System and method for carrying out process steps on containers

Abstract

The invention relates to a system (1) for carrying out process steps on containers at least partly under clean room conditions, wherein the process steps comprise at least the steps of filling and closing the containers under clean room conditions. The system (1) has a clean room structure (2), a filling station (3) for filling a container, and a closing station (4) for closing a filled container; the clean room structure (2) comprises a housing (20); the interior of the housing (20) is separated from the surrounding area; and the clean room conditions can be implemented in the interior of the housing (20) of the clean room structure. The interior has a main chamber (201) and a sub-chamber (202) separated from the main chamber (201), and the filling station (3) and the closing station (4) are provided in the sub-chamber (202) separated from the main chamber. The invention also relates to a method for carrying out process steps on containers at least partly under clean room conditions.

Description

[0001] Equipment and procedures for carrying out process steps on containers

[0002] SCOPE OF APPLICATION AND STATE OF THE ART

[0003] The invention relates to a system and a method for carrying out process steps on containers at least partially under cleanroom conditions, wherein the process steps include at least filling and closing the containers under cleanroom conditions.

[0004] Process steps here refer to any form of handling, processing and / or manipulation 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] The containers in question are primarily pharmaceutical containers, such as vials, syringes, cartridges or ampoules.

[0006] It is known to prepare pharmaceutical containers for filling in a ready-to-use (ENGI) form. This involves preparing the containers in trays, particularly so-called nests or trays. Nests are plate-shaped trays containing recesses in which the containers can be arranged in several parallel rows. The recesses are typically designed with a hexagonal offset for high packing density. A tray is an open-topped packaging medium with a rim, in which the containers are usually, but not exclusively, held upside down. Nests, trays, or other carriers for holding objects are hereinafter referred to as trays. Objects arranged in a tray are hereinafter referred to as nested objects, regardless of the tray's design. A unit comprising a tray and the objects arranged therein is called a container.

[0007] The containers grouped in the slides are pre-sterilized using suitable methods and can then be used for filling without further sterilization. In some configurations, the containers are placed in tubs and subsequently enclosed with at least one bag as a sterile barrier. It is also known to place cover films on the containers in the tubs and / or to seal the tubs with cover films, in particular so-called TyvekO films.

[0008] For example, it is known from DE102005006733A1 for a filling process to remove all containers from the nest and transfer the containers individually or in series to devices for a filling process. For a filling process with a defined fill weight and a directly subsequent capping process, it is provided that an empty weight (tare) of the containers before filling and a fill weight (gross) after filling are determined, whereby a fill weight for each container can be precisely determined from the difference between gross and tare.

[0009] Alternatively, filling within the nest is known. For example, DE 10345338 A1 discloses a device for the controlled filling of nested containers, wherein the containers are arranged in parallel rows in a microscope slide. The device comprises a filling station for simultaneously filling a series of containers, a sealing station for sealing the containers, a weighing station for weighing at least one container, and a gripping device for removing a series of containers to be filled and transferring them to the weighing station, transferring the series of weighed containers from the weighing station to the filling station, transferring the series of filled containers to the weighing station, and transferring the series of doubly weighed containers into the same or a subsequent microscope slide in front of the sealing station.

[0010] 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.

[0011] 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, cleanroom conditions are 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.

[0012] 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 the EU GMP Guide, Annex 1, especially classes A, B, and C.In particular, the required cleanroom condition for filling and sealing the containers is class A.

[0013] 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.

[0014] TASK AND SOLUTION

[0015] The object of the invention is to create a system and a method which enables cost-efficient and safe, at least partially automated filling of products under cleanroom conditions, especially with small batches.

[0016] According to a first aspect, a plant for carrying out process steps on containers at least partially under cleanroom conditions is created, wherein the process steps include at least filling and closing the containers under cleanroom conditions, wherein the plant comprises a cleanroom structure, a filling station for filling a container and a closing station for closing a filled container, wherein the cleanroom structure comprises an enclosure, wherein an interior of the enclosure is separated from an environment, in particular by an outer wall, and the cleanroom condition can be fulfilled in the interior of the enclosure of the cleanroom structure, wherein the interior has a main room and a sub-room separated from the main room, wherein the filling station and the closing station are arranged in the separated sub-room.

[0017] The terms "a", "an", "a", etc. are used in connection with the application only as indefinite articles and not as counters. In particular, the filling station and / or the sealing station are configured to fill or seal a group of containers provided in the separate sub-space simultaneously or sequentially. In these configurations, it is stipulated that only exactly one container is placed in the separate sub-space for filling and sealing at a time.

[0018] The separated compartment can be cleaned as needed, particularly when changing batches of the product being filled and / or when changing the product being filled, to prevent cross-contamination between two batches and / or between two different products. Cleaning of the separated compartment can be carried out independently of cleaning the main compartment. Specifically, cleaning the separated compartment includes cleaning, and in particular disinfecting, the interior surfaces of the separated compartment and / or components within the separated compartment.

[0019] For example, cleaning the separated sub-space includes mechanical cleaning and / or cleaning with a cleaning medium, particularly a fluid, and / or washing, particularly wiping and / or rinsing, and / or irradiation, particularly with ultraviolet (UV) radiation. For example, the cleaning medium includes a disinfectant, such as alcohol. For example, the cleaning medium includes at least some gaseous components, such as water vapor and / or hydrogen peroxide.

[0020] In the main room, only the containers to be filled are processed before filling and / or after sealing, so that contamination of the main room during the processing of a batch is avoided, at least as a rule. Cleaning and / or decontamination of the main room is therefore unnecessary when switching between two batches and / or when switching between two different products to be filled. In some configurations, the cleanroom structure comprises an enclosure with a base area that is, in particular, at least substantially rectangular, with the separated sub-chamber located on this base area.

[0021] In various configurations, the main room has a floor area that is at least essentially rectangular, with the separate sub-room attached to the main room.

[0022] In certain embodiments, it is provided that the separated sub-space is designed to separate from the main space in order to prevent fluids and / or aerosols present in the separated sub-space from entering the main space, particularly at least from the beginning of filling a container until the completion of closing the filled container, especially during filling and / or closing a container and / or moving a filled and unsealed container.

[0023] In certain embodiments, a partition wall is arranged within the housing to separate the separated sub-compartment from the main compartment. This partition wall extends at least partially, and in particular largely, across an interface between the separated sub-compartment and the main compartment. "Largely" refers specifically to a configuration in which at least 80%, and in particular at least 90%, of the interface between the separated sub-compartment and the main compartment is closed by exactly one partition wall or several partition walls. Depending on the specific embodiment, the interface comprises exactly one or more surface sections arranged in a plane, to which the separated sub-compartment adjoins the main compartment.

[0024] In some embodiments, the partition wall has at least one opening for inserting containers to be filled into the separated compartment and for removing the filled containers from the separated compartment. In some embodiments, exactly one opening is provided, with both the insertion and removal of the containers occurring through this single opening. In other embodiments, at least one first and one second opening are provided, with the containers being inserted through the first opening and removed through the second opening.

[0025] In particular, a passageway in the partition wall forms a transfer area between the main room and the separated sub-room. A transfer area between the main room and the separated sub-room is defined, in particular, as an area through which the main room and the separated sub-room are connected and / or can be connected for the transfer of materials and / or products.

[0026] The at least one through-opening can be closed in certain configurations, in particular in a fluid-tight manner. The at least one through-opening can be closed, in particular, during the filling process and / or for cleaning the separated compartment.

[0027] In some embodiments, the housing is provided with a lockable access opening. In these embodiments, the access opening is located in a wall section that defines the boundaries of the separated compartment. Specifically, the access opening faces the surroundings of the system and is accessible from those surroundings. The lockable access opening allows, in particular, the introduction of materials and / or products into the separated compartment without the material and / or product passing through the main compartment.

[0028] In particular, a transfer component can be connected to the access opening.

[0029] In particular, the transfer component can be connected to the access opening from the surrounding area.

[0030] In certain designs, the access opening can be opened, so that the separated sub-space is directly connected to the surroundings.

[0031] In this configuration, the access opening can only be opened when a transfer component is connected. This prevents a direct connection between the separated sub-space and the surrounding environment via the access opening. Specifically, the interior of the transfer component meets the required cleanroom conditions. For example, the interior of the transfer component is sterile.

[0032] 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 moved into and out of the interior of the cleanroom enclosure. The alpha port is integrated into an outer wall of the enclosure. 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.

[0033] The filling station includes a filling needle holder in some configurations. In some configurations, a filling needle can be connected to the filling needle holder. In some configurations, the filling needle holder remains in the separate compartment during batch changes. To prevent cross-contamination during batch changes, the filling needle is replaced in advantageous configurations.

[0034] In some embodiments, a supply of the product to be filled is introduced into the separated compartment, particularly via the access opening. This supply is connected to a filling needle via a fluid line. In these embodiments, the filling needle is introduced into the separated compartment along with the product supply and connected there to the filling needle holder of the filling station.

[0035] In some embodiments, a transfer component connectable to the access opening is provided with a feedthrough for a fluid line. A filling needle, fluidically connected via a fluid line to a product reservoir located outside the interior, can be supplied to the separated compartment via this transfer component. In some embodiments, the transfer component is designed as the beta component of an alpha-beta port system.

[0036] In some configurations, the filling needle can be attached to a filling needle holder located at the filling station. 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 configurations, the filling station is equipped with the filling needle manually, particularly by reaching through gloves. In other configurations, a manipulator is provided for equipping the filling station with the filling needle.

[0037] In the preceding and / or following, a manipulator is defined as a fully or partially automated single-axis or multi-axis system, in particular a two- to six-axis system, 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.

[0038] The sealing station includes, in various embodiments, a sealing device for closing a filled container positioned at a sealing location. In some embodiments, the containers are sealed without a sealing element, for example, by welding. In advantageous embodiments, the sealing device is configured to close the container with a sealing element.

[0039] In particular, the containers are closed with a closure element, such as stoppers, caps, snap closures or others.

[0040] For example, the locking mechanism is designed,

[0041] - to close a container with a stopper, and / or

[0042] - to close a container with a cap, and / or

[0043] - to close a container by crimping.

[0044] In various configurations, the filling position of the filling station, where a container is filled, and the closing position of the closing station, where a container is filled, are different positions.

[0045] In certain embodiments, the containers to be filled can be arranged in the same position within the separated compartment, serving as both a filling and a sealing position. This eliminates the need to transport an open, filled container. For example, this reduces the risk of product escaping from an open, filled container, such as through the generation of aerosols during movement and / or a malfunction during transport. It also eliminates the need for a transport device within the separated compartment for moving containers between the filling and sealing stations. Furthermore, it minimizes the number of components requiring cleaning during batch changes within the separated compartment.

[0046] In certain embodiments, the separated compartment is bounded by at least one section of an outer wall of the housing. In these embodiments, a glove port and / or access opening is provided in this at least one wall section. In particular, the glove port allows manual access to the separated compartment, even under cleanroom conditions. For example, the glove port enables manual intervention to rectify a malfunction.

[0047] For example, the glove access allows for manual intervention to perform a process step. This includes, for instance, manually opening and closing the access opening and / or manually setting up the filling station and / or the sealing station. Alternatively or additionally, the glove access allows for at least partial manual cleaning of the separated compartment.

[0048] In certain embodiments, the separated sub-space is bounded by at least two wall sections of an outer wall of the housing, wherein the wall sections are abutting each other and enclosing an angle. In particular, the two wall sections extend vertically in one direction. In particular, the two wall sections run perpendicular to each other. In particular, the wall sections enclose an angle between at least approximately 45° and at least approximately 135°, and further, in particular, an angle between at least approximately 85° and at least approximately 95°. In certain embodiments, the separated sub-space is located in a corner of an interior space of the housing. By arranging the separated sub-space against adjacent wall sections and / or in a corner, the boundary surface between the main space and the separated sub-space and / or the floor area of ​​the separated sub-space can be minimized.

[0049] In some embodiments, a glove opening is provided on one of the at least two wall sections, and an access opening is provided on the second of the at least two wall sections. The arrangement of the glove opening and the access opening on two adjacent, angled wall sections is particularly advantageous for space-saving design. For example, this facilitates the manual handling of material and / or product supplied via the access opening.

[0050] For example, the interior of the separated sub-space can be accessed, at least for the most part, manually via glove insertion.

[0051] In certain embodiments, the separation of the separated sub-compartment from the main compartment, in order to prevent fluids and / or aerosols present in the separated sub-compartment from entering the main compartment, is at least partially achieved through fluid dynamics, in particular by a pressure difference and / or by a directed flow. Specifically, in certain embodiments, a lower pressure is generated in the separated sub-compartment than in the main compartment, whereby the pressure difference prevents fluids and / or aerosols from escaping the separated sub-compartment into the main compartment.

[0052] In certain configurations, the cleanroom structure includes a flow system. This flow system provides (in particular, global) air supply to the separated sub-room and the main room, especially via a ceiling of the enclosure, whereby filtered air, for example, Class A clean air, is supplied. The flow system also enables (in particular, global) air exhaust.

[0053] In particular, the air supply to the separated sub-compartment and to the main compartment, and / or the air extraction from the separated sub-compartment and from the main compartment, is carried out by a common airflow device. In certain configurations, the airflow device is a "Unidirectional Airflow (UDAF) unit (previously referred to as a Laminar Airflow Unit or LAF)" according to the EC GMP Guide, Annex 1.

[0054] In certain embodiments, the separated sub-compartment is provided with an extraction device. In particular, the extraction device is designed for local extraction at least at the filling position and / or the closing position. In some embodiments, the extraction device is provided in addition to a device for (in particular global) air supply and (in particular global) air exhaust, at least in the separated sub-compartment, especially in the interior space encompassing the main compartment and the separated sub-compartment.

[0055] For example, during a filling process and / or from a filled open container, escaping aerosols can be selectively extracted using the extraction device.

[0056] In some configurations, at least partial manual insertion of containers to be filled from the main room into the separated sub-room and / or at least partial manual removal of filled and sealed containers from the separated sub-room into the main room is provided.

[0057] In certain embodiments, a transport device is provided, wherein the transport device is configured to transfer containers to be filled from the main compartment, in particular from a transfer station located in the main compartment, into the separated sub-compartment and / or to transfer filled and sealed containers from the separated sub-compartment into the main compartment, in particular to a transfer station located in the main compartment. In certain embodiments, the transport device allows for at least semi-automated, and preferably fully automated, transfer of sterile containers from the main compartment to the separated sub-compartment and / or from the separated sub-compartment to the main compartment.In certain embodiments, the transport device includes a manipulator which is at least semi-automatically, and in particular fully automatically, operable to move containers to be filled from the main room into the separated sub-room, in particular to move them into a filling position in the separated sub-room, and to remove filled and sealed containers from the separated sub-room into the main room, in particular to take them from the filling position.

[0058] In certain embodiments, a manipulator, in particular exactly one manipulator, is provided which moves containers partly within the main chamber and partly within the separated sub-chamber, in particular moving containers to be filled from the main chamber into the separated sub-chamber and, for example, moving them to the filling position there, and / or removing filled and sealed containers from the separated sub-chamber, in particular from the sealing position, into the main chamber. In particular, this manipulator is located, at least with a part, for example, at least with one manipulator arm, temporarily in the separated sub-chamber and temporarily in the main chamber.

[0059] In configurations, particularly those with multiple manipulators, it is provided that a transport unit, especially a manipulator, is located entirely within the separated sub-space and / or that a transport unit, especially a manipulator, is located entirely within the main space. Specifically, these transport units are designed for transporting a container to and / or from a transfer area, the transfer area being situated between the main space and the separated sub-space.For example, it is provided that a transport unit located entirely within the main room, on the one hand, and a transport unit located entirely within the separated sub-room, on the other hand, transfer a container in a transfer area between the main room and the separated sub-room, in particular directly or indirectly, in particular transferring a container to be filled for placement in the separated sub-room and / or transferring a filled and sealed container for placement in the main room.

[0060] Depending on the application, the manipulator is suitable for moving exactly one container or a group comprising at least two or more containers into a filling position or taking them out of the filling position.

[0061] In particular, the transport device is configured such that a transport segment of the transport device, which is located partly in the main chamber and partly in the separated sub-chamber, is located in the main chamber at least during the filling and / or closing of a container, especially from the beginning of filling a container until the completion of closing the filled container. For example, part of a manipulator is located in the main chamber at least during the filling and / or closing of a container. In particular, at least during the filling and / or closing of a container, especially from the beginning of filling a container until the completion of closing the filled container, a manipulator arranged in the main chamber is located entirely within the main chamber.

[0062] In some configurations, a transfer station with at least one container position is provided in the main room. "Container" refers, above and / or below, 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. In some configurations, the containers are provided pre-sterilized as containers. The transfer station is designed to provide containers to be filled, comprising the microscope slide and the containers to be filled held therein, for filling. In some configurations, the transport device is designed to remove containers to be filled individually or in groups from a container provided at the transfer station, and / or to place filled and sealed containers individually or in groups at the transfer station.The transport device is configured, for example, to use an end effector of a multi-axis manipulator to remove containers directly from the microscope slide and move them to the filling position. In various configurations, the transport device comprises at least one removal device that extracts the containers from the microscope slide and at least one transport unit for moving them to the filling position.

[0063] In some configurations, the transfer station comprises two container positions, each for one container. In these configurations, containers to be filled are removed from a container located at one of the first of the at least two container positions, and filled and sealed containers are inserted into a container carrier located at a second of the at least two container positions, the second container position being different from the first container position.

[0064] 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.

[0065] In some embodiments, a container feeder is provided for feeding containers to be filled into the main room. In other embodiments, the container feeder is configured to unpack ready-to-use, particularly pre-sterilized, containers, for example, in the main room. In other embodiments, the container feeder is configured to move containers to be filled from the surrounding area to a transfer station located in the main room. Containers provided in trays are transported in the trays, at least in sections, in some embodiments. In other embodiments, the containers provided in trays are removed from the trays, at least at the transfer station. For example, it is provided that the containers are removed from the trays manually. In other embodiments, the container feeder is configured to remove the containers from the trays automatically.

[0066] In some configurations, the transport device is designed to deliver filled and sealed containers individually or in groups to the transfer station. In other configurations, a container removal device is provided for removing filled and sealed containers from the main room. Specifically, the container removal device is designed to transport filled and sealed containers, particularly as bundles, from a transfer station located in the main room to the surrounding area.

[0067] In certain embodiments, a control device is arranged in the separated compartment. Specifically, the control device is designed to monitor the containers and / or the filling process. In particular, the control device includes a scale for measuring the weight of the containers, especially before and after filling. For example, the control device includes a sensor, particularly an optical sensor, specifically for monitoring a container and / or 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, capable of measuring both the empty weight and the filled weight.In certain configurations, the filling station is designed to terminate the filling process of the containers depending on a fill weight and / or fill level detected during filling. The control device allows for in-process control (IPC) during the filling process for controlling, monitoring, and, if necessary, correcting the filling process. In particular, the filling station is equipped with the control device to monitor each container being filled and each one that has been filled.

[0068] 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 interior of the housing. When equipped, the conveying device is configured to transport the product to be filled to the filling station via the fluid line. Specifically, the control device and the conveying device are connected via signal transmission. Specifically, the conveying device transports the product to be filled, at least partially, based on signals sent to it by the control device.

[0069] The filled containers are closed, in particular each by at least one closure element.

[0070] In some designs, locking elements are inserted into the separated sub-space via the access opening.

[0071] In some configurations, closure elements are introduced into the separated sub-compartment via the main compartment, particularly through a through-opening in the partition wall. In some configurations, the through-opening for inserting the closure elements is different from the through-opening for inserting and / or removing the containers. In other configurations, the closure elements are inserted and the containers are inserted and / or removed through the same through-opening.

[0072] In some configurations, a locking mechanism is arranged in the main room, which is specifically designed to store locking elements.

[0073] In some embodiments, the closure dispensing device is designed to introduce closure elements individually or in groups into the separated compartment and, in particular, to provide them at the sealing station. Specifically, the closure dispensing device is configured to provide a closure element in the separated compartment before the start of a filling process and to retract in such a way that, from the start of filling a container until the completion of sealing the filled container, the components of the closure dispensing device are located in the main compartment. In other embodiments, the closure dispensing device is configured to remove closure elements individually or in groups from a supply provided in the main compartment and to provide the closure elements at a sealing dispensing position.In particular, the closure dispensing position is provided in a transfer area between the main room and the separated sub-room, for example in the passage opening of the partition wall.

[0074] In some embodiments, a closure insertion device is provided, which is designed to transfer the closure elements into the separate compartment leading to the sealing station. Specifically, the closure insertion device receives a closure element provided in the transfer area. In some embodiments, the closure insertion device also serves to seal the filled containers with the closure elements.

[0075] According to a second aspect, a method for carrying out process steps on containers at least partially under cleanroom conditions is provided, wherein the process steps include at least filling and closing the containers under cleanroom conditions, wherein the execution of process steps under cleanroom conditions takes place at least partially in an interior of an enclosure of a cleanroom setup and the interior has a main chamber and a sub-chamber separated from it, wherein the filling and closing of the containers takes place in the separated sub-chamber, wherein a batch of a product to be filled is filled into containers in the separated sub-chamber and subsequently the separated sub-chamber and the components arranged therein are cleaned and subsequently a batch of another product to be filled is filled into containers.

[0076] In particular, cleaning, especially decontamination, of the main room does not take place every time a batch of the product to be filled is changed and / or every time a product to be filled is changed.

[0077] Since the separated compartment is isolated from the main compartment and the components, equipment, and / or materials located within it, cleaning the separated compartment and its components is sufficient to at least minimize the risk of cross-contamination between the previously filled product and the subsequently filled product. In particular, the risk of cross-contamination can be eliminated, at least with regard to relevant regulations, by cleaning the separated compartment. In some embodiments, the surfaces of the separated compartment and / or its components are cleaned manually or automatically, in particular by wiping. For example, in some embodiments, cleaning the separated compartment includes cleaning with a cleaning medium that is at least partially gaseous, in particular steam and / or hydrogen peroxide.For example, in some configurations, cleaning the separated sub-space includes cleaning with rays, especially with ultraviolet rays.

[0078] In some configurations, the surfaces of the separated compartment and / or its components are wiped with a cloth, particularly a cloth soaked in a disinfectant, such as an alcohol-soaked cloth, to clean the compartment. A lint-free cloth is especially recommended for wiping.

[0079] In particular, the procedure comprises procedural steps that correspond to features of the system's configurations. Specifically, the system is designed to implement these configurations of the procedure. To avoid repetition, reference is made to the respective descriptions for full details.

[0080] 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.

[0081] 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.

[0082] 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.

[0083] BRIEF DESCRIPTION OF THE DRAWINGS

[0084] 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:

[0085] Fig. 1 : a first embodiment of a system for carrying out process steps at least partially under cleanroom conditions during a filling process;

[0086] Fig. 2: the system according to Fig. 1 when a container is moved to a filling station;

[0087] Fig. 3: the system according to Fig. 1 during cleaning after or before a filling process;

[0088] Fig. 4: a second embodiment of a system for carrying out process steps on containers at least partially under cleanroom conditions during a filling process; and

[0089] Fig. 5: a third embodiment of a system for carrying out process steps on containers at least partially under cleanroom conditions during a filling process.

[0090] DETAILED DESCRIPTION OF THE EXECUTION EXAMPLES

[0091] Figures 1 to 3 schematically show a first embodiment of a system 1 for carrying out process steps on containers at least partially under cleanroom conditions, wherein the process steps include at least filling and closing the containers under cleanroom conditions. Figure 1 shows the system 1 during a filling process at a filling station 3. Figure 2 shows the system 1 according to Figure 1 during the transfer of a container 5 to the filling station 3. Figure 3 shows the system 1 during cleaning after or before the filling process according to Figure 1.

[0092] The system 1 comprises a cleanroom structure 2, the filling station 3 for filling the container 5 shown schematically in Fig. 1, and a closing station 4 for closing a filled container 5. In the illustrated embodiment, the filling station 3 and the closing station 4 are arranged such that filling and closing take place at a common filling position 30.

[0093] Cleanroom setup 2 comprises an enclosure 20. An interior space of enclosure 20 is separated from the environment of enclosure 20. The required cleanroom conditions for the operation of system 1 can be created within the interior space of enclosure 20 of cleanroom setup 2. The interior space has a main chamber 201 and a sub-chamber 202 separated from the main chamber 201.

[0094] The filling station 3 and the sealing station 4 are located in the separate sub-room 202.

[0095] In the embodiment shown in Fig. 1, exactly one container 5, which is placed in the separated sub-space 202 and arranged at the filling position 30, is filled. In other embodiments, several containers are placed together in the separated sub-space 202 and filled simultaneously or one after the other.

[0096] The separated sub-room 202 is separated from the main room 201 in such a way that, at least when filling and closing the containers 5 in the separated sub-room 202, it is prevented that fluids and / or aerosols present and / or accumulating in the separated sub-room 202 enter the main room 201.

[0097] In the illustrated embodiment, the cleanroom structure 2 has a base area that is at least substantially rectangular, with the main chamber 201 and the separated sub-chamber 202 arranged on this base area. In the illustrated embodiment, the separated sub-chamber 202 is located at a corner of the housing 20 and is bounded by two adjacent wall sections 203 and 204 of an outer wall of the housing 20, forming a right angle to each other. In the illustrated embodiment, an access opening 24 is provided in a first wall section 203, and a glove opening 26 is provided in a second wall section 204.

[0098] A cleaning device, in particular a cloth soaked with alcohol and / or another disinfectant, can be introduced into the segregated sub-chamber 202 via the access opening 24. In some embodiments, a cleaning device is introduced into the segregated sub-chamber 202 via a different route, for example, via the main chamber 201. The cleaning device is introduced into the segregated sub-chamber 202, in particular before the cleanroom conditions are established, and in some embodiments, after the cleanroom conditions have already been established. The glove opening 26 allows access to the segregated sub-chamber 202, for example, for manual cleaning of the segregated sub-chamber 202. In some embodiments, a manipulator for semi- or fully automated cleaning of the segregated sub-chamber 202 is provided in the segregated sub-chamber 202. The segregated sub-chamber 202 can be cleaned without decontamination of the main chamber 201.

[0099] In the illustrated embodiment, a partition wall 22 is arranged in the interior of the housing 20 between the separated sub-compartment 202 and the main compartment 201, separating the separated sub-compartment 202 from the main compartment 201. To separate the separated sub-compartment 202, which is located in the corner of the housing 20, the illustrated partition wall 22 has two partition wall sections 221, 222, which, together with the two wall sections 203, 204 of the outer wall, define the separated sub-compartment 202. In other embodiments, the partition wall 22 has only one wall section or more than two wall sections.

[0100] In particular, the partition wall 22 is mounted on the outer wall. In some embodiments, a gap, especially a small one, is formed between the partition wall 22 and the outer wall. In some embodiments, a boundary area between the partition wall 22 and the outer wall is sealed, at least partially, especially at least in a lower area.

[0101] Alternatively or additionally to separation by a partition 22, in certain embodiments, flow-related measures ensure that, at least during the filling and sealing of the containers 5 in the separated sub-compartment 202, no fluids and / or aerosols from the separated sub-compartment 202 enter the main compartment 201. In particular, in certain embodiments, a lower pressure is generated in the separated sub-compartment 202 than in the main compartment, whereby the pressure difference prevents fluids and / or aerosols from the separated sub-compartment 202 into the main compartment 201. In some embodiments, separation is achieved at least partially by a flow directed from the main compartment 201 into the sub-compartment 202. In other embodiments, separation is achieved at least partially in the form of an air curtain.

[0102] In particular, the cleanroom setup 2 includes a flow device. The flow device provides an air supply, preferably via a ceiling of the housing 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 some embodiments, a common flow device is provided and configured for the main chamber 201 and for the separate sub-chamber 202. In the illustrated embodiment, an extraction device 6 is provided in the separate sub-chamber 202. In particular, the extraction device 6 provides local air extraction, especially at the filling station 3 and / or sealing station 4.

[0103] The introduction of containers 5 to be filled from the surroundings into the separated sub-chamber 202, as well as the removal of filled and sealed containers from the separated sub-chamber 202 into the surroundings, each takes place via the main chamber 201, as schematically shown in Fig. 2. An inlet 11 and an outlet 12 are provided for transferring the containers 5 into and out of the main chamber 201. Alternatively, in some embodiments, only one passage is provided. In these embodiments, transfer into and out of the main chamber 201 occurs via the common passage. Alternatively or additionally, in some embodiments, an interface is provided on an outer wall of the housing 20, whereby containers 5 can be introduced into and / or removed from the main chamber 201 via this interface.In some embodiments, the inlet 11 and / or the outlet 12 are open for the continuous or semi-continuous transfer of 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 other embodiments, an airlock is provided at the inlet 11 and / or the outlet 12 to allow the introduction of containers 20 into the closed interior of the housing 20.

[0104] The partition wall 22, more precisely a first partition wall section 221 in the illustrated embodiment, has at least one through-opening 220 for moving the containers 5 between the main chamber 201 and the separated sub-chamber 202. In the illustrated embodiment, insertion and removal take place via the same through-opening 220.

[0105] As schematically shown in Fig. 3, a door 224 is provided in embodiments of the exemplary embodiment, wherein the passage opening 220 is at least covered by the door 224 and, in particular, can be closed. For example, a seal is provided on the door 224 and / or on the passage opening so that the passage opening 220 can be closed fluid-tight with the door 224. The passage opening 220 can be closed, in particular, during the filling and closing of a container and / or for cleaning.

[0106] In the illustrated embodiment, a transport device 7 is provided for the at least partially automated transfer of the containers 5 into or out of the separated sub-compartment 202. In various embodiments, the transport device 7 comprises a schematically depicted manipulator 70, for example, an articulated robot arm. The transport device, in particular the manipulator 70, can be operated as schematically shown in Fig. 2 to move containers 5 to be filled from the main compartment 201 into the separated sub-compartment 202, in particular to the filling position 30 in the separated sub-compartment 202. Specifically, during the transfer of the containers, a transport segment of the transport device 7, for example, a manipulator arm of the articulated robot 70, is located temporarily in the main compartment 201 and temporarily in the separated sub-compartment 202.

[0107] 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 separated sub-chamber 202, 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 separated sub-chamber 202. In particular, this prevents contamination of the manipulator 70 during the filling process.

[0108] 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 separated sub-chamber 202 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 separated sub-chamber 202 with a manipulator arm and transports the filled and sealed container from the separated sub-chamber 202, in particular from the filling and / or sealing position 30, into the main chamber 201.

[0109] In certain embodiments, the transport device 7 comprises at least two transport units, 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 within 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 within the separated sub-chamber 202, with all its components. To transfer containers to be filled from the main chamber 201 to the separated sub-chamber 202, the first transport unit transports the container to be filled to a transfer area, in particular to the through-opening 220, and the second transport unit transports the container to be filled from the transfer area to the separated sub-chamber 202, in particular to the filling position.To remove filled and sealed containers from the separated sub-room 202, the second transport unit transports the filled and sealed container, in particular from the sealing and / or filling position 30, to the transfer area, in particular to the passage opening 220, and the first transport unit transports the filled and sealed container from the transfer area into the main room 201.

[0110] In particular, a container 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 between the first and second transport units within the transfer area occurs indirectly.

[0111] The containers 5 to be filled are provided as packages in various configurations. In the illustrated embodiment, 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 the containers to be filled inserted therein can be provided. In the illustrated embodiment, the containers 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 separated sub-chamber 202. The removed containers are then moved by the same manipulator or another transport unit into the separated sub-chamber 202 for a filling process.After the filled container 5 has been closed, the container 5 can be removed from the separated sub-space 202 with the transport device 7, for example with the manipulator 70, and placed in a slide provided at the second container position 82 with the manipulator 70 or another transport unit.

[0112] In the illustrated embodiment, a schematically depicted container feed device 83 is further provided for supplying containers 5 to be filled via the inlet 11 into the main chamber 201. The container feed device 83 is configured to transport containers to be filled, in particular as containers, from the surrounding area via the inlet 11 into the transfer station 8 provided in the main chamber.

[0113] In one embodiment of the exemplary embodiment, a schematically depicted container discharge device 84 is further provided for the discharge of filled and sealed containers via the outlet 12 from the main chamber 201. The container discharge device 84 is configured to convey filled and sealed containers 5 from the transfer station 8 provided in the main chamber 201 via the outlet 12 into the surrounding area.

[0114] The illustrated housing 20 has a lockable access opening 24. The access opening 24 is oriented towards the surroundings and is accessible from the surroundings. In the illustrated embodiment, the access opening 24 is provided on a first wall section 203 that delimits the separated sub-space 202.

[0115] The access opening 24 is designed in particular as a connection opening of a transfer system, in particular as an alpha port of an alpha-beta port system.

[0116] In particular, the access opening 24 is designed such that the access opening 24 can only be opened when a transfer component 25 is connected to the access opening 24.

[0117] A transfer component 25 connected to the access opening 24 prevents a 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 separated sub-chamber 202 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 separated sub-chamber 202.

[0118] In the illustrated embodiment, a filling needle 32 can be inserted into the separated compartment 202 via the access opening 24. In this embodiment, a transfer component 25, connectable to the access opening 24, is provided with a feedthrough 250 for a fluid line 34. The fluid line 34 runs through the feedthrough, and any other connection through the feedthrough is prevented, so that the cleanroom conditions inside the transfer component 25 are not compromised. 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, through which a defined quantity of product can be conveyed from the product reservoir 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 for detecting a fill level, is provided for in-process control at the filling position 30.

[0119] 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.

[0120] 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 access opening mechanism and / or by a manipulator. The manipulator 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.

[0121] 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.

[0122] The filled containers 5 are closed by closure elements 40. In some embodiments, the closure elements 40 are inserted into the separated compartment 202 via the access opening 24. In the illustrated embodiment, a supply 400 of closure elements 40 is provided in the main compartment 201. This supply 400 can be introduced into the main compartment 201, in particular via the inlet 11.

[0123] In the illustrated embodiment, a closure supply device 41 is arranged in the main chamber 201 and a closure insertion device 42 is arranged in the separate chamber 202 for transferring the closure elements 40 from the supply 400 to the separate chamber 202. The closure supply 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 separate chamber 202, particularly in a passageway in the partition wall.

[0124] In various configurations, a locking provision device transfers locking elements 40 individually or in groups from the supply 400 provided in the main room 201 directly into the separated sub-room 202, in particular to the locking station 4.

[0125] 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, and in embodiments of a process.

[0126] In certain configurations, the entire facility 1 is first decontaminated.

[0127] Subsequently, containers 5 and closure elements 40 can be fed into the main chamber 201, for example, via inlet 11. In certain configurations, this feeding process is at least partially automated.

[0128] The filling station 3 is set up at least partially manually and / or automatically using a filling needle 32 supplied via the access opening 24, wherein in particular the filling needle 32 is provided in a particularly sterile interior of a transfer component 25.

[0129] In particular, the filling needle 32 is connected via the fluid line to the supply 36 of product to be filled, which is located outside the interior of the transfer component 25.

[0130] In particular, during setup the conveying device 38 is equipped with 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 into a container to be filled via the filling needle 32.

[0131] To fill a batch of a product, the containers 5 are fed individually or in groups into the separate sub-chamber 202, where they are filled and sealed. The filled and sealed containers 5 are then returned to the main chamber 201 and discharged from the main chamber 201 via outlet 12.

[0132] Once the batch of product to be filled has been emptied into the containers, and in particular once the product supply 36 has been used up, the filling needle 32 can be deployed from the separated compartment 202, 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 removed from the conveying device 38. Subsequently, the separated compartment 202 and the components located therein are cleaned, in particular disinfected.

[0133] After cleaning the separated compartment 202, 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 the setup, the product to be filled is filled into container 5.

[0134] For example, containers to be filled with the next product can be fed at least partially via the feed device 83 while containers with a previously filled product are still being filled at filling station 3 and / or while sealed containers filled with a previously filled product are being removed via the discharge device 84. In particular, the containers to be filled with the next product are only fed in to the extent that these containers do not come within physical proximity of the sealed containers filled with a previously filled product.

[0135] By cleaning the separated sub-room 202, the risk of cross-contamination between batches can be reduced to at least a tolerable level.

[0136] In particular, by separating the sub-room 202 (in which the filling station 3 and the sealing station 4 are located) from the main room 201, the main room 201 can be kept so clean even when filling and sealing the containers that decontamination of the main room is not required every time a batch of product to be filled is changed and / or every time a product to be filled is changed.

[0137] In particular, this can save resources. For example, a larger quantity of product, especially different products, can be filled into containers in a given time.

[0138] Fig. 4 shows a second embodiment of a system 1 for carrying out process steps on containers 5, at least partially under cleanroom conditions. The system 1 according to Fig. 4 comprises a cleanroom structure 2, a filling station 3 for filling a container 5 (schematically shown in Fig. 4), and a sealing station 4 for sealing a filled container 5. In the illustrated embodiment, the filling station 3 and the sealing station 4 are arranged such that filling and sealing take place at a common filling position 30.

[0139] Cleanroom setup 2 comprises an enclosure 20. An interior space of enclosure 20 is separated from the environment of enclosure 20. The necessary cleanroom conditions for operating system 1 can be created in an interior space 200 of enclosure 20 of cleanroom setup 2.

[0140] The cleanroom structure 2 shown in Fig. 4 has a "closed interior" during production and / or cleanroom operation. Before decontamination of the interior 200 for operation of the system 1, all pass-throughs and / or openings through which the interior 200 is in direct contact with the environment are closed, in particular sealed to be fluid-tight. Air supply and / or exhaust to the closed interior is provided by a dedicated airflow system.

[0141] For introducing material, in particular containers 5, closure elements 40 and / or consumables, into the enclosed interior space 200, especially after decontamination for a product facility, a passage 13 with an airlock 130 is provided on the housing 20 in the configuration according to Fig. 4. Containers 5, closure elements 40 and / or consumables can be introduced into the interior space 200 via the passage 13 and the airlock 130.

[0142] In some configurations, the passage 13 can also be used to remove material from the enclosed interior space 200.

[0143] In the embodiment according to Fig. 4, a discharge interface 28 is provided on the housing 20 for the discharge of material, in particular of filled and sealed containers, from the enclosed interior space 200. The filled and sealed containers 5 can be removed from the enclosed interior space 200 into the environment via the discharge interface without the enclosed interior space 200 coming into contact with the environment.

[0144] In the embodiment shown in Fig. 4, the dispensing interface 28 is designed as an interface of a transfer system, comprising the dispensing interface 28 and a container 280 that can be detachably connected to it. For example, the dispensing interface 28 is designed as an alpha port and the container 280 as a beta component of an alpha-beta port system.

[0145] Container 280 has a rigid and / or flexible wall and is designed to accommodate filled and sealed containers 5.

[0146] Container 280 can be attached to the discharge interface 28. Inside the attached container 280, the cleanroom conditions of plant 1 are present and / or can be created, and / or a negative pressure prevails inside container 280 that is lower than the pressure prevailing in the interior 200. After the container 280 has been attached to the discharge interface 28, a closable opening of the discharge interface 28 can be opened so that filled and sealed containers 5 can be discharged from the interior 200 of the housing 20 into container 280 without the interior 200 of the housing 20 coming into direct contact with the environment.

[0147] In particular, filled and sealed containers 5 can be transferred from the interior 200 of the housing 20 into the container 280, so that neither a fluid from the interior 200 of the housing 20 enters the environment nor a fluid from the environment enters the interior of the housing 20.

[0148] The passage 13 with the lock 130 is configured to introduce at least one container (not shown in Fig. 4) comprising a microscope slide and containers 5 to be filled arranged therein into the interior via the lock 130. In some configurations, the containers are packaged in an outer packaging, the removal of which is carried out manually or at least semi-automatically within the interior 200.

[0149] Manual removal of the outer packaging is achieved in some designs via a glove opening 29.

[0150] In certain embodiments, the airlock 130 includes a cleaning unit 131, schematically depicted in Fig. 4, for cleaning, disinfecting, sterilizing, and / or decontaminating the surfaces of objects located in the airlock 130. In certain embodiments, the cleaning unit 131 is designed to decontaminate microbiologically contaminated surfaces. For this purpose, the cleaning unit 131 may include a radiation source, in particular for generating ultraviolet radiation (UV radiation), especially UV-C radiation, and / or an electron accelerator. Alternatively or additionally, in certain embodiments, the cleaning unit 131 may include a fumigation device, in particular for nebulizing an H₂O₂ solution, also referred to as vaporized hydrogen peroxide.

[0151] As mentioned, in certain embodiments the airlock 130 is designed to introduce at least one container comprising a microscope slide and containers 5 arranged therein, to be filled, into the interior 200 via the airlock 130. In certain embodiments, the container is packed in an outer packaging comprising, in particular, a tray into which the container can be placed, a film placed on the container, a film sealing the tray to the container, and / or a bag receiving the tray and the container.

[0152] The container is placed in the interior 200 together with its outer packaging. The cleaning unit 131 is therefore, in particular, designed to decontaminate the surface of the outer packaging of a container 50 before the container 50 is placed in the interior 200 of the housing together with its outer packaging.

[0153] The containers are removed from their outer packaging manually or at least semi-automatically within the interior space 200. In some configurations, the containers are removed before a tray is filled, and after filling and sealing, they are placed back into a tray and removed from the interior space 200 along with the tray. Depending on the configuration, the container is either placed back into the tray from which it was removed or into a different tray.

[0154] In the illustrated embodiment, the containers 5 are each individually moved into the filling position. In various embodiments, the system 1 according to Fig. 3 comprises a transfer station 8, shown in Figs. 1 to 3, with a first container position 81 and a second container position 82. At least one container with containers to be filled can be provided at the first container position 81. The containers 5 can be removed individually or in groups from the container located at the first container position 81 and moved into the filling position 30 for a filling operation. After the filled container 5 has been closed, it can be moved from the filling position 30 to the second container position 82, and a slide provided at the second container position 82 can be inserted.The dispensing interface 28 is specifically designed to dispense containers comprising microscope slides and filled and sealed receptacles 5 arranged therein from the enclosed interior 200 of the housing 20. In some embodiments, the containers are placed back into trays after filling and sealing, and then inserted into trays from the interior 200 via the dispensing interface 28.

[0155] In certain embodiments, the handling of the containers 5 to be filled and / or the filled containers 5 is at least partially automated by a transport device 7, schematically depicted in Fig. 4, which includes, in particular, a manipulator not shown in Fig. 4. As schematically shown in Fig. 4, the containers 5 move from the opening 13 towards the filling position 30 along a first transport path 71. The containers 5 move from the filling position 30 towards the dispensing interface along a second transport path 72. The first transport path 71 and the second transport path 72 differ in their configurations, such that the movement of containers 5 along the first transport path 71 and along the second transport path 72 is possible at least partially simultaneously and without collision.

[0156] In the illustrated embodiment, a supply 400 for the closure elements 40 is provided, wherein the closure elements 40 are transported from the passage 13 along a third transport path 72 to the supply 400, in particular transported at least semi-automatically.

[0157] In the illustrated embodiment, the filling station 3 and the closing station 4 are arranged such that filling and closing take place at the common filling position 30.

[0158] In the illustrated embodiment, an access opening 24, designed as a connection opening for a transfer system, is provided for inserting a filling needle 32 into the interior 200. The access opening 24 is specifically designed as an alpha port of an alpha-beta port system. In the illustrated embodiment, a transfer component 25, connectable to the access opening 24, is provided with a feedthrough 250 for a fluid line 34. The filling needle 32 is connected via the fluid line 34 to a reservoir 36 located outside the housing 20. A conveying device 38 is provided on the fluid line 34, through which a defined quantity of fluid can be conveyed from the reservoir 36 to the container 5 for filling the container 5. For in-process control, a control device 9, for example, a scale or an optical control device for detecting a fill level, is further provided at the filling position 30.In some embodiments, the filling station 3 is at least partially automated, and in particular fully automated, by being fitted with the filling needle 32. For example, in some embodiments, a manipulator (not shown in Fig. 4) can be operated to open the access opening 24, remove the filling needle 32 from the connected transfer component 25, and attach the filling needle 32 to a filling needle holder 33. The filling needle 32 is attached to the filling needle holder, in particular, by means of a tool-free quick-release fastener, for example, by means of a snap-fit ​​and / or magnetic connection.

[0159] In the illustrated embodiment, the closure elements 40 are moved from the supply to the filling position by means of a closure feeding device 43. Depending on the application, the closure feeding device 43 is designed to transport the closure elements 40 actively with a drive and / or passively, for example due to gravity, from the supply 400 towards the filling position 30.

[0160] Fig. 5 shows a third embodiment of a system 1 for carrying out process steps on containers 5, at least partially under cleanroom conditions. The system 1 according to Fig. 5 is similar to the system 1 according to Fig. 4. Identical reference numerals are used for identical or similar components, and for a detailed description of the similar or identical components, reference is made to the description of Fig. 4.

[0161] In contrast to the design according to Fig. 4, an endless bag 281 is attached to the dispensing interface 28.

[0162] The filled and sealed containers 5 can be inserted from the interior 200 into the continuous bag 281 at the dispensing interface 28. In particular, the filled and sealed containers 5 are inserted from the interior 200 into the continuous bag 281 as a unit 50 comprising a slide 51 and containers 5 inserted therein.

[0163] When the container 50 is inserted, the continuous bag 281 is withdrawn from a supply of tubing 282. A filled section of the continuous bag 281 can be separated at a separation point from the tubing 282 remaining at the dispensing interface 28. Separation is effected, in particular, by closing a free end of the tubing 282 remaining at the dispensing interface 28, especially by sealing it fluid-tight, for example, by welding. Separation is effected in embodiments with a schematically depicted separation device 283. In embodiments, the filled section of the continuous bag 281 is separated in such a way that the filled section is also closed, in particular by welding. The separated filled section of the continuous bag 281 then serves as outer packaging for the container 50 with the filled and sealed containers 5.

[0164] In contrast to the embodiment shown in Fig. 4, the embodiment shown in Fig. 5 also includes a glove opening 26 in the area of ​​the filling position 20. The glove opening 26 allows, for example, manual setup of the filling station 3. However, the number and / or position of the glove openings are merely examples. In other embodiments, several glove openings 26, 29 are provided, for example, in the area of ​​the filling station 3 and on another wall of the housing 20.

[0165] Figures 4 and 5 do not show a partition wall (22 cf. Figures 1 to 3). In embodiments of the systems 1 shown in Figures 4 and / or 5, these also include a partition wall and / or an alternative measure by which a main chamber and a separate sub-chamber, in which the filling position 30 is provided, are created in the interior of the housing 20.

[0166] The systems shown in Figures 4 and 5 are also particularly suitable for filling small batches of products. After filling a batch, depending on the application, either the entire interior space 200 or – if separated by suitable measures – only a portion of the interior space containing the filling position can be decontaminated.

[0167] The embodiments described with reference to the figures are merely examples, and numerous variations are conceivable. In particular, features of the embodiments shown in the figures can be combined in different configurations to obtain further embodiments.

[0168] The configurations include, in particular, the following combinations of features:

[0169] 1. Plant for carrying out process steps on containers at least partially under cleanroom conditions, wherein the processing includes at least filling and closing the containers under cleanroom conditions, wherein the plant 1 comprises a cleanroom structure 2, a filling station 3 for filling a container and a closing station 4 for closing a filled container, wherein the cleanroom structure 2 comprises a housing 20, wherein an interior of the housing 20 is separated from an environment and the cleanroom condition can be met in the interior of the housing 20 of the cleanroom structure, wherein the interior has a main chamber 201 and a sub-chamber 202 separated from the main chamber 201, wherein the filling station 3 and the closing station 4 are arranged in the separated sub-chamber 202.

[0170] Plant according to one of the preceding configurations, wherein

[0171] a separation of the separated sub-space 202 from the main space 201 is designed to prevent fluids and / or aerosols present in the separated sub-space 202, in particular at least from the beginning of the filling of a container 5 until the completion of the closing of the filled container 5, from the separated sub-space 202 into the main space 201.

[0172] Plant according to one of the preceding configurations, wherein

[0173] in the interior of the housing 20 a partition wall 22 is arranged between the main room 201 and the separated sub-room 202, wherein the partition wall 22 extends at least partially, in particular largely, over an interface between the separated sub-room 202 and the main room 201.

[0174] Plant according to one of the preceding configurations, wherein

[0175] the partition wall has at least one passage opening 220 for the insertion of the containers 5 to be filled into the separated sub-space 202 and for the removal of the filled containers 5 from the separated sub-space 202.

[0176] System according to one of the preceding embodiments, wherein the at least one through-opening 220 is closable, in particular fluid-tight.

[0177] Plant according to one of the preceding configurations, wherein

[0178] the housing 20 has a lockable access opening 24, wherein the access opening 24 is oriented from the separated subspace 202 to the environment, wherein in particular the access opening 24 is accessible from the environment, especially for connecting a transfer component 25.

[0179] Plant according to one of the preceding configurations, wherein

[0180] the access opening 24 is designed as a connection opening of a transfer system, wherein in particular an interior of the connected transfer component is connected to the separated subspace 202 via the opened access opening 24, to which a transfer component is connected, for the purpose of transferring material and / or products and / or for the passage of a fluid line.

[0181] Plant according to one of the preceding configurations, wherein

[0182] a transfer component 25 connectable to the access opening 24 with a feedthrough for a fluid line 34 is provided, wherein a filling needle 32, which is fluidically connected via a fluid line 34 to a product reservoir 36 arranged outside the interior, can be made available for the separated sub-space 202 via the transfer component 25, wherein the transfer component 25 is designed in particular as a beta component of an alpha-beta port system.

[0183] Plant according to one of the preceding configurations, wherein

[0184] The filling station 3 includes a filling needle holder 33.

[0185] Plant according to one of the preceding configurations, wherein

[0186] The closing station 4 comprises a closing device for closing a filled container 5 arranged at a closing position.

[0187] Plant according to one of the preceding configurations, wherein

[0188] A filling position 30 of the filling station and a closing position of the closing station are the same position.

[0189] Plant according to one of the preceding configurations, wherein

[0190] the separated sub-space 202 is bounded by at least one wall section 203, 204 of an outer wall of the housing 20, wherein in particular a glove opening 26 and / or the access opening 24 is provided on the at least one wall section 203, 204.

[0191] Plant according to one of the preceding configurations, wherein

[0192] The separated sub-space 202 is bounded by at least two wall sections 203, 204 of an outer wall of the housing, wherein the wall sections 203, 204 in particular adjoin each other and enclose an angle, in particular an angle between at least approximately 60° and at least approximately 120°, and further in particular an angle of at least approximately 85° to at least approximately 95°. A system according to one of the preceding embodiments, wherein

[0193] The separation of the separated sub-space 202 from the main space 201, in order to prevent fluids and / or aerosols present in the separated sub-space 202 from entering the main space 201, is at least partially achieved through fluid dynamics, in particular by a pressure difference and / or by a directed flow.

[0194] Plant according to one of the preceding configurations, wherein

[0195] the separated sub-room 202 has an extraction device 6,

[0196] Plant according to one of the preceding configurations, wherein

[0197] at least one of the following is provided for:

[0198] that the suction device 6 is designed for local suction at the filling position 30 and / or the closing position; and / or

[0199] that the extraction device 6 is provided in addition to a device for air supply and air extraction at least in the separated sub-room 202.

[0200] Plant according to one of the preceding configurations, wherein

[0201] a transport device 7 is provided, wherein the transport device 7 is designed to bring containers 5 to be filled from the main room 201 into the separated sub-room 202 and / or to bring filled and closed containers 5 from the separated sub-room 202 into the main room 201, in particular to bring them in and / or out at least semi-automatically.

[0202] Plant according to one of the preceding configurations, wherein

[0203] the transport device 7 comprises a manipulator 70, which is at least semi-automatically, in particular fully automatically, operable to bring containers 5 to be filled from the main room 201 into the separated sub-room 202, in particular to bring them into a filling position 30 in the separated sub-room 202, and to remove filled and sealed containers 5 from the separated sub-room 202 into the main room 201, in particular to take them from the filling position 30.

[0204] Plant according to one of the preceding configurations, wherein

[0205] The transport device 7 is arranged such that a transport segment of the transport device, which is temporarily located in the main room 201 and temporarily in the separated sub-room 202, is located in the main room at least when filling and / or closing a container, in particular from the beginning of filling a container until the completion of closing the filled container.

[0206] Plant according to one of the preceding configurations, wherein

[0207] in the main room a transfer station 8 with a container position 81, 82 for a container is provided, wherein in particular the transport device 7 is set up to remove containers 5 to be filled individually or in groups from a container provided at the transfer station 8, in particular at the container position 81, 82, and / or wherein in particular the transport device 7 is set up to place filled and closed containers 5 individually or in groups at the transfer station, in particular at the container position 81, 82.

[0208] Plant according to one of the preceding configurations, wherein

[0209] a container feed device is provided for the supply of containers to be filled into the main room, wherein in particular the container feed device is designed to transfer containers to be filled, especially as containers, from the surroundings into a transfer station 8 provided in the main room, in particular to transfer at least semi-automatically.

[0210] Plant according to one of the preceding configurations, wherein

[0211] a container removal device 84 is provided for the removal of filled and sealed containers from the main room 201, wherein in particular the container removal device 84 is designed to transport filled and sealed containers 5, especially as containers, from a transfer station 8 provided in the main room 201 to the surrounding area.

[0212] Plant according to one of the preceding configurations, wherein

[0213] The containers 5 to be filled can be arranged in the separated sub-room 202 at a filling position 30 for filling and closing.

[0214] Plant according to one of the preceding configurations, wherein

[0215] In the separated sub-chamber 202, a control device 9 for the filling process is arranged, wherein the control device 9 in particular comprises a scale for recording the weight of the containers 5 to be filled, in particular for recording a weight before and / or after filling, and / or wherein the control device 9 in particular comprises an optical sensor device for recording a fill level. A system according to one of the preceding embodiments, wherein a closure dispensing device 41 is provided in the main chamber 201, wherein in particular the closure dispensing device is configured to remove closure elements individually or in groups from a supply provided in the main chamber, 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 separated sub-chamber.

[0216] Plant according to one of the preceding configurations, wherein

[0217] a closure insertion device 42 is provided which is designed to move the closure elements 40 into the separated sub-space 202 to the closure station 4.

[0218] Plant according to one of the preceding configurations and / or plant for carrying out process steps on containers at least partially under cleanroom conditions, wherein the process steps include at least filling and closing the containers under cleanroom conditions,

[0219] wherein the system 1 comprises a cleanroom structure 2, a filling station 3 for filling a container and a sealing station 4 for sealing a filled container,

[0220] wherein the cleanroom setup 2 comprises an enclosure 20, wherein an interior 200 of the enclosure 20 is separated from an environment and the cleanroom condition can be met in the interior 200 of the enclosure 20 of the cleanroom setup,

[0221] wherein the interior 200 of the housing 20 is closed in an operating state, wherein a passage with a lock for introducing containers 5 to be filled into the closed interior 200 of the housing 20 is provided on the housing 20, and / or

[0222] wherein a discharge interface 28 is provided on the housing 20 for the discharge of filled and sealed containers 5 from the closed interior 200 of the housing 20.

[0223] Plant according to one of the preceding configurations, wherein

[0224] the dispensing interface 28 is designed to dispense containers comprising microscope slides and filled and sealed containers 5 arranged therein from the closed interior 200 of the housing 20,

[0225] the containers are used particularly in tubs. System according to one of the preceding configurations, wherein

[0226] A container 280, 281 with a rigid and / or flexible wall for receiving filled and sealed containers 5 can be connected to the dispensing interface 28, wherein the filled and sealed containers 5 can be dispensed from the interior 200 of the housing 20 into the container 280, 281 without direct contact of the interior 200 of the housing 20 with the environment.

[0227] wherein in particular the container 280, 281 is designed to accommodate container 50 comprising microscope slides 51 and containers 5 inserted therein.

[0228] Plant according to one of the preceding configurations, wherein

[0229] The dispensing interface 28 is designed as an alpha port of an alpha-beta port system.

[0230] Plant according to one of the preceding configurations, wherein

[0231] An endless bag 281 can be attached to the dispensing interface 28.

[0232] Plant according to one of the preceding configurations, wherein

[0233] a separating device 283 is provided which is configured to separate a filled section of the endless bag 281 at a separation point from a hose supply 282 of the endless bag 281 remaining at the dispensing interface, wherein in particular

[0234] - the separating device 283 is configured to separate the filled section of the continuous bag 281 without direct contact between the interior of the tube supply 282 and / or the interior of the filled section with the environment, and / or

[0235] - the separating device 283 is set up to weld a free end of the continuous bag 281 and / or the filled section at the separation point.

[0236] Plant according to one of the preceding configurations, wherein

[0237] the passage 13 is equipped with the lock 130 in order to introduce at least one container 50 comprising a microscope slide and containers arranged therein into the interior 200 via the lock 131,

[0238] in particular the container 50 is packed in an outer packaging.

[0239] Plant according to one of the preceding configurations, wherein

[0240] The lock 130 has a cleaning unit 131 for cleaning, in particular disinfection, sterilization and / or decontamination, of surfaces of objects present in the lock 130,

[0241] in particular cleaning unit 131 is set up to decontaminate microbiologically contaminated surfaces, and / or

[0242] The cleaning unit 131 comprises a radiation source, in particular for the generation of ultraviolet radiation and / or an electron accelerator, and / or a fumigation device, in particular for nebulizing an H2-O2 solution.

[0243] Plant according to one of the preceding configurations, wherein

[0244] the housing 20 has a lockable access opening 24, wherein the access opening 24 is oriented from the housing 20 towards the environment,

[0245] wherein in particular the access opening 24 is accessible from the environment, especially for connecting a transfer component 25.

[0246] Plant according to one of the preceding configurations, wherein

[0247] the access opening is designed as a connection opening of a transfer system, wherein in particular via the opened access opening 24, to which a transfer component is connected, an interior of the connected transfer component is connected to the closed interior space 200 for the transfer of material and / or products and / or for the passage of a fluid line.

[0248] Plant according to one of the preceding configurations, wherein

[0249] a transfer component 25 connectable to the access opening 24 with a feedthrough for a fluid line 34 is provided, wherein a filling needle 32, which is fluidically connected via a fluid line 34 to a product reservoir 36 arranged outside the interior 200, can be made available for the filling station 3 via the transfer component 25,

[0250] where the transfer component 25 is specifically designed as a beta component of an alpha-beta port system.

[0251] Method for carrying out process steps on containers at least partially under cleanroom conditions, wherein the process steps include at least filling and closing the containers under cleanroom conditions, in particular on a system according to one of the preceding embodiments, wherein

[0252] the process is carried out under cleanroom conditions, at least partially within an interior of a housing 20 of a cleanroom setup 2, and the interior comprises a main chamber 201 and a separate sub-chamber 202, wherein the filling and sealing of the containers takes place in the separate sub-chamber 202, wherein a batch of a product to be filled is filled into container 5 in the separate sub-chamber 202, and subsequently the separate sub-chamber and the components arranged therein are cleaned, and subsequently a batch of another product to be filled is filled into containers.

[0253] in particular, cleaning, especially decontamination, of the main room does not take place with every change of batch of the product to be filled and / or with every change of product to be filled.

[0254] Method according to a preceding method and / or on a plant according to one of the preceding configurations, wherein

[0255] To clean the separated sub-room 202, the surfaces of the separated sub-room 202 and / or the components in the separated sub-room 202 must be cleaned manually and / or automatically, in particular wiped and / or disinfected.

[0256] Method for carrying out process steps on containers at least partially under cleanroom conditions, wherein the process steps include at least filling and closing the containers under cleanroom conditions, in particular according to a preceding method and / or on a system according to one of the preceding embodiments, wherein

[0257] the execution of the process steps under cleanroom conditions takes place at least partially in an enclosed interior space 200 of a housing 20 of a cleanroom setup 2 in cleanroom operation,

[0258] wherein containers 5 to be filled are introduced into the closed interior 200 of the housing 20 via a passage provided on the housing 20 using a lock, and / or

[0259] Filled and sealed containers are dispensed from the enclosed interior 200 of the housing 20 via a dispensing interface 28 on the housing 20.

[0260] Method according to a preceding method and / or on a plant according to one of the preceding configurations, wherein

[0261] A container 280, 281 with a rigid and / or flexible wall for receiving filled and sealed containers 5 is connected to the dispensing interface 28, wherein the filled and sealed containers 5 are dispensed from the interior 200 of the housing 20 into the container without contact between the interior 200 of the housing 20 and the environment. 42. Method according to a preceding method and / or on a system according to one of the preceding embodiments, wherein

[0262] Filled and sealed containers 5 are placed into a container designed as an endless bag 281, wherein, after placement, a filled section of the endless bag 281 is separated at a separation point from a hose supply 282 of the endless bag 281 remaining at the dispensing interface 28, wherein, in particular, the filled section of the endless bag 281 is separated from the hose supply 282 without connecting the interior of the endless bag and / or the filled section with the environment, and / or

[0263] wherein in particular a free end of the continuous bag 281 and / or the filled section are welded at the separation point.

[0264] 43. Procedure according to a preceding procedure and / or on a plant according to one of the preceding configurations, wherein

[0265] via the airlock at least one container comprising a microscope slide and containers arranged therein is introduced into the interior 200 of the housing 20, wherein in particular the container is introduced into the interior 200 of the housing 20 in an outer packaging.

[0266] 44. Procedure according to a preceding procedure and / or on a plant according to one of the preceding configurations, wherein

[0267] In lock 130, surfaces of objects present in lock 130 are cleaned, sterilized, disinfected and / or decontaminated, with particular attention paid to decontaminating microbiologically contaminated surfaces.

[0268] Reference symbol list

[0269] 1 Annex

[0270] 11 Admission

[0271] 12 Outlet

[0272] 13 Passage

[0273] 130 Lock

[0274] 131 Cleaning unit

[0275] 2 Cleanroom setup

[0276] 20 cases

[0277] 200 interior

[0278] 201 Main Room

[0279] 202 sub-area

[0280] 203 Wall section Wall section

[0281] partition

[0282] Passage opening

[0283] T partition wall section

[0284] T partition wall section

[0285] flap

[0286] Access opening

[0287] Transfer component implementation

[0288] Glove intervention

[0289] Application interface

[0290] container

[0291] Endless bag

[0292] Hose supply, disconnect device, glove access

[0293] Filling station

[0294] Filling position

[0295] filling needle

[0296] Filling needle holder

[0297] Fluid line

[0298] Product stock

[0299] Conveyor system, sealing station, sealing elements

[0300] stock

[0301] Closure dispensing device, closure insertion device, closure feeding device, container

[0302] extraction device

[0303] Transport device manipulator

[0304] Transport route

[0305] Transport path

[0306] Transport path

[0307] Transfer station Container position Container position

[0308] Container feeding device Container discharge device

[0309] Control device

Claims

Patent claims 1. A system for carrying out process steps on containers at least partially under cleanroom conditions, wherein the process steps include at least filling and closing the containers under cleanroom conditions, wherein the system (1) comprises a cleanroom structure (2), a filling station (3) for filling a container and a closing station (4) for closing a filled container, wherein the cleanroom setup (2) comprises an enclosure (20), wherein an interior of the enclosure (20) is separated from an environment and the cleanroom condition can be met in the interior of the enclosure (20) of the cleanroom setup, wherein the interior space comprises a main space (201) and a subspace (202) separated from the main space (201), wherein the filling station (3) and the closing station (4) are arranged in the separated subspace (202).

2. System according to claim 1, characterized in that a separation of the separated subspace (202) from the main space (201) is designed to prevent fluids and / or aerosols present in the separated subspace (202), in particular at least from the beginning of the filling of a container (5) until the completion of the closing of the filled container (5), from the separated subspace (202) into the main space (201).

3. System according to claim 1 or 2, characterized in that a partition wall (22) is arranged in the interior of the housing (20) between the main chamber (201) and the separated sub-chamber (202), wherein the partition wall (22) extends at least partially, in particular largely, over an interface between the separated sub-chamber (202) and the main chamber (201).

4. System according to claim 3, characterized in that the partition wall has at least one passage opening (220) for the insertion of the containers (5) to be filled into the separated sub-space (202) and for the removal of the filled containers (5) from the separated sub-space (202).

5. System according to claim 4, characterized in that the at least one through-opening (220) is closable, in particular fluid-tight.

6. System according to one of the preceding claims, characterized in that the housing (20) has a lockable access opening (24), wherein the access opening (24) is oriented from the separated subspace (202) to the environment, wherein in particular the access opening (24) is accessible from the environment, especially for connecting a transfer component (25).

7. System according to claim 6, characterized in that the access opening is designed as a connection opening of a transfer system, wherein in particular via the opened access opening (24), to which a transfer component is connected, an interior of the connected transfer component is connected to the separated subspace (202) for the transfer of material and / or products and / or for the passage of a fluid line.

8. System according to claim 6 or 7, characterized in that a transfer component (25) connectable to the access opening (24) with a feedthrough for a fluid line (34) is provided, wherein a filling needle (32), which is fluidically connected via a fluid line (34) to a product supply (36) arranged outside the interior, can be made available for the separated sub-space (202) via the transfer component (25), wherein the transfer component (25) is designed in particular as a beta component of an alpha-beta port system.

9. Plant according to one of the preceding claims characterized by at least one of the following: that the filling station (3) includes a filling needle holder (33); and / or that the closing station (4) comprises a closing device for closing a filled container (5) arranged at a closing position; and / or that a filling position (30) of the filling station and a closing position of the closing station are the same position.

0. System according to one of the preceding claims, characterized in that the separated partial space (202) is bounded by at least one wall section (203, 204) of an outer wall of the housing (20), wherein in particular a glove opening (26) and / or the access opening (24) is provided on the at least one wall section (203, 204).

11. System according to one of the preceding claims, characterized in that the separated partial space (202) is bounded by at least two wall sections (203, 204) of an outer wall of the housing, wherein the wall sections (203, 204) in particular adjoin each other and enclose an angle, in particular an angle between at least approximately 60° and at least approximately 120°, further in particular an angle of at least approximately 85° to at least approximately 95°.

12. System according to one of the preceding claims, characterized in that the separation of the separated subspace (202) from the main space (201) in order to prevent fluids and / or aerosols present in the separated subspace (202) from entering the main space (201) is at least partially realized by flow engineering, in particular by a pressure difference and / or by a directed flow.

13. System according to one of the preceding claims, characterized in that the separated subspace (202) has a suction device (6), In particular, at least one of the following is provided for: that the suction device (6) is designed for local suction at the filling position (30) and / or the closing position; and / or that the extraction device (6) is provided in addition to a device for air supply and air extraction at least in the separated sub-space (202).

14. System according to one of the preceding claims, characterized in that a transport device (7) is provided, wherein the transport device (7) is configured to introduce containers (5) to be filled from the main chamber (201) into the separated sub-chamber (202) and / or to remove filled and sealed containers (5) from the separated sub-chamber (202) into the main chamber (201), in particular to introduce and / or remove them at least semi-automatically.

15. System according to claim 14, characterized in that The transport device (7) comprises a manipulator (70) which is at least semi-automatically, and in particular fully automatically, operable to move containers (5) to be filled from the main chamber (201) into the separated sub-chamber (202), in particular to move them into a filling position (30) in the separated sub-chamber (202), and to move filled and sealed containers (5) from the separated sub-chamber (202) into to remove the main chamber (201), in particular to take over from the filling position (30).

16. System according to one of the two preceding claims, characterized in that the transport device (7) is arranged such that a transport segment of the transport device, which is temporarily located in the main space (201) and temporarily in the separated subspace (202), is located in the main space at least during the filling and / or closing of a container, in particular from the beginning of filling a container until the completion of closing the filled container.

17. Plant according to one of the preceding claims, characterized in that a transfer station (8) with a container position (81, 82) for a container is provided in the main room, wherein in particular the transport device (7) is configured to remove containers (5) to be filled individually or in groups from a container provided at the transfer station (8), in particular at the container position (81, 82), and / or wherein in particular the transport device (7) is configured to place filled and sealed containers (5) individually or in groups at the transfer station, in particular at the container position (81, 82).

18. Plant according to one of the preceding claims, characterized in that a container feed device is provided for supplying containers to be filled into the main room, wherein in particular the container feed device is configured to transfer containers to be filled, in particular as containers, from the surroundings into a transfer station (8) provided in the main room, in particular to transfer at least semi-automatically.

19. Plant according to one of the preceding claims, characterized in that a container discharge device (84) is provided for the discharge of filled and closed containers from the main room (201), wherein in particular the container discharge device (84) is designed to transport filled and sealed containers (5), in particular as bundles, from a transfer station (8) provided in the main room (201) to the surrounding area.

20. System according to one of the preceding claims, characterized in that the containers (5) to be filled can be arranged in the separated subspace (202) at a filling position (30) for filling and closing.

21. Plant according to one of the preceding claims, characterized in that a control device (9) for the filling process is arranged in the separated subspace (202), wherein in particular the control device (9) comprises a scale for recording the weight of the containers (5) to be filled, in particular for recording the 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.

22. System according to one of the preceding claims, characterized in that a closure provision device (41) is provided in the main chamber (201), wherein in particular the closure provision device is configured to take closure elements individually or in groups from a supply provided in the main chamber, 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 separated sub-chamber.

23. System according to one of the preceding claims, characterized in that a closure insertion device (42) is provided which is configured to move the closure elements (40) into the separated subspace (202) to the closure station (4).

24. Method for carrying out process steps on containers at least partially under cleanroom conditions, wherein the process steps include at least filling and closing the containers under cleanroom conditions, wherein the process is carried out under cleanroom conditions at least partially within an interior of an enclosure (20) of a cleanroom setup (2) and the interior comprises a main chamber (201) and a separate sub-chamber (202) thereof, wherein the filling and sealing of the containers takes place in the separate sub-chamber (202), wherein a batch of a product to be filled is filled into containers (5) in the separate sub-chamber (202) and subsequently the separate sub-chamber and the components arranged therein are cleaned and subsequently a batch of a further product to be filled into containers in particular, cleaning, especially decontamination, of the main room does not take place with every change of batch of the product to be filled and / or with every change of product to be filled.

25. Method according to claim 20, characterized in that, for cleaning the separated subspace (202), surfaces of the separated subspace (202) and / or the components in the separated subspace (202) are cleaned manually and / or automatically, in particular wiped and / or disinfected.

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