DE102021207744A1 - Production plant and process for manufacturing a product - Google Patents

Abstract

The present application relates to a production plant (10), in particular for the production of biological-pharmaceutical products (20), and/or a method for the production of a product (20), in particular a biological-pharmaceutical product (20).

Description

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

Conventional production systems, especially in the pharmaceutical sector for personalized therapeutics, have a high proportion of manual intervention. Although this makes it possible to produce these therapeutics at a high personalized level or highly personalized, such individual and/or very small productions are associated with high costs and high fluctuations in quality and, associated with this, high production rejects and/or defective parts. Furthermore, there is no possibility for large-scale application and/or industrial production of individual and/or very small batch sizes.

The object of the present invention is to solve the aforementioned problems, in particular to be able to produce individual and/or very small lot sizes of products in the pharmaceutical sector efficiently and in particular with consistent quality.

According to the invention, this object is achieved by the features of claim 1 . Advantageous developments of the invention are described in the dependent claims.

• - einen, insbesondere geeigneten, Reinraumbereich,
• - eine Schleusenvorrichtung zur Zuführung eines Objekts aus einer Umgebung der Produktionsanlage in den, insbesondere geeigneten, Reinraumbereich und/oder zum Entfernen eines Objekts aus dem Reinraumbereich,
• - eine Handhabungsvorrichtung zum Bewegen des Objekts innerhalb des Reinraumbereichs, und
• - eine innerhalb des Reinraumbereichs angeordnete Lagervorrichtung, welche mehrere Lagerplätze zur Aufnahme mehrerer Objekte umfasst.

A production plant according to the invention, in particular for the production of biological-pharmaceutical products, preferably comprises:

• - a particularly suitable clean room area,
• - a lock device for feeding an object from an area surrounding the production plant into the particularly suitable clean room area and/or for removing an object from the clean room area,
• - a handling device for moving the object within the clean room area, and
• - A storage device arranged within the clean room area, which comprises a plurality of storage locations for accommodating a plurality of objects.

• - 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 Werkzeug bzw. eine Werkzeugeinheit, insbesondere ein edukt- und/oder produktberührendes Werkzeug bzw. eine edukt- und/oder produktberührende Werkzeugeinheit und/oder insbesondere ein nichtedukt- und/oder nicht-produktberührendes Werkzeug bzw. eine nichtedukt- und/oder nicht-produktberührende Werkzeugeinheit,
• - ein oder mehrere Verbrauchsmaterialien,
• - ein, beispielsweise das herzustellende, Produkt, insbesondere ein biologisch-pharmazeutisches Produkt, beispielsweise das herzustellende biologisch-pharmazeutische Produkt.

An object, in particular the object from the vicinity of the production plant for feeding into the clean room area and/or the object for removal from the clean room area, can include at least one of the following:

• - an educt, in particular a material containing cells, for example a starting material containing cells, and/or a biological-pharmaceutical material and/or a biological-pharmaceutical workpiece,
• - an intermediate product, in particular an intermediate product containing cells and/or a biological-pharmaceutical intermediate product,
• - a tool or a tool unit, in particular a tool that comes into contact with educt and/or product or a tool unit that comes into contact with educt and/or product and/or in particular a tool that does not come into contact with educt and/or product or a tool that does not come into contact with educt and/or product - tool unit in contact with the product,
• - one or more consumables,
• - a product, for example the product to be produced, in particular a biological-pharmaceutical product, for example the biological-pharmaceutical product to be produced.

It should be understood that the foregoing listing is exemplary and not exhaustive.

Alternatively or additionally, it can be provided that the object comprises one or more and/or a combination of the enumeration elements described above.

The educt can have cells and/or a biological material that differs in particular from cells.

The starting material can be at least partially liquid and/or at least partially semisolid and/or at least partially solid.

Alternatively, the educt can be completely liquid, or completely semi-solid, or completely solid.

• - eine Zellsuspension, beispielsweise als Zellen in einer Suspensionskultur, oder
• - adhärente Zellen, beispielsweise als Zellen an einer Kulturoberfläche insbesondere eines Behälters bzw. Eduktbehälters, beispielsweise eines Kulturgefäßes und/oder eines Beutels,

vorliegen, beispielsweise ausgebildet sein.The cells of the starting material can in particular as

• - a cell suspension, for example as cells in a suspension culture, or
• - Adherent cells, for example as cells on a culture surface, in particular of a container or educt container, for example a culture vessel and/or a bag,

present, for example, be formed.

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

It can be provided that the educt is in a container or educt container, in particular a vessel, for example a culture vessel, a cell culture vessel, a bottle, a vial, a bag, a cassette (e.g. a cassette made of, in particular, biocompatible, hard plastic) and /or a titer plate (e.g. a microtiter plate). It can be provided that the container or educt container, including the examples mentioned above, is suitable, in particular biocompatible, partially or completely coated and/or partially or completely uncoated.

Provision can be made for a container for receiving and processing an educt to have a volume of between 1 μl and 1000 ml, in particular between 1 μl and 500 ml, and furthermore in particular between 1 μl and 1000 μl. The volume can be 250 ml or 750 ml, for example. Furthermore, it can be provided that the volume is less than 1 μl and/or greater than 1000 ml.

The product can be a biopharmaceutical product for personalized therapy.

To a certain extent, the biological-pharmaceutical product can be a personalized therapeutic agent.

It can be provided that one or the personalization is provided for a patient or a patient group, in other words for one or more patients.

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

The clean room area can define an aseptic production area. The clean room area can have at least a clean room class CNC (i.e. Controlled but not Classified) according to good manufacturing practice (GMP).

It is conceivable that the clean room area has at least one of the clean room classes D, C, B or A in accordance with good manufacturing practice (GMP).

The clean room area can have an overpressure, in particular to protect educts and/or products, in particular with regard to sterility. In addition, the clean room area can have a negative pressure in an area of the clean room area that is separate from the overpressure area, in particular to protect a human operator or user from educts and/or products.

The production plant can have a system for adjusting the environmental properties of the clean room area.

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

Additionally or alternatively, the air device can be used to adjust air supply and/or air discharge into or out of the clean room area and/or air circulation, in particular including air return, within the clean room area, in particular via one or more filter devices of the system for setting the environment properties.

To a certain extent, an overpressure area in the production plant can define the clean room area and/or be the clean room area.

The production plant can have a housing, in particular for separating/delimiting the clean room area from the area surrounding the production plant and for maintaining its clean room class, with the housing surrounding the clean room area, in particular the clean room area and the lock device.

It can be provided that the housing to a certain extent surrounds the entire production plant.

The lock device can be configured to supply an object from an environment of the production plant via or through the housing (through) into the clean room area and/or to remove an object from the clean room area via or through the housing (through). To a certain extent, the lock device can serve as at least one interface, for example as at least one entrance and/or as at least one exit, of the housing, which surrounds at least the clean room area, to the environment of the production plant.

Additionally or alternatively, it can be provided that the lock device has at least one entry lock and at least one exit lock. In other words, the sluice device can have one or more entry sluices and one or more exit sluices. This can be used in particular for a directed object guidance or a directed object flow.

In addition or as an alternative, it can be provided that the entry locks and the exit locks can be categorized in relation to an object to be locked by them and can be provided accordingly as part of the lock device. For example, an entry lock and an exit lock can be provided for reactants and/or for consumables and/or for tools or tool units and/or for waste, or for any combination thereof.

Provision can be made, for example, for the entry lock and/or the exit lock to serve as an interface between the clean room area and the environment of the production facility.

The sluice device can have one or more maintenance sluices, via which the clean room area is accessible from an area surrounding the production plant, in particular for human operators or users.

In addition or as an alternative, it can be provided that one or more maintenance locks are designed as separate devices of the production plant from the lock device.

Additionally or alternatively, it can be provided that the clean room area has several clean room sub-areas.

In other words, the clean room area can be divided into several clean room sub-areas.

For example, it is conceivable that the handling device and the storage device are arranged in a common clean room subarea or in different clean room subareas.

The clean room sections can have an identical clean room class or different clean room classes.

It can be provided that one or more clean room sections have different overpressures.

In other words, one or more clean room sub-areas can have pressure differences in relation to overpressures relative to one another.

• - Reinraumklasse CNC,
• - Reinraumklasse D,
• - Reinraumklasse C,
• - Reinraumklasse B,
• - Reinraumklasse A,

jeweils gemäß der guten Herstellungspraxis (GMP).A clean room class can be one of the following clean room classes:

• - Clean room class CNC,
• - Clean room class D,
• - Clean room class C,
• - Clean room class B,
• - clean room class A,

each according to good manufacturing practice (GMP).

Each clean room sub-area can be assigned a respective sub-area housing, in particular for separating or delimiting the respective clean room sub-area and for maintaining its respective clean room class.

Additionally or alternatively, clean room sub-areas that have the same clean room class can be assigned a common sub-area enclosure.

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

Additionally or alternatively, the respective sub-area housing and/or the common sub-area housing can be formed separately, in particular independently.

Each partial area enclosure can be assigned at least one partial area lock device, which can be designed as a part of this partial area enclosure.

Additionally or alternatively, the at least one partial area lock device can be configured separately, in particular independently.

Each partition lock apparatus may be configured to deliver an object from one clean room partition to another clean room partition and/or to remove an object from one clean room partition to another clean room partition.

It can be provided that a clean room sub-area is divided into several sub-clean room sub-areas. For a possible design and/or configuration of the sub-clean room sections, reference is made to the description of the clean room sections.

Provision can be made for one or more clean room sub-areas to be set up with clean room class A in relation to processes and/or procedures, in particular for treatment and/or transport and/or storage and/or analysis and/or packing and/or or unpacking, in which there is contact with educt, intermediate product and/or product or there is a particularly theoretical possibility of such contact, for example by means of one or more objects that can lead to contamination, for example by means of a or several tools and/or one or more consumables and/or one or more devices of the production plant.

Provision can be made for one or more clean room sub-areas to be set up with clean room class B in relation to the lock device, the storage device, in particular the storage locations of the storage device, the handling device and/or a cleaning device of the production plant. In addition or as an alternative, one or more clean room sub-areas with clean room class A can also be set up in this regard.

Provision can be made for one or more clean room sub-areas to be set up with clean room class C or D in relation to a storage transport device of the storage device.

Provision can be made for one or more clean room sub-areas to be set up with clean room class CNC in relation to one or more remaining spatial areas of the production plant. In particular, these one or more remaining spatial areas can be provided for technical trades and/or machines that are required for the general operation of the production plant and/or parts of the production plant.

The production plant can have one or more (electrical) power sources and/or one or more interfaces that can be connected to one or more (electrical) power sources, which are arranged within the clean room area, in particular the housing, and which are configured to at least one of the To supply production plant comprised components or part of the production plant with electricity, the (component) or the (part) of the one or more power sources, for example via the one or more interfaces, is assigned.

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

The production plant can have one or more control units, which are arranged within the clean room area, in particular the housing, or on the production plant and which are designed and programmed to regulate at least one of the components included in the production plant or a part of the production plant and/or or to control the (component) or the (part) associated with the one or more control units.

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

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

Additionally or alternatively, it can be provided that the control units are programmed and designed to identify, code and/or assign one or more objects in the production plant, in particular using an ID assigned to an object, with the ID optionally being identified in particular using RFID -Aids and/or barcode means can be assigned to a respective object.

The production plant can include a number of workpiece carriers, which are used to hold objects, including educts and/or tools and/or consumables.

Provision can be made for one or more clean room sub-areas to be set up with clean room class A, based on the workpiece carrier. For example, it can be provided.

Additionally or alternatively, it can be provided that one or more clean room sub-areas are set up with clean room class B based on the workpiece carrier.

It can be provided that workpiece carriers are only within and/or between one or more clean room subareas with the same and/or essentially the same clean room class.

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

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

The production plant can include several types of workpiece carriers, which differ from one another with regard to the shape and/or dimensioning of a receiving area of the respective workpiece carrier. One type of workpiece carrier can be used to hold a vessel, for example a culture vessel, for holding an educt.

One type of workpiece carrier can be used to accommodate one or more tool units and/or tool consumables for carrying out a treatment process on an educt and/or for carrying out a maintenance process within the clean room area.

One type of workpiece carrier can be used to hold consumables for supplying them to a starting material and/or for carrying out a treatment process on a starting material.

One or more workpiece carriers can each include one or more action units for carrying out an action on an educt and/or on a tool.

One or more action units can be designed as a treatment unit, for example as a tool unit, for carrying out a treatment process on the starting material.

Provision can be made for a treatment unit, for example a tool unit, to be configured to carry out a rocking and/or a tilting and/or a shaking and/or a rotary movement, in particular by means of at least one correspondingly assigned actuator unit or actuator unit, see above that this type of movement, for example this type of combination of movements, can be transferred to the educt.

Provision can be made for a treatment unit, for example a tool unit or a component of a tool unit, to be configured in order to control the temperature of the workpiece carrier, in particular to heat and/or cool it.

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

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

It should be understood that the foregoing listing is exemplary and not exhaustive.

Alternatively or additionally, it can be provided that the parameter is a combination of the enumeration elements described above.

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

The workpiece carriers can be reused several times, in particular the storage device can be electrically recharged and/or refilled with consumables.

The workpiece carriers can have at least one interface, by means of which the electrical energy and/or the consumable can be charged or refilled and (re)dispensed.

The production plant can include a charging station arranged within the clean room area for charging the storage device and/or a refilling station arranged within the clean room area for refilling the storage device.

Provision can be made for the refilling station to be designed as a stationary refilling station, to which consumables can be fed via the lock device in order to refill it.

Provision can be made for the refilling station to be designed as a locally mobile refilling station which, in particular when filled with consumables, can be fed via the lock device from an area surrounding the production plant into the clean room area, and in particular when it is emptied of consumables through the lock device from the clean room area is removable.

The refilling station can in particular be arranged, for example arranged, on a storage location of the storage device.

The refilling station can, for example, comprise a vessel for a liquid or be designed as a vessel for a liquid.

The container for a liquid of the refilling station can have a volume between 1 ml and 100 l, preferably between 50 ml and 50 l, for example. The vessel can have an interface for removing and/or topping up the liquid.

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

The storage device can comprise a storage transport device for transporting objects to and/or from the storage locations.

The handling device can have a distribution unit, via which objects to be transported can be fed to the storage transport device and/or can be received by it. Optionally, the distribution unit can be embodied as or as part of a sluice transport device, or can be associated with such a device.

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

The storage transport device can comprise a rail-guided transport system and/or one or more free-moving transport vehicles.

The storage transport device can include one or more rail-guided storage transport units, by means of which one or more storage racks of the storage device are accessible, in particular for storage and retrieval processes and for treatment processes and/or maintenance processes.

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

In addition or as an alternative, it can be provided that the storage transport device comprises one or more storage transport units designed as a pick-and-place robot or as a cable robot.

Provision can be made for one or more storage space areas of the storage device to be accessible by means of the one or more portal conveyors, in particular for storage and retrieval processes and for treatment processes and/or maintenance processes.

The storage transport device, in particular the rail-guided transport system, the one or more free-moving transport vehicles, the one or more rail-guided storage transport units and/or the one or more portal conveyors, can be guided by induction loops and/or magnetically, in particular guided by permanent magnets and/or guided by magnetic coils , being. In addition or as an alternative, sensor-based guidance, in particular camera-based guidance and/or radar/LIDAR-based guidance, can be provided.

It can be provided that the storage transport device, in particular the rail-guided transport system, the one or more free-moving transport vehicles, the one or more rail-guided storage transport units and/or the one or more portal conveyors, is configured to have at least two clean room sub-areas that are one from the other have different clean room class to be able to drive through, for example to drive through.

The storage transport device, in particular the rail-guided transport system, the one or more free-moving transport vehicles, the one or more rail-guided storage transport units and/or the one or more portal conveyors, can be at least partially encapsulated, whereby, for example, in the case of encapsulated actuators of the storage transport device, release of possible contaminants, in particular due to particle abrasion of the actuators, can be avoided or at least reduced.

Additionally or alternatively, it can be provided that the storage transport device comprises one or more elevator devices, by means of which one or more storage space areas of the storage device are accessible in particular for storage and retrieval processes and for treatment processes and/or maintenance processes.

The handling device can be or comprise a multi-axis robotic arm.

Additionally or alternatively, it can be provided that the handling device is or includes a pick-and-place robot or a cable robot, and/or that the handling device is or includes a suitable gripper actuator set up on a planar runner.

In addition or as an alternative, it can be provided that the rail-guided transport system and/or the one or more freely moving transport vehicles of the storage transport device each comprise at least one multi-axis robotic arm.

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

The changing device can have at least one adapter device and/or at least one matrix device, which are each designed to correspond to the gripping units and/or carrier units in order to be able to grip them in particular in a form-fitting manner and to attach them to the one or more storage transport units of the storage transport device and/or to to be able to mount the one or more handling units of the handling device.

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

Provision can be made for the cleaning device to be set up for cleaning, in particular using radiation and/or gassing.

The cleaning device of the production plant assigned to the storage transport device and/or the handling device can be arranged in particular in or on the lock device or, for example, directly adjacent to the lock device within the clean room area. It can be provided that the cleaning device of the production plant assigned to the storage transport device and/or the handling device is spatially separated from the lock device within the clean room area.

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

The lock device can include an entry lock, via which a lock location, in particular an entry lock location, is accessible from the environment and which is configured to supply an object from an area surrounding the production plant into the clean room area, and an exit lock, via which a lock location, in particular a Exit airlock site accessible from the environment and configured to remove an object from the cleanroom area.

The handling device can comprise a lock transport device, by means of which one or more objects can be moved from one lock location, in particular an entry lock location, to another lock location, in particular a transfer lock location, and/or from one lock location, in particular a transfer lock location, to another lock location, in particular an exit lock location. are transportable.

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

In addition or as an alternative to at least one lock, especially the entrance lock place and/or the exit lock place, an unpacking place and/or a packing place can be provided in the lock device.

The unpacking station can be assigned to the entrance airlock station, arranged adjacent or spatially separated. In addition or as an alternative, the entry lock location can be the unpacking location.

The packing station can be assigned to the exit lock station, arranged adjacent or spatially separate. In addition or as an alternative, the exit lock area can be the packing area.

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

It can be provided that, by means of the handling device, one or more workpiece carriers, in particular one or more loaded workpiece carriers (e.g. equipped with an educt), from a lock location of the lock device to the storage transport device, in particular to the one or more storage transport units of the storage transport device, can be transferred in particular via the one or more workpiece carrier receptacles.

In other words, one or more workpiece carrier changes can be carried out, for example carried out, by means of the handling device.

The lock device can include a cleaning device for cleaning one or more workpiece carriers and/or for cleaning one or more workpiece carrier receptacles.

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

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

Provision can be made for each of the respective cleaning devices to be designed at least partially or completely separately from one another, in particular to form independent devices.

The storage device can comprise one or more storage racks and/or one or more storage space areas, each of which has a number of storage spaces.

The respective storage locations can have different clean room classes from each other. In this context, reference is also made to the corresponding part of the description regarding the clean room classes.

The respective storage locations can serve as decoupling areas and/or rooms to areas and/or rooms that are used to carry out treatment processes.

It can be provided that the storage locations are temperature-controlled, in particular individually temperature-controlled, by means of a temperature control device, in particular that is assigned to the storage device.

The storage locations can be thermally decoupled from one another and/or can be decoupled by means of thermal insulation, whereby the storage locations can be temperature-controlled independently and/or differently from one another, for example can be heated or cooled using a respectively assigned temperature control device.

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

Provision can be made for several storage space areas, in particular two or more storage space areas, to be arranged one above the other, in particular in a vertical direction.

To a certain extent, the multiple storage space areas can be arranged in a stacked manner.

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

Using the storage transport device, starting materials and/or tools and/or consumables can be stored in the storage locations or removed from them.

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

One or more storage locations can be accessible from a number of directions and/or by means of a number of storage transport units of the storage transport device. For example, a storage rack can be arranged between two storage transport units, for example, so that access can be guaranteed from each storage transport unit to the intermediate storage rack or so that each of the two storage transport units, for example, has access to the intermediate storage rack.

It can be conceivable that a further storage rack is arranged on the respective other side of the two storage transport units, for example.

To a certain extent, there can be a storage rack-storage transport unit-storage rack-storage transport unit-storage rack arrangement.

It is conceivable that in particular tools and/or consumables can be stored in the intermediate or central storage rack and educts can be stored in the respective outer storage racks.

Such an exemplary arrangement can enable, for example, short distances from tools and/or consumables in particular to the starting materials.

A comparable advantage with regard to short distances or an optimization of distances can be achieved in addition to such an alternating arrangement of the storage racks, for example, by a star arrangement of storage racks, which can be provided additionally or alternatively in the present case.

The storage locations can be accessible in the vertical direction from above or in the horizontal direction from the side by means of the storage transport device.

Several essentially horizontally aligned rows of storage locations can be arranged one above the other in the vertical direction.

To a certain extent, the storage locations can be arranged in a matrix.

Several of the storage locations, in particular all storage locations, can be shelf locations of one or more storage shelves.

The storage device can include several different types of storage locations for receiving different types of workpiece carriers.

The various types of storage locations can differ from one another in terms of their shape and/or dimensions.

The various types of storage space can differ from one another in terms of their function and/or equipment.

The different types of storage locations can be distributed in a regular pattern in a storage location shelf and/or a storage location area of the storage device.

In this way, for example, quick access to tools or tool units that are required for a treatment process of a starting material can be guaranteed.

Provision can be made for the various types of storage locations to be arranged in a storage space shelf and/or a storage space area of the storage device according to an optimized, in particular a minimum, distance with regard to the objects to be stored or stored in the storage spaces.

In this way, for example, quick access to tools that are required for a treatment process for an educt can be guaranteed.

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

The storage device can include several storage locations, which form treatment stations for treating starting materials.

The storage device can include several storage locations, which form tool stations for storing, maintaining, cleaning, changing, charging and/or checking tools.

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

The workpiece carriers already described can be designed in particular as receiving boxes for receiving educts.

In addition or as an alternative, it can be provided that the production plant comprises a plurality of receiving boxes for receiving one or more workpiece carriers together with the educts arranged and/or received thereon.

To a certain extent, the production plant can comprise a plurality of workpiece carriers designed as receiving boxes for receiving educts or a number of receiving boxes for receiving one or more workpiece carriers together with educts arranged and/or received thereon.

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

To a certain extent, the receiving box can be a process cell, in particular an aseptic process cell, or a process unit, in particular an aseptic process unit.

Provision can be made for one or more clean room sub-areas to be set up with clean room class A in relation to the storage boxes or a respective storage box.

It can be provided that a primary function of a storage box is the provision of an air-conditioned pharmaceutical process room or an air-conditioned pharmaceutical process environment, in particular in compliance with the highest clean room requirements, in particular in compliance with clean room class A.

A receiving box can be configured in particular for incubation, with the receiving box in particular having interfaces for one or more tool units, in particular for gassing and/or temperature control.

The storage box can be 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, as a result of which the cleaning ability of the storage box is optimized.

For the hygienic design of a storage box, it can be equipped in particular with a means for magnetic fixation, whereby in particular the educts can be reliably kept under optimized hygienic conditions, whereby, for example, the means for magnetic fixation can be configured to be connected to an at least partially magnetic counter-element of a vessel to cooperate for receiving an educt or an educt container.

In addition or as an alternative, it can be provided for this purpose that a storage box is equipped with a means for positive and/or non-positive fixing.

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

One or more of the storage boxes can surround a closable inner space.

A clean room section and/or an aseptic production area can be defined by the closable interior.

To a certain extent, it can be provided that the lockable interior is a clean room subarea and/or an aseptic production area.

The clean room area that can be defined by the lockable interior can have a clean room class A.

The receiving boxes for introducing an educt and/or for removing a product made from an educt can be openable and/or closable automatically and/or by means of the handling device.

One or more of the storage boxes can each comprise one or more conditioning units that are integrated or detachably arranged thereon or can be arranged detachably thereon, by means of which a temperature and/or pressure and/or humidity and/or gas composition in the interior of the respective storage box can be influenced, in particular controlled and/or adjustable.

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

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

The storage boxes can include one or more connection elements, which can be connected to corresponding connection elements at one or more treatment stations, in particular to supply the respective storage box with electrical energy and/or consumables, in particular liquids and/or gases, and/or to provide signaling Coupling of the respective receiving box with a particular higher-level control device, such as one or more control units to produce.

The storage device can include storage locations provided with connection elements, so that one or more treatment processes for treating the educts can be carried out at the storage location of the storage device serving as treatment locations.

The storage locations of the storage device and/or the storage boxes can include fixing elements, by means of which the storage boxes can be positioned and/or fixed at the storage locations.

The storage boxes can each include one or more tool holders for receiving and fixing one or more tools, in particular in the interior of the respective storage box.

The one or more tool holders can each comprise one or more connection elements, which can be connected to corresponding connection elements on the tool to be held in each case, in particular in order to supply the respective tool with electrical energy and/or consumables, in particular liquids and/or gases, and /or to produce a signal-technical coupling of the respective tool with the receiving box and/or a particular higher-level control device.

The receiving boxes can also be stored in storage locations (respectively) in a state not used for product manufacture, in particular after cleaning by means of a cleaning device of the production plant, for example the one already described.

The receiving boxes stored at storage locations in a state not used for product manufacture can be removed from the storage locations for receiving or introducing educts, in particular fully automatically by means of the storage transport device of the storage device.

In addition or as an alternative, it can be provided that a receiving box comprises one or more connecting elements, which can be connected to corresponding connecting elements on a further receiving box, as a result of which an assembled receiving box can be provided.

For a possible design and/or configuration of the assembled storage box, reference is made to the description of the storage box(es).

Provision can be made for one or more storage locations to be configured as storage locations for assembled storage boxes.

In addition or as an alternative, it can be provided that one or more, in particular all, receiving boxes are configured to receive one or more workpiece carriers together with tools and/or consumables arranged and/or received thereon. In addition or as an alternative, it can be provided that a workpiece carrier is designed as a tool carrier and/or as a consumables carrier. The production facility can include an unpacking device for unpacking objects to be supplied to the clean room area.

The unpacking device can be integrated into the lock device or form part of it.

Additionally or alternatively, it can be provided that the unpacking device is attached to the handling device and/or the storage device, in particular via an autoclaving device, for example a pass-through autoclaving device, by means of which unpacked and/or partially unpacked objects can be received, then sterilized and dried, and then the can be fed to the handling device and/or the storage device, in particular in an automated manner.

The sluice device can include an entry sluice location, which is accessible from the vicinity of the production plant and at which a packed object can be arranged, in particular by a person and/or automatically.

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

The lock device can include a cleaning device, for example the one already described, for cleaning a packaging of the packaged object.

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

The cleaning by means of the cleaning device of the lock device can be carried out in particular at the entry lock location, the unpacking location and/or a cleaning location provided in the lock device.

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

One or more unpacking units for unpacking starting materials and one or more further unpacking units for unpacking tools and/or consumables can be configured.

The packaging of the packaged object, in particular the packaged educt, can be removed in a sterile manner by means of one or more unpacking units after unpacking, for example via the exit lock location and/or via a waste lock location of a separately designed waste lock of the unpacking device or the lock device, whereby the unpacked object, in particular the unpacked educt cannot come into contact with the packaging.

The object, in particular the educt, can be fed to the handling device after unpacking, in particular by means of the lock transport device.

Provision can be made for the unpacking station in the lock device to be spatially separate from the rest of the lock device.

The unpacking can be carried out fully automatically by means of one or more unpacking units.

In addition or as an alternative, it can be provided that the unpacking can be carried out manually and/or semi-automatically, for example automatically using at least one manual action.

It can be provided that the lock device, in particular one of the lock locations provided in the lock device, for example the unpacking location, can be cleaned before, during and/or after unpacking by means of the cleaning device of the lock device, in particular by means of irradiation and/or gassing.

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

The unpacking device can comprise a detection device and a control device, by means of which a type of object to be unpacked and/or a type of packaging to be removed can be determined.

The control device can be used to select and control an unpacking unit of the unpacking device to carry out the unpacking process, with the unpacking unit being one of several unpacking units for carrying out different unpacking processes, with the selected unpacking unit depending on the determined type of object to be unpacked and/or the type of object to be removed Packaging can be assigned.

In addition or as an alternative, it can be provided that unpacking can be carried out manually, for example at the entry lock location.

The production plant can include a packaging device for packaging the objects to be removed from the clean room area, for example the manufactured product.

The packaging device can be integrated into the lock device or form part of it.

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

The sluice device can include an exit sluice location, which is accessible from the vicinity of the production plant and from which a packaged object can be removed in particular by a person and/or automatically.

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

The packaging device can comprise a number of packaging units for packaging different types of objects and/or packaging, in particular for packaging the objects with different types of packaging.

One or more packaging units for packaging manufactured products and one or more further unpacking units for packaging used tools and/or consumables to be removed can be configured.

The object to be packaged, in particular the manufactured product, can be moved, in particular handled or transported, before, during and/or after packaging by means of the handling device and/or the lock transport device.

Provision can be made for the packing station in the lock device to be set up spatially separately from the rest of the lock device.

The packaging can be carried out fully automatically by means of one or more packaging units.

In addition or as an alternative, it can be provided that the packaging can be carried out manually and/or semi-automatically, for example automatically using at least one manual action.

It can be provided that the lock device, in particular one of the lock locations provided in the lock device, for example the packaging location, can be cleaned before, during and/or after packaging by means of the cleaning device of the lock device, in particular by means of irradiation and/or gassing.

The packaging device can comprise a detection device and a control device, by means of which a type of object to be packaged and/or a type of packaging to be used can be determined.

A packaging unit of the packaging device for carrying out the packaging process can be selected and controlled by means of the control device, wherein the packaging unit can be one of several packaging units for carrying out different packaging processes, with the selected packaging unit depending on the determined type of object to be packaged and/or the type of packaging used can be assigned.

It can be provided that the packaging device and the unpacking device are designed in a common device for unpacking and/or packaging.

As has already been described in connection with the conditioning units of the receiving boxes, the production plant can include a tool system.

In particular, the production plant can include a tool system, by means of which treatment processes on educts and/or maintenance processes can be carried out within the clean room area.

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

It can be provided that a tool unit described herein is a tool described herein and/or a tool described herein is a tool unit described herein.

The tool system can include one or more tool units designed as feed units for feeding consumables to the educts.

Provision can be made for consumables to include at least one liquid and/or at least one gas and/or gas mixture.

In addition or as an alternative, it can be provided that consumables comprise at least one solid, for example at least one lyophilized solid.

The tool system can comprise one or more tool units configured as extraction units for extracting a sample from an educt.

One or more of the tool units of the tool system can each include one or more multi-use components and/or one or more single-use components.

The tool system can include a set-up unit, by means of which one or more single-use components of a tool unit can be removed, in particular disposed of, fully automatically after it has been used and replaced by one or more new single-use components.

A single-use component can in particular be a component that cannot be used again after it has been used once, in particular for the first time.

A multi-use component can in particular be a component that can be used at least one more time after it has been used once, in particular for the first time.

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

It can optionally be provided that such an element and/or such a system comprises at least one of the following: a tube, a needle, a syringe, a container, in particular a vessel or a bag, for example a vessel for an educt, a valve, a microfluidic unit, a probe, a cartridge, a vial, and/or a small bottle, in particular for reagents.

It should be understood that the foregoing listing is exemplary and not exhaustive.

Alternatively or additionally, it can be provided that the element has a combination of the enumeration elements described above.

A multi-use component can be cleanable and/or sterilizable.

The set-up unit can be arranged entirely within the clean room area.

The set-up unit can include a handling unit, in particular a multi-axis robotic arm, by means of which a fully automatic set-up process can be carried out.

It can be provided that the set-up process, in particular a dismounting process and/or a set-up process of the set-up process, can be carried out in one or in several, in particular different, clean room sub-areas of the clean room area.

The set-up unit can include a cleaning unit or a cleaning unit can be assigned to the set-up unit, by means of which multi-use components of one or more tool units can be cleaned, in particular sterilized, after they have been used.

In addition or as an alternative, it can be provided that the cleaning unit is designed independently or separately as a tool unit.

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

The tool system can include a number of portable tool units which, in order to carry out a treatment process, can be fed to a treatment station for treating an educt, which in particular is also a storage location for storing the educt, and can be temporarily stored there.

One or more portable tool units of the tool system can be fed to a tool storage area and/or to a treatment area and/or to a set-up area by means of a storage transport device, in particular one or more storage transport units.

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

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

Provision can be made for a tool unit to be disposable or reusable.

A tool unit can be parked in a storage location, temporarily stored, storable and/or can be connected to assigned interfaces in the storage location.

A tool unit can be a mechanical tool.

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

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

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

A tool unit can be a means for the biochemical manipulation of cells, by means of which at least one substance can be supplied to an educt, and/or the temperature of an educt can be changed, and/or the ambient pressure of an educt can be changed, the educt being in particular in a tool carrier , In particular in a receiving box, arranged, in particular recorded, is. In this way, in particular the environment of the educt, in particular the cells of the educt, can be changed in order to change the educt itself, in particular the cells of the educt themselves, in particular with regard to cell growth and/or a cell surface, for example a cell membrane surface, and/or or a cellular metabolism.

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

In addition or as an alternative, it can be provided that at least one auxiliary substance, for example magnetic particles, is used for concentrating and/or separating off liquids.

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

It should be understood that the foregoing listing is exemplary and not exhaustive.

• - dem Reinraumbereich selbst, beispielsweise einem Reinraumteilbereich des Reinraumbereichs selbst, um deren Reinraumeigenschaften, beispielsweise deren Reinraumklasse-Eigenschaften, aufrechtzuerhalten,
• - der Lagertransportvorrichtung, insbesondere einer Lagertransporteinheit der Lagertransportvorrichtung, um die Reinraumeigenschaften, beispielsweise die Reinraumklasse-Eigenschaften, des Reinraumbereichs, beispielsweise des Reinraumteilbereichs, in welchem die Lagertransportvorrichtung bzw. deren Lagertransporteinheit angeordnet und/oder bewegbar ist, aufrechtzuerhalten,
• - Verbrauchsmaterial,
• - einem Werkzeug bzw. einer Werkzeugeinheit
• - einem Werkstückträger.

Provision can be made for the tool system to include a recycling and/or reprocessing unit, by means of which cleaning and/or reprocessing processes can be carried out in the clean room area, in particular on at least one of the following:

• - the clean room area itself, for example a clean room sub-area of the clean room area itself, in order to maintain its clean room properties, for example its clean room class properties,
• - the storage transport device, in particular a storage transport unit of the storage transport device, in order to maintain the clean room properties, for example the clean room class properties, of the clean room area, for example the clean room partial area, in which the storage transport device or its storage transport unit is arranged and/or movable,
• - consumables,
• - a tool or a tool unit
• - a workpiece carrier.

It should be understood that the foregoing listing is exemplary and not exhaustive.

The recycling and/or reprocessing unit can have a sensor system, by means of which a success, in particular a quality, of a cleaning and/or reprocessing process can be determined.

It can be provided that what has been cleaned and/or reprocessed by means of the recycling and/or reprocessing unit, for example at least one of the listed items described above, can be made available after a cleaning and/or reprocessing process for a subsequent process, in particular in or at a storage location.

It can be provided that a defective and/or the surplus tool unit can be removed from the production plant via the lock device; in particular, the defective and/or the surplus tool unit can be removed from a storage location and automatically transported to the lock device for removal from the production plant .

Provision can be made for the tool system to be set up fully automatically, in particular.

To a certain extent, the production plant can include a fully automatic tool system, in particular, which includes one or more tool units for carrying out treatment processes on an educt, the tool system being arranged within the clean room area, for example within a clean room sub-area, for example within a receiving box as a clean room sub-area.

The tool system can include one or more tool units designed as a fluid delivery device, by means of which a fluid can be delivered, in particular in an adjustable manner with regard to a volume flow.

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

The fluid delivery device can have a directing element, by means of which a directed volume flow can be generated.

The fluid delivery device can have thermal insulation, by means of which a temperature of a fluid can be kept constant during delivery.

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

The fluid conveying device can have at least one sensor system in order to be able to monitor and/or control and/or regulate the fluid conveyance and/or to analyze components, for example particles and/or turbidity and/or air bubbles and/or fluorescence-marked components in the conveyed fluid and/or to be able to detect.

The fluid delivery device can have a fluid guiding arrangement, by means of which the fluid can be delivered essentially without foam.

The fluid delivery device can be dead volume optimized.

The tool system can include one or more tool units designed as a micro fluid delivery device, by means of which a fluid can be delivered in an adjustable manner with regard to a volume flow, in particular for aliquoting.

A volume flow that can be conveyed by means of the micro fluid conveying device can, for example, be less than 500 ml/min, preferably greater than or equal to 100 μl/min and less than 500 ml/min. A tolerance of ±5% may be provided for each.

The micro fluid delivery device can have a directing element, by means of which a directed volume flow can be generated.

The micro fluid delivery device can have thermal insulation, by means of which a temperature of a fluid can be kept constant during delivery. Additionally or alternatively, the micro fluid delivery device can have a heating source and/or a cooling unit and/or the micro fluid delivery device can be assigned a heating source and/or a cooling unit, by means of which a temperature of a fluid during delivery can be kept constant and/or adjustable.

The micro fluid delivery device can have at least one sensor system in order to be able to monitor and/or control and/or regulate the fluid delivery and/or to detect components, for example particles and/or turbidity and/or air bubbles and/or fluorescence-marked components, in the pumped To be able to analyze and/or detect fluid.

The micro-fluid-conveying device can have a micro-fluid-guiding arrangement, by means of which the fluid can be conveyed in a substantially foam-free manner. The micro fluid delivery device can be dead volume optimized.

The tool system can include one or more tool units designed as a device for dividing a fluid, by means of which the fluid can be conveyed in a particularly adjustable manner with regard to a volume flow and by means of which the fluid can be divided into at least two, in particular two to twelve, fluid parts, in particular in an adjustable manner.

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

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

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

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

Additionally or alternatively, the device for dividing a fluid can have a heating source and/or a cooling unit and/or the device for dividing a fluid can be assigned a heating source and/or a cooling unit, by means of which a temperature of a fluid during conveying and/or during Splitting is constantly durable and / or adjustable.

The device for dividing a fluid can have a fluid guide arrangement for the fluid to be distributed and/or for the divided fluid, in particular for the respective fluid parts, by means of which the fluid and/or the fluid parts can be conveyed and/or divided essentially foam-free.

The device for dividing a fluid can be dead volume-optimized.

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

The fluid mixing device can have a mixing unit, in particular a mechanical mixing unit and/or a geometric mixing unit, which has a defined fluid guidance arrangement for mixing, in particular for essentially foam-free mixing.

It can be provided that the fluid can be mixed with a defined shearing force, in particular with a low shearing force, in particular can be mixed through essentially without foam, by means of the mixing unit of the fluid mixing device.

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

The tool system can comprise one or more tool units designed as a mixing device, by means of which at least two components can be mixed with one another, with one of the at least two components being a fluid in particular.

The mixing device can be configured essentially like the fluid mixing device, in particular the mixing device can be configured like the fluid mixing device or can be embodied as the fluid mixing device. To a certain extent, the fluid mixing device can also be designed as the mixing device.

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

Provision can be made for the measuring device to be configured to measure a pH value and/or a gas value or a gas mixture value, for example an oxygen value, a cell density and/or turbidity, in particular turbidity in a fluid .

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

Provision can be made for the material separation device to have means for tangential flow filtration, for centrifugation, for example with 200 to 300g, for affinity chromatography, and/or for magnet ical separation, by means of which the starting component can be separated into at least two components.

Additionally or alternatively, the material separation device can have a temperature control element and/or the material separation device can be assigned a temperature control element, by means of which a temperature of a starting component to be separated and/or the separated starting component can be kept constant and/or adjustable before, during and/or after the separation is, for example to a temperature of 5 to 10°C.

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

The heating device can be designed as a separate device.
It can be provided that the heating source and/or the temperature control element of the devices of the tool system described above are designed as part of the heating device and/or are assigned to it.

The heating device can be arranged and/or configured in order to form a homogeneous temperature field, in particular in terms of space and/or time.

The tool system can comprise one or more tool units designed as a device for supplying and/or discharging a gas, in particular a gas mixture, by means of which a gas, in particular a gas mixture, can be fed and/or discharged, in particular homogeneously.

Oxygen, carbon dioxide and/or hydrogen peroxide, for example, can be supplied and/or discharged by means of the device for supplying and/or discharging a gas.

It can be provided that the fluid delivery device, the micro fluid delivery device, the device for dividing a fluid, the fluid mixing device, the mixing device, the measuring device, the substance separation device, the heating device and device for supplying and/or discharging a gas in any combination with each other as one or more devices are formed, for example in a single common device.

• (mittels) eines elektrischen Felds, einer Zugabe einer Chemikalie, einer rezeptorvermittelten Transfektion, einer Mikroinjektion, einer Genkanone, einer Magnet Assisted Transfektion, einer Sonoporation, einer optischen Transfektion, eines Mikrofluidkanals, beispielsweise eines Quetschens in einen Mikrofluidkanal.

The tool system can comprise one or more tool units designed as a manipulator, by means of which a cell membrane, in particular a cell membrane of a cell of an educt, can be manipulated, in particular by means of at least one of the following or any combination thereof:

• (by means of) an electric field, chemical addition, receptor-mediated transfection, microinjection, gene gun, magnet assisted transfection, sonoporation, optical transfection, microfluidic channel, e.g., squeezing into a microfluidic channel.

Additionally or alternatively, the manipulator can be used to introduce genetic material, in particular genetic material foreign to the cell, for example DNA, for example foreign DNA, and/or RNA, for example foreign RNA, through the cell membrane into the cell is.

In addition or as an alternative, it can be provided that the manipulator can be used to deliver viruses to the cell, which viruses can carry out the actual manipulation of the cell.

The tool system can comprise one or more tool units designed as a radiation source and/or a light-emitting device, the radiation source being configured to emit ionized radiation, in particular onto a target object, for example onto a starting material, and the light-emitting device being configured to emit light with to emit a predetermined wavelength, in particular onto a target object, for example onto a starting material.

In addition or as an alternative, it can be provided that the tool system comprises one or more tool units designed as a flow cell sequencing device and/or as a next-generation sequencing device.

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

Provision can be made for the tool system to be assigned a supply device for supplying the tool system with consumables.

To a certain extent, the production plant can be a plant, for example the plant described above tool system and a supply device for supplying the tool system with consumables.

The supply device can include or use one or more storage locations of the storage device arranged within the clean room area for storing consumables.

To a certain extent, storage locations of the storage device can be assigned to the supply device.

The lock device can form part of the supply device or interact with it, it being possible to bring consumables into the clean room area by means of the lock device.

The consumables to be used in a treatment process can, in particular before their use, be made available in the lock device, in particular at an exit lock location of the lock device, and can optionally be prepared for use, in particular unpacked and/or temperature controlled.

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

By means of a storage transport device of the storage device, in particular by means of one or more storage transport units of the storage transport device of the storage device, consumables supplied from an area surrounding the production plant, in particular supplied through the lock device, can be fed to one or more storage locations of the storage device.

By means of a storage transport device of the storage device, in particular by means of one or more storage transport units of the storage transport device of the storage device, consumables can be supplied to the tool system, in particular to one or more tool units of the tool system, for example for supplying consumables and/or tool consumables to one or more tool units of the tool system.

Provision can be made for the consumables and/or the tool consumables to comprise one or more multi-use components and/or one or more single-use components.

The consumables to be used in a treatment process can be made available in the storage locations, in particular before they are used, and can optionally be prepared for use, in particular the temperature can be controlled.

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

One or more disposal units can be assigned to the set-up unit of the tool system, in particular be manageable by it, and/or form part of the set-up unit of the tool system.

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

In addition or as an alternative, the refilling device can be designed as the previously described refilling station and/or can be assigned to it. The storage device can in particular be configured to store energy and/or one or more consumables; in particular the storage device can be electrically rechargeable and/or refillable with consumables.

The storage device can be used to provide energy and/or one or more consumables for carrying out a treatment course.

The storage device can include at least one interface for refilling and/or providing the energy and/or consumables, in particular the interface can be configured to be able to be coupled to a tool/a tool unit in particular for said provision.

The supply device can have a water system, in particular an ultrapure water system, for providing water, in particular ultrapure water, as at least one consumable.

The water system can, for example, be connected to a water source, in particular to a source of ultrapure water, via interfaces provided in the production system hen it may be that the water source is located in the vicinity of the production plant.

As already described, one or more probes, sensors, sensor units and/or measuring elements of the same nature can be included in the production plant.

To a certain extent, the production plant can include one or more sensor units for determining one or more values of one or more parameters of one or more reactants and/or one or more workpiece carriers and/or one or more tools.

It can be provided that the production plant comprises one or more sensor units for determining one or more values of one or more parameters of one or more consumables.

The determination can be carried out at least partially automatically, in particular fully automatically, using one or more sensor units. An occupancy status of one or more storage locations of a storage device of the production plant can be determined, in particular monitored, by means of one or more sensor units.

Using one or more sensor units, a local temperature and/or a local humidity and/or a local illuminance or irradiation intensity can be determined, in particular monitored, at or in one or more storage locations of the storage device of the production plant.

The production plant can include one or more sensor units for determining a treatment progress during the treatment of a starting material or between two treatment processes.

Provision can be made for the production plant to include one or more sensor units for determining the progress of treatment during the treatment of an educt or between two treatment processes using at least one fluid of the educt.

To determine the progress of treatment, one or more sensor units can be microscopy devices for visually detecting microscopic components of the starting material.

• - eine automatisierte Mikroskopievorrichtung, und/oder
• - eine linsenlose Mikroskopievorrichtung, und/oder
• - eine lichtmikroskopische Mikroskopievorrichtung, und/oder
• - eine Mikroskopievorrichtung zur Fluoreszenz- und/oder Lumineszenzuntersuchung

aufweisen und/oder als eine solche ausgebildet sein.The microscopy device can

• - an automated microscopy device, and/or
• - a lensless microscopy device, and/or
• - a light microscopic microscopy device, and/or
• - A microscopy device for fluorescence and/or luminescence examination

have and/or be designed as such.

The microscopy device can have a data and/or image processing unit that is designed and programmed to record and/or determine at least one treatment progress and/or one or more values of one or more parameters of one or more reactants.

A morphology and/or a concentration and/or a motility and/or a functionality of respective cells of one or more reactants can be detected and/or determined by means of the data and/or image processing unit of the microscopy device.

One or more sensor units for determining the progress of treatment can be arranged at or in one or more storage locations, in particular integrated therein, for receiving reactants.

The production plant, in particular one or more tools for carrying out one or more treatment processes, can be controlled and/or regulated depending on the one or more determined values, with one or more treatment parameters being varied, in particular being changeable, in particular depending on a determined treatment progress .

The production facility can include one or more sensor units for monitoring a quantity of consumables stored within the clean room area.

The production plant can include one or more communication interfaces and/or one or more human-machine interface interfaces, in short: HMI interfaces, by means of which information that the production plant has fallen below a predetermined quantity of consumables can be made available, in particular to a user and/or a computer system.

Provision can be made for one or more sensor units to be used as a device for polymerase chain reaction analysis (PCR analysis) and/or endotoxin testing and/or mycoplasma testing.

One or more sensor units can be used to carry out a protein analysis, in particular a protein determination and/or an enzymatic activity test and/or an immunological test and/or an amino acid analysis and/or a protein sequence analysis, on the starting material and/or a part, in particular Part of the starting material is feasible.

Additionally and/or alternatively, one or more sensor units can be used to perform spectroscopy and/or a light microscopic method and/or a chromatography method and/or an electrophoresis method and/or mass spectrometry on the starting material and/or a part, in particular Part of the starting material is feasible.

It can be provided that, by means of one or more sensor units, a 3D structure determination, in particular a magnetic resonance spectroscopy and/or an electron microscopic method and/or a scanning electron microscopic method and/or an X-ray analysis, can be carried out on the educt and/or a part, in particular a component of the starting material can be carried out.

It can be provided that a peptide analysis and/or a carbohydrate analysis, in particular a high-performance liquid chromatography and/or an electrophoresis and/or a mass spectrometry and/or a magnetic resonance spectroscopy, and/or a lipid analysis, in particular a solid phase extraction and/or or chromatography and/or mass spectrometry and/or an immunoassay test, and/or phosphorylation and acetylation analysis, in particular with regard to at least one protein, and/or metabolite testing and/or metabolite monitoring, in particular with regard to glucose, Lactate, oxygen, carbon dioxide, ammonium, phosphate and/or derivatives thereof can be carried out on the starting material and/or a part, in particular a component, of the starting material.

It can be provided that a nucleic acid analysis can be carried out on the educt and/or a part, in particular a component, of the educt by means of one or more sensor units.

Provision can be made for the production plant, in particular for nucleic acid analysis, to have an extraction device and/or a gel filtration device and/or a precipitation device and/or a concentration device and/or a centrifugation device and/or an isolation device and/or a PCR analysis device and/or or a magnetic beads handling device for separating magnetic beads and coupled material and fluid, which is/are and/or is/are assignable to one or more sensor units, in particular for nucleic acid analysis.

It can be provided, for example, that by means of one or more sensor units, in particular for nucleic acid analysis, absorption measurement and/or gel electrophoresis, in particular for the separation and/or purification of RNA and/or DNA and/or proteins, and/or gel documentation, in particular with regard to an RNA and/or a DNA and/or protein gel and/or Western blot, and/or an RNA analysis and/or a DNA analysis and/or a sequence analysis and/or a chip analysis, in particular for a RNA/DNA/protein quantification and/or DNA mapping and/or protein-DNA interaction analysis and/or genotyping and/or epigenetic analysis and/or proteome analysis and/or metabolome fingerprinting, - Profiling, -Targetanalyis on the starting material and / or a part, in particular a component, of the starting material can be carried out.

It can be provided that the production plant, in particular for cell analysis, a morphology determination device and/or a metabolite test device and/or a receptor binding test device and/or a signal transduction test device and/or a cell differentiation test device and/or a viscosity test device and/or DNA/RNA -/protein expression test device and/or a chip/microfluidic-based test device, which can be assigned and/or is/are assigned to one or more sensor units, in particular for cell analysis.

Additionally or alternatively, one or more sensor units can be used to carry out an expression analysis, in particular for gene and/or protein expression, and/or a transfection analysis and/or flow cytometry and/or an ELISA test and/or a luciferase test and /or a kinase test can be carried out on the starting material and/or a part, in particular a component, of the starting material.

It can be provided that an osmolality test and/or a freezing point reduction measurement and/or a turbidity measurement, in particular a measurement of the optical density, and/or a particle measurement, in particular a particle density measurement, and/or a pH measurement and/or or one Viscosity measurement on the educt and / or a part, in particular part of the educt is feasible.

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

In particular, the sensor units can address: at least one temperature, at least one particle, for example at least one particle concentration, at least one vibration, at least one acceleration, at least one number of cells, at least one cell density, at least one turbidity, in particular a turbidity of an educt and/or Product suspension, for example at least one light absorption due to liquid turbidity, in particular in an educt and/or product suspension, at least one gas composition, at least one gas, for example CO2, and/or at least one chemical substance, in particular at least one biochemical substance, for example at least a metabolite such as glucose.

The sensor units described above or the sensor technology units described above can be arranged in the production plant as required, in particular with regard to one or more objects, for example reactants and/or tools and/or storage locations and/or consumables, in the clean room area.

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

In particular, additionally or alternatively, one or more sensor units or one or more sensor technology units can be and/or can be arranged online in order to enable continuous automated measurement, in particular with regard to one or more reactants, with positioning of the sensor unit or The sensory unit does not take place in the immediate treatment environment of an educt, but in a branch set up for this purpose, leading away from the treatment environment, for example a bypass, in which (the branch) a sample of the substances to be examined, in particular the educt, can be taken automatically are, where, optionally, an addition of reagents, for example for a color change, can be introduced in the branch.

In particular, additionally or alternatively, one or more sensor units or one or more sensor technology units can be and/or can be arranged at-line, with a sample of the educt taken from the treatment environment of an educt being able to be examined separately, in particular locally separately, from the treatment environment , whereby, optionally, a separate test preparation can be carried out.

It can be provided that the one or more sensor units arranged at-line can be arranged and/or are arranged adjacent, in particular in the immediate vicinity, to the treatment environment of a starting material in the clean room area.

Alternatively or additionally, it can be provided that the one or more sensor units arranged at-line can be arranged and/or are arranged adjacent to, in particular in the immediate vicinity of, the production plant in the vicinity of the production plant.

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

As already described above, the production plant can include one or more cleaning devices.

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

The cleaning device can include one or more interfaces, by means of which the cleaning device can be connected to a particular pharmaceutical cleaning system for cleaning in place (CIP for short), for washing in place (WIP for short) and/or for a local sterilization (sterilization in place, short: SIP) can be connected.

Local cleaning, local washing and/or local sterilization can be carried out in particular in the storage locations and/or on the workpiece carriers, in particular the receiving boxes.

The cleaning device can comprise one or more interfaces, by means of which a gas and/or a gas mixture and/or a liquid can be fed to the cleaning device, for example gaseous and/or liquid hydrogen peroxide, around one or more objects within the clean room area and/or parts, in particular everything , of the clean room area, in particular of at least one clean room partial area, to be able to clean, in particular decontaminate, and/or sterilize.

The cleaning device can include one or more drying devices, by means of which one or more objects, in particular tools and/or workpiece carriers, for example storage boxes, can be dried within the clean room area and/or parts, in particular everything, of the clean room area, in particular of at least one partial clean room area, can be dried in particular after a completed cleaning.

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

Provision can be made for the one or more autoclaving devices to be implemented as an autoclaving device described in connection with the unpacking device and/or with the packaging device.

The cleaning device can include one or more interfaces, by means of which waste water, in particular contaminated liquids, can be discharged from the clean area.

Provision can be made for the cleaning device to have one or more distribution elements, for example nozzles and/or sprinklers, which are connected to a cleaning agent source within the clean room area and/or can be connected to a cleaning agent source in the vicinity of the production plant and by means of which (i.e. distribution elements ) Cleaning agent, for example steam and/or hydrogen peroxide, can be distributed for cleaning.

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

By means of the cleaning device, in particular objects that do not come into direct contact, in particular, with educts can be cleaned, in particular sterilized, in particular by means of gassing.

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

The workpiece carrier can be fed to the cleaning station by means of the storage transport device and/or the handling device.

The cleaning station may include a washing machine and/or an autoclave device.

The method according to the invention is described below.

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

In addition, the production plant according to the invention described above can be configured to carry out the method according to the invention below, and the method according to the invention below can be designed to be executable by means of the production plant according to the invention described above.

• - Auswählen eines von mehreren Produktionsprogrammen zur Herstellung eines von mehreren mittels der Produktionsanlage herstellbaren Produkten,
• - Einbringen eines Edukts in eine Schleusenvorrichtung der Produktionsanlage,
• - automatisches Transportieren des Edukts in einen Reinraumbereich der Produktionsanlage, und
• - automatisches Durchführen eines oder mehrerer Behandlungsvorgänge an dem Edukt.

A method according to the invention for manufacturing a product, in particular a biological-pharmaceutical product, by means of a production plant, in particular a production plant as described above (ie which in particular comprises the following: a clean room area, a lock device for feeding an object from an area surrounding the production plant into the clean room area and /or for removing an object from the clean room area, a handling device for moving the object within the clean room area, and a storage device arranged within the clean room area, which has several storage locations for capturing multiple objects) (the method) includes the following:

• - selecting one of several production programs for the production of one of several products that can be produced by means of the production plant,
• - Introduction of an educt into a lock device of the production plant,
• - automatic transport of the educt into a clean room area of the production plant, and
• - Automatic implementation of one or more treatment processes on the starting material.

Provision can be made for a product made from the educt to be automatically transported out of the production plant after the treatment processes have been completed.

The educt can be a patient-related or a pooled educt.

A pooled educt can be produced and/or manufactured from several patient-related educts in order to serve for the production of a product for a patient and/or a patient group, i.e. in other words: for the production of a product for one or more patients.

The treatment operations may involve pooling of two or more reactants to produce a pooled reactant.

The treatment processes can include a particularly recurring pairing and/or combination of objects, particularly tools or tool units, educts, consumables, etc., in order to depict the biological production process in particular in its individual process steps.

When the educt is automatically transported into the clean room area of the production plant, the educt can be stored in a storage location of a storage device of the production plant located within the clean room area.

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

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

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

The product manufactured in this way can be removed from the storage location and automatically transported to the lock device for removal from the production plant.

The product can be filled and/or packaged before it is removed, in particular can be filled and/or packaged ready for use.

One or more vessels, receptacles and/or tools used to manufacture the product can remain at least partially within the clean room area after the product has been completed, cleaned and sterilized and then reused to manufacture another product.

To manufacture the product and/or to manufacture several different products, the consumables required, in particular consumables and/or tool consumables, can be stored within the clean room area, in particular before the product to be manufactured is selected.

The consumables can be transported automatically into the clean room area via the lock device and stored there in particular in one or more storage locations of the storage device.

A quantity of the consumables stored within the clean room area can be monitored and, if the quantity falls below a predetermined minimum, the stock can be increased by supplying the required consumables, in particular via a notice or a warning message on an operator unit.

Several products, in particular several different products, can be manufactured within the clean room area at the same time.

• - Zuführen einer Flüssigkeit und/oder eines Gases, insbesondere eines Gasgemischs,
• - Abführen, insbesondere Abpumpen, einer Flüssigkeit und/oder eines Gases, insbesondere eines Gasgemischs,
• - Abführen, insbesondere Abpumpen, eines Teils einer Flüssigkeit und/oder eines Gases, insbesondere eines Gasgemischs, für eine Analyse mittels einer oder mehrerer Sensoreinheiten,
• - Mischen einer oder mehrerer Komponenten, insbesondere zumindest einer Flüssigkeit mit zumindest einer weiteren Komponente, beispielsweise einer weiteren Flüssigkeit,
• - Aufkonzentrieren und/oder Abtrennen einer Flüssigkeit insbesondere mittels einer Säule, beispielsweise einer Trennsäule, und/oder einer Zentrifuge,
• - Analysieren eines Edukts und/oder eines Zwischenprodukts und/oder eines Produkts insbesondere mittels einer oder mehrerer Sensoreinheiten,
• - Lagern, insbesondere Einlagern und/oder Auslagern, von einem oder mehreren Objekten insbesondere mittels der Lagertransportvorrichtung,
• - Temperieren, insbesondere Inkubieren, von einem oder mehreren Objekten insbesondere von einem oder mehreren Edukten.

One or more treatment processes, which can be carried out in particular using one or more tool units, can include:

• - supplying a liquid and/or a gas, in particular a gas mixture,
• - draining, in particular pumping, of a liquid and/or a gas, in particular a gas mixture,
• - removing, in particular pumping out, part of a liquid and/or a gas, in particular a gas mixture, for an analysis using one or more sensor units,
• - Mixing one or more components, in particular at least one liquid with at least one other component, for example another liquid,
• - Concentration and/or separation of a liquid, in particular by means of a column, for example a separation column, and/or a centrifuge,
• - Analyzing an educt and/or an intermediate product and/or a product, in particular by means of one or more sensor units,
• - Storage, in particular storage and/or retrieval, of one or more objects, in particular by means of the storage transport device,
• - Tempering, in particular incubating, of one or more objects, in particular of one or more reactants.

It should be understood that the foregoing listing of treatment procedures is exemplary and not exhaustive.

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

A combination of treatment processes can result in particular from instructions, in particular a prescription, for producing a product, in particular instructions for producing a personalized product based on patient-related information.

A treatment process can, for example, include supplying a consumable, in particular a liquid, to an educt, in particular after a workpiece carrier, by means of which the consumable, in particular the liquid, is held, and a workpiece carrier, in particular a receiving box, by means of which the educt and /or an educt container or a vessel with an educt is held, have been fluidly connected to one another in particular by means of one or more tool units and/or a handling device, the consumable material is fed to the educt, in particular directed towards the educt and conveyed in a defined manner.

Provision can be made for the workpiece carriers connected to one another to define a process cell, in particular an aseptic process cell, or a process unit, in particular an aseptic process unit. In this way, for example, a suspension from the liquid and from the educt, in particular a cell suspension, can be produced and/or changed in a defined manner.

Furthermore, it can be provided that after the feeding, in particular the conveying, the workpiece carriers can be separated from one another again by means of the one or more tool units and/or the handling device.

Provision can be made for one or more tool units and/or one or the handling device to be cleaned and/or sterilized by means of a cleaning device before or after a treatment process.

After cleaning and/or sterilization has taken place, the tool units can be stored again in a storage location by means of the storage transport device.

Additionally or alternatively, after cleaning and/or sterilization has taken place, the handling device can be reequipped and/or prepared for a subsequent treatment process, in particular with one or more tool units.

A treatment process can include, for example, incubating an educt, in particular part of an educt, for example cells, in particular at a storage location.

The incubation can be carried out after the introduction of a consumable in order to generate a cell suspension. The incubation can be carried out before the introduction of a consumable, for example in order to change a cell suspension, in particular at a storage location.

Provision can be made for the workpiece carrier on which the cell suspension is arranged to be cleaned and sterilized by means of a cleaning device before the incubation can be carried out or is carried out.

During incubation, gassing and temperature control can be carried out or carried out by means of one or more tool units.

During incubation, one or more functions, in particular heating, fixing and/or gassing, can be carried out in a single receiving box in particular.

It can be provided that parallel or in series with a treatment process, in particular the incubation, a workpiece carrier, in particular the workpiece carrier, by means of which the consumable material, in particular the liquid, is or was held, can be cleaned and/or sterilized by means of the cleaning device.

In addition, it can be provided that a container held by the workpiece carrier and in which the liquid was stored can be removed from the clean room area by means of the handling device via the lock device. Optionally, the workpiece carrier can then be cleaned and/or sterilized or cleaned and/or sterilized by means of the cleaning device. Furthermore, optionally, the workpiece carrier can subsequently be loaded again, in particular with consumables, in particular from the storage device and/or via the lock device by means of the storage transport device and/or the handling device.

Each product to be manufactured can be assigned a sequence of treatment processes, which are carried out using tools that are arranged within the clean room area and remain in the clean room area after the treatment processes have been carried out.

One or more tools are cleaned, in particular sterilized, after one or more treatment processes have been carried out within the clean room area.

One or more tools can be loaded with tool consumables before carrying out one or more treatment processes within the clean room area.

• - einer Zeitdauer für die Bereitstellung des für den jeweiligen Behandlungsvorgang erforderlichen mindestens einen Werkzeugs, insbesondere einschließlich dessen Bestückung mit einem oder mehreren Werkzeugverbrauchsmitteln, und/oder
• - einer Zeitdauer für die Zuführung und/oder Anordnung und/oder Inbetriebnahme des mindestens einen Werkzeugs an dem zu behandelnden Edukt, insbesondere an einem Lagerplatz, an welchem das Edukt angeordnet ist, und/oder
• - einer Zeitdauer der Einwirkung auf das Edukt zur Erzielung eines erwünschten Behandlungsergebnisses, und/oder
• - einer Zeitdauer für das Entfernen des mindestens einen Werkzeugs von dem Edukt, insbesondere von dem Lagerplatz;
• - vorzugsweise einschließlich:
  • o einer Reinigung des mindestens einen Werkzeugs, und/oder
  • o eines Entfernens und/oder Entsorgens von Werkzeugverbrauchsmitteln, und/oder
  • o eines Rücktransports des Werkzeugs zu einem Ausgangsort, insbesondere einem dem Werkzeug zugeordneten Lagerplatz.

One or more tool consumables may be removed from the one or more tools and/or discarded after the performance of one or more treatment operations within the clean room area. Treatment time values can be assigned to several, in particular all, treatment processes, which indicate the period of time that elapses from the start of the respective treatment process to its end, in particular including:

• - a period of time for the provision of the at least one tool required for the respective treatment process, in particular including its equipping with one or more tool consumables, and/or
• - a period of time for feeding and/or arranging and/or starting up the at least one tool on the educt to be treated, in particular at a storage location at which the educt is arranged, and/or
• - a duration of action on the educt to achieve a desired treatment result, and / or
• - A period of time for the removal of the at least one tool from the educt, in particular from the storage location;
• - preferably including:
  • o cleaning of the at least one tool, and/or
  • o removal and/or disposal of tool consumables, and/or
  • o a return transport of the tool to a starting point, in particular to a storage location assigned to the tool.

The treatment processes required for the manufacture of a specific product and the associated treatment time values can be stored or taken into account in each production program.

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

• - ein oder mehrere Reinigungsvorgänge zur Reinigung eines oder mehrerer Werkzeuge und/oder zur Reinigung eines oder mehrerer Lagerplätze, und/oder
• - ein oder mehrere Entsorgungsvorgänge zur Entsorgung von Verbrauchsmaterialien, und/oder
• - ein oder mehrere Rüstvorgänge zur Bestückung eines oder mehrere Werkzeuge mit Verbrauchsmaterialien, und/oder
• - ein oder mehrere Kontrollvorgänge zur Kontrolle eines Behandlungsergebnisses

zugeordnet werden oder sein, wobei abhängig von der Prädiktion des Produktionsablaufs Zeitslots an einer oder mehreren derjenigen Vorrichtungen vorreserviert sein/werden können, welche für die Durchführung des einen oder der mehreren Reinigungsvorgänge, des einen oder der mehreren Entsorgungsvorgänge, des einen oder der mehreren Rüstvorgänge und/oder des einen oder der mehreren Kontrollvorgänge erforderlich sind.One or more treatment processes can each

• - one or more cleaning operations to clean one or more tools and/or to clean one or more storage locations, and/or
• - one or more disposal operations for the disposal of consumables, and/or
• - one or more set-up processes for equipping one or more tools with consumables, and/or
• - one or more control processes to control a treatment result

be assigned or be, depending on the prediction of the production process timeslots one or more of those devices can be/be pre-reserved which are required to carry out the one or more cleaning processes, the one or more disposal processes, the one or more set-up processes and/or the one or more control processes.

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

If a production program is to start, it can be determined on the basis of a prediction of the production process whether all the necessary tools and/or other devices for completing the product are available within the required time slots, and the production program can only be started if this determination is made gave a positive result.

Additionally or alternatively, at the start of an entire production program and/or a section of a production program, based on a prediction of the production process, it can be determined whether all the necessary tools and/or other devices for completing the product are available within the required time slots and/or the production duration and/or whether there are resource bottlenecks, in particular with regard to consumables, and/or other production risks, and the production program can only be started if this determination has delivered a positive result with regard to availability and a negative result with regard to resource bottlenecks and production risks.

In addition or as an alternative, it can be provided that, when a production program and/or a section of a production program is desired to start, it is determined on the basis of a prediction of the production process whether all the necessary tools and/or other devices and/or objects and/or other materials for Completion of the product are available within the required time slots and/or can be supplied within the required time slots, in particular by a user, for example whether there is a confirmation that the user can enter that said tools, devices, objects and/or materials can be supplied within the required time slots , and the production program can only be started if this determination has returned a positive result.

It can be provided that the production plant comprises one or more control units, in particular the control units already described, for controlling and/or regulating the production plant, in particular for controlling and/or regulating at least one component comprised by the production plant or a part of the production plant.

The production plant can have one or more storage units and/or the production plant can be assigned one or more, in particular decentralized storage units, for example located in a cloud and/or on a server, with a computer program product being storable or stored on at least one storage unit that Includes commands which, when the computer program product is executed by at least one control unit of the production facility, cause the production facility described above to execute a method described above. The computer program product can additionally or alternatively be stored on a computer-readable (further) storage medium.

A product, in particular a biological-pharmaceutical product, can be manufactured by means of the production plant by means of one or more control units.

One or more control units can be designed and programmed to categorize one or more products to be manufactured into production batches, in particular in an automated manner.

One or more control units can be designed and programmed to carry out order planning for one or more products and/or production batches, in particular with regard to time and/or with regard to resources located within the production plant, for example tools and/or consumables, and/or a current utilization of the production plant.

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

One or more control units can be configured and programmed to store on one or more memory units to be able to access bare or stored information management unit and to be able to generate and/or change them.

One or more control units can be designed and programmed to be able to access and change a billing unit that can be stored or stored on one or more storage units, whereby automated billing and/or cost calculation of products to be manufactured can be made possible.

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

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

Information can be managed, in particular stored and/or changed and/or generated by means of the information management unit, which includes, for example: one or more recipes for one or more products and/or intermediate products, patient-related information, machine-related information regarding the production plant, runtime information regarding the production plant , Information about material logistics and/or material requirements of the production plant.

Instructions for manufacturing a product, in particular instructions for manufacturing a personalized product based on patient-related information, can be stored by means of one or more memory units.

An educt can be a patient-related educt.

Additionally or alternatively, a starting material can be a pooled starting material.

A pooled educt can be produced and/or manufactured from several patient-related educts in order to serve for the production of a product for a patient and/or a patient group, i.e. in other words: for the production of a product for one or more patients.

The instructions for manufacturing a product can define a sequence of one or more treatment processes.

To a certain extent, the instructions can define a production program. Provision can be made for one or more production programs to be able to be stored on one or more memory units and to be executable for producing one of several products that can be produced using the production system, in particular by means of one or more control units. Using the production plant, a product, in particular a patient-related product, can be produced from at least one starting material, in particular from at least one patient-related starting material, using the instructions based on the patient-related information.

One or more control units can be designed and programmed to be able to communicate with one or more communication interfaces and/or one or more human-machine interface interfaces, in short: HMI interfaces, of the production plant.

One or more control units can be designed and programmed to provide information to a human operator or user via the communication interfaces and/or via the HMI interfaces, for example fault information and/or information about a production status of a product and/or or information about inventories of the storage device.

Referring to the previous description of the production plant according to the invention and the method according to the invention, an exemplary sequence, in particular an exemplary material flow, of one or more objects of the production plant and/or an exemplary sequence, in particular an exemplary material flow, of one or more of the production plant can be fed and/or objects removable therefrom to further explain the present invention.

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

• Ein Edukt kann in einem Behälter, insbesondere einem Eduktbehälter oder einem Gefäß, angeordnet und/oder aufgenommen sein.

The following description refers in particular to an educt:

• A starting material can be arranged and/or accommodated in a container, in particular a starting material container or a vessel.

The educt container with the educt can define a clean room area with a clean room class A.

The educt container with the educt can be packed by means of packaging, which can be designed in the sense of a partial area housing of the educt container with the educt.

The educt container with the educt can be introduced into the lock device of the production plant, in particular to an entry lock location of the lock device.

The packaging of the educt container can be removable from the educt container in particular at the entry lock location and/or at a separate unpacking location in the lock device, in particular by means of one or more unpacking units.

Provision can preferably be made for the packaging to be cleaned and/or sterilized before it is removed by means of a cleaning device of the lock device or a part of the cleaning device of the production plant assigned to the lock device.

The lock device can include a clean room sub-area with a clean room class B.

The entry lock area and/or the unpacking area can include a clean room section with a clean room class A.

It can be provided that the educt container with the educt can be moved within the lock device by means of a lock transport device and/or the handling device.

By means of the handling device, the educt container with the educt in or immediately adjacent to the lock device can be transferred to a workpiece carrier, in particular a receiving box, or to a workpiece carrier that can be arranged or is arranged in a receiving box.

The receiving box, which received the educt container with the educt, can define an aseptic process unit.

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

Additionally or alternatively, this storage box can be made available for one or more treatment processes, in particular by means of one or more tool units, by means of the storage transport device.

Additionally or alternatively, it can be provided that the handling device can be used to transfer the educt container with the educt in or immediately adjacent to the lock device to a workpiece carrier and, after the educt container has been transferred, this workpiece carrier can be transported to a storage location by means of the storage transport device, whereby, after storage in the storage area, the workpiece carrier together with the educt container can be transferred from the storage area to a receiving box that defines an aseptic process unit, in particular with a clean room class A.

The storage transport device can be used to transport one or more workpiece carriers, by means of which one or more tool units from the storage device and/or one or more consumables from the storage device are held and transported, to the receiving box, with the workpiece carriers optionally being arranged in a respective receiving box could be.

The receiving box and the one or more workpiece carriers or the receiving boxes in which a respective workpiece carrier is arranged can be connected/coupled to one another or can be connected/coupled to one another for one or more treatment processes on the educt arranged in the receiving box, with one or multiple treatment processes of the treatment processes, one or more tool units and/or one or more consumables of the one or more workpiece carriers may be required.

In other words, it can also be provided that the storage box and one or more further storage boxes can be connected/coupled or are connected/coupled to one another, the further storage boxes each having received at least one workpiece carrier, by means of which one or more tool units and/or one or more consumables are durable or are kept for one or more treatment processes.

A product can be generated from the starting material by means of the treatment processes.

To a certain extent, the educt container held in the receiving box can now be referred to as a product container.

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

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

The product container with the product can be packaged or packaged at the exit lock location, in particular at the packaging location, in particular by means of one or more packaging units, so that it can then be removed or removed from the lock device.

• Der Werkstückträger kann insbesondere im funktionalen Sinne als Aufnahmebox zur Aufnahme von Edukten ausgebildet sein. Gewissermaßen kann der Werkstückträger konfiguriert sein, die Funktion einer Aufnahmebox zu haben und zu erfüllen.

The following description refers in particular to a workpiece carrier or a storage box:

• In the functional sense in particular, the workpiece carrier can be designed as a receiving box for receiving educts. To a certain extent, the workpiece carrier can be configured to have and fulfill the function of a receiving box.

In addition or as an alternative, it can be provided that the production plant comprises a plurality of receiving boxes for receiving one or more workpiece carriers together with the educts arranged and/or received thereon.

A workpiece carrier or a receiving box can be fed to the clean room area via the lock device.

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

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

If necessary, the workpiece carrier and/or the receiving box can be fed from the storage location to a designated use by means of the storage transport device and, optionally, the handling device and/or the lock transport device.

For example, the workpiece carrier can be or can be equipped with one or more starting materials and/or one or more tool units and/or one or more consumables, for example by means of the handling device, in particular so that it can then be or will be stored in the storage device or for to be able to provide one or more treatment processes, in which case, in particular, a number of workpiece carriers can be made available in this way.

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

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

A plurality of workpiece carriers, in particular workpiece carriers designed as a receiving box, and/or receiving boxes can be connected/coupled to one another in order to form an aseptic process unit for carrying out one or more treatment processes.

• - ein als Aufnahmebox ausgebildeter oder in einer Aufnahmebox angeordneter Werkstückträger, der einen Eduktbehälter mit einem Edukt aufgenommen hat,
• - ein als Aufnahmebox ausgebildeter oder in einer Aufnahmebox angeordneter Werkstückträger, der Verbrauchsmaterial für einen oder mehrere Behandlungsvorgänge aufgenommen hat, und
• - ein als Aufnahmebox ausgebildeter oder in einer Aufnahmebox angeordneter Werkstückträger, der eine oder mehrere Werkzeugeinheiten für einen oder mehrere Behandlungsvorgänge aufgenommen hat,

miteinander verbindbar/koppelbar sind bzw. verbunden/gekoppelt werden insbesondere mittels der Lagertransportvorrichtung und/oder der Handhabungsvorrichtung, um eine gemeinsame aseptische Prozesseinheit zu bilden, um anschließend eine Durchführung von einem oder mehreren Behandlungsvorgänge zu ermöglichen.For example, can

• - a workpiece carrier designed as a receiving box or arranged in a receiving box, which has received an educt container with an educt,
• - a workpiece designed as a receiving box or arranged in a receiving box carrier that has picked up consumables for one or more treatment operations, and
• - a workpiece carrier designed as a receiving box or arranged in a receiving box, which has received one or more tool units for one or more treatment processes,

can be connected/coupled to one another or are connected/coupled in particular by means of the storage transport device and/or the handling device in order to form a common aseptic process unit in order to subsequently enable one or more treatment processes to be carried out.

After the treatment processes have been carried out, the workpiece carriers or the receiving boxes can be detached/uncoupled from one another again or can be detached/uncoupled.

The storage box with the manufactured product is transported to the lock device as previously described by means of the storage transport device. Said workpiece carriers or receiving boxes assigned to the tool units and the consumables can be fed to a cleaning device of the production plant, by means of which the workpiece carriers can be cleaned and/or sterilized.

The cleaned and/or sterilized workpiece carriers or receiving boxes can be stored again in storage locations of the storage device and can be available for renewed use.

• Eine Werkzeugeinheit oder ein Verbrauchsmaterial kann via der Schleusenvorrichtung dem Reinraumbereich zuführbar sein.

The following description refers in particular to a tool or a tool unit and to a consumable:

• A tool unit or a consumable can be fed to the clean room area via the lock device.

The tool unit or the consumable can be brought into the lock device of the production plant, in particular to an entry lock location of the lock device.

The tool unit or the consumable can be cleaned and/or sterilized in the lock device by means of a cleaning device of the lock device or a part of the cleaning device of the production plant assigned to the lock device.

Provision can be made for the tool unit or the consumable to have packaging which can be removed from the tool unit or the consumable, in particular at the entry lock location and/or at a separate unpacking location in the lock device, in particular by means of one or more unpacking units.

Provision can preferably be made for the packaging to be cleaned and/or sterilized by means of the cleaning device of the lock device before it is removed.

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

It can be provided that the tool unit or the consumable material can be moved within the lock device by means of a lock transport device and/or the handling device.

The handling device can be used to transfer the tool unit or the consumables in or directly adjacent to the lock device to a workpiece carrier, in particular a receiving box, or to a workpiece carrier that can be arranged or is arranged in a receiving box.

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

This workpiece carrier or this receiving box can be made available for one or more treatment processes by means of the tool unit or using the consumable material or can be made available by means of the storage transport device as already described in connection with the educt and the workpiece carrier or the receiving box.

After one or more treatment processes have been carried out and after the storage boxes have been detached/decoupled from one another again, the tool unit used or the consumables used can be fed to the handling device by means of the storage transport device, whereby by means of the Handling device, in particular single-use components, can be removed from the tool unit as required, in particular before cleaning and/or sterilization by the cleaning device.

Furthermore, after one or more treatment processes have been carried out and after the receiving boxes have been detached/uncoupled from one another again, the used tool unit can be fed to the cleaning device by means of the storage transport device.

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

Used and/or damaged tool units or used consumables can be removed from the clean room area via the lock device by means of the handling device.

The cleaned and/or sterilized tool unit can be stored again in a storage location of the storage device and can be used again.

With reference to the previous description, the present invention can be used to create a fully automated overall system for the production of biological-pharmaceutical products for the industrial production of individual lot sizes, in particular individual and/or very small lot sizes, in particular with modularly configured and/or autonomously acting components.

With the present invention, in particular by means of the provided sensors or the provided sensor units, analytical functions can be integrated into automated processes, in particular treatment processes, so that the environmental and/or processing conditions required for the growth of cells outside an organism can be finely tuned and/or or can be controllable and/or adjustable, whereby an efficient manufacture of the product can be ensured.

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

With the present invention, in particular through the cleaning device and the storage device integrated in the clean room area, a fully automated overall system for the production of biological-pharmaceutical products can be created, which can be loaded automatically as well as cleaning and sterilizing objects required for treatment processes on a starting material and can be reprocessed in this way for an aseptic production area.

With the present invention, biological-pharmaceutical products, in particular personalized therapeutics, can be produced in an automated, in particular fully automated, and flexible manner, in particular due to the individually combinable treatment processes in a particular single process room, for example the clean room area and/or a storage area and/or a storage box.

A more efficient system and method can be created with the present invention compared to the usually existing tightly linked individual process steps of conventional production processes of comparable biological-pharmaceutical products.

With the present invention, a system, i.e. the production plant, and a method can be created by means of which a human operator or user is no longer required in the immediate process environment, whereby in particular both manufacturing efficiency can be increased and the probability of manual errors reduced can be.

Additionally or alternatively, the production plant can take up less space or installation space, since a human operator or user only has to enter the clean room area of the production plant in emergencies and/or for maintenance.

Thus, a cost-intensive building and room structure can be economically and technically reduced to the starting material to be processed directly, in other words the biological workpiece to be processed that is to be converted into a product.

A clean environment, especially clean room class A, in which the product is openly processed, can be reduced to a minimum.

It can be particularly advantageous that, with the present invention, all the necessary systems and/or devices for self-sufficient operation and associated equipment and/or consumables can be present within the production plant and, furthermore, all the necessary information for self-sufficient operation is available within the production plant and/or or can be processed in particular by means of one or more control units.

1. 1. Produktionsanlage, insbesondere zur Herstellung von biologisch-pharmazeutischen Produkten, wobei die Produktionsanlage Folgendes umfasst:
   • - einen Reinraumbereich;
   • - eine Schleusenvorrichtung zur Zuführung eines Objekts aus einer Umgebung der Produktionsanlage in den Reinraumbereich und/oder zum Entfernen eines Objekts aus dem Reinraumbereich;
   • - eine Handhabungsvorrichtung zum Bewegen des Objekts innerhalb des Reinraumbereichs;
   • - eine innerhalb des Reinraumbereichs angeordnete Lagervorrichtung, welche mehrere Lagerplätze zur Aufnahme mehrerer Objekte umfasst.
2. 2. Produktionsanlage gemäß Satz 1, dadurch gekennzeichnet, dass die Lagervorrichtung eine Lagertransportvorrichtung zum Transportieren von Objekten zu den Lagerplätzen hin und/oder von den Lagerplätzen weg umfasst.
3. 3. Produktionsanlage gemäß Satz 2, dadurch gekennzeichnet, dass die Lagertransportvorrichtung eine von der Handhabungsvorrichtung verschiedene Vorrichtung ist.
4. 4. Produktionsanlage gemäß Satz 2 oder 3, dadurch gekennzeichnet, dass die Lagertransportvorrichtung ein schienengeführtes Transportsystem und/oder ein oder mehrere freifahrende Transportfahrzeuge umfasst.
5. 5. Produktionsanlage gemäß einem der Sätze 2 bis 4, dadurch gekennzeichnet, dass die Lagertransportvorrichtung eine oder mehrere schienengeführte Lagertransporteinheiten umfasst, mittels welcher ein oder mehrere Lagerregale der Lagervorrichtung insbesondere für Einlagerungs- und Auslagerungsvorgänge sowie für Behandlungsvorgänge und/oder Wartungsvorgänge zugänglich sind.
6. 6. Produktionsanlage gemäß einem der Sätze 2 bis 5, dadurch gekennzeichnet, dass die Lagertransportvorrichtung eine oder mehrere als Portalförderer ausgebildete Lagertransporteinheiten umfasst.
7. 7. Produktionsanlage gemäß einem der Sätze 1 bis 6, dadurch gekennzeichnet, dass die Handhabungsvorrichtung ein Mehrachs-Roboterarm ist oder einen solchen umfasst.
8. 8. Produktionsanlage gemäß einem der Sätze 2 bis 7, dadurch gekennzeichnet, dass der Lagertransportvorrichtung und/oder der Handhabungsvorrichtung eine Wechselvorrichtung der Produktionsanlage zugeordnet ist, mittels welcher an einer oder mehreren Lagertransporteinheiten der Lagertransportvorrichtung und/oder an einer oder mehreren Handhabungseinheiten der Handhabungsvorrichtung unterschiedliche Greifeinheiten und/oder Trägereinheiten montierbar sind, insbesondere zur Durchführung unterschiedlicher Lagervorgänge, Transportvorgänge, Handlingsvorgänge, Wartungsvorgänge und/oder Behandlungsvorgänge mittels der jeweiligen Lagertransporteinheit und/oder Handhabungseinheit.
9. 9. Produktionsanlage gemäß einem der Sätze 2 bis 8, dadurch gekennzeichnet, dass der Lagertransportvorrichtung und/oder der Handhabungsvorrichtung eine Reinigungsvorrichtung der Produktionsanlage zugeordnet ist, mittels welcher zumindest eine Greifeinheit und/oder Trägereinheit einer oder mehrerer Lagertransporteinheiten der Lagertransportvorrichtung und/oder einer oder mehrerer Handhabungseinheiten der Handhabungsvorrichtung reinigbar ist, insbesondere nach der Durchführung eines Lagervorgangs, Transportvorgangs, Handlingsvorgangs, Wartungsvorgangs und/oder Behandlungsvorgangs.
10. 10. Produktionsanlage gemäß einem der Sätze 2 bis 9, dadurch gekennzeichnet, dass mittels der Handhabungsvorrichtung ein oder mehrere Objekte von einem Schleusenplatz der Schleusenvorrichtung an eine Lagertransportvorrichtung, insbesondere an eine oder mehrere Lagertransporteinheiten einer Lagertransportvorrichtung, übergebbar sind.
11. 11. Produktionsanlage gemäß einem der Sätze 1 bis 10, dadurch gekennzeichnet, dass die Handhabungsvorrichtung eine Schleusentransportvorrichtung umfasst, mittels welcher ein oder mehrere Objekte von einem Schleusenplatz, insbesondere einem Eingangsschleusenplatz, zu einem weiteren Schleusenplatz, insbesondere einem Übergabeschleusenplatz, und/oder von einem Schleusenplatz, insbesondere einem Übergabeschleusenplatz, zu einem weiteren Schleusenplatz, insbesondere einem Ausgangsschleusenplatz, transportierbar sind.
12. 12. Produktionsanlage gemäß einem der Sätze 2 bis 11, dadurch gekennzeichnet, dass die Lagertransportvorrichtung und/oder die Handhabungsvorrichtung jeweils eine oder mehrere Werkstückträgeraufnahmen zur Aufnahme und zum Transport von einem oder mehreren Werkstückträgern umfassen.
13. 13. Produktionsanlage gemäß einem der Sätze 1 bis 12, dadurch gekennzeichnet, dass die Schleusenvorrichtung eine Reinigungsvorrichtung zur Reinigung eines oder mehrerer Werkstückträger und/oder zur Reinigung einer oder mehrerer Werkstückträgeraufnahmen umfasst.
14. 14. Produktionsanlage gemäß einem der Sätze 1 bis 13, dadurch gekennzeichnet, dass die Produktionsanlage eine Reinigungsvorrichtung umfasst, welcher Werkstückträger zur Reinigung derselben zuführbar sind, insbesondere nach erfolgtem Transport eines Objekts mittels des jeweiligen Werkstückträgers.
15. 15. Produktionsanlage gemäß einem der Sätze 1 bis 14, dadurch gekennzeichnet, dass die Lagervorrichtung ein oder mehrere Lagerregale und/oder ein oder mehrere Lagerplatzflächen umfasst, welche jeweils mehrere Lagerplätze aufweisen, wobei mittels der Lagertransportvorrichtung Edukte und/oder Werkzeuge und/oder Verbrauchsmaterialien in die Lagerplätze einlagerbar oder aus denselben entnehmbar sind.
16. 16. Produktionsanlage gemäß einem der Sätze 1 bis 15, dadurch gekennzeichnet, dass die Produktionsanlage mehrere Werkstückträger umfasst, welche der Aufnahme von Edukten und/oder Werkzeugen und/oder Verbrauchsmaterialien dienen.
17. 17. Produktionsanlage gemäß Satz 16, dadurch gekennzeichnet, dass die Werkstückträger permanent, insbesondere über einen oder mehrere vollständige Produktionsvorgänge hinweg, innerhalb des Reinraumbereichs verbleiben.
18. 18. Produktionsanlage gemäß einem der Sätze 1 bis 17, dadurch gekennzeichnet, dass die Produktionsanlage mehrere Arten von Werkstückträgern umfasst, welche sich hinsichtlich der Form und/oder Dimensionierung eines Aufnahmebereichs des jeweiligen Werkstückträgers voneinander unterscheiden.
19. 19. Produktionsanlage gemäß einem der Sätze 16 bis 18, dadurch gekennzeichnet, dass eine Art von Werkstückträgern der Aufnahme eines Gefäßes zur Aufnahme eines Edukts dient.
20. 20. Produktionsanlage gemäß einem der Sätze 16 bis 19, dadurch gekennzeichnet, dass eine Art von Werkstückträgern der Aufnahme eines oder mehrerer Werkzeugeinheiten und/oder Werkzeugverbrauchsmittel zur Durchführung eines Behandlungsvorgangs an einem Edukt und/oder zur Durchführung eines Wartungsvorgangs innerhalb des Reinraumbereichs dient.
21. 21. Produktionsanlage gemäß einem der Sätze 16 bis 20, dadurch gekennzeichnet, dass eine Art von Werkstückträgern der Aufnahme von Verbrauchsmaterialien zur Zuführung derselben zu einem Edukt und/oder zur Durchführung eines Behandlungsvorgangs an einem Edukt dient.
22. 22. Produktionsanlage gemäß einem der Sätze 16 bis 21, dadurch gekennzeichnet, dass ein oder mehrere Werkstückträger jeweils eine oder mehrere Aktionseinheiten zur Durchführung einer Aktion an einem Edukt und/oder an einem Werkzeug umfassen.
23. 23. Produktionsanlage gemäß einem der Sätze 16 bis 22, dadurch gekennzeichnet, dass eine oder mehrere Aktionseinheiten als Behandlungseinheit zur Durchführung eines Behandlungsvorgangs an dem Edukt ausgebildet sind.
24. 24. Produktionsanlage gemäß einem der Sätze 16 bis 23, dadurch gekennzeichnet, dass eine oder mehrere Aktionseinheiten als Sensoreinheit zur Ermittlung eines aktuellen Werts eines Parameters des jeweiligen Werkstückträgers und/oder eines daran angeordneten Edukts und/oder eines daran angeordneten Werkzeugs und/oder von daran angeordneten Verbrauchsmaterialien ausgebildet sind.
25. 25. Produktionsanlage gemäß einem der Sätze 16 bis 24, dadurch gekennzeichnet, dass ein oder mehrere Werkstückträger eine Speichervorrichtung zur Speicherung von Energie und/oder eines oder mehrere Verbrauchsmaterialien umfasst.
26. 26. Produktionsanlage gemäß einem der Sätze 16 bis 25, dadurch gekennzeichnet, dass die Werkstückträger mehrfach wiederverwendbar sind, insbesondere dass die Speichervorrichtung elektrisch wieder aufladbar und/oder mit Verbrauchsmaterial nachfüllbar ist.
27. 27. Produktionsanlage gemäß einem der Sätze 1 bis 26, dadurch gekennzeichnet, dass die Produktionsanlage eine innerhalb des Reinraumbereichs angeordnete Aufladestation zum Aufladen der Speichervorrichtung und/oder eine innerhalb des Reinraumbereichs angeordnete Nachfüllstation zum Auffüllen der Speichervorrichtung umfasst.
28. 28. Produktionsanlage gemäß einem der Sätze 1 bis 27, dadurch gekennzeichnet, dass die Produktionsanlage mehrere als Aufnahmeboxen ausgebildete Werkstückträger zur Aufnahme von Edukten oder mehrere Aufnahmeboxen zur Aufnahme von jeweils einem oder mehreren Werkstückträgern samt daran angeordneten und/oder aufgenommenen Edukten umfasst.
29. 29. Produktionsanlage gemäß Satz 28, dadurch gekennzeichnet, dass die Aufnahmeboxen in Lagerplätze der Lagervorrichtung einlagerbar sind, insbesondere vollautomatisch mittels einer Lagertransportvorrichtung der Lagervorrichtung.
30. 30. Produktionsanlage gemäß Satz 28 oder 29, dadurch gekennzeichnet, dass eine oder mehrere der Aufnahmeboxen einen verschließbaren Innenraum umgeben.
31. 31. Produktionsanlage gemäß einem der Sätze 28 bis 30, dadurch gekennzeichnet, dass die Aufnahmeboxen zur Einbringung eines Edukts und/oder zum Entnehmen eines aus einem Edukt hergestellten Produkts selbsttätig und/oder mittels der Handhabungsvorrichtung öffenbar und/oder schließbar sind.
32. 32. Produktionsanlage gemäß einem der Sätze 28 bis 31, dadurch gekennzeichnet, dass eine oder mehrere der Aufnahmeboxen jeweils eine oder mehrere integrierte oder lösbar daran angeordnete oder lösbar daran anordenbare Konditioniereinheiten umfasst, mittels welcher eine Temperatur und/oder ein Druck und/oder eine Feuchtigkeit und/oder eine Gaszusammensetzung im Innenraum der jeweiligen Aufnahmebox beeinflussbar, insbesondere steuerbar und/oder regelbar, ist.
33. 33. Produktionsanlage gemäß Satz 32, dadurch gekennzeichnet, dass eine oder mehrere der Konditioniereinheiten Werkzeugeinheiten eines Werkzeugsystems der Produktionsanlage sind, welche bedarfsweise an der jeweiligen Aufnahmebox anordenbar oder von derselben entfernbar sind, insbesondere vollautomatisch mittels einer Lagertransportvorrichtung der Lagervorrichtung und/oder mittels der Handhabungsvorrichtung.
34. 34. Produktionsanlage gemäß einem der Sätze 28 bis 33, dadurch gekennzeichnet, dass die Aufnahmeboxen eine oder mehrere Anschlusselemente umfassen, welche mit hierzu korrespondieren Anschlusselementen an einem oder mehreren Behandlungsplätzen verbindbar sind, insbesondere um die jeweilige Aufnahmebox mit elektrischer Energie und/oder Verbrauchsstoffen, insbesondere Flüssigkeiten und/oder Gasen, zu versorgen und/oder um eine signaltechnische Kopplung der jeweiligen Aufnahmebox mit einer insbesondere übergeordneten Steuerungsvorrichtung herzustellen.
35. 35. Produktionsanlage gemäß einem der Sätze 1 bis 34, dadurch gekennzeichnet, dass die Lagervorrichtung mit Anschlusselementen versehene Lagerplätze umfasst, so dass ein oder mehrere Behandlungsvorgänge zur Behandlung der Edukte an als Behandlungsplätzen dienenden Lagerplätz der Lagervorrichtung durchführbar sind.
36. 36. Produktionsanlage gemäß einem der Sätze 28 bis 35, dadurch gekennzeichnet, dass die Lagerplätze der Lagervorrichtung und/oder die Aufnahmeboxen Fixierelemente umfassen, mittels welcher die Aufnahmeboxen an den Lagerplätzen positionierbar und/fixierbar sind.
37. 37. Produktionsanlage gemäß einem der Sätze 28 bis 36, dadurch gekennzeichnet, dass die Aufnahmeboxen jeweils eine oder mehrere Werkzeugaufnahmen zur Aufnahme und Festlegung eines oder mehrerer Werkzeuge umfasst, insbesondere im Innenraum der jeweiligen Aufnahmebox.
38. 38. Produktionsanlage gemäß Satz 37, dadurch gekennzeichnet, dass die eine oder die mehreren Werkzeugaufnahmen jeweils ein oder mehrere Anschlusselemente umfassen, welche mit hierzu korrespondieren Anschlusselementen an dem jeweils aufzunehmenden Werkzeug verbindbar sind, insbesondere um das jeweilige Werkzeug mit elektrischer Energie und/oder Verbrauchsstoffen, insbesondere Flüssigkeiten und/oder Gasen, zu versorgen und/oder um eine signaltechnische Kopplung des jeweiligen Werkzeugs mit der Aufnahmebox und/oder einer insbesondere übergeordneten Steuerungsvorrichtung herzustellen.
39. 39. Produktionsanlage gemäß einem der Sätze 1 bis 38, dadurch gekennzeichnet, dass die Lagervorrichtung ein oder mehrere Lagerregale und/oder ein oder mehrere Lagerplatzflächen umfasst, welche jeweils mehrere Lagerplätze aufweisen.
40. 40. Produktionsanlage gemäß einem der Sätze 1 bis 39, dadurch gekennzeichnet, dass mittels einer Lagertransportvorrichtung der Lagervorrichtung Edukte und/oder Werkstückträger und/oder Werkzeuge und/oder Verbrauchsmaterialien in die Lagerplätze einlagerbar und/oder aus denselben entnehmbar sind.
41. 41. Produktionsanlage gemäß Satz 40, dadurch gekennzeichnet, dass ein oder mehrere Lagerplätze aus mehreren Richtungen und/oder mittels mehrerer Lagertransporteinheiten der Lagertransportvorrichtung zugänglich sind.
42. 42. Produktionsanlage gemäß Satz 40 oder 41, dadurch gekennzeichnet, dass die Lagerplätze in vertikaler Richtung von oben oder in horizontaler Richtung seitlich mittels der Lagertransportvorrichtung zugänglich sind.
43. 43. Produktionsanlage gemäß einem der Sätze 1 bis 42, dadurch gekennzeichnet, dass mehrere im Wesentlichen horizontal ausgerichtete Reihen von Lagerplätzen in vertikaler Richtung übereinanderliegend angeordnet sind.
44. 44. Produktionsanlage gemäß einem der Sätze 1 bis 43, dadurch gekennzeichnet, dass mehrere der Lagerplätze, insbesondere sämtliche Lagerplätze, Regalplätze eines oder mehrerer Lagerregale sind.
45. 45. Produktionsanlage gemäß einem der Sätze 1 bis 44, dadurch gekennzeichnet, dass die Lagervorrichtung mehrere voneinander verschiedene Arten von Lagerplätzen zur Aufnahme verschiedener Arten von Werkstückträgern umfasst.
46. 46. Produktionsanlage gemäß Satz 45, dadurch gekennzeichnet, dass die verschiedenen Arten von Lagerplätzen sich hinsichtlich ihrer Form und/oder Dimensionierung voneinander unterscheiden.
47. 47. Produktionsanlage gemäß Satz 45 oder 46, dadurch gekennzeichnet, dass die verschiedenen Arten von Lagerplätzen sich hinsichtlich ihrer Funktion und/oder Ausstattung voneinander unterschieden.
48. 48. Produktionsanlage gemäß einem der Sätze 45 bis 47, dadurch gekennzeichnet, dass die verschiedenen Arten von Lagerplätzen in einem regelmäßigen Muster verteilt in einem Lagerplatzregal und/oder einer Lagerplatzfläche der Lagervorrichtung angeordnet sind.
49. 49. Produktionsanlage gemäß einem der Sätze 1 bis 48, dadurch gekennzeichnet, dass die Lagervorrichtung mehrere Bereiche zur Aufnahme unterschiedlicher Arten von Werkstückträgern aufweist.
50. 50. Produktionsanlage gemäß einem der Sätze 1 bis 49, dadurch gekennzeichnet, dass die Lagervorrichtung mehrere Lagerplätze umfasst, welche Behandlungsstationen zur Behandlung von Edukten bilden.
51. 51. Produktionsanlage gemäß einem der Sätze 1 bis 50, dadurch gekennzeichnet, dass die Lagervorrichtung mehrere Lagerplätze umfasst, welche Werkzeugstationen zur Aufbewahrung, zur Wartung, zur Reinigung, zum Wechsel, zum elektrischen Laden und/oder zur Kontrolle von Werkzeugen bilden.
52. 52. Produktionsanlage gemäß einem der Sätze 1 bis 51, dadurch gekennzeichnet, dass die Produktionsanlage eine Entpackungsvorrichtung zum Entpacken von dem Reinraumbereich zuzuführenden Objekten umfasst.
53. 53. Produktionsanlage gemäß Satz 52, dadurch gekennzeichnet, dass die Entpackungsvorrichtung in die Schleusenvorrichtung integriert ist oder einen Bestandteil hiervon bildet.
54. 54. Produktionsanlage gemäß einem der Sätze 1 bis 53, dadurch gekennzeichnet, dass die Schleusenvorrichtung einen Eingangsschleusenplatz umfasst, welcher von der Umgebung der Produktionsanlage aus zugänglich ist und an welchem insbesondere von einer Person oder automatisiert ein verpacktes Objekt anordenbar ist.
55. 55. Produktionsanlage gemäß Satz 54, dadurch gekennzeichnet, dass das verpackte Objekt mittels einer Schleusentransportvorrichtung der Produktionsanlage von dem Eingangsschleusenplatz zu einem Entpackungsplatz transportierbar und an dem Entpackungsplatz automatisiert entpackbar ist oder dass das verpackte Objekt an dem Eingangsschleusenplatz automatisiert entpackbar ist, und/oder dadurch gekennzeichnet, dass die Produktionsanlage eine Autoklaviervorrichtung aufweist, welche von einer Seite aus von einem Benutzer insbesondere manuell beladbar und/oder entladbar ist und von einer anderen Seite innerhalb des Reinraumbereichs insbesondere nach einem Sterilisieren und Trocknen durch die Autoklaviervorrichtung automatisiert entladbar und/oder beladbar ist insbesondere mittels der Handhabungsvorrichtung und/oder der Lagertransportvorrichtung, wodurch geringer verpackte bzw. teilverpackte Objekte und/oder unverpackte Objekte in den Reinraumbereich aseptisch ein- und ausbringbar sind.
56. 56. Produktionsanlage gemäß einem der Sätze 1 bis 55, dadurch gekennzeichnet, dass die Schleusenvorrichtung eine Reinigungsvorrichtung zur Reinigung einer Verpackung des verpackten Objekts umfasst.
57. 57. Produktionsanlage gemäß einem der Sätze 52 bis 56, dadurch gekennzeichnet, dass die Entpackungsvorrichtung mehrere Entpackungseinheiten zum Entpacken unterschiedlicher Arten von Objekten und/oder Verpackungen, insbesondere zum Entfernen unterschiedlicher Verpackungsarten von den Objekten, umfasst.
58. 58. Produktionsanlage gemäß Satz 57, dadurch gekennzeichnet, dass eine oder mehrere Entpackungseinheiten zum Entpacken von Edukten und eine oder mehrere weitere Entpackungseinheiten zum Entpacken von Werkzeugen und/oder Verbrauchsmaterialien ausgebildet sind.
59. 59. Produktionsanlage gemäß einem der Sätze 52 bis 58, dadurch gekennzeichnet, dass die Entpackungsvorrichtung eine Detektionsvorrichtung und eine Steuerungsvorrichtung umfasst, mittels welchen eine Art des zu entpackenden Objekts und/oder eine Art der zu entfernenden Verpackung ermittelbar ist.
60. 60. Produktionsanlage gemäß Satz 59, dadurch gekennzeichnet, dass mittels der Steuerungsvorrichtung eine Entpackungseinheit der Entpackungsvorrichtung zur Durchführung des Entpackungsvorgangs auswählbar und ansteuerbar ist, wobei die Entpackungseinheit eine von mehreren Entpackungseinheiten zur Durchführung unterschiedlicher Entpackungsvorgänge ist, wobei die ausgewählte Entpackungseinheit der ermittelten Art des zu entpackenden Objekts und/oder der Art der zu entfernenden Verpackung zugeordnet ist.
61. 61. Produktionsanlage gemäß einem der Sätze 1 bis 60, dadurch gekennzeichnet, dass die Produktionsanlage ein Werkzeugsystem umfasst, mittels welchem Behandlungsvorgänge an Edukten und/oder Wartungsvorgänge innerhalb des Reinraumbereichs durchführbar sind.
62. 62. Produktionsanlage gemäß Satz 61, dadurch gekennzeichnet, dass das Werkzeugsystem mehrere insbesondere vollautomatische Werkzeugeinheiten zur Durchführung unterschiedlicher Behandlungs- und/oder Wartungsvorgänge umfasst.
63. 63. Produktionsanlage gemäß Satz 61 oder 62, dadurch gekennzeichnet, dass das Werkzeugsystem eine oder mehrere als Zuführeinheiten ausgebildete Werkzeugeinheiten zum Zuführen von Verbrauchsmaterialien zu den Edukten umfasst.
64. 64. Produktionsanlage gemäß einem der Sätze 61 bis 63, dadurch gekennzeichnet, dass das Werkzeugsystem eine oder mehrere als Entnahmeeinheiten ausgebildete Werkzeugeinheiten zum Entnehmen einer Probe von einem Edukt umfasst.
65. 65. Produktionsanlage gemäß einem der Sätze 61 bis 64, dadurch gekennzeichnet, dass eine oder mehrere der Werkzeugeinheiten des Werkzeugsystems jeweils eine oder mehrere Multi-Use-Komponenten und eine oder mehrere Single-Use-Komponenten umfasst.
66. 66. Produktionsanlage gemäß einem der Sätze 61 bis 65, dadurch gekennzeichnet, dass das Werkzeugsystem eine Rüsteinheit umfasst, mittels welcher vollautomatisch ein oder mehrere Single-Use-Komponenten einer Werkzeugeinheit nach einer Nutzung derselben entfernbar, insbesondere entsorgbar, und durch ein oder mehrere neue Single-Use-Komponenten ersetzbar sind.
67. 67. Produktionsanlage gemäß Satz 66, dadurch gekennzeichnet, dass die Rüsteinheit vollständig innerhalb des Reinraumbereichs angeordnet ist.
68. 68. Produktionsanlage gemäß Satz 66 oder 67, dadurch gekennzeichnet, dass die Rüsteinheit eine Handlingseinheit, insbesondere einen Mehrachs-Roboterarm und/oder einen Pick-and-Place-Roboter und/oder einen Seilroboter, umfasst, mittels welchem ein vollautomatischer Rüstvorgang durchführbar ist.
69. 69. Produktionsanlage gemäß einem der Sätze 66 bis 68, dadurch gekennzeichnet, dass die Rüsteinheit eine Reinigungseinheit umfasst oder dass der Rüsteinheit eine Reinigungseinheit zugeordnet ist, mittels welcher Multi-Use-Komponenten einer oder mehrere Werkzeugeinheiten nach einer Nutzung derselben reinigbar, insbesondere sterilisierbar, sind.
70. 70. Produktionsanlage gemäß einem der Sätze 61 bis 69, dadurch gekennzeichnet, dass das Werkzeugsystem mehrere portable Werkzeugeinheiten umfasst, welche zur Durchführung eines Behandlungsvorgangs einem Behandlungsplatz zur Behandlung eines Edukts, welcher insbesondere zugleich ein Lagerplatz zur Lagerung des Edukts ist, zuführbar und dort temporär zwischenlagerbar sind.
71. 71. Produktionsanlage gemäß Satz 70, dadurch gekennzeichnet, dass ein oder mehrere portable Werkzeugeinheiten des Werkzeugsystems mittels einer Lagertransportvorrichtung, insbesondere einer oder mehreren Lagertransporteinheiten, der Produktionsanlage zu einem Werkzeuglagerplatz und/oder zu einem Behandlungsplatz und/oder zu einem Rüstplatz zuführbar sind.
72. 72. Produktionsanlage gemäß einem der Sätze 1 bis 71, dadurch gekennzeichnet, dass ein oder mehrere Werkzeugeinheiten mittels der Handhabungsvorrichtung zur Durchführung eines Behandlungsvorgangs und/oder eines Wartungsvorgangs ausgebildet und eingerichtet sind.
73. 73. Produktionsanlage gemäß einem der Sätze 1 bis 72, dadurch gekennzeichnet, dass ein oder mehrere Werkzeugeinheiten unabhängig von der Handhabungsvorrichtung, insbesondere selbsttätig, zur Durchführung eines Behandlungsvorgangs und/oder eines Wartungsvorgangs ausgebildet und eingerichtet sind.
74. 74. Produktionsanlage gemäß einem der Sätze 1 bis 73, dadurch gekennzeichnet, dass die Produktionsanlage ein insbesondere vollautomatisches Werkzeugsystem umfasst, welches eine oder mehrere Werkzeugeinheiten zur Durchführung von Behandlungsvorgängen an einem Edukt umfasst, wobei das Werkzeugsystem innerhalb des Reinraumbereichs angeordnet ist.
75. 75. Produktionsanlage gemäß einem der Sätze 61 bis 74, dadurch gekennzeichnet, dass das Werkzeugsystem eine oder mehrere als eine Fluidfördervorrichtung ausgebildete Werkzeugeinheiten umfasst, mittels welcher ein Fluid insbesondere einstellbar bezüglich eines Volumenstroms förderbar ist.
76. 76. Produktionsanlage gemäß einem der Sätze 61 bis 75, dadurch gekennzeichnet, dass das Werkzeugsystem eine oder mehrere als eine Mikro-Fluidfördervorrichtung ausgebildete Werkzeugeinheiten umfasst, mittels welcher ein Fluid insbesondere einstellbar bezüglich eines Volumenstroms förderbar ist, insbesondere zur Aliquotierung.
77. 77. Produktionsanlage gemäß einem der Sätze 61 bis 76, dadurch gekennzeichnet, dass das Werkzeugsystem eine oder mehrere als eine Vorrichtung zum Aufteilen eines Fluids ausgebildete Werkzeugeinheiten umfasst, mittels welcher das Fluid insbesondere einstellbar bezüglich eines Volumenstroms förderbar ist und mittels welcher das Fluid in mindestens zwei Fluidteile insbesondere einstellbar aufteilbar ist.
78. 78. Produktionsanlage gemäß einem der Sätze 61 bis 77, dadurch gekennzeichnet, dass das Werkzeugsystem eine oder mehrere als eine Fluiddurchmischungsvorrichtung ausgebildete Werkzeugeinheiten umfasst, mittels welcher ein Fluid durchmischbar ist.
79. 79. Produktionsanlage gemäß einem der Sätze 61 bis 78, dadurch gekennzeichnet, dass das Werkzeugsystem eine oder mehrere als eine Mischvorrichtung ausgebildete Werkzeugeinheiten umfasst, mittels welcher mindestens zwei Komponenten miteinander mischbar sind, wobei insbesondere eine der mindestens zwei Komponenten ein Fluid ist.
80. 80. Produktionsanlage gemäß einem der Sätze 61 bis 79, dadurch gekennzeichnet, dass das Werkzeugsystem eine oder mehrere als eine Messvorrichtung ausgebildete Werkzeugeinheiten umfasst, mittels welcher mindestens eine Eigenschaft eines Fluids und/oder eines Edukts messbar ist.
81. 81. Produktionsanlage gemäß einem der Sätze 61 bis 80, dadurch gekennzeichnet, dass das Werkzeugsystem eine oder mehrere als eine Stofftrennungsvorrichtung ausgebildete Werkzeugeinheiten umfasst, mittels welcher eine Ausgangskomponente in mindestens zwei Komponenten trennbar ist.
82. 82. Produktionsanlage gemäß einem der Sätze 61 bis 81, dadurch gekennzeichnet, dass das Werkzeugsystem eine oder mehrere als eine Heizvorrichtung ausgebildete Werkzeugeinheiten umfasst, mittels welcher ein Fluid temperierbar ist.
83. 83. Produktionsanlage gemäß einem der Sätze 61 bis 82, dadurch gekennzeichnet, dass das Werkzeugsystem eine oder mehrere als eine Vorrichtung zum Zuführen und/oder Abführen eines Gases ausgebildete Werkzeugeinheiten umfasst, mittels welcher ein Gas zuführbar und/oder abführbar ist.
84. 84. Produktionsanlage gemäß einem der Sätze 61 bis 83, dadurch gekennzeichnet, dass das Werkzeugsystem eine oder mehrere als einen Manipulator ausgebildete Werkzeugeinheiten umfasst, mittels welchem eine Zellmembran manipulierbar ist insbesondere mittels eines elektrischen Felds.
85. 85. Produktionsanlage gemäß einem der Sätze 61 bis 84, dadurch gekennzeichnet, dass das Werkzeugsystem eine oder mehrere als eine Strahlungsquelle und/oder eine Lichtemittiervorrichtung ausgebildete Werkzeugeinheiten umfasst, wobei die Strahlungsquelle konfiguriert ist, um eine ionisierte Strahlung zu emittieren, und die Lichtemittiervorrichtung konfiguriert ist, um Licht mit einer vorbestimmten Wellenlänge zu emittieren.
86. 86. Produktionsanlage gemäß einem der Sätze 61 bis 85, dadurch gekennzeichnet, dass das Werkzeugsystem eine oder mehrere als eine Reinigungsvorrichtung ausgebildete Werkzeugeinheiten umfasst, mittels welcher ein Ort, an dem die Behandlungsvorgänge an dem Edukt mittels der einen oder mehreren Werkzeugeinheiten durchführbar sind, reinigbar und/oder sterilisierbar ist.
87. 87. Produktionsanlage gemäß einem der Sätze 1 bis 86, dadurch gekennzeichnet, dass die Produktionsanlage ein Werkzeugsystem und eine Versorgungsvorrichtung zur Versorgung des Werkzeugsystems mit Verbrauchsmaterialien umfasst.
88. 88. Produktionsanlage gemäß Satz 87, dadurch gekennzeichnet, dass die Versorgungsvorrichtung zur Lagerung von Verbrauchsmaterialien ein oder mehrere innerhalb des Reinraumbereichs angeordnete Lagerplätze der Lagervorrichtung umfasst oder nutzt.
89. 89. Produktionsanlage gemäß Satz 87 oder 88, dadurch gekennzeichnet, dass die Schleusenvorrichtung einen Bestandteil der Versorgungsvorrichtung bildet oder hiermit zusammenwirkt, wobei mittels der Schleusenvorrichtung Verbrauchsmaterialien in den Reinraumbereich einbringbar sind.
90. 90. Produktionsanlage gemäß einem der Sätze 87 bis 89, dadurch gekennzeichnet, dass die Lagervorrichtung einen Bestandteil der Versorgungsvorrichtung bildet oder hiermit zusammenwirkt.
91. 91. Produktionsanlage gemäß einem der Sätze 87 bis 90, dadurch gekennzeichnet, dass mittels einer Lagertransportvorrichtung der Lagervorrichtung, insbesondere mittels einer oder mehrere Lagertransporteinheiten der Lagertransportvorrichtung der Lagervorrichtung, von einer Umgebung der Produktionsanlage zugeführte Verbrauchsmaterialien einem oder mehreren Lagerplätzen der Lagervorrichtung zuführbar sind.
92. 92. Produktionsanlage gemäß einem der Sätze 61 bis 91, dadurch gekennzeichnet, dass mittels einer Lagertransportvorrichtung der Lagervorrichtung, insbesondere mittels einer oder mehrere Lagertransporteinheiten der Lagertransportvorrichtung der Lagervorrichtung, Verbrauchsmaterialien dem Werkzeugsystem, insbesondere einer oder mehreren Werkzeugeinheiten des Werkzeugsystems, zuführbar sind, beispielsweise zum Zuführen von Verbrauchsstoffen und/oder Werkzeugverbrauchsmitteln zu einer oder mehreren Werkzeugeinheiten des Werkzeugsystems.
93. 93. Produktionsanlage gemäß einem der Sätze 87 bis 92, dadurch gekennzeichnet, dass die Versorgungsvorrichtung eine oder mehrere Entsorgungseinheiten umfasst, mittels welcher insbesondere gebrauchte, verbrauchte und/oder verunreinigte Verbrauchsstoffe und/oder Werkzeugverbrauchsmittel aus dem Reinraumbereich entfernbar sind.
94. 94. Produktionsanlage gemäß einem der Sätze 87 bis 93, dadurch gekennzeichnet, dass die Versorgungsvorrichtung eine innerhalb des Reinraumbereichs angeordnete Nachfüllvorrichtung umfasst, mittels welcher insbesondere in flüssiger Form vorliegende Verbrauchsstoffe einer oder mehreren Speichervorrichtungen eines oder mehrerer Werkstückträger und/oder eines oder mehrerer Lagerplätze zuführbar sind.
95. 95. Produktionsanlage gemäß einem der Sätze 1 bis 94, dadurch gekennzeichnet, dass die Produktionsanlage eine oder mehrere Sensoreinheiten zur Ermittlung eines oder mehrerer Werte eines oder mehrerer Parameter von
    1. a) einem oder mehreren Edukten; und/oder
    2. b) einem oder mehreren Werkstückträgern; und/oder
    3. c) einem oder mehreren Werkzeugen; und/oder
    4. d) einer oder mehreren Aufnahmeboxen, insbesondere als aseptische Prozesseinheiten ausgebildete Aufnahmeboxen,
    umfasst.
96. 96. Produktionsanlage gemäß einem der Sätze 1 bis 95, dadurch gekennzeichnet, dass mittels einer oder mehrerer Sensoreinheiten ein Belegungszustand eines oder mehrere Lagerplätze einer Lagervorrichtung der Produktionsanlage ermittelbar, insbesondere überwachbar ist.
97. 97. Produktionsanlage gemäß einem der Sätze 1 bis 96, dadurch gekennzeichnet, dass mittels einer oder mehrerer Sensoreinheiten eine lokale Temperatur und/oder eine lokale Feuchtigkeit und/oder eine lokale Beleuchtungs- oder Bestrahlungsstärke an oder in einem oder mehreren Lagerplätzen der Lagervorrichtung der Produktionsanlage ermittelbar, insbesondere überwachbar ist.
98. 98. Produktionsanlage gemäß einem der Sätze 1 bis 97, dadurch gekennzeichnet, dass die Produktionsanlage eine oder mehrere Sensoreinheiten zur Ermittlung eines Behandlungsfortschritts während der Behandlung eines Edukts oder zwischen zwei Behandlungsvorgängen umfasst.
99. 99. Produktionsanlage gemäß einem der Sätze 1 bis 98, dadurch gekennzeichnet, dass eine oder mehrere Sensoreinheiten zur Ermittlung des Behandlungsfortschritts Mikroskopievorrichtungen zur visuellen Erfassung von mikroskopischen Bestandteilen des Edukts sind.
100. 100. Produktionsanlage gemäß einem der Sätze 1 bis 99, dadurch gekennzeichnet, dass an oder in einem oder mehreren Lagerplätzen zur Aufnahme von Edukten jeweils eine oder mehrere Sensoreinheiten zur Ermittlung des Behandlungsfortschritts angeordnet, insbesondere darin integriert, sind.
101. 101. Produktionsanlage gemäß einem der Sätze 1 bis 100, dadurch gekennzeichnet, dass die Produktionsanlage, insbesondere ein oder mehrere Werkzeuge zur Durchführung eines oder mehrere Behandlungsvorgänge, abhängig von dem einen oder den mehreren ermittelten Werten steuerbar und/oder regelbar ist, wobei insbesondere abhängig von einem ermittelten Behandlungsfortschritt ein oder mehrere Behandlungsparameter variiert werden.
102. 102. Produktionsanlage gemäß einem der Sätze 1 bis 101, dadurch gekennzeichnet, dass die Produktionsanlage eine oder mehrere Sensoreinheiten zur Überwachung einer Menge von innerhalb des Reinraumbereichs bevorrateten Verbrauchsmaterialien umfasst.
103. 103. Verfahren zur Herstellung eines Produkts, insbesondere eines biologisch-pharmazeutischen Produkts, mittels einer Produktionsanlage, insbesondere einer Produktionsanlage gemäß einem der Sätze 1 bis 102, wobei das Verfahren Folgendes umfasst:
     • - Auswählen eines von mehreren Produktionsprogrammen zur Herstellung eines von mehreren mittels der Produktionsanlage herstellbaren Produkten;
     • - Einbringen eines Edukts in eine Schleusenvorrichtung der Produktionsanlage;
     • - Automatisches Transportieren des Edukts in einen Reinraumbereich der Produktionsanlage;
     • - Automatisches Durchführen eines oder mehrerer Behandlungsvorgänge an dem Edukt.
104. 104. Verfahren gemäß Satz 103, dadurch gekennzeichnet, dass beim automatischen Transportieren des Edukts in den Reinraumbereich der Produktionsanlage das Edukt in einen innerhalb des Reinraumbereichs befindlichen Lagerplatz einer Lagervorrichtung der Produktionsanlage eingelagert wird.
105. 105. Verfahren gemäß Satz 104, dadurch gekennzeichnet, dass ein oder mehrere Behandlungsvorgänge vollautomatisch durchgeführt werden, bis ein aus dem Edukt herzustellendes Produkt fertiggestellt ist.
106. 106. Verfahren gemäß Satz 104 oder 105, dadurch gekennzeichnet, dass ein oder mehrere, insbesondere sämtliche, Behandlungsvorgänge an dem Lagerplatz durchgeführt werden.
107. 107. Verfahren gemäß einem der Sätze 104 bis 106, dadurch gekennzeichnet, dass das so hergestellte Produkt aus dem Lagerplatz ausgelagert und zur Entnahme desselben aus der Produktionsanlage automatisch zur Schleusenvorrichtung transportiert wird.
108. 108. Verfahren gemäß Satz 107, dadurch gekennzeichnet, dass das Produkt vor der Entnahme desselben abgefüllt und/oder verpackt wird, insbesondere gebrauchsfertig abgefüllt und/oder verpackt wird.
109. 109. Verfahren gemäß einem der Sätze 104 bis 108, dadurch gekennzeichnet, dass ein oder mehrere Gefäße, Aufnahmen und/oder Werkzeuge, welche zur Herstellung des Produkts genutzt wurden, nach der Fertigstellung des Produkts zumindest teilweise innerhalb des Reinraumbereichs verbleiben, gereinigt werden und anschließend zur Herstellung eines weiteren Produkts wiederverwendet werden.
110. 110. Verfahren gemäß einem der Sätze 104 bis 109, dadurch gekennzeichnet, dass zur Herstellung des Produkts und/oder zur Herstellung mehrerer unterschiedlicher Produkte erforderliche Verbrauchsmaterialien, insbesondere Verbrauchsstoffe und/oder Werkzeugverbrauchsmittel, innerhalb des Reinraumbereichs bevorratet werden, insbesondere bevor eine Auswahl des herzustellenden Produkts getroffen wird.
111. 111. Verfahren gemäß Satz 110, dadurch gekennzeichnet, dass die Verbrauchsmaterialien über die Schleusenvorrichtung automatisch in den Reinraumbereich transportiert und dort insbesondere in einen oder in mehrere Lagerplätze der Lagervorrichtung eingelagert werden.
112. 112. Verfahren gemäß Satz 110 oder 111, dadurch gekennzeichnet, dass eine Menge der innerhalb des Reinraumbereichs bevorrateten Verbrauchsmaterialien überwacht wird und dass bei Unterschreiten einer vorgegebenen Mindestmenge eine Aufstockung des Vorrats durch Zuführung der benötigten Verbrauchsmaterialien veranlasst wird, insbesondere über einen Hinweis oder eine Warnmeldung an einer Bedienereinheit.
113. 113. Verfahren gemäß einem der Sätze 104 bis 112, dadurch gekennzeichnet, dass zeitgleich mehrere Produkte, insbesondere mehrere unterschiedliche Produkte, innerhalb des Reinraumbereichs hergestellt werden.
114. 114. Verfahren gemäß Satz 103, dadurch gekennzeichnet, dass jedem herzustellenden Produkt eine Abfolge von Behandlungsvorgängen zugeordnet ist, welche mittels innerhalb des Reinraumbereichs angeordneter und nach Durchführung der Behandlungsvorgänge im Reinraumbereich verbleibender Werkzeuge durchgeführt werden.
115. 115. Verfahren gemäß einem der Sätze 103 bis 114, dadurch gekennzeichnet, dass ein oder mehrere Werkzeuge nach der Durchführung eines oder mehrerer Behandlungsvorgänge innerhalb des Reinraumbereichs gereinigt, insbesondere sterilisiert, werden.
116. 116. Verfahren gemäß einem der Sätze 103 bis 115, dadurch gekennzeichnet, dass ein oder mehrere Werkzeuge vor der Durchführung eines oder mehrerer Behandlungsvorgänge innerhalb des Reinraumbereichs mit Werkzeugverbrauchsmitteln bestückt werden.
117. 117. Verfahren gemäß Satz 116, dadurch gekennzeichnet, dass ein oder mehrere Werkzeugverbrauchsmittel nach der Durchführung eines oder mehrerer Behandlungsvorgänge innerhalb des Reinraumbereichs von dem einen oder den mehreren Werkzeugen entfernt und/oder entsorgt werden.
118. 118. Verfahren gemäß einem der Sätze 103 bis 117, dadurch gekennzeichnet, dass mehreren, insbesondere sämtlichen, Behandlungsvorgängen Behandlungszeitwerte zugeordnet sind, welche denjenigen Zeitraum angeben, der verstreicht von einem Start des jeweiligen Behandlungsvorgangs bis zu dessen Ende, insbesondere einschließlich
     • - einer Zeitdauer für die Bereitstellung des für den jeweiligen Behandlungsvorgang erforderlichen mindestens einen Werkzeugs, insbesondere einschließlich dessen Bestückung mit einem oder mehreren Werkzeugverbrauchsmitteln; und/oder
     • - einer Zeitdauer für die Zuführung und/oder Anordnung und/oder Inbetriebnahme des mindestens einen Werkzeugs an dem zu behandelnden Edukt, insbesondere an einem Lagerplatz, an welchem das Edukt angeordnet ist; und/oder
     • - einer Zeitdauer der Einwirkung auf das Edukt zur Erzielung eines erwünschten Behandlungsergebnisses; und/oder
     • - einer Zeitdauer für das Entfernen des mindestens einen Werkzeugs von dem Edukt, insbesondere von dem Lagerplatz,
     • - vorzugsweise einschließlich
     • - a) einer Reinigung des mindestens einen Werkzeugs; und/oder
     • - b) eines Entfernens und/oder Entsorgens von Werkzeugverbrauchsmitteln; und/oder
     • - c) eines Rücktransports des Werkzeugs zu einem Ausgangsort, insbesondere einem dem Werkzeug zugeordneten Lagerplatz.
119. 119. Verfahren gemäß einem der Sätze 103 bis 118, dadurch gekennzeichnet, dass in jedem Produktionsprogramm die für die Herstellung eines bestimmten Produkts erforderlichen Behandlungsvorgänge sowie die zugehörigen Behandlungszeitwerte hinterlegt oder berücksichtigt sind.
120. 120. Verfahren gemäß einem der Sätze 103 bis 119, dadurch gekennzeichnet, dass bei einem Start eines Produktionsprogramms eine Prädiktion eines Produktionsablaufs erstellt wird und dass die für die Durchführung der Behandlungsvorgänge erforderlichen und/oder vorgesehenen Werkzeuge für sich aus der Prädiktion ergebende Zeitslots vorreserviert werden.
121. 121. Verfahren gemäß einem der Sätze 103 bis 120, dadurch gekennzeichnet, dass einem oder mehreren Behandlungsvorgängen jeweils
     1. a) ein oder mehrere Reinigungsvorgänge zur Reinigung eines oder mehrerer Werkzeuge und/oder zur Reinigung eines oder mehrerer Lagerplätze; und/oder
     2. b) ein oder mehrere Entsorgungsvorgänge zur Entsorgung von Verbrauchsmaterialien; und/oder
     3. c) ein oder mehrere Rüstvorgänge zur Bestückung eines oder mehrere Werkzeuge mit Verbrauchsmaterialien; und/oder
     4. d) ein oder mehrere Kontrollvorgänge zur Kontrolle eines Behandlungsergebnisses zugeordnet werden oder sind,
     wobei abhängig von der Prädiktion des Produktionsablaufs Zeitslots an einer oder mehreren derjenigen Vorrichtungen vorreserviert werden, welche für die Durchführung des einen oder der mehreren Reinigungsvorgänge, des einen oder der mehreren Entsorgungsvorgänge, des einen oder der mehreren Rüstvorgänge und/oder des einen oder der mehreren Kontrollvorgänge erforderlich sind.
122. 122. Verfahren gemäß Satz 120 oder 121, dadurch gekennzeichnet, dass nach einem oder mehreren Behandlungsvorgängen, insbesondere nach jedem Behandlungsvorgang, die Prädiktion des Produktionsablaufs überprüft und/oder aktualisiert wird, insbesondere zur Bestätigung oder Korrektur der Zeitslots für die noch erforderlichen Werkzeuge und/oder sonstige Vorrichtungen zur Fertigstellung des Produkts.
123. 123. Verfahren gemäß einem der Sätze 103 bis 122, dadurch gekennzeichnet, dass bei einem gewünschten Start eines Produktionsprogramms auf der Basis einer Prädiktion des Produktionsablaufs ermittelt wird, ob alle erforderlichen Werkzeuge und/oder sonstige Vorrichtungen zur Fertigstellung des Produkts innerhalb der erforderlichen Zeitslots verfügbar sind, und dass das Produktionsprogramm nur dann gestartet wird, wenn diese Ermittlung ein positives Ergebnis geliefert hat.

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

1. 1. Production plant, in particular for the manufacture of biological-pharmaceutical products, the production plant comprising the following:
   • - a clean room area;
   • - a lock device for feeding an object from an area surrounding the production plant into the clean room area and/or for removing an object from the clean room area;
   • - a handling device for moving the object within the clean room area;
   • - A storage device arranged within the clean room area, which comprises a plurality of storage locations for accommodating a plurality of objects.
2. 2. Production plant according to sentence 1, characterized in that the storage device comprises a storage transport device for transporting objects to the storage locations and/or away from the storage locations.
3. 3. Production plant according to clause 2, characterized in that the storage transport device is a different device from the handling device.
4. 4. Production plant according to clause 2 or 3, characterized in that the storage transport device comprises a rail-guided transport system and/or one or more free-moving transport vehicles.
5. 5. Production plant according to one of sentences 2 to 4, characterized in that the storage transport device comprises one or more rail-guided storage transport units, by means of which one or more storage racks of the storage device are accessible in particular for storage and retrieval processes as well as for treatment processes and/or maintenance processes.
6. 6. Production plant according to one of sentences 2 to 5, characterized in that the storage transport device comprises one or more storage transport units designed as portal conveyors.
7. 7. Production plant according to one of sentences 1 to 6, characterized in that the handling device is a multi-axis robotic arm or comprises such.
8. 8. Production plant according to one of sentences 2 to 7, characterized in that the storage transport device and/or the handling device is assigned a changing device of the production plant, by means of which different gripping units can be attached to one or more storage transport units of the storage transport device and/or to one or more handling units of the handling device and/or carrier units can be assembled, in particular for carrying out different storage processes, transport processes, handling processes, maintenance processes and/or treatment processes using the respective storage transport unit and/or handling unit.
9. 9. Production plant according to one of sentences 2 to 8, characterized in that the storage transport device and/or the handling device is assigned a cleaning device of the production plant, by means of which at least one gripping unit and/or carrier unit of one or more storage transport units of the storage transport device and/or one or more Handling units of the handling device can be cleaned, in particular after carrying out a storage process, transport process, handling process, maintenance process and/or treatment process.
10. 10. Production plant according to one of sentences 2 to 9, characterized in that the handling device can be used to transfer one or more objects from a lock location of the lock device to a storage transport device, in particular to one or more storage transport units of a storage transport device.
11. 11. Production plant according to one of sentences 1 to 10, characterized in that the handling device comprises a lock transport device, by means of which one or more objects from a lock place, in particular an entrance lock place, to another lock place, esp special a transfer lock place, and / or from a lock place, in particular a transfer lock place, to a further lock place, in particular an exit lock place.
12. 12. Production plant according to one of sentences 2 to 11, characterized in that the storage transport device and/or the handling device each comprise one or more workpiece carrier receptacles for receiving and transporting one or more workpiece carriers.
13. 13. Production plant according to one of sentences 1 to 12, characterized in that the lock device comprises a cleaning device for cleaning one or more workpiece carriers and/or for cleaning one or more workpiece carrier receptacles.
14. 14. Production plant according to one of sentences 1 to 13, characterized in that the production plant comprises a cleaning device, which workpiece carrier can be fed for cleaning the same, in particular after an object has been transported by means of the respective workpiece carrier.
15. 15. Production plant according to one of sentences 1 to 14, characterized in that the storage device comprises one or more storage racks and/or one or more storage space areas, each of which has a number of storage locations, with the storage transport device being used to transport reactants and/or tools and/or consumables into the storage locations can be stored or removed from the same.
16. 16. Production plant according to one of sentences 1 to 15, characterized in that the production plant comprises a plurality of workpiece carriers which are used to hold starting materials and/or tools and/or consumables.
17. 17. Production plant according to sentence 16, characterized in that the workpiece carriers remain permanently, in particular over one or more complete production processes, within the clean room area.
18. 18. Production plant according to one of sentences 1 to 17, characterized in that the production plant comprises several types of workpiece carriers which differ from one another with regard to the shape and/or dimensioning of a receiving area of the respective workpiece carrier.
19. 19. Production plant according to one of sentences 16 to 18, characterized in that one type of workpiece carrier is used to hold a vessel for holding an educt.
20. 20. Production plant according to one of sentences 16 to 19, characterized in that one type of workpiece carrier is used to accommodate one or more tool units and/or tool consumables for carrying out a treatment process on an educt and/or for carrying out a maintenance process within the clean room area.
21. 21. Production plant according to one of sentences 16 to 20, characterized in that one type of workpiece carrier is used to hold consumables for supplying them to an educt and/or for carrying out a treatment process on an educt.
22. 22. Production plant according to one of sentences 16 to 21, characterized in that one or more workpiece carriers each comprise one or more action units for carrying out an action on an educt and/or on a tool.
23. 23. Production plant according to one of sentences 16 to 22, characterized in that one or more action units are designed as a treatment unit for carrying out a treatment process on the starting material.
24. 24. Production plant according to one of sentences 16 to 23, characterized in that one or more action units as a sensor unit for determining a current value of a parameter of the respective workpiece carrier and/or an educt arranged thereon and/or a tool arranged thereon and/or of it arranged consumables are formed.
25. 25. Production plant according to one of sentences 16 to 24, characterized in that one or more workpiece carriers comprises a storage device for storing energy and/or one or more consumables.
26. 26. Production plant according to one of sentences 16 to 25, characterized in that the workpiece carriers can be reused several times, in particular that the storage device can be electrically recharged and/or refilled with consumables.
27. 27. Production plant according to one of sentences 1 to 26, characterized in that the production plant comprises a charging station arranged within the clean room area for charging the storage device and/or a refilling station arranged within the clean room area for refilling the storage device.
28. 28. Production plant according to one of sentences 1 to 27, characterized in that the production plant comprises a plurality of workpiece carriers designed as receiving boxes for receiving educts or a number of receiving boxes for receiving one or more workpiece carriers together with educts arranged and/or received thereon.
29. 29. Production plant according to sentence 28, characterized in that the receiving boxes can be stored in storage locations of the storage device, in particular fully automatically by means of a storage transport device of the storage device.
30. 30. Production plant according to sentence 28 or 29, characterized in that one or more of the receiving boxes surround a closable interior.
31. 31. Production plant according to one of sentences 28 to 30, characterized in that the receiving boxes for introducing an educt and/or for removing a product made from an educt can be opened and/or closed automatically and/or by means of the handling device.
32. 32. Production plant according to one of sentences 28 to 31, characterized in that one or more of the receiving boxes each comprises one or more integrated or detachably arranged or detachably arranged thereon conditioning units, by means of which a temperature and/or a pressure and/or a humidity and/or a gas composition in the interior of the respective storage box can be influenced, in particular controlled and/or regulated.
33. 33. Production plant according to sentence 32, characterized in that one or more of the conditioning units are tool units of a tool system of the production plant, which can be arranged on the respective receiving box or removed from the same as required, in particular fully automatically by means of a storage transport device of the storage device and/or by means of the handling device.
34. 34. Production plant according to one of sentences 28 to 33, characterized in that the storage boxes comprise one or more connection elements, which can be connected to corresponding connection elements at one or more treatment stations, in particular around the respective storage box with electrical energy and/or consumables, in particular Liquids and / or gases to supply and / or to produce a signal-technical coupling of the respective receiving box with a particular higher-level control device.
35. 35. Production plant according to one of sentences 1 to 34, characterized in that the storage device comprises storage locations provided with connecting elements, so that one or more treatment processes for treating the educts can be carried out at storage locations of the storage device serving as treatment locations.
36. 36. Production plant according to one of sentences 28 to 35, characterized in that the storage locations of the storage device and/or the storage boxes comprise fixing elements, by means of which the storage boxes can be positioned and/or fixed at the storage locations.
37. 37. Production plant according to one of sentences 28 to 36, characterized in that the receiving boxes each comprise one or more tool holders for receiving and fixing one or more tools, in particular in the interior of the respective receiving box.
38. 38. Production system according to sentence 37, characterized in that the one or more tool holders each comprise one or more connection elements, which can be connected to corresponding connection elements on the tool to be held in each case, in particular to supply the respective tool with electrical energy and/or consumables, in particular liquids and/or gases, and/or in order to establish a signal-technical coupling of the respective tool with the receiving box and/or an in particular higher-level control device.
39. 39. Production plant according to one of sentences 1 to 38, characterized in that the storage device comprises one or more storage racks and/or one or more storage space areas, each of which has a number of storage spaces.
40. 40. Production plant according to one of sentences 1 to 39, characterized in that reactants and/or workpiece carriers and/or tools and/or consumables can be stored in and/or removed from the storage locations by means of a storage transport device of the storage device.
41. 41. Production plant according to sentence 40, characterized in that one or more storage locations are accessible from a number of directions and/or by means of a number of storage transport units of the storage transport device.
42. 42. Production plant according to sentence 40 or 41, characterized in that the storage locations are accessible in the vertical direction from above or in the horizontal direction from the side by means of the storage transport device.
43. 43. Production plant according to one of sentences 1 to 42, characterized in that several substantially horizontally aligned rows of storage locations are arranged one above the other in the vertical direction.
44. 44. Production plant according to one of sentences 1 to 43, characterized in that several of the storage locations, in particular all storage locations, are shelf locations of one or more storage shelves.
45. 45. Production plant according to one of sentences 1 to 44, characterized in that the storage device comprises a plurality of different types of storage locations for receiving different types of workpiece carriers.
46. 46. Production plant according to sentence 45, characterized in that the different types of storage locations differ from one another in terms of their shape and/or dimensions.
47. 47. Production plant according to sentence 45 or 46, characterized in that the different types of storage locations differ from one another in terms of their function and/or equipment.
48. 48. Production plant according to one of the clauses 45 to 47, characterized in that the different types of storage locations are distributed in a regular pattern in a storage location shelf and/or a storage location area of the storage device.
49. 49. Production plant according to one of sentences 1 to 48, characterized in that the storage device has several areas for receiving different types of workpiece carriers.
50. 50. Production plant according to one of sentences 1 to 49, characterized in that the storage device comprises a plurality of storage locations which form treatment stations for treating starting materials.
51. 51. Production plant according to one of sentences 1 to 50, characterized in that the storage device comprises a plurality of storage locations which form tool stations for storing, maintaining, cleaning, changing, electrically charging and/or checking tools.
52. 52. Production plant according to one of sentences 1 to 51, characterized in that the production plant comprises an unpacking device for unpacking objects to be supplied to the clean room area.
53. 53. Production plant according to sentence 52, characterized in that the unpacking device is integrated into the lock device or forms a part thereof.
54. 54. Production installation according to one of sentences 1 to 53, characterized in that the lock device comprises an entry lock location which is accessible from the vicinity of the production installation and at which a packed object can be arranged in particular by a person or automatically.
55. 55. Production plant according to sentence 54, characterized in that the packaged object can be transported by means of a lock transport device of the production plant from the entry lock location to an unpacking station and can be automatically unpacked at the unpacking station or that the packaged object can be automatically unpacked at the entry lock location, and/or characterized in that that the production plant has an autoclave device, which can be loaded and/or unloaded from one side by a user, in particular manually, and can be automatically unloaded and/or loaded from another side within the clean room area, in particular after sterilization and drying by the autoclave device, in particular by means the handling device and/or the storage transport device, whereby less packed or partially packed objects and/or unpackaged objects can be aseptically brought in and taken out of the clean room area.
56. 56. Production plant according to one of sentences 1 to 55, characterized in that the lock device comprises a cleaning device for cleaning a packaging of the packaged object.
57. 57. Production plant according to one of the clauses 52 to 56, characterized in that the unpacking device comprises several unpacking units for unpacking different types of objects and/or packaging, in particular for removing different types of packaging from the objects.
58. 58. Production plant according to sentence 57, characterized in that one or more unpacking units for unpacking reactants and one or more further unpacking units units are designed to unpack tools and/or consumables.
59. 59. Production plant according to one of sentences 52 to 58, characterized in that the unpacking device comprises a detection device and a control device, by means of which a type of object to be unpacked and/or a type of packaging to be removed can be determined.
60. 60. Production plant according to sentence 59, characterized in that the control device can be used to select and control an unpacking unit of the unpacking device for carrying out the unpacking process, the unpacking unit being one of a plurality of unpacking units for carrying out different unpacking processes, the selected unpacking unit corresponding to the determined type of product to be unpacked Object and / or the type of packaging to be removed is assigned.
61. 61. Production plant according to one of sentences 1 to 60, characterized in that the production plant comprises a tool system, by means of which treatment processes on educts and/or maintenance processes can be carried out within the clean room area.
62. 62. Production plant according to sentence 61, characterized in that the tool system comprises several, in particular fully automatic, tool units for carrying out different treatment and/or maintenance processes.
63. 63. Production plant according to sentence 61 or 62, characterized in that the tool system comprises one or more tool units designed as feed units for feeding consumables to the educts.
64. 64. Production installation according to one of sentences 61 to 63, characterized in that the tool system comprises one or more tool units designed as extraction units for removing a sample from an educt.
65. 65. Production plant according to one of sentences 61 to 64, characterized in that one or more of the tool units of the tool system each includes one or more multi-use components and one or more single-use components.
66. 66. Production plant according to one of sentences 61 to 65, characterized in that the tool system comprises a set-up unit, by means of which fully automatically one or more single-use components of a tool unit can be removed, in particular disposed of, after use and by one or more new single -Use components are replaceable.
67. 67. Production plant according to sentence 66, characterized in that the set-up unit is arranged entirely within the clean room area.
68. 68. Production system according to sentence 66 or 67, characterized in that the set-up unit comprises a handling unit, in particular a multi-axis robot arm and/or a pick-and-place robot and/or a cable robot, by means of which a fully automatic set-up process can be carried out.
69. 69. Production plant according to one of sentences 66 to 68, characterized in that the set-up unit comprises a cleaning unit or that the set-up unit is assigned a cleaning unit, by means of which multi-use components of one or more tool units can be cleaned, in particular sterilized, after they have been used .
70. 70. Production plant according to one of sentences 61 to 69, characterized in that the tool system comprises a plurality of portable tool units which, in order to carry out a treatment process, can be fed to a treatment station for treating an educt, which in particular is also a storage location for storing the educt, and can be temporarily stored there are.
71. 71. Production plant according to sentence 70, characterized in that one or more portable tool units of the tool system can be fed to a tool storage area and/or to a treatment area and/or to a setup area by means of a storage transport device, in particular one or more storage transport units.
72. 72. Production plant according to one of sentences 1 to 71, characterized in that one or more tool units are designed and set up by means of the handling device for carrying out a treatment process and/or a maintenance process.
73. 73. Production plant according to one of sentences 1 to 72, characterized in that one or more tool units are designed and set up independently of the handling device, in particular automatically, for carrying out a treatment process and/or a maintenance process.
74. 74. Production plant according to one of sentences 1 to 73, characterized in that the production plant comprises a particularly fully automatic tool system which comprises one or more tool units for carrying out treatment processes on an educt, the tool system being arranged within the clean room area.
75. 75. Production plant according to one of sentences 61 to 74, characterized in that the tool system comprises one or more tool units designed as a fluid delivery device, by means of which a fluid can be delivered, in particular in an adjustable manner with regard to a volume flow.
76. 76. Production plant according to one of sentences 61 to 75, characterized in that the tool system comprises one or more tool units designed as a micro fluid delivery device, by means of which a fluid can be delivered in an adjustable manner with regard to a volume flow, in particular for aliquoting.
77. 77. Production plant according to one of sentences 61 to 76, characterized in that the tool system comprises one or more tool units designed as a device for dividing a fluid, by means of which the fluid can be conveyed, in particular in an adjustable manner with regard to a volume flow, and by means of which the fluid can be divided into at least two Fluid parts can be divided in particular adjustable.
78. 78. Production installation according to one of sentences 61 to 77, characterized in that the tool system comprises one or more tool units designed as a fluid mixing device, by means of which a fluid can be mixed.
79. 79. Production plant according to one of sentences 61 to 78, characterized in that the tool system comprises one or more tool units designed as a mixing device, by means of which at least two components can be mixed with one another, with one of the at least two components being a fluid in particular.
80. 80. Production plant according to one of sentences 61 to 79, characterized in that the tool system comprises one or more tool units designed as a measuring device, by means of which at least one property of a fluid and/or an educt can be measured.
81. 81. Production plant according to one of sentences 61 to 80, characterized in that the tool system comprises one or more tool units designed as a material separation device, by means of which a starting component can be separated into at least two components.
82. 82. Production plant according to one of sentences 61 to 81, characterized in that the tool system comprises one or more tool units designed as a heating device, by means of which a fluid can be heated.
83. 83. Production installation according to one of sentences 61 to 82, characterized in that the tool system comprises one or more tool units designed as a device for supplying and/or discharging a gas, by means of which a gas can be supplied and/or discharged.
84. 84. Production plant according to one of sentences 61 to 83, characterized in that the tool system comprises one or more tool units designed as a manipulator, by means of which a cell membrane can be manipulated, in particular by means of an electric field.
85. 85. Production plant according to one of sentences 61 to 84, characterized in that the tool system comprises one or more tool units designed as a radiation source and/or a light emitting device, wherein the radiation source is configured to emit ionized radiation and the light emitting device is configured to emit light with a predetermined wavelength.
86. 86. Production plant according to one of sentences 61 to 85, characterized in that the tool system comprises one or more tool units designed as a cleaning device, by means of which a location at which the treatment processes on the educt can be carried out using the one or more tool units can be cleaned and /or can be sterilized.
87. 87. Production plant according to one of sentences 1 to 86, characterized in that the production plant comprises a tool system and a supply device for supplying the tool system with consumables.
88. 88. Production plant according to sentence 87, characterized in that the supply device for storing consumables includes or uses one or more storage locations of the storage device arranged within the clean room area.
89. 89. Production plant according to sentence 87 or 88, characterized in that the locks device forms part of the supply device or interacts with it, with consumables being able to be brought into the clean room area by means of the lock device.
90. 90. Production plant according to one of sentences 87 to 89, characterized in that the storage device forms part of the supply device or interacts with it.
91. 91. Production plant according to one of sentences 87 to 90, characterized in that by means of a storage transport device of the storage device, in particular by means of one or more storage transport units of the storage transport device of the storage device, consumables supplied from an area surrounding the production plant can be fed to one or more storage locations of the storage device.
92. 92. Production plant according to one of sentences 61 to 91, characterized in that consumables can be fed to the tool system, in particular one or more tool units of the tool system, for example by means of a storage transport device of the storage device, in particular by means of one or more storage transport units of the storage transport device of the storage device of consumables and/or tool consumables to one or more tool units of the tool system.
93. 93. Production plant according to one of sentences 87 to 92, characterized in that the supply device comprises one or more disposal units, by means of which in particular used, exhausted and/or contaminated consumables and/or tool consumables can be removed from the clean room area.
94. 94. Production plant according to one of sentences 87 to 93, characterized in that the supply device comprises a refilling device arranged within the clean room area, by means of which consumables, in particular in liquid form, can be fed to one or more storage devices of one or more workpiece carriers and/or one or more storage locations .
95. 95. Production plant according to one of sentences 1 to 94, characterized in that the production plant has one or more sensor units for determining one or more values of one or more parameters
    1. a) one or more starting materials; and or
    2. b) one or more workpiece carriers; and or
    3. c) one or more tools; and or
    4. d) one or more receiving boxes, in particular receiving boxes designed as aseptic process units,
    includes.
96. 96. Production plant according to one of sentences 1 to 95, characterized in that an occupancy status of one or more storage locations of a storage device of the production plant can be determined, in particular monitored, by means of one or more sensor units.
97. 97. Production plant according to one of sentences 1 to 96, characterized in that a local temperature and/or a local humidity and/or a local illuminance or irradiation intensity can be determined at or in one or more storage locations of the storage device of the production plant by means of one or more sensor units , In particular, can be monitored.
98. 98. Production plant according to one of sentences 1 to 97, characterized in that the production plant comprises one or more sensor units for determining a treatment progress during the treatment of a starting material or between two treatment processes.
99. 99. Production installation according to one of sentences 1 to 98, characterized in that one or more sensor units for determining the progress of treatment are microscopy devices for visual detection of microscopic components of the educt.
100. 100. Production plant according to one of sentences 1 to 99, characterized in that one or more sensor units for determining the progress of treatment are arranged at or in one or more storage locations for receiving educts, in particular integrated therein.
101. 101. Production plant according to one of sentences 1 to 100, characterized in that the production plant, in particular one or more tools for carrying out one or more treatment processes, can be controlled and/or regulated depending on the one or more determined values, with in particular depending on a determined treatment progress one or more treatment parameters are varied.
102. 102. Production plant according to one of sentences 1 to 101, characterized in that that the production plant comprises one or more sensor units for monitoring a quantity of consumables stored within the clean room area.
103. 103. A method for manufacturing a product, in particular a biological-pharmaceutical product, by means of a production facility, in particular a production facility according to one of sentences 1 to 102, the method comprising the following:
     • - selecting one of a plurality of production programs for producing one of a plurality of products which can be produced by means of the production facility;
     • - Introducing an educt into a lock device of the production plant;
     • - Automatic transport of the educt into a clean room area of the production plant;
     • - Automatic implementation of one or more treatment processes on the starting material.
104. 104. The method according to sentence 103, characterized in that during the automatic transport of the educt into the clean room area of the production plant, the educt is stored in a storage location of a storage device of the production plant located within the clean room area.
105. 105. The method according to sentence 104, characterized in that one or more treatment processes are carried out fully automatically until a product to be manufactured from the starting material is finished.
106. 106. The method according to sentence 104 or 105, characterized in that one or more, in particular all, treatment processes are carried out at the storage location.
107. 107. The method according to any one of sentences 104 to 106, characterized in that the product manufactured in this way is removed from the storage location and automatically transported to the lock device for removal of the same from the production plant.
108. 108. Method according to sentence 107, characterized in that the product is filled and/or packaged before it is removed, in particular is filled and/or packaged ready for use.
109. 109. The method according to any one of sentences 104 to 108, characterized in that one or more vessels, receptacles and/or tools used to manufacture the product remain at least partially within the clean room area after the product has been completed, are cleaned and then be reused to make another product.
110. 110. The method according to one of sentences 104 to 109, characterized in that the consumables required to manufacture the product and/or to manufacture a plurality of different products, in particular consumables and/or tool consumables, are stored within the clean room area, in particular before the product to be manufactured is selected is hit.
111. 111. The method according to sentence 110, characterized in that the consumables are automatically transported via the lock device into the clean room area and stored there in particular in one or more storage locations of the storage device.
112. 112. The method according to sentence 110 or 111, characterized in that a quantity of the consumables stored within the clean room area is monitored and that if the quantity falls below a predetermined minimum, the stock is increased by supplying the required consumables, in particular via a notice or a warning message an operator unit.
113. 113. Method according to one of sentences 104 to 112, characterized in that several products, in particular several different products, are produced within the clean room area at the same time.
114. 114. The method according to sentence 103, characterized in that each product to be manufactured is assigned a sequence of treatment processes, which are carried out using tools that are arranged within the clean room area and remain in the clean room area after the treatment processes have been carried out.
115. 115. Method according to one of sentences 103 to 114, characterized in that one or more tools are cleaned, in particular sterilized, after carrying out one or more treatment processes within the clean room area.
116. 116. Method according to one of sentences 103 to 115, characterized in that one or more tools are equipped with tool consumables before carrying out one or more treatment processes within the clean room area.
117. 117. The method according to sentence 116, characterized in that one or more tool consumables after the implementation one or more treatment processes within the clean room area are removed from the one or more tools and/or disposed of.
118. 118. Method according to one of sentences 103 to 117, characterized in that several, in particular all, treatment processes are assigned treatment time values which indicate the period of time that elapses from the start of the respective treatment process to its end, in particular inclusive
     • - a period of time for the provision of the at least one tool required for the respective treatment process, in particular including its equipping with one or more tool consumables; and or
     • - a period of time for the supply and/or arrangement and/or commissioning of the at least one tool on the educt to be treated, in particular at a storage location at which the educt is arranged; and or
     • - A duration of action on the educt to achieve a desired treatment result; and or
     • - a period of time for removing the at least one tool from the educt, in particular from the storage location,
     • - preferably including
     • - a) cleaning of the at least one tool; and or
     • - b) removal and/or disposal of tool consumables; and or
     • - c) a return transport of the tool to a starting point, in particular to a storage location assigned to the tool.
119. 119. Method according to one of sentences 103 to 118, characterized in that the treatment processes required for the manufacture of a specific product and the associated treatment time values are stored or taken into account in each production program.
120. 120. Method according to one of sentences 103 to 119, characterized in that when a production program starts, a prediction of a production sequence is created and that the tools required and/or provided for carrying out the treatment processes are reserved in advance for the time slots resulting from the prediction.
121. 121. The method according to any one of sentences 103 to 120, characterized in that one or more treatment processes respectively
     1. a) one or more cleaning operations to clean one or more tools and/or to clean one or more storage locations; and or
     2. b) one or more disposal operations for the disposal of consumables; and or
     3. c) one or more set-up processes for equipping one or more tools with consumables; and or
     4. d) one or more control processes are or are assigned to control a treatment result,
     depending on the prediction of the production process, time slots are pre-reserved on one or more of those devices which are used to carry out the one or more cleaning processes, the one or more disposal processes, the one or more set-up processes and/or the one or more control processes required are.
122. 122. The method according to sentence 120 or 121, characterized in that after one or more treatment processes, in particular after each treatment process, the prediction of the production process is checked and/or updated, in particular to confirm or correct the time slots for the tools and/or that are still required other devices for finishing the product.
123. 123. Method according to one of sentences 103 to 122, characterized in that when a production program is desired to start, it is determined on the basis of a prediction of the production process whether all the necessary tools and/or other devices for completing the product are available within the required time slots , and that the production program is only started if this determination has delivered a positive result.

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

• 1 eine schematische Perspektivdarstellung einer Produktionsanlage gemäß einer beispielhaften Ausführungsform der vorliegenden Erfindung,
• 2 eine schematische Perspektivdarstellung eines Teils der Produktionsanlage, die in 1 gezeigt ist,
• 3 eine schematische Draufsichtdarstellung eines Teils der Produktionsanlage, die in 1 gezeigt ist,
• 4 eine schematische Draufsichtdarstellung eines Teils der Produktionsanlage, die in 1 gezeigt ist,
• 5 eine schematische Draufsichtdarstellung der Produktionsanlage, die in 1 gezeigt ist,
• 6 eine schematische Draufsichtdarstellung der Produktionsanlage, die in 1 gezeigt ist,
• 7 eine schematische Draufsichtdarstellung der Produktionsanlage, die in 1 gezeigt ist,
• 8 eine schematische Draufsichtdarstellung eines Teils der Produktionsanlage, die in 1 gezeigt ist,
• 9 eine schematische Perspektivdarstellung eines Teils der Produktionsanlage, die in 1 gezeigt ist,
• 10 eine schematische Draufsichtdarstellung eines Teils der Produktionsanlage, die in 1 gezeigt ist,
• 11 eine schematische Draufsichtdarstellung eines Teils der Produktionsanlage, die in 1 gezeigt ist,
• 12 eine schematische Perspektivdarstellung einer Produktionsanlage gemäß einer weiteren beispielhaften Ausführungsform der vorliegenden Erfindung,
• 13 eine schematische Perspektivdarstellung eines Teils der Produktionsanlage, die in 12 gezeigt ist,
• 14 eine schematische Draufsichtdarstellung eines Teils der Produktionsanlage, die in 12 gezeigt ist,
• 15 eine schematische Draufsichtdarstellung eines Teils der Produktionsanlage, die in 12 gezeigt ist,
• 16 eine schematische Draufsichtdarstellung der Produktionsanlage, die in 12 gezeigt ist,
• 17 eine schematische Draufsichtdarstellung der Produktionsanlage, die in 12 gezeigt ist,
• 18 eine schematische Draufsichtdarstellung der Produktionsanlage, die in 12 gezeigt ist,
• 19 eine schematische Draufsichtdarstellung eines Teils der Produktionsanlage, die in 12 gezeigt ist,
• 20 eine schematische Perspektivdarstellung eines Teils der Produktionsanlage, die in 12 gezeigt ist,
• 21 eine schematische Draufsichtdarstellung eines Teils der Produktionsanlage, die in 12 gezeigt ist,
• 22 eine schematische Draufsichtdarstellung eines Teils der Produktionsanlage, die in 12 gezeigt ist,
• 23 eine schematische Perspektivdarstellung einer Produktionsanlage gemäß einer weiteren beispielhaften Ausführungsform der vorliegenden Erfindung,
• 24 eine schematische Perspektivdarstellung einer Produktionsanlage gemäß einer weiteren beispielhaften Ausführungsform der vorliegenden Erfindung, und
• 25 ein Verfahren gemäß einer beispielhaften Ausführungsform der vorliegenden Erfindung.

In the drawings show:

• 1 a schematic perspective view of a production plant according to an example liable embodiment of the present invention,
• 2 a schematic perspective view of a part of the production plant, which is shown in 1 is shown
• 3 a schematic top view representation of a part of the production plant, which is shown in 1 is shown
• 4 a schematic top view representation of a part of the production plant, which is shown in 1 is shown
• 5 a schematic top view representation of the production plant, which is shown in 1 is shown
• 6 a schematic top view representation of the production plant, which is shown in 1 is shown
• 7 a schematic top view representation of the production plant, which is shown in 1 is shown
• 8th a schematic top view representation of a part of the production plant, which is shown in 1 is shown
• 9 a schematic perspective view of a part of the production plant, which is shown in 1 is shown
• 10 a schematic top view representation of a part of the production plant, which is shown in 1 is shown
• 11 a schematic top view representation of a part of the production plant, which is shown in 1 is shown
• 12 a schematic perspective view of a production plant according to a further exemplary embodiment of the present invention,
• 13 a schematic perspective view of a part of the production plant, which is shown in 12 is shown
• 14 a schematic top view representation of a part of the production plant, which is shown in 12 is shown
• 15 a schematic top view representation of a part of the production plant, which is shown in 12 is shown
• 16 a schematic top view representation of the production plant, which is shown in 12 is shown
• 17 a schematic top view representation of the production plant, which is shown in 12 is shown
• 18 a schematic top view representation of the production plant, which is shown in 12 is shown
• 19 a schematic top view representation of a part of the production plant, which is shown in 12 is shown
• 20 a schematic perspective view of a part of the production plant, which is shown in 12 is shown
• 21 a schematic top view representation of a part of the production plant, which is shown in 12 is shown
• 22 a schematic top view representation of a part of the production plant, which is shown in 12 is shown
• 23 a schematic perspective view of a production plant according to a further exemplary embodiment of the present invention,
• 24 a schematic perspective view of a production plant according to a further exemplary embodiment of the present invention, and
• 25 a method according to an exemplary embodiment of the present invention.

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

In 1 1 is a schematic perspective view of a production facility 10 according to an exemplary embodiment of the present invention.

• - einen Reinraumbereich 100;
• - eine Schleusenvorrichtung 200 zur Zuführung eines Objekts aus einer Umgebung der Produktionsanlage 10 in den Reinraumbereich 100 und/oder zum Entfernen eines Objekts aus dem Reinraumbereich 100;
• - eine Handhabungsvorrichtung 300 zum Bewegen des Objekts innerhalb des Reinraumbereichs 100; und
• - eine innerhalb des Reinraumbereichs angeordnete Lagervorrichtung 400, welche mehrere Lagerplätze 402 zur Aufnahme mehrerer Objekte umfasst.

Referring to 1 includes a production plant 10 in particular for the production of biological-pharmaceutical products 20:

• - a clean room area 100;
• - a lock device 200 for supplying an object from an environment of the production plant 10 in the clean room area 100 and / or for removing an object from the clean room area 100;
• - a handling device 300 for moving the object within the clean room area 100; and
• - A storage device 400 arranged within the clean room area, which comprises a plurality of storage locations 402 for accommodating a plurality of objects.

The biopharmaceutical product 20 can be intended for a personalized therapy and can consequently be a personalized therapeutic, for example a personalized cellular therapeutic, for example an autologous and/or an allogeneic cell therapeutic, or a gene therapeutic, for example an autologous and/or an allogeneic gene therapeutic.

The production plant 10 has a housing (not shown in the figures) for delimiting the clean room area 100 from the surroundings of the production plant 10 .

To a certain extent, the housing surrounds the entire production plant 10.

The lock device 200 is therefore configured to supply an object from the vicinity of the production plant 10 via or through the housing into the clean room area 100 and/or to remove an object from the clean room area 100 via or through the housing.

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

Furthermore, air is supplied to and removed from the clean room area 100 by means of the system for adjusting the environmental properties of the clean room area 100.

As in 1 As can be seen, the storage device 400 comprises a plurality of storage racks 404, here three by way of example, which each have a plurality of storage locations 402.

To a certain extent, the storage locations 402 are shelf locations for one or more, for example the three, storage shelves 404.

The storage device 400 also includes a storage transport device 406 for transporting objects to the storage locations 402, in particular the storage racks 404, towards and/or from the storage locations 402, in particular the storage racks 404.

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

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

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

The storage racks 404 are arranged essentially parallel to one another and spaced apart from one another in the clean room area 100 .

The storage transport device 406 is arranged at the respective distances between the storage racks 404 , with a storage transport unit 408 being assigned to a respective distance between the storage racks 404 .

To a certain extent, there is a storage rack-storage transport unit-storage rack-storage transport unit-storage rack arrangement.

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

Other arrangements of the storage racks 404 in combination with the storage transport units 408 are also conceivable in the present case.

The parallel arrangement described above can, for example, be expanded or implemented as required in its alternating manner.

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

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

A plurality of essentially horizontally aligned rows of storage locations 402 are arranged one above the other in the vertical direction in the storage racks 404 .

To a certain extent, the storage locations 402 are arranged in a matrix in the storage racks 404; example in 1 Matrix arrangements of 4x13 (outer storage racks 404) and 4x10 (middle storage rack 404) are shown.

As already described, the storage locations 402 are configured to accommodate different types of objects, it being possible for the storage locations 402 to differ from one another in terms of their shape and/or dimensions.

For a simplified representation, the storage locations are 402 in 1 shown only in a uniform manner, in particular a uniform shape and dimensioning, by way of example.

The storage locations 402 can also differ from one another with regard to their function and/or their equipment.

The different types of storage locations can be distributed in a regular pattern in a storage location shelf and/or a storage location area of the storage device.

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

The cleaning device 500 is designed as a separate device in the clean room area and as a component of a tool system, in particular a tool or a tool unit 702 .

The cleaning device 500 can be used to clean and/or sterilize objects, in particular tools 702 and/or consumables 704, in particular that come into direct contact with educts, in particular by means of irradiation.

The cleaning device 500 can be used in particular to clean and/or sterilize or sterilize objects that do not come into direct contact with educts, in particular by means of gassing.

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

The unpacking device 212 and the packaging device 214 are integrated or attached to the lock device 200, in particular integrated or attached to the side in the present case.

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

As in 1 and 2 is also shown, the lock device 200 has an exit lock 204, via which a lock location 208, in particular an exit lock location 208, is accessible from the environment and which is configured to remove an object from the clean room area 100.

The entry lock 202 and the exit lock 204 also include means for spatially isolating the lock locations 206, 208 assigned to the entry lock 202 and the exit lock 204 (not shown in the figures).

Isolating can be carried out selectively towards the surroundings of the production plant 10 and/or towards a respective part of the lock device 200 that is different from the lock locations 206, 208, in each case by means of the respective means for isolating from the inlet lock 202 and from the outlet lock 204.

Furthermore, the production plant 10 has a plurality of maintenance airlocks 210, via which the clean room area 100 is accessible from an area surrounding the production plant 10, for example for users, in particular for maintenance work within the clean room area 100.

The production plant 10 has one or more control units, which are set up within the clean room area 100 in a control system 600 arranged in switching cabinets and which are designed and programmed to regulate at least one component comprised by the production plant or a part of the production plant and/or to control associated with the one or more control units.

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

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

The communication interfaces not shown in the figures can be used, for example, to ensure data exchange with a higher-level control system and/or data management system, for example an assigned cloud system, in order, for example, to carry out data evaluation and/or data optimization via artificial intelligence and/or a enabling deep learning.

The one or more control units are also designed and programmed to provide information to a user via the communication interfaces and/or via the HMI interfaces 602, for example fault information and/or information about a state of manufacture of a product 20 and/or information about inventories of the storage device 400.

Furthermore, the production of the biological-pharmaceutical product 20 can be carried out by means of the production plant 10 by means of the one or more control units.

Said product manufacture can be carried out according to one or more production programs by means of the one or more control units.

Each product 20 to be manufactured is assigned a sequence of treatment processes which can be carried out using tool units 702 which are arranged within the clean room area 100 and remain in the clean room area after the treatment processes have been carried out.

The treatment processes required for the manufacture of a specific product 20 and associated treatment time values are stored or taken into account in each production program.

Production plant 10 also includes one or more sensor units for determining one or more values of one or more parameters of one or more reactants 40 and/or one or more workpiece carriers 30 and/or one or more tools or tool units 702 and/or one or more consumables 704.

The sensor units can be connected or are connected to the control units.

The sensor units serve in particular to determine the progress of treatment during the treatment of an educt or between two treatment processes.

The sensor units are used in particular to control and/or regulate one or more tool units 702 for carrying out one or more treatment processes depending on the one or more determined values, with one or more treatment parameters being varied or changeable in particular depending on a determined treatment progress .

The sensor units are used in particular to monitor storage device 400, for example storage conditions and/or storage quantities at storage locations 402.

The production facility 10 is further connected to at least one electric power source (not shown in the figures) located in the vicinity of the production facility for power supply.

In 2 FIG. 14 is an enlarged view particularly of the sheath device 200 of FIG 1 too shown.

Referring to 2 and 3 Handling device 300 comprises a multi-axis robotic arm 302, which is arranged adjacent to lock device 200, and a lock transport device 304, by means of which one or more objects are transported from one lock location, in particular an entry lock location 206, to another lock location, in particular a transfer lock location 216, and /or can be transported from one lock location, in particular a transfer lock location, to another lock location, in particular an exit lock location 208.

It is also conceivable that the handling device 300 has a first multi-axis robotic arm and a second multi-axis robotic arm (not shown in the figures), with the first multi-axis robotic arm providing an input material flow into the production plant and the second multi-axis robotic arm providing an output material flow assigned to the production plant. To a certain extent, it can also be conceivable that the handling device 300 can be divided into a first handling device and a second handling device, which can each be assigned to an input material flow into the production plant and a starting material flow out of the production plant.

In the entry airlock 202 there is a workpiece carrier 30 at the entry airlock location 206 of the production plant 10 and an educt 40, which is accommodated in an educt container 42, the educt container 42 being arranged on the workpiece carrier 30.

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

The starting material 40 has cells and a culture medium, with the cells and the culture medium forming a cell suspension.

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

In addition to said workpiece carrier 30, the production system 10 has one or more additional workpiece carriers 30, which can be or are stored, for example, in the storage locations 402.

The workpiece carriers 30 are used to hold educts and/or tools or tool units and/or consumables.

The workpiece carrier 30 has a means for fixing, not shown in the figures, in particular a means for positive and/or force-fitting and/or magnetic fixing, for receiving starting materials and/or tools and/or consumables .

The means for fixing can in particular comprise at least one adapter device and/or at least one mold cavity device, in particular in order to create a secure receiving connection between a workpiece carrier and an educt container.

The means for fixing can in particular be designed individually to correspond to the objects to be accommodated, such as the educt container.

the inside 1 and 2 Workpiece carrier 30 shown has received an educt 40 arranged in an educt container 42 .

The production plant 10 includes several types of workpiece carriers 30 which differ from one another in terms of the shape and/or dimensioning of a receiving area of the respective workpiece carrier 30 .

As in 1 and 2 shown as an example, one type of workpiece carrier 30 is used to hold a reactant container 42.

Another type of workpiece carrier 30 is used to hold one or more tool units 702 and/or tool consumables 704 for carrying out a treatment process on one or the starting material 40 and/or for carrying out a maintenance process within the clean room area 100.

Another type of workpiece carrier 30 is used to hold consumables 704 for feeding them to a starting material 40 and/or for carrying out a treatment process on a starting material 40.

One or more workpiece carriers 30 each comprise one or more action units (not shown in the figures) for performing an action on one or the educt 40 and/or on a tool 702, one or more action units acting as a treatment unit, for example as a tool unit 702, are designed to carry out a treatment process on educt 40 and/or one or more action units as a sensor unit for determining a current value of a parameter of the respective workpiece carrier 30 and/or an educt 40 arranged thereon and/or a tool 702 arranged thereon and/or of consumables 704 arranged thereon are formed. As a result, functions of the, in particular, independent tool system (see description below) can be taken over in a functional unit, here the workpiece carrier 30 .

One or more workpiece carriers 30 include a storage device (not shown in the figures) for storing energy and/or one or more consumables 704, wherein the workpiece carriers 30 can be reused multiple times, in particular the storage device can be electrically recharged and/or with consumables 704 refillable.

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

the inside 1 and 2 The workpiece carrier 30 shown arranged on the lock transport device 304 was fed to the entry lock location 206 for receiving the educt container 42 in a process not shown in the figures.

In this case, a production program of the production system 10 was first selected by a user, for example via the HMI interface set 602 in order to produce the desired product 20 from the starting material 40 .

The user then places the educt container 42 with an educt 40 arranged therein on a workpiece carrier 30 which is provided at the entry lock location 206 and which has already been made available at the entry lock location 206 for receiving an object.

Alternatively, it is also conceivable that a workpiece carrier 30 stored in a storage location 402 of one of the storage racks 404 was removed from the storage location 402 by means of the storage transport unit 408 of the storage transport device 406 and transported to the lock device 200, so that the workpiece carrier 30 could be moved by means of the multi-axis robotic arm 302 and the lock transport device 304 can be fed to the entry lock location 206 .

As soon as the workpiece carrier 30 is provided at the entry lock location 206 for receiving the educt 40, the educt container 42 with an educt 40 arranged therein is manually transferred by the user to the workpiece carrier 30 and fixed to it by means of the fixing means.

The educt container 42 generally also has packaging for maintaining an aseptic state of the educt 30 .

The entrance lock 202 can now be converted into a closed state or is now closed.

A cleaning and sterilization process is now carried out on the packaged educt container 42 at the entry lock location 206 by means of gassing and/or irradiation using a gassing source and/or radiation source (not shown in the figures) appropriately set up at the entry lock location 206.

The packaged educt container 42 is then moved on the workpiece carrier 30 by means of the lock transport device 304 within the reach of the multi-axis robotic arm 302 .

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

It is also conceivable here that the in 2 and 3 shown entry lock place 208 serves as an unpacking place 206 and this is accessible by means of one or more unpacking units of the unpacking device 212.

Furthermore, it is also conceivable that the packaging of the educt container 42 can be removed by the multi-axis robotic arm 302 by means of one or more unpacking units.

After the packaged educt container 42 has been transferred to the unpacking device 212, the workpiece carrier 30 is moved back to the entry lock location 206 for a new pick-up of an object by means of the lock transport device 304, as shown in particular in 4 is shown.

After unpacking by means of the unpacking device 212, the unpacked educt container 42 is transferred to another, in particular sterile, workpiece carrier 30, which is provided at the transfer lock location or the transfer lock locations 216 on the lock transport device 304 (cf 4 ), transferred by means of the multi-axis robotic arm 302.

The other workpiece carrier 30 was previously removed from a storage location 402 of the storage racks 404 and was made available accordingly by means of the storage transport unit 408, the multi-axis robotic arm 302 and the lock transport device 304, as in 4 is shown.

The lock transport device 304 and/or the multi-axis robot arm 302 moves the workpiece carrier 30 together with the educt container 42 arranged on it into a receiving box 50 (which is in the 3 until 5 shown left receiving box 50), which was provided for this purpose by means of the storage transport unit 408 on the lock transport device 304 (cf 3 until 5 ).

There is also another receiving box 50 for receiving an object (which is shown in Figs 3 until 5 shown right receiving box 50).

The production plant 10 comprises a plurality of receiving boxes 50 for receiving one or more workpiece carriers 30 together with reactants 40 arranged and/or received thereon, which are arranged in a reactant container 42 .

It is also conceivable that, in addition or as an alternative, a tool carrier 30 as described above is designed as a receiving box 50 .

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

One or more of the containment boxes 50 enclose a closable interior space that can define an aseptic processing environment.

To a certain extent, a receiving box 50 defines a process unit, in particular an aseptic process unit.

The receiving boxes 50 can be opened and/or closed automatically and/or by means of the handling device 300 in order to introduce an educt 40 and/or to remove a product 20 produced from an educt 40 .

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

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

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

For this purpose, the storage locations 402 are provided with connection elements, so that one or more treatment processes for treating the educts 40 can be carried out at storage locations 402 of the storage device 400 serving as treatment locations.

The storage locations 402 of the storage device 400 and/or the storage boxes 50 comprise fixing elements, by means of which the storage boxes 50 can be positioned and/or fixed at the storage locations 402.

The storage boxes 50 each include one or more tool holders for receiving and securing one or more tools or tool units 702, in particular in the interior of the respective storage box 50.

The one or more tool holders can each include one or more connection elements, which can be connected to corresponding connection elements on the tool 702 to be held in each case, in particular in order to supply the respective tool 702 with electrical energy and/or consumables, in particular liquids and/or gases and/or in order to establish a signaling connection between the respective tool 702 and the receiving box 50 and/or the higher-level control device.

It is also conceivable that the storage boxes 50 comprise one or more connection elements, which can be connected to corresponding connection elements on a further storage box 50, as a result of which an assembled storage box 50 can be provided.

Referring to 4 and 5 the workpiece carrier 30, together with the educt container 42 arranged on it, was moved into the (left) receiving box 50 by means of the lock transport device 304 and/or the multi-axis robotic arm 302.

The receiving box 50 is now using the in 5 illustrated left storage transport unit 408 in the 5 illustrated left or center storage rack 404 storable.

The receiving box 50 is transported to the said central storage rack 404 by means of the said left storage transport unit 408 and stored there.

Depending on the production program of the production system 10 selected by the user, by means of which the production system 10 is able to produce the desired product 20 from the starting material 40, one or more objects are transported to the storage locations 402 of the storage device by means of the storage transport units 408 400 are stored, in particular tools or work tool units 702 and/or consumables can be transported or are transported to this receiving box 50.

As exemplified in 6 represented by the arrows, a tool unit 702 for performing one or more treatment processes is removed from the left-hand storage shelf 404 by means of the storage transport unit 408 and the receiving box 50 with the educt container 42, for example, in order to carry out the one or more treatment processes on the educt 40 in the Educt container 42 to be carried out by means of the tool unit 702.

The arrows shown can represent a tool path 706 of the tool unit 702 within the clean room area 100 .

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

The tool unit 702 is part of a tool system of the production plant 10, by means of which treatment processes on educts and/or maintenance processes can be carried out within the clean room area 100.

The tool system includes a number of, in particular, fully automatic tool units 702 for carrying out different treatment and/or maintenance processes.

The tool system comprises one or more tool units 702 designed as feed units for feeding consumables 704 to the educts 40 or the educt 40.

The tool system comprises one or more tool units 702 designed as extraction units for removing a sample from a reactant 40.

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

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

This takes place in a receiving box 50.

As in 7 shown by the arrows, the storage transport unit 408 transports the used tool unit 702 in this storage box 50 to the handling device 300 in order to be removed there from the storage box 50 by means of the handling device 300 (cf 8th ).

The arrows shown can represent a tool path 706 of the tool unit 702 used within the clean room area 100 . The tool path can be understood in the sense of a material flow, whereby in the present production plant a directed material flow, in particular a material flow directed from clean to dirty, is to be favored.

By means of the handling device 300, in particular the multi-axis robotic arm 302 of the handling device 300, the tool unit 702 used is separated from single-use components used in the one or more treatment processes and set up on the tool unit 702, such as hoses, cannulas and/or others Disposable elements, separately, the removed single-use components being removable or being removed from the clean room area 100 via the lock device 200 .

As in 8th is shown schematically, this is done in particular via a waste lock 218 of the lock device 200 by means of the multi-axis robotic arm 302. It is conceivable that the waste lock 218 is configured as a separate device from the handling device 300 in such a way that a clean room separation is set up between them in order to to ensure a directed flow of material from clean to dirty.

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

As in 10 is shown schematically, the cleaned by means of the cleaning device 500 is and sterilized tool unit 702 returned to the handling device 300 .

Furthermore, the handling device 300 is supplied with a consumable 704, in particular one or more new sterile single-use components from the storage shelves 404 by means of the storage transport unit 408 on a workpiece carrier 30 and/or in a further storage box 50 (which is located in 10 shown right receiving box 50) supplied.

Using the handling device 300, in particular the multi-axis robotic arm 302, the tool unit 702 is equipped with the new consumables 704, i.e. the new single-use components, in order to be able to be used again for one or more treatment processes.

The tool unit 702 that has been reprocessed in this way can be stored again in a storage location 402 on a tool carrier 30 and/or in the receptacle box 50 that has also been reprocessed, in particular until it is used again, by means of storage transport units 408.

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

The educt container 42 can now be designated as a product container 22 in which the product 20 produced from the educt 40 is now located.

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

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

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

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

It is also conceivable here that the in 11 exit lock location 208 shown serves as a packaging location and this is accessible by means of one or more packaging units of the packaging device 214. Furthermore, it is also conceivable that the product container 42 can be sterilely packed with the packaging by the multi-axis robotic arm 302 by means of one or more packaging units.

After packaging by means of the packaging device 214, the packaged product container 22 is transferred back to the workpiece carrier 30 by means of the multi-axis robotic arm 302 (cf 11 ) and fed to the exit lock location 208 by means of the lock transport device 304, where the packaged product container 22 with the product 20 can be removed by the user.

The workpiece carrier 30, on which the product container 22 was arranged, and the receiving box 50, in which the product container 22 was arranged, are fed to the cleaning device 500 of the production system 10 as described above and then cleaned and sterilized in order to be returned to the respective storage locations 402 to be stored.

In 12 1 shows a schematic perspective illustration of a production plant 10 according to a further exemplary embodiment of the present invention.

In the 12 The production plant 10 shown according to a further exemplary embodiment of the present invention essentially has the same structural and functional features as those in FIG 1 illustrated exemplary embodiment of the production plant 10 according to the invention, so that only the structural and functional differences in features are shown below.

In the 12 The storage transport device 406 shown schematically comprises one or more transport vehicles 410 traveling freely in the clean room area 100 .

In other words, it can be provided that the transport vehicles 410 driving freely in the clean room area 100 are transport vehicles that can be controlled and driven freely in the clean room area 100 as required, so that with a corresponding control by means of at least one of the control units, these are free-moving as required.

The storage racks 404 of the storage device 400 are accessible by means of the transport vehicles 410, in particular for storage and retrieval processes and for treatment processes and/or maintenance processes.

The storage racks 404, in particular the storage locations 402 of the storage racks 404, are accessible via one or more storage rack locks 412 for storage and retrieval processes and for treatment processes and/or maintenance processes by the transport vehicles 410 (cf 20 ).

It is conceivable for the storage locations 402 of the storage racks 404 to be arranged on different storage space areas in the storage racks 404, which are arranged one above the other, for example, and for each storage space area of a storage rack 404 to be accessible to the transport vehicles 410 via a, in particular, common displacement unit in the respective storage rack 404.

Any arrangement of the storage racks 404 is also possible through the use of the free-moving transport vehicle 410 .

In the 12 and the substantially parallel arrangement of the storage shelves 404 shown in the related figures is shown purely by way of example for explanation purposes.

Referring to 13 a workpiece carrier 30, on which an educt 40 arranged in an educt container 42 is/is held, is arranged on a freely moving transport vehicle 410 at the entry lock location 206.

the inside 13 and 14 The workpiece carrier 30 shown arranged on the transport vehicle 410 was fed to the entry lock location 206 for receiving the educt container 42 in a process not shown in the figures by means of the transport vehicle 410.

In this case, a production program of the production plant 10 was first selected by a user, for example via the HMI interface 602, in order to produce the desired product 20 from the educt 40.

The user then places the educt container 42 with an educt 40 arranged therein on a workpiece carrier 30 which is provided at the entry lock location 206 and which has already been made available at the entry lock location 206 on the transport vehicle 410 for receiving an object.

Alternatively, it is also conceivable that a workpiece carrier 30 stored in a storage location 402 of one of the storage racks 404 was removed from the storage location 402 by means of the transport vehicle 410 of the storage transport device 406 and transported to the lock device 200 . As soon as the workpiece carrier 30 is provided at the entry lock location 206 for receiving the educt 40, the educt container 42 with an educt 40 arranged therein is manually transferred by the user to the workpiece carrier 30 arranged on the transport vehicle 410 and fixed to it by means of the fixing means.

As in 15 is shown schematically, the packaged educt container 42 is then moved on the workpiece carrier 30 by means of the transport vehicle 410 within the reach of the multi-axis robotic arm 302 .

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

After the packaged educt container 42 has been transferred to the unpacking device 212, the workpiece carrier 30 is moved back to the entry lock location 206 for another pick-up of an object by means of the transport vehicle 410, so that essentially a state as in FIG 14 can be shown.

After unpacking by means of the unpacking device 212, the unpacked educt container 42 is transferred to another, in particular sterile, workpiece carrier 30, which is arranged in a storage box 50 and which is provided at the transfer lock location 216 in the storage box 50 on another sterile transport vehicle 410 (cf 15 ), transferred by means of the multi-axis robotic arm 302.

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

Referring to 15 and 16 is/will be the receiving box 50 together with the workpiece carrier 30 arranged therein with the on it arranged educt container 42 can be moved to a storage location 402 in a storage rack 404 and stored or moved and stored by means of the transport vehicle 410.

As exemplified in 17 represented by the arrows (tool path 706), for example a tool unit 702 for carrying out one or more treatment processes is removed from the left-hand storage rack 404 by means of a transport vehicle 410 and fed to the receiving box 50 with the educt container 42 stored in the central storage rack 404 in order to transport the one or to carry out the multiple treatment processes on the educt 40 in the educt container 42 using the tool unit 702 .

After the one or more treatment processes have been carried out on educt 40, tool unit 702, which was delivered previously and is now being used, is removed again from storage box 50, which contains educt 40, by means of transport vehicle 410, in particular removed from storage box 50 and transported away.

As in 18 shown by the arrows, the transport vehicle 410 transports the used tool unit 702 in its storage box 50 to the handling device 300 in order to be removed there from the storage box 50 by means of the handling device 300 in order to remove single-use components set up on the tool unit 702 (compare 19 ).

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

As in 21 is shown schematically, tool unit 702, which has been cleaned and sterilized using cleaning device 500, is returned to handling device 300 using transport vehicle 410, in order to be reequipped with consumables 704, in particular one or more new sterile single-use components from storage shelves 404, using the Handling device 300, which was provided to the handling device 300 by means of another transport vehicle 410, for example during the cleaning of the tool unit 702 used.

In parallel or in series with this, the manufactured product 20, which is arranged in a product container 22, is removed from the storage rack 404 by means of a further transport vehicle 410 and transported to the transfer lock location 216 in order to be packaged by means of the packaging device 214.

After packaging by means of the packaging device 214, the packaged product container 22 is transferred back to the workpiece carrier 30 by means of the multi-axis robotic arm 302 (cf 22 ) and fed to the exit lock location 208 by means of the transport vehicle 410, where the packaged product container 22 with the product 20 can be removed by the user.

In 23 1 shows a schematic perspective illustration of a production plant 10 according to a further exemplary embodiment of the present invention.

In the 23 The production plant 10 shown according to a further exemplary embodiment of the present invention essentially has the same structural and functional features as those in FIG 1 illustrated exemplary embodiment of the production plant 10 according to the invention, so that only the structural and functional differences in features are shown below.

The warehouse transport device 406 includes one or more free-moving transport vehicles 410, which have already been mentioned in connection with the 12 illustrated exemplary embodiment of the production plant 10 according to the invention have been described.

The storage device 400 comprises a plurality of storage space areas 414, in this case four, which each have a plurality of storage spaces 402.

The storage area areas 414 are arranged one above the other, in particular in a vertical direction.

To a certain extent, the storage space areas 414 are arranged in a stacked manner, as in FIG 23 is shown schematically.

Different types of storage locations 402 are arranged on the storage space areas 414 for receiving different types of objects.

As in 23 As shown schematically, the different types of bins 402 are distributed in a regular pattern.

For example, several, in particular all, receiving boxes 50, and several, in particular all of them, tools 702, which are in particular arranged on respective value-carriers 30, and several, in particular all, consumables 704, which are in particular arranged on respective value-carriers 30, arranged spatially adjacent in said pattern.

The storage transport device 406 also includes one or more elevator devices 416, by means of which the storage space areas 414 of the storage device 400 are accessible in particular for storage and retrieval processes and for treatment processes and/or maintenance processes.

The transport vehicles 410 can be moved to the individual storage area areas 414 by means of the elevator devices 416 .

Additionally or alternatively, it is conceivable that the elevator devices 416 can be used to transfer a transported object from a transport vehicle 410 located on a storage bin area 414 to another transport vehicle 410 located on a different storage bin area 414. To a certain extent, such a transfer process can be carried out from one transport vehicle 410 to another transport vehicle 410 via the elevator devices 416 .

In 24 1 shows a schematic perspective illustration of a production plant 10 according to a further exemplary embodiment of the present invention.

In the 24 The production plant 10 shown according to a further exemplary embodiment of the present invention essentially has the same structural and functional features as those in FIG 1 illustrated exemplary embodiment of the production plant 10 according to the invention, so that only the structural and functional differences in features are shown below.

The storage device 400 includes a storage space area 414 which has a plurality of storage spaces 402 .

Various types of storage bins 402 are arranged on storage bin area 414 to accommodate different types of objects.

As in 24 As shown schematically, the different types of bins 402 are distributed in a regular pattern.

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

The storage transport device 406 comprises a storage transport unit 408 designed as a portal conveyor 418, the storage space area 414 being accessible by means of the portal conveyor 418 in particular for storage and retrieval processes and for treatment processes and/or maintenance processes.

In 25 A method is outlined in accordance with an exemplary embodiment of the present invention.

• - Auswählen eines von mehreren Produktionsprogrammen zur Herstellung eines von mehreren mittels der Produktionsanlage 10 herstellbaren Produkten 20 (S1);
• - Einbringen eines Edukts 40 in eine Schleusenvorrichtung 200 der Produktionsanlage 10 (S2);
• - Automatisches Transportieren des Edukts 40 in einen Reinraumbereich 100 der Produktionsanlage 10, wobei, optional, das Edukt 40 in einen innerhalb des Reinraumbereichs 100 befindlichen Lagerplatz 402 einer Lagervorrichtung 400 der Produktionsanlage 10 eingelagert wird (S4);
• - Automatisches Durchführen eines oder mehrerer Behandlungsvorgänge an dem Edukt 40 (S4).

The method for producing a biological-pharmaceutical product 20 by means of a production plant, in particular the production plant 10 described above, comprises:

• - selecting one of a plurality of production programs for producing one of a plurality of products 20 (S1) that can be produced by means of the production facility 10;
• - Introduction of a starting material 40 in a lock device 200 of the production plant 10 (S2);
• - Automatic transport of the educt 40 into a clean room area 100 of the production plant 10, wherein, optionally, the educt 40 is stored in a storage location 402 of a storage device 400 of the production plant 10 located within the clean room area 100 (S4);
• - Automatic implementation of one or more treatment processes on the starting material 40 (S4).

In S4, one or more treatment processes are carried out fully automatically until a product 20 to be produced from the starting material 40 is completed.

One or more, in particular all, treatment processes can be carried out at the storage location 402 in S4.

The product 20 that can be manufactured or manufactured in S4 is retrieved from the storage location 402 and automatically transported to the lock device 200 for removal from the production plant 10 .

The product 20 is filled and/or packaged, in particular filled and/or packaged ready for use, in a subsequent step S4 before it is removed.

One or more vessels, receptacles and/or tools used to manufacture the product 20 will remain at least partially within the clean room area 100 after the product 20 has been completed, will be cleaned and then reused to manufacture another product 20 .

For the production of the product 20 and/or for the production of several different products 20, the consumables 704 required, in particular consumables and/or tool consumables, are/are stored within the clean room area 100, in particular before the product 20 to be produced is/was selected.

The consumables 704 are automatically transported into the clean room area 100 via the lock device 200 and stored there in particular in one or more storage locations 402 of the storage device 400 .

A quantity of the consumables 704 stored within the clean room area 100 is monitored and, if the quantity falls below a predetermined minimum, the supply is increased by supplying the required consumables 704, in particular via a message or a warning message on an operator unit, for example the HMI interface 602.

Several products 20, in particular several different products 20, can be produced within the clean room area 100 at the same time.

To a certain extent, the method can be carried out one or more times simultaneously and/or at different times.

• - Zuführen einer Flüssigkeit und/oder eines Gases, insbesondere eines Gasgemischs,
• - Abführen, insbesondere Abpumpen, einer Flüssigkeit und/oder eines Gases, insbesondere eines Gasgemischs,
• - Abführen, insbesondere Abpumpen, eines Teils einer Flüssigkeit und/oder eines Gases, insbesondere eines Gasgemischs, für eine Analyse mittels einer oder mehrerer Sensoreinheiten,
• - Mischen einer oder mehrerer Komponenten, insbesondere zumindest einer Flüssigkeit mit zumindest einer weiteren Komponente, beispielsweise einer weiteren Flüssigkeit,
• - Aufkonzentrieren und/oder Abtrennen einer Flüssigkeit insbesondere mittels einer Säule, beispielsweise einer Trennsäule, und/oder einer Zentrifuge,
• - Analysieren eines Edukts und/oder eines Zwischenprodukts und/oder eines Produkts insbesondere mittels einer oder mehrerer Sensoreinheiten,
• - Lagern, insbesondere Einlagern und/oder Auslagern, von einem oder mehreren Objekten insbesondere mittels der Lagertransportvorrichtung 406,
• - Temperieren, insbesondere Inkubieren, von einem oder mehreren Objekten insbesondere von einem oder mehreren Edukten 40.

One or more treatment processes that can be carried out in particular using one or more tool units 702 have:

• - supplying a liquid and/or a gas, in particular a gas mixture,
• - draining, in particular pumping, of a liquid and/or a gas, in particular a gas mixture,
• - removing, in particular pumping out, part of a liquid and/or a gas, in particular a gas mixture, for an analysis using one or more sensor units,
• - Mixing one or more components, in particular at least one liquid with at least one other component, for example another liquid,
• - Concentration and/or separation of a liquid, in particular by means of a column, for example a separation column, and/or a centrifuge,
• - Analyzing an educt and/or an intermediate product and/or a product, in particular by means of one or more sensor units,
• - Storage, in particular storage and/or retrieval, of one or more objects, in particular by means of the storage transport device 406,
• - Temperature control, in particular incubation, of one or more objects, in particular of one or more reactants 40.

It should be understood that the foregoing listing of treatment procedures is exemplary and not exhaustive.

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

Each product 20 to be manufactured is assigned a sequence of treatment processes, which are carried out by means of tools 702 arranged within the clean room area 100 and remaining in the clean room area 100 after the treatment processes have been carried out.

One or more tools 702 are cleaned, in particular sterilized, after one or more treatment processes have been carried out within the clean room area.

One or more tools 702 are equipped with tool consumables, in particular single-use components, before carrying out one or more treatment processes within the clean room area 100 .

One or more tool consumables are removed and/or discarded from the one or more tools 702 after the performance of one or more treatment operations within the clean room area 100 .

Treatment time values are assigned to several, in particular all, treatment processes, which indicate the period of time that elapses from the start of the respective treatment process to its end, in particular including:

• - einer Zeitdauer für die Bereitstellung des für den jeweiligen Behandlungsvorgang erforderlichen mindestens einen Werkzeugs 702, insbesondere einschließlich dessen Bestückung mit einem oder mehreren Werkzeugverbrauchsmitteln, und/oder
• - einer Zeitdauer für die Zuführung und/oder Anordnung und/oder Inbetriebnahme des mindestens einen Werkzeugs 702 an dem zu behandelnden Edukt 40, insbesondere an einem Lagerplatz 402, an welchem das Edukt 40 angeordnet ist, und/oder
• - einer Zeitdauer der Einwirkung auf das Edukt 40 zur Erzielung eines erwünschten Behandlungsergebnisses, und/oder
• - einer Zeitdauer für das Entfernen des mindestens einen Werkzeugs 702 von dem Edukt 40, insbesondere von dem Lagerplatz 402;
• - vorzugsweise einschließlich:
  • ◯ einer Reinigung des mindestens einen Werkzeugs 702, und/oder
  • ◯ eines Entfernens und/oder Entsorgens von Werkzeugverbrauchsmitteln, und/oder
  • ◯ eines Rücktransports des Werkzeugs 702 zu einem Ausgangsort, insbesondere einem dem Werkzeug 702 zugeordneten Lagerplatz 402.
  • ◯

In jedem Produktionsprogramm sind/werden die für die Herstellung eines bestimmten Produkts 20 erforderlichen Behandlungsvorgänge sowie die zugehörigen Behandlungszeitwerte hinterlegt oder berücksichtigt.

• - a period of time for the provision of the at least one tool 702 required for the respective treatment process, in particular including its equipping with one or more tool consumables, and/or
• - a period of time for feeding and/or arranging and/or starting up the at least one tool 702 on the educt 40 to be treated, in particular at a storage location 402 at which the educt 40 is arranged, and/or
• - A duration of action on the educt 40 to achieve a desired treatment result, and / or
• - A period of time for the removal of the at least one tool 702 from the starting material 40, in particular from the storage location 402;
• - preferably including:
  • ◯ cleaning of the at least one tool 702, and/or
  • ◯ removal and/or disposal of tool consumables, and/or
  • ◯ a return transport of the tool 702 to a starting point, in particular a storage location 402 assigned to the tool 702.
  • ◯

The treatment processes required for the manufacture of a specific product 20 and the associated treatment time values are/are stored or taken into account in each production program.

When a production program starts, a prediction of a production sequence is created and the tools 702 required and/or provided for carrying out the treatment processes are reserved in advance for time slots resulting from the prediction.

• - ein oder mehrere Reinigungsvorgänge zur Reinigung eines oder mehrerer Werkzeuge 702 und/oder zur Reinigung eines oder mehrerer Lagerplätze 402, und/oder
• - ein oder mehrere Entsorgungsvorgänge zur Entsorgung von Verbrauchsmaterialien 704, und/oder
• - ein oder mehrere Rüstvorgänge zur Bestückung eines oder mehrere Werkzeuge 702 mit Verbrauchsmaterialien 704, und/oder
• - ein oder mehrere Kontrollvorgänge zur Kontrolle eines Behandlungsergebnisses

zugeordnet, wobei abhängig von der Prädiktion des Produktionsablaufs Zeitslots an einer oder mehreren derjenigen Vorrichtungen vorreserviert sind/werden, welche für die Durchführung des einen oder der mehreren Reinigungsvorgänge, des einen oder der mehreren Entsorgungsvorgänge, des einen oder der mehreren Rüstvorgänge und/oder des einen oder der mehreren Kontrollvorgänge erforderlich sind.One or more treatment processes are / are respectively

• - one or more cleaning processes for cleaning one or more tools 702 and/or for cleaning one or more storage locations 402, and/or
• - one or more disposal processes for the disposal of consumables 704, and/or
• - One or more set-up processes for equipping one or more tools 702 with consumables 704, and/or
• - one or more control processes to control a treatment result

assigned, whereby, depending on the prediction of the production process, time slots are/are reserved in advance for one or more of those devices which are used to carry out the one or more cleaning processes, the one or more disposal processes, the one or more set-up processes and/or the one or where multiple checks are required.

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

If a production program is to start, it is determined on the basis of a prediction of the production process whether all the necessary tools 702 and/or other devices for completing the product 20 are available within the required time slots, and the production program is only started if this determination is a gave a positive result.

Regarding the in 25 Outlined method should be understood that all structural and functional features associated with the production plant according to the invention and in particular also with their previously described embodiments of the production plant 10 can also be included in the method according to the invention either alone or in combination and the properties associated therewith , configurations and advantages can also be included and achieved accordingly. The production plant 10 described above is also configured to 25 carry out the procedure outlined, and the in 25 The method outlined is also designed to be executable using the production system 10 described above.

Claims (14)

Production plant (10), in particular for the production of biological-pharmaceutical products (20), the production plant (10) comprising the following: - a clean room area (100); - A lock device (200) for supplying an object from an area surrounding the production plant (10) into the clean room area (100) and/or for removing an object from the clean room area (100); - a handling device (300) for moving the object within the clean room area (100); - A storage device (400) arranged within the clean room area (100) and comprising a plurality of storage locations (402) for accommodating a plurality of objects. Production plant (10) according to claim 1 , characterized in that the production plant (10) comprises an in particular fully automatic tool system which comprises one or more tool units (702) for carrying out treatment processes on an educt (40), the tool system being arranged within the clean room area (100). Production plant (10) according to claim 2 , characterized in that the tool system comprises one or more tool units (702) designed as a fluid delivery device, by means of which a fluid can be delivered, in particular in an adjustable manner with regard to a volume flow. Production plant (10) according to claim 2 or 3 , characterized in that the tool system comprises one or more tool units (702) embodied as a micro fluid delivery device, by means of which a fluid can be delivered in an adjustable manner with regard to a volume flow, in particular for aliquoting. Production plant (10) according to one of claims 2 until 4 , characterized in that the tool system comprises one or more tool units (702) designed as a device for dividing a fluid, by means of which the fluid can be conveyed, in particular adjustably with regard to a volume flow, and by means of which the fluid can be divided into at least two fluid parts, in particular adjustably. Production plant (10) according to one of claims 2 until 5 , characterized in that the tool system comprises one or more tool units (702) designed as a fluid mixing device, by means of which a fluid can be mixed. Production plant (10) according to one of claims 2 until 6 , characterized in that the tool system comprises one or more tool units (702) configured as a mixing device, by means of which at least two components can be mixed with one another, one of the at least two components being a fluid in particular. Production plant (10) according to one of claims 2 until 7 , characterized in that the tool system comprises one or more tool units (702) designed as a measuring device, by means of which at least one property of a fluid and/or an educt (40) can be measured. Production plant (10) according to one of claims 2 until 8th , characterized in that the tool system comprises one or more tool units (702) designed as a material separation device, by means of which a starting component can be separated into at least two components. Production plant (10) according to one of claims 2 until 9 , characterized in that the tool system comprises one or more tool units (702) designed as a heating device, by means of which a fluid can be heated. Production plant (10) according to one of claims 2 until 10 , characterized in that the tool system comprises one or more tool units (702) designed as a device for supplying and/or discharging a gas, by means of which a gas can be supplied and/or discharged. Production plant (10) according to one of claims 2 until 11 , characterized in that the tool system comprises one or more tool units (702) designed as a manipulator, by means of which a cell membrane can be manipulated, in particular by means of an electric field. Production plant (10) according to one of claims 2 until 12 , characterized in that the tool system comprises one or more tool units (702) configured as a radiation source and/or a light emitting device, wherein the radiation source is configured to emit ionized radiation and the light emitting device is configured to emit light having a predetermined wavelength to emit. Production plant (10) according to one of claims 2 until 13 , characterized in that the tool system comprises one or more tool units (702) designed as a cleaning device (500) by means of which a location at which the treatment processes on the educt (40) can be carried out using the one or more tool units (702) can be cleaned and/or sterilized.

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