DE102023130775A1 - System and method for setting up and/or preparing process units for manufacturing a product - Google Patents

Abstract

The present invention relates to a system (100) for setting up and/or preparing process units (102) for producing a product, in particular a biological-pharmaceutical product, wherein the system (100) comprises: a storage device (104) for receiving and/or storing and/or providing set-up material (106), in particular one or more tool units (108) and/or one or more sensor units and/or consumables; a docking device (110) for receiving and/or coupling to a process unit (102); and at least one handling device (112) for feeding setup material (106) from the storage device (104) into a process unit (102) and for arranging the same in this process unit (102) and/or for removing setup material (106) from a process unit (102), wherein the setup material (106) can be fed by means of the at least one handling device (112) from the storage device (104) via the docking device (110) to a process unit (102) received by the storage device and/or coupled to the docking device. Furthermore, the present invention relates to a production plant for producing a product and to methods for setting up and/or preparing process units (102) for producing a product.

Description

The present invention relates to a system and a method for equipping and/or preparing process units for producing a product, in particular a biological-pharmaceutical product.

Furthermore, the present invention relates to a production plant for producing a product, in particular a biological-pharmaceutical product.

Conventional production systems, particularly in the pharmaceutical sector for highly personalized therapeutics or highly personalized therapeutics, are associated with high costs due to their individual and/or micro-production scale. Personalized therapeutics in particular often require a variety of different processing units and/or materials to manufacture a biological-pharmaceutical intermediate and/or product, for example, to enable different treatment processes for the manufacture of the intermediate and/or product. With regard to such processing units and/or materials, for example, during their operation, setup, disposal, replacement, etc., a high degree of efficiency is desired, and in particular, the highest degree of sterility is required.

Furthermore, there is often no possibility for large-scale application and/or industrial production of individual and/or small batch sizes, which is a further challenge in this segment.

The present invention is based on the object of solving the aforementioned problems, in particular of providing a system for setting up and/or preparing process units for producing a product, by means of which a production process for products, preferably for individual and/or very small batch sizes, can be made possible in the pharmaceutical sector efficiently and in particular with consistent quality.

This object is achieved according to the invention by the features of the independent claim. Advantageous developments of the invention are described in the dependent claims.

A system according to the invention for setting up and/or preparing process units for producing a product, in particular a biological-pharmaceutical product, comprises the following: a storage device for receiving and/or storing and/or providing setting material; a docking device for receiving and/or coupling it to a process unit; and at least one handling device for feeding setting material from the storage device into a process unit and for arranging it in this process unit and/or for removing setting material from a process unit, wherein the setting material can be fed by means of the at least one handling device from the storage device via the docking device to a process unit received by the storage device and/or coupled to the latter.

Reprocessing of process units can be understood, for example, as meaning that a particularly used and/or contaminated process unit is converted into a state that allows later reuse of the process unit for the production of a product, in particular a biological-pharmaceutical product.

It may be provided that setup material can be and/or can include stored setup material; new, cleaned, sterilized and/or reprocessed setup material; and/or used, consumed and/or contaminated setup material.

For example, the setup material that can be received or received and/or stored and/or made available and/or made available by means of the storage device can be stored and/or new, cleaned, sterilized and/or reprocessed setup material.

For example, the setup material that can be fed from the storage device to the process unit by means of the at least one handling device can be the setup material that can be received or received and/or stored or stored and/or provided and/or made available by means of the storage device.

For example, the setup material that can be removed from the process unit by means of the at least one handling device can be used, consumed and/or contaminated setup material.

It can be provided that setup material is and/or comprises one or more tool units and/or one or more sensor units and/or consumables.

It can be provided that a respective tool unit for treating a object that can be used to create a product and/or the product itself.

It can be provided that a respective sensor unit serves to analyze an object that can be used to manufacture a product and/or the product itself.

It may be provided that the consumable material serves to produce and/or treat an object that can be used to manufacture a product and/or the product itself.

It may be intended that such a product is and/or comprises a biological-pharmaceutical product.

• - ein Edukt, insbesondere ein Zellen aufweisendes Material, beispielsweise ein Zellen aufweisender Ausgangsstoff, und/oder ein biologisch-pharmazeutisches Material und/oder ein biologisch-pharmazeutisches Werkstück,
• - ein Zwischenprodukt, insbesondere ein Zellen aufweisendes Zwischenprodukt und/oder ein biologisch-pharmazeutisches Zwischenprodukt,
• - ein, beispielsweise das herzustellende, Produkt, insbesondere ein biologisch-pharmazeutisches Produkt, beispielsweise das herzustellende biologisch-pharmazeutische Produkt,
• - ein Verbrauchsstoff, beispielsweise ein Fluid und/oder eine aus einem Fluid gewonnene oder gewinnbare Komponente.

It may be provided that such an object comprises, for example, at least one of the following:

• - a reactant, in particular a material containing cells, for example a starting material containing cells, and/or a biological-pharmaceutical material and/or a biological-pharmaceutical workpiece,
• - an intermediate product, in particular a cell-containing intermediate product and/or a biological-pharmaceutical intermediate product,
• - a product, for example the product to be manufactured, in particular a biological-pharmaceutical product, for example the biological-pharmaceutical product to be manufactured,
• - a consumable, for example a fluid and/or a component obtained or obtainable from a fluid.

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

It can be provided that the at least one handling device is, for example, a particularly motorized articulated arm or a multi-axis robot arm, and/or comprises such a device.

It can be provided that the at least one handling device is designed as a mobile or a stationary handling device.

It can be provided that the at least one handling device is assigned a dismantling station, which is arranged adjacent to the at least one handling device and to which setup material removed from the process unit can be fed by means of the at least one handling device. It is understood that, additionally or alternatively, a separate clearing station can be provided in the system, by means of which setup material can be removed from a process unit. This can be understood in particular that such a separate station takes over or can take over this function from the at least one handling device. It is also understood that such a separate station can be arranged upstream of the at least one handling device and in particular of the storage device with a view to proper operation of the system.

It can be provided that the system comprises a cleaning device by means of which an interior of a process unit can be cleaned and preferably sterilized.

To a certain extent, an interior of a process unit can be cleaned and in particular decontaminated and/or preferably sterilized by means of the cleaning device.

It is understood that it may be conceivable that such cleaning and preferably sterilization may also extend to and/or relate to objects, e.g., equipment designed as multi-use components or multi-use equipment which is present, e.g., arranged, in the interior.

In particular, it can be provided that an interior of a process unit can be cleaned and preferably sterilized by means of the cleaning device after removal of setup material from the process unit by means of the at least one handling device and/or before supplying setup material from the storage device into the process unit by means of the at least one handling device.

This can be understood in particular as meaning that setup material, preferably any removable setup material, is first removed from a process unit by means of the at least one handling device, then the interior of the respective process unit is cleaned and preferably sterilized by means of the cleaning device, and then the respective process unit is re-equipped with setup material by means of the at least one handling device. The removed setup material can preferably be used, consumed and/or contaminated setup material. The loaded setup material can preferably be new, cleaned, sterilized and/or reprocessed setup material. In this case, it may be conceivable that undercuts of objects in the process unit are engaged and/or cleaned and/or sterilized, in particular by means of the cleaning device.

This can also be understood in particular to mean that setup material, preferably any removable setup material, is first removed from a process unit by means of the at least one handling device, wherein setup material or multi-use setup material optionally designed as a multi-use component can remain in the process unit, and then the interior of the process unit in question, and optionally the setup material or multi-use setup material remaining there, designed as a multi-use component, is cleaned and preferably sterilized by means of the cleaning device, and then the process unit in question is re-equipped with new and/or further setup material by means of the at least one handling device.

It can be provided that the cleaning device has one or more nozzle devices and/or one or more suction devices.

It can be provided that a respective nozzle device and/or a respective suction device is designed to be stationary and/or mobile, in particular movable and/or displaceable.

It may additionally or alternatively be provided that the cleaning device has at least one radiation source and/or one or more radiation emitting devices which are connected to the at least one radiation source.

It can be provided that the radiation source and/or a respective radiation emitting device is designed to be stationary and/or mobile, in particular movable and/or displaceable.

The cleaning device may be configured, e.g., equipped, for cleaning and, in particular, for sterilization using irradiation and/or gassing and/or fluid and/or foam-like cleaning agents. For example, this can be achieved by means of the nozzle devices and/or the suction devices.

Additionally or alternatively, the cleaning device may be configured, e.g., equipped, for chemical and/or thermal cleaning and, in particular, for chemical and/or thermal sterilization. For example, this can be achieved by means of the nozzle devices and/or the suction devices.

Additionally or alternatively, it can be provided that a blow-out process, in particular of particles and/or foreign bodies, can be carried out by means of the nozzle devices and a, preferably parallel, suction process, in particular of particles and/or foreign bodies, can be carried out by means of the suction devices.

Additionally or alternatively, it can be provided that a suction process, in particular an exclusive one, preferably of particles and/or foreign bodies, can be carried out by means of the suction devices.

It can be provided that the cleaning device has a handling device for, in particular, two- and/or three-dimensional guiding and/or aligning of at least one of the nozzle devices and/or suction devices.

It may additionally or alternatively be provided that the cleaning device has a handling device, for example the one mentioned above, for guiding and/or aligning at least one of the radiation source and/or the radiation emitting devices, in particular in two and/or three dimensions.

It can further be provided that those components which can be guided or guided by the handling device of the cleaning device, in particular two- and/or three-dimensionally, can be aligned with respect to the docking device and preferably with respect to a process unit received by the docking device and/or coupled thereto, in particular for a cleaning process and preferably a sterilization process.

It can be provided that the handling device of the cleaning device is, for example, a particularly motorized articulated arm or a multi-axis robot arm, and/or comprises such a respective one.

It can be provided that the handling device of the cleaning device is a second handling device of the system and the at least one handling device for supplying and/or removing setup material is a first handling device of the system.

It can be provided that the docking device is designed as a lock device, for example e.g. a washing lock device.

To a certain extent, since a process unit can be received by means of the docking device and/or coupled to the docking device, the docking device can also be regarded and/or referred to as a coupling device.

It can be provided that the docking device is designed as part of the storage device, is designed to a certain extent integrally with the storage device, or is designed as a separate device.

It can be provided that the docking device has one or more access devices through which an interior, in particular an interior space, of the docking device is accessible, for example for a process unit and/or the at least one handling device and/or the cleaning device.

For example, such an access device can be arranged on the docking device between the docking device and the storage device, and in particular between the docking device and the at least one handling device.

It can be provided that a respective access device has a door element which can be opened and/or closed in an automated and/or motorized manner in order to be able to allow and prevent access to the interior, in particular the interior, of the docking device.

It can be provided that the docking device has an interior space formed by a wall and an adapter device for coupling to a process unit.

It can be provided that the adapter device is designed to be at least partially corresponding and/or complementary to the process unit.

It can be provided that the adapter device is arranged in the interior or is arranged on the outside, in particular partially or completely, with respect to the interior.

This can be understood, in particular, to mean that a process unit can be coupled to the docking device via the adapter device inside the docking device or externally with respect to the docking device. It is understood that if a process unit can be coupled to the docking device via the adapter device inside the docking device, this process unit can be accommodated by means of the docking device. It is further understood that if a process unit can be coupled to the docking device via the adapter device externally with respect to the docking device, a spatial connection between this process unit and the interior of the docking device can be realized via an access device of the docking device.

It can be provided that the adapter device arranged on the outside comprises one or more, in particular exchangeable, adapter elements.

For example, an adapter element can be designed as a plate-like adapter element, for example as an adapter plate.

Advantageously, an exchangeable adapter element can be part of a plurality of adapter elements which are designed to correspond to different sized and/or different types of process units in order to ensure or enable improved adaptability of the system.

It can be provided that the adapter device arranged on the outside comprises one or more sealing elements by means of which a process unit and the docking device can be sealed and/or are sealed with respect to one another.

It may be provided that the externally arranged adapter device is formed integrally with an access device of the docking device. However, it is understood that the externally arranged adapter device can also be formed independently or separately from an access device of the docking device.

Additionally or alternatively, it can be provided that the adapter device arranged in the interior comprises a, in particular motorized, rotating and/or tilting platform.

It can be provided that the adapter device arranged in the interior, for example, the rotating and/or tilting platform, has at least two retaining elements by means of which a processing unit can be releasably secured to this adapter device. For example, this can be used to access hidden surfaces during cleaning and/or sterilization, or to expose them.

It can be provided that the docking device has one or more laminar flow devices by means of which the interior can be exposed to an air flow to reduce contamination.

Additionally or alternatively, it may be provided that the docking device has one or more laminar flow devices, which are each arranged on an access device of the docking device and by means of which a respective access opening to the interior and/or interior of the docking device can be subjected to an air flow to reduce contamination.

It can be provided that the docking device has a waste lock for removing waste, in particular used, consumed and/or contaminated equipment material, from the docking device and preferably from the system.

It can be provided that setup material removed from a process unit by means of the at least one handling device can be fed to the waste lock and removed via the latter.

It can be provided that the waste lock is arranged in the docking device and in particular in the interior of the docking device. It is understood that the waste lock can be aseptically sealed in order to keep the interior of the docking device germ-free, in particular after cleaning and/or sterilization of the interior, for example, by means of the cleaning device.

It can be provided that the system comprises a setup material cleaning device, by means of which setup material designed as multi-use components can be cleaned and in particular sterilized and which can be equipped with setup material by means of the at least one handling device.

It can be provided that the elm material cleaning device has an upstream buffer space for elm material to be cleaned and/or a downstream buffer space for cleaned elm material.

It may be provided that the upstream and downstream buffer areas are aseptically separated from each other.

It can be provided that setup material designed as multi-use components has, for example, a technology container or a technology box, which can be connected, in particular interchangeably, to a process unit. For example, it can be provided that such a technology box has an interior, in particular for receiving and accommodating preferably temperature-sensitive and/or moisture-sensitive components for operating setup material, for example tool units and/or sensor units. It can be conceivable that this interior of the technology box can be arranged or is arranged adjacent to the interior of the process unit and is spatially separated from this interior of the process unit in which setup material can be arranged by means of the at least one handling device. This technical box can, for example, be removable before cleaning and/or sterilizing, e.g. autoclaving, the rest of the process unit and/or can be insulated and/or cooled, in particular passively or actively cooled, in such a way that the said sensitive components are not damaged during cleaning and/or sterilizing, e.g. autoclaving, the process unit and in particular the interior of the process unit.

It can be provided that setup material which has been cleaned and in particular sterilized by means of the setup material cleaning device can be fed back into the storage device in a sort of cleaned or sterilized state.

It can be provided that the setup material cleaning device and the cleaning device are designed as one device, for example integrally, or are each designed as a separate device.

It can be provided that the cleaning device is arranged at a cleaning station of the system and the setup material cleaning device is arranged at a removal station upstream of the cleaning station, at which setup material can be removed from a process unit, for example by means of the at least one handling device.

It can be provided that the system comprises a first handling device for feeding setup material from the storage device into the process unit and for arranging the same in this process unit and a second handling device for removing setup material from a process unit.

To a certain extent, the at least one handling device can comprise the first handling device and the second handling device and/or can be designed as such.

It can be provided that the first handling device is part of the storage device and/or is assigned thereto and the first handling device is arranged between the docking device and a storage area of the storage device.

For example, it can be provided that the first handling device is designed as a mobile or a stationary handling device, which also serves for storing, relocating and/or retrieving setup material with respect to the storage device.

Additionally or alternatively, it can be provided that the first and the second handling device are arranged opposite one another or laterally to one another with respect to the docking device.

For example, it can be provided that the docking device has corresponding access devices, as already described, with respect to the first and second handling devices. Furthermore, it can be provided that the docking device has a corresponding, further access device with respect to the cleaning device.

It can be provided that the first handling device, the second handling device and the cleaning device are arranged on the docking device.

For example, the first handling device, the second handling device and the cleaning device can be arranged on the outside of the docking device and preferably arranged at least partially around the docking device.

For example, the cleaning device can be arranged between the first handling device and the second handling device with respect to the docking device.

It is understood that the handling device of the cleaning device may be a third handling device of the system.

It can be provided that the second handling device is arranged adjacent to the setup material cleaning device and, in particular, that the setup material cleaning device can be loaded by means of the second handling device. To a certain extent, the second handling device can be assigned and/or associated with the setup material cleaning device.

For example, it can be provided that setup material can be removed from a process unit received by the docking device and/or coupled thereto by means of the second handling device and, optionally, in the case of setup material designed as a multi-use component, can be fed to the setup material cleaning device for cleaning and in particular sterilization.

For example, it can be provided that the interior of the process unit received by the docking device and/or coupled thereto can be cleaned and/or sterilized by means of the cleaning device, preferably after setup material has been removed from the interior by means of the second handling device.

For example, it can be provided that setup material can be fed from the storage device to the process unit received by the docking device and/or coupled thereto by means of the first handling device, preferably after the interior of this process unit has been cleaned and/or sterilized by means of the cleaning device.

It can be provided that a process unit can be opened by means of the second handling device and/or that a process unit can be opened or is openable in a motorized and/or automated manner.

It is understood that a process unit may be designed to be able to close in a motorized and/or automated manner.

It can be provided that a process unit can be closed by means of the first handling device.

Additionally or alternatively, it may be provided that a separate device for opening and/or closing the process unit may be provided on and/or in the docking device.

It can be provided that the second handling device, optionally together with the setup material cleaning device, serves as a clearing station of the system.

It may be provided that the cleaning device serves as a cleaning station of the system.

It can be provided that the first handling device, optionally together with the storage device, serves as a setup station of the system systems. In a sense, the setup station can be a type of assembly station.

It can be provided that the system is designed as a coherent system or is formed from two or more system sections.

For example, it can be provided that the system is formed from at least a first and a second system section.

It can be provided that the first system section comprises at least the first handling device and the storage device and the second system section comprises at least the second handling device.

It can be provided that the first and the second system section are operatively connected to one another via the docking device or that the first and the second system section are spaced apart from one another.

It can be provided that a setup material cleaning device is assigned to the second handling device and the setup material cleaning device can be equipped with setup material by means of the second handling device.

For example, it can be provided that the removal station, the cleaning station, and/or the setup station each form a system section, which (system sections) are partially or completely operatively connected to one another via the docking device and/or are partially or completely spaced apart from one another. This can, for example, enable sequential operation of the system. It can further be provided that, in the case of system sections spaced apart from one another, each system section has its own docking device, which can be configured like the docking device already described herein.

It can be provided that the system comprises a transport device and/or can be arranged or is arranged on a transport device, wherein one or more process units can be conveyed by means of the transport device along a direction of movement.

It can be provided that setup material can be removed from a process unit at a first position along the direction of movement and setup material can be fed from the storage device into a process unit at a second position along the direction of movement, wherein the first position is located upstream of the second position.

For example, the second handling device and optionally the setup material cleaning device can be arranged at the first position.

For example, the first handling device and optionally the storage device can be arranged at the second position.

For example, it may be provided that a third position is provided between the first and the second position, at which the cleaning device is arranged for cleaning and/or sterilizing a process unit.

For example, it may further be provided that the third position is subdivided to separate the cleaning and sterilization processes, with a sub-position assigned to cleaning being located upstream of a sub-position assigned to sterilization. To a certain extent, this can also be understood as a third and a fourth position, which can be provided between the first and second positions.

To a certain extent, the removal station, the cleaning station and/or the setup station can be arranged along the transport device.

This can be understood in particular to mean that removal, cleaning, sterilization and setup and preferably loading can take place along the transport device, in particular with regard to setup material and a process unit.

It can be provided that the transport device is designed as a rail-guided transport system and/or one or more freely moving transport vehicles and/or a conveyor belt system.

For example, the conveyor belt system may comprise one or more conveyor belts and/or one or more roller belts.

Additionally or alternatively, the system may extend along the transport device.

Additionally or alternatively, it can be provided that the system extends along a transport path of the transport device.

It can be provided that the system comprises a setup material transport device, by means of which setup material designed as multi-use components in a cleaned and in particular sterilized state, which is preferably carried out by means of a setup material cleaning device of the system is available, can be fed back into the storage device, in particular again.

In a sense, a transport path of the setup material transport device can extend from the setup material cleaning device to the storage device.

For example, such equipment designed as a multi-use component can be the aforementioned technical container or the aforementioned technical box.

It can be provided that the setup material transport device is designed as a rail-guided setup material transport system and/or one or more freely moving setup material transport vehicles and/or a setup material conveyor belt system.

For example, the setup material conveyor belt system may comprise one or more conveyor belts and/or one or more roller belts.

Additionally or alternatively, it can be provided that the setup material transport system extends along a transport device of the system.

Additionally or alternatively, it can be provided that a transport path of the setup material transport system extends correspondingly to a transport path of a transport device of the system.

For example, the setup material transport system can extend substantially parallel to the system's transport device, in particular as a setup material conveyor belt system. The same can also apply to the transport paths, for example.

It can be provided that the storage device has at least two storage sections, wherein a first storage section is temperature-controlled and preferably cooled and a second storage section is temperature-controlled.

It can be provided that the first storage section can be or is temperature-controlled to a temperature range of -32°C to 10°C, in particular from -30°C to 8°C, preferably from -30°C to -15°C or from 4°C to 8°C; and/or the second storage section can be or is temperature-controlled to a temperature range of 18°C to 39°C, in particular from 20°C to 37°C, preferably 20°C±5% or 37°C±5%; and/or a temperature difference between the first and the second storage section is at least 12°C, in particular 15°C±15% or 40°C±15%.

For example, the first storage section can be designed as a freezing section and/or have one which can be or is tempered to a temperature range of -30°C to -15°C, for example.

For example, the first storage section can be designed as a cooling section and/or have such a section which can be or is tempered to a temperature range of 4°C to 8°C, for example.

For example, the second bearing section can be designed as a room temperature section and/or have one which can be tempered or tempered to a temperature range of 20°C±5%, for example.

For example, the second storage section can be designed as a thawing section and/or preheating section and/or can have one which can be or is tempered to a temperature range of 37°C±5%, for example.

It can be provided that the storage device and/or a respective storage section has one or more storage racks and/or one or more storage area areas, each of which has a plurality of storage locations.

It may additionally or alternatively be provided that a respective storage section is designed as one or more storage racks and/or one or more storage area areas, each of which has a plurality of storage locations.

To a certain extent, the storage device can be provided with at least two storage sections, each configured as storage shelves and/or storage areas, wherein a first storage section is temperature-controlled and preferably cooled, and a second storage section is temperature-controlled. This can be advantageous, for example, because excess heat can be dissipated more easily and/or requirements for temperature control equipment can be reduced.

To a certain extent, it can be provided that a respective storage section can have one or more subsections, in particular storage racks and/or storage areas, which can be tempered or controlled to a temperature range. For example, the said temperature ranges can be substantially the same or different from one another. It can be conceivable that the first storage section has several subsections, e.g. storage racks, which can be tempered or controlled to several temperature ranges, which, for example, can be within -80°C to -2°C, and the second storage section has several subsections, e.g. storage shelves, which can be tempered or are tempered to several temperature ranges, which are, for example, within 0°C to 20°C. It is understood that, in addition or alternatively, the temperature ranges mentioned above can be conceivable here.

It can be provided that each storage section has a storage handling device for storing and/or relocating and/or retrieving setup material and/or a respective storage handling device of the storage device can be assigned or is assigned to a respective storage section; and/or respective storage sections with a substantially identical temperature range prevailing there have a storage handling device for storing and/or relocating and/or retrieving setup material and/or such a device can be assigned or is assigned to them accordingly.

It can be provided that a respective storage handling device is a device different from the at least one handling device and/or from the first handling device.

Additionally or alternatively, it can be provided that a respective warehouse handling device has a gripper actuator and/or a robot arm.

Additionally or alternatively, it can be provided that a respective warehouse handling device has a rail-guided transport system and/or one or more freely moving transport vehicles.

Additionally or alternatively, it can be provided that a respective storage handling device has 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 storing and/or relocating and/or retrieving setup material.

Additionally or alternatively, it can be provided that a respective storage handling device has one or more storage transport units designed as portal conveyors.

Additionally or alternatively, it can be provided that a respective warehouse handling device comprises one or more warehouse transport units designed as pick-and-place robots or as cable robots.

It can be provided that the storage device comprises an inlet-side lock device, wherein the inlet-side lock device comprises at least one lock station, in particular an unpacking lock station, at which setup material to be stored in the storage device can be unpacked manually and/or automatically.

Additionally or alternatively, it can be provided that the storage device comprises an output-side lock device, via which a setup material feed path extends from the storage device to a process unit and/or the docking device.

It can be provided that the at least one handling device is arranged in and/or adjacent to the exit-side lock device.

It can be provided that the inlet-side and/or the outlet-side lock device has a preferably integrated cleaning device for cleaning and/or sterilizing setup material to be stored and/or fed to a process unit.

It can be provided that the system has a setup station for feeding cell-containing setup material and/or fluidic setup material, in particular into a process unit.

It can be provided that the supplying refers to a first supplying of cell-containing preparation material and/or fluidic preparation material, which can form a starting material for the production of a product, in particular a biological-pharmaceutical product.

It can be provided that the setup station is provided in and/or on the docking device or is a setup device different from the docking device.

It can be provided that the setup station has one or more laminar flow devices, by means of which an area of the setup station can be subjected to an air flow to reduce contamination, in which a supply of cell-containing setup material and/or fluidic setup material takes place or can take place.

It can be provided that the setup station is equipped with one or more sterile connectors and/or one or more rapid transfer ports, preferably for supplying cell-containing sending setup material and/or fluid setup material through them.

It can be provided that a respective sterile connector and/or a respective rapid transfer port can enable a connection between a respective process unit, in particular its interior, and an exit area from which cell-containing setup material and/or fluidic setup material can be supplied. For example, this exit area can be the storage device and/or the lock device and/or an environment of the system.

It can be provided that the equipment material is designed as one or more single-use components and/or single-use material and as one or more multi-use components and/or multi-use material.

Alternatively, it may be provided that the setup material is designed exclusively as one or more single-use components and/or single-use material.

This can be understood, in particular, to mean that a system with exclusively single-use equipment can be free of a equipment cleaning device and/or a equipment transport device. Such a system preferably includes the aforementioned waste lock.

Alternatively, it may be provided that the equipment material is designed exclusively as one or more multi-use components and/or multi-use material.

This can be understood, in particular, to mean that a system with exclusively multi-use setup material can be free of a storage device and/or free of a waste lock. However, it is understood that the storage device can be provided for the temporary storage or buffering of setup material and/or for the storage of setup material to be used for the first time. Such a system preferably comprises the said setup material cleaning device and/or setup material transport device.

The present invention further provides a production plant for producing a product, in particular a biological-pharmaceutical product.

The production plant according to the invention comprises: a system configured according to the preceding and/or following description; and one or more process units for producing a product, in particular a biological-pharmaceutical product.

All structural and functional features associated with the previously described system and/or embodiments thereof may also be included in the production plant according to the invention, either alone or in combination, and the associated properties, configurations and advantages may also be included and achieved accordingly.

The production facility may be provided with a particularly suitable cleanroom area. The cleanroom area may define an aseptic production area. The cleanroom area may have at least a CNC cleanroom class (i.e., Controlled but not Classified) in accordance with Good Manufacturing Practice (GMP).

The present invention further provides a method for equipping and/or preparing process units for producing a product, in particular a biological-pharmaceutical product.

The method according to the invention comprises at least the following steps: opening a process unit received by a docking device and/or coupled thereto; feeding setup material from a storage device into the process unit and arranging the same in this process unit by means of at least one handling device; and closing the process unit.

All structural and functional features associated with the previously described system and/or the previously described production plant and/or their embodiments can also be included in the method according to the invention, either alone or in combination, and the associated properties, configurations and advantages can also be included and achieved accordingly.

In addition, the above-described system and/or the above-described production plant may each be configured to carry out the method described herein, and the method described herein may be designed to be executable by means of the above-described system and/or the above-described production plant.

It can be provided that, before the supply of setup material, used, consumed and/or contaminated setup material is removed from the process unit, in particular automatically.

It can be provided that an interior of the process unit is cleaned and in particular sterilized by means of a cleaning device.

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

• 1 eine schematische Darstellung eines Systems zum Rüsten und/oder zum Aufbereiten von Prozesseinheiten zur Herstellung eines Produkts, insbesondere eines biologisch-pharmazeutischen Produkts, gemäß einer beispielhaften Ausführungsform der vorliegenden Erfindung;
• 2 eine schematische Darstellung eines Systems zum Rüsten und/oder zum Aufbereiten von Prozesseinheiten zur Herstellung eines Produkts, insbesondere eines biologisch-pharmazeutischen Produkts, gemäß einer weiteren beispielhaften Ausführungsform der vorliegenden Erfindung;
• 3 eine schematische Darstellung eines Systems zum Rüsten und/oder zum Aufbereiten von Prozesseinheiten zur Herstellung eines Produkts, insbesondere eines biologisch-pharmazeutischen Produkts, gemäß einer weiteren beispielhaften Ausführungsform der vorliegenden Erfindung;
• 4 eine schematische Darstellung eines Systems zum Rüsten und/oder zum Aufbereiten von Prozesseinheiten zur Herstellung eines Produkts, insbesondere eines biologisch-pharmazeutischen Produkts, gemäß einer weiteren beispielhaften Ausführungsform der vorliegenden Erfindung;
• 5 eine schematische Darstellung eines Systems zum Rüsten und/oder zum Aufbereiten von Prozesseinheiten zur Herstellung eines Produkts, insbesondere eines biologisch-pharmazeutischen Produkts, gemäß einer weiteren beispielhaften Ausführungsform der vorliegenden Erfindung;
• 6 eine schematische Darstellung eines Systems zum Rüsten und/oder zum Aufbereiten von Prozesseinheiten zur Herstellung eines Produkts, insbesondere eines biologisch-pharmazeutischen Produkts, gemäß einer weiteren beispielhaften Ausführungsform der vorliegenden Erfindung;
• 7 eine schematische Darstellung eines Teils eines Systems zum Rüsten und/oder zum Aufbereiten von Prozesseinheiten zur Herstellung eines Produkts, insbesondere eines biologisch-pharmazeutischen Produkts, gemäß einer weiteren beispielhaften Ausführungsform der vorliegenden Erfindung;
• 8 eine schematische Darstellung eines Teils eines Systems zum Rüsten und/oder zum Aufbereiten von Prozesseinheiten zur Herstellung eines Produkts, insbesondere eines biologisch-pharmazeutischen Produkts, gemäß einer weiteren beispielhaften Ausführungsform der vorliegenden Erfindung;
• 9 eine schematische Darstellung eines Teils eines Systems zum Rüsten und/oder zum Aufbereiten von Prozesseinheiten zur Herstellung eines Produkts, insbesondere eines biologisch-pharmazeutischen Produkts, gemäß einer weiteren beispielhaften Ausführungsform der vorliegenden Erfindung;
• 10 eine schematische Darstellung eines Teils eines Systems zum Rüsten und/oder zum Aufbereiten von Prozesseinheiten zur Herstellung eines Produkts, insbesondere eines biologisch-pharmazeutischen Produkts, gemäß einer weiteren beispielhaften Ausführungsform der vorliegenden Erfindung;
• 11 eine schematische Darstellung eines Teils eines Systems zum Rüsten und/oder zum Aufbereiten von Prozesseinheiten zur Herstellung eines Produkts, insbesondere eines biologisch-pharmazeutischen Produkts, gemäß einer weiteren beispielhaften Ausführungsform der vorliegenden Erfindung;
• 12 eine schematische Darstellung eines Teils eines Systems zum Rüsten und/oder zum Aufbereiten von Prozesseinheiten zur Herstellung eines Produkts, insbesondere eines biologisch-pharmazeutischen Produkts, gemäß einer weiteren beispielhaften Ausführungsform der vorliegenden Erfindung;
• 13 eine schematische Perspektivdarstellung einer Prozesseinheit zur Herstellung eines Produkts, insbesondere eines biologisch-pharmazeutischen Produkts, welche Teil einer Produktionsanlage zur Herstellung eines Produkts, insbesondere eines biologisch-pharmazeutischen Produkts, gemäß einer beispielhaften Ausführungsform der vorliegenden Erfindung ist;
• 14 eine schematische Seitendarstellung der Prozesseinheit von 13;
• 15 eine schematische Darstellung eines Systems zum Rüsten und/oder zum Aufbereiten von Prozesseinheiten zur Herstellung eines Produkts, insbesondere eines biologisch-pharmazeutischen Produkts, gemäß einer weiteren beispielhaften Ausführungsform der vorliegenden Erfindung;
• 16 eine schematische Darstellung eines Systems zum Rüsten und/oder zum Aufbereiten von Prozesseinheiten zur Herstellung eines Produkts, insbesondere eines biologisch-pharmazeutischen Produkts, gemäß einer weiteren beispielhaften Ausführungsform der vorliegenden Erfindung; und
• 17 eine schematische Darstellung eines Verfahrens zum Rüsten und/oder zum Aufbereiten von Prozesseinheiten zur Herstellung eines Produkts, insbesondere eines biologisch-pharmazeutischen Produkts, gemäß einer beispielhaften Ausführungsform der vorliegenden Erfindung.

The figures show:

• 1 a schematic representation of a system for equipping and/or preparing process units for producing a product, in particular a biological-pharmaceutical product, according to an exemplary embodiment of the present invention;
• 2 a schematic representation of a system for equipping and/or preparing process units for producing a product, in particular a biological-pharmaceutical product, according to a further exemplary embodiment of the present invention;
• 3 a schematic representation of a system for equipping and/or preparing process units for producing a product, in particular a biological-pharmaceutical product, according to a further exemplary embodiment of the present invention;
• 4 a schematic representation of a system for equipping and/or preparing process units for producing a product, in particular a biological-pharmaceutical product, according to a further exemplary embodiment of the present invention;
• 5 a schematic representation of a system for equipping and/or preparing process units for producing a product, in particular a biological-pharmaceutical product, according to a further exemplary embodiment of the present invention;
• 6 a schematic representation of a system for equipping and/or preparing process units for producing a product, in particular a biological-pharmaceutical product, according to a further exemplary embodiment of the present invention;
• 7 a schematic representation of a part of a system for equipping and/or preparing process units for producing a product, in particular a biological-pharmaceutical product, according to a further exemplary embodiment of the present invention;
• 8 a schematic representation of a part of a system for equipping and/or preparing process units for producing a product, in particular a biological-pharmaceutical product, according to a further exemplary embodiment of the present invention;
• 9 a schematic representation of a part of a system for equipping and/or preparing process units for producing a product, in particular a biological-pharmaceutical product, according to a further exemplary embodiment of the present invention;
• 10 a schematic representation of a part of a system for equipping and/or preparing process units for producing a product, in particular a biological-pharmaceutical product, according to a further exemplary embodiment of the present invention;
• 11 a schematic representation of a part of a system for equipping and/or preparing process units for producing a product, in particular a biological-pharmaceutical product, according to a further exemplary embodiment of the present invention;
• 12 a schematic representation of a part of a system for equipping and/or preparing process units for producing a product, in particular a biological-pharmaceutical product, according to a further exemplary embodiment of the present invention;
• 13 a schematic perspective view of a process unit for producing a product, in particular a biological-pharmaceutical product, which is part of a production plant for producing a product, in particular a biological-pharmaceutical product, according to an exemplary embodiment of the present invention;
• 14 a schematic side view of the process unit of 13 ;
• 15 a schematic representation of a system for setting up and/or preparing process units for producing a product, in particular a biological-pharmaceutical product, according to another exemplary embodiment of the present invention;
• 16 a schematic representation of a system for equipping and/or preparing process units for producing a product, in particular a biological-pharmaceutical product, according to a further exemplary embodiment of the present invention; and
• 17 a schematic representation of a method for equipping and/or preparing process units for producing a product, in particular a biological-pharmaceutical product, according to an exemplary embodiment of the present invention.

Identical or functionally equivalent elements are provided with the same reference numerals in all figures.

Referring to 1 a system 100 according to an exemplary embodiment of the present invention is schematically illustrated.

The system 100 is used for setting up and/or preparing process units 102.

A respective process unit 102 serves to produce a product, in particular a biological-pharmaceutical product. A possible exemplary embodiment of a process unit 102 is further shown in 13 and 14 shown schematically.

Reconditioning of process units 102 can be understood, for example, as meaning that a particularly used and/or contaminated process unit 102 is converted into a state that allows later reuse of the process unit 102 for producing a product, in particular a biological-pharmaceutical product.

The system 100 has a storage device 104 for receiving and/or storing and/or providing setup material 106.

The setup material 106 may be and/or comprise one or more tool units 108 and/or one or more sensor units and/or consumables (cf., e.g., 13 and 14 ).

A respective tool unit 108 serves to treat an object that can be used to manufacture a product and/or the product itself.

Each sensor unit is used to analyze an object that can be used to manufacture a product and/or the product itself.

The consumable is used to produce and/or treat an object that can be used to manufacture a product and/or the product itself. However, the consumable can also be and/or comprise the object that can be used to manufacture a product itself.

As already described, such a product is preferably a biological-pharmaceutical product and/or comprises such a product.

• - ein Edukt, insbesondere ein Zellen aufweisendes Material, beispielsweise ein Zellen aufweisender Ausgangsstoff, und/oder ein biologisch-pharmazeutisches Material und/oder ein biologisch-pharmazeutisches Werkstück,
• - ein Zwischenprodukt, insbesondere ein Zellen aufweisendes Zwischenprodukt und/oder ein biologisch-pharmazeutisches Zwischenprodukt,
• - ein, beispielsweise das herzustellende, Produkt, insbesondere ein biologisch-pharmazeutisches Produkt, beispielsweise das herzustellende biologisch-pharmazeutische Produkt,
• - ein Verbrauchsstoff, beispielsweise ein Fluid und/oder eine aus einem Fluid gewonnene oder gewinnbare Komponente.

Furthermore, such a said object comprises, for example, at least one of the following:

• - a reactant, in particular a material containing cells, for example a starting material containing cells, and/or a biological-pharmaceutical material and/or a biological-pharmaceutical workpiece,
• - an intermediate product, in particular a cell-containing intermediate product and/or a biological-pharmaceutical intermediate product,
• - a product, for example the product to be manufactured, in particular a biological-pharmaceutical product, for example the biological-pharmaceutical product to be manufactured,
• - a consumable, for example a fluid and/or a component obtained or obtainable from a fluid.

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

The system 100 comprises a docking device 110 and a handling device 112.

The docking device 110 is used for coupling with a process unit 102.

The docking device 110 is arranged adjacent to the storage device 104.

The handling device 112 serves to feed setup material 106 from the storage device 104 into a process unit 102 and to arrange it in this process unit 102.

Furthermore, the handling device 112 serves to remove setup material 106 from a process unit 102.

A process unit 102 has an interior space 116 formed by a wall 114 and at least one opening device 118 for enabling opening and closing of the interior space 116.

The process unit 102 and preferably the interior space 116 are designed and constructed to have a hygienic design, in particular to meet criteria of a hygienic design, for example with regard to a minimized number of undercuts, thereby optimizing the cleanability.

Access to the interior 116 is possible by means of the opening device 118. The opening device 118 has an automatically pivoting door element, which is located in 1 is in an open state.

In a sense, the handling device 112 serves to feed setup material 106 from the storage device 104 into the interior 116 of a process unit 102 and to arrange it in this interior 116.

Furthermore, the handling device 112 serves to remove setup material 106 from the interior 116 of a process unit 102.

The handling device 112 is arranged between the storage device 104 and the docking device 110.

The setup material 106 can be fed by means of the handling device 112 from the storage device 104 via the docking device 110 to a process unit 102 coupled to the docking device 110.

A coupled state of a process unit 102 with the docking device 110 is, for example, the 1 removable.

It is understood that the setup material 106, which can be fed by means of the handling device 112 from the storage device 104 via the docking device 110 to a process unit 102 coupled to the docking device 110, is stored and new, cleaned, sterilized and/or processed setup material 106.

To a certain extent, setup material 106 can be and/or include stored setup material 106; new, cleaned, sterilized and/or reprocessed setup material 106; and/or used, consumed and/or contaminated setup material 106.

For example, the setup material 106, which can be received or received and/or stored and/or provided and/or made available by means of the storage device 104, can be stored and/or new, cleaned, sterilized and/or processed setup material 106.

For example, the setup material 106, which can be fed from the storage device 104 to the process unit 102 by means of the handling device 112, can be the setup material 106 which can be received or received and/or stored or stored and/or provided and/or made available by means of the storage device 104.

For example, the setup material 106, which can be removed from the process unit 102 by means of the handling device 112, can be used, consumed and/or contaminated setup material 106.

In the present embodiment, the handling device 112 is a multi-axis robot arm which is stationary positioned between the storage device 104 and the docking device 110, in a sense docking station 110.

In this exemplary embodiment, the handling device 112 is assigned a dismantling station 120, which is arranged adjacent to the handling device 112 and to which dismantling material 106 removed from the process unit 102 can be fed by means of the handling device 112.

The dismantling station 120 can optionally be part of the system 100 or be assigned to it, e.g., as part of a higher-level production facility. It is also conceivable that removed setup material 106 can be stored and/or temporarily stored in the storage device 104 in a storage area that is aseptically separated from the remaining setup material 106.

The docking device 110 has a first and a second access device 122, 124, through which an interior, in particular an interior space 126, of the docking device 110 is accessible, for example for a process unit 102 and the handling device 112.

The first access device 122 serves to make the interior 126 of the docking device 110 of a process unit 102 accessible.

The second access device 124 serves to access the interior 126 of the docking device 110 of the handling device 112 accessible.

The second access device 124 is arranged between the docking device 110 and the storage device 104 on the docking device 110.

In particular, the second access device 124 is arranged between the docking device 110 and the handling device 112 on the docking device 110.

The first and second access devices 122, 124 are each arranged between sealing elements 128 on the docking device 110.

As a result, a respective transition between the docking device 110 and the storage device 104, and in particular the handling device 112, as well as between the docking device 110 and a process unit 102 coupled to the docking device 110 can be reliably sealed and/or is sealed.

A respective access device 122, 124 has a door element, not shown separately in the figures, which can be opened and/or closed in an automated and/or motorized manner in order to be able to allow and prevent access to the interior, in particular the interior space 126, of the docking device 110.

As in 1 As can be seen, the interior 126 of the docking device 110 is formed by a wall 130.

The interior space 126 of the docking device 110 is designed and configured to have a hygienic shape, in particular to meet hygienic design criteria, for example with regard to a minimized number of undercuts, thereby optimizing cleanability.

The docking device 110 further comprises an adapter device 132 for coupling to a process unit 102.

The adapter device 132 is designed to be at least partially corresponding and/or complementary to the process unit 102.

The adapter device 132 is arranged on the outside with respect to the interior space 126.

This can be understood in particular to mean that a process unit 102 can be coupled to the docking device 110 via the adapter device 132 on the outside with respect to the docking device 110.

It is understood that if a process unit 102 can be coupled to the docking device 110 via the adapter device 132 on the outside with respect to the docking device 110, a spatial connection between this process unit 102 and the interior 126 of the docking device 110 can be realized via the first access device 122 of the docking device 110.

The externally arranged adapter device 132 has an exchangeable adapter element 134.

The adapter element 134 is designed as a plate-like adapter element, for example as an adapter plate.

Advantageously, such an exchangeable adapter element 134 can be part of a plurality of adapter elements, which are respectively designed to correspond to different sized and/or different types of process units 102, in order to ensure or enable improved adaptability and/or flexibility of the system 100.

On the plate-like adapter element 134, one or more holding elements (not shown in the figures) can be provided, by means of which a process unit 102 can be releasably fixed to this adapter device 132 or as in 1 shown.

By means of said holding elements, a force-locking and/or form-locking connection with one or more of the process units 102 can be realized. It is understood that counter elements corresponding to the holding elements can be provided on a respective process unit 102 for this purpose.

As in 1 As can be seen, the sealing elements 128 are provided on the adapter elements 134 and can be encompassed by the adapter device 132. By means of the sealing elements 128, one or the 1 The process unit 102 shown and the docking device 110 are sealable and/or sealed with respect to one another.

In the present embodiment, the adapter device 132 is formed integrally with the first access device 122 of the docking device 110 and further functions as a wall section of the wall 130, which forms the interior 126 of the docking device 110.

The 1 The docking device 110 shown can optionally have one or more laminar flow devices by means of which the interior 126 can be subjected to an air flow to reduce contamination.

One or more of the laminar flow devices can be arranged on the first and/or second access device 122, 124 of the docking device 110, respectively, and a respective access opening to the interior 126 of the docking device 110 can be supplied with an air flow to reduce contamination by means of said laminar flow devices.

• Eine Prozesseinheit 102 wird aktiv oder passiv an die Dockingvorrichtung 110 des Systems 100 aus einer Umgebung des Systems 100, beispielsweise einer Produktionsanlage und/oder einem Abschnitt einer Produktionsanlage, herangeführt.

A possible exemplary operation of the system 100 is described below:

• A process unit 102 is actively or passively brought to the docking device 110 of the system 100 from an environment of the system 100, for example a production plant and/or a section of a production plant.

This can be understood in particular to mean that the process unit 102 reaches the docking device 110 independently, for example by means of a drive unit assigned to the process unit 102, or by means of a transport unit separate from the process unit 102, for example the production plant.

The docking device 110 and the processing unit 102 are coupled to one another by means of the adapter device 132 and in particular the adapter element 134. Access is enabled via the first access device 122.

Subsequently, the interior 116 of the processing unit 102 is made accessible to the handling device 112. For this purpose, the door element of the opening device 118 of the processing unit 102 pivots into an open state, which in 1 is shown schematically. Furthermore, access is or is enabled via the second access device 124.

If the process unit 102 is equipped with used setup material 106, the handling device 112 removes it from the interior 116 of the process unit 102 and transports it to the dismantling station 120.

In a sense, the handling device 112 removes setup material 106 from the process unit 102 via the docking device 110.

Subsequently, new setup material 106 is fed from the storage device 104 to the process unit 102 by means of the handling device 112 and arranged in the interior 116 of the process unit 102.

In a sense, the handling device 112 feeds setup material 106 from the storage device 104 via the docking device 110 to the process unit 102 and arranges it in the interior 116 of the process unit 102.

Subsequently, the interior 116 of the processing unit 102 is closed again. For this purpose, the door element of the opening device 118 of the processing unit 112 pivots into a closed state. Access via the first and second access devices 122, 124 is terminated.

The process unit 102 and the docking device 110 are decoupled from each other again, and the process unit 102 is ready for the production of a product, in particular a biological-pharmaceutical product. In a sense, the process unit 102 has been prepared and/or reconditioned.

The handling device 112 serves both as a removal station of the system 100 and as a setup station or as a loading station of the system 100.

The docking device 110 serves, in a sense, as a lock device of the system 100. Furthermore, the docking device 110 can also be regarded as a coupling device.

Referring to 2 a system 100 according to another exemplary embodiment of the present invention is schematically illustrated.

The 2 The embodiment of the system 100 shown is substantially configured and/or designed as the system 100 shown in 1 shown embodiment of the system 100, so that only the differences are described below.

As in 2 As can be seen, the system 100 has a docking device 110 for receiving and coupling with a process unit 102.

In a sense, a process unit 102 can be accommodated in the interior 126 of the docking device 110 and coupled there.

For this purpose, the first access device 122 is designed such that a process unit 102 can enter the interior space 126 through it.

To a certain extent, the said reception of a process unit 102 can be effected or can be realized via the first access device 122.

Furthermore, the system 100 has a cleaning device 136, by means of which the interior 116 of a process unit 102 can be cleaned and preferably sterilized.

The cleaning device 136 serves as a cleaning station of the system 100.

The cleaning device 136 is adjacent to the docking device 110 and is arranged adjacent to the storage device 104.

The docking device 110 has a third access device 138, which serves to make the interior 126 of the docking device 110 and in particular the interior 116 of a or the process unit 102 of the cleaning device 136 accessible.

The third access device 138 is arranged between the cleaning device 136 and the docking device 110 on the docking device 110.

The third access device 138 is arranged between sealing elements 128 on the docking device 110, whereby a transition between the docking device 110 and the cleaning device 136 is sealable and/or sealed.

The third access device 138 is essentially configured and/or designed like the second access device 124.

The interior 116 of a process unit 102 can advantageously be cleaned and preferably sterilized by the cleaning device 136 after removal of setup material 106 from the process unit 102 by means of the handling device 112.

Furthermore, the interior 116 of the process unit 102 can advantageously be cleaned and preferably sterilized by the cleaning device 136 by means of the handling device 112 before supplying setup material 106 from the storage device 104 into the process unit 102.

This can be understood in particular to mean that setup material 106, preferably any removable setup material, is first removed from the process unit 102 by means of the handling device 112.

Subsequently, the interior 116 of the respective process unit 102 is cleaned and preferably sterilized by means of the cleaning device 136.

It is understood that the interior 126 of the docking device 110 can also be cleaned and preferably sterilized by means of the cleaning device 136.

Subsequently, the respective process unit 102 is again equipped with setup material 106 by means of the handling device 112.

The removed setup material 106 preferably concerns used, consumed and/or contaminated setup material 106.

The loaded setup material 106 preferably relates to new, cleaned, sterilized and/or reprocessed setup material 106.

The cleaning device 136 is configured for cleaning and sterilizing using irradiation and/or gassing and/or fluidic and/or foam-like cleaning agents.

It is understood that the cleaning device 136 may additionally or alternatively be configured for chemical and/or thermal cleaning and in particular for chemical and/or thermal sterilization.

For this purpose, the cleaning device 136 has one or more nozzle devices not shown in the figures and/or one or more suction devices not shown in the figures.

Optionally, the cleaning device 136 comprises a radiation source (not shown in the figures) and one or more radiation emitting devices (not shown in the figures) connected to the radiation source.

Furthermore, in the present embodiment, the handling device 112 is assigned to the cleaning device 136.

In a sense, the cleaning device 136 comprises the handling device 112.

This can be understood in particular as meaning that the handling device 112 serves to feed setup material 106 from the storage device 104 into a or the process unit 102 and to arrange the same in this process unit 102, to remove setup material 106 from a or the process unit 102 and to preferably two- and/or three-dimensional guiding and/or aligning of at least one of the nozzle devices and/or suction devices.

Optionally, the handling device 112 can serve for preferably two- and/or three-dimensional guiding and/or aligning of the radiation emitting devices.

Those components which can be guided or guided preferably two- and/or three-dimensionally by the handling device 112 of the cleaning device 136 can be aligned or aligned with respect to the docking device 110 and preferably with respect to a process unit 102 received by the docking device 110 and coupled thereto for a cleaning process and preferably a sterilization process.

It is understood, however, that the handling device of the cleaning device 136 can alternatively also be a second, separately designed handling device of the system 100 and the handling device 112 for supplying and/or removing setup material 106 can be a first, separately designed handling device 112 of the system.

Since the docking device 100 can not only supply and remove setup material 106, but also clean and/or sterilize the process unit 102 and optionally the docking device 110 itself, the docking device 110 can be designed as a lock device, for example a washing lock device, and/or alternatively be viewed or referred to as such.

As already described, a process unit 102 can be accommodated in the interior 126 of the docking device 110 and coupled there.

The adapter device 132 of the docking device 110 for coupling to a process unit 102 is designed at least partially to correspond and/or complement the process unit 102 and is arranged in the interior space 126 of the docking device 110.

The adapter device 132 arranged in the interior space 126 comprises a motorized rotating and/or tilting platform (not shown in the figures), by means of which a or the process unit 102, which is coupled to this rotating and/or tilting platform, can be rotated and/or tilted, whereby the cleaning device 136 can advantageously clean and sterilize substantially any surface of the process unit 100.

In a sense, this rotating and/or tilting platform preferably serves to align the process unit 102 with respect to the cleaning device 136. For example, this can be used to access hidden surfaces during cleaning and/or sterilization or so that these can be exposed.

Furthermore, the adapter device 132 arranged in the interior 126, for example the rotating and/or tilting platform, has at least two holding elements by means of which one or the process unit 102 can be releasably fixed and preferably coupled to this adapter device 132.

As in 2 As can be seen, the docking device 110 further comprises a waste lock 140 for removing waste from the docking device 110 and preferably from the system 100.

In this case, waste includes, in particular, used, consumed and/or contaminated equipment material 106. Preferably, this primarily concerns equipment material 106 designed as single-use components and/or single-use material.

By means of the handling device 112, setup material 106 removed from a process unit 102 can be fed to the waste lock 140 and removed via the latter.

The waste lock 140 is arranged in the docking device 110 and in particular in the interior 126 of the docking device 110.

It is understood that the waste lock 140 is aseptically closable in order to keep the interior 126 of the docking device 110 germ-free, preferably after cleaning and/or sterilizing the interior 126 of the docking device 110 and/or the interior 116 of the process unit 102 by means of the cleaning device 136.

This can be understood, in particular, to mean that when the handling device 112 removes setup material 106 from the process unit 102, the waste lock 140 is or becomes open, and the handling device 112 then feeds the removed setup material 106 to the waste lock 140 and then closes the waste lock 140. As a result, the said setup material 106 is removed from the docking device 110 and preferably, the said setup material 106 is then removed from the system 100 by means of the waste lock 140.

As in 2 As can also be seen, the system 100 has a setup material cleaning device 142.

By means of the setup material cleaning device 142, setup material 106 designed as multi-use components can be cleaned and, in particular, sterilized.

The setup material cleaning device 142 is arranged directly adjacent to the cleaning device 136 and the handling device 112.

In the present case, the setup material cleaning device 142 is a separate device from the cleaning device 136.

The setup material cleaning device 142 can be loaded with setup material 106 by means of the handling device 112, and preferably with setup material 106 removed from the process unit 102.

The tooling material cleaning device 142 has a downstream buffer location 144 for cleaned tooling material 106.

In a sense, the said setup material 106 can be removed from the process unit 102 by means of the handling device 112 and fed to the setup material cleaning device 142.

The setup material cleaning device 142 cleans and sterilizes said setup material 106 and the handling device 112 can then feed the cleaned and sterilized setup material 106 to the buffer location 144.

The setup material 106 can be temporarily stored or stored at the buffer location 144.

The setup material 106, which has been cleaned and in particular sterilized by means of the setup material cleaning device 142, can be fed back to the storage device 104 as cleaned or sterilized setup material 106 and can advantageously be reused.

For example, setup material 106 designed as multi-use components can have a technology container or a technology box 146, which can be connected, in particular exchangeably, to a process unit 102 (cf. 13 ). Such a technology box can preferably be arranged on the outside of a process unit 102, for example on the wall 114.

For example, such a technology box 146 may have an interior space, in particular for receiving and accommodating preferably temperature-sensitive and/or moisture-sensitive components for operating setup material 106, for example, tool units 108 and/or sensor units. It may be conceivable that this interior space of the technology box 146 can be arranged or is arranged adjacent to the interior space 116 of the process unit 102 and is spatially separated from this interior space 116 of the process unit 102, in which setup material 106 can be arranged by means of the handling device 112. This technology box 146 can, for example, be removable before cleaning and/or sterilizing, e.g., autoclaving, the rest of the process unit 102 and/or can be insulated and/or cooled, in particular passively or actively cooled, such that the said sensitive components are not damaged during cleaning and/or sterilization, e.g., autoclaving, of the process unit 102 and in particular of the interior 116 of the process unit 102.

• Im Wesentlichen kann das System 100 von 2 so betrieben werden wie das System 100 von 1, wobei vorliegend zwischen dem Zuführen von Rüstmaterial 106 mittels der Handhabungsvorrichtung 112 und dem Entnehmen von gebrauchtem, verbrauchtem und/oder verunreinigtem Rüstmaterial 106 aus der Prozesseinheit 102 mittels der Handhabungsvorrichtung 112 der Innenraum 116 der Prozesseinheit 102 mittels der Reinigungsvorrichtung 136 gereinigt und insbesondere sterilisiert wird.

A possible exemplary operation of the system 100 is described below:

• Essentially, the system can 100 of 2 be operated like the System 100 of 1 , wherein in the present case between the supply of setup material 106 by means of the handling device 112 and the removal of used, consumed and/or contaminated setup material 106 from the process unit 102 by means of the handling device 112, the interior 116 of the process unit 102 is cleaned and in particular sterilized by means of the cleaning device 136.

This can be understood, for example, as meaning that the handling device 112 opens the process unit 102 accommodated in the docking device 110 and coupled thereto, or that the process unit 102 opens independently and the handling device 112 removes the setup material 106 located in the process unit 102.

The handling device 112 feeds setup material 106 designed as single-use components to the waste lock 140, whereby that setup material 106 is or can be removed from the docking device 110 and preferably from the system 100.

The handling device 112 feeds setup material 106 designed as multi-use components to the setup material cleaning device 142, whereby that setup material 106 can be cleaned and sterilized so that it can be fed to the storage device 104 in order to be subsequently reused.

Subsequently, the interior 116 of the process unit 102 and/or the interior 126 of the docking device 110 is cleaned and sterilized by means of the cleaning device 136, in particular the nozzle devices and/or suction devices that can be guided and/or guided by means of the handling device 112.

Once the interior 116 of the processing unit 102 and/or the interior 126 of the docking device 110 has been cleaned and sterilized, the handling device 112 removes setup material 106 from the storage device 104 and/or setup material 106 is fed to the handling device 112 from the storage device 104. The handling device 112 supplies this setup material 106 to the processing unit 102 and arranges it in the interior 116 of the processing unit 102.

Referring to 3 a system 100 according to another exemplary embodiment of the present invention is schematically illustrated.

The 3 The embodiment of the system 100 shown is substantially configured and/or designed as the system 100 shown in 1 and/or 2 shown embodiments of the system 100, so that only the differences are described below.

As in 3 As can be seen, the system 100 is formed from two system sections 148, 150, namely a first system section 148 and a second system section 150. The respective system 100 of 1 and/or 2 is, however, formed coherently and/or a first system section 148 and a second system section 150 of system 100 of 2 are operatively connected to one another via the docking device 110. It is understood that more than two system sections can be provided in the respective systems 100.

In the present case, the first and second system sections 148, 150 are mutually objectionable.

In particular, the first and second system sections 148, 150 are arranged spaced apart from one another with respect to an environment of the system 100, e.g., a production plant.

As in 3 As can also be seen, the system 100 has the handling device 112 and a further handling device 152.

In a sense, the handling device 112 is a first handling device 112 and the further handling device 152 is a second handling device 152.

Here, the first handling device 112 serves to feed setup material 106 from the storage device 104 into the process unit 102 and to arrange the same in this process unit 102, and the second handling device 152 serves to remove setup material 106 from a process unit 102.

The first system section 148 includes the docking device 110, the first handling device 112, the cleaning device 136 and the storage device 104.

The second system section 150 comprises the second handling device 152, the waste lock 140, the equipment cleaning device 142 and the buffer area 144.

The cleaning device 136 is arranged between the storage device 104 and the docking device 110.

The first handling device 112 is arranged between the storage device 104 and the docking device 110. In particular, the first handling device 112 is arranged between a storage area of the storage device 104 and the docking device 110.

In the present embodiment, the first handling device 112 is assigned to the cleaning device 136 and the storage device 104.

This can be understood in particular that the first handling device 112 serves to feed setup material 106 from the storage device 104 into a or the process unit 102 and to arrange the same in this process unit 102 and to preferably guide and/or align two- and/or three-dimensionally at least one of the already described in connection with 2 described nozzle devices and/or suction devices.

It is understood that the first handling device 112 can also be used to remove setup material 106 from a or the process unit 102.

The second system section 150 is located upstream of the first system section 148.

In a sense, the cleaning device 136 is arranged at a cleaning station of the system 100, which can be assigned to the first system section 148, and the setup material cleaning device 142 is arranged at a clearing station upstream of the cleaning station which can be assigned to the second system section 150.

The setup material cleaning device 142 is assigned to the second handling device 152.

The setup material cleaning device 142 can be loaded with setup material 106 by means of the second handling device 152.

Furthermore, the waste lock 140 is accessible by means of the second handling device 152.

To a certain extent, preparation material 106 can be or can be fed to the waste lock 140 by means of the second handling device 152.

In a sense, in the second system section 150, the second handling device 152 is operatively connected to the setup material cleaning device 142 and the waste lock 140, as well as optionally to the buffer location 144.

By means of the second handling device 152, the setup material 106 that can be removed and/or removed from a process unit 102 can be fed to the waste lock 140 and removed via this, which has already been explained in connection with 2 was described.

It is understood that said setup material 106 can be or is removed from said process unit 102 by means of the second handling device 152.

The setup material cleaning device 142 can be equipped with the said setup material 106 for cleaning the same by means of the second handling device 152.

The setup material 106 can be temporarily stored on the buffer location 144 or can be temporarily stored there, for example, before the cleaned setup material 106 is fed back to the storage device 104.

Referring to 3 preparation material 106 can be removed from a or the process unit 102 by means of the second handling device 152 and fed to the waste lock 140 or first, preparation material 106 is removed from the process unit 102 by means of the second handling device 152 and fed to the waste lock 140.

Preferably, this primarily concerns equipment material 106 designed as single-use components and/or single-use material.

Furthermore, setup material 106 can be removed from a or the process unit 102 by means of the second handling device 152 and fed to the setup material cleaning device 142, or setup material 106 is first removed from the process unit 102 by means of the second handling device 152 and fed to the setup material cleaning device 142.

Preferably, this primarily concerns equipment material 106 designed as multi-use components and/or multi-use material.

The process unit 102 which can be emptied and/or emptied in this way is then actively or passively moved to the first system section 148 and in particular brought to the docking device 110.

There, the interior 116 of said process unit 102 can be cleaned and preferably sterilized by means of the cleaning device 136, or the interior 116 of the process unit 102 is then cleaned and preferably sterilized by means of the cleaning device 136.

The cleaned and preferably sterilized process unit 102 can then be supplied with setup material 106 from the storage device 104 by means of the first handling device 112 in the manner already described, or the cleaned and preferably sterilized process unit 102 can then be supplied with setup material 106 from the storage device 104 by means of the first handling device 112 in the manner already described.

As a result, the process unit 102 can advantageously be converted back into a reprocessed state and can be or be reused for the production of a product, in particular a biological-pharmaceutical product.

The 3 The system 100 shown can in particular serve for a sequential reprocessing of process units 102 in that first the second system section 150 or the clearing station arranged there and then the first system section 148 or the cleaning station arranged there is controlled and/or passed through by a respective process unit 102.

It is understood that in this sequential reprocessing, two process units 102 can also be located in parallel in the described system 100, which in 3 is indicated graphically.

It is understood that a or the process unit 102 by means of the second handling device device 152 is openable and/or a or the process unit 102 can open or is openable in a motorized and/or automated manner.

It is further understood that a or the process unit 102 can be closed in a motorized and/or automated manner, for example by means of the opening device 118.

It is further understood that one or the process unit 102 can be closed by means of the first handling device 112.

Additionally or alternatively, it may be provided that a separate device for opening and/or closing the process unit 102 may be provided on and/or in the docking device 110.

Referring to 4 a system 100 according to another exemplary embodiment of the present invention is schematically illustrated.

The 4 The embodiment of the system 100 shown is substantially configured and/or designed as the system 100 shown in 1 and/or 2 shown embodiments of the system 100, so that only the differences are described below.

The System 100 from 4 shows how the system 100 of 3 , a first handling device 112 and a second handling device 152.

Furthermore, the system 100 has a third handling device 154.

The first handling device 112 is assigned to the storage device 104 and further serves for storing, relocating and/or retrieving setup material 106 with respect to said storage device 104 and for loading a or the process unit 102 with setup material 106, which has already been described in connection with the previously described embodiments of the system 100.

In the present case, the first handling device 112 can be designed as a mobile or a stationary handling device, preferably depending on the design of the storage device 104.

The second handling device 152 is assigned to the setup material cleaning device 142 and further serves to remove setup material 106 from a or the process unit 102 and/or to dispose of setup material 106 in the waste lock 140, which has already been described in connection with the previously described embodiments of the system 100.

The third handling device 154 is assigned to the cleaning device 136 and further serves for the in particular two- and/or three-dimensional guidance and/or alignment of at least one of the nozzle devices and/or suction devices of the cleaning device 136, which has already been described in connection with the previously described embodiments of the system 100.

As in 4 As can be seen, the docking device 110 is arranged centrally with respect to the first, second and third handling devices 112, 152, 154.

The docking device 110 of 4 is essentially designed as the docking device 110 of 1 , wherein the docking device 110 of 4 further comprises a or the third access device 138, as already described in connection with the system 100 of 2 described, and further comprises a fourth access device 156, through which access to the interior 126 of the docking device 110 for the second handling device 152 is possible.

In a sense, the docking device 110 has corresponding access devices 122, 124, 138, 156 with respect to the connectable and/or coupled process unit 102 as well as to the first, second and third handling devices 112, 152, 154.

As already described, the respective access devices 122, 124, 138, 156 are enclosed or surrounded by sealing elements 128 to enable a preferably aseptic working environment with respect to the docking device 110.

The first handling device 112, the second handling device 152 and the third handling device 154 or the cleaning device 136 are arranged on the centrally arranged docking device 110 and preferably on the said respective access devices 124, 138, 156.

Here, the first handling device 112, the second handling device 152 and the third handling device 154 or the cleaning device 136 are arranged on the outside of the docking device 110 and preferably arranged at least partially around the docking device 110, respectively on the associated access device 124, 138, 156.

The first and second handling devices 112, 152 are arranged opposite one another with respect to the docking device 110. It is understood that they can alternatively also be arranged laterally to one another.

The third handling device 154 and the cleaning device 136 are arranged between the first handling device 112 and the second handling device 152 with respect to the docking device 110.

As already described, the second handling device 152 is associated with the setup material cleaning device 142.

Furthermore, the second handling device 152 is arranged adjacent to the setup material cleaning device 142 and the setup material cleaning device 142 can be equipped with setup material 106 by means of the second handling device 152 for cleaning and/or sterilization thereof.

To a certain extent, setup material 106 can be removed from a process unit 110 coupled to the docking device 110 by means of the second handling device 152.

In this case, in the case of setup material 106 designed as a multi-use component, the setup material 106 can then be fed to the setup material cleaning device 142 for cleaning and in particular sterilization.

Cleaned and/or sterilized preparation material 106 can be temporarily stored, preferably subsequently, on the buffer location 144, preferably before this preparation material 106 can be or is fed back to the storage device 104, for example by means of a corresponding transport device 160.

The interior 126 of the process unit 102 coupled to the docking device 110 can be cleaned and/or sterilized by means of the cleaning device 136.

This preferably occurs after setup material 106 has been removed from the interior 126 by means of the second handling device 152.

Furthermore, setup material 106 can be fed from the storage device 104 to the process unit 102 coupled to the docking device 110 by means of the first handling device 112

This preferably occurs after the interior 126 of this process unit 102 has been cleaned and/or sterilized by means of the cleaning device 136.

As already described, in the present embodiment, the second handling device 152 together with the setup material cleaning device 142 also serves as a clearing station of the system 100.

The cleaning device 136 and/or the third handling device 154 serve as a cleaning station of the system 100.

The first handling device, together with the storage device 104, serves as a setup station of the system 100, which can be a type of assembly station of the system 100.

The emptying station, the cleaning station and the setup station each form a system section, which (system sections) are all operatively connected to one another via the docking device 110.

A spacing of the respective stations is not planned in this case, but such a spacing can be done analogously to 3 be conceivable.

To a certain extent, it is understood that said stations may also be partially or completely spaced apart from each other, as for example in the embodiment of 3 .

This may, for example, enable sequential operation of the system 100.

It may further be provided that, in the case of system sections spaced apart from one another, each system section may have its own docking device 110, which may be configured like the docking device 110 already described herein.

• Eine Prozesseinheit 102 wird aktiv oder passiv an die Dockingvorrichtung 110 des Systems 100 aus einer Umgebung des Systems 100, beispielsweise einer Produktionsanlage und/oder einem Abschnitt einer Produktionsanlage, herangeführt.

A possible exemplary operation of the system 100 is described below:

• A process unit 102 is actively or passively brought to the docking device 110 of the system 100 from an environment of the system 100, for example a production plant and/or a section of a production plant.

This can be understood in particular as meaning that the process unit 102 reaches the docking device 110 independently, for example by means of a drive unit assigned to the process unit 102, or by means of a transport unit separate from the process unit 102, for example, the production plant, to the docking device 110.

The docking device 110 and the processing unit 102 are coupled to one another by means of the adapter device 132 and in particular the adapter element 134. Access is enabled via the first access device 122.

Subsequently, the interior 116 of the processing unit 102 is made accessible to the second handling device 152. For this purpose, the door element of the opening device 118 of the processing unit 102 pivots into an open state, which in 4 is shown schematically. Furthermore, access is or is enabled via the fourth access device 156.

If the process unit 102 is loaded with used setup material 106, the second handling device 152 removes it from the interior 116 of the process unit 102 and transports it, in the case of single-use setup material, to the waste lock 140 or, in the case of multi-use setup material, to the setup material cleaning device 142.

In a sense, the second handling device 152 removes setup material 106 from the process unit 102 via the docking device 110.

Subsequently, access is terminated again via the fourth access device 156.

Access is enabled via the third access device 138, and the interior 116 of the processing unit 102, preferably including the interior 126 of the docking device 110, is cleaned and preferably sterilized by means of the cleaning device 136 using the third handling device 154. This is done in the manner described herein.

Subsequently, access via the third access device 138 is terminated again.

Access via the second access device 124 is enabled and new setup material 106 is fed from the storage device 104 to the process unit 102 by means of the first handling device 112 and arranged in the interior 116 of the process unit 102.

In a sense, the first handling device 112 feeds setup material 106 from the storage device 104 via the docking device 110 to the process unit 102 and arranges it in the interior 116 of the process unit 102.

Subsequently, the interior 116 of the processing unit 102 is closed again. For this purpose, the door element of the opening device 118 of the processing unit 112 pivots into a closed state. Access via the first and second access devices 122, 124 is terminated.

The process unit 102 and the docking device 110 are decoupled from each other again, and the process unit 102 is ready for the production of a product, in particular a biological-pharmaceutical product. In a sense, the process unit 102 has been prepared and/or reconditioned.

Referring to 5 a system 100 according to another exemplary embodiment of the present invention is schematically illustrated.

The 5 The embodiment of the system 100 shown is substantially configured and/or designed as the system 100 shown in 4 shown embodiment of the system 100, so that only the differences are described below.

As in 5 As can be seen, the system 100 has a docking device 110 for receiving and coupling with a process unit 102.

In a sense, a process unit 102 can be accommodated in the interior 126 of the docking device 110 and coupled there.

For this purpose, the first access device 122 is designed such that a process unit 102 can enter the interior space 126 through it.

To a certain extent, the said reception of a process unit 102 can be effected or can be realized via the first access device 122.

This can be understood in particular to mean that the system 100 is essentially designed like the system 100 from 4 and a docking device 100, which is essentially designed like the docking device 100 of the embodiment of 2 .

Referring to 6 a system 100 according to another exemplary embodiment of the present invention is schematically illustrated.

The 6 The embodiment of the system 100 shown is substantially configured and/or designed as the system 100 shown in 4 and/or 5, so that only the differences are described below.

The first handling device 112 and the docking device 110 are part of the storage device 104.

A or the process unit 102 can be coupled via the docking device 110 in order to supply setup material 106 from the storage device 104 to the process unit 102 by means of the first handling device 112 and to arrange it in the latter.

Again 6 As can also be seen, the system 100 has a transport device 158 and a setup material transport device 160.

By means of the transport device 158, one or more process units 102 can be conveyed along a direction of movement 162.

In particular, several process units 102 can be conveyed simultaneously along the direction of movement 162 by means of the transport device 158.

The transport device 158 has a plurality of positions which are provided along the direction of movement 162 and at which various actions with respect to setup material 106 and/or process units 102 can be carried out or are carried out.

At a first position 164 along the direction of movement 162, setup material 106 can be removed from a process unit 102.

At a second position 166 along the direction of movement 162, setup material 106 can be fed into a process unit 102.

Here, the first position 164 is positioned upstream of the second position 166 with respect to the direction of movement 162.

The second handling device 152, the waste lock 140 and the equipment material cleaning device 142 are arranged at the first position 164.

At the second position 166, the first handling device 112, the docking device 110 and the storage device 104 are arranged, which in the present embodiment are formed together with one another.

Furthermore, between the first and second positions 164, 166, a third position 168 and a fourth position 170 are provided, at which the cleaning device 136 is arranged for cleaning and/or sterilizing a process unit 102 or process units 102.

In this case, a process separation of cleaning and sterilization is provided, wherein cleaning can be carried out by means of the cleaning device 136 at the third position 168 and sterilization can be carried out by means of the cleaning device 136 at the fourth position 170.

It is understood that the third position 168 or cleaning precedes the fourth position 170 or sterilization.

This can be understood in particular to mean that, with respect to the direction of movement 162, first the first position 164, then the third position 168, then the fourth position 170 and then the second position 166 is provided.

In a sense, along the transport device 158 and with respect to the direction of movement 162, first the clearing station, then the cleaning station and then the setup station are arranged.

This can be understood in particular to mean that along the transport device 158, removal, cleaning, sterilization and setup and preferably loading of setup material 106 and one or more process units 102 can take place.

In other words, the system 100 extends along the transport device 158 or is constructed along the transport device 158.

In other words, the system 100 extends along a transport path 172 of the transport device 158 or is constructed along the transport path 172.

In the present embodiment, the transport device 158 is designed as a conveyor belt system. It is understood that the transport device 158 can also be designed as a rail-guided transport system and/or one or more freely moving transport vehicles.

The transport device 158 is housed in a transport tunnel 174. It should be understood that said transport tunnel 174 is optional. Furthermore, it is conceivable that the transport tunnel 174 can be configured as the docking device 110, in which the respective process units 102 can be accommodated. Here, the access device 122 for the process units 102 can be formed from an input-side and an output-side access device.

At the respective positions 164, 166, 168, 170, respective access devices for access to the interior of the transport tunnel 174 are provided on the respective positions 164, 166, 168, 170. This allows access for the first handling device 112, the second handling device 152, and the cleaning device 136.

As in 6 As can be seen, the said setup material transport device 160 extends at a distance from and along the transport device 158.

In particular, said setup material transport device 160 extends from the setup material cleaning device 142 to the storage device 104.

In a sense, a transport path 176 of the setup material transport device 160 extends from the setup material cleaning device 142 to the storage device 104.

The transport path 176 of the setup material transport device 160 thus extends correspondingly to the transport path 172 of the transport device 158.

Here, the setup material transport device 160 is designed as a setup material conveyor belt system. It is understood that the setup material transport device 160 can also be designed as a rail-guided setup material transport system and/or one or more freely moving setup material transport vehicles.

By means of the setup material transport device 160, setup material 106 designed as multi-use components can be fed to the storage device 104 in a cleaned and, in particular, sterilized state, which is obtainable by means of the setup material cleaning device 142.

This can be understood in particular to mean that setup material 106 designed as multi-use components can be removed from a process unit 102 at the first position 164 by means of the second handling device 152, can be fed to the setup material cleaning device 142 and can be cleaned and sterilized there, and can then be transferred to the setup material transport device 160, for example by means of the second handling device 152, so that it can then be fed to the storage device 104 and/or can and/or will then be fed again.

Advantageously, the said setup material 106 configured as multi-use components can be, among other things, the technology containers or technology boxes 146 already described herein. In this case, these can be dismounted from the remaining process unit 102 by means of the second handling device 152 at the first position 164 and fed to the setup material transport device 160.

It is understood that setup material 106 designed as single-use components can be removed from a or the process unit 102 at the first position 164 by means of the second handling device 152 and can be fed to the waste lock 140.

• Eine oder mehrere Prozesseinheiten 102 werden nacheinander aktiv oder passiv an einen Beginn der Transportvorrichtung 158 aus einer Umgebung des Systems 100, beispielsweise einer Produktionsanlage und/oder einem Abschnitt einer Produktionsanlage, herangeführt.

A possible exemplary operation of the system 100 is described below:

• One or more process units 102 are successively brought actively or passively to a start of the transport device 158 from an environment of the system 100, for example a production plant and/or a section of a production plant.

The process units 102 are picked up one after the other by the transport device 158 and conveyed one after the other along the transport path 172 of the transport device 158 in the direction of movement 162.

Specifically, respective process units 102 are first conveyed to the first position 164, then to the third position 168, then to the fourth position 170, and then to the second position 166.

At the first position 164, a respective interior 116 of a process unit 102 located there is made accessible to the second handling device 152. For this purpose, a door element of the opening device 118 of the respective process unit 102 pivots into an open state, which in 6 is shown schematically.

If this process unit 102 is equipped with used setup material 106, the second handling device 152 removes it from the interior 116 of the process unit 102 and transports it, in the case of single-use setup material, to the waste lock 140 or, in the case of multi-use setup material, to the setup material cleaning device 142. It is understood that this can also refer to a technology box 146 attached to the outside of the process unit 102.

At the third position 168, a respective interior 116 of a process unit 102 located there is made accessible to the cleaning device 136 and/or such access still exists. The said interior 116 is cleaned at the third position 168 by means of the cleaning device 136. This is done on the in the manner described herein. Cleaning with foam may be conceivable here.

At the fourth position 170, a respective interior space 116 of a process unit 102 located there is made accessible to the cleaning device 136 and/or such access still exists. Said interior space 116 is sterilized at the fourth position 170 by means of the cleaning device 136. This is done in the manner described herein. Plasma sterilization may also be conceivable here.

At the second position 166, new setup material 106 is fed from the storage device 104 to the process unit 102 by means of the first handling device 112 and arranged in the interior 116 of the process unit 102 and/or a technology box 146 is reattached to the process unit 102.

The interior 116 of the processing unit 102 is then closed again. For this purpose, the door element of the opening device 118 of the processing unit 112 pivots into a closed state.

Afterwards, a respective process unit 102 is conveyed further and returned to the environment of the system 100. The process unit 102 is again ready for the production of a product, in particular a biological-pharmaceutical product. In a sense, the process unit 102 has been prepared and/or reconditioned.

It is understood that a respective process unit 102 first passes through the first position 164, then the third position 168, then the fourth position 170 and then the second position 166.

It is further understood that a plurality of process units 102 can be conveyed simultaneously in the manner described by means of the transport device 158 and can each move to the said positions one after the other.

To a certain extent, in the present exemplary embodiment, a first processing unit 102 can be arranged at the first position 164, a second processing unit 102 at the third position 168, a third processing unit 102 at the fourth position 170 and a fourth processing unit 102 at the second position 166, as shown by way of example in 6 is shown.

It is understood that between the four process units 102 shown, several further process units 102 can be arranged, which have already passed through the corresponding previous position and the associated action on the process unit 102 and are waiting for the subsequent position and the associated action on the process unit 102.

Referring to 7 A possible embodiment of a bearing device 104 is shown schematically.

The bearing device 104 of 7 can be, for example, the bearing device 104 which is provided in the respective system 100 according to the above and/or following embodiments.

This can be understood in particular to mean that this bearing device 104 of 7 can be part of said systems 100 according to the above and/or following embodiments.

The bearing device 104 has two bearing sections 178, 180, namely a first bearing section 178 and a second bearing section 180.

The first bearing section 178 is temperature-controlled and preferably cooled.

The second storage section 180 is temperature-controlled and preferably temperature-controlled such that a temperature prevailing in the second storage section 180 is above a temperature of the first storage section 178. For example, this temperature can be an ambient temperature, e.g., room temperature, of the system 100 or the rest of the system 100.

The first storage section 178 is preferably temperable or tempered to a temperature range of -32°C to 10°C, preferably from 4°C to 8°C.

The second bearing section 180 is preferably temperature-controlled or temperable to a temperature range of 20°C to 37°C, preferably 20°C±5%.

In a sense, a temperature difference between the first and the second bearing section is preferably at least 12°C.

The storage device 104 and in particular a respective storage section 178, 180 has a plurality of storage racks 182, each of which has a plurality of storage locations.

Each storage section 178, 180 has a storage handling device 184, 186, each associated with a first and a second storage handling device 184, 186, for loading gladly and/or relocate and/or retrieve setup material 106.

It is understood that alternatively it may be conceivable for respective storage sections 178, 180 with a substantially identical temperature range prevailing there to have a storage handling device for storing and/or relocating and/or retrieving setup material 106.

The storage handling devices 184, 186 are each a different device from the first handling device 112. It is understood that the storage handling devices 184, 186 can alternatively also form the first handling device 112.

The storage handling devices 184, 186 each have a gripper actuator and/or a robot arm in order to be able to remove setup material 106 from the storage shelves 182 and/or to store it in these and/or to relocate it.

Furthermore, the storage handling devices 184, 186 are movable along the storage racks 182 (see arrows in the 7 ) to allow full accessibility of the storage racks 182 for the storage handling devices 184, 186.

The storage device 104 comprises an inlet-side lock device 188.

The inlet-side lock device 188 serves for the preferably aseptic feeding of setup material 106 from an environment of the storage device 104 and in particular of the system 100 into the storage device 104.

It is understood that the setup material transport device 160 can also open into the inlet-side lock device 188 or, because the setup material 106 transported by the setup material transport device 160 has already been cleaned, can open directly into the storage device 104.

The inlet-side lock device 188 has an unpacking lock station 190, which is enclosed by an upstream and a downstream lock unit 192, on the one hand with respect to the environment and on the other hand with respect to the storage device 104 for aseptic demarcation.

At the unpacking lock station 190, setup material 106 to be stored in the storage device 104 can be unpacked automatically and/or manually by a user 194.

In the present embodiment, the storage sections 178, 180 are arranged directly on the docking device 110 (not shown in the figure) and the first and second storage handling devices 184, 186 can supply setup material 106 from the respective storage section 178, 180 to a process unit 102 and arrange it in the same.

It is understood that the first storage handling device 184 serves to feed cooled and/or cooling-requiring setup material 106 from the first storage section 178 into a process unit 102 and to arrange the same in this process unit 102. The same applies to the second storage handling device 186 and the setup material 106 stored in the second storage section 180.

Referring to 8 A possible embodiment of a bearing device 104 is shown schematically.

The 8 The embodiment of the bearing device 104 shown is essentially configured and/or designed like the one shown in 7 shown embodiment of the bearing device 104, so that only the differences are described below.

The bearing device 104 of 8 can be, for example, the bearing device 104 which is provided in the respective system 100 according to the above and/or following embodiments.

This can be understood in particular to mean that this bearing device 104 of 8 can be part of said systems 100 according to the above and/or following embodiments.

As in 8 As can be seen, the storage device 104 further comprises an output-side lock device 196.

Setup material 106 from the respective storage sections 178, 180 can be fed to a process unit 102 via the exit-side lock device 196.

In a sense, a setup material supply path extends from the storage device 104 and in particular the respective storage sections 178, 180 to the docking device 110 and preferably to a process unit 102 coupled to the docking device 110 and/or accommodated therein.

In this case, it can be provided that the first handling device 112 is arranged in and/or adjacent to the exit-side lock device 196 (not in the 8 shown, compare here for example 1 and/or 4 ).

In the exit-side lock device 196, setup material 106 can be transferred from the respective storage handling devices 184, 186 to the first handling device 112, preferably under aseptic ambient conditions.

It is understood that it can be provided that the inlet-side and/or the outlet-side lock device has a preferably integrated cleaning device for cleaning and/or sterilizing setup material 106 to be stored and/or fed to a process unit 102.

Advantageously, by using the exit-side lock device 196, an access device into the interior of the docking device 110 can be eliminated.

Referring to 9 to 12 a setup station 198 of a system 100 for setting up and/or preparing process units 102 for producing a product, in particular a biological-pharmaceutical product, is provided.

This can be understood in particular to mean that the system 100 has a setup station 198 for supplying cell-containing setup material 106 and/or fluidic setup material 106.

The feeding preferably relates to a process unit 102.

In particular, the supplying refers to a first supply of cell-containing preparation material 106 and/or fluidic preparation material 106, which can, for example, form a starting material for producing a product, in particular a biological-pharmaceutical product.

Optionally, a transport system (see handling device symbol in 9 and 10 ), by means of which a process unit 102 can be brought to the setup station 198 and preferably positioned there.

The respective design of the setup station 198 of 9 , 10 , 11 and/or 12 can be provided, for example, in the respective system 100 according to the above and/or following embodiments.

This can be understood in particular as meaning that a said setup station 198 of 9 , 10 , 11 and/or 12 can be part of said systems 100 according to the above and/or following embodiments.

The setup station 198 is provided in and/or on the docking device 110 or a setup device different from the docking device 110.

In the present exemplary embodiments, the setup station 198 is designed as a setup device different from the docking device 110, which is preferably arranged in and/or at a system boundary 200 of the system 100. For example, such a boundary 200 can be a cleanroom class boundary of the system 100 or of a production facility with the said system 100. Alternatively, it is conceivable that the said boundary 200 refers to the wall 130 of the docking device 110.

Referring to 9 The setup point 198 is located at the border 200.

The setup station 198 has a laminar flow device 202, by means of which an area 204 of the setup station 198 can be subjected to an air flow for contamination reduction, in which a supply of cell-containing setup material 106 and/or fluidic setup material 106 takes place or can take place.

Furthermore, the setup station 198 has a lock 204, via which cell-containing setup material 106 and/or fluidic setup material 106 can be supplied to the said area 204 from an environment of the system 100, preferably aseptically.

In the region 204, the setup material 106 provided with a sterile connector 208 can be aseptically connected to a complementarily designed sterile connector 210 of a process unit 102 for supplying cell-containing setup material 106 and/or fluidic setup material 106 therethrough, for example into a container arranged in the process unit 102.

Preferably, such a process can be fully automated.

Advantageously, due to the sterile connectors 208, 210, such a process can be carried out without actuating the opening device 118 of the process unit 102.

Referring to 10 The setup station 198 shown there is essentially configured trained and/or educated as those in 9 shown design of the setup station 198, so that only the differences are described below.

In the present case, no sterile connector 210 is formed and/or provided on the process unit 102.

In the present case, the region 204 serves to transfer the cell-containing setup material 106 and/or fluidic setup material 106 into the process unit 102; for example, for transferring fluidic material.

In this case, access to the interior 116 of the process unit 102 is made possible by means of the opening device 118 of the process unit 102, and the cell-containing setup material 106 and/or fluidic setup material 106 is transferred, for example, into a container arranged in the process unit 102, for example by means of a fluid conveying device of the process unit 102 or the setup station 198. Such a process can preferably be carried out fully automatically.

Referring to 11 the setup station 198 is arranged in the boundary 200, for example the clean room class boundary of the system 100 or a production plant with the said system 100 or the wall 130 of the docking device 110.

As in 11 As can be seen, the setup station 198 has a door device 212 to which a process unit 102 can be docked. The door device 212 is arranged in the boundary 200.

In the docked state, the process unit 102 and the door device 212 are sealed to the outside by means of sealing elements 214.

The door device 212 can be opened and/or closed automatically.

In the docked state, the door device 212 can be opened so that the setup material 106 provided with a sterile connector 208 can be aseptically connected to a complementarily designed sterile connector 210 of a process unit 102 for supplying cell-containing setup material 106 and/or fluidic setup material 106 therethrough, for example into a container arranged in the process unit 102.

After such a feeding process, the door device 212 can be closed again.

Referring to 12 the setup station 198 is arranged in the boundary 200, for example the clean room class boundary of the system 100 or a production plant with the said system 100 or the wall 130 of the docking device 110.

As in 12 As can be seen, the setup station 198 is provided with a sterile connector 216, which serves to supply cell-containing setup material 106 and/or fluidic setup material 106 therethrough.

The sterile connector 216 is set up in the limit 200.

The sterile connector 216 can be connected internally to a sterile connector 210 of a process unit 102.

The sterile connector 216 can be connected externally to a sterile connector 208 of the cell-containing setup material 106 and/or fluidic setup material 106.

The said sterile connectors 208, 210, 216 are each designed to be complementary to one another.

In a sense, the said sterile connectors 208 are each aseptically connectable to a complementarily designed sterile connector 216 of the setup station 198 for feeding cell-containing setup material 106 and/or fluidic setup material 106 therethrough, and the sterile connector 216 of the setup station 198 is aseptically connectable to a complementarily designed sterile connector 210 of the process unit 102 for feeding said material, for example, into a container arranged in the process unit 102.

Referring to 9 , 10 , 11 and/or 12, it may be conceivable that, in addition to or as an alternative to the sterile connectors 208, 210, 216, the setup station is provided with one or more rapid transfer ports, preferably for supplying cell-containing setup material 106 and/or fluidic setup material 106 through them.

In other words and referring to 9 , 10 , 11 and/or 12, a respective sterile connector 208, 210, 216 and/or a respective rapid transfer port can enable a connection between a respective process unit 102, in particular its interior 116, and an exit area from which cell-containing setup material 106 and/or fluidic setup material 106 can be supplied. For example, this exit area can be the storage device 104 and/or the lock device 188 and/or the lock 206 and/or an environment of the system 100.

Referring to 13 and 14 a process unit 102 according to an exemplary embodiment of the present invention is schematically illustrated.

The processing unit 102 may, for example, be a processing unit 102 as already described in connection with the system 100 herein.

The process unit 102 serves to produce a product, in particular a biological-pharmaceutical product.

The process unit 102 can, for example, be designed as a treatment box, e.g. a patient box, in particular for receiving and/or transporting and/or treating an object.

The process unit 102 can, for example, be designed as a tool box, in particular for treating an object, which can in particular comprise a tool unit, in particular for treating the object and/or a sensor unit, in particular for analyzing the object.

The process unit 102 can, for example, be designed as a supply box, in particular for providing a material, e.g. a consumable material, and/or a substance which may be required for the treatment of an object.

In the 13 and 14 For the purpose of description, the opening device 118 is omitted, in particular to illustrate the interior space 116.

The process unit 100 has a first access device 218 and a second access device 220, which can each selectively enable access to the interior space 116.

The first and second access devices 218, 220 each have a door element 222.

The door elements 222 serve to open and close a respective access opening to the interior 116, which is formed in the wall section of the wall 114 and is not shown in the figures.

The door elements 222 can be pivoted into the interior space 116 for opening and can be pivoted back into the respective access opening for closing.

The first and second access devices 218, 220 are each motorized.

In the present embodiment, the access openings are formed in a lower section, in particular the lowest section, of the wall 114 with respect to the direction of gravity G.

In a sense, the access openings are formed in a bottom side of the process unit 102.

Accordingly, the access devices 218, 220 are provided and particularly arranged on the underside of the process unit 102.

By means of the access devices 218, 220, a respective access to the interior space 116 along the direction of gravity G is possible.

As in the respective 13 and 14 As can also be seen, the process unit 102 comprises a first tool unit 108, 224, a second tool unit 108, 226 and a third tool unit 108, 228.

As already described, the tool units 108, 224, 226, 228 are setup material 106.

In particular, the said tool units 108, 224, 226, 228 are setup material 106, which is partly designed as single-use components and partly as multi-use components.

The said tool units 108, 224, 226, 228 were fed into the interior 116 of the process unit 102 via the said opening device 118 and then mounted in the interior 116 in the manner described herein.

Furthermore, the process unit 102 has a further interior space which is arranged adjacent to the interior space 116 and is spatially separated from the interior space 116.

The further interior space and the interior space 116 are separated from each other by a part of the wall 114, for example, a wall section. In this case, this is the wall section that can be assigned to the rear surface to which the aforementioned tool units 108, 224, 226, 228 are attached.

The further interior space serves to accommodate and house particularly temperature-sensitive and/or moisture-sensitive components, such as drive devices, motors, circuit boards, etc., which are assigned, for example, to the said tool units 108, 224, 226, 228 and/or the opening device and/or the Access device 220 can be assigned or is assigned.

In a sense, the further interior space is a type of technical box 146, which was already described at the beginning and is also equipment material 106, in particular multi-use equipment material 106.

This technology box 146 is, for example, removable before autoclaving the remaining process unit 102 and/or is insulated and/or cooled, in particular passively or actively cooled, in such a way that the said sensitive components are not damaged during autoclaving of the interior 116.

A preferably aseptic production area can be defined or is defined and/or formed by the interior space 116 of the process unit 102. In a sense, the interior space 116 of the process unit 102 is a preferably aseptic production area.

A respective access device 218, 220 of the process unit 102 can enable access to the particularly aseptic production area of the process unit 102, which is definable or defined and/or formed by the interior space 116.

The tool units 224, 226, 228 are used here to treat an object that can be used to manufacture the product.

• - ein Edukt, insbesondere ein Zellen aufweisendes Material, beispielsweise ein Zellen aufweisender Ausgangsstoff, und/oder ein biologisch-pharmazeutisches Material und/oder ein biologisch-pharmazeutisches Werkstück,
• - ein Zwischenprodukt, insbesondere ein Zellen aufweisendes Zwischenprodukt und/oder ein biologisch-pharmazeutisches Zwischenprodukt,
• - ein, beispielsweise das herzustellende, Produkt, insbesondere ein biologisch-pharmazeutisches Produkt, beispielsweise das herzustellende biologisch-pharmazeutische Produkt,
• - ein Verbrauchsstoff, beispielsweise ein Fluid und/oder eine aus einem Fluid gewonnene oder gewinnbare Komponente.

As already described, an object may, for example, include at least one of the following:

• - a reactant, in particular a material containing cells, for example a starting material containing cells, and/or a biological-pharmaceutical material and/or a biological-pharmaceutical workpiece,
• - an intermediate product, in particular a cell-containing intermediate product and/or a biological-pharmaceutical intermediate product,
• - a product, for example the product to be manufactured, in particular a biological-pharmaceutical product, for example the biological-pharmaceutical product to be manufactured,
• - a consumable, for example a fluid and/or a component obtained or obtainable from a fluid.

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

The first tool unit 224 is arranged in the interior 116 corresponding to the first access device 218.

The second tool unit 226 is arranged in the interior 116 corresponding to the second access device 220.

The first and second tool units 224, 226 are each movable within the interior space 116 and are each movable at least partially out of the interior space 116 when access is enabled via the first and second access devices 218, 220.

Such mobility of the first and second tool units 224, 226 is made possible by their design as an articulated arm arrangement.

The articulated arm arrangements are each fixed to a rear side of the interior 116 by means of coupling elements and connecting elements.

The temperature-sensitive and/or moisture-sensitive components of the articulated arm assemblies, such as motors, circuit boards, etc., are housed in the technical box 146 behind the rear of the interior 116.

Furthermore, the respective articulated arm assemblies are designed as multi-use components and can remain in the interior 116 during cleaning and/or sterilization of the interior 116 of the process unit 102 by means of the cleaning device 136. Furthermore, it is conceivable that the articulated arm assemblies cannot be considered as setup material but rather as part of the process unit.

Furthermore, the third tool unit 228 is designed as a fluid conveying device in the form of a syringe device 228, by means of which a fluid can be conveyed.

The syringe device is fluidically arranged between tool elements 230, which are each preferably releasably held on the first and second tool units 224, 226 and through which fluid can be conveyed.

The tool elements 230 and the associated fluid tubing are single-use equipment 106.

The left tool element 230 is designed, for example, as a feed element, by means of into which a consumable, in particular a fluid, can be dispensed.

The right tool element 230 is designed, for example, as a discharge element by means of which a consumable, in particular a fluid, can be absorbed.

Both tool elements 230 are tubular, for example as hollow needles or injection needles or hose elements or tube elements.

The syringe device 228 is at least partially designed as an exchangeable module which can be selectively installed and/or removed from the process unit 102, preferably in the manner described herein, for example by means of the first handling device 112.

The syringe device 228 is fluidically arranged between the tool elements 230.

The syringe device 228 comprises a syringe element 232, a valve 234 designed as a 3-way valve and an actuating actuator 236.

The syringe element 232 and the valve 234 are designed as single-use equipment 106, whereas the actuating actuator 236 is designed as multi-use equipment 106.

To a certain extent, the actuating actuator 236 can remain in the interior 116 during cleaning and/or sterilization of the interior 116 of the process unit 102 by means of the cleaning device 136. It is further understood that the actuator actuating the valve 234 can be designed as a multi-use tooling material 106 and/or can be permanently installed in the process unit 102, which (actuating actuator) can then also remain in the interior 116 during cleaning and/or sterilization.

The left tool element 230 is fluidically connected to the valve 234 and the right tool element 230 is fluidically connected to the valve 234.

Furthermore, the syringe element 232 is fluidly connected to the valve 234.

The valve 234 is fluidically arranged upstream of the syringe element 232 for switching a fluid path relative to the syringe element 232 and in particular a fluid path between the left and right tool elements 230.

For example, by means of the valve 234, fluid intake into the syringe element 232 via the left or right tool element 230 is possible depending on a switching state of the valve 234.

For example, by means of the valve 234, a fluid discharge from the syringe element 232 via the left or the right tool element 230 is possible depending on a switching state of the valve 234.

By means of the actuating actuator 236, the syringe element 232 can be actuated and, in particular, can be pulled open for fluid intake into the syringe element 232 and compressed for fluid discharge from the syringe element 232.

To a certain extent, depending on the switching state of the valve 234 and/or actuation of the syringe element 232, fluid can flow into the left or right tool element 230 for fluid intake or flow out again for fluid discharge by means of the actuation actuator 236.

A respective drive unit of the valve 234 and the actuating actuator 236 for the respective actuation thereof are further arranged in the technology box 146. In a sense, the drive units are multi-use equipment 106.

It can be provided that the process unit 102 comprises a control unit which is in particular designed and programmed to at least partially or completely regulate and/or control the process unit 102.

It is understood that it can be provided that the respective tool units 108, 224, 226, 228 can be controlled with the said control unit.

It is further understood that the process unit 102 may comprise an energy storage device, in particular for power supply, and/or may be connectable to such a device for power supply. Preferably, the respective tool units 108, 224, 226, 228 may be supplied with power in this way.

In the present embodiment, the process unit 102 can be coupled to further process units 102 by means of coupling devices provided on the process units 102.

In the 13 and 14 For example, a coupled state of the process unit 102 with two further process units 102 is shown.

The further process units 102 may, for example, have fluid containers with and/or without fluid in their respective interiors.

If access to the respective interior spaces of the process units 102 is enabled, the respective tool elements 230 can be moved by means of the respective articulated arm arrangements into the respective interior spaces and preferably the fluid containers of the further process units 102 for fluid conveyance and can be moved out again after the fluid conveyance has taken place.

As can be seen in the figures, the process unit 102 can be connected simultaneously and, in particular, mechanically coupled to a number of further process units 102 corresponding to the number of its own access devices 218, 220.

A particularly aseptic transition between the process units 102 coupled to one another via the respective access devices 218, 220 is possible.

The particularly aseptic transition between these process units 100 serves, for example, to supply something, preferably one of the said tool units 108, 224, 226 and/or a sensor unit, a material and/or a substance, to one of the said process units 102 from another of the said process units 102, in particular to supply it temporarily and/or permanently.

• Die Prozesseinheit 102 wird, beispielsweise durch eine Handhabungsvorrichtung 112 des Systems 100, mit dem beschriebenen Rüstmaterial 106, insbesondere den Werkzeugeinheiten 224, 226, 228 ausgestattet. Analog können die weiteren Prozesseinheiten 102 ausgestattet werden.

A possible exemplary operation of the process unit 102 will be described below:

• The process unit 102 is equipped, for example, by a handling device 112 of the system 100, with the described setup material 106, in particular the tool units 224, 226, 228. The other process units 102 can be equipped analogously.

The respective process units 102 are coupled together as shown in 13 and 14 is shown.

As in 13 and 14 As can be seen, a door element 222 then pivots from a closed state into the interior space 116 into an open state. A corresponding opening of the oppositely coupled further process unit 102 also occurs.

Subsequently, the associated tool element 230 can or will be moved out of the interior 116 of the process unit 102 by means of the articulated arm arrangement and into the interior of the further process unit 102.

In particular, fluid intake or fluid discharge can take place via the tool element 230 with respect to the further process unit 102 in the manner already described.

Parallel to this or subsequently, and conceivably also before this, the other door element 222 pivots from a closed state into the interior 116 into an open state in order to allow access to the other further process unit 102.

Subsequently, the other tool element 230 can be or will be moved out of the interior 116 of the process unit 102 by means of the other articulated arm arrangement and into the interior of the other further process unit 102. This occurs in a manner analogous to the movement already described.

With respect to the other further process unit 102, fluid intake or fluid discharge can thus take place in the manner already described.

The fluid can then be pumped by means of the syringe device 228.

For this purpose, the valve 234 switches to a switching state which corresponds to the intended conveying direction, and the actuating actuator 236 pulls the syringe element 232 apart so that the object to be conveyed, here fluid, is received in the syringe element 232 via the corresponding tool element 230.

Subsequently, the valve 234 switches to a further switching state, which is inverse to the previously mentioned switching state, and the actuating actuator 236 compresses the syringe element 232 so that the object to be conveyed, here fluid, is dispensed from the syringe element 232 via the corresponding tool element 230.

After completion of such a conveying process, the tool elements 230 are moved back into the interior 116 by means of the articulated arm arrangements.

The respective interior spaces 116 of the involved process units 102 are closed again by means of the access devices 218, 220.

The process units 102 can be decoupled from each other again and the single-use components can be connected to by means of the handling device 112, 152 can be replaced by new single-use components for a new treatment process.

Referring to 15 a system 100 according to another exemplary embodiment of the present invention is schematically illustrated.

The 15 The embodiment of the system 100 shown is substantially configured and/or designed as the system 100 shown in 4 shown embodiment of the system 100, so that only the differences are described below.

The 15 However, the system 100 shown is designed exclusively for equipment 106 designed as single-use components and/or single-use material.

In a sense, only equipment 106 designed as single-use components and/or single-use material is provided.

Accordingly, no setup material cleaning device 142 and no associated buffer space 144 are provided.

This can be understood in particular to mean that the system 100 with exclusively single-use setup material 106 is free of a setup material cleaning device 142 and/or free of a setup material transport device 160.

Referring to 16 a system 100 according to another exemplary embodiment of the present invention is schematically illustrated.

The 16 The embodiment of the system 100 shown is substantially configured and/or designed as the system 100 shown in 4 shown embodiment of the system 100, so that only the differences are described below.

The 16 However, the system 100 shown is designed exclusively for equipment 106 designed as multi-use components and/or multi-use material.

In a sense, only equipment 106 designed as multi-use components and/or multi-use material is provided.

Accordingly, no setup material cleaning device 142 and no associated buffer space 144 as well as no storage device 104 are provided.

In the present embodiment, the interior 116 of a process unit 102, including the setup material 106 located therein, which is designed as multi-use components and/or multi-use material, is cleaned and preferably sterilized by means of the cleaning device 136.

Optionally, the first handling device 112 can make changes in the arrangement of setup material 106 in the process unit 102 and/or remove objects from the interior 116 of the process unit 102 and feed them to the waste lock 140.

This can be understood in particular to mean that a system 100 with exclusively multi-use setup material 102 can be free of a storage device 102 and/or free of a setup material cleaning device 142.

Optionally, the system 100 may also be free of said waste lock 140.

Referring to 1 to 16 It should be understood that the system 100 described herein may be provided in a production facility not explicitly shown in the figures.

In a sense, a production facility may be provided for the manufacture of a product, in particular a biological-pharmaceutical product.

The production plant comprises: a system 100 configured according to the preceding description; and one or more process units 102 for producing a product, in particular a biological-pharmaceutical product, which (process unit(s) 102) is/are configured according to the preceding description.

All structural and functional features associated with the previously described system 100 and/or embodiments thereof may also be incorporated into the production facility, either alone or in combination, and the associated properties, configurations, and advantages may also be incorporated and achieved accordingly.

The production facility may have a particularly suitable clean room area.

For example, the limit 200 described herein may refer to this.

The cleanroom area can define an aseptic production area. The cleanroom area can have at least a cleanroom class CNC (ie Controlled but not Classified) according to Good Manufacturing Practice (GMP).

Referring to 17 a method for equipping and/or preparing process units 102 for producing a product, in particular a biological-pharmaceutical product, is shown schematically.

The method comprises: opening a process unit 102 received by a docking device 110 and/or coupled thereto and, preferably automated, removing used, consumed and/or contaminated setup material 106 from the process unit 102, step S1.

The method further comprises: cleaning and preferably sterilizing an interior 116 of the process unit 102 by means of a cleaning device 136, step S2.

The method further comprises: feeding setup material 106 from a storage device 104 into the process unit 102 and arranging it in this process unit 102 by means of at least one handling device 112 and closing the process unit 102, step S3.

It is understood that the method may also comprise further steps. For example, an intermediate step S2A of storing the process unit 102, e.g., in the storage device 104 or a corresponding storage location of a production facility, may be provided between steps S2 and S3. After such storage S2A, a further cleaning and/or sterilization step S2B of the process unit 102 may also be provided. In such an embodiment, the method may then comprise at least the aforementioned five steps S1, S2, S2A, S2B, and S3.

All structural and functional features associated with the previously described system 100 and/or the previously described production facility and/or embodiments thereof may also be included in the said method, either alone or in combination, and the associated properties, configurations, and advantages may also be included and achieved accordingly.

In addition, the previously described system 100 and/or the previously described production facility may each be configured to carry out the method described herein, and the method described herein may be configured to be executable by means of the previously described system 100 and/or the previously described production facility.

List of reference symbols

100

system

102

Process unit

104

Storage device

106

Equipment

108

tool unit

110

docking device; docking station

112

handling device; first handling device

114

Wall of process unit

116

Interior of process unit

118

Opening device of process unit

120

Dismantling area

122

first access facility

124

second access facility

126

Interior of docking device

128

Sealing element

130

wall

132

Adapter device

134

Adapter elements

136

Cleaning device

138

third access facility

140

Waste lock

142

Equipment cleaning device

144

Buffer space

146

Technical box of process unit

148

first system section

150

second system section

152

further handling device; second handling device

154

third handling device

156

fourth access facility

158

Transport device

160

Equipment transport device

162

Direction of movement

164

first position

166

second position

168

third position

170

fourth position

172

Transport path of transport device

174

Transport tunnel

176

Transport path of setup material transport device

178

first camp section

180

second camp section

182

storage rack

184

first warehouse handling device

186

second warehouse handling device

188

entrance-side lock device

190

Unpacking lock area

192

Lock unit

194

user

196

exit-side lock device

198

Preparation area

200

boundary; system boundary

202

Laminar flow facility

204

Area of setup area

206

Lock from the preparation area

208

Sterile connector

210

Sterile connector of process unit

212

Door device

214

Sealing element

216

Sterile connector from setup station

218

first access device of process unit

220

second access device of process unit

222

Door element of process unit

224

first tool unit

226

second tool unit

228

third tool unit, syringe device

230

Tool element

232

syringe element

234

valve

236

Actuating actuators

S1

Process step

S2

Process step

S3

Process step

Claims (15)

A system (100) for setting up and/or preparing process units (102) for manufacturing a product, in particular a biological-pharmaceutical product, wherein the system (100) comprises: a storage device (104) for receiving and/or storing and/or providing setup material (106), in particular one or more tool units (108) and/or one or more sensor units and/or consumables; a docking device (110) for receiving and/or coupling to a process unit (102); and at least one handling device (112) for feeding setup material (106) from the storage device (104) into a process unit (102) and for arranging the same in this process unit (102) and/or for removing setup material (106) from a process unit (102), wherein the setup material (106) can be fed by means of the at least one handling device (112) from the storage device (104) via the docking device (110) to a process unit (102) received by the storage device and/or coupled to the docking device. System (100) according to Claim 1 , characterized in that the system (100) comprises a cleaning device (136), by means of which an interior (116) of a process unit (102) can be cleaned and preferably sterilized, in particular after removal of setup material (106) from the process unit (102) by means of the at least one handling device (112) and/or before supplying setup material (106) from the storage device (104) into the process unit (102) by means of the at least one handling device (112), wherein it is preferably provided that the cleaning device (136) has one or more nozzle devices and/or one or more suction devices and optionally a handling device (112, 154) for, in particular, two- and/or three-dimensional guiding and/or aligning of at least one of the nozzle devices and/or suction devices. System (100) according to one of the preceding claims, characterized in that the docking device (110) has an interior space (126) formed by means of a wall (130) and an adapter device (132) for coupling to a process unit (102), wherein the adapter device (132) is formed at least partially corresponding and/or complementary to the process unit (102) and wherein the adapter device (132) is arranged in the interior space (126) or relative to the interior space (126), in particular partially or completely, is arranged on the outside, wherein it is preferably provided that the adapter device (132) arranged on the outside comprises one or more, in particular interchangeable, adapter elements (134); and/or wherein it is preferably provided that the adapter device (132) arranged in the interior (126) comprises a, in particular motorized, rotating and/or tilting platform. System (100) according to one of the preceding claims, characterized in that the docking device (110) has a waste lock (140) for removing waste, in particular used, consumed and/or contaminated setup material (106), from the docking device (110) and preferably from the system (100), wherein setup material (106) removed from a process unit (102) by means of the at least one handling device (112) can be fed to the waste lock (140) and removed via the latter. System (100) according to one of the preceding claims, characterized in that the system (100) comprises a setup material cleaning device (142), by means of which setup material (106) designed as multi-use components can be cleaned and in particular sterilized and which can be equipped with setup material (106) by means of the at least one handling device (112), wherein it is preferably provided that the setup material cleaning device (142) has an upstream buffer space for setup material to be cleaned and/or a downstream buffer space (144) for cleaned setup material (106), wherein it is preferably provided that the upstream and downstream buffer spaces are aseptically separated from one another. System (100) according to one of the preceding claims, characterized in that the system (100) comprises a first handling device (112) for feeding setup material (106) from the storage device (104) into the process unit (102) and for arranging the same in this process unit (102), and a second handling device (152) for removing setup material (102) from a process unit (102), wherein it is preferably provided that a) the first handling device (112) is part of the storage device (104) and/or is assigned thereto and the first handling device (112) is arranged between the docking device (110) and a storage area of the storage device (104); and/or b) the first and second handling devices (112, 152) are arranged opposite one another or laterally to one another with respect to the docking device (110). System (100) according to Claim 6 , characterized in that the system (100) is formed from at least a first and a second system section (148, 150), wherein the first system section (148) comprises at least the first handling device (112) and the storage device (104) and the second system section (150) comprises at least the second handling device (152), wherein the first and the second system section (148, 150) are operatively connected to one another via the docking device (110) or the first and the second system section (148, 150) are spaced apart from one another, wherein it is preferably provided that a setup material cleaning device (142) is assigned to the second handling device (152) and the setup material cleaning device (142) can be equipped with setup material (106) by means of the second handling device (152). System (100) according to one of the preceding claims, characterized in that the system (100) comprises a transport device (158) and/or can be arranged or is arranged on a transport device (158), wherein one or more process units (102) can be conveyed by means of the transport device (158) along a direction of movement (162), wherein setup material (106) can be removed from a process unit (102) at a first position (164) along the direction of movement (162) and setup material (106) can be fed from the storage device (104) into a process unit (102) at a second position (166) along the direction of movement (162), wherein the first position (164) is arranged upstream of the second position (166), wherein it is preferably provided that a) the transport device (158) is designed as a rail-guided transport system and/or one or more freely moving transport vehicles and/or a conveyor belt system and/or b) the system (100) extends along the transport device (158). System (100) according to one of the preceding claims, characterized in that the system (100) comprises a setup material transport device (160), by means of which setup material (106) designed as multi-use components can be fed to the storage device (104), in particular again, in a cleaned and in particular sterilized state, which is preferably obtainable by means of a setup material cleaning device (142) of the system (100), wherein it is preferably provided that a) the setup material transport device (160) is designed as a rail-guided setup material transport system and/or one or more freely moving setup material transport vehicles and/or a setup material conveyor belt system; and/or b) the setup material transport system (160) extends along a transport device (158) of the system (100). System (100) according to one of the preceding claims, characterized in that the storage device (104) has at least two storage sections (178, 180), wherein a first storage section (178) is temperature-controlled and preferably cooled and a second storage section (180) is temperature-controlled, wherein it is preferably provided that a) each storage section (178, 180) has a storage handling device (184, 186) for storing and/or relocating and/or retrieving setup material (106); or b) respective storage sections (178, 180) with a substantially identical temperature range prevailing there have a storage handling device (178, 180) for storing and/or relocating and/or retrieving setup material (106). System (100) according to one of the preceding claims, characterized in that the storage device (104) comprises an inlet-side lock device (188), wherein the inlet-side lock device (188) comprises at least one lock station, in particular an unpacking lock station (190), at which setup material (106) to be stored in the storage device (104) can be unpacked manually and/or automatically; and/or the storage device (104) comprises an outlet-side lock device (196), via which a setup material feed path extends from the storage device (104) to a process unit (102) and/or the docking device (1109), wherein it is preferably provided that the at least one handling device (112) is arranged in and/or adjacent to the outlet-side lock device (196). System (100) according to one of the preceding claims, characterized in that the system (100) has a setup station (198) for supplying cell-containing setup material (106) and/or fluidic setup material (106), wherein the setup station (198) is provided in and/or on the docking device (110) or is a setup device different from the docking device (110). System (100) according to one of the preceding claims, characterized in that a) the setup material (106) is designed as one or more single-use components and/or single-use material and as one or more multi-use components and/or multi-use material; or b) the setup material (106) is designed exclusively as one or more single-use components and/or single-use material; or c) the setup material (106) is designed exclusively as one or more multi-use components and/or multi-use material. A production plant for producing a product, in particular a biological-pharmaceutical product, comprising: a system (100) according to one of the preceding claims; and one or more process units (102) for producing a product, in particular a biological-pharmaceutical product. A method for setting up and/or preparing process units (102) for producing a product, in particular a biological-pharmaceutical product, the method comprising: opening a process unit (102) received by a docking device (110) and/or coupled thereto; feeding set-up material (106) from a storage device (104) into the process unit (102) and arranging the same in this process unit (102) by means of at least one handling device (112); and closing the process unit (102), wherein optionally, before the set-up material (106) is supplied, used, consumed, and/or contaminated set-up material (106) is removed from the process unit (102), in particular in an automated manner, and wherein an interior space (116) of the process unit (102) is preferably cleaned and, in particular, sterilized by means of a cleaning device (136).

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