System and method for carrying out process steps using and / or on objects

Abstract

The invention relates to a system (1) and a method for carrying out process steps using and / or on objects, at least partially under clean room conditions, wherein: the system (1) comprises a clean room structure (10); the clean room structure (10) comprises a housing (20), an introduction device and a discharge device; a main space (201) of the housing (20) is separated from an environment and the clean room condition can be met in the main space (201) of the housing (20) of the clean room structure; the system (1) comprises a plurality of process chambers (14, 15, 16, 17); the process chambers (14, 15, 16, 17) each have a chamber interior (140, 150, 160, 170) and an apparatus arranged in the chamber interior (140, 150, 160, 170) for carrying out a process step; at least one interface (152, 162) with the main space (201) is provided; in a connected state of the chamber interior (140, 150, 160, 170), the relevant chamber interior (140, 150, 160, 170) is connected to the main space (201) via the at least one interface (152, 162) in order to, in particular directly, move objects between the chamber interior (140, 150, 160, 170) and the main space (201); and the clean room condition of the main space (201) can be met at least in the connected state in the relevant chamber interior (140, 150, 160, 170).

Description

[0001] Equipment and procedures for carrying out process steps with and / or on objects

[0002] SCOPE OF APPLICATION AND STATE OF THE ART

[0003] The invention relates to a system and a method for carrying out process steps with and / or on objects, at least partially under cleanroom conditions. The invention particularly relates to a system and a method for carrying out process steps with and / or on packaging materials, for example, with and / or on containers and / or with and / or on pharmaceutical packaging materials.

[0004] Process steps are defined here as any form of handling, processing and / or treatment of an object, in particular a container, and / or its contents, including but not limited to filling, closing, labeling of objects designed as containers, as well as treatments without material change to the object and / or its contents, such as weighing and / or other recording, in particular optical inspection.

[0005] For the manufacture and / or processing, in particular the filling, of pharmaceutical products, biopharmaceutical products, biological products, highly potent products and / or other highly sensitive products, facilities are known to have a comprehensive cleanroom setup.

[0006] A cleanroom setup comprises an enclosure, the interior of which is separated from the environment, and within which a cleanroom condition is created. In particular, the cleanroom setup includes a barrier device, especially an isolator and / or a restricted access barrier system (RABS). The barrier device protects the cleanroom condition within the enclosure by separating it from the environment. An isolator is defined as a decontaminated unit that allows its interior to be isolated from the external environment. Both closed and open isolators are known. In closed isolators, material transfer to and from the isolator occurs exclusively via auxiliary devices such as alpha-beta port systems and not through pass-throughs to the environment.Closed isolators remain fluid-tight throughout operation. Open isolators have pass-throughs that are open during operation, particularly permanently open pass-throughs for continuous material transfer. These pass-throughs are designed to prevent the ingress of external contaminants into the isolator, for example, through appropriate pressure conditions and / or airlocks. In some configurations, the cleanroom environment is created within the interior of a housing designed as a RABS (Remotely Absorbed Boiling System). Such systems have an interior separated from the environment by the housing, but not necessarily fluid-tight. Depending on the ventilation, a distinction is made between open and closed RABS systems.

[0007] The required cleanroom conditions are defined by the application, in particular by the product being handled and / or the intended use of the handled object. Specifically, cleanroom conditions require at least a certain degree of sterility. Regulations defining cleanroom conditions include, for example, DIN EN ISO 14644-1 and / or VDI 2083 and / or "The Rules Governing Medicinal Products in the European Union, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use" (EU GMP Guide), Annex 1 (currently: Volume 4 dated August 22, 2022) and the regulations referenced therein. The cleanroom conditions required, at least in part, for handling objects in the system disclosed herein are, in particular, classes A, B, C, and D according to EU GMP, Annex 1, especially classes A, B, and C.In particular, the required cleanroom condition for filling and sealing the containers is class A.

[0008] Among other things, to avoid cross-contamination, it is known to completely clean and / or decontaminate the interior of the cleanroom setup after each batch of processed product.

[0009] TASK AND SOLUTION

[0010] The object of the invention is to create a system and a method which enables cost-efficient and safe execution of process steps under cleanroom conditions, especially for products with small batches.

[0011] According to a first aspect, a facility for carrying out process steps with and / or on objects is created at least partially under cleanroom conditions.

[0012] In particular, a facility is being created for carrying out process steps with and / or on packaging materials, for example, with and / or on containers and / or with and / or on pharmaceutical packaging. For example, a facility is being created for carrying out process steps under cleanroom conditions, whereby the process steps include filling and / or sealing containers under cleanroom conditions. The containers are, in particular, pharmaceutical containers such as vials, syringes, cartridges, or ampoules.

[0013] The system comprises a cleanroom setup, wherein the cleanroom setup includes a housing, an insertion device and an ejection device.

[0014] A main chamber of the enclosure is separated from an environment, in particular an environment of the enclosure, and the cleanroom condition can be met in the main chamber of the enclosure of the cleanroom setup.

[0015] The insertion device is designed to introduce objects from the surrounding area into the main room. The discharge device is designed to discharge objects from the main room into the surrounding area. In some embodiments, the cleanroom structure is arranged within a surrounding area, with objects being introduced from the surrounding area into the main room and discharged from the main room into the surrounding area. In particular, the surrounding area is a space within a building. In some embodiments, objects are introduced from a first surrounding area into the main room and discharged from the main room into the same first surrounding area. In other embodiments, objects are introduced from a first surrounding area into the main room and discharged from the main room into a second surrounding area that differs from the first. In some embodiments, the insertion device and the discharge device are at least partially designed as a single structural unit.In some embodiments, the insertion device and the dispensing device are designed as separate building units and are, in particular, arranged spatially separated.

[0016] The main room can be configured to meet high-level cleanroom requirements, in particular Class A as defined in Annex 1 to the EU GMP Guide. The insertion and / or removal devices are designed to introduce and / or remove objects from a lower-level cleanroom environment, such as Class D or, at most, Class C, into the main room without compromising the cleanroom condition of the main room.

[0017] The system, for example the cleanroom setup, comprises several process chambers. In some configurations, the system comprises exactly two process chambers. In others, the system comprises more than two process chambers. Each process chamber comprises an interior space and a device located within that interior space for carrying out a process step.

[0018] The system includes at least one interface to the main room.

[0019] The interior spaces of the process chambers can each be connected to the main chamber via at least one interface for the direct transfer of objects between the chamber interior and the main chamber, specifically for introducing objects from the main chamber into the chamber interior and / or removing objects from the chamber interior into the main chamber. A state in which a chamber interior is connected to the main chamber for the transfer of objects is referred to as the connected state of the chamber interior or the connected state. At least in the connected state, the cleanroom conditions of the main chamber can be met in the respective chamber interior.

[0020] The terms "first," "second," etc., serve only for differentiation in the context of the application and do not indicate any order or total number. The terms "a," "an," "a," etc., are used in the context of the application only as indefinite articles and not as counters. If a feature is described in the singular, the description should also apply analogously to the feature in the plural, unless explicitly stated otherwise. In particular, more than one insertion device and / or more than one ejection device is provided in the embodiments.

[0021] In certain configurations, exactly one interface is provided, whereby the interior chambers of the two or more process chambers can be alternately connected to the main chamber via this single interface, particularly to move objects between the chamber interior and the main chamber for the execution of at least one process step on and / or with the objects. Specifically, certain configurations provide for the preparation of a chamber interior that is not connected for a subsequent process step to be carried out in that chamber interior. Specifically, certain configurations provide for the subsequent dismantling and / or cleaning of a chamber interior that is not connected following the execution of a process step.

[0022] Several interfaces are provided in the configurations, whereby the interiors of two or more process chambers can be connected to the main chamber at least partially simultaneously via one interface each. In particular, process steps can be carried out at least partially simultaneously in the interiors of two or more process chambers. Specifically, this at least partially simultaneous execution of process steps can include handling, for example, filling, different products. In particular, cross-contamination between the products can be avoided by handling them in different chamber interiors.

[0023] The chamber interiors can be cleaned as needed, particularly when changing batches of the product being filled in the chamber interior and / or when changing the product being filled in the chamber interior, in order to prevent cross-contamination between two batches and / or between two different products handled successively in the same chamber interior. Cleaning of the respective chamber interior can be carried out independently of cleaning of the main chamber and / or cleaning of another chamber interior. In particular, cleaning of the respective chamber interior can be carried out at least partially simultaneously with the execution of process steps in another chamber interior.

[0024] In particular, the process chambers are designed so that the cleanliness condition of the main room can be established in the respective chamber interior before the respective chamber interior is connected to the main room.

[0025] In the main chamber, handling of objects without product contact takes place exclusively. This includes, for example, performing process steps on containers to be filled before filling and / or performing process steps on filled containers after sealing. Therefore, contamination of the main chamber during the processing of one batch and / or during the at least partially simultaneous processing of several batches in two or more chamber interiors is generally avoided. Consequently, cleaning and / or decontamination of the main chamber is unnecessary in configurations where cleaning and / or decontamination of a chamber interior is performed when switching between two batches and / or when switching between two different products being filled.

[0026] The interior of each process chamber is connected to the main chamber in its tethered state, allowing objects to be moved between the main chamber and the respective chamber interior without contact with the surrounding environment. Specifically, the interior of each process chamber is directly connected to the main chamber in its tethered state. In some configurations, objects can be moved individually between the chamber interior in its tethered state and the main chamber. Specifically, objects can be individually placed into the respective chamber interior, where exactly one or more process steps are performed on and / or with the respective object, and then the object is removed from the chamber interior into the main chamber. In other configurations, objects can be moved between the chamber interior and the main chamber in groups of two or more.In particular, the same process step is carried out in the respective chamber room on and / or with the objects of the group, especially simultaneously.

[0027] In configurations with multiple interfaces, the interior of at least one process chamber is connected to the main chamber in the connected state via one, and in particular exactly one, assigned interface. In other configurations, the interiors of at least some, for example all, process chambers are each connected to the main chamber in the connected state via one, and in particular exactly one, assigned interface. In particular, some configurations provide for a one-to-one mapping of interfaces and process chambers.

[0028] In certain configurations, at least one interface is assigned two or more process chambers, wherein, in particular, the interior of each of the assigned process chambers is connected to the main chamber via the interface in the connected state, and the interior of the other process chamber(s) is / are not in the connected state. The interiors of the assigned process chambers can be alternately brought into the connected state at the interface.

[0029] In certain configurations, at least one trial chamber with its interior space can be connected to at least several interfaces. In certain configurations, at least several trial chambers with their respective interior spaces can be connected to at least one interface, particularly alternately.

[0030] In configurations with multiple interfaces, the interior of at least one process chamber is connected to the main chamber in the connected state via one, and in particular exactly one, assigned interface. At least one further interface is assigned to two or more process chambers, wherein, in particular, the interior of each of the assigned process chambers is connected to the main chamber in the connected state via the interface, and the interior of the other process chamber(s) is / are not in the connected state. The interiors of the assigned process chambers can be alternately brought into the connected state at the interface.

[0031] In certain configurations, the interior of at least one process chamber, and in particular the interiors of some, for example all, process chambers, can be converted into a separate state. Specifically, the interface to the main chamber is fluid-tight in the separated state, and the respective interior of the chamber is fluid-tight from its surroundings and / or the main chamber, for example, by means of a wall.

[0032] In certain configurations, the interface is fluid-tight when no process chamber is connected to the interface. Specifically, the interface and the interiors of the process chambers are fluid-tight in the disconnected state. In particular, the interface, for example, the interface and the interior of the respective process chamber, can be fluid-tightly sealed before and / or during transition to the disconnected state, especially by a wall. In particular, a fluid-tight seal of the interface ensures that the cleanroom conditions in the main chamber are maintained when the process chamber is transitioned to the disconnected state.In particular, a fluid-tight sealing of the chamber interior ensures that the cleanroom conditions are maintained in the chamber interior when the process chamber is transferred to the isolated state.

[0033] In certain configurations, at least one process chamber, in particular some, for example all process chambers, can be transferred at least semi-automatically from the connected state of the chamber interior to the disconnected state of the chamber interior and / or from the disconnected state of the chamber interior to the connected state of the chamber interior.

[0034] In certain configurations, cleaning treatment, particularly for the removal of germs and / or residues, can be carried out in the respective chamber interior while it is separated.

[0035] In the preceding and following, germ elimination is understood to mean, in particular, the elimination of at least active germs and, for example, inactive germs.

[0036] In particular, a treatment to eliminate germs includes the inactivation of germs. For example, a treatment to eliminate germs includes the removal of germs, in particular the removal of at least active and, for example, inactive germs.

[0037] For example, a residue removal treatment includes the removal of residues, in particular the removal of product residues, especially the removal of residues of a product, for example, a batch, which is filled into a container during a process step, for example, residues of pharmaceutical products, biopharmaceutical products, biological products, highly potent microbiological products and / or other highly sensitive products.

[0038] In particular, germ and / or residue removal includes disinfection and / or sterilization and / or decontamination and / or autoclaving.

[0039] In particular, in the case of germ and / or residue elimination, an exemption is carried out in a manner and / or to a degree in accordance with relevant regulations, for example in accordance with the “The Rules Governing Medicinal Products in the European Union, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use” (EC-GMP Guide) and its annexes, in particular Annex 1 and 2 (currently: Volume 4 of 22.

[0040] August 2022) and / or the “Guideline on Good Manufacturing Practice for Advanced Therapy Medicinal Products”, published in Part IV of Eudralex Volume 4 (in force from 22 May 2018) and / or the regulations mentioned therein.

[0041] Germ and / or residue removal, in particular decontamination and / or sterilization, is achieved in embodiments using a radiation source, especially for generating ultraviolet radiation (UV radiation), particularly UV-C radiation, and / or an electron accelerator, and / or using a germ and / or residue removal agent, in particular a sterilizing agent. Germ and / or residue removal specifically includes nebulization of a hydrogen peroxide (H₂O₂) solution, also referred to as vaporized hydrogen peroxide. In embodiments, germ and / or residue removal includes wet cleaning, in particular using a high-pressure steam jet, also referred to as a wash-down. In embodiments, cleaning, in particular residue removal, includes treatment using water, in particular with subsequent germ removal.In certain embodiments, cleaning, in particular residue removal, comprises treatment using a sterile, especially fluid, germ- and / or residue-removal agent, which, for example, comprises an alcohol and / or a sterile solution. In certain embodiments, it is provided that at least one process chamber, in particular some, for example all, process chambers, can be brought into a disconnected state. In the disconnected state, the respective process chamber is, in particular, movable relative to the main chamber. In the disconnected state, the respective process chamber is, in particular, not connected to the housing at least at one interface. In certain embodiments, the respective process chamber is completely separated from the housing in the disconnected state.In some embodiments, the respective process chamber is connected to the housing in its disconnected state, but can be moved from a working position in which the chamber interior can be connected to the main chamber. For example, the process chamber is movably mounted on the housing and, in particular, can be moved between the working position and at least one other position.

[0042] In some embodiments, the fluid-tight, isolated state of the chamber interior is a disconnected state of the process chamber. In other embodiments, the fluid-tight, isolated state of the chamber interior is not a disconnected state of the process chamber. For example, in the fluid-tight, isolated state, the process chamber is arranged on the housing in its operating position.

[0043] In certain configurations, the interface is fluid-tight when no process chamber is connected at the interface. Specifically, the interface, for example, the interface and the interior of the respective process chamber, can be fluid-tightly sealed before and / or during a transition to the disconnected state, particularly by a wall.

[0044] In certain configurations, at least one process chamber, in particular some, for example all process chambers, can be transferred at least semi-automatically from the connected state of the chamber interior to the disconnected state of the process chamber and / or from the disconnected state of the process chamber to the connected state of the chamber interior.

[0045] In certain configurations, at least one process chamber, in particular some, for example all process chambers, are movable in the vicinity of the main room relative to the main room in the disconnected state of the respective process chamber.

[0046] In particular, certain embodiments provide that the process chamber can be moved away from the housing in the disconnected state, for example for cleaning and / or for a setup process, in particular including dismantling and / or conversion and / or setup.

[0047] In certain embodiments, the at least one process chamber, which can be converted into a disconnected state, is movably mounted on the housing, in particular slidably. Process chambers movably mounted on the housing are also referred to as semi-stationary process chambers. For example, at least two process chambers are assigned to an interface, in particular exactly one interface. For example, the at least two process chambers are each arranged in a connected state at the interface in a first operating position and are movable from the operating position to a second position. Advantageously, when one process chamber moves into the operating position, another process chamber can be moved out of the operating position via a different path. For example, the second positions of different process chambers are different from each other.For example, the process chamber is transferred to a disconnected state by transferring the chamber interior out of a connected state. For example, the process chamber is transferred to a disconnected state after the chamber interior is transferred out of a connected state.

[0048] In certain embodiments, the at least one process chamber, which can be converted into a disconnected state, has movement elements for movement over a surface, in particular rollers for travel movement over a surface. For example, the process chamber with its movement elements is designed to be movable over a surface in the environment, in particular a surface in the room, and / or to be movable away from the housing, and / or to be movable relative to the housing at the housing.

[0049] In certain configurations, at least two process chambers are provided. For example, exactly two process chambers are provided. For example, more than two process chambers are provided. In these configurations, the at least two process chambers are assigned to a corresponding interface, and the interior spaces of the at least two process chambers can optionally be connected to the main chamber via this interface.

[0050] In particular, at least one chamber interior that is not connected to the main chamber via its assigned interface is placed in a separate state. In some configurations, multiple process chambers and multiple interfaces are provided. In some configurations, the number of process chambers is equal to the number of interfaces. In other configurations, the number of process chambers is greater than the number of interfaces. Specifically, the chamber interior of some, and in particular each, of the process chambers can be selectively connected to the main chamber via any one of the available interfaces.

[0051] In certain configurations, the at least two process chambers are assigned to exactly one designated interface.

[0052] In certain embodiments, the at least two process chambers can each be switched to a disconnected state, and optionally, the process chambers can be moved in and out of a working position in this disconnected state. The interior of a process chamber in the working position can be switched to the connected state in order to connect the interior of the process chamber in the working position to the main chamber via the one and only assigned interface. In certain embodiments, the at least one additional process chamber is switched to a rest and / or cleaning position. For example, two semi-stationary process chambers are assigned to a common interface.

[0053] In certain embodiments, at least one process chamber, and in particular some, for example all, of the process chambers are arranged in a stationary position. In these embodiments, the system comprises at least one stationary process chamber and at least one process chamber that can be switched to a disconnected state and, in particular, is movable relative to the housing in this disconnected state. In some embodiments, the interior of the stationary process chamber can be switched to a separate state.

[0054] In some configurations, the interior of a stationary process chamber is arranged within the housing of the cleanroom structure. The interior of the process chamber is separated from the main room, in particular by a partition wall, and connected to the main room in its connected state via an interface comprising a through-opening in the partition wall.

[0055] In some embodiments, the chamber housing of the respective stationary process chamber is at least partially connected to and / or integrated into the housing of the cleanroom structure. In particular, the chamber housing of a stationary process chamber is mounted on an outer surface of the housing facing the environment. In other embodiments, the chamber housing of the respective stationary process chamber is part of the housing of the cleanroom structure.

[0056] The interior of a stationary process chamber is also referred to as a separate sub-chamber. In some configurations, the interior of the housing comprises both the main chamber and the interior of the stationary process chamber.

[0057] In certain embodiments, the interior of the respective process chamber, when connected, is fluidically separated and / or separable from the main chamber, at least during the execution of a process step, to prevent fluids and / or aerosols present in the chamber interior from entering the main chamber. In certain embodiments, the process steps carried out in the respective process chambers include at least the filling and closing of containers, wherein, in particular, the interior of the respective chamber is fluidically separated and / or separable from the main chamber during the filling and / or closing of a container and / or the movement of a filled and unsealed container.

[0058] In particular, the interior of each chamber is fluidically separated and / or separable from the main chamber at least from the start of the filling process until the completion of the sealing of the filled container. In certain embodiments, the separation of the respective connected interior chamber from the main chamber is achieved, at least partially, through fluid flow control, in order to prevent fluids and / or aerosols present in the separated chamber from entering the main chamber. This separation is achieved, in particular, by a pressure difference between the main chamber and the interior of the chamber, and / or by a directed airflow, for example, a directed airflow at least within the interior of the chamber, especially away from the interface, and / or a directed airflow from the main chamber into the interior of the chamber.In particular, certain embodiments provide that a lower pressure is generated in the respective connected chamber interior than in the main chamber, whereby the pressure difference prevents fluids and / or aerosols from escaping from the respective connected chamber interior into the main chamber.

[0059] In certain configurations, the cleanroom structure includes a flow system. This flow system provides (in particular, global) air supply to the connected process chamber(s) and the main room, especially via a ceiling of the enclosure, supplying filtered air, for example, Class A clean air. The flow system also enables (in particular, global) air exhaust. Specifically, the air supply to the connected process chamber(s) and the main room, and / or the air exhaust from the main room and the connected process chamber(s), is achieved through a common flow system. In certain configurations, the flow system is a "Unidirectional Airflow (UDAF) unit (previously referred to as a Laminar Airflow Unit or LAF)" according to the EC GMP Guide, Annex 1.

[0060] In some embodiments, at least one process chamber, and in particular some, for example all, process chambers, have a flow device. In particular, at least one process chamber, and in particular at least some, for example all, process chambers, each have their own flow device. In some embodiments, at least two process chambers, and in particular at least two process chambers assigned to the same interface, have a common flow device. In some embodiments, at least one process chamber, and in particular a stationary process chamber and / or a semi-stationary process chamber, has a common flow device with the main chamber.The flow system of a process chamber provides (in particular, global) air supply to the interior of the process chamber, especially via a ceiling of the process chamber, whereby filtered air, for example, Class A clean air, is supplied. In particular, the flow system of a process chamber also enables (in particular, global) air extraction from the interior of the process chamber. In certain configurations, the flow system of a process chamber is a "Unidirectional Airflow (UDAF) unit (previously referred to as a Laminar Airflow Unit or LAF)" according to the EC GMP Guide, Annex 1.

[0061] In certain embodiments, at least one process chamber, and in particular some, for example all, process chambers, have an extraction device. Specifically, the extraction device is designed for local extraction at the unit used to carry out a process step, such as a filling station and / or a sealing station. In some embodiments, the extraction device is additionally provided for a (particularly global) air supply and (particularly global) air exhaust to the chamber interior and / or to the main chamber. For example, this allows aerosols escaping during a filling process and / or from a filled open container to be selectively extracted by the extraction device. In some embodiments, at least one process chamber, and in particular some, for example all, process chambers, has an access opening and / or a glove opening.

[0062] In particular, a transfer component can be connected to the access opening.

[0063] In particular, the transfer component can be connected to the access opening from the surrounding area.

[0064] In certain designs, the access opening can be opened, so that the respective chamber interior is directly connected to the surroundings.

[0065] In this configuration, the access opening can only be opened when a transfer component is connected. This prevents a direct connection between the interior of the chamber and the surrounding environment via the access opening. Specifically, the interior of the transfer component meets the required cleanroom conditions.

[0066] For example, the interior of the transfer component is sterile.

[0067] In certain configurations, the access opening is designed as a connection port for a transfer system, specifically as an alpha port of an alpha-beta port system. An alpha-beta port system, also known as a rapid transfer port, is a transfer system that allows material and / or product to be quickly and without contamination transferred into and out of the interior of the process chamber and / or the main chamber of the cleanroom setup. The alpha port is integrated, in particular, into an outer wall of a chamber housing. A unit of the transfer system, referred to as a beta component, can be docked to the alpha port. After docking, the alpha port can be opened to access the interior of the beta component for the insertion or removal of material and / or products.

[0068] In certain embodiments, at least some, and in particular all, process chambers are designed to perform at least one identical process step. Specifically, in certain embodiments, it is provided that process steps for objects introduced into the main chamber by the insertion device are performed in only one of the several process chambers. Identical process steps for different objects can be performed in different process chambers. In certain embodiments, at least one, and in particular several, or for example all, of the process chambers are designed to perform multiple process steps. Specifically, in certain embodiments, the equipment in at least some of the process chambers is designed to perform the filling and sealing of containers, particularly with in-process control.

[0069] In its various configurations, the system is designed and / or includes a process step for packaging a product with and / or in a packaging material and / or for unpacking an object, for example, a primary packaging material, from a packaging material, for example, a secondary packaging material. In particular, the process steps include at least filling objects designed as containers with a product, especially a pharmaceutical product, and / or closing the containers, and / or recording properties of the objects and / or the processed product, in particular checking the processed objects and / or the processed, for example, filled, product.

[0070] The process chambers each comprise at least one facility arranged within the chamber interior for carrying out a process step.

[0071] In certain embodiments, at least one process chamber, and in particular some, for example all, process chambers, includes a filling station located within the respective chamber interior for filling a container. Each filling station can be equipped with at least one filling path.

[0072] In some embodiments, the filling station features a filling needle holder located inside the chamber. In other embodiments, a filling needle can be attached to the filling needle holder. Attachment is achieved, in particular, via a tool-free quick-release fastener, for example, by means of a snap-fit ​​and / or magnetic connection. In some embodiments, the filling station is manually fitted with the filling needle, particularly by reaching through gloves. In other embodiments, a manipulator is provided for fitting the filling station with the filling needle.

[0073] In the preceding and / or following terms, a manipulator is defined as a fully or partially automated single-axis or multi-axis system, in particular a two- to six-axis system, and especially a six-axis system. In certain embodiments, the manipulator is configured for at least translational movement along at least one axis. Alternatively or additionally, in certain embodiments, the manipulator is configured for at least rotational movement along at least one axis. Depending on the specific embodiment, a multi-axis system is configured as a serial mechanism, a parallel kinematic system, or a hybrid mechanism. In certain embodiments, the manipulator is configured as a serial mechanism, in particular as an articulated robot arm, and further, in particular, as a SCARA robot.

[0074] In some embodiments, a product supply of the product to be filled is introduced into the interior of the process chamber, particularly via an access opening. This product supply is connected to a filling needle via a fluid line. In some embodiments, the filling needle is introduced into the interior of the chamber along with the product supply and connected there to the filling needle holder of the filling station.

[0075] In some embodiments, a transfer component with a fluid line feedthrough is provided, connectable to the access opening of the process chamber. A filling needle, fluidically connected via a fluid line to a product reservoir located outside the chamber interior, can be supplied to the chamber interior via this transfer component. In some embodiments, the transfer component is designed as the beta component of an alpha-beta port system.

[0076] In particular, the system includes a conveying device for transporting a product to be filled. In certain configurations, the conveying device can be equipped with a fluid line outside the main compartment of the housing and / or the interior of the chamber. In its equipped state, the conveying device is designed to transport the product to be filled to the filling station via the installed fluid line.

[0077] The filling station has one filling position in the chamber interior in some configurations. In other configurations, each chamber interior has exactly one filling position. In other configurations, at least one chamber interior has exactly two, exactly three, or exactly five filling positions, for example, fewer than ten filling positions. In particular, several filling needles, especially one for each filling position, can be attached to the filling needle holder.

[0078] In certain configurations, it is provided that at least one process chamber, in particular some, for example all process chambers, includes a sealing station arranged in the respective chamber interior for sealing a filled container.

[0079] The sealing station has one sealing position in the chamber interior in some configurations. In some configurations, each chamber interior has exactly one sealing position. In others, at least one chamber interior has exactly two, exactly three, or exactly five sealing positions, for example, fewer than ten sealing positions. In particular, the number of sealing positions is equal to the number of filling positions.

[0080] In particular, filled containers are closed at the closing station, specifically by at least one closing element, such as stoppers, caps, snap closures, or other fasteners. In some configurations, the containers are closed without a closing element, for example, by welding.

[0081] In some configurations, locking elements are inserted into the interior of the respective chamber via an access opening on the process chamber.

[0082] In some configurations, closure elements are introduced into the respective process chamber via the main chamber, particularly via the interface. In some configurations, a through-opening is provided for inserting the closure elements, which is a different through-opening than the through-opening of the interface for moving the containers.

[0083] In some configurations, a locking mechanism is arranged in the main room, which is specifically designed to store locking elements.

[0084] In some configurations, a locking mechanism is provided in the main compartment. In particular, several locking mechanisms are provided in some configurations. Specifically, in some configurations, one, and in particular exactly one, locking mechanism is provided for each interface.

[0085] In some embodiments, the closure dispensing device is designed to remove closure elements individually or in groups from a supply located in the main chamber and to provide the closure elements at a closure dispensing position, wherein the closure dispensing position is specifically located in a transfer area between the main chamber and the respective chamber interior. In some embodiments, exactly one supply is provided in the main chamber. In others, multiple supplies are provided. In particular, a supply, for example, exactly one supply, is provided for each interface. In some embodiments, a closure insertion device is provided in at least one chamber interior, in particular in some, for example, in all chamber interiors, which is designed to move the closure elements in the respective chamber interior to the closure station.

[0086] In certain configurations, at least one chamber interior features a filling position of the filling station and a closing position of the closing station as identical positions. Specifically, objects, such as containers to be filled, can be moved individually from the main chamber into precisely this one filling position and, after closing, back into the main chamber from this exact filling position. Alternatively, objects, such as containers to be filled, can be moved from the main chamber into a number of filling positions in groups and, after closing, back into the main chamber from these filling positions.

[0087] In certain embodiments, at least one process chamber, and in particular some, for example all, process chambers, includes a control device for the filling process. In certain embodiments, the control device includes a scale for measuring the weight of the containers to be filled, in particular for measuring the weight before, during, and / or after filling. In certain embodiments, the control device includes an optical sensor for measuring the fill level. The control device is specifically designed to monitor the filling process at the filling position. In certain embodiments, a load cell is provided at the filling position, which can measure the empty weight and the filled weight. In certain embodiments, the filling station is designed to terminate the filling process of the containers depending on a fill weight and / or a fill level measured during filling.The control device allows for in-process control (IPC) during the filling process, enabling control, monitoring, and, if necessary, correction of the filling process. Specifically, the filling station is equipped with the control device to monitor each container being filled and each filled container.

[0088] In certain configurations, the system includes a cleaning system for cleaning at least the interior of the process chambers and, in particular, the components located therein. The cleaning includes, in particular, the elimination of germs and / or the removal of residues, especially product residues. The cleaning system is configured to perform cleaning semi-automatically and / or fully automatically. The cleaning system is also configured to perform cleaning manually. Furthermore, the cleaning system is configured to allow process chambers to be cleaned selectively and / or alternately.

[0089] The cleaning system comprises, in various configurations, at least one, and in particular several, cleaning devices for cleaning identical and / or different process chambers. At least two of the multiple cleaning devices are of the same type in some configurations. At least two of the multiple cleaning devices are of different types in other configurations.

[0090] For example, some configurations include a cleaning device for primary cleaning. Primary cleaning refers to cleaning performed at longer intervals, such as once a day or once per period longer or shorter than a day, with the aim of removing germs and / or contaminants from the interior of the chamber and all components located therein to the greatest extent possible. In particular, a cleaning device for primary cleaning is designed to remove germs and / or other highly potent substances from surfaces and / or from deeper layers.

[0091] In some embodiments, a cleaning unit is provided for intermediate cleaning between two main cleaning processes. This intermediate cleaning is particularly faster than the main cleaning. It is performed specifically between two batches of a product processed within the chamber to remove product residues and / or to kill microbiological residues, such as product mRNA. For example, the main cleaning and the intermediate cleaning can be performed by different cleaning units. In other embodiments, the main cleaning and the intermediate cleaning can be performed by exactly one cleaning unit.

[0092] For example, the cleaning, in particular intermediate cleaning, of a chamber interior includes mechanical cleaning and / or cleaning with a cleaning medium, in particular a fluid, and / or washing, in particular wiping and / or rinsing, and / or irradiation, in particular with ultraviolet (UV) radiation. For example, the cleaning medium includes a germicidal medium, in particular a disinfectant, such as alcohol. For example, the cleaning medium includes at least partially gaseous components, such as water vapor and / or hydrogen peroxide. In particular, at least one unit of the cleaning device is arranged in the process chamber, in particular in its interior. In certain embodiments, a radiation source is arranged in the process chamber.In some embodiments, a unit for introducing a cleaning medium, in particular a germ-free medium and / or residue-free medium, is arranged in the process chamber, for example for introducing a cleaning medium that is at least partially gaseous and / or for introducing a cleaning medium for a wash-down.

[0093] In some configurations, the cleaning device is designed for at least partially automated cleaning, for example, fully automated cleaning. In other configurations, the cleaning device is designed for at least partially manual cleaning.

[0094] In some versions, the objects were transported manually in the main room, particularly via gloved interventions.

[0095] In particular, the main room is equipped with a transport system for moving the objects. The transport of the objects is carried out by this system in a semi- or fully automated manner.

[0096] In some configurations, at least partial manual insertion of objects from the main room into the respective chamber interior and / or at least partial manual removal of objects from the respective chamber interior into the main room is provided for.

[0097] In various embodiments, the transport system comprises a transport device designed to move objects, in particular containers to be filled, from the main chamber into the interior of the respective process chamber for the purpose of carrying out a process step in one of the several process chambers, and / or to remove objects, in particular filled and sealed containers, from the interior of the respective process chamber into the main chamber after the execution of a process step in one of the several process chambers.

[0098] In certain embodiments, the transport device allows for at least semi-automated, and preferably fully automated, movement of objects from the main chamber into a chamber interior and / or from the chamber interior into the main chamber. In certain embodiments, the transport device comprises several transport units, with each interface having its own transport unit for moving the objects.

[0099] In certain embodiments, the transport device includes a manipulator that is at least semi-automatically, and in particular fully automatically, capable of being operated to move objects from the main chamber into the interior of one, and in particular exactly one, of the several process chambers for the execution of a process step, and / or to remove objects from the interior of the respective process chamber into the main chamber after the execution of a process step in one of the several process chambers. In particular, several manipulators are provided, with each interface having a manipulator, and in particular exactly one, for moving the objects.

[0100] The manipulator is configured to move exactly one object and / or several objects simultaneously between the main chamber and a process chamber, particularly an associated one. Specifically, the manipulator is configured to move objects to some, and in particular all, process positions within a chamber interior with a single movement and / or stroke.

[0101] The manipulator is configured to move containers to be filled from the main chamber into the interior of the respective process chamber, in particular to a filling position within the chamber, and to remove filled and sealed containers from the chamber interior into the main chamber, in particular from a sealing position. In some configurations, the sealing position is the same as the filling position. For example, the manipulator is configured to move containers to some, in particular all, filling positions of a filling station within a chamber interior with a single movement and / or stroke.

[0102] In certain embodiments, the transport device is configured such that a transport segment, which is located partly in the main chamber and partly in the respective chamber interior, is located in the main chamber at least during one process step, particularly when filling and / or closing a container, for example, from the start of filling a container until the completion of closing the filled container. In particular, in embodiments with a manipulator, a transport segment is at least a part, for example, an arm and / or an end effector of a manipulator. In certain embodiments, a transfer station is provided in the main chamber. Specifically, a transfer station is provided at each interface.

[0103] In particular, it is intended that objects are transported from the surrounding area to the transfer station, specifically to the respective transfer station, by means of the introduction device. In some embodiments, objects are transported by the introduction device from the surrounding area to an inlet station at the entrance of the main room and from the inlet station to the transfer station via the transport system.

[0104] In particular, it is intended that objects are transported from the transfer station into the surrounding area by the discharge device. In some embodiments, a transfer station is provided. In other embodiments, objects are transported by the transport system to an outlet station at the outlet of the main chamber and from the outlet station by the discharge device from the main chamber into the surrounding area.

[0105] In some configurations, a transfer station with at least one container position for one container is provided in the main room.

[0106] The term "container" is used above and / or below to refer to both a unit comprising a microscope slide and containers to be filled arranged therein, and a unit comprising a microscope slide and filled and sealed containers arranged therein. The containers are provided pre-sterilized in various configurations as containers.

[0107] The transfer station is specifically designed to provide containers to be filled, comprising the microscope slide and the containers themselves, for filling. In some embodiments, the transfer station includes two slide positions, each for one container. In these embodiments, containers to be filled are removed, for example, by the transport device, particularly by the manipulator, from a slide located at one of the at least two slide positions. Filled and sealed containers are then placed into a slide located at a second slide position, the second slide position being different from the first. In some embodiments, a slide position is provided at the transfer station, where objects are returned to the same slide from which they were removed.

[0108] In various embodiments, the transport system, in particular the transport device, is designed to remove objects, especially containers to be filled, individually or in groups from a container provided at the transfer station, in particular the container position, and / or to place objects, in particular filled and sealed containers, individually or in groups at the transfer station, in particular the container position. Specifically, the transport device moves the objects individually or in groups between the main chamber and the respective inner chamber housing. In some embodiments, the transport device is designed to, for example, use an end effector of a manipulator designed as a multi-axis system to remove containers directly from the slide and move them, in particular to the respective filling position, within the chamber interiors.In various embodiments, the transport device includes at least one removal device which removes the containers from the slide, and at least one transport unit for transport within the chamber interior, in particular to the filling position.

[0109] In various configurations, several transfer stations are provided, in particular each with at least one container position, each of which is assigned to one, in particular exactly one, interface.

[0110] Unpacking the ready-to-use containers and / or moving the containers with the containers to be filled into the main room and in particular to the transfer station for subsequent filling and sealing, and / or moving the containers with filled and sealed containers from the main room into the surroundings after filling and sealing, in particular from the transfer station into the surroundings, is carried out at least partially manually and, for example, completely manually in some configurations.

[0111] In its various configurations, the transport system is designed to transport objects, especially containers to be filled, in groups, particularly as packages, from an inlet of the main room to at least one transfer station.

[0112] In its various configurations, the transport system is designed to transport objects, especially filled and sealed containers, in groups, particularly as packages, from at least one transfer station to the outlet.

[0113] The transport system, in its various configurations, comprises a conveyor system arranged in the main room for transporting objects, particularly as containers, to and / or from at least one transfer station. The conveyor system, in its various configurations, includes a conveyor track and transport elements movable relative to it. In some configurations, the conveyor track is designed as the stator of a linear motor system, and the transport elements are designed as associated runners. For example, permanent magnets are provided on the transport elements, and the conveyor track, particularly actuators on the conveyor track, are controlled to move the transport elements relative to the conveyor track.

[0114] The conveying system comprises, in various configurations, a conveying surface and transport elements movable relative to it. In some configurations, the conveying surface is designed as the stator of a planar motor system, and the transport elements are designed as the associated rotors. For example, permanent magnets are provided on the transport elements, and the conveying surface, in particular actuators on the transport surface, are controlled to move the transport elements relative to the conveying surface. Such planar transport systems are known, for example, from WO 2013 / 059934A1 or DE102018209401 A1, to which full reference is hereby made. However, the system is not limited to the use of a conveying system known from these documents.

[0115] In some embodiments, an inlet and an outlet are arranged at opposite ends of the housing, with transport elements of a conveyor system moving along a closed orbit from the inlet to the outlet and from the outlet to the inlet. In some embodiments, the transport elements move from the inlet to the outlet while loaded, and in others, they move from the outlet to the inlet while unloaded. In some embodiments, the interfaces are located along the feeder section of the transport system, i.e., along the movement path of the transport elements from the inlet to the outlet.

[0116] In various configurations, the insertion device is designed to move objects from the surroundings into the main room, in particular to move them at least semi-automatically.

[0117] The loading device is configured in various embodiments as a container feeder for supplying containers to be filled into the main chamber. In particular, the container feeder is designed to transfer containers to be filled, especially as bundles, from the surrounding area into the main chamber, and especially to transfer them at least semi-automatically. In some embodiments, the container feeder is configured to unpack ready-to-use, especially pre-sterilized, containers, for example, in the main chamber. In other embodiments, the container feeder is configured to transfer containers to be filled from the surrounding area to a transfer station provided in the main chamber. In embodiments, especially those with multiple transfer stations, the transport system, especially the conveyor system, moves the containers to the transfer stations within the main chamber.

[0118] Containers placed in trays are transported in the trays, at least in sections, in some configurations. In others, the containers placed in trays are removed from the trays at least at the transfer station. For example, it is intended that the containers are removed from the trays manually. In other configurations, the container feed device is designed to remove the containers from the trays automatically.

[0119] In particular, in certain embodiments, the insertion device has multiple insertion paths. For example, it is possible to load and / or unload and / or clean one insertion path while another insertion path is being cleaned, unloaded, or loaded.

[0120] In various configurations, the insertion device includes a lock. For example, the insertion device may include exactly one lock. In particular, the insertion device may include several locks. A configuration with multiple locks is especially advantageous in systems with multiple interfaces, each of which has a process chamber for carrying out the process steps.

[0121] For example, an airlock is provided for each interface. For example, at least two airlocks are provided. For example, it is possible to load and / or unload and / or clean one airlock while another airlock is being cleaned, unloaded, or loaded. In particular, the airlock is designed to introduce at least one container comprising a microscope slide and containers arranged therein into the main chamber. For example, the airlock is designed to introduce several containers into the main chamber simultaneously.

[0122] In some configurations, the lock includes a cleaning device, particularly for the removal of germs and / or residues.

[0123] The discharge device is designed in configurations to transport objects from the main room into the surrounding area, in particular to transport them at least semi-automatically.

[0124] In some embodiments, the discharge device is designed as a container removal system for removing filled and sealed containers from the main chamber. In particular, the container removal system is designed to transport filled and sealed containers, especially as bundles, from the main chamber into the surrounding area.

[0125] In certain configurations, the container discharge device is designed to move filled containers from a transfer station located in the main room to the surrounding area. In configurations, particularly those with multiple transfer stations, the transport system, especially the conveyor system, moves the containers away from the transfer stations within the main room.

[0126] In particular, the application device comprises multiple application paths. For example, it is possible to load and / or unload and / or clean one application path while another application path is being cleaned, unloaded, or loaded.

[0127] In some configurations, the dispensing device includes a lock. For example, the dispensing device may have exactly one lock. Alternatively, the dispensing device may have several locks. A configuration with multiple locks is particularly advantageous in systems with multiple interfaces, each with a process chamber for carrying out the process steps.

[0128] For example, a lock is provided for each interface.

[0129] In some configurations, the dispensing device has a dispensing interface. This interface includes, for example, a through-opening on a wall of the housing to the surrounding environment.

[0130] In some embodiments, a container with a rigid and / or flexible wall for receiving objects after a process step, in particular filled and sealed containers, can be connected to the dispensing interface, wherein the objects, in particular the filled and sealed containers, can be dispensed from the main chamber into the container without direct contact of the main chamber with the environment.

[0131] In particular, the container is designed to accommodate packages comprising microscope slides and the containers inserted therein.

[0132] In some embodiments, the dispensing interface is designed as an alpha port of an alpha-beta port system. In some embodiments, an endless bag can be attached to the dispensing interface, wherein in particular a separating device is provided which is designed to separate a filled section of the endless bag at a separation point from a hose supply of the endless bag remaining at the dispensing interface.

[0133] The separating device is designed to separate the filled section of the continuous bag without direct contact between the interior of the tube supply and / or the interior of the filled section with the environment.

[0134] The separating device is designed in configurations to weld a free end of the continuous bag and / or the filled section at the separation point.

[0135] In some configurations, the system includes a marking device designed to mark objects, in particular to mark objects before and / or after a process step. In some configurations, the marking device is located at the at least one interface and / or at the dispensing device.

[0136] The marking device is designed in configurations to apply a marking for automatic identification and data acquisition of the objects.

[0137] In certain configurations, the main chamber is fluid-tight, with the cleanroom structure being designed as a closed isolator in accordance with Annex 1 of the EU GMP Guide. The main chamber remains fluid-tight throughout operation. Material transfer into and out of the isolator is accomplished via the infeed and outfeed devices. Some configurations include additional auxiliary devices for material transfer on the housing, such as alpha-beta port systems.

[0138] According to a second aspect, a method for carrying out process steps with and / or on objects at least partially under cleanroom conditions, in particular with and / or on packaging materials, for example with and / or on containers and / or with and / or on pharmaceutical packaging materials, and / or wherein the process steps in particular include filling and / or closing containers under cleanroom conditions,

[0139] wherein objects, in particular containers to be filled, are introduced into a main chamber of an enclosure of a cleanroom setup.

[0140] In some embodiments, it is provided that a first batch of objects is moved from the main room to the interior of a first process chamber for the purpose of carrying out at least one process step, wherein, after the process step has been carried out, the first batch of objects is moved from the interior of the first process chamber to the main room and subsequently the interior of the first process chamber and the components arranged therein are cleaned.

[0141] In some configurations, it is provided that, at least partially simultaneously with the execution of the process step on the first batch of objects in the interior of the first process chamber, a second batch of objects from the main room is moved and / or is moved into the interior of a second process chamber.

[0142] In some configurations, it is provided that, at least partially simultaneously with the execution of the process step on the first batch of objects in the interior of the first process chamber, a process step on the second batch in the interior of the second process chamber is carried out.

[0143] In some configurations, it is provided that, at least partially simultaneously with the cleaning of the interior of the first trial chamber, a second batch of objects from the main room is and / or is moved to the interior of a second trial chamber.

[0144] In some configurations, it is provided that, at least partially simultaneously with the cleaning of the interior of the first trial chamber, a process step is carried out on the second batch in the interior of the second trial chamber.

[0145] In some configurations, it is provided that, for cleaning the interior of the first and / or second process chamber, surfaces of the respective chamber interior and / or the components in the respective chamber interior are cleaned manually and / or automatically, in particular treated to eliminate germs and / or residues, for example by wiping and / or disinfecting.

[0146] In some configurations, the interior of the first and / or second process chamber is separated for cleaning purposes. Specifically, the interior of the respective chamber is fluid-tightly separated from the main chamber in this isolated state, for example, by a fluid-tight wall. For instance, a cleaning treatment, particularly for decontamination and / or the removal of germs and / or residues, is carried out in the separated interior of the respective chamber. In some configurations, the objects are containers, especially pharmaceutical containers.

[0147] In particular, the process step in the interior of the first process chamber and the process step in the interior of the second process chamber each include filling and closing the containers.

[0148] In some configurations, cleaning, specifically the removal of germs and / or residues, of the respective chamber interior occurs each time a batch of product to be filled is changed and / or each time the product to be filled is changed within a respective chamber interior. Other configurations provide that cleaning, specifically the removal of germs and / or residues, of the main chamber does not occur each time a batch of product to be filled is changed and / or each time the product to be filled is changed.In the main room, the objects are handled exclusively without product contact, for example, carrying out process steps on containers to be filled before filling and / or carrying out process steps on filled containers after closing, so that contamination of the main room during the processing of a batch and / or also during at least partially simultaneous processing of several batches in two or more chamber interiors is avoided at least as a rule.

[0149] In some embodiments, containers to be filled are inserted into the main chamber of the housing via an inlet provided on the housing and a sluice gate. Insertion can be carried out manually, for example. Insertion can also be fully or partially automated, particularly by means of an insertion device.

[0150] In certain embodiments, filled and sealed containers are discharged from the main chamber of the housing via an outlet, in particular a sluice gate at the outlet and / or a discharge interface on the housing. The outlet differs from an inlet, particularly in certain embodiments. Discharge can be carried out manually, for example. Discharge can also be fully or partially automated, for example, by a discharge device.

[0151] In particular, the method comprises process steps that correspond to features of embodiments of the system. Specifically, the system is designed to implement embodiments of the method. To avoid repetition, reference is made to the respective descriptions in full. In particular, two directions within the meaning of this disclosure are perpendicular to each other if the angle between these directions is at least 20 degrees, in particular at least 45 degrees, and / or if these two directions are at least mostly, in particular at least approximately, perpendicular to each other.

[0152] In particular, a feature is at least largely realized in an entity within the meaning of this disclosure if the feature is realized in at least 65%, and in particular in at least 80% of the entity, and / or if the feature is realized at least approximately in the entity.

[0153] In particular, a feature is realized at least approximately in an entity within the meaning of this disclosure if the feature is realized in at least 90% of the entity and / or if the feature is realized with technically irrelevant deviations and / or technically caused deviations.

[0154] BRIEF DESCRIPTION OF THE DRAWINGS

[0155] Further advantages and aspects of the invention will become apparent from the claims and from the description of exemplary embodiments of the invention, which are explained below with reference to the schematic figures. Identical or similar elements are represented by the same reference numerals in the figures. These figures show:

[0156] Fig. 1: a first embodiment of a system for carrying out process steps at least partially under cleanroom conditions, in particular for carrying out process steps on containers during a filling process;

[0157] Fig. 2: a second embodiment of a system for carrying out process steps at least partially under cleanroom conditions, in particular for carrying out process steps on containers during a filling process; and

[0158] Fig. 3: a third embodiment of a system for carrying out process steps on objects at least partially under cleanroom conditions.

[0159] DETAILED DESCRIPTION OF THE EXECUTION EXAMPLES

[0160] Fig. 1 schematically shows a first embodiment of a system 1 for carrying out process steps on objects at least partially under cleanroom conditions. In embodiments, the objects are containers 5 as shown in Fig. 1, wherein the process steps in particular include at least filling and closing the containers 5 under cleanroom conditions.

[0161] Plant 1 comprises a cleanroom structure 10. The cleanroom structure 10 includes an enclosure 20. A main compartment 201 of the enclosure 20 is separated from the surrounding environment. The necessary cleanroom conditions for operating Plant 1 can be created in the main compartment 201 of the enclosure 20. In some configurations, the cleanroom structure 10 is designed as a closed isolator in accordance with Annex 1 to the EU GMP Guide.

[0162] In the illustrated embodiment, an inlet 11 and a spatially separate outlet 12 are provided. A feed device 83 is provided at the inlet 11. A discharge device 84 is provided at the outlet 12. The feed device 83 is designed to introduce objects from the surroundings into the main chamber 201. In some embodiments, the feed device 83 is configured as a container feed device. The discharge device 84 is designed to discharge the objects from the main chamber 201 into the surroundings. In some embodiments, the discharge device 84 is configured as a container discharge device.

[0163] The system 1 comprises several process chambers 15, 16. In the embodiment shown in Fig. 1, the system 1 comprises a first process chamber 15, which is designed as a stationary process chamber, and a second process chamber 16, which can be converted into a disconnected state. In some embodiments, all process chambers 15, 16 are arranged in a stationary state. In other embodiments, all process chambers 15, 16 can be converted into a disconnected state.

[0164] The process chambers 15, 16 each comprise an interior chamber space 150, 160 and a device arranged in the interior chamber space 150, 160 for carrying out a process step. In the illustrated embodiment, each process chamber 15, 16 comprises three devices, namely a filling station 3 for filling the containers 5, a closing station 4 for closing the filled containers 5, and a control device 9.

[0165] Fig. 1 shows the system 1 during a filling process at a filling station 3 of the first process chamber 15. The second process chamber 16 is in a disconnected state, whereby in the illustrated embodiment the second process chamber 16 is not connected to the housing 20 in this disconnected state. The second process chamber 16 can be cleaned, in particular, in the disconnected state shown. In the illustrated embodiment, the filling station 3 and the closing station 4 are arranged in both process chambers 15, 16 such that filling and closing each take place at a common filling position 30.

[0166] The system 1 includes at least one interface to the main chamber 201, in the illustrated embodiment two interfaces 152, 162. In the illustrated embodiment, each process chamber 15, 16 is assigned exactly one interface 152, 162.

[0167] The chamber interiors 150 and 160 can be connected to the main chamber 201 via their respective interfaces 152 and 162 for the transfer of objects, particularly directly, between the respective chamber interiors 150 and 160 and the main chamber 201. A state in which a chamber interior 150 or 160 is connected to the main chamber 201 for the transfer of objects is referred to as the connected state of the chamber interior 150 or 160.

[0168] In the illustrated embodiment, the first process chamber 15 is arranged in a stationary position. Specifically, in this embodiment, the interior space 150 of the stationary process chamber 15 is located within the housing 20 of the cleanroom structure 10. The interior space 150 of the stationary process chamber 15 is separated from the main chamber 201 by a partition 22. The interface 152 is designed as a through-opening 220 in the partition 22. An interior space 150 of the first process chamber 15 is also referred to as a separate sub-chamber.

[0169] In the illustrated embodiment, the second process chamber 16 can be converted into a disconnected state and, in particular, is converted into a disconnected state in the illustrated process state. In this disconnected state, the second process chamber 16 is movable relative to the main chamber 201. In this illustrated process state, the second process chamber 16 is spatially separated from the housing 20. The second process chamber 16 can be moved towards the housing 20, and the interior space 160 of the second process chamber 16 can be connected, in particular directly, to the main chamber 201 via the interface 162, so that objects can be moved between the interior space 160 of the second process chamber 16 and the main chamber 201.In embodiments, the interface 162 and the second process chamber 16, as schematically shown, can each be closed in a fluid-tight manner in the unconnected state, in particular by a wall, for example each by a wall, in a fluid-tight manner.

[0170] The interior chambers 150 and 160 of process chambers 15 and 16 can each be cleaned, in particular to remove germs and / or residues from the interior chambers 150 and 160 and all components located therein. As shown schematically, it is possible, in particular, to clean the respective interior chamber 150 or 160 while process steps are carried out in the second interior chamber 150 or 160. In particular, the interior chambers 150 and 160 can be cleaned without cleaning the main chamber 201.

[0171] In the embodiment shown in Fig. 1, the chamber interiors 150, 160 are each designed such that exactly one container 5, placed in the respective chamber interior 150, 160 and arranged at the respective filling position 30, is filled. In other embodiments, at least for carrying out process steps in one of the several process chambers 15, 16, several containers 5 are placed together in the respective chamber interior 150, 160 and filled simultaneously or sequentially.

[0172] The chamber interiors 150, 160 are separated from the main room 201 in such a way that, at least when filling and closing the containers 5 in the respective chamber interior 150, 160, it is prevented that fluids and / or aerosols present and / or accumulating in the respective chamber interior 150, 160 enter the main room 201.

[0173] In certain configurations, when the chamber interiors 150 and 160 are connected, it is ensured that fluids and / or aerosols present and / or accumulating in the respective chamber interiors 150 and 160 do not enter the main chamber 201. In particular, in certain configurations, the partition wall 22 between the main chamber 201 and the chamber interior 150, which is designed as a separate sub-chamber, is sufficient, even when the passage opening is open, to prevent fluids and / or aerosols present and / or accumulating in the chamber interior 150 from entering the main chamber 201.

[0174] Alternatively or in addition to separation by a partition wall 22, in embodiments it is achieved by flow engineering measures that at least when filling and closing the containers 5 in the chamber interior 150 designed as a separate sub-space no fluids and / or aerosols from the chamber interior 150 enter the main room 201.

[0175] In particular, certain embodiments provide that, in a connected state, a lower pressure is generated in the interior of a chamber 150, 160 than in the main chamber 201, whereby the pressure difference prevents fluids and / or aerosols from escaping the respective interior of the chamber 150, 160 into the main chamber 201. In some embodiments, separation is achieved at least partially by a flow directed from the main chamber 201 into the respective interior of the chamber 150, 160. In other embodiments, separation is achieved at least partially in the form of an air curtain.

[0176] In particular, the cleanroom setup 10 includes a flow device. The flow device provides an air supply, preferably via a ceiling of the enclosure 20, and enables the exhaust of air. Specifically, the flow device forms a "Unidirectional Airflow (UDAF) unit (previously referred to as a Laminar Airflow Unit or LAF)" according to the EC GMP Guide, Annex 1. In certain embodiments, a common flow device is provided and implemented for the main room 201 and for the separate sub-room 202.

[0177] In the illustrated embodiment, an extraction device 6 is provided in each of the chamber interiors 150, 160. In particular, the extraction device 6 provides local air extraction, especially at the filling station 3 and / or sealing station 4 of the process chambers 15, 16.

[0178] The interior chamber 160 of the second trial chamber 16 is separated from the main room 201 in the depicted unconnected state of trial chamber 16.

[0179] In some embodiments, the interior chamber 150 of the first process chamber 15 can also be converted into a separate state, wherein the interior chamber 150 of the process chamber 15 is fluid-tightly separated from the main chamber 201 in the separated state. For example, the interior chamber 150 is fluid-tightly separated from the main chamber 201 by a wall (not shown in Fig. 1) in the separated state. In particular, the interior chamber 150 of the first process chamber 15 can be converted into the separated state after a filling cycle, especially during a batch and / or product change, for cleaning treatment, especially for germ and / or residue removal. In the illustrated embodiment, the chamber housings of the process chambers 15, 16 each have a first wall section with an access opening 24 and a second wall section with a glove opening 26.In some configurations, an access opening 24 and a glove opening 26 are arranged on a common wall section.

[0180] A cleaning device, in particular a cloth soaked with alcohol and / or another disinfectant, can be inserted into the interior of chamber 150, 160 of the respective process chamber 15, 16 via the access opening 24. In some configurations, a cleaning device is inserted into the interior of chamber 150, 160 of the respective process chamber 15, 16 via a different route, for example, via the main room 201. The cleaning device is inserted into the interior of chamber 150, 160 of the respective process chamber 15, 16, particularly before the cleanroom conditions are established, and in some configurations, after the cleanroom conditions have already been established. The glove opening 26 allows access to the interior of chamber 150, 160 of the respective process chamber 15, 16, for example, for manual cleaning of the interior of chamber 150, 160 of the respective process chamber 15, 16.In certain configurations, a manipulator for semi- or fully automated cleaning of the interior of chamber 150, 160 of at least one process chamber 15, 16 is provided.

[0181] The interior of chamber 150, 160 of the respective trial chamber 15, 16 can be cleaned without decontamination of the main room 201 and / or the interior of chamber 150, 160 of the respective other trial chamber 15, 16.

[0182] The introduction of objects, in particular containers 5 to be filled, from the surroundings into an attached chamber interior 150, 160, as well as the removal of objects, in particular filled and sealed containers, from the respective chamber interior 150, 160 into the surroundings, each takes place via the main chamber 201. Inlet 11 and outlet 12 are provided for transferring objects into and out of the main chamber 201. Alternatively, in some configurations, only one passage is provided. In these configurations, transfer into and out of the main chamber 201 takes place via the common passage. Alternatively or additionally, in some configurations, a discharge interface is provided on an outer wall of the housing 20, whereby objects can be introduced into and / or removed from the main chamber 201 via the discharge interface.In some embodiments, the inlet 11 and / or the outlet 12 are open for the continuous or semi-continuous transfer of objects, in particular containers 5, and / or other materials into and out of the housing 20. In other embodiments, the inlet 11 and the outlet 12 are closed after decontamination of the interior of the housing 20. In some embodiments, an airlock is provided at the inlet 11 and / or the outlet 12 to allow the introduction of objects, in particular containers 5, into the closed interior of the housing 20.

[0183] For the at least partially automated transfer of the objects, in particular the containers 5, into or from an attached chamber interior 150, 160, a transport system 700 with a transport device 7 is provided in the illustrated embodiment. In various embodiments, the transport device 7 comprises at least one schematically depicted manipulator 70, for example, an articulated robot arm. The transport device 7, in particular the manipulator 70, is particularly operable to move containers 5 to be filled from the main chamber 201 into an attached chamber interior 150, 160, in particular to the filling position 30 in an attached chamber interior 150, 160.

[0184] In particular, during the transfer of the containers 5, a transport segment of the transport device 7, for example a manipulator arm of the manipulator 70 designed as an articulated robot, is located temporarily in the main chamber 201 and temporarily in the connected chamber interior 150, 160. Specifically, in embodiments, a manipulator 70 is provided for each interface 152, 162 in order to transfer objects from the main chamber 201 into a chamber interior 150, 160 connected at the interface 152, 162.

[0185] As schematically shown in Fig. 1, in certain embodiments it is provided that during a filling process, particularly before filling and until the container 5 is closed, at least transport segments, for example the manipulator arm, which are located temporarily in the main chamber 201 and temporarily in the connected chamber interior 150, 160, are located in the main chamber 201. For example, the manipulator 70 is in a retracted position during the filling process, whereby in the retracted position no part of the manipulator 70 engages in the connected chamber interior 150, 160. In particular, this prevents contamination of the manipulator 70 during the filling process.

[0186] After the container 5 is sealed, the transport device 7, for example the manipulator 70, moves to transfer the filled and sealed container 5 from the respective connected chamber interior 150, 160 into the main chamber 201, in particular from the filling and / or sealing position 30. Specifically, the manipulator 70, designed as an articulated-arm robot, engages the respective chamber interior 150, 160 with a manipulator arm and transports the filled and sealed container 5 from the respective chamber interior 150, 160, in particular from the filling and / or sealing position 30, into the main chamber 201.

[0187] In embodiments, the transport device 7 has at least two transport units per interface 152, 162, for example at least two manipulators 70. In particular, a first of the at least two transport units, for example a first manipulator 70, is located entirely and always during the execution of the process steps in the main chamber 201, and a second of the at least two transport units, for example a second manipulator 70, is located entirely and always during the execution of the process steps in the respective connected chamber interior 150, 160.To transfer containers 5 to be filled from the main chamber 201 to an adjacent chamber interior 150, 160, the first transport unit transports the container 5 to be filled to a transfer area, in particular to the interface 152, 162, and the second transport unit transports the container 5 to be filled from the transfer area to the respective chamber interior 150, 160, in particular to the respective filling position. To remove filled and sealed containers 5 from the respective chamber interior 150, 160, the second transport unit transports the filled and sealed container 5, in particular from the sealing and / or filling position 30, to the transfer area, in particular to the interface 152, 162, and the first transport unit transports the filled and sealed container 5 from the transfer area to the main chamber 201.In particular, a container 5 is transferred directly from the first transport unit to the second transport unit and / or vice versa within the transfer area. In some configurations, the transfer of a container 5 between the first and second transport units within the transfer area occurs indirectly.

[0188] The containers 5 to be filled are provided as packages in various configurations. In the embodiment shown in Fig. 1, a transfer station 8 with a first package position 81 and a second package position 82 is provided in the main chamber 201. At the first package position 81, a package comprising a slide (not shown) and containers 5 to be filled inserted therein can be provided. In the illustrated embodiment, the containers 5 can be individually removed from the package located at the first package position 81 by the manipulator 70 or another transport unit and moved by the manipulator 70 at least in the direction of the respective process chamber 15, 16. The removed containers 5 are then moved by the same manipulator 70 or another transport unit into the respective chamber interior 150, 160 for a filling operation.After the filled container 5 has been closed, the container 5 can be removed from the respective chamber interior 150, 160 with the transport device 7, for example with the manipulator 70, and can be inserted into a slide provided at the second container position 82 with the manipulator 70 or another transport unit.

[0189] In some configurations, manipulators 70, which are assigned to different interfaces 152 and 162, remove objects from a common container position 81. In other configurations, manipulators 70, which are assigned to different interfaces 152 and 162, place objects back at a common 82. In other configurations, separate container positions are provided for manipulators 70, which are assigned to different interfaces 152 and 162.

[0190] In the illustrated embodiment, a schematically depicted feeding device 83, for example a container feeding device, is further provided for feeding the objects, in particular containers 5 to be filled, via the inlet 11 into the main chamber 201. The feeding device 83, in particular the container feeding device, is configured to transport objects, in particular containers 5 to be filled, for example as packages, from the surroundings via the inlet 11 into the transfer station 8 provided in the main chamber 201.

[0191] In one embodiment of the exemplary embodiment, a schematically depicted discharge device 84, for example a container discharge device for removing objects, in particular filled and sealed containers 5, from the main chamber 201 via the outlet 12, is further provided. The discharge device 84, in particular the container discharge device, is configured to transport objects, in particular filled and sealed containers 5, from the transfer station 8 provided in the main chamber 201 via the outlet 12 into the surrounding area.

[0192] The access opening 24 to the chamber interiors 150, 160 are each designed as a connection opening of a transfer system, in particular as an alpha port of an alpha-beta port system.

[0193] In particular, the access opening 24 is designed such that it can only be opened when a transfer component 25 is connected to it. A transfer component 25 connected to the access opening 24 prevents any connection to the environment. When a transfer component 25 is connected to the access opening 24, the access opening 24 can be opened without the respective chamber interior 150, 160 being connected to the environment. In particular, the interior of the transfer component 25 meets cleanroom requirements; specifically, the interior of the transfer component 25 is sterile. If the transfer component 25 is connected to the access opening 24 and the access opening 24 is open, the interior of the transfer component 25 is accessible from the respective chamber interior 150, 160.

[0194] In the illustrated embodiment, a filling needle 32 can be inserted into the respective chamber interior 150, 160 via the access opening 24. As shown for the first process chamber 15, a transfer component 25, connectable to the access opening 24, is provided in the illustrated embodiment with a feedthrough 250 for a fluid line 34. The fluid line 34 runs through the feedthrough 250, and any other connection through the feedthrough 250 is prevented, so that the cleanroom conditions inside the transfer component 25 are not compromised by the feedthrough 250. The filling needle 32 is connected via the fluid line 34 to a product reservoir 36 located outside the housing 20 and, in particular, outside the interior of the transfer component 25.In its prepared state, a conveying device 38 is provided on the fluid line 34, via which a defined quantity of product can be conveyed from the product supply 36 to the container 5 for filling the container 5. In some embodiments, a control device 9, for example a scale and / or an optical control device 9 for detecting a fill level, is further provided at the filling position 30 for in-process control.

[0195] The conveying device 38 is, in particular, arranged at least largely outside the interior of the housing 20. Specifically, the control device 9 and the conveying device 38 are connected to each other via signal transmission.

[0196] In some embodiments, the filling station 3 is at least partially automated, and in particular fully automated, in others. The filling station 3 includes, in particular, a filling needle holder 33. For example, in some embodiments, the manipulator 70 of the transport device 7 and / or an additional manipulator (not shown in the figures) can be operated to equip the filling station 3 with the filling needle 32. In some embodiments, the access opening 24 can be opened automatically, for example, by an automatic mechanism for the access opening 24 and / or by a manipulator 70. The manipulator 70 can be operated, in particular, to remove the filling needle 32 from the connected transfer component 25 and to attach the filling needle 32 to the filling needle holder 33. The filling needle 32 is attached to the filling needle holder 33, in particular, by means of a tool-free quick-release fastener, for example, by means of a snap-fit ​​and / or magnetically.

[0197] Alternatively or additionally, in some configurations at least partial manual setup of the filling station 3 is possible, in particular via the glove opening 26.

[0198] The filled containers 5 are closed by closure elements 40. In various embodiments, the closure elements 40 are inserted into the respective chamber interiors 150, 160 via the access opening 24. In the illustrated embodiment, a supply 400 of closure elements 40 is provided in the main chamber 201. This supply 400 can be introduced into the main chamber 201, in particular via the inlet 11.

[0199] In the illustrated embodiment, a closure dispensing device 41 is arranged in the main chamber 201 and a closure insertion device 42 is arranged in the respective chambers 150, 160 to transfer the closure elements 40 from the supply 400 to the respective chamber interiors 150, 160. The closure dispensing device 41 is specifically designed to remove closure elements 40 individually or in groups from the supply 400 provided in the main chamber 201 and to make the closure elements 40 available at a closure dispensing position. The closure insertion device 42 is designed to receive the closure elements 40 at the closure dispensing position. The closure dispensing position is specifically provided in a transfer area between the main chamber 201 and the respective chamber interiors 150, 160.

[0200] In various configurations, a closure provisioning device 41 transports closure elements 40 individually or in groups from the supply 400 provided in the main room 201 directly into the respective chamber interior 150, 160, in particular to the closure station 4.

[0201] The system 1 is particularly suitable for filling products in small batches, whereby more than one batch of the same product and / or batches of different products are to be and can be filled between two successive decontaminations of at least the main room 201, and in embodiments of a process.

[0202] In particular, in certain embodiments of the process, batches of different products can be filled at least partially simultaneously in separate chamber interiors 150, 160 of process chambers 15, 16. In these embodiments, the entire system 1 is first decontaminated. Subsequently, containers 5 and closure elements 40 can be fed into the main chamber 201, for example, via inlet 11. In these embodiments, this feeding is at least partially automated.

[0203] The setup of the filling station 3 of a process chamber 15, 16 is carried out at least partially manually and / or automatically using a filling needle 32 supplied via the access opening 24, wherein the filling needle 32 is provided, in particular, in a sterile interior of a transfer component 25. Specifically, the filling needle 32 is connected via the fluid line 34 to the supply 36 of product to be filled, which is located outside the interior of the transfer component 25. During setup, the conveying device 38 is connected to the fluid line 34 so that the product to be filled can be conveyed from the product supply 36 in a defined manner and filled via the filling needle 32 into a container 5 to be filled.

[0204] To fill a batch of a product, the containers 5 are fed individually or in groups into the respective chamber interior 150, 160 while connected to the chamber interior 150, 160, and filled and sealed there. The filled and sealed containers 5 are then returned to the main chamber 201 and discharged from the main chamber 201 via outlet 12.

[0205] Once the batch of product to be filled has been emptied into the containers 5, and in particular once the product supply 36 has been used up, the filling needle 32 can be extended from the respective chamber interior 150, 160, in particular via the transfer component 25 connected to the access opening 24. The access opening 24 is then closed. The fluid line 34 is then disconnected from the conveying device 38.

[0206] Subsequently, the respective chamber interior 150, 160 and the components arranged therein are cleaned, in particular disinfected.

[0207] In particular, while one chamber interior 150, 160 is being cleaned, a filling process can be started and / or continued in another chamber interior 150, 160.

[0208] After cleaning the respective chamber interiors 150 and 160, the filling station 3 and, for example, the conveying device 38 can be re-set up. Specifically, the setup is carried out with a filling path comprising a filling needle 32 and a product reservoir 36, wherein the filling needle 32 and the product reservoir 36 are fluid-conducting and connected to each other via the fluid line 34. Specifically, the filling needle 32 is provided within a sterile interior of a transfer component 25, and the product reservoir 36 is provided outside the interior of the transfer component 25. The product reservoir 36 of the newly set up filling path contains a batch of another product to be filled, which may be a different product than the one previously filled. After setup, the product to be filled is filled into container 5.

[0209] For example, containers 5, which are to be filled with the next product, can already be fed at least partially via the feed device 83 while containers 5 are still being filled with a previously filled product at the filling station 3 and / or while sealed containers 5, which are filled with a previously filled product, are being discharged via the discharge device 84. In particular, the containers 5, which are to be filled with the next product, are only fed in to such an extent that these containers 5 do not come into close proximity to the sealed containers 5, which are filled with a previously filled product.

[0210] By cleaning the interiors of chambers 150 and 160, the risk of cross-contamination between batches and / or different products can be reduced to at least a tolerable level.

[0211] In particular, by separating the chamber interiors 150, 160, in which the filling station 3 and the sealing station 4 are located, from the main chamber 201, the main chamber 201 can be kept so clean even during the filling and sealing of the containers 5 that different products can be filled simultaneously and / or decontamination of the main chamber 201 is not required with each change of batch of product to be filled and / or with each change of product to be filled. This allows for resource savings. For example, a larger quantity of products, especially different products, can be filled into containers 5 within a given time.

[0212] In the embodiment shown in Fig. 1, the cleanroom structure 10 has a base area that is at least substantially rectangular, with the main chamber 201 and the interior chamber 150 of the first process chamber 15, designed as a separate sub-chamber, arranged on the rectangular base area. In the illustrated embodiment, the interior chamber 150 of the first process chamber 15 is located at a corner of the housing 20, and is bounded by two adjacent wall sections of an outer wall of the housing 20 that form a right angle.

[0213] In the embodiment shown in Fig. 1, a partition wall 22 is arranged in the interior of the housing 20 between the chamber interior 150, designed as a separate sub-chamber, and the main chamber 201, thereby separating the chamber interior 150 from the main chamber 201. To separate the chamber interior 150, located in the corner of the housing 20, the partition wall 22 has two partition wall sections 221, 222, which, together with the two wall sections of the outer wall, define the chamber interior 150, designed as a separate sub-chamber. In other embodiments, the partition wall 22 has only one wall section or more than two wall sections.

[0214] In particular, the partition 22 is mounted on the outer wall of the housing 20. In certain embodiments, a gap, particularly a small one, is formed between the partition 22 and the outer wall. In certain embodiments, a boundary area between the partition 22 and the outer wall is sealed, at least partially, particularly at least in a lower area.

[0215] Fig. 2 shows a second embodiment of a plant 1 for carrying out process steps at least partially under cleanroom conditions, in particular for carrying out process steps on containers 5, especially for filling and closing the containers 5.

[0216] Annex 1 according to Fig. 2 is similar to Annex 1 according to Fig. 1, and uniform reference numerals are used for identical or similar components. For a description of components already described, please refer to the preceding text.

[0217] In contrast to the design shown in Fig. 1, the design shown in Fig. 2 provides two interfaces 152, 162 on a wall of the housing 20 that bounds the main chamber 201. In the illustrated embodiment, the interfaces 152, 162 are arranged on opposite sides of the housing 20. In other embodiments, the interfaces 152, 162 are arranged on a common side of the housing 20. In the embodiment shown in Fig. 2, two process chambers 15, 16 are provided. The interior spaces 150, 160 of the process chambers 15, 16 can each be connected to the main chamber 201 via one of the interfaces 152, 162. In other embodiments, one or both process chambers 15, 16 are arranged in a stationary position and, for example, mounted on the housing 20.In some embodiments, one or both process chambers 15, 16 can be brought into a disconnected state and, in this disconnected state, are at least not connected to the housing 20 at the respective interface 152, 162. In other embodiments, one or both process chambers 15, 16, which can be brought into a disconnected state, are arranged semi-stationarily and, for example, movably attached to the housing 20.

[0218] In embodiments, as schematically shown in Fig. 2, the interior chambers 150, 160 of the process chambers 15, 16 can each be converted into a separate state, wherein the respective interior chamber 150, 160 of the process chamber 15, 16 is fluid-tightly separated from the main chamber 201 in the separated state. For example, in the separated state, the interior chambers 150, 160 are each fluid-tightly separated from the main chamber 201 by a wall 154, 164, which is shown schematically. In embodiments, the wall 154, 164 is designed as a door, wherein a passage opening present at the interface 152, 162 is at least covered and, in particular, closable by the door. For example, a seal is provided on the door and / or on the passage opening so that the passage opening can be fluid-tightly closed by the door.The through-opening can be closed through the wall 154, 164, particularly during filling and closing of a container 5 and / or for cleaning.

[0219] As schematically shown in Fig. 2, a process step can be carried out simultaneously in the interiors of chambers 150, 160 in certain configurations. In particular, containers 5 can be filled simultaneously in the interiors of chambers 150, 160 in certain configurations. For example, containers with different products can be filled simultaneously in the interiors of chambers 150, 160 in certain configurations. When the filling process in one interior of chamber 150, 160 is completed, the interior of that chamber 150, 160 can be cleaned. For example, the filling process can continue in the interior of chamber 150, 160 of one process chamber 15, 16 while the interior of chamber 160, 150 of the other process chamber 16, 15 is being cleaned.

[0220] Fig. 3 shows a third embodiment of a plant 1 for carrying out process steps at least partially under cleanroom conditions, in particular for carrying out process steps on containers 5, especially for filling and closing the containers 5.

[0221] Annex 1 according to Fig. 3 is similar to Annex 1 according to Fig. 1, and uniform reference numerals are used for identical or similar components. For a description of components already described, please refer to the preceding text.

[0222] In contrast to the design according to Fig. 1, the design according to Fig. 3 provides three interfaces 142, 152, 162. The three interfaces are, for example, all located on a wall of the housing 20 that defines the main chamber 201. In the illustrated embodiment, the interfaces 142, 152, 162 are arranged on a common side of the housing 20.

[0223] In the embodiment shown in Fig. 3, four process chambers 14, 15, 16, 17 are provided. The chamber interiors 140, 150, 160, 170 of the process chambers 14, 15, 16, 17 can each be connected to the main chamber 201 via one of the interfaces 142, 152, 162.

[0224] In some embodiments, a first process chamber 15 is stationary and, for example, mounted on the housing 20. In some embodiments, an interior chamber of the first process chamber 15 is connected to the main chamber 201 in a connected state. For example, in the connected state, the interior chamber 150 of the first process chamber 15 is fluidically separated from the main chamber 201, at least during one execution of the process step in the interior chamber 150, to prevent fluids and / or aerosols present in the interior chamber 150 from entering the main chamber 201. The interior chamber 150 of the first process chamber 15 can, for example, be converted into a separated state, wherein the interior chamber 150 is fluid-tightly separated from the main chamber 201 in the separated state. For example, in the separated state, the interior chamber 150 is separated from the main chamber 201 by a wall (not shown in Fig. 1).3) fluid-tight separation. In particular, the interior of the chamber 150 of the stationary process chamber 15 can be converted into a separated state for treatment for cleaning, especially for germ and / or residue removal.

[0225] In embodiments, as shown, a second process chamber 16 and a third process chamber 17 can be brought into a disconnected state. The second and third process chambers 16, 17 are assigned to exactly one common interface 162. In the disconnected state, the respective process chamber 16, 17 can be moved relative to the housing 20. In particular, the two process chambers 16, 17 are each arranged in a semi-stationary manner and, for example, are slidably mounted on the housing 20. For example, the process chambers 16, 17 can be moved alternately into a working position. In the embodiment shown in Fig.

[0226] In the process state shown in Fig. 3, the second process chamber 16 is arranged in a working position. The second process chamber 16 is also shown in a second position (dashed line) in which it is moved away from the interface 162. Specifically, in the working position, the interior 160 of the second process chamber 16 is connected to the main chamber 201 via the associated interface 162 for the direct transfer of objects (not shown in Fig. 3) between the interior 160 and the main chamber 201. The third process chamber 17 is moved away from the interface 162. In the disconnected state, the third process chamber 17 is fluid-tightly separated from the environment, thus maintaining cleanroom conditions within the process chamber 17. The third process chamber 17 can be cleaned in the disconnected state.

[0227] In certain embodiments, as shown, a fourth process chamber 14 is provided, which can be switched to a disconnected state. In this disconnected state, the fourth process chamber 14 is spatially separated from the housing 20. The process chamber 14 is, in particular, freely movable within the vicinity of the housing 20. The fourth process station 14 can be moved from the depicted rest or cleaning position, in which it is spatially separated from the housing 20, to a working position on the housing 20. In the working position, the interior space 140 of the fourth process chamber 14 can be connected to the main chamber 201 for transferring objects.

[0228] In some embodiments, each interface 142, 152, 162 is assigned a manipulator (not shown in Fig. 3), in particular to move objects into a respective connected chamber interior 140, 150, 160, 170. Specifically, the manipulator is configured to move objects from a transfer station 8 assigned to the respective interface 142, 152, 162 into the respective connected chamber interior 140, 150, 160, 170.

[0229] For the transport of the objects to the transfer stations 8, the transport system 700 in its various configurations further includes a conveyor system 701.

[0230] Conveyor system 701 comprises, in various configurations, a conveyor track and transport elements movable relative to it. In some configurations, the conveyor track is designed as the stator of a linear motor system, and the transport elements as the associated runners. In other configurations, conveyor system 701 comprises a conveying surface and transport elements movable relative to it. In some configurations, the conveying surface is designed as the stator of a planar motor system, and the transport elements as the associated runners.

[0231] In the embodiment shown in Fig. 3, the inlet 11 and the outlet 12 are arranged at opposite ends of the housing 20. The conveying system 701 is designed, in particular, to move objects, for example with transport bodies, from the inlet 11 to the transfer stations 8 and from the transfer stations 8 to the outlet 12. In other embodiments, the conveying system 701 is designed to move transport bodies along a closed path from the inlet 11 to the outlet 12 and from the outlet 12 to the inlet 11.

[0232] For example, a transfer station 8 is provided for each interface 142, 152, 162. For example, the transport system 700, in particular the conveyor system 701, is designed to transport objects, especially containers 5 to be filled, individually or in groups from the inlet 11 to the transfer stations 8 at the interfaces 142, 152, 162. In particular, transport takes place as packages, with at least one, in particular two, package positions provided at each transfer station 8. Objects can, for example, be taken individually or in groups from a package located at a package position, for example a first package position, and placed in the respective connected chamber interior 150, 160.For example, objects can be moved individually or in groups from the respective connected chamber interior 150, 160 into the main room 201 and placed in a container located at the container position or at a second container position.

[0233] For example, as shown in Fig. 3, system 1 includes a insertion device 83. The insertion device 83 includes, for example, several insertion paths 830, each configured to insert objects from the surroundings into the main chamber 201. In some embodiments, the number of insertion paths 830 corresponds to the number of interfaces. In some embodiments, exactly two insertion paths 830 are provided.

[0234] For example, as shown in Fig. 3, system 1 includes a dispensing device 84. The dispensing device 84 includes, for example, several dispensing paths 840, for example, two dispensing paths 840, each configured to dispense the objects from the main chamber 201 into the surrounding area. In some embodiments, the number of dispensing paths 840 is equal to the number of interfaces. System 1 includes, in some embodiments, at least one marking device 90, shown here as several, in particular two, marking devices 90, each configured to mark objects.

[0235] The marking device 90 is specifically designed to mark objects before and / or after a process step has been carried out.

[0236] The marking device 90 is arranged in particular at the interface 152, 162 and / or as schematically shown in Fig. 3, at the outlet 12, for example of the dispensing device 84.

[0237] In the design according to Fig. 3, the inlet 11 and the outlet 12 are provided on opposite sides of the main room 201 with a rectangular floor plan.

[0238] In some configurations, an inlet and an outlet are arranged on a common side of a main room with a rectangular floor plan, with the interfaces being located on one or more of the three other sides.

[0239] In some designs, a main room with a polygonal floor plan is provided, for example, with a pentagonal, hexagonal, or octagonal floor plan. The inlet and outlet are located, for example, on a common side or on adjacent sides.

[0240] The illustrated examples are merely illustrative, and numerous variations are conceivable. For instance, entities from one embodiment can be combined with those from another to obtain further embodiments.

[0241] The configuration shown in Fig. 3 is merely exemplary. In embodiments, all process chambers are arranged in a stationary position and each is assigned to one, in particular exactly one, interface 142, 152, 162. In embodiments, all process chambers can be converted into a disconnected state in which the process chambers are, in particular, freely movable within the vicinity of the housing. In embodiments, each of the freely movable process chambers is assigned to one, in particular exactly one, interface 142, 152, 162. In embodiments, each of the freely movable process chambers can be connected to any interface 142, 152, 162. In embodiments, all process chambers are arranged in a semi-stationary position, for example, movably attached to the housing 20. In particular, semi-stationary process chambers are assigned to an interface in pairs and can be alternately converted into a working position.In some configurations, the system features stationary process chambers and freely movable process chambers. In other configurations, the system features stationary process chambers and semi-stationary process chambers. In other configurations, the system features semi-stationary process chambers and freely movable process chambers.

[0242] Reference symbol list

[0243] I Annex

[0244] 10 Cleanroom setup

[0245] II Entrance

[0246] 12 Outlet

[0247] 14th Trial Chamber

[0248] 140 chamber interior

[0249] 142 Interface

[0250] 15th Trial Chamber

[0251] 150 chamber interior

[0252] 152 Interface

[0253] 154 wall

[0254] 16th Tribunal

[0255] 160 chamber interior

[0256] 162 Interface

[0257] 17th Tribunal

[0258] 170 chamber interior

[0259] 164 wall

[0260] 20 cases

[0261] 201 Main Room

[0262] 22 Partition wall

[0263] 220 Through opening

[0264] 221 Partition wall section

[0265] 222 Partition wall section

[0266] 24 Access opening

[0267] 25 Transfer component

[0268] 26 Glove insertion

[0269] 3 filling stations

[0270] 30 Filling positions

[0271] 32 Filling needle

[0272] 33 Filling needle holders

[0273] 34 Fluid line

[0274] 36 product stock

[0275] 38 Funding facility

[0276] 4 locking stations

[0277] 40 locking elements

[0278] 400 stock

[0279] 41 Locking device

[0280] 42 Closure insertion device

[0281] 43 Closure feeder

[0282] 5 containers

[0283] 6 Extraction device

[0284] 7 Transport device Mampulator

[0285] Transport system, conveyor system, transfer station, container position, container position, insertion device, insertion path, discharge device, discharge path, control device

[0286] Marking device

Claims

Patent claims 1. A facility for carrying out process steps with and / or on objects at least partially under cleanroom conditions, in particular with and / or on packaging materials, for example with and / or on containers and / or with and / or on pharmaceutical packaging materials, and / or wherein the process steps in particular include filling and / or closing containers under cleanroom conditions, wherein the facility (1) comprises a cleanroom structure (10), wherein the cleanroom setup (10) comprises a housing (20), an insertion device and an ejection device, wherein a main chamber (201) of the enclosure (20) is separated from an environment and the cleanroom condition can be met in the main chamber (201) of the enclosure (20) of the cleanroom setup, wherein the insertion device (83) is designed to introduce the objects from the surroundings into the main chamber (201), and wherein the discharge device (84) is designed to discharge the objects from the main chamber (201) into the surrounding area, characterized by the fact that the facility (1) comprises several process chambers (14, 15, 16, 17), wherein the process chambers (14, 15, 16, 17) each comprise an interior chamber space (140, 150, 160, 170) and a device arranged in the interior chamber space (140, 150, 160, 170) for carrying out a process step, where at least one interface (152, 162) to the main room (201) is provided, wherein in a connected state of the chamber interior (140, 150, 160, 170) the respective chamber interior (140, 150, 160, 170) is connected to the main room (201) via at least one interface (152, 162) for the, in particular, direct, transfer of objects between the chamber interior (140, 150, 160, 170) and the main room (201), wherein at least in the connected state in the respective chamber interior (140, 150, 160, 170) the cleanroom condition of the main room (201) can be fulfilled.

2. System according to claim 1, characterized in that the cleanroom setup (2) includes several interfaces (142, 152, 162), wherein in particular the chamber interior (140, 150, 160, 170) of at least one process chamber (15, 16) is connected to the main room in the connected state via an interface (142, 152, 162), in particular exactly one, assigned interface, wherein in particular the chamber interiors (140, 150, 160, 170) of at least some process chambers (14, 15, 16, 17) are each connected to the main room (201) in the connected state via an interface (142, 152, 162), in particular exactly one assigned interface.

3. System according to one of the preceding claims, characterized in that the interior space (140, 150, 160, 170) of at least one trial chamber (14, 15, 16, 17), in particular the interior spaces (140, 150, 160, 170) of some, for example all, trial chambers (14, 15, 16, 17), can be converted into a separated state, wherein in particular the respective chamber interior (140, 150, 160, 170) is fluid-tightly separated from the environment and / or the main chamber (201) in the separated state, for example, by means of a wall (154, 164) separating it from the main chamber (201), and / or in the respective chamber interior (140, 150, 160, 170) in the separated state, treatment for cleaning, in particular for germ and / or residue removal, is possible.

4. System according to one of the preceding claims, characterized in that at least one process chamber (14, 16, 17), in particular some, for example all, process chambers, can be converted into a disconnected state, wherein, in particular in the disconnected state, the respective process chamber (14, 16, 17) is movable relative to the main room, and / or wherein, in particular, in the disconnected state, the respective process chamber (14, 16, 17) is not connected to the housing at least at one interface (162), wherein, in particular, the interface (162) and / or the respective process chamber (14, 16, 17) can be closed in a fluid-tight manner in the disconnected state, in particular by a wall, for example, each by a wall.

5. System according to the preceding claim, characterized in that at least one process chamber (14, 16, 17), in particular some, for example all process chambers, is movable in the vicinity of the main chamber (201) relative to the main chamber (201) in the disconnected state of the respective process chamber (14, 16, 17), wherein, in particular, which at least one process chamber (14, 16, 17) is / are movably, in particular slidably, mounted on the housing (20), and / or which has at least one process chamber (14, 16, 17) motion elements for movement over a surface, in particular rollers for driving movement over a surface.

6. System according to one of the preceding claims, characterized in that at least two process chambers (14, 15, 16, 17) are provided, wherein in particular the at least two process chambers (16, 17) are assigned to an associated interface (162), and the chamber interiors (160, 170) of the at least two process chambers (16, 17) can be optionally connected to the main room (201) via the associated interface (162), in particular at least one chamber interior (160, 170) which is not connected to the main chamber (201) via the associated interface (162) is transferred into the separated state.

7. System according to the preceding claim, characterized in that the at least two process chambers (14, 16, 17) are assigned to exactly one assigned interface (162), wherein in particular the at least two process chambers (14, 16, 17) can each be transferred into a disconnected state and optionally the process chambers (14, 16, 17) can be moved in and out of a working position in the disconnected state, wherein the chamber interior (140, 160, 170) of a process chamber (14, 16, 17) arranged in the working position can be transferred into the connected state in order to connect the chamber interior (140, 16, 170) of the process chamber (14, 16, 17) arranged in the working position to the main chamber (201) via the exactly one assigned interface.

8. System according to one of the preceding claims, characterized in that at least one process chamber (15), in particular some, for example all, process chambers is / are arranged in a stationary manner, wherein in particular a chamber interior (150, 160) of a stationary process chamber (15, 16) is arranged in the housing (20) of the cleanroom structure (2), and / or a chamber housing of a stationary process chamber is connected to the housing (20) of the cleanroom structure (2) and / or is part of the housing (20) of the cleanroom structure (2).

9. System according to one of the preceding claims, characterized in that the chamber interior (140, 150, 160, 170) of the respective process chamber (14, 15, 16, 17) in the connected state is fluidically separated and / or separable from the main chamber (201) at least during one execution of the process step, in order to prevent fluids and / or aerosols present in the chamber interior (140, 150, 160, 170) from entering the main chamber (201).

10. Plant according to the preceding claim, characterized in that at least some, in particular all, process chambers (14, 15, 16, 17) are configured to perform at least one identical process step, and / or at least one, in particular some, for example all, process chambers (14, 15, 16, 17) is / are configured to perform several process steps.

11. Plant according to one of the preceding claims, characterized in that at least one process chamber (14, 15, 16, 17), in particular some, for example all, process chambers (14, 15, 16, 17), comprises a filling station (4) arranged in the respective chamber interior for filling a container (5), in particular for filling a container in the chamber interior (140, 150, 160, 170), wherein in particular the filling station can be equipped with at least one filling path, and / or at least one process chamber (14, 15, 16, 17), in particular some, for example all process chambers (14, 15, 16, 17), comprises a closing station (4) arranged in the interior of the respective chamber for closing a filled container (5), wherein in particular a filling position (30) of the filling station (3) and a closing position of the closing station (4) are the same position.

12. System according to one of the preceding claims, characterized in that a closure provision device (41) is provided in the main chamber, wherein in particular a closure provision device (41) is provided for each interface, and / or wherein in particular the closure provision device is designed to take closure elements (40) individually or in groups from a supply provided in the main chamber (201), and to provide the closure elements at a closure dispensing position, wherein in particular the closure dispensing position is provided in a transfer area between the main chamber and the respective chamber interior (140, 150, 160, 170).

13. System according to one of the preceding claims, characterized in that a closure insertion device (42) is provided in at least one chamber interior (140, 150, 160, 170), in particular in some, for example in all chamber interiors (140, 150, 160, 170), which is designed to move the closure elements (40) in the respective chamber interior (140, 150, 160, 170) to the closure station (4).

14. Plant according to one of the preceding claims, characterized in that at least one process chamber, in particular some, for example all process chambers, comprises a control device (9) for the filling process, wherein in particular the control device (9) comprises a scale for recording a weight of the containers (5) to be filled, in particular for recording a weight before and / or after filling, and / or wherein in particular the control device (9) comprises an optical sensor device for detecting a fill level.

15. Plant according to one of the preceding claims, characterized in that the plant comprises a cleaning system for cleaning at least the interior spaces of the chambers (140, 150, 160, 170) and in particular components of the process chambers (14, 15, 16, 17) arranged therein, wherein in particular the cleaning includes germ and / or residue removal, and / or the cleaning system is designed to selectively and / or alternately subject process chambers (14, 15, 16, 17) to cleaning, and / or the cleaning system includes at least one, in particular several, cleaning devices for cleaning identical and / or different process chambers (14, 15, 16, 17), wherein, for example, a cleaning device for main cleaning and a cleaning device for intermediate cleaning between two main cleanings is provided.

16. System according to one of the preceding claims, characterized in that a transport system for transporting the objects is provided in the main room.

17. Plant according to the preceding claim, characterized in that the transport system comprises a transport device, wherein the transport device is designed to introduce objects, in particular containers to be filled, from the main chamber into the interior of the respective process chamber for the execution of a process step in one of the several process chambers, and / or to remove objects, in particular filled and sealed containers (5), from the interior of the respective process chamber into the main chamber after the execution of a process step in one of the several process chambers, in particular at least semi-automatically, in particular fully automatically, and wherein in particular the transport device for interface has its own transport device for moving the objects.

18. Plant according to the preceding claim, characterized in that The transport device (7) comprises a manipulator (70) which is at least semi-automatically, and in particular fully automatically, operable to introduce objects from the main chamber (201) into the chamber interior (140, 150, 160, 170) of the respective process chamber (14, 15, 16, 17) for the execution of a process step in one, in particular exactly one, of the several process chambers (14, 15, 16, 17), and / or to remove objects from the chamber interior (140, 150, 16, 170) of the respective process chamber (14, 15, 16, 17) into the main chamber (201) after the execution of a process step in one of the several process chambers (14, 15, 16, 17), in particular to introduce containers to be filled from the main chamber into the chamber interior of the respective process chamber, in particular into a filling position (30) to move into the interior of the chamber, and to move filled and sealed containers (5) from the interior of the chamber into the main room,in particular to be taken over from a locking position (30).

19. Plant according to one of the two preceding claims, characterized in that the transport device (7) is configured such that a transport segment of the transport device, which is temporarily located in the main chamber and temporarily in the respective chamber interior, is located in the main chamber at least during one process step, in particular during the filling and / or closing of a container, for example from the beginning of filling a container until the completion of closing the filled container.

20. Plant according to one of the preceding claims, characterized in that a transfer station (8), in particular with a container position (81, 82), for a container is provided in the main room, wherein in particular the transport system (700), for example the transport device (7), is designed to remove objects, in particular containers (5) to be filled, individually or in groups from a container provided at the transfer station, in particular the container position (81, 82), and to transfer them into the respective chamber interior (140, 150, 160, 170), and / or wherein in particular the transport system (700), for example the transport device (7), is designed to transfer objects, in particular filled and sealed containers (5), individually or in groups from the respective chamber interior (140, 150, 160, 170) into the main chamber and to place them at the transfer station, in particular the container position (81, 82), wherein in particular several transfer stations, in particular with at least one container position (81, 82) each, are provided, each of which is assigned to one, in particular exactly one, interface.

21. System according to one of the preceding claims, characterized in that the transport system is designed to transport objects, in particular containers (5) to be filled, in groups, in particular as packages, from an inlet of the main room to the at least one transfer station (8), and / or to transport objects, in particular filled containers (5), in groups, especially as packages, from the at least one transfer station (8) to the outlet, wherein in particular the transport system (700) comprises a conveying system (701) arranged in the main room (201) for transporting the objects, in particular as containers, to the at least one transfer station (8) and / or away from the at least one transfer station (8).

22. System according to one of the preceding claims, characterized in that the insertion device is designed to move objects from the environment into an inlet provided in the main room, in particular to move them at least semi-automatically, wherein in particular the insertion device is designed as a container feed device for feeding containers to be filled into the main room, wherein in particular the container feed device is designed to bring containers to be filled, in particular as containers, from the surroundings into the inlet provided in the main room, in particular to bring them at least semi-automatically.

23. Plant according to one of the preceding claims, characterized in that the insertion device comprises a lock (130), wherein in particular the sluice (131) is designed to introduce at least one container (50) comprising a microscope slide and containers arranged therein into the main room (200), in particular the sluice gate has a cleaning device, especially for the removal of germs and / or residues.

24. System according to one of the preceding claims, characterized in that the discharge device (84) is designed to transport objects from a discharge station (8) provided in the main room into the environment, in particular to transport them at least semi-automatically, wherein in particular the discharge device (84) is designed as a container discharge device for the removal of filled and closed containers from the main room, wherein in particular the container discharge device is designed to transport filled and sealed containers (5), especially as containers, from the discharge station (8) provided in the main room into the surrounding area.

25. Plant according to one of the preceding claims, characterized in that the dispensing device has a dispensing interface, wherein in particular a container (280, 281) with a rigid and / or flexible wall for receiving objects after the execution of a process step, in particular filled and sealed containers (5), can be connected to the dispensing interface (28), wherein the objects, in particular the filled and sealed containers (5), can be dispensed from the main chamber into the container (280, 281) without direct contact of the main chamber with the environment, wherein in particular the container (280, 281) is designed to receive containers (50) comprising microscope slides (51) and containers (5) inserted therein.

26. System according to one of the preceding claims, characterized in that the dispensing device has a sluice gate.

27. System according to one of the preceding claims, characterized in that the system comprises a marking device (90) configured to mark objects, in particular to mark objects before and / or after the execution of a process step, in particular wherein the marking device (90) is arranged at the at least one interface and / or at the dispensing device, and / or wherein the marking device (90) is designed to apply a mark for automatic identification and data acquisition of the objects.

28. Plant according to one of the preceding claims, characterized in that the main room is fluid-tight closed, wherein in particular the cleanroom structure is designed as a closed isolator in accordance with Annex 1 to the EC GMP Guide.

29. Methods for carrying out process steps with and / or on objects at least partially under cleanroom conditions, in particular with and / or on packaging materials, for example with and / or on containers and / or with and / or on pharmaceutical packaging materials, and / or wherein the process steps in particular include filling and / or closing containers under cleanroom conditions, wherein objects, in particular containers to be filled, are introduced into a main chamber (201) of an enclosure (20) of a cleanroom structure (10), wherein a first batch of objects, individually or in groups, are transferred from the main chamber (201) to the interior of a first process chamber (140, 150, 160, 170) for the purpose of carrying out at least one process step, wherein after carrying out the process step the first batch of objects, individually or in groups, are transferred from the interior of the first process chamber (140, 150, 160, 170) to the main chamber and subsequently the interior of the first process chamber (140, 150, 160, 170) and components arranged therein are cleaned.

30. Method according to the preceding claim, characterized in that, at least partially simultaneously with the execution of the process step on the first batch of objects in the interior of the first process chamber (140, 150, 160, 170), a second batch of objects from the main chamber is transferred to the interior of a second process chamber and / or is transferred. a process step is carried out on the second batch in the interior of the second process chamber, and / or at least partially concurrent with a cleaning of the interior of the chamber (140, 150, 160, 170) of the first trial chamber (14, 15, 16, 17) a second batch of objects from the main room is moved and / or is moved into an interior chamber of a second trial chamber, and / or A process step is carried out on the second batch in the interior of the second process chamber.

1. Method according to one of the two preceding claims, characterized in that For cleaning the interior of the chamber (140, 150, 160, 170) of the first and / or the second process chamber (14, 15, 16, 17), the surfaces of the respective chamber interior and / or the components in the respective chamber interior are cleaned manually and / or automatically, in particular wiped and / or disinfected, and / or For cleaning the interior of the chamber (140, 150, 160, 170) of the first and / or the second process chamber (14, 15, 16, 17), the respective interior of the chamber (140, 150, 160, 170) is brought into a separated state, wherein in particular the respective interior of the chamber (140, 150, 160, 170) is fluid-tightly separated from the main chamber (201) in the separated state, for example by a wall, and / or in the respective chamber interior (140, 150, 160, 170) in the separated state, a treatment for cleaning, in particular for decontamination and / or for germ and / or residue removal, is carried out.

2. Method according to one of the three preceding claims, characterized in that the objects are containers (5), in particular pharmaceutical containers, wherein the process step in the interior of the chamber (140, 150, 160, 170) of the first process chamber (14, 15, 16, 17) and the process step in the interior of the chamber (140, 150, 160, 170) of the second process chamber (14, 15, 16, 17) each comprise filling and closing the containers (5).

33. Method according to the preceding claim, characterized in that cleaning, in particular the removal of germs and / or residues, of the main chamber (201) does not take place with each change of batch of the product to be filled and / or with each change of product to be filled.

34. Method according to one of the two preceding claims, characterized in that Containers (5) to be filled are introduced into the main chamber (201) of the housing (20) via an inlet (11) provided on the housing (20) with a sluice gate, and / or filled and sealed containers are discharged from the main chamber (201) of the housing (20) via an outlet (12), in particular a sluice gate at an outlet and / or a discharge interface (28) on the housing (20).

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