling device, one or more workpiece carriers, in particular one or more loaded workpiece carriers (for example loaded with a feeder), can be transferred from a locking station of the locking device to the storage transport device, in particular to one or more storage transport units of the storage transport device, especially via the one or more workpiece carrier receptacles.

[0115] In other words, one or more workpiece carrier changes can be carried out, for example, using the handling device.

[0116] The lock device may include a cleaning device for cleaning one or more workpiece carriers and / or for cleaning one or more workpiece carrier receptacles.

[0117] The production plant may include a cleaning device to which workpiece carriers can be fed for cleaning, in particular after transport of an object using the respective workpiece carrier.

[0118] It may be provided that the cleaning device associated with the storage transport device and / or the handling device, the cleaning device of the lock device and the cleaning device of the production plant form a common cleaning device of the production plant.

[0119] It may be provided that each of the respective cleaning devices is designed at least partially or completely separately from one another, in particular forming independent devices.

[0120] The storage facility can comprise one or more storage racks and / or one or more storage areas, each of which has several storage locations.

[0121] The individual storage areas may have different cleanroom classes. In this context, please refer to the corresponding section describing the cleanroom classes.

[0122] The respective storage areas can serve as decoupling areas and / or rooms to areas and / or rooms used for carrying out treatment procedures.

[0123] It may be provided that the storage locations are temperature-controlled, in particular individually temperature-controlled, by means of a temperature control device specifically assigned to the storage device.

[0124] The storage areas can be thermally decoupled from each other and / or decoupled by means of thermal insulation, whereby the storage areas can be temperature-controlled independently of each other and / or differently from each other, for example, heated or cooled, by means of a respective assigned temperature control device.

[0125] It is conceivable that thermal decoupling of at least two storage locations is achieved by means of a further storage location, for example a storage position of a tool that is not to be temperature controlled, which is arranged between the at least two storage locations.

[0126] It may be provided that several storage areas, in particular two or more storage areas, are arranged one above the other, especially in one vertical direction.

[0127] In a sense, the multiple storage areas can be arranged in a stacked fashion.

[0128] It may be provided that several storage areas, in particular two or more storage areas, for example two or more storage areas arranged one above the other, can be connected or linked together via the storage transport device, in particular via one or more lifting devices of the storage transport device.

[0129] Using the storage transport device, raw materials and / or tools and / or consumables can be stored in or removed from the storage locations.

[0130] In particular, by means of the storage transport device of the storage device, raw materials and / or workpiece carriers and / or tools and / or consumables can be stored in the storage locations and / or removed from them.

[0131] One or more storage locations can be accessible from multiple directions and / or by means of multiple storage transport units of the storage transport device.

[0132] For example, a storage rack can be arranged between, for example, two storage transport units, so that access to the intermediate storage rack can be ensured from each storage transport unit, or so that each of, for example, the two storage transport units has access to the intermediate storage rack.

[0133] It is conceivable that on the opposite side of, for example, two storage transport units, another storage rack is arranged.

[0134] In a sense, a storage rack-storage transport unit-storage rack-storage transport unit-storage rack arrangement can exist.

[0135] It is conceivable that tools and / or consumables could be stored in the intermediate or central storage rack, and raw materials could be stored in the respective outer storage racks.

[0136] Such an exemplary arrangement can, for example, enable short distances between tools and / or consumables and the raw materials.

[0137] A comparable advantage regarding short distances or route optimization can be achieved, in addition to such an alternating arrangement of storage racks, for example by a star arrangement of storage racks, which may be provided additionally or alternatively in this case.

[0138] The storage locations can be accessed vertically from above or horizontally from the side using the storage transport device. Several essentially horizontally oriented rows of storage locations can be arranged vertically, one above the other.

[0139] In a sense, the storage locations can be arranged in a matrix shape.

[0140] Several of the storage locations, in particular all storage locations, can be shelf locations of one or more storage racks.

[0141] The storage device can include several different types of storage locations for accommodating different types of workpiece carriers.

[0142] The different types of storage areas can differ from each other in terms of their shape and / or dimensions.

[0143] The different types of storage facilities can differ from each other in terms of their function and / or equipment.

[0144] The different types of storage locations can be arranged in a regular pattern distributed within a storage rack and / or storage area of ​​the storage device.

[0145] This ensures, for example, quick access to tools or tool units required for the treatment of a starting material.

[0146] It may be provided that the different types of storage locations are arranged according to an optimized, in particular a minimal, path distance with respect to the objects to be stored or stored in the storage locations in a storage location rack and / or a storage location area of ​​the storage device.

[0147] This ensures, for example, quick access to tools needed for the treatment of a starting material.

[0148] The storage device can have several areas for accommodating different types of workpiece carriers.

[0149] The storage device can include several storage locations, which form treatment stations for the treatment of starting materials.

[0150] The storage system can include multiple storage locations, which form tool stations for storing, maintaining, cleaning, changing, electrically charging and / or checking tools.

[0151] The storage device can comprise several storage locations, which have one or more interfaces, in particular for an (electrical) power supply and / or for a signal transmission, for example a control and / or regulation signal transmission, which can be connected to one or more corresponding interfaces of an object to be accommodated in the storage locations, in particular workpiece carriers, for example receiving boxes.

[0152] The workpiece carriers already described can be designed in particular as receiving boxes for receiving raw materials.

[0153] Additionally or alternatively, the production plant may include several receiving boxes for receiving one or more workpiece carriers, each with the raw materials arranged on them and / or received.

[0154] In a sense, the production plant can comprise several workpiece carriers designed as receiving boxes for receiving raw materials, or several receiving boxes for receiving one or more workpiece carriers each, including raw materials arranged on them and / or received on them.

[0155] A receiving box can define a process cell, in particular an aseptic process cell, or a process unit, in particular an aseptic process unit.

[0156] In a sense, the receiving box can be a process cell, in particular an aseptic process cell, or a process unit, in particular an aseptic process unit.

[0157] It may be provided that one or more cleanroom sub-areas are set up with cleanroom class A with regard to the receiving boxes or a respective receiving box.

[0158] It may be intended that a primary function of a receiving box is the provision of an air-conditioned pharmaceutical process room or an air-conditioned pharmaceutical process environment, in particular in compliance with the highest cleanroom requirements, especially in compliance with cleanroom class A.

[0159] A receiving box can be configured specifically for incubation, wherein the receiving box has interfaces for one or more tool units, in particular for gassing and / or temperature control.

[0160] The receiving box can be designed and constructed to have a hygienic shape, in particular to meet the criteria of a hygienic design, for example with regard to a minimized number of undercuts, thereby optimizing the cleanability of the receiving box.

[0161] To ensure the hygienic design of a receiving box, it can in particular be equipped with a means for magnetic fixation, whereby the reactants can be reliably held under optimized hygienic conditions, whereby, for example, the means for magnetic fixation can be configured to cooperate with an at least partially magnetic counterpart element of a vessel for receiving a reactant or a reactant container.

[0162] Additionally or alternatively, for this purpose it may be provided that a receiving box is equipped with a means for form-fitting and / or force-fitting fixation.

[0163] The receiving boxes can be stored in storage locations of the storage device, in particular fully automatically by means of a storage transport device of the storage device, for example the one already described.

[0164] One or more of the recording boxes can surround a lockable interior.

[0165] The lockable interior allows for the definition of a cleanroom sub-area and / or an aseptic production area.

[0166] In a sense, the lockable interior space may be intended to be a cleanroom sub-area and / or an aseptic production area.

[0167] The cleanroom sub-area, defined by the lockable interior space, can have a cleanroom class A.

[0168] The receiving boxes for introducing a starting material and / or for removing a product manufactured from a starting material can be opened and / or closed automatically and / or by means of the handling device.

[0169] One or more of the receiving boxes can each include one or more integrated or detachably arranged or detachably arranged conditioning units, by means of which a temperature and / or a pressure and / or a humidity and / or a gas composition in the interior of the respective receiving box can be influenced, in particular controlled and / or regulated.

[0170] One or more of the conditioning units can be tool units of a tool system of the production plant, which can be arranged on or removed from the respective receiving box as required, in particular fully automatically by means of a storage transport device of the storage device and / or by means of the handling device, for example the one already described.

[0171] Additionally or alternatively, it may be provided that one or more of the conditioning units are tool units of a tool system of the production plant, which can be arranged on or removed from the respective receiving box as required, in particular independently by means of their own actuators and / or using actuators installed in or on the respective receiving box.

[0172] The receiving boxes can include one or more connection elements which can be connected to corresponding connection elements at one or more treatment stations, in particular to supply the respective receiving box with electrical energy and / or consumables, especially liquids and / or gases, and / or to establish a signal coupling of the respective receiving box with a control device, especially a higher-level one, for example one or more control units.

[0173] The storage device can include storage locations equipped with connection elements, so that one or more treatment processes for the treatment of the starting materials can be carried out at storage locations of the storage device that serve as treatment locations.

[0174] The storage locations of the storage device and / or the receiving boxes may include fixing elements by means of which the receiving boxes can be positioned and / or fixed at the storage locations.

[0175] The holding boxes can each include one or more tool holders for receiving and securing one or more tools, particularly inside the respective holding box.

[0176] The one or more tool holders can each comprise one or more connection elements which can be connected to corresponding connection elements on the respective tool to be held, in particular to supply the respective tool with electrical energy and / or consumables, especially liquids and / or gases, and / or to establish a signal coupling of the respective tool with the holding box and / or a control device, in particular a higher-level one.

[0177] The receiving boxes can also be stored in storage locations (each) in a state not used for product manufacturing, especially after cleaning by means of a cleaning device of the production plant, for example the one already described.

[0178] The receiving boxes, stored in a state not used for product manufacturing, can be removed from the storage locations for receiving or introducing raw materials, in particular fully automatically by means of the storage transport device of the storage device.

[0179] Additionally or alternatively, it may be provided that a recording box includes one or more connection elements which can be connected to corresponding connection elements on another recording box, thus making it possible to provide a composite recording box.

[0180] For possible designs and / or configurations of the composite storage box, please refer to the description of the storage box(es). It may be possible for one or more storage locations to be configured as storage locations for composite storage boxes.

[0181] Additionally or alternatively, it may be provided that one or more, in particular all, receiving boxes are configured to hold one or more workpiece carriers, including any tools and / or consumables arranged on them and / or held therein. Additionally or alternatively, it may be provided that a workpiece carrier is designed as a tool carrier and / or as a consumable carrier. The production system may include an unpacking device for unpacking objects being supplied to the cleanroom area.

[0182] The unpacking device can be integrated into the airlock device or form a part thereof.

[0183] Additionally or alternatively, it may be provided that the unpacking device is connected to the handling device and / or the storage device, in particular via an autoclaving device, for example a pass-through autoclaving device, by means of which unpacked and / or partially unpacked objects can be received, then sterilized and dried, and subsequently fed to the handling device and / or the storage device, in particular in each case automatically.

[0184] The airlock system can include an entry airlock station which is accessible from the surroundings of the production plant and at which, in particular, a packaged object can be placed by a person and / or automatically.

[0185] The packaged object can be transported from the entry airlock station to an unpacking station, for example the one already described, by means of a sluice transport device of the production plant and can be automatically unpacked at the unpacking station, or the packaged object can be automatically unpacked at the entry airlock station.

[0186] The airlock device may include, for example, a cleaning device for cleaning the packaging of the packaged object, such as the one already described.

[0187] It may be provided that the object can be cleaned and / or sterilized in a packaged state by means of the cleaning device of the lock device, in particular by means of irradiation and / or fumigation.

[0188] Cleaning using the cleaning device of the airlock system can be carried out in particular at the entrance airlock station, the unpacking station and / or a cleaning station provided in the airlock system.

[0189] The unpacking device can include several unpacking units for unpacking different types of objects and / or packaging, in particular for removing different types of packaging from the objects.

[0190] One or more unpacking units for unpacking raw materials and one or more further unpacking units for unpacking tools and / or consumables may be provided.

[0191] The packaging of the packaged object, in particular the packaged starting material, can be disposed of sterilely after unpacking by means of one or more unpacking units, for example via the exit airlock and / or via a waste airlock of a separately designed waste airlock of the unpacking device or the airlock device, whereby the unpacked object, in particular the unpacked starting material, cannot come into contact with the packaging.

[0192] The object, in particular the starting material, can be fed into the handling device after unpacking, especially by means of the airlock transport device.

[0193] It may be provided that the unpacking area in the airlock device is spatially separated from the rest of the airlock device.

[0194] Unpacking can be carried out fully automatically using one or more unpacking units.

[0195] Additionally or alternatively, it may be provided that unpacking can be carried out manually and / or semi-automatically, for example automatically using at least one manual action.

[0196] It may be provided that the airlock device, in particular one of the airlock positions provided in the airlock device, for example the unpacking position, is cleanable before, during and / or after unpacking by means of the cleaning device of the airlock device, in particular by means of irradiation and / or fumigation.

[0197] Cleaning during unpacking can be carried out, for example, between individual unpacking steps.

[0198] The unpacking device may include a detection device and a control device by means of which a type of object to be unpacked and / or a type of packaging to be removed can be determined.

[0199] By means of the control device, an unpacking unit of the unpacking device can be selected and controlled for carrying out the unpacking process, wherein the unpacking unit can be one of several unpacking units for carrying out different unpacking processes, wherein the selected unpacking unit can be assigned to the determined type of object to be unpacked and / or the type of packaging to be removed.

[0200] Additionally or alternatively, it may be provided that unpacking can be carried out manually, for example at the entrance airlock.

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

[0202] The packaging device can be integrated into the airlock device or form a part thereof.

[0203] Additionally or alternatively, it may be provided that the packaging device is connected to the handling device and / or the storage device, in particular via an autoclaving device, for example a pass-through autoclaving device, by means of which objects can be received, then sterilized and dried, and subsequently removed, in particular in an automated manner.

[0204] The airlock system can include an exit airlock station, which is accessible from the surroundings of the production plant and from which, in particular, a packaged object can be removed by a person and / or automatically.

[0205] The object to be packaged can be transported from a transfer airlock station to a packaging station by means of a sluice transport device of the production plant and can be packaged automatically at the packaging station, or the object to be packaged can be packaged automatically at the exit airlock station.

[0206] The packaging device can comprise several packaging units for packaging different types of objects and / or packaging, in particular for packaging the objects with different types of packaging.

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

[0208] The object to be packaged, in particular the manufactured product, may be movable, in particular manageable or transportable, before, during and / or after packaging by means of the handling device and / or the airlock transport device.

[0209] It may be provided that the packaging area in the airlock system is spatially separated from the rest of the airlock system.

[0210] Packaging can be carried out fully automatically using one or more packaging units.

[0211] Additionally or alternatively, it may be provided that the packaging can be carried out manually and / or semi-automatically, for example automatically using at least one manual action.

[0212] It may be provided that the airlock device, in particular one of the airlock stations provided in the airlock device, for example the packaging station, is cleanable before, during and / or after packaging by means of the cleaning device of the airlock device, in particular by means of irradiation and / or fumigation.

[0213] The packaging device may include a detection device and a control device by means of which a type of object to be packaged and / or a type of packaging to be used can be determined.

[0214] By means of the control device, a packaging unit of the packaging device can be selected and controlled for carrying out the packaging process, wherein the packaging unit can be one of several packaging units for carrying out different packaging processes, and wherein the selected packaging unit can be assigned to the determined type of object to be packaged and / or the type of packaging used.

[0215] It may be provided that the packaging device and the unpacking device are designed in a common device for unpacking and / or packaging.

[0216] As already described in connection with the conditioning units of the receiving boxes, the production plant can include a tooling system.

[0217] In particular, the production plant may include a tooling system by means of which treatment processes on raw materials and / or maintenance processes can be carried out within the cleanroom area.

[0218] The tooling system can include several, in particular fully automatic, tool units for carrying out different treatment and / or maintenance processes.

[0219] It may be provided that a tool unit described herein is a tool described herein and / or a tool described herein is a tool unit described herein.

[0220] The tooling system can include one or more tool units designed as feeding units for supplying consumables to the raw materials.

[0221] It may be stipulated that consumables include at least one liquid and / or at least one gas and / or gas mixture.

[0222] Additionally or alternatively, it may be provided that consumables include at least one solid, for example at least one lyophilized solid.

[0223] The tooling system can include one or more tool units designed as sampling units for taking a sample from a starting material.

[0224] One or more of the tool units of the tool system can each comprise one or more multi-use components and / or one or more single-use components.

[0225] The tooling system can include a setup unit by means of which one or more single-use components of a tooling unit can be removed fully automatically after use, in particular disposed of, and replaced by one or more new single-use components.

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

[0227] A multi-use component can, in particular, be a component that, after its single, especially first, use, can be used at least once more.

[0228] A single-use component and / or a multi-use component can each be, for example, an element and / or a system.

[0229] Optionally, such an element and / or system may include at least one of the following: a tube, a needle, a syringe, a container, in particular a vessel or a bag, for example a vessel for a starting material, a valve, a microfluidic unit, a probe, a cartridge, a vial, and / or a bottle, in particular for reagents.

[0230] It should be understood that the preceding list is exemplary and not exhaustive.

[0231] Alternatively or additionally, the element may be a combination of the previously described enumerated elements. A multi-use component may be cleanable and / or sterilizable. The setup unit may be located entirely within the cleanroom area.

[0232] The setup unit can include a handling unit, in particular a multi-axis robot arm, by means of which a fully automatic setup process can be carried out.

[0233] It may be provided that the setup process, in particular a dismantling process and / or a setup process of the setup process, can be carried out in one or in several, in particular different, cleanroom sub-areas of the cleanroom area.

[0234] The setup unit can include a cleaning unit, or a cleaning unit can be assigned to the setup unit, by means of which multi-use components of one or more tool units can be cleaned, in particular sterilized, after use.

[0235] Additionally or alternatively, it may be provided that the cleaning unit is designed as an independent or separate tool unit.

[0236] It may be provided that cleaning can be carried out before, during, in particular between the dismantling process and the setup process, and / or after the setup process using the cleaning unit.

[0237] The tool system can comprise several portable tool units, which can be supplied to a treatment station for the treatment of a starting material, which is also a storage station for storing the starting material, and can be temporarily stored there for the purpose of carrying out a treatment process.

[0238] One or more portable tool units of the tool system can be supplied to the production plant by means of a storage transport device, in particular one or more storage transport units, to a tool storage location and / or to a treatment location and / or to a setup location.

[0239] One or more tool units can be designed and set up by means of the handling device to carry out a treatment process and / or a maintenance process.

[0240] One or more tool units can be designed and set up to carry out a treatment process and / or a maintenance process independently of the handling device, in particular automatically.

[0241] It may be intended that a tool unit is either single-use or reusable.

[0242] A tool unit can be placed in a storage location, temporarily stored, stored and / or connected to assigned interfaces in the storage location.

[0243] A tool unit can be a mechanical tool.

[0244] A tool unit can be moved and / or used as intended by means of a robot arm, for example a multi-axis robot arm.

[0245] A tool unit can be a tool for supplying and / or removing, for example, suctioning a liquid, in particular a tool for pumping a liquid, for example, a pumping tool, wherein the tool unit can in particular be configured to supply and / or remove a predetermined quantity of liquid, in particular for sampling for analysis.

[0246] A tool unit can be a tool for mixing at least one liquid, in particular at least one liquid with at least one liquid, gaseous and / or solid substance. For example, the tool unit can be a pump for circulation.

[0247] A tool unit can be a means for the biochemical manipulation of cells, by means of which at least one substance can be introduced into a reactant, and / or the temperature of a reactant can be changed, and / or the ambient pressure of a reactant can be changed, wherein the reactant is arranged, and in particular contained, in a tool carrier, especially in a receiving box. This allows, in particular, the environment of the reactant, and especially the cells of the reactant, to be changed in order to modify the reactant itself, and in particular the cells of the reactant themselves, especially with regard to cell growth and / or a cell surface, for example a cell membrane surface, and / or cell metabolism.

[0248] A tool unit can be a means of concentrating and / or separating liquids, in particular by means of a column, for example a separation column, and / or a centrifuge.

[0249] Additionally or alternatively, it may be provided that at least one auxiliary material, for example magnetic particles, is used to concentrate and / or separate liquids.

[0250] A tool unit can be a means for analyzing process parameters by means of a probe and / or a sensor, wherein the probe and / or the sensor is configured, for example, to detect, measure, and / or ascertain at least one of the following: at least one temperature, at least one particle, for example, at least one particle concentration, at least one vibration, at least one acceleration, at least one cell count, at least one cell density, at least one turbidity, for example, at least one light absorption due to liquid turbidity, at least one gas composition, at least one gas, for example, CO2, and / or at least one chemical substance, in particular at least one biochemical substance, for example, at least one metabolite.

[0251] It should be understood that the preceding list is exemplary and not exhaustive.

[0252] The tooling system may include a recycling and / or reprocessing unit, by means of which cleaning and / or reprocessing operations can be carried out in the cleanroom area, in particular on at least one of the following: - the cleanroom area itself, for example a cleanroom sub-area of ​​the cleanroom area itself, in order to maintain its cleanroom properties, for example its cleanroom class properties, - the storage transport device, in particular a storage transport unit of the storage transport device, in order to maintain the cleanroom properties, for example the cleanroom class properties, of the cleanroom area, for example the cleanroom sub-area, in which the storage transport device or its storage transport unit is arranged and / or movable, - Consumables, - a tool or tool unit - a workpiece carrier.

[0253] It should be understood that the preceding list is exemplary and not exhaustive.

[0254] The recycling and / or reprocessing unit may have sensors that allow the success, in particular the quality, of a cleaning and / or reprocessing process to be determined.

[0255] It may be provided that the material cleaned and / or reprocessed by means of the recycling and / or reprocessing unit, for example at least one of the previously described enumerated items, is available for a subsequent process after a cleaning and / or reprocessing operation, in particular in or at a storage location.

[0256] It may be provided that a defective and / or excess tool unit can be removed from the production plant via the airlock device; in particular, the defective and / or excess tool unit can be stored from a storage location and automatically transported to the airlock device for removal from the production plant.

[0257] It may be intended that the tooling system is set up to be fully automated.

[0258] In a sense, the production plant can include a particularly fully automatic tooling system, which comprises one or more tooling units for carrying out treatment processes on a raw material, wherein the tooling system is arranged within the cleanroom area, for example within a cleanroom sub-area, for example within a receiving box as a cleanroom sub-area.

[0259] The tool system can comprise one or more tool units designed as a fluid conveying device, by means of which a fluid can be conveyed, in particular with respect to a volume flow rate that is adjustable.

[0260] The volume flow rate that can be conveyed by the fluid conveying device can be, for example, equal to or greater than 500 ml / min. A tolerance of ±5% can be provided.

[0261] The fluid conveying device can have a directing element by means of which a directed volume flow can be generated.

[0262] The fluid conveying device can have thermal insulation, which allows the temperature of a fluid to be kept constant during conveying.

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

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

[0265] The fluid conveying device can have a fluid guidance arrangement by means of which the fluid can be conveyed essentially without foaming.

[0266] The fluid conveying device can be optimized for dead volume.

[0267] The tool system can comprise one or more tool units designed as a micro-fluid conveying device, by means of which a fluid can be conveyed, in particular with respect to a volume flow rate, especially for aliquoting.

[0268] The volume flow rate that can be conveyed by the micro-fluidic conveying device can, for example, be less than 500 ml / min, preferably greater than or equal to 100 µl / min and less than 500 ml / min. A tolerance of ±5% can be provided in each case.

[0269] The micro-fluidic conveying device can have a directional element by means of which a directed volume flow can be generated.

[0270] The micro-fluidic conveying device can have thermal insulation, which ensures that the temperature of the fluid is maintained at a constant level during conveying. Additionally or alternatively, the micro-fluidic conveying device can have a heating source and / or a cooling unit, and / or a heating source and / or a cooling unit can be associated with the micro-fluidic conveying device, which allows the temperature of the fluid to be maintained at a constant level and / or be adjustable during conveying.

[0271] The micro-fluidic conveying device can have at least one sensor to monitor and / or control and / or regulate the fluid conveying, and / or to analyze and / or detect components, such as particles and / or turbidity and / or air bubbles and / or fluorescently labeled components, in the conveyed fluid.

[0272] The micro-fluidic conveying device can include a micro-fluidic guide arrangement by means of which the fluid can be conveyed essentially without foaming. The micro-fluidic conveying device can be optimized for dead volume.

[0273] The tool system can comprise one or more tool units designed as a device for dividing a fluid, by means of which the fluid can be conveyed, in particular with respect to a volume flow rate, and by means of which the fluid can be divided into at least two, in particular two to twelve, fluid parts, in particular with respect to a volume flow rate.

[0274] The fluid components, in particular their associated volume flows, can be, for example, less than 500 ml / min, preferably greater than or equal to 100 µl / min and less than 500 ml / min. A tolerance of ±5% can be provided in each case.

[0275] It may be provided that the divided fluid, in particular at least one fluid part of the divided fluid, can be discharged into at least one associated container, in particular vessel, workpiece carrier and / or receiving box, and / or into and / or onto a sensor by means of the device for dividing a fluid.

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

[0277] The device for dividing a fluid can have thermal insulation, by means of which the temperature of a fluid can be kept constant during conveying and / or dividing.

[0278] Additionally or alternatively, the device for dividing a fluid may include a heating source and / or a cooling unit, and / or the device for dividing a fluid may be assigned a heating source and / or a cooling unit by means of which a constant and / or adjustable temperature of a fluid can be maintained during conveying and / or dividing. The device for dividing a fluid may include a fluid guide arrangement for the fluid to be dispensed and / or for the fluid to be divided, in particular for the respective fluid components, by means of which the fluid and / or the fluid components can be conveyed and / or divided in a substantially foam-free manner.

[0279] The device for dividing a fluid can be optimized for dead volume.

[0280] The tool system can comprise one or more tool units designed as a fluid mixing device, by means of which a fluid can be mixed.

[0281] The fluid mixing device may include a mixing unit, in particular a mechanical mixing unit and / or a geometric mixing unit, which has a defined fluid guidance arrangement for mixing, in particular for essentially foam-free mixing.

[0282] It may be provided that the fluid is mixable with a defined shear force, in particular with low shear force, and in particular is essentially foam-free, by means of the mixing unit of the fluid mixing device.

[0283] Additionally or alternatively, the fluid mixing device may have a heating source and / or a cooling unit, and / or a heating source and / or a cooling unit may be assigned to the fluid mixing device, by means of which a temperature of a fluid can be kept constant and / or adjusted during mixing.

[0284] The tool system can comprise one or more tool units designed as a mixing device, by means of which at least two components can be mixed together, wherein in particular one of the at least two components is a fluid.

[0285] The mixing device can be configured essentially like the fluid mixing device; in particular, the mixing device can be configured like the fluid mixing device or can be designed as the fluid mixing device. In a sense, the fluid mixing device can also be designed as the mixing device.

[0286] The tool system can comprise one or more tool units designed as a measuring device, by means of which at least one property of a fluid and / or a reactant can be measured.

[0287] The measuring device may be configured to measure a pH value, and / or a gas value or a gas mixture value, for example an oxygen value, a cell density, and / or a turbidity, in particular a turbidity in a fluid.

[0288] The tool system can comprise one or more tool units designed as a material separation device, by means of which an initial component can be separated into at least two components.

[0289] The separation device may include means for tangential flow filtration, centrifugation (for example with 200 to 300 g), affinity chromatography, and / or magnetic separation, by means of which the starting component can be separated into at least two components.

[0290] Additionally or alternatively, the separation device may have a temperature control element and / or a temperature control element may be assigned to the separation device, by means of which a temperature of a component to be separated and / or the separated output component can be kept constant and / or adjusted before, during and / or after separation, for example to a temperature of 5 to 10°C.

[0291] The tool system can comprise one or more tool units designed as a heating device, by means of which a fluid can be temperature-controlled, in particular heated and / or cooled, for example to a temperature less than or equal to 37°C.

[0292] The heating device can be designed as a separate unit. It is also possible for the heating source and / or the temperature control element of the previously described devices of the tool system to be designed as part of the heating device and / or associated with it.

[0293] The heating device can be arranged and / or configured to create a homogeneous temperature field, particularly in spatial and / or temporal terms.

[0294] The tool system can comprise one or more tool units designed as a device for supplying and / or removing a gas, in particular a gas mixture, by means of which a gas, in particular a gas mixture, can be supplied and / or removed, in particular homogeneously.

[0295] The device for supplying and / or removing a gas can, for example, supply and / or remove oxygen, carbon dioxide and / or hydrogen peroxide.

[0296] It may be provided that the fluid conveying device, the micro-fluidic conveying device, the device for dividing a fluid, the fluid mixing device, the mixing device, the measuring device, the mass separation device, the heating device and the device for supplying and / or removing a gas are designed together in any combination as one or more devices, for example in a single common device.

[0297] The tool system can comprise one or more tool units designed as a manipulator, by means of which a cell membrane, in particular a cell membrane of a cell of a reactant, can be manipulated, in particular by means of at least one of the following or any combination thereof: (by means of) an electric field, the addition of a chemical, receptor-mediated transfection, microinjection, a gene gun, magnet-assisted transfection, sonoporation, optical transfection, a microfluidic channel, for example, by squeezing into a microfluidic channel.

[0298] Additionally or alternatively, it may be provided that genetic material, in particular foreign genetic material, for example DNA, for example foreign DNA, and / or RNA, for example foreign RNA, can be introduced into the cell through the cell membrane by means of the manipulator.

[0299] Additionally or alternatively, it may be provided that viruses can be introduced into the cell via the manipulator, which can then carry out the actual manipulation of the cell.

[0300] The tool system can comprise one or more tool units configured as a radiation source and / or a light-emitting device, wherein the radiation source is configured to emit ionized radiation, in particular onto a target object, for example a reactant, and the light-emitting device is configured to emit light with a predetermined wavelength, in particular onto a target object, for example a reactant.

[0301] Additionally or alternatively, the tooling system may include one or more tool units designed as a Flowcell sequencing device and / or as a Next-Generation sequencing device.

[0302] The tool system can comprise one or more tool units designed as a cleaning device, in particular as the cleaning device and / or cleaning unit already described, by means of which a location where the treatment processes on the starting material can be carried out by means of the one or more tool units can be cleaned and / or sterilized.

[0303] It may be provided that a supply facility for the tool system is assigned to supply the tool system with consumables.

[0304] In a sense, the production plant can include a tooling system, such as the one described above, and a supply device for supplying the tooling system with consumables.

[0305] The supply device may include or utilize one or more storage locations of the storage device arranged within the cleanroom area for the storage of consumables.

[0306] In a sense, storage locations of the storage device can be assigned to the supply device.

[0307] The airlock device can form part of the supply device or interact with it, whereby consumables can be introduced into the cleanroom area by means of the airlock device.

[0308] The consumables to be used in a treatment process can be made available in the airlock device, especially at an exit airlock station of the airlock device, particularly before their use, and optionally be prepared for use, in particular by unpacking and / or temperature-controlling them.

[0309] The storage device can form part of the supply device or interact with it.

[0310] Consumables supplied from the environment of the production plant, in particular supplied by means of the airlock device, can be supplied to one or more storage locations of the storage device 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 device.

[0311] Consumables can be supplied to the tool system, in particular 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 device, for example for supplying consumables and / or tool consumables to one or more tool units of the tool system.

[0312] It may be provided that the consumables and / or the tool consumables include one or more multi-use components and / or one or more single-use components.

[0313] The consumables to be used in a treatment process can be made available in storage areas, especially before their use, and optionally can be prepared for use, in particular by temperature control.

[0314] The supply device can include one or more disposal units, by means of which, in particular, used, consumed and / or contaminated consumables and / or tool consumables can be removed from the cleanroom area.

[0315] One or more disposal units can be assigned to the setup unit of the tool system, in particular be manageable by it, and / or form a component of the setup unit of the tool system.

[0316] The supply device may include a refilling device located within the cleanroom area, by means of which consumables, particularly those in liquid form, can be supplied to one or more storage devices, one or more workpiece carriers and / or one or more storage locations.

[0317] Additionally or alternatively, the refilling device can be designed as and / or associated with the refilling station described above. The storage device can be configured, in particular, to store energy and / or one or more consumables; specifically, the storage device can be electrically rechargeable and / or refillable with consumables.

[0318] The storage device can provide energy and / or one or more consumables for carrying out a treatment cycle.

[0319] The storage device may include at least one interface for refilling and / or supplying energy and / or consumables; in particular, the interface may be configured to be coupled to a tool / tool ​​unit, especially for said supply.

[0320] The supply device may include a water system, in particular a pure water system, for providing water, in particular pure water, as at least one consumable.

[0321] The water system can, for example, be connected to a water source, particularly an ultrapure water source, via interfaces provided in the production plant. The water source may be located in the vicinity of the production plant. As already described, the production plant may include one or more probes, sensors, sensor units, and / or similar measuring elements.

[0322] In a sense, the production plant can include one or more sensor units for determining one or more values ​​of one or more parameters of one or more raw materials, and / or one or more workpiece carriers, and / or one or more tools. It can also include one or more sensor units for determining one or more values ​​of one or more parameters of one or more consumables.

[0323] The investigation can be carried out at least partially automatically, and in particular fully automatically, using one or more sensor units.

[0324] By means of one or more sensor units, the occupancy status of one or more storage locations of a storage device in the production plant can be determined, and in particular monitored.

[0325] By means of one or more sensor units, a local temperature and / or a local humidity and / or a local illuminance or irradiance can be determined, in particular monitored, at or in one or more storage locations of the storage device of the production plant.

[0326] The production plant can include one or more sensor units to determine the progress of treatment during the treatment of a raw material or between two treatment processes.

[0327] The production plant may include one or more sensor units for determining the progress of a treatment during the treatment of a feedstock or between two treatment processes using at least one fluid of the feedstock.

[0328] One or more sensor units can be microscopy devices for the visual detection of microscopic components of the starting material in order to determine the progress of the treatment.

[0329] The microscopy device can - an automated microscopy device, and / or - a lensless microscopy device, and / or - a light microscopy device, and / or - have a microscopy device for fluorescence and / or luminescence examination and / or be designed as such.

[0330] The microscopy device may include a data and / or image processing unit that is designed and programmed to detect and / or determine at least one treatment progress and / or one or more values ​​of one or more parameters of one or more starting materials.

[0331] Using the data and / or image processing unit of the microscopy device, the morphology, and / or concentration, and / or motility, and / or functionality of respective cells of one or more reactants can be detected and / or determined.

[0332] One or more sensor units for determining the progress of the treatment can be arranged, and in particular integrated, at or in one or more storage locations for receiving starting materials.

[0333] The production plant, in particular one or more tools for carrying out one or more treatment processes, can be controlled and / or regulated depending on one or more determined values, whereby in particular one or more treatment parameters can be varied, in particular can be changed, depending on a determined treatment progress.

[0334] The production plant may include one or more sensor units for monitoring a quantity of consumables stored within the cleanroom area.

[0335] The production plant can include one or more communication interfaces and / or one or more human-machine interfaces, or HMI interfaces for short, by means of which information about a shortfall in a predetermined quantity of consumables can be provided from the production plant, in particular to a user and / or a computer system.

[0336] It may be provided that one or more sensor units are designed as a device for polymerase chain reaction analysis (PCR analysis) and / or for endotoxin testing and / or for mycoplasma testing.

[0337] It may be provided that, by means of one or more sensor units, protein analysis, in particular protein determination and / or an enzymatic activity test and / or an immunological test and / or an amino acid analysis and / or a protein sequence analysis, can be carried out on the starting material and / or a part, in particular a component, of the starting material.

[0338] Additionally and / or alternatively, it may be provided that spectroscopy and / or a light microscopy method and / or a chromatography method and / or an electrophoresis method and / or a mass spectrometry can be carried out on the reactant and / or a part, in particular a component, of the reactant by means of one or more sensor units.

[0339] It may be provided that 3D structure analysis, in particular magnetic resonance spectroscopy and / or electron microscopy and / or scanning electron microscopy and / or X-ray analysis, can be carried out on the reactant and / or a part, in particular a component, of the reactant by means of one or more sensor units.

[0340] It may be provided that peptide analysis and / or carbohydrate analysis, in particular high-performance liquid chromatography and / or electrophoresis and / or mass spectrometry and / or magnetic resonance spectroscopy, and / or lipid analysis, in particular solid-phase extraction and / or chromatography and / or mass spectrometry and / or immunoassay, and / or phosphorylation and acetylation analysis, in particular with regard to at least one protein, and / or metabolite testing and / or metabolite monitoring, in particular with regard to glucose, lactate, oxygen, carbon dioxide, ammonium, phosphate and / or their derivatives, can be carried out on the starting material and / or a part, in particular a component, of the starting material by means of one or more sensor units.It may be provided that nucleic acid analysis of the starting material and / or a part, in particular a component, of the starting material can be carried out by means of one or more sensor units.

[0341] It may be provided that the production plant, in particular for nucleic acid analysis, includes an extraction device and / or a gel filtration device and / or a precipitation device and / or a concentration device and / or a centrifugation device and / or an isolation device and / or a PCR analysis device and / or a magnetic bead handling device for separating magnetic beads and coupled material and fluid, which is / are attributable to one or more sensor units, in particular for nucleic acid analysis.

[0342] It may be provided, for example, that one or more sensor units, in particular for nucleic acid analysis, absorption measurement and / or gel electrophoresis, in particular for the separation and / or purification of RNA and / or DNA and / or proteins, and / or gel documentation, in particular with regard to RNA and / or DNA and / or protein gels and / or Western blot, and / or RNA analysis and / or DNA analysis and / or sequence analysis and / or chip analysis, in particular for RNA / DNA / protein quantification, and / or DNA mapping and / or protein-DNA interaction analysis and / or genotyping and / or epigenetic analysis and / or proteome analysis and / or metabolome fingerprinting, profiling, and targeting analysis can be performed on the starting material and / or a part, in particular a component, of the starting material.

[0343] The production facility may include, in particular for cell analysis, a morphology determination device and / or a metabolite testing device and / or a receptor binding testing device and / or a signal transduction testing device and / or a cell differentiation testing device and / or a viscosity testing device and / or DNA / RNA / protein expression testing device and / or a chip / microfluidics-based testing device, which is / are assignable to and / or is assigned to one or more sensor units, in particular for cell analysis.

[0344] Additionally or alternatively, it may be provided that one or more sensor units can be used to perform expression analysis, in particular for gene and / or protein expression, and / or transfection analysis and / or flow cytometry and / or an ELISA test and / or a luciferase test and / or a kinase test on the starting material and / or a part, in particular a component, of the starting material.

[0345] It may be provided that an osmolality test and / or a freezing point depression measurement and / or a turbidity measurement, in particular a measurement of optical density, and / or a particle measurement, in particular a particle density measurement, and / or a pH measurement and / or a viscosity measurement can be carried out on the reactant and / or a part, in particular a component, of the reactant by means of one or more sensor units.

[0346] In other words, it can be summarized that the production plant comprises one or more sensor units by means of which one or more, essentially all, process steps, in particular one or more, essentially all, treatment processes, and / or one or more, essentially all, process states, in particular one or more, essentially all, treatment states, can be monitored and, in particular, if necessary, controlled, in particular, readjusted, and / or steered, in particular, readjusted.

[0347] The sensor units can, in particular, address: at least one temperature, at least one particle, for example, at least one particle concentration, at least one vibration, at least one acceleration, at least one cell count, at least one cell density, at least one turbidity, in particular one turbidity of a reactant and / or product suspension, for example, at least one light absorption due to liquid turbidity, in particular in a reactant and / or product suspension, at least one gas composition, at least one gas, for example, CO2, and / or at least one chemical substance, in particular at least one biochemical substance, for example, at least one metabolite, for example, glucose.

[0348] The sensor units described above can be arranged in the production plant as needed, particularly with regard to one or more objects, for example raw materials and / or tools and / or storage areas and / or consumables, in the cleanroom area.

[0349] In particular, one or more sensor units or sensor technology units can be arranged inline and / or arranged to enable continuous automated measurement and / or real-time monitoring, especially with regard to one or more reactants.

[0350] In particular, additionally or alternatively, one or more sensor units or sensor technology units can be arranged online and / or arranged to enable continuous automated measurement, especially with regard to one or more reactants, wherein the sensor unit or sensor technology unit is not positioned in the immediate treatment environment of a reactant, but in a branch line, for example a bypass, provided for this purpose, from the treatment environment, in which a sample of the substances to be examined, especially the reactant, can be automatically extracted, and wherein, optionally, reagents, for example for a color change, can be added in the branch line.

[0351] In particular, additionally or alternatively, one or more sensor units or one or more sensory units can be arranged atline and / or be arranged, wherein a sample of the reactant taken from the treatment environment of a reactant can be examined separately, in particular in a location separate, from the treatment environment, wherein, optionally, separate sample preparation can be carried out.

[0352] It may be provided that one or more atline arranged sensor units can be arranged and / or are arranged adjacent to, in particular in the immediate vicinity of, the treatment environment of a starting material in the cleanroom area.

[0353] Alternatively or additionally, it may be provided that the one or more atline arranged sensor units can be arranged and / or are arranged adjacent to, in particular in the immediate vicinity of, the production plant in the vicinity of the production plant.

[0354] In particular, additionally or alternatively, one or more sensor units or one or more sensor technology units can be arranged and / or be arranged offline, especially outside the cleanroom area and / or the entire production plant, for example in an external laboratory.

[0355] As previously described, the production plant can include one or more cleaning devices.

[0356] The cleaning device can be designed as a separate device in the cleanroom area and / or be a component of the tool system, in particular a tool or tool unit, and / or the airlock device and / or the storage device.

[0357] The cleaning device may include one or more interfaces by means of which the cleaning device can be connected to a cleaning system, particularly a pharmaceutical one, for in-place cleaning (CIP), in-place washing (WIP) and / or in-place sterilization (SIP).

[0358] On-site cleaning, washing, and / or sterilization can be carried out, in particular in the storage areas and / or on the workpiece carriers, especially the receiving boxes.

[0359] The cleaning device may include one or more interfaces by means of which a gas and / or a gas mixture and / or a liquid can be supplied to the cleaning device, for example gaseous and / or liquid hydrogen peroxide, in order to be able to clean, in particular decontaminate, and / or sterilize one or more objects within the cleanroom area and / or parts, in particular everything, of the cleanroom area, in particular of at least one cleanroom sub-area.

[0360] The cleaning device can include one or more drying devices by means of which one or more objects, in particular tools and / or workpiece carriers, for example receiving boxes, within the cleanroom area and / or parts, in particular everything, of the cleanroom area, in particular of at least one cleanroom sub-area, can be dried, especially after cleaning has been carried out.

[0361] Additionally or alternatively, the cleaning device may include one or more autoclaving devices by means of which one or more objects within the cleanroom area can be sterilized.

[0362] It may be provided that one or more autoclaving devices are implemented as one autoclaving device described in connection with the unpacking device and / or with the packaging device.

[0363] The cleaning device can include one or more interfaces by means of which wastewater, in particular contaminated liquids, can be discharged from the cleanroom area.

[0364] The cleaning device may be provided with one or more distribution elements, for example nozzles and / or sprinklers, which are connected to a cleaning agent source within the cleanroom area and / or can be connected to a cleaning agent source in the vicinity of the production plant and by means of which (i.e. distribution elements) cleaning agents, for example water vapor and / or hydrogen peroxide, can be distributed for cleaning.

[0365] The cleaning device can be used to clean, and in particular sterilize, objects that come into direct contact with reactants, especially tools and / or consumables, particularly by means of irradiation.

[0366] The cleaning device can be used to clean objects, especially those not in direct contact with reactants, and in particular to disinfect them, especially by means of fumigation.

[0367] The cleaning device may include a cleaning station, in particular a stationary one, by means of which at least one workpiece carrier, in particular at least one receiving box, can be cleaned, in particular disinfected and / or sterilized.

[0368] The workpiece carrier can be fed to the cleaning station by means of the storage transport device and / or the handling device. The cleaning station can include a washing machine and / or an autoclave.

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

[0370] All structural and functional features associated with the previously described system according to the invention, i.e., the production plant according to the invention, and its embodiments, can also be included in the method according to the invention, either alone or in combination, and the associated properties, designs, and advantages can also be included and achieved accordingly.

[0371] In addition, the production plant described above according to the invention can be configured to carry out the method according to the invention below, and the method according to the invention below can be designed to be carried out using the production plant described above according to the invention.

[0372] A method according to the invention for producing a product, in particular a biological-pharmaceutical product, by means of a production plant, in particular a production plant as described above (i.e., which in particular comprises: a cleanroom area, an airlock device for feeding an object from an environment of the production plant into the cleanroom area and / or for removing an object from the cleanroom area, a handling device for moving the object within the cleanroom area, and a storage device arranged within the cleanroom area, which comprises several storage places for receiving several objects) (the method) comprises the following: - Selecting one of several production programs to manufacture one of several products that can be produced using the production plant, - Introducing a feedstock into a sluice device of the production plant, - automatic transport of the raw material to a cleanroom area of ​​the production plant, and - Automatic execution of one or more treatment processes on the starting material.

[0373] It may be planned that, after completion of the treatment processes, an automatic transport of a product manufactured from the starting material takes place from the production plant.

[0374] The starting material can be a patient-specific or a pooled starting material.

[0375] A pooled starting material can be produced from and / or manufactured from several patient-specific starting materials to serve as a product for a patient and / or a group of patients, i.e., in other words, to produce a product for one or more patients.

[0376] The treatment processes may involve pooling two or more starting materials to produce a pooled starting material.

[0377] The treatment processes may involve, in particular, recurring pairing and / or combining of objects, especially tools or tool units, starting materials, consumables, etc., in order to depict the manufacturing process, especially biological manufacturing processes, in its individual process steps.

[0378] During the automatic transport of the raw material into the cleanroom area of ​​the production plant, the raw material can be stored in a storage location within the cleanroom area of ​​a storage device of the production plant.

[0379] One or more treatment processes can be carried out fully automatically until a product to be manufactured from the starting material is finished.

[0380] Alternatively, one or more treatment processes can be carried out fully automatically until a product to be manufactured from the starting material is finished, taking into account quality analysis that has been carried out or can be carried out, in particular by means of one or more sensor units or sensors.

[0381] One or more, in particular all, treatment processes can be carried out at the storage location.

[0382] The product manufactured in this way can be removed from the storage area and automatically transported to the sluice gate for removal from the production plant.

[0383] The product can be filled and / or packaged before being dispensed, in particular filled and / or packaged ready for use.

[0384] One or more vessels, fixtures and / or tools used in the manufacture of the product may, at least partially, remain within the cleanroom area after the product is finished, be cleaned and sterilized, and then reused to manufacture another product.

[0385] For the production of the product and / or for the production of several different products, necessary consumables, in particular consumables and / or tool consumables, may be stored within the cleanroom area, especially before a selection of the product to be produced is made.

[0386] The consumables can be automatically transported into the cleanroom area via the airlock device and stored there, in particular in one or more storage locations of the storage device.

[0387] The quantity of consumables stored within the cleanroom area can be monitored, and if a predetermined minimum quantity is undershot, the stock can be replenished by supplying the required consumables, in particular via a notification or warning message on an operator unit.

[0388] Several products, especially several different products, can be manufactured simultaneously within the cleanroom area.

[0389] One or more treatment processes, which can be carried out in particular by means of one or more tool units, may include: - Supplying a liquid and / or a gas, in particular a gas mixture, - Discharge, in particular pumping, of a liquid and / or a gas, in particular a gas mixture, - Removal, in particular pumping, of a portion of a liquid and / or a gas, in particular a gas mixture, for analysis using one or more sensor units, - Mixing one or more components, in particular at least one liquid with at least one other component, for example another liquid, - Concentrating and / or separating a liquid, in particular by means of a column, for example a separation column, and / or a centrifuge, - Analyzing a reactant and / or an intermediate and / or a product, in particular by means of one or more sensor units, - Storing, in particular storing and / or retrieving, one or more objects, especially by means of the storage transport device, - Tempering, in particular incubating, one or more objects, especially one or more reactants.

[0390] It should be understood that the preceding list of treatment procedures is exemplary and not exhaustive.

[0391] Alternatively or additionally, it may be provided that one or more treatment processes can be combined with one or more treatment processes in a single treatment process and / or in any combination of these.

[0392] A combination of treatment processes may result in particular from instructions, especially a prescription, for the manufacture of a product, especially instructions for the manufacture of a personalized product based on patient-related information.

[0393] A treatment process can, for example, include adding a consumable, in particular a liquid, to a reactant, wherein, in particular, after a workpiece carrier, by means of which the consumable, in particular the liquid, is held, and a workpiece carrier, in particular a receiving box, by means of which the reactant and / or a reactant container or a vessel with a reactant is held, have been connected to each other, in particular fluidically, by means of one or more tool units and / or a handling device, the consumable is supplied to the reactant, in particular directed towards the reactant and conveyed in a defined manner.

[0394] It can be provided that the interconnected workpiece carriers define a process cell, in particular an aseptic process cell, or a process unit, in particular an aseptic process unit. This allows, for example, the defined generation and / or modification of a suspension from the liquid and the reactant, in particular a cell suspension.

[0395] Furthermore, it may be provided that, after feeding, in particular conveying, the workpiece carriers can be separated from one another again by means of one or more tool units and / or the handling device. It may be provided that one or more tool units and / or the handling device are cleaned and / or sterilized before or after a processing operation by means of a cleaning device. After cleaning and / or sterilization, the tool units can be stored again in a storage location by means of the storage transport device.

[0396] Additionally or alternatively, after cleaning and / or sterilization, the handling device can be re-equipped and / or prepared for a subsequent treatment process, particularly with one or more tool units.

[0397] A treatment process may, for example, include incubating a starting material, in particular a part of a starting material, such as cells, especially at a storage location.

[0398] Incubation can be carried out after the addition of a consumable to generate a cell suspension. Incubation can also be carried out before the addition of a consumable, for example to modify a cell suspension, particularly at a storage location.

[0399] It may be necessary to clean and sterilize the workpiece carrier on which the cell suspension is arranged using a cleaning device before incubation can be carried out or is carried out.

[0400] During incubation, gassing and temperature control can be performed using one or more tool units. During incubation, one or more functions, in particular heating, fixing, and / or gassing, can be performed in a single receiving box.

[0401] It may be provided that, in parallel or serial to a treatment process, in particular incubation, a workpiece carrier, in particular the workpiece carrier, by means of which the consumable material, in particular the liquid, is or was held, is cleanable and / or sterilizable by means of the cleaning device.

[0402] Additionally, it can be provided that a container held by the workpiece carrier, in which the liquid was stored, can be removed from the cleanroom area via the airlock using the handling device. Optionally, the workpiece carrier can then be cleaned and / or sterilized using the cleaning device. Furthermore, optionally, the workpiece carrier can then be restocked, particularly with consumables from the storage device and / or via the airlock using the storage transport device and / or the handling device.

[0403] Each product to be manufactured can be assigned a sequence of treatment processes, which are carried out using tools located within the cleanroom area and which remain in the cleanroom area after the treatment processes have been carried out.

[0404] One or more tools are cleaned, in particular sterilized, after the execution of one or more treatment processes within the cleanroom area.

[0405] One or more tools can be equipped with tool consumables before one or more treatment processes are carried out within the cleanroom area.

[0406] One or more tool consumables can be removed from the tool(s) and / or disposed of after one or more treatment processes have been carried out within the cleanroom area. Treatment time values ​​can be assigned to several, in particular all, treatment processes, specifying the period that elapses from the start of the respective treatment process until its end, including, in particular: - a time period for providing the at least one tool required for the respective treatment process, in particular including its fitting with one or more tool consumables, and / or - a time period for the supply and / or arrangement and / or commissioning of the at least one tool on the raw material to be processed, in particular at a storage location where the raw material is arranged, and / or - a duration of exposure to the starting material to achieve a desired treatment result, and / or - a time period for removing the at least one tool from the raw material, in particular from the storage location; - preferably including: • cleaning of at least one tool, and / or ◯ removal and / or disposal of tool consumables, and / or ◯ of a return transport of the tool to a starting point, in particular a storage location assigned to the tool.

[0407] In each production program, the treatment processes required for the manufacture of a specific product, as well as the associated treatment time values, can be stored or taken into account.

[0408] When a production program is started, a prediction of a production process can be created and the tools required and / or intended for carrying out the treatment processes can be reserved in advance for time slots resulting from the prediction.

[0409] One or more treatment processes can each - 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 the disposal of consumables, and / or - one or more setup operations for loading one or more tools with consumables, and / or - one or more control processes are assigned to control a treatment result, whereby, depending on the prediction of the production process, time slots may be reserved in advance at one or more of the devices required for carrying out the one or more cleaning processes, the one or more disposal processes, the one or more setup processes and / or the one or more control processes.

[0410] After one or more treatment processes, in particular after each treatment process, the prediction of the production sequence can be checked and / or updated, especially to confirm or correct the time slots for the tools and / or other equipment still required to complete the product.

[0411] When a production program is to be started, it can be determined, based on a prediction of the production process, whether all necessary tools and / or other equipment for completing the product are available within the required time slots, and the production program can only be started if this determination has yielded a positive result.

[0412] Additionally or alternatively, when starting an entire production program and / or a section of a production program, it can be determined, based on a prediction of the production process, whether all necessary tools and / or other equipment for completing the product are available within the required time slots and / or production duration, and / or whether there are resource bottlenecks, particularly with regard to consumables, and / or other production risks, and the production program can only be started if this determination has yielded a positive result regarding availability and a negative result regarding resource bottlenecks and production risks.

[0413] Additionally or alternatively, it may be provided that, when a production program and / or a section of a production program is to be started, a prediction of the production process is used to determine whether all necessary tools and / or other devices and / or objects and / or other materials for completing the product are available within the required time slots and / or can be supplied within the required time slots, in particular by a user, for example, whether there is a confirmation that said tools, devices, objects and / or materials can be supplied within the required time slots, and the production program can only be started if this determination has yielded a positive result.

[0414] It may be provided that the production plant includes one or more control units, in particular the control units already described, for controlling and / or regulating the production plant, in particular for controlling and / or regulating at least one component or part of the production plant included in the production plant.

[0415] The production plant can have one or more storage units and / or one or more storage units, in particular decentralized units located, for example, in a cloud and / or on a server, can be assigned to the production plant, wherein a computer program product can be stored or is stored on at least one storage unit, which comprises instructions that, when executed by at least one control unit of the production plant, cause the production plant described above to execute a previously described process. The computer program product can additionally or alternatively be stored on a computer-readable (further) storage medium.

[0416] By means of one or more control units, it is possible to manufacture a product, in particular a biological-pharmaceutical product, using the production plant.

[0417] One or more control units can be trained and programmed to categorize one or more products to be manufactured into production batches, particularly in an automated manner.

[0418] One or more control units can be trained and programmed to carry out order planning for one or more products and / or production lots, particularly with regard to time and / or with regard to resources located within the production plant, for example tools and / or consumables, and / or the current utilization of the production plant.

[0419] Additionally or alternatively, the aforementioned order planning can be carried out with regard to a predetermined production strategy, such as with regard to quality, for example product quality, over a period of time and / or with regard to costs over a period of time.

[0420] One or more control units can be trained and programmed to access and generate and / or modify an information management unit that can be stored or is stored on one or more storage units.

[0421] One or more control units can be trained and programmed to access and modify a billing unit that can be stored or is stored on one or more storage units, thereby enabling automated billing and / or cost calculation of products to be manufactured.

[0422] One or more control units can be trained and programmed to encrypt and decrypt information, especially patient-related information for the manufacture of a product, which can be stored on at least one storage unit, for example in the information management unit.

[0423] Additionally or alternatively, it may be provided that one or more control units are designed and programmed to anonymize and / or pseudonymize information, in particular patient-related information for the manufacture of a product, which can be stored on at least one storage unit, for example in the information management unit.

[0424] The information management unit allows information to be managed, in particular stored and / or modified and / or generated, which may include, for example: one or more recipes for one or more products and / or intermediate products, patient-related information, machine-related information regarding the production plant, runtime information regarding the production plant, information about material logistics and / or material requirements of the production plant.

[0425] Instructions for the manufacture of a product, in particular instructions for the manufacture of a personalized product based on patient-related information, can be stored using one or more storage units.

[0426] An educt can be a patient-specific educt.

[0427] Additionally or alternatively, a reactant can be a pooled reactant.

[0428] A pooled starting material can be produced from and / or manufactured from several patient-specific starting materials to serve as a product for a patient and / or a group of patients, i.e., in other words, to produce a product for one or more patients.

[0429] The instructions for manufacturing a product can define a sequence of one or more processing steps.

[0430] In a sense, the instructions can define a production program. It may be provided that one or more production programs can be stored on one or more storage units and executed for the manufacture of one of several products that can be produced using the production plant, particularly by means of one or more control units. Using the production plant, a product, in particular a patient-specific product, can be manufactured from at least one raw material, in particular from at least one patient-specific raw material, based on the instructions and the patient-specific information.

[0431] One or more control units can be trained and programmed to communicate with one or more communication interfaces and / or one or more human-machine interfaces, or HMI interfaces for short, of the production plant.

[0432] One or more control units can be designed and programmed to provide information to a human operator or user via the communication interfaces and / or the HMI interfaces, for example, fault information and / or information about the status of a product's manufacture and / or information about the stock levels of the storage device.

[0433] Referring to the preceding description of the production plant and the method according to the invention, an exemplary sequence, in particular an exemplary material flow, of one or more objects of the production plant and / or an exemplary sequence, in particular an exemplary material flow, of one or more objects that can be fed into and / or removed from the production plant is described below in order to further explain the present invention.

[0434] It should be understood that the following exemplary processes and / or material flows are modifiable with respect to all structural and functional features associated with the previously described production plant according to the invention and its embodiments, and also with respect to all process features of the previously described process according to the invention and its embodiments, either alone or in any combination.

[0435] The following description refers in particular to one reactant: A reactant can be arranged and / or contained in a container, in particular a reactant container or a vessel.

[0436] The reactant container with the reactant can define a cleanroom sub-area with a cleanroom class A.

[0437] The reactant container with the reactant can be enclosed by means of packaging, which can be designed as a partial enclosure of the reactant container with the reactant.

[0438] The feed container with the feed can be introduced into the sluice device of the production plant, in particular onto an inlet sluice station of the sluice device.

[0439] The packaging of the feed container can be removed from the feed container, in particular at the entry airlock station and / or at a separate unpacking station in the airlock device, especially by means of one or more unpacking units.

[0440] Preferably, it may be provided that the packaging is cleaned and / or sterilized before removal by means of a cleaning device of the airlock device or a part of the cleaning device of the production plant associated with the airlock device.

[0441] The airlock device can encompass a cleanroom sub-area with a cleanroom class B.

[0442] The entry airlock area and / or the unpacking area may comprise a cleanroom sub-area with a cleanroom class A.

[0443] It may be provided that the reactant container with the reactant can be moved within the lock device by means of a lock transport device and / or the handling device.

[0444] By means of the handling device, the reactant container with the reactant can be transferred to a workpiece carrier, in particular a receiving box, in or immediately adjacent to the sluice device, or can be transferred to a workpiece carrier that can be arranged or is arranged in a receiving box.

[0445] The receiving box that has received the reactant container with the reactant can define an aseptic processing unit.

[0446] The receiving box, which has received the reactant container with the reactant, can be stored in or at a storage location of the storage device by means of a storage transport device of the storage device.

[0447] Additionally or alternatively, this receiving box can be provided for one or more treatment processes, in particular by means of one or more tool units, using the storage transport device.

[0448] Additionally or alternatively, it may be provided that, by means of the handling device, the reactant container with the reactant can be transferred to a workpiece carrier in or immediately adjacent to the airlock device, and that this workpiece carrier can be transported to a storage location by means of the storage transport device after the transfer of the reactant container, wherein, after storage in the storage location, the workpiece carrier together with the reactant container can be transferred from the storage location to a receiving box, which defines an aseptic process unit, in particular with a cleanroom class A.

[0449] By means of the storage transport device, one or more workpiece carriers, by means of which one or more tool units from the storage device and / or one or more consumables from the storage device are held and transported, can be transported to the receiving box, whereby, optionally, the workpiece carriers can be arranged in a respective receiving box.

[0450] The receiving box and the one or more workpiece carriers or receiving boxes in which a respective workpiece carrier is arranged can be connected / coupled together for one or more treatment processes on the raw material arranged in the receiving box, whereby one or more tool units and / or one or more consumables of the one or more workpiece carriers may be required for one or more treatment processes.

[0451] In other words, it may also be provided that the receiving box and one or more further receiving boxes can be connected / coupled to each other, with the further receiving boxes each having at least one workpiece carrier by means of which one or more tool units and / or one or more consumables can be held for one or more treatment processes.

[0452] Through these treatment processes, a product can be generated from the starting material.

[0453] In a sense, the reactant container held in the receiving box can now be referred to as the product container.

[0454] Additionally or alternatively, a separate container, which may be assigned to the consumables, can be provided and / or made available by means of a workpiece carrier, which can serve as a product container into which the product can be transferred by means of one or more tool units.

[0455] The product container with the product, which is arranged in the receiving box, can be moved to an exit airlock station, in particular to a packaging station, of the airlock system by means of the storage transport device and / or the airlock transport device and / or handling device.

[0456] The product container with the product can be packaged at the exit airlock station, in particular at the packaging station, especially by means of one or more packaging units, in order to subsequently be removable from the airlock device.

[0457] The following description refers in particular to a workpiece carrier or a receiving box: The workpiece carrier can be designed, particularly in a functional sense, as a receiving box for receiving raw materials. In a sense, the workpiece carrier can be configured to have and fulfill the function of a receiving box.

[0458] Additionally or alternatively, the production plant may include several receiving boxes for receiving one or more workpiece carriers, each with the raw materials arranged on them and / or received.

[0459] A workpiece carrier or a receiving box can be fed into the cleanroom area via the airlock device.

[0460] The workpiece carrier or the receiving box can be cleaned and / or sterilized in the airlock device by means of a cleaning device of the airlock device or a part of the cleaning device of the production plant assigned to the airlock device.

[0461] The workpiece carrier or the receiving box can be stored at a storage location of the storage device by means of a storage transport device of the storage device, to which the workpiece carrier or the receiving box can be transferred by means of a sluice transport device and / or the handling device.

[0462] If required, the workpiece carrier and / or the receiving box can be transported from the storage location to its intended use by means of the storage transport device and, optionally, the handling device and / or the airlock transport device.

[0463] For example, the workpiece carrier can be equipped with one or more raw materials and / or one or more tool units and / or one or more consumables, for example by means of the handling device, in particular to be subsequently stored in the storage device or to be made available for one or more treatment processes, whereby in particular several workpiece carriers can be made available in this way.

[0464] The workpiece carriers can be arranged in respective receiving boxes, for example by means of the handling device, by means of which the workpiece carriers can be stored and / or made available.

[0465] Additionally or alternatively, it may be provided that the workpiece carriers can be arranged in respective receiving boxes, for example by means of the handling device and / or an actuator set up in the respective receiving box and / or on the respective workpiece carrier, by means of which the workpiece carriers can be stored and / or made available.

[0466] Several workpiece carriers, in particular workpiece carriers designed as receiving boxes, and / or receiving boxes can be connected / coupled together to form an aseptic process unit for carrying out one or more treatment processes.

[0467] For example, - a workpiece carrier designed as a receiving box or arranged in a receiving box, which has received a reactant container with a reactant, - a workpiece carrier designed as a receiving box or arranged in a receiving box, which has received consumables for one or more treatment processes, and - a workpiece carrier designed as a receiving box or arranged in a receiving box, which has received one or more tool units for one or more processing operations, are connectable / coupled to each other, or are connected / coupled, in particular by means of the storage transport device and / or the handling device, in order to form a common aseptic process unit in order to subsequently enable the execution of one or more treatment processes.

[0468] After the treatment processes have been carried out, the workpiece carriers or the receiving boxes can be separated / decoupled from each other or can be separated / decoupled.

[0469] The receiving box containing the manufactured product is transported to the airlock device as described previously, using the storage transport device. The workpiece carriers or receiving boxes associated with the tool units and consumables can be fed to a cleaning device within the production plant, allowing the workpiece carriers to be cleaned and / or sterilized.

[0470] The cleaned and / or sterilized workpiece carriers or receiving boxes can be stored again in storage locations of the storage device and can be available for reuse.

[0471] The following description refers in particular to a tool or tool unit and to a consumable: A tool unit or consumable can be supplied to the cleanroom area via the airlock device.

[0472] The tool unit or consumable can be introduced into the airlock system of the production plant, in particular onto an entry airlock station of the airlock system.

[0473] The tool unit or consumable can be cleaned and / or sterilized in the airlock device by means of a cleaning device of the airlock device or a part of the cleaning device of the production plant associated with the airlock device.

[0474] It may be provided that the tool unit or the consumable has packaging which can be removed from the tool unit or the consumable, in particular at the entry airlock station and / or at a separate unpacking station in the airlock device, especially by means of one or more unpacking units.

[0475] Preferably, it may be provided that the packaging is cleaned and / or sterilized before removal using the cleaning device of the airlock device.

[0476] The tool unit or consumable can be stored at a storage location of the storage device by means of a storage transport device of the storage device, to which the tool unit or consumable arranged on a workpiece carrier by means of the handling device can be transferred by means of a sluice transport device and / or the handling device.

[0477] It may be provided that the tool unit or the consumables within the lock device can be moved by means of a lock transport device and / or the handling device.

[0478] By means of the handling device, the tool unit or the consumable material can be transferred to a workpiece carrier, in particular a receiving box, in or immediately adjacent to the locking device, or can be transferred to a workpiece carrier that can be arranged or is arranged in a receiving box.

[0479] The workpiece carrier or receiving box, which has received the tool unit or consumables, can be stored in a storage location of the storage device by means of a storage transport device of the storage device.

[0480] This workpiece carrier or receiving box can be provided for one or more treatment processes using the tool unit or using the consumables, or can be provided using the storage transport device as already described in connection with the feedstock and the workpiece carrier or receiving box.

[0481] After one or more treatment processes have been carried out and after the receiving boxes have been separated / decoupled from each other, the tool unit or consumable used can be supplied to the handling device by means of the storage transport device, whereby single-use components in particular can be removed from the tool unit as required by means of the handling device, especially before cleaning and / or sterilization by the cleaning device.

[0482] Furthermore, after one or more treatment processes have been carried out and after the receiving boxes have been separated / decoupled from each other, the tool unit used can be fed to the cleaning device by means of the storage transport device.

[0483] Additionally or alternatively, it may be provided that a consumable material used, in particular a liquid consumable material used, can be removed from the respective receiving box and, optionally, from the production plant, in particular via the airlock device, during one or more treatment processes.

[0484] Used and / or damaged tool units or consumables can be removed from the cleanroom area via the airlock device using the handling device.

[0485] The cleaned and / or sterilized tool unit can be stored again in a storage location of the storage device and can be available for reuse.

[0486] Referring to the preceding description, the present invention enables the creation of a fully automated overall system for the production of biological-pharmaceutical products for the industrial production of individual batch sizes, in particular individual and / or micro-batch sizes, especially with modularly configured and / or autonomously operating components.

[0487] With the present invention, in particular by means of the provided sensors or sensor units, analytical functions can be integrated into automated processes, especially treatment processes, so that environmental and / or processing conditions required for the growth of cells outside an organism can be finely tuned and / or controlled and / or adjusted, thereby ensuring efficient production of the product.

[0488] With the present invention, in particular through the flexible and modular design of the production plant, which can be made possible by the various devices, both individual and / or small batch sizes as well as large-volume production of biological-pharmaceutical products can be carried out automatically, in particular fully automatically, for example for the production of autologous and / or allogeneic cell therapeutics, whose starting material, in particular patient's own cells, reacts highly sensitively to their environmental conditions.

[0489] With the present invention, in particular through the cleaning device and the storage device integrated in the cleanroom area, a fully automated overall system for the production of biological-pharmaceutical products can be created, which can be automatically loaded as well as clean and sterilize objects required for treatment processes on a starting material and thus reprocess them for an aseptic production area.

[0490] The present invention enables the automated, in particular fully automated, and flexible production of biological-pharmaceutical products, especially personalized therapeutics, particularly due to the individually configurable treatment processes in a single process room, for example, the cleanroom area and / or a storage area and / or a receiving box.

[0491] Compared to the typically existing, tightly linked individual process steps of conventional production processes for comparable biological-pharmaceutical products, the present invention allows for the creation of a more efficient system and process.

[0492] The present invention enables the creation of a system, i.e., the production plant, and a method by which a human operator or user is no longer required in the immediate process environment, thereby increasing both manufacturing efficiency and reducing the probability of manual errors.

[0493] Additionally or alternatively, the production plant can require less space or construction space, as a human operator or user only needs to enter the cleanroom area of ​​the production plant in emergencies and / or during maintenance.

[0494] Thus, a cost-intensive building and room structure can be reduced economically and technically to the raw material to be processed directly, in other words, the biological workpiece to be processed and transformed into the product.

[0495] A cleanroom environment, especially cleanroom class A, in which the product is processed openly, can be reduced to a minimum.

[0496] It may be particularly advantageous that, in the present invention, all necessary systems and / or devices for autonomous operation and associated equipment and / or consumables can be present within the production plant, and furthermore, all necessary information for autonomous operation can be stored and / or processed within the production plant, in particular by means of one or more control units.

[0497] As the foregoing description shows, the invention relates in particular to a production plant and a method according to one of the following sentences, in which further special embodiments of the invention are described: 1. Production facility, in particular for the manufacture of biological pharmaceutical products, wherein the production facility comprises the following: - a cleanroom area; - a lock device for feeding an object from an environment of the production plant into the cleanroom area and / or for removing an object from the cleanroom area; - a handling device for moving the object within the cleanroom area; - a storage device located within the cleanroom area, which includes several storage locations for holding multiple objects. 2. Production plant according to sentence 1, characterized in that the storage device includes a storage transport device for transporting objects to and / or from the storage locations. 3. Production plant according to sentence 2, characterized in that the storage transport device is a device different from the handling device. 4. Production plant according to sentence 2 or 3, characterized in that the storage transport device comprises a rail-guided transport system and / or one or more free-moving transport vehicles. 5. Production plant according to one of sentences 2 to 4, characterized in that the storage transport device comprises one or more rail-guided storage transport units by means of which one or more storage racks of the storage device are accessible, in particular for storage and retrieval operations as well as for treatment operations and / or maintenance operations. 6. Production plant according to one of sentences 2 to 5, characterized in that the storage transport device comprises one or more storage transport units designed as portal conveyors. 7. Production plant according to one of sentences 1 to 6, characterized in that the handling device is a multi-axis robot arm or comprises one. 8. Production plant according to one of sentences 2 to 7, characterized in that a changeover device of the production plant is assigned to the storage transport device and / or the handling device, by means of which different gripping units and / or carrier units can be mounted on one or more storage transport units of the storage transport device and / or on one or more handling units of the handling device, in particular for carrying out different storage operations, transport operations, handling operations, maintenance operations and / or treatment operations by means of the respective storage transport unit and / or handling unit. 9. Production plant according to one of sentences 2 to 8, characterized in that a cleaning device of the production plant is assigned to the storage transport device and / or the handling device, by means of which at least one gripping unit and / or carrier unit of one or more storage transport units of the storage transport device and / or one or more handling units of the handling device can be cleaned, in particular after the execution of a storage process, transport process, handling process, maintenance process and / or treatment process. 10. Production plant 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 point of the locking device to a storage transport device, in particular to one or more storage transport units of a storage transport device. 11. Production plant according to one of sentences 1 to 10, characterized in that the handling device comprises a lock transport device by means of which one or more objects can be transported from a lock station, in particular an entrance lock station, to another lock station, in particular a transfer lock station, and / or from a lock station, in particular a transfer lock station, to another lock station, in particular an exit lock station. 12. Production plant according to one of sentences 2 to 11, characterized in that the storage transport device and / or the handling device each comprise one or more workpiece carrier receptacles for receiving and transporting one or more workpiece carriers. 13. Production plant according to one of sentences 1 to 12, characterized in that the lock device comprises a cleaning device for cleaning one or more workpiece carriers and / or for cleaning one or more workpiece carrier receptacles. 14. Production plant according to one of sentences 1 to 13, characterized in that the production plant comprises a cleaning device to which workpiece carriers can be supplied for cleaning, in particular after transport of an object by means of the respective workpiece carrier. 15. Production plant according to one of sentences 1 to 14, characterized in that the storage device comprises one or more storage racks and / or one or more storage areas, each of which has several storage locations, wherein raw materials and / or tools and / or consumables can be stored in or removed from the storage locations by means of the storage transport device. 16. Production plant according to one of sentences 1 to 15, characterized in that the production plant comprises several workpiece carriers which serve to hold raw materials and / or tools and / or consumables. 17. Production plant according to sentence 16, characterized in that the workpiece carriers remain permanently within the cleanroom area, in particular over one or more complete production processes. 18. Production plant according to one of sentences 1 to 17, characterized in that the production plant comprises several types of workpiece carriers which differ from each other with regard to the shape and / or dimensioning of a receiving area of ​​the respective workpiece carrier. 19. Production plant according to one of sentences 16 to 18, characterized in that a type of workpiece carrier serves to receive a vessel for receiving a starting material. 20. Production plant according to one of sentences 16 to 19, characterized in that a type of workpiece carrier serves to receive one or more tool units and / or tool consumables for carrying out a treatment process on a feedstock and / or for carrying out a maintenance process within the cleanroom area. 21. Production plant according to one of sentences 16 to 20, characterized in that a type of workpiece carrier serves to receive consumables for feeding them to a reactant and / or for carrying out a treatment process on a reactant. 22. Production plant according to one of sentences 16 to 21, characterized in that one or more workpiece carriers each comprise one or more action units for carrying out an action on a raw material and / or on a tool. 23. Production plant according to one of sentences 16 to 22, characterized in that one or more action units are designed as treatment units for carrying out a treatment process on the starting material. 24. Production plant according to one of sentences 16 to 23, characterized in that one or more action units are designed as sensor units for determining a current value of a parameter of the respective workpiece carrier and / or an additive arranged thereon and / or a tool arranged thereon and / or consumables arranged thereon. 25. Production plant according to one of sentences 16 to 24, characterized in that one or more workpiece carriers comprise a storage device for storing energy and / or one or more consumables. 26. Production plant according to one of sentences 16 to 25, characterized in that the workpiece carriers are reusable multiple times, in particular that the storage device is electrically rechargeable and / or refillable with consumables. 27. Production plant according to one of sentences 1 to 26, characterized in that the production plant comprises a charging station arranged within the cleanroom area for charging the storage device and / or a refilling station arranged within the cleanroom area for refilling the storage device. 28. Production plant according to one of sentences 1 to 27, characterized in that the production plant comprises several workpiece carriers designed as receiving boxes for receiving raw materials or several receiving boxes for receiving one or more workpiece carriers together with raw materials arranged and / or received thereon. 29. Production plant according to sentence 28, characterized in that the receiving boxes can be stored in storage places of the storage device, in particular fully automatically by means of a storage transport device of the storage device. 30. Production plant according to sentence 28 or 29, characterized in that one or more of the receiving boxes surround a lockable interior space. 31. Production plant according to one of sentences 28 to 30, characterized in that the receiving boxes for introducing a starting material and / or for removing a product made from a starting material can be opened and / or closed automatically and / or by means of the handling device. 32. Production plant according to one of sentences 28 to 31, characterized in that one or more of the receiving boxes each comprise one or more integrated or detachably arranged or detachably arranged conditioning units, by means of which a temperature and / or a pressure and / or a humidity and / or a gas composition in the interior of the respective receiving box can be influenced, in particular controlled and / or regulated. 33. Production plant according to sentence 32, characterized in that one or more of the conditioning units are tool units of a tool system of the production plant, which can be arranged on the respective receiving box or removed from it as required, in particular fully automatically by means of a storage transport device of the storage device and / or by means of the handling device. 34. Production plant according to one of sentences 28 to 33, characterized in that the receiving boxes comprise one or more connection elements which can be connected to corresponding connection elements at one or more treatment stations, in particular to supply the respective receiving box with electrical energy and / or consumables, in particular liquids and / or gases and / or to establish a signal coupling of the respective receiving box with a control device, in particular a higher-level one. 35. Production plant according to one of sentences 1 to 34, characterized in that the storage device comprises storage locations provided with connecting elements, so that one or more treatment processes for the treatment of the starting materials can be carried out at storage locations of the storage device serving as treatment locations. 36. Production plant according to one of sentences 28 to 35, characterized in that the storage locations of the storage device and / or the receiving boxes comprise fixing elements by means of which the receiving boxes can be positioned and / or fixed at the storage locations. 37. Production plant according to one of sentences 28 to 36, characterized in that the receiving boxes each comprise one or more tool receptacles for receiving and securing one or more tools, in particular in the interior of the respective receiving box. 38. Production plant according to sentence 37, characterized in that the one or more tool holders each comprise one or more connection elements which can be connected to corresponding connection elements on the tool to be held, in particular to supply the respective tool with electrical energy and / or consumables, in particular liquids and / or gases and / or to establish a signal coupling of the respective tool with the holding box and / or a control device, in particular a higher-level one. 39. Production plant according to one of sentences 1 to 38, characterized in that the storage device comprises one or more storage racks and / or one or more storage areas, each of which has several storage places. 40. Production plant according to one of sentences 1 to 39, characterized in that by means of a storage transport device of the storage device raw materials and / or workpiece carriers and / or tools and / or consumables can be stored in the storage places and / or removed from them. 41. Production plant according to sentence 40, characterized in that one or more storage locations are accessible from several directions and / or by means of several storage transport units of the storage transport device. 42. Production plant according to sentence 40 or 41, characterized in that the storage places are accessible vertically from above or horizontally from the side by means of the storage transport device. 43. Production plant according to one of sentences 1 to 42, characterized in that several essentially horizontally oriented rows of storage places are arranged one above the other in a vertical direction. 44. Production plant according to one of sentences 1 to 43, characterized in that several of the storage locations, in particular all storage locations, are shelf locations of one or more storage racks. 45. Production plant according to one of sentences 1 to 44, characterized in that the storage device comprises several different types of storage places for receiving different types of workpiece carriers. 46. ​​Production plant according to sentence 45, characterized in that the different types of storage places differ from each other with regard to their shape and / or dimensions. 47. Production plant according to sentence 45 or 46, characterized in that the different types of storage places differ from each other with regard to their function and / or equipment. 48. Production plant according to one of sentences 45 to 47, characterized in that the different types of storage locations are arranged in a regular pattern distributed in a storage rack and / or a storage area of ​​the storage device. 49. Production plant according to one of sentences 1 to 48, characterized in that the storage device has several areas for receiving different types of workpiece carriers. 50. Production plant according to one of sentences 1 to 49, characterized in that the storage device comprises several storage locations which form treatment stations for the treatment of starting materials. 51. Production plant according to one of sentences 1 to 50, characterized in that the storage device comprises several storage locations which form tool stations for storing, maintaining, cleaning, changing, electrically charging and / or checking tools. 52. Production plant according to one of sentences 1 to 51, characterized in that the production plant includes an unpacking device for unpacking objects to be supplied to the cleanroom area. 53. Production plant according to sentence 52, characterized in that the unpacking device is integrated into the airlock device or forms a component thereof. 54. Production plant according to one of sentences 1 to 53, characterized in that the lock device comprises an entry lock station which is accessible from the surroundings of the production plant and at which, in particular, a packaged object can be placed by a person or automatically. 55. Production plant according to sentence 54, characterized in that the packaged object can be transported from the entry airlock station to an unpacking station by means of an airlock transport device of the production plant and can be automatically unpacked at the unpacking station, or that the packaged object can be automatically unpacked at the entry airlock station, and / or characterized in that the production plant has an autoclaving device which can be loaded and / or unloaded from one side by a user, in particular manually, and which can be automatically unloaded and / or loaded from another side within the cleanroom area, in particular after sterilization and drying by the autoclaving device, in particular by means of the handling device and / or the storage transport device, whereby less extensively packaged or partially packaged objects and / or unpacked objects can be aseptically introduced into and removed from the cleanroom area. 56. Production plant according to one of sentences 1 to 55, characterized in that the sluice device comprises a cleaning device for cleaning a packaging of the packaged object. 57. Production plant according to one of sentences 52 to 56, characterized in that the unpacking device comprises several unpacking units for unpacking different types of objects and / or packaging, in particular for removing different types of packaging from the objects. 58. Production plant according to sentence 57, characterized in that one or more unpacking units are designed for unpacking starting materials and one or more further unpacking units are designed for unpacking tools and / or consumables. 59. Production plant according to one of sentences 52 to 58, characterized in that the unpacking device comprises a detection device and a control device by means of which a type of object to be unpacked and / or a type of packaging to be removed can be determined. 60. Production plant according to sentence 59, characterized in that an unpacking unit of the unpacking device can be selected and controlled by means of the control device for carrying out the unpacking process, wherein the unpacking unit is one of several unpacking units for carrying out different unpacking processes, wherein the selected unpacking unit is assigned to the determined type of object to be unpacked and / or the type of packaging to be removed. 61. Production plant according to one of sentences 1 to 60, characterized in that the production plant comprises a tool system by means of which treatment processes on raw materials and / or maintenance processes can be carried out within the cleanroom area. 62. Production plant according to sentence 61, characterized in that the tooling system comprises several, in particular fully automatic, tooling units for carrying out different treatment and / or maintenance operations. 63. Production plant according to sentence 61 or 62, characterized in that the tooling system comprises one or more tool units designed as feed units for feeding consumables to the raw materials. 64. Production plant according to one of sentences 61 to 63, characterized in that the tooling system comprises one or more tool units designed as sampling units for taking a sample from a starting material. 65. Production plant according to one of sentences 61 to 64, characterized in that one or more of the tool units of the tool system each comprises one or more multi-use components and one or more single-use components. 66. Production plant according to one of sentences 61 to 65, characterized in that the tooling system comprises a setup unit by means of which one or more single-use components of a tooling unit can be removed fully automatically after use, in particular disposed of, and replaced by one or more new single-use components. 67. Production plant according to sentence 66, characterized in that the setup unit is arranged completely within the cleanroom area. 68. Production plant according to sentence 66 or 67, characterized in that the setup unit comprises a handling unit, in particular a multi-axis robot arm and / or a pick-and-place robot and / or a rope robot, by means of which a fully automatic setup process can be carried out. 69. Production plant according to one of sentences 66 to 68, characterized in that the setup unit includes a cleaning unit or that a cleaning unit is assigned to the setup unit, by means of which multi-use components of one or more tool units can be cleaned, in particular sterilized, after use. 70. Production plant according to one of sentences 61 to 69, characterized in that the tool system comprises several portable tool units which can be supplied to a treatment station for the treatment of a starting material, which in particular is also a storage station for storing the starting material, and can be temporarily stored there for the purpose of carrying out a treatment process. 71. Production plant according to sentence 70, characterized in that one or more portable tool units of the tool system can be supplied to the production plant to a tool storage location and / or to a treatment location and / or to a setup location by means of a storage transport device, in particular one or more storage transport units. 72. Production plant according to one of sentences 1 to 71, characterized in that one or more tool units are designed and equipped by means of the handling device for carrying out a treatment process and / or a maintenance process. 73. Production plant according to one of sentences 1 to 72, characterized in that one or more tool units are designed and equipped independently of the handling device, in particular automatically, for carrying out a treatment process and / or a maintenance process. 74. Production plant according to one of sentences 1 to 73, characterized in that the production plant comprises a tool system, in particular a fully automatic one, which includes one or more tool units for carrying out treatment processes on a starting material, wherein the tool system is arranged within the cleanroom area. 75. Production plant according to one of sentences 61 to 74, characterized in that the tool system comprises one or more tool units designed as a fluid conveying device, by means of which a fluid can be conveyed, in particular with respect to a volume flow rate. 76. Production plant according to one of sentences 61 to 75, characterized in that the tool system comprises one or more tool units designed as a micro-fluid conveying device, by means of which a fluid can be conveyed, in particular with respect to a volume flow rate, in particular for aliquoting. 77. Production plant according to one of sentences 61 to 76, characterized in that the tool system comprises one or more tool units designed as a device for dividing a fluid, by means of which the fluid can be conveyed, in particular with respect to a volume flow rate, and by means of which the fluid can be divided, in particular with respect to a volume flow rate, into at least two fluid parts. 78. Production plant according to one of sentences 61 to 77, characterized in that the tool system comprises one or more tool units designed as a fluid mixing device by means of which a fluid can be mixed. 79. Production plant according to one of sentences 61 to 78, characterized in that the tool system comprises one or more tool units designed as a mixing device, by means of which at least two components can be mixed together, wherein in particular one of the at least two components is a fluid. 80. Production plant according to one of sentences 61 to 79, characterized in that the tool system comprises one or more tool units designed as a measuring device, by means of which at least one property of a fluid and / or a reactant can be measured. 81. Production plant according to one of sentences 61 to 80, characterized in that the tool system comprises one or more tool units designed as a material separation device, by means of which an initial component can be separated into at least two components. 82. Production plant according to one of sentences 61 to 81, characterized in that the tool system comprises one or more tool units designed as a heating device, by means of which a fluid can be temperature controlled. 83. Production plant according to one of sentences 61 to 82, characterized in that the tool system comprises one or more tool units designed as a device for supplying and / or removing a gas, by means of which a gas can be supplied and / or removed. 84. Production plant according to one of sentences 61 to 83, characterized in that the tool system comprises one or more tool units designed as a manipulator, by means of which a cell membrane can be manipulated, in particular by means of an electric field. 85. Production plant according to one of sentences 61 to 84, characterized in that the tool system comprises one or more tool units designed as a radiation source and / or a light-emitting device, wherein the radiation source is configured to emit ionized radiation and the light-emitting device is configured to emit light with a predetermined wavelength. 86. Production plant according to one of sentences 61 to 85, characterized in that the tool system comprises one or more tool units designed as a cleaning device, by means of which a location where the treatment processes on the feedstock can be carried out by means of the one or more tool units can be cleaned and / or sterilized. 87. Production plant according to one of sentences 1 to 86, characterized in that the production plant comprises a tooling system and a supply device for supplying the tooling system with consumables. 88. Production plant according to sentence 87, characterized in that the supply device for storing consumables comprises or uses one or more storage locations of the storage device arranged within the cleanroom area. 89. Production plant according to sentence 87 or 88, characterized in that the airlock device forms a component of the supply device or interacts with it, wherein consumables can be introduced into the cleanroom area by means of the airlock device. 90. Production plant according to one of sentences 87 to 89, characterized in that the storage device forms part of the supply device or interacts with it. 91. Production plant according to one of sentences 87 to 90, characterized in that consumables supplied from the environment of the production plant can be supplied to one or more storage locations of the storage plant by means of a storage transport device of the storage plant, in particular by means of one or more storage transport units of the storage transport device of the storage plant. 92. Production plant according to one of sentences 61 to 91, characterized in that consumables can be supplied to the tool system, in particular 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, for example to supply consumables and / or tool consumables to one or more tool units of the tool system. 93. Production plant 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, consumed and / or contaminated consumables and / or tool consumables can be removed from the cleanroom area. 94. Production plant according to one of sentences 87 to 93, characterized in that the supply device comprises a refilling device arranged within the cleanroom area, by means of which consumables, in particular in liquid form, can be supplied to one or more storage devices of one or more workpiece carriers and / or one or more storage places. 95. Production plant according to one of sentences 1 to 94, characterized in that the production plant includes one or more sensor units for determining one or more values ​​of one or more parameters of a) one or more reactants; and / or b) one or more workpiece carriers; and / or c) one or more tools; and / or d) one or more receiving boxes, in particular receiving boxes designed as aseptic processing units, includes. 96. Production plant according to one of sentences 1 to 95, characterized in that the occupancy status of one or more storage locations of a storage device of the production plant can be determined, in particular monitored, by means of one or more sensor units. 97. Production plant according to one of sentences 1 to 96, characterized in that a local temperature and / or a local humidity and / or a local illuminance or irradiance can be determined, in particular monitored, by means of one or more sensor units at or in one or more storage locations of the storage device of the production plant. 98. Production plant according to one of sentences 1 to 97, characterized in that the production plant comprises one or more sensor units for determining the progress of the treatment during the treatment of a starting material or between two treatment processes. 99. Production plant according to one of sentences 1 to 98, characterized in that one or more sensor units for determining the treatment progress are microscopy devices for the visual detection of microscopic components of the starting material. 100. Production plant according to one of sentences 1 to 99, characterized in that one or more sensor units for determining the progress of the treatment are arranged at or in one or more storage places for receiving starting materials, in particular integrated therein. 101. Production plant according to one of sentences 1 to 100, characterized in that the production plant, in particular one or more tools for carrying out one or more treatment processes, is controllable and / or adjustable depending on the one or more determined values, wherein in particular one or more treatment parameters are varied depending on a determined treatment progress. 102. Production plant according to one of sentences 1 to 101, characterized in that the production plant comprises one or more sensor units for monitoring a quantity of consumables stored within the cleanroom area. 103. Method for the manufacture of a product, in particular a biological pharmaceutical product, using a production plant, in particular a production plant according to one of sentences 1 to 102, the procedure includes the following: - Selecting one of several production programs to manufacture one of several products that can be produced using the production plant; - Introducing a starting material into a sluice device of the production plant; - Automatic transport of the raw material to a cleanroom area of ​​the production plant; - Automatic execution of one or more treatment processes on the starting material. 104. Method according to sentence 103, characterized in that, during the automatic transport of the reactant into the cleanroom area of ​​the production plant, the reactant is stored in a storage location of a storage device of the production plant located within the cleanroom area. 105. Method according to sentence 104, characterized in that one or more treatment processes are carried out fully automatically until a product to be produced from the starting material is finished. 106. Method according to sentence 104 or 105, characterized in that one or more, in particular all, treatment processes are carried out at the storage location. 107. Method according to one of sentences 104 to 106, characterized in that the product produced in this way is removed from the storage area and automatically transported to the sluice device for removal from the production plant. 108. Method according to sentence 107, characterized in that the product is filled and / or packaged before being taken out, in particular filled and / or packaged ready for use. 109. A method according to one of sentences 104 to 108, characterized in that one or more vessels, fixtures and / or tools used for the manufacture of the product remain at least partially within the cleanroom area after the product has been completed, are cleaned and then reused for the manufacture of another product. 110. Method according to one of sentences 104 to 109, characterized in that consumables required for the manufacture of the product and / or for the manufacture of several different products, in particular consumables and / or tool consumables, are stored within the cleanroom area, in particular before a selection of the product to be manufactured is made. 111. Method according to sentence 110, characterized in that the consumables are automatically transported into the cleanroom area via the airlock device and are stored there, in particular, in one or more storage locations of the storage device. 112. Method according to sentence 110 or 111, characterized in that a quantity of the consumables stored within the cleanroom area is monitored and that, if a predetermined minimum quantity is undershot, the supply is replenished by adding the required consumables, in particular via a notification or a warning message on an operator unit. 113. Method according to one of sentences 104 to 112, characterized in that several products, in particular several different products, are manufactured simultaneously within the cleanroom area. 114. Method according to sentence 103, characterized in that each product to be manufactured is assigned a sequence of treatment processes which are carried out using tools arranged within the cleanroom area and which remain in the cleanroom area after the treatment processes have been carried out. 115. Method according to one of sentences 103 to 114, characterized in that one or more tools are cleaned, in particular sterilized, after the execution of one or more treatment processes within the cleanroom area. 116. Method according to one of sentences 103 to 115, characterized in that one or more tools are equipped with tool consumables before one or more treatment processes are carried out within the cleanroom area. 117. Method according to sentence 116, characterized in that one or more tool consumables are removed and / or disposed of from the one or more tools after the execution of one or more treatment processes within the cleanroom area. 118. Method according to one of sentences 103 to 117, characterized in that treatment time values ​​are assigned to several, in particular all, treatment processes, which indicate the period of time that elapses from a start of the respective treatment process until its end, in particular including - a time period for providing the at least one tool required for the respective treatment process, in particular including its fitting with one or more tool consumables; and / or - a time period for the supply and / or arrangement and / or commissioning of the at least one tool on the raw material to be processed, in particular at a storage location where the raw material is arranged; and / or - a duration of exposure to the starting material to achieve a desired treatment result; and / or - a time period for removing the at least one tool from the raw material, in particular from the storage location, - preferably including - a) cleaning of at least one tool; and / or - b) the removal and / or disposal of tool consumables; and / or - c) the return transport of the tool to a starting point, in particular a storage location assigned to the tool. 119. A method according to one of sentences 103 to 118, characterized in that the treatment processes required for the manufacture of a specific product and the associated treatment time values ​​are stored or taken into account in each production program. 120. Method according to one of sentences 103 to 119, characterized in that when a production program is started, a prediction of a production sequence is created and that the tools required and / or intended for carrying out the treatment processes are reserved in advance for time slots resulting from the prediction. 121. Method according to one of sentences 103 to 120, characterized in that one or more treatment processes each a) one or more cleaning processes for cleaning one or more tools and / or for cleaning one or more storage locations; and / or b) one or more disposal operations for the disposal of consumables; and / or c) one or more setup operations for loading one or more tools with consumables; and / or d) are assigned or are assigned one or more control procedures for monitoring a treatment outcome, where, depending on the prediction of the production process, time slots are reserved in advance at one or more of the devices required for carrying out one or more cleaning processes, one or more disposal processes, one or more setup processes and / or one or more inspection processes. 122. Method according to paragraph 120 or 121, characterized in that after one or more treatment processes, in particular after each treatment process, the prediction of the production sequence is checked and / or updated, in particular to confirm or correct the time slots for the tools and / or other devices still required to complete the product. 123. Method according to one of sentences 103 to 122, characterized in that, when a production program is to be started, it is determined on the basis of a prediction of the production process whether all the necessary tools and / or other devices for the completion of the product are available within the required time slots, and that the production program is only started if this determination has yielded a positive result.

[0498] Further preferred features and / or advantages of the present invention are the subject of the following description and the graphic representation of exemplary embodiments.

[0499] The drawings show: Fig. 1 a schematic perspective view of a production plant according to an exemplary embodiment of the present invention, Fig. 2. A schematic perspective view of part of the production plant, which is located in Fig. 1 is shown, Fig. 3 A schematic top view of a part of the production plant, which is located in Fig. 1 is shown, Fig. 4 A schematic top view of a part of the production plant, which is located in Fig. 1 is shown, Fig. 5 a schematic top view of the production plant, which is located in Fig. 1 is shown, Fig. 6 a schematic top view of the production plant, which is located in Fig. 1 is shown, Fig. 7 a schematic top view of the production plant, which is located in Fig. 1 is shown, Fig. 8 A schematic top view of a part of the production plant located in Fig. 1 is shown, Fig. 9 a schematic perspective view of part of the production plant, which is located in Fig. 1 is shown, Fig. 10 A schematic top view of a part of the production plant, which is located in Fig. 1 is shown, Fig. 11 A schematic top view of a part of the production plant, which is located in Fig. 1 is shown, Fig. 12 a schematic perspective view of a production plant according to a further exemplary embodiment of the present invention, Fig. 13 A schematic perspective view of part of the production plant, which is located in Fig. 12 is shown, Fig. 14 A schematic top view of a part of the production plant, which is located in Fig. 12 is shown, Fig. 15 a schematic top view of a part of the production plant, which is located in Fig. 12 is shown, Fig. 16 a schematic top view of the production plant, which is located in Fig. 12 is shown, Fig. 17 a schematic top view of the production plant, which is located in Fig. 12 is shown, Fig. 18 a schematic top view of the production plant, which is located in Fig. 12 is shown, Fig. 19 a schematic top view of a part of the production plant, which is located in Fig. 12 is shown, Fig. 20 a schematic perspective view of part of the production plant, which is located in Fig. 12 is shown, Fig. 21 a schematic top view of a part of the production plant, which is located in Fig. 12 is shown, Fig. 22 a schematic top view of a part of the production plant, which is located in Fig. 12 is shown, Fig. 23 a schematic perspective view of a production plant according to a further exemplary embodiment of the present invention, Fig. 24 a schematic perspective view of a production plant according to a further exemplary embodiment of the present invention, and Fig. 25 a method according to an exemplary embodiment of the present invention.

[0500] Identical or functionally equivalent elements are provided with the same reference symbols in all figures.

[0501] In Fig. Figure 1 shows a schematic perspective view of a production plant 10 according to an exemplary embodiment of the present invention.

[0502] Referring to Fig. 1 includes a production facility 10 in particular for the manufacture of biological-pharmaceutical products 20: - a cleanroom area of ​​100; - a lock device 200 for feeding an object from an environment of the production plant 10 into the cleanroom area 100 and / or for removing an object from the cleanroom area 100; - a handling device 300 for moving the object within the cleanroom area 100; and - a storage device 400 arranged within the cleanroom area, which includes several storage places 402 for holding several objects.

[0503] The biopharmaceutical product 20 may be intended for personalized therapy and may therefore be a personalized therapeutic agent, for example a personalized cell therapeutic agent, such as an autologous and / or an allogeneic cell therapeutic agent, or a gene therapeutic agent, such as an autologous and / or an allogeneic gene therapeutic agent.

[0504] Production plant 10 has an enclosure, not shown in the figures, to separate the cleanroom area 100 from the surroundings of production plant 10.

[0505] In a sense, the enclosure surrounds the entire production plant 10.

[0506] Therefore, the airlock device 200 is configured to feed an object from the environment of the production plant 10 via or through the enclosure into the cleanroom area 100 and / or to remove an object from the cleanroom area 100 via or through the enclosure.

[0507] The cleanroom area 100 can be pressurized, or is pressurized, by means of a system for adjusting the environmental properties of the cleanroom area 100 of the production plant 10 (not shown in the figures) in order to ensure predetermined cleanroom properties of the cleanroom area 100, in particular to prevent the ingress of contaminants.

[0508] Furthermore, air is supplied to and extracted from the cleanroom area 100 by means of the system for adjusting the environmental properties of the cleanroom area 100.

[0509] As in Fig. As can be seen from Figure 1, the storage device 400 comprises several, here by way of example three, storage racks 404, each of which has several storage places 402.

[0510] In a sense, the storage locations 402 are shelf locations of one or more, for example the three, storage racks 404.

[0511] The storage device 400 further comprises a storage transport device 406 for transporting objects to and / or from the storage locations 402, in particular the storage racks 404, to and / or from the storage locations 402, in particular the storage racks 404.

[0512] In particular, by means of the storage transport device 406 of the storage device 400, raw materials and / or workpiece carriers and / or tools or tool units and / or consumables can be stored in the storage places 402 of the storage racks 404 and / or removed from them.

[0513] The storage transport device 406 is a device different from the handling device 300.

[0514] The storage transport device 406 is a rail-guided transport system and comprises one or more, here by way of example two, rail-guided storage transport units 408, by means of which the storage racks 404 of the storage device 400 are accessible in particular for storage and retrieval operations as well as for treatment operations and / or maintenance operations.

[0515] The storage racks 404 are arranged essentially parallel to each other and at a distance from each other in the cleanroom area 100.

[0516] The storage transport device 406 is arranged at the respective intervals of the storage racks 404, with a storage transport unit 408 being assigned to a respective distance between the storage racks 404.

[0517] In a sense, there is a storage rack-storage transport unit-storage rack-storage transport unit-storage rack arrangement.

[0518] This arrangement makes it possible for at least the storage locations 402 of the central storage rack 404 to be accessible from several directions and / or by means of both storage transport units 408 of the storage transport device 406.

[0519] Other arrangements of the storage racks 404 in combination with the storage transport units 408 are also conceivable in this case.

[0520] The parallel arrangement described above can, for example, be expanded as needed or implemented in its alternating manner.

[0521] Furthermore, a star-shaped arrangement of the storage racks 404 is also conceivable, for example.

[0522] The storage locations 402 of the storage racks 404 are accessible laterally in a horizontal direction by means of the storage transport device 406.

[0523] Several essentially horizontally oriented rows of storage locations 402 are arranged vertically one above the other in the storage racks 404.

[0524] In a sense, the storage locations 402 in the storage racks 404 are arranged in a matrix-like manner; for example in Fig. Figure 1 shows matrix-shaped arrangements of 4x13 (outer storage racks 404) and 4x10 (central storage rack 404).

[0525] As already described, the storage locations 402 are configured to accommodate various types of objects, and the storage locations 402 may differ from each other in terms of their shape and / or dimensions.

[0526] For a simplified representation, the storage locations are 402 in Fig. 1 merely shown by way of example in a uniform manner, in particular in a uniform form and dimensions.

[0527] The storage locations 402 may also differ from each other in terms of their function and / or their equipment.

[0528] The different types of storage locations can be arranged in a regular pattern distributed within a storage rack and / or storage area of ​​the storage device.

[0529] The production plant 10 also includes a cleaning device 500, by means of which one or more workpiece carriers 30 and / or one or more tools or tool units 702 and / or one or more consumables 704 can be cleaned and / or sterilized.

[0530] The cleaning device 500 is designed as a separate device in the cleanroom area and as a component of a tool system, in particular a tool or tool unit 702.

[0531] By means of the cleaning device 500, objects that come into direct contact with reactants, in particular tools 702 and / or consumables 704, can be cleaned and / or sterilized, in particular by means of irradiation.

[0532] Using the cleaning device 500, objects that do not come into direct contact with reactants can be cleaned and / or disinfected or sterilized, especially by means of fumigation.

[0533] The production plant 10 also includes an unpacking device 212 for unpacking objects to be supplied to the cleanroom area 100 and a packaging device 214 for packaging objects to be removed from the cleanroom area 100, for example for packaging the manufactured product 20.

[0534] The unpacking device 212 and the packaging device 214 are integrated or attached to the airlock device 200, in particular in this case arranged laterally.

[0535] As in Fig. 1 and Fig. As shown in Figure 2, the airlock device 200 has an entrance airlock 202, through which an airlock station 206, in particular an entrance airlock station 206, is accessible from the surroundings and which is configured for feeding an object from an environment of the production plant 10 into the cleanroom area 100.

[0536] As in Fig. 1 and Fig. As further shown in Figure 2, the airlock device 200 has an exit airlock 204, through which an airlock station 208, in particular an exit airlock station 208, is accessible from the surroundings and which is configured for removing an object from the cleanroom area 100.

[0537] The entrance lock 202 and the exit lock 204 also include means for the spatial isolation of the lock bays 206, 208 (not shown in the figures) assigned to the entrance lock 202 and the exit lock 204 respectively.

[0538] Isolation can optionally be carried out towards the surroundings of the production plant 10 and / or towards a respective part of the lock device 200 different from the lock positions 206, 208, each by means of the respective means for isolating the entrance lock 202 and the exit lock 204.

[0539] Furthermore, the production facility 10 has several maintenance locks 210, through which the cleanroom area 100 is accessible from an environment of the production facility 10, for example for users, in particular for maintenance work within the cleanroom area 100.

[0540] The production plant 10 has one or more control units which are set up within the cleanroom area 100 in a control system 600 arranged in control cabinets and which are designed and programmed to regulate and / or control at least one component or part of the production plant which is assigned to the one or more control units.

[0541] It is conceivable that one or more control units could form a higher-level control device.

[0542] The one or more control units are designed and programmed to communicate with one or more communication interfaces (not shown in the figures) and / or one or more human-machine interfaces, or HMI interfaces, 602 of production plant 10 (an HMI interface 602 is shown as an example in the figures).

[0543] The communication interfaces not shown in the figures can, for example, serve to ensure data exchange with a higher-level control system and / or data management system, such as an associated cloud system, in order to enable, for example, data evaluation and / or data optimization via artificial intelligence and / or deep learning.

[0544] The one or more control units are furthermore designed and programmed to provide information to a user via the communication interfaces and / or via the HMI interfaces 602, for example fault information and / or information about the status of the manufacture of a product 20 and / or information about the stock levels of the storage device 400.

[0545] Furthermore, the production of the biological-pharmaceutical product 20 is possible using the production plant 10 by means of one or more control units.

[0546] The production of said product can be carried out according to one or more production programs by means of one or more control units.

[0547] Each product 20 to be manufactured is assigned a sequence of treatment processes which can be carried out by means of tool units 702 arranged within the cleanroom area 100 and which remain in the cleanroom area after the treatment processes have been carried out.

[0548] Each production program contains or takes into account the 20 treatment processes required for the manufacture of a specific product, as well as the associated treatment time values.

[0549] The production plant 10 further comprises one or more sensor units for determining one or more values ​​of one or more parameters of one or more reactants 40, and / or one or more workpiece carriers 30, and / or one or more tools or tool units 702 and / or one or more consumables 704.

[0550] The sensor units can be connected to, or are connected to, the control units.

[0551] The sensor units are used in particular to determine treatment progress during the treatment of a starting material or between two treatment processes.

[0552] The sensor units serve in particular to control and / or regulate one or more tool units 702 for carrying out one or more treatment processes depending on the one or more determined values, whereby in particular one or more treatment parameters are varied or can be changed depending on a determined treatment progress.

[0553] The sensor units serve in particular to monitor the storage device 400, for example storage conditions and / or storage quantities at the storage locations 402.

[0554] The production plant 10 is furthermore connected to at least one electrical power source (not shown in the figures) located in the vicinity of the production plant for power supply.

[0555] In Fig. Figure 2 is an enlarged view, in particular of the lock device 200. Fig. 1 to be shown.

[0556] Referring to Fig. 2 and Fig. 3 The handling device 300 comprises a multi-axis robot arm 302, which is arranged adjacent to the lock device 200, and a lock transport device 304, by means of which one or more objects can be transported from a lock location, in particular an entrance lock location 206, to another lock location, in particular a transfer lock location 216, and / or from a lock location, in particular a transfer lock location, to another lock location, in particular an exit lock location 208.

[0557] 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 in the figures), wherein the first multi-axis robot arm is assigned to an input material flow into the production plant and the second multi-axis robot arm to an output material flow out of the production plant. In a sense, it is also conceivable that the handling device 300 can be divided into a first handling device and a second handling device, each of which can be assigned to an input material flow into the production plant and an output material flow out of the production plant, respectively.

[0558] In the entrance lock 202, a workpiece carrier 30 of the production plant 10 and an educt 40, which is received in an educt container 42, are arranged on the entrance lock station 206, wherein the educt container 42 is arranged on the workpiece carrier 30.

[0559] The workpiece carrier 30 is arranged on the lock transport device 304.

[0560] The reactant 40 comprises cells and a culture medium, wherein the cells and the culture medium form a cell suspension.

[0561] The cell suspension has a volume between 1 µl and 1000 ml.

[0562] Production plant 10 has, in addition to the aforementioned workpiece carrier 30, one or more further workpiece carriers 30, which can be stored or are stored, for example, in storage locations 402.

[0563] The workpiece carriers 30 serve to hold raw materials and / or tools or tool units and / or consumables.

[0564] The workpiece carrier 30 has a means for fixing, in particular a means for a form-fit and / or force-fit and / or magnetic fixing, for receiving raw materials and / or tools and / or consumables, which is not shown in the figures.

[0565] The means of fixing can in particular include at least one adapter device and / or at least one mold cavity device, especially to create a secure receiving connection between a workpiece carrier and a feed container.

[0566] The means of fixation can be individually designed to correspond to the objects to be mounted, such as the reactant container.

[0567] The in Fig. 1 and Fig. The workpiece carrier 30 shown in the present case has received a reactant 40 arranged in a reactant container 42.

[0568] The production plant 10 includes several types of workpiece carriers 30, which differ from each other in terms of the shape and / or dimensioning of a receiving area of ​​the respective workpiece carrier 30.

[0569] As in Fig. 1 and Fig. As shown in Figure 2, a type of workpiece carrier 30 serves to hold a reactant container 42.

[0570] Another type of workpiece carrier 30 serves to hold one or more tool units 702 and / or tool consumables 704 for carrying out a treatment process on one or the feedstock 40 and / or for carrying out a maintenance process within the cleanroom area 100.

[0571] Another type of workpiece carrier 30 serves to hold consumables 704 for feeding them to a or the reactant 40 and / or for carrying out a treatment process on a or the reactant 40.

[0572] One or more workpiece carriers 30 each comprise one or more action units (not shown in the figures) for performing an action on a workpiece 40 and / or on a tool 702, wherein one or more action units are configured as a treatment unit, for example as a tool unit 702, for performing a treatment process on the workpiece 40, and / or one or more action units are configured as a sensor unit for determining the current value of a parameter of the respective workpiece carrier 30 and / or a workpiece 40 arranged thereon and / or a tool 702 arranged thereon and / or consumables 704 arranged thereon. This allows functions of the particularly independent tool system (see description below) to be integrated into a functional unit, here the workpiece carrier 30.

[0573] One or more workpiece carriers 30 comprise a storage device (not shown in the figures) for storing energy and / or one or more consumables 704, wherein the workpiece carriers 30 are reusable multiple times, in particular the storage device is electrically rechargeable and / or refillable with consumables 704.

[0574] The workpiece carrier 30 has one or more coupling devices (not shown in the figures) by means of which several, in particular two or more, workpiece carriers 30 can be connected to each other.

[0575] The in Fig. 1 and Fig. The workpiece carrier 30 shown on the sluice transport device 304 was brought to the entrance sluice station 206 to receive the feed container 42 in a process not shown in the figures.

[0576] In this process, a user first selected a production program for production plant 10, for example via the HMI interface 602, in order to produce the desired product 20 from the feedstock 40.

[0577] The user then places the feed container 42, containing a feed 40, onto a workpiece carrier 30 provided at the entry airlock station 206, which was already positioned at the entry airlock station 206 to receive an object. Alternatively, it is also conceivable that a workpiece carrier 30 stored at a storage location 402 of one of the storage racks 404 was removed from storage location 402 by means of the storage transport unit 408 of the storage transport device 406 and transported to the airlock device 200, so that the workpiece carrier 30 can be fed to the entry airlock station 206 by means of the multi-axis robot arm 302 and the airlock transport device 304.

[0578] As soon as the workpiece carrier 30 is ready at the entry airlock station 206 to receive the feed 40, the feed container 42 with a feed 40 arranged therein is manually transferred by the user to the workpiece carrier 30 and fixed to it by means of the fixing means.

[0579] The reactant container 42 typically also includes packaging to maintain an aseptic condition of the reactant 30.

[0580] The entrance lock 202 can now be moved to a closed state or will now be closed.

[0581] A cleaning and sterilization process is now carried out on the packaged starting material container 42 at the entry airlock station 206 by means of gassing and / or irradiation using a gassing source and / or irradiation source appropriately set up at the entry airlock station 206 (not shown in the figures).

[0582] The packaged product container 42 is then moved on the workpiece carrier 30 by means of the airlock transport device 304 into a reach of the multi-axis robot arm 302.

[0583] The multi-axis robot arm 302 separates the packaged input container 42 from the workpiece carrier 30 and transfers the input container 42 to the unpacking device 212, in which the packaging of the input container 42 can be removed / is removed by means of one or more unpacking units of the unpacking device 212.

[0584] It is also conceivable that the in Fig. 2 and Fig. 3 shown entrance airlock station 208 serves as an unpacking station 206 and is accessible by means of one or more unpacking units of the unpacking device 212.

[0585] Furthermore, it is also conceivable that the packaging of the feed container 42 can be removed by the multi-axis robot arm 302 using one or more unpacking units.

[0586] After the packaged feed container 42 has been transferred to the unpacking device 212, the workpiece carrier 30 is moved back to the entry airlock station 206 for the next pickup of an object by means of the airlock transport device 304, as shown in particular in Fig. 4 is shown.

[0587] After unpacking by means of the unpacking device 212, the unpacked starting material container 42 is transferred to another, in particular sterile, workpiece carrier 30, which is provided at the transfer airlock station or stations 216 on the airlock transport device 304 (compare Fig. 4), transferred by means of the multi-axis robot arm 302.

[0588] The other workpiece carrier 30 was previously retrieved from a storage location 402 of the storage racks 404 and was provided accordingly by means of the storage transport unit 408, the multi-axis robot arm 302 and the airlock transport device 304, as shown in Fig. 4 is shown.

[0589] The sluice transport device 304 and / or the multi-axis robot arm 302 moves the workpiece carrier 30 together with the feed container 42 arranged on it into a receiving box 50 (which is located in the Fig. 3, Fig. 4 to Fig. 5 shown left receiving box 50), which was provided for this purpose by means of the storage transport unit 408 at the lock transport device 304 (compare Fig. 3, Fig. 4 to Fig. 5).

[0590] Furthermore, another recording box 50 is available for recording an object (which is located in the Fig. 3, Fig. 4 to Fig. 5 shown right recording box 50).

[0591] The production plant 10 comprises several receiving boxes 50 for receiving one or more workpiece carriers 30 each, including the reactants 40 arranged on them and / or received in a reactant container 42.

[0592] It is also conceivable that, additionally or alternatively, a previously described tool carrier 30 is designed as a receiving box 50.

[0593] As in Fig. As shown in Figure 1, the receiving boxes 50 can be stored in storage locations 402 of the storage device 400, in particular fully automatically by means of the storage transport units 408.

[0594] One or more of the receiving boxes 50 surround a lockable interior space that can define an aseptic process environment.

[0595] In a sense, a recording box 50 defines a process unit, in particular an aseptic process unit.

[0596] The receiving boxes 50 are automatically and / or can be opened and / or closed by means of the handling device 300 for the introduction of a starting material 40 and / or for the removal of a product 20 made from a starting material 40.

[0597] The receiving boxes 50 each comprise one or more integrated or detachably arranged or detachably arranged conditioning units (not shown in the figures), by means of which a temperature and / or a pressure and / or a humidity and / or a gas composition in the interior of the respective receiving box 50 can be influenced, in particular controlled and / or regulated.

[0598] One or more of the conditioning units are tool units 702 of a tool system of the production plant 10, which can be arranged on or removed from the respective receiving box 50 as required, in particular fully automatically by means of the storage transport device 406, in particular the storage transport units 408 of the storage transport device 406, and / or by means of the handling device 300, in particular the multi-axis robot arm 302 of the handling device 300.

[0599] The receiving boxes 50 comprise one or more connection elements which can be connected to corresponding connection elements at one or more storage locations 402, in particular to supply the respective receiving box 50 with electrical energy and / or consumables 704, in particular liquids and / or gases, and / or to establish a signal coupling of the respective receiving box 50 with a control device of the production plant 10, in particular a higher-level control device, for example one or more control units which serve as a higher-level control device.

[0600] The storage locations 402 are equipped with connection elements so that one or more treatment processes for the treatment of the reactants 40 can be carried out at storage locations 402 of the storage device 400 which serve as treatment locations.

[0601] The storage locations 402 of the storage device 400 and / or the receiving boxes 50 include fixing elements by means of which the receiving boxes 50 can be positioned and / or fixed at the storage locations 402.

[0602] The receiving boxes 50 each comprise one or more tool receptacles for receiving and securing one or more tools or tool units 702, particularly in the interior of the respective receiving box 50.

[0603] The one or more tool holders can each comprise one or more connection elements which can be connected to corresponding connection elements on the respective tool 702 to be held, in particular to supply the respective tool 702 with electrical energy and / or consumables, in particular liquids and / or gases and / or to establish a signal coupling of the respective tool 702 with the holding box 50 and / or the higher-level control device.

[0604] It is also conceivable that the recording boxes 50 include one or more connection elements which can be connected to corresponding connection elements on another recording box 50, thus making a composite recording box 50 available.

[0605] Referring to Fig. 4 and Fig. 5 The workpiece carrier 30 together with the reactant container 42 arranged on it was moved into the (left) receiving box 50 by means of the sluice transport device 304 and / or the multi-axis robot arm 302.

[0606] The recording box 50 is now accessible via the in Fig. 5 shown left storage transport unit 408 in the in Fig. The 5 items shown can be stored in the left or middle storage rack 404.

[0607] By means of the aforementioned left-hand storage transport unit 408, the receiving box 50 is transported to the aforementioned central storage rack 404 and stored there. Depending on the production program selected by the user for the production plant 10, by means of which the production plant 10 is able to produce the desired product 20 from the raw material 40, one or more objects stored at the storage locations 402 of the storage device 400, in particular tools or tool units 702 and / or consumables, can be transported by means of the storage transport units 408 to the receiving box 50 containing the raw material container 42 in the central storage rack 404 in a defined sequence specified by the selected production program, at defined times also specified by the selected production program.

[0608] As exemplified in Fig. As shown in Figure 6 by means of the arrows, for example a tool unit 702 is taken from the left storage rack 404 to carry out one or more treatment operations, is supplied to the feed container 42 by means of the storage transport unit 408 and the receiving box 50, in order to carry out the one or more treatment operations on the feed 40 in the feed container 42 by means of the tool unit 702.

[0609] The arrows shown can represent a toolpath 706 of the tool unit 702 within the cleanroom area 100.

[0610] The removed tool unit 702 is arranged on a workpiece carrier 30 and / or in a receiving box 50.

[0611] The tool unit 702 is part of a tool system of the production plant 10, by means of which treatment processes on raw materials and / or maintenance processes can be carried out within the cleanroom area 100.

[0612] The tooling system includes several, in particular fully automatic, tool units 702 for carrying out different treatment and / or maintenance operations.

[0613] The tool system comprises one or more tool units 702 designed as feeding units for feeding consumables 704 to the reactants 40 or the reactant 40.

[0614] The tool system comprises one or more tool units 702 designed as sampling units for taking a sample from one or the reactant 40.

[0615] One or more of the tool units 702 of the tool system each comprise one or more multi-use components and / or one or more single-use components.

[0616] After one or more treatment processes have been carried out on the feedstock 40, the previously delivered and now used tool unit 702 is removed from the receiving box 50, which contains the feedstock 40, by means of the storage transport unit 408, in particular removed from or out of the receiving box 50 and transported away.

[0617] This is done in a recording box 50.

[0618] As in Fig. As shown by the arrows in Figure 7, the storage transport unit 408 transports the used tool unit 702 in this receiving box 50 to the handling device 300, in order to be removed from the receiving box 50 by means of the handling device 300 (compare Figure 7). Fig. 8).

[0619] The arrows shown can represent a toolpath 706 of the tool unit 702 used within the cleanroom area 100. The toolpath can be understood as a material flow, whereby in the present production plant a directed material flow, in particular one directed from clean to dirty, is generally preferred.

[0620] By means of the handling device 300, in particular the multi-axis robot arm 302 of the handling device 300, the tool unit 702 used is separated from single-use components used in the one or more treatment processes and set up on the tool unit 702, such as hoses, cannulas and / or other disposable elements, wherein the removed single-use components can be removed from the cleanroom area 100 via the airlock device 200 or are removed.

[0621] As in Fig. As shown schematically in Figure 8, this is done in particular via a waste chute 218 of the chute device 200 by means of the multi-axis robot arm 302. It is conceivable that the waste chute 218 is configured as a device separate from the handling device 300 in such a way that a cleanroom separation is established between them in order to ensure a directed material flow from clean to dirty.

[0622] Referring to Fig. 9 The used tool unit 702 is moved back into the receiving box 50 and then fed to the cleaning device 500 of the production plant 10 together with the receiving box 50, in particular by means of the storage transport unit 408 and / or the handling device 300, by means of which the used tool unit 702 and its receiving box 50 can be cleaned and sterilized or are cleaned and sterilized.

[0623] As in Fig. As shown schematically in Figure 10, the tool unit 702, which has been cleaned and sterilized by means of the cleaning device 500, is fed back to the handling device 300.

[0624] Furthermore, a consumable 704, in particular one or more new sterile single-use components, is transferred from the storage racks 404 to the handling device 300 by means of the storage transport unit 408 onto a workpiece carrier 30 and / or into a further receiving box 50 (which is in Fig. 10 shown right recording box 50) supplied.

[0625] By means of the handling device 300, in particular the multi-axis robot arm 302, the tool unit 702 is equipped with the new consumable material 704, i.e. the new single-use components, in order to be able to be used again for one or more treatment processes.

[0626] The tool unit 702, thus refurbished, can be stored again at a storage location 402 on a tool carrier 30 and / or in the also refurbished receiving box 50, in particular until it is used again, by means of the storage transport units 408.

[0627] Such an exemplary process described above can be repeated until all treatment processes provided for and required by a production program have been carried out on the starting material 40 and the product 20 to be manufactured has been generated from the starting material 40.

[0628] The reactant container 42 can now be called the product container 22, in which the product 20 produced from the reactant 40 is now located.

[0629] The receiving box 50, in which the product container 22 is located, is transported to the handling device 300 by means of the storage transport units 408.

[0630] There, the product container 22 is removed from the receiving box 50 by means of the handling device 300 and placed on the workpiece carrier 30, which receives the product container 22 and transports it to the packaging device 214.

[0631] The product container 22 can be fed to the packaging device for sterile packaging by means of the multi-axis robot arm 302.

[0632] The multi-axis robot arm 302 separates the product container 22 from the workpiece carrier 30 and transfers the product container 22 to the packaging device 214, in which the product container 22 and thus the product 20 can be packaged with sterile packaging and is packaged or surrounded by means of one or more packaging units of the packaging device 214.

[0633] It is also conceivable that the in Fig. The exit airlock station 208 shown in Figure 11 serves as a packaging station and is accessible by means of one or more packaging units of the packaging device 214. Furthermore, it is also conceivable that the product container 42 can be sterilely packaged by the multi-axis robot arm 302 using one or more packaging units.

[0634] After packaging using the packaging device 214, the packaged product container 22 is transferred back to the workpiece carrier 30 by means of the multi-axis robot arm 302 (compare Fig. 11) and fed to the exit lock station 208 by means of the lock transport device 304, where the packaged product container 22 with the product 20 can be removed by the user.

[0635] The workpiece carrier 30, on which the product container 22 was arranged, and the receiving box 50, in which the product container 22 was arranged, are fed to the cleaning device 500 of the production plant 10 as described above and are then cleaned and sterilized in order to be stored again at their respective storage locations 402 for the next use.

[0636] In Fig. Figure 12 shows a schematic perspective view of a production plant 10 according to a further exemplary embodiment of the present invention.

[0637] The in Fig. The production plant 10 shown in Figure 12, according to a further exemplary embodiment of the present invention, has essentially the same structural and functional features as the one shown in Figure 12. Fig. Figure 1 shows an exemplary embodiment of the production plant 10 according to the invention, so that only the structural and functional differences in features are shown below.

[0638] The in Fig. 12. The schematically represented storage transport device 406 comprises one or more free-moving transport vehicles 410 in the cleanroom area.

[0639] In other words, it may be provided that the 100 free-moving transport vehicles in the cleanroom area are 410 transport vehicles that can be controlled and driven freely in the cleanroom area 100 as needed, so that, with appropriate control by means of at least one of the control units, they are driven freely as required.

[0640] The storage racks 404 of the storage device 400 are accessible by means of the transport vehicles 410, in particular for storage and retrieval operations as well as for treatment operations and / or maintenance operations.

[0641] The storage racks 404, in particular the storage locations 402 of the storage racks 404, are accessible via one or more storage rack airlocks 412 for storage and retrieval operations as well as for treatment operations and / or maintenance operations by the transport vehicles 410 (compare Fig. 20).

[0642] It is conceivable that the storage locations 402 of the storage racks 404 are arranged on different storage areas in the storage racks 404, which are arranged, for example, one above the other, and that each storage area of ​​a storage rack 404 is accessible to the transport vehicles 410 via a common moving unit in the respective storage rack 404.

[0643] Furthermore, the use of the free-moving transport vehicle 410 allows for any arrangement of the storage racks 404.

[0644] The in Fig. The essentially parallel arrangement of the storage racks 404 shown in Figure 12 and in the figures relating thereto is shown purely as an example for illustrative purposes.

[0645] Referring to Fig. 13 is a workpiece carrier 30, on which an educt 40 arranged in an educt container 42 is held, on a free-moving transport vehicle 410 at the entrance lock station 206.

[0646] The in Fig. 13 and Fig. The workpiece carrier 30 shown in Figure 14, arranged on the transport vehicle 410, was brought to the entrance lock station 206 for receiving the feed container 42 in a process not shown in the figures by means of the transport vehicle 410.

[0647] In this process, a user first selected a production program for production plant 10, for example via the HMI interface 602, in order to produce the desired product 20 from the feedstock 40.

[0648] The user then places the reactant container 42 with an reactant 40 arranged therein onto a workpiece carrier 30 provided at the entrance lock station 206, which was already provided at the entrance lock station 206 on the transport vehicle 410 to receive an object.

[0649] Alternatively, it is also conceivable that a workpiece carrier 30 stored at storage location 402 in one of the storage racks 404 was removed from storage location 402 by means of the transport vehicle 410 of the storage transport device 406 and transported to the airlock device 200. As soon as the workpiece carrier 30 is ready at the entrance airlock station 206 to receive the feed 40, the feed container 42 with a feed 40 arranged therein is manually transferred by the user to the workpiece carrier 30 arranged on the transport vehicle 410 and fixed to it by means of the fixing device.

[0650] As in Fig. As shown schematically in Figure 15, the packaged product container 42 is then moved on the workpiece carrier 30 by means of the transport vehicle 410 into a reach of the multi-axis robot arm 302.

[0651] The multi-axis robot arm 302 separates the packaged input container 42 from the workpiece carrier 30 and transfers the input container 42 to the unpacking device 212, in which the packaging of the input container 42 can be removed / is removed by means of one or more unpacking units of the unpacking device 212.

[0652] After the packaged feed container 42 has been transferred to the unpacking device 212, the workpiece carrier 30 is moved back to the entry airlock station 206 for the re-collection of an object by means of the transport vehicle 410, so that essentially a state as in Fig. 14 can be shown.

[0653] After unpacking by means of the unpacking device 212, the unpacked starting material container 42 is transferred to another, in particular sterile, workpiece carrier 30, which is arranged in a receiving box 50 and which is provided at the transfer station 216 in the receiving box 50 on another sterile transport vehicle 410 (compare Fig. 15), transferred by means of the multi-axis robot arm 302.

[0654] The other workpiece carrier 30 was previously removed together with the receiving box 50 from a storage location 402 of the storage racks 404 and was transported to the transfer sluice station 216 by means of the other transport vehicle 410.

[0655] Referring to Fig. 15 and Fig. 16 The receiving box 50 together with the workpiece carrier 30 arranged therein with the product container 42 arranged on it can be moved and stored at a storage location 402 in a storage rack 404 or moved and stored by means of the transport vehicle 410.

[0656] As exemplified in Fig. As shown in Figure 17 by means of the arrows (tool path 706), for example, a tool unit 702 is taken from the left storage rack 404 to carry out one or more treatment operations, is supplied to the receiving box 50 stored in the middle storage rack 404 by means of a transport vehicle 410 and the receiving box 50 with the reactant container 42, in order to carry out the one or more treatment operations on the reactant 40 in the reactant container 42 by means of the tool unit 702.

[0657] After one or more treatment processes have been carried out on the starting material 40, the previously delivered and now used tool unit 702 is removed from the receiving box 50, which contains the starting material 40, by means of the transport vehicle 410, in particular removed from or out of the receiving box 50 and transported away.

[0658] As in Fig. As shown by the arrows in Figure 18, the transport vehicle 410 transports the used tool unit 702 in its receiving box 50 to the handling device 300, in order to be removed from the receiving box 50 by means of the handling device 300 in order to remove the single-use components installed on the tool unit 702 (see Figure 18). Fig. 19).

[0659] Referring to Fig. 19 and Fig. 20 The used tool unit 702 is moved back into the receiving box 50 by means of the handling device 300 and subsequently supplied to the cleaning device 500 of the production plant 10 together with the receiving box 50 by means of the transport vehicle 410, by means of which the used tool unit 702 and its receiving box 50 can be cleaned and sterilized or are cleaned and sterilized.

[0660] As in Fig. As shown schematically in Figure 21, the tool unit 702, cleaned and sterilized by means of the cleaning device 500, is returned to the handling device 300 by means of the transport vehicle 410 in order to be re-equipped with consumables 704, in particular one or more new sterile single-use components from the storage racks 404, by means of the handling device 300, which was provided to the handling device 300 by means of another transport vehicle 410, for example during the cleaning of the used tool unit 702.

[0661] In parallel or serially, the manufactured product 20, which is arranged in a product container 22, is removed from the storage rack 404 by means of another transport vehicle 410 and transported to the transfer sluice station 216 in order to be packaged by means of the packaging device 214.

[0662] After packaging using the packaging device 214, the packaged product container 22 is transferred back to the workpiece carrier 30 by means of the multi-axis robot arm 302 (compare Fig. 22) and is conveyed by means of the transport vehicle 410 to the exit lock station 208, where the packaged product container 22 containing the product 20 can be removed by the user.

[0663] In Fig. Figure 23 shows a schematic perspective view of a production plant 10 according to a further exemplary embodiment of the present invention.

[0664] The in Fig. The production plant 10 shown in Figure 23, according to a further exemplary embodiment of the present invention, has essentially the same structural and functional features as the one shown in Figure 23. Fig. Figure 1 shows an exemplary embodiment of the production plant 10 according to the invention, so that only the structural and functional differences in features are shown below.

[0665] The storage transport device 406 comprises one or more free-moving transport vehicles 410, which are already in connection with the in Fig. The exemplary embodiment of the production plant 10 according to the invention is described in Figure 12.

[0666] The storage device 400 comprises several, in this case four, storage areas 414, each of which has several storage locations 402.

[0667] The storage areas 414 are arranged one above the other, particularly in one vertical direction.

[0668] In a sense, the storage areas 414 are arranged in a stacked fashion, as in Fig. 23 is shown schematically.

[0669] On the storage area 414, various types of storage locations 402 are arranged to accommodate different types of objects.

[0670] As in Fig. Figure 23 shows schematically that the different types of storage locations 402 are distributed in a regular pattern.

[0671] For example, several, in particular all, receiving boxes 50, and several, in particular all, tools 702, which are in particular arranged on respective valuables carriers 30, and several, in particular all, consumables 704, which are in particular arranged on respective valuables carriers 30, are arranged spatially adjacent in the said pattern.

[0672] The storage transport device 406 further comprises one or more lifting devices 416, by means of which the storage areas 414 of the storage device 400 are accessible, in particular for storage and retrieval operations as well as for treatment operations and / or maintenance operations.

[0673] The transport vehicles 410 can be moved to the individual storage areas 414 by means of the lifting devices 416.

[0674] Additionally or alternatively, it is conceivable that a transfer operation of a transported object from one transport vehicle 410 located on a storage area 414 to another transport vehicle 410 located on a different storage area 414 can be carried out using the lifting devices 416. In a sense, such a transfer operation from one transport vehicle 410 to another transport vehicle 410 can be carried out via the lifting devices 416.

[0675] In Fig. Figure 24 shows a schematic perspective view of a production plant 10 according to a further exemplary embodiment of the present invention.

[0676] The in Fig. The production plant 10 shown in Figure 24, according to a further exemplary embodiment of the present invention, has essentially the same structural and functional features as the one shown in Figure 24. Fig. Figure 1 shows an exemplary embodiment of the production plant 10 according to the invention, so that only the structural and functional differences in features are shown below.

[0677] The storage device 400 comprises a storage area 414, which has several storage locations 402.

[0678] On storage area 414, various types of storage spaces 402 are arranged to accommodate different types of objects.

[0679] As in Fig. Figure 24 schematically shows that the different types of storage locations 402 are distributed in a regular pattern.

[0680] For example, several, in particular all, tools 702, which are in particular arranged on respective valuables carriers 30, and several, in particular all, consumables 704, which are in particular arranged on respective valuables carriers 30, are arranged spatially adjacent in the said pattern.

[0681] The storage transport device 406 comprises a storage transport unit 408 designed as a portal conveyor 418, wherein the storage area 414 is accessible by means of the portal conveyor 418, in particular for storage and retrieval operations as well as for treatment operations and / or maintenance operations.

[0682] In Fig. 25 outlines a method according to an exemplary embodiment of the present invention.

[0683] The process for manufacturing a biological-pharmaceutical product 20 using a production plant, in particular the previously described production plant 10, comprises: - Selecting one of several production programs to manufacture one of several products 20 (S1) that can be manufactured using production plant 10; - Introducing a reactant 40 into a lock device 200 of the production plant 10 (S2); - Automatic transport of the raw material 40 into a cleanroom area 100 of the production plant 10, wherein, optionally, the raw material 40 is stored in a storage location 402 of a storage device 400 of the production plant 10 located within the cleanroom area 100 (S4); - Automatic execution of one or more treatment processes on the starting material 40 (S4).

[0684] In S4, one or more treatment processes are carried out fully automatically until a product 20 to be manufactured from the starting material 40 is completed. In S4, one or more, in particular all, treatment processes can be carried out at storage location 402.

[0685] The product 20, which can be manufactured or has been manufactured in S4, is removed from storage location 402 and automatically transported to the airlock device 200 for removal from production plant 10.

[0686] The product 20 will be filled and / or packaged in a downstream step (S4) before its removal, in particular filled and / or packaged ready for use.

[0687] One or more vessels, fixtures and / or tools used to manufacture product 20 will, at least partially, remain within cleanroom area 100 after the completion of product 20, be cleaned and subsequently reused to manufacture another product 20.

[0688] For the production of product 20 and / or for the production of several different products 20, required consumables 704, in particular consumables and / or tool consumables, are / will be stored within the cleanroom area 100, in particular before a selection of the product 20 to be produced is / has been made.

[0689] The consumables 704 are automatically transported via the airlock device 200 into the cleanroom area 100 and are stored there, in particular, in one or more storage locations 402 of the storage device 400.

[0690] A quantity of the consumables 704 stored within the cleanroom area 100 is monitored and if a predetermined minimum quantity is undershot, the supply is replenished by adding the required consumables 704, in particular via a notification or warning message on an operator unit, for example the HMI interface 602.

[0691] Several products 20, in particular several different products 20, can be manufactured simultaneously within the cleanroom area 100.

[0692] In a sense, the procedure can be executed simultaneously and / or at different times, one or more times.

[0693] One or more treatment processes, which can be carried out in particular by means of one or more tool units 702, exhibit: - Supplying a liquid and / or a gas, in particular a gas mixture, - Discharge, in particular pumping, of a liquid and / or a gas, in particular a gas mixture, - Removal, in particular pumping, of a portion of a liquid and / or a gas, in particular a gas mixture, for analysis using one or more sensor units, - Mixing one or more components, in particular at least one liquid with at least one other component, for example another liquid, - Concentrating and / or separating a liquid, in particular by means of a column, for example a separation column, and / or a centrifuge, - Analyzing a reactant and / or an intermediate and / or a product, in particular by means of one or more sensor units, - Storing, in particular storing and / or retrieving, one or more objects, in particular by means of the storage transport device 406, - Tempering, in particular incubating, of one or more objects, especially of one or more reactants 40.

[0694] It should be understood that the preceding list of treatment procedures is exemplary and not exhaustive.

[0695] Alternatively or additionally, it is provided that one or more treatment processes can be combined with one or more treatment processes in a single treatment process and / or in any combination of these.

[0696] Each product 20 to be manufactured is assigned a sequence of treatment processes, which are carried out using tools 702 arranged within the cleanroom area 100 and which remain in the cleanroom area 100 after the treatment processes have been carried out.

[0697] One or more tools 702 are cleaned, in particular sterilized, after the performance of one or more treatment processes within the cleanroom area.

[0698] One or more tools 702 are equipped with tool consumables, in particular single-use components, before one or more treatment processes are carried out within the cleanroom area 100.

[0699] One or more tool consumables are removed and / or disposed of from the one or more tools 702 after the execution of one or more treatment processes within the cleanroom area 100.

[0700] Several, in particular all, treatment processes are assigned treatment time values, which indicate the period that elapses from the start of the respective treatment process until its end, including in particular: - a time period for the provision of at least one tool 702 required for the respective treatment process, in particular including its fitting with one or more tool consumables, and / or - a time period for the supply and / or arrangement and / or commissioning of the at least one tool 702 on the reactant 40 to be processed, in particular at a storage location 402 where the reactant 40 is arranged, and / or - a duration of exposure to the starting material 40 to achieve a desired treatment result, and / or - a time period for removing the at least one tool 702 from the starting material 40, in particular from the storage location 402; - preferably including: ◯ cleaning of at least one tool 702, and / or ◯ removal and / or disposal of tool consumables, and / or ◯ of a return transport of the tool 702 to a starting point, in particular a storage location 402 assigned to the tool 702. ◯

[0701] In every production program, the 20 treatment processes required for the manufacture of a specific product, as well as the associated treatment time values, are stored or taken into account.

[0702] When a production program is started, a prediction of a production process is created and the tools 702 required and / or intended for carrying out the treatment processes are reserved in advance for time slots resulting from the prediction.

[0703] One or more treatment processes are / will each be - one or more cleaning operations for cleaning one or more tools 702 and / or for cleaning one or more storage locations 402, and / or - one or more disposal operations for the disposal of consumables 704, and / or - one or more setup operations for loading one or more tools 702 with consumables 704, and / or - one or more control processes are assigned to check a treatment result, whereby, depending on the prediction of the production process, time slots are reserved / will be reserved on one or more of the devices required for carrying out the one or more cleaning processes, the one or more disposal processes, the one or more setup processes and / or the one or more control processes.

[0704] After one or more treatment processes, in particular after each treatment process, the prediction of the production sequence is checked and / or updated, in particular to confirm or correct the time slots for the tools 702 and / or other devices still required to complete the product 20.

[0705] When a production program is to be started, a prediction of the production process is used to determine whether all the necessary tools 702 and / or other equipment for completing product 20 are available within the required time slots, and the production program is only started if this determination has yielded a positive result.

[0706] Regarding the in Fig. The method outlined in Section 25 should be understood to mean that all structural and functional features associated with the production plant according to the invention, and in particular with its previously described embodiments of the production plant 10, can also be included in the method according to the invention, either alone or in combination, and the associated properties, configurations, and advantages can accordingly also be included and achieved. The previously described production plant 10 is also configured to accommodate the process described in Section 25. Fig. to carry out 25 outlined procedures, and that in Fig. The procedure outlined in section 25 is further designed to be executable using the production plant 10 described above.

Claims

[1] Production plant (10) for the manufacture of biological pharmaceutical products (20), for example cell therapeutics or gene therapeutics, wherein the production plant (10) comprises: - a cleanroom area (100); - a lock device (200) for feeding an object from an environment of the production plant (10) into the cleanroom area (100) and / or for removing an object from the cleanroom area (100); - a handling device (300) for moving the object within the cleanroom area (100); - a storage device (400) arranged within the cleanroom area (100), which includes several storage places (402) for holding several objects, wherein the storage device (400) comprises several storage locations (402) which form treatment stations for the treatment of starting materials (40). [2] Production plant (10) according to claim 1, characterized bythat a reactant is arranged in a container, in particular a vessel, for example a bag. [3] Production plant (10) according to claim 1 or 2, characterized by , that the storage device (400) comprises one or more storage racks (404) and / or one or more storage areas (414), each of which has several storage locations (402). [4] Production plant (10) according to any one of the preceding claims, characterized by , that the storage device (400) comprises a storage transport device (406) for transporting objects to and / or from the storage locations (402), optionally providing that the storage transport device (406) is a device different from the handling device (300). [5] Production plant (10) according to claim 4, characterized bythat the storage transport device (406) comprises a rail-guided transport system (408) and / or one or more free-moving transport vehicles (410). [6] Production plant (10) according to one of claims 4 or 5, characterized by , that the storage transport device (406) comprises one or more rail-guided storage transport units (408) by means of which one or more storage racks (404) of the storage device (400) are accessible, in particular for storage and retrieval operations as well as for treatment operations and / or maintenance operations. [7] Production plant (10) according to any one of claims 4 to 6, characterized by , that the storage transport device (406) and / or the handling device (300) each comprise one or more workpiece carrier receptacles for receiving and transporting one or more workpiece carriers (30). [8] Production plant (10) according to any one of claims 4 to 7, characterized by, that by means of the storage transport device (406) of the storage device (400) raw materials (40) and / or workpiece carriers (30) and / or tools (702) and / or consumables (704) can be stored in the storage locations (402) and / or removed from them. [9] Production plant (10) according to claim 8 characterized by that one or more storage locations (402) are accessible from several directions and / or by means of several storage transport units (408) of the storage transport device (406). [10] Production plant (10) according to claim 8 or 9, characterized by , that the storage locations (402) are accessible vertically from above or horizontally from the side by means of the storage transport device (406). [11] Production plant (10) according to any one of the preceding claims, characterized by , that several essentially horizontally oriented rows of storage places (402) are arranged one above the other in a vertical direction. [12] Production plant (10) according to any one of the preceding claims, characterized by , that several of the storage locations (402), in particular all of the storage locations (402), are shelf locations of one or more storage racks (404). [13] Production plant (10) according to any one of the preceding claims, characterized by , that the production plant (10) comprises several workpiece carriers (30) which serve to hold objects, in particular raw materials (40) and / or tools (702) and / or consumables (704). [14] Production plant (10) according to claim 13, characterized by , that a type of workpiece carrier (30) serves to hold a vessel (42) for receiving a reactant (40). [15] Production plant (10) according to one of claims 13 or 14, characterized by , that one or more workpiece carriers (30) each comprise one or more action units for performing an action on a feedstock (40) and / or on a tool (702). [16] Production plant (10) according to claim 15, characterized by , that one or more action units are designed as treatment units for carrying out a treatment process on the reactant (40). [17] Production plant (10) according to claim 16, characterized by , that a treatment unit, for example a tool unit, is configured to perform a rocking and / or a tilting and / or a shaking and / or a rotating movement, in particular by means of at least one appropriately assigned actuator unit, so that this type of movement, for example this type of combination of movements, can be transferred to the feedstock (40). [18] Production plant (10) according to any one of claims 15 to 17, characterized by, that one or more action units are designed as sensor units for determining a current value of a parameter of the respective workpiece carrier (30) and / or an educt (40) arranged thereon and / or a tool (702) arranged thereon and / or consumables (704) arranged thereon. [19] Production plant (10) according to any one of the preceding claims, characterized by , that the production plant (10) includes a tooling system by means of which treatment processes on raw materials (40) and / or maintenance processes can be carried out within the cleanroom area (100). [20] Production plant (10) according to claim 19, characterized by , that the tooling system comprises several, in particular fully automatic, tooling units (702) for carrying out different treatment and / or maintenance operations. [21] Production plant (10) according to claim 19 or 20, characterized bythat the tool system comprises one or more tool units (702) designed as feed units for feeding consumables (704) to the reactants (40). [22] Production plant (10) according to claim 21, characterized by , that consumables (704) comprise at least one liquid and / or at least one gas and / or gas mixture. [23] Production plant (10) according to one of claims 19 to 22, characterized by , that the tool system comprises one or more tool units (702) designed as a fluid conveying device, by means of which a fluid can be conveyed, in particular with respect to a volume flow rate adjustable. [24] Production plant (10) according to any one of claims 19 to 23, characterized bythat the tool system comprises one or more tool units (702) designed as a device for dividing a fluid, by means of which the fluid can be conveyed, in particular with respect to a volume flow rate, and by means of which the fluid can be divided, in particular with respect to a volume flow rate, into at least two fluid parts, in particular with respect to a volume flow rate. [25] Production plant (10) according to any one of claims 19 to 24, characterized by that the tool system comprises one or more tool units (702) designed as a fluid mixing device by means of which a fluid can be mixed. [26] Production plant (10) according to any one of claims 19 to 25, characterized by that the tool system comprises one or more tool units (702) designed as a mixing device, by means of which at least two components can be mixed together, wherein in particular one of the at least two components is a fluid. [27] Production plant (10) according to any one of claims 19 to 26, characterized by that the tool system comprises one or more tool units (702) designed as a measuring device, by means of which at least one property of a fluid and / or a reactant (40) can be measured. [28] Production plant (10) according to claim 27, characterized by that the measuring device is configured to measure a pH value, and / or a gas value and / or a gas mixture value, for example an oxygen value, a cell density, and / or a turbidity, in particular a turbidity in a fluid. [29] Production plant (10) according to any one of claims 19 to 28, characterized by , that a tool unit (702) is a means for analyzing process parameters by means of a probe and / or a sensor. [30] Production plant (10) according to claim 29, characterized bythat the probe and / or sensor is configured to detect, measure and / or measure at least one of the following: at least one temperature, at least one particle, for example at least one particle concentration, at least one vibration, at least one acceleration, at least one cell count, at least one cell density, at least one turbidity, for example at least one light absorption due to liquid turbidity, at least one gas composition, at least one gas, for example CO2, and / or at least one chemical substance, in particular at least one biochemical substance, for example at least one metabolite. [31] Production plant (10) according to any one of claims 19 to 30, characterized bythat the tool system comprises one or more tool units (702) designed as a device for supplying and / or removing a gas, in particular a gas mixture, by means of which a gas, in particular a gas mixture, can be supplied and / or removed, in particular homogeneously. [32] Production plant (10) according to claim 31, characterized by , that oxygen, carbon dioxide and / or hydrogen peroxide can be supplied and / or removed by means of the device for supplying and / or removing a gas. [33] Production plant (10) according to any one of claims 19 to 32, characterized by that the tool system comprises one or more tool units (702) designed as a heating device by means of which a fluid can be temperature controlled. [34] Production plant (10) according to any one of the preceding claims, characterized by, that the production plant (10) has one or more sensor units for determining one or more values ​​of one or more parameters of a) one or more reactants (40); and / or b) one or more workpiece carriers (30); and / or c) one or more tools (702) includes. [35] Production plant (10) according to any one of the preceding claims, characterized by , that by means of one or more sensor units the occupancy status of one or more storage locations (402) of a storage device (400) of the production plant (10) can be determined, in particular monitored. [36] Production plant (10) according to any one of the preceding claims, characterized by, that by means of one or more sensor units a local temperature and / or a local humidity and / or a local illuminance or irradiance at or in one or more storage locations (402) of the storage device (400) of the production plant (10) can be determined, in particular monitored. [37] Production plant (10) according to any one of the preceding claims, characterized by , that the production plant (10) includes one or more sensor units for determining the progress of the treatment during the treatment of a starting material (40) or between two treatment processes. [38] Production plant (10) according to any one of the preceding claims, characterized by , that one or more sensor units for determining the progress of the treatment are arranged, in particular integrated, at or in one or more storage locations (402) for receiving starting materials (40). [39] Production plant (10) according to any one of the preceding claims in combination with claim 34, characterized by , that the production plant (10), in particular one or more tools (702) for carrying out one or more treatment processes, is controllable and / or adjustable depending on the one or more determined values, wherein in particular one or more treatment parameters are varied depending on a determined treatment progress. [40] Production plant (10) according to any one of the preceding claims, characterized by , that a treatment process of a starting material (40) includes incubating a starting material (40) at a storage location (402). [41] Production plant (10) according to claim 40, characterized by , that during incubation gassing and temperature control can be carried out using one or more tool units (702). [42] Production plant (10) according to any one of the preceding claims in combination with claim 13, characterized by that one or more workpiece carriers (30) have one or more coupling devices by means of which several, in particular two or more, workpiece carriers can be connected to each other. [43] Production plant (10) according to any one of the preceding claims in combination with claim 9, characterized by , that a storage rack is arranged between, for example, two storage transport units (408), so that access to the intermediate storage rack is ensured from each storage transport unit (408). [44] Production plant (10) according to any one of the preceding claims, characterized by , that the storage locations (402) are temperature-controlled, in particular individually temperature-controlled, by means of a temperature control device of the storage device (400) which is assigned in particular to each storage location.

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