System for carrying out process steps on containers

Abstract

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, 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 (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, wherein the interior (200) of the housing (20) is closed in an operating state, wherein the housing (20) has a passage with a lock for introducing containers (5) to be filled into the closed interior (200) of the housing (20), and / or 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).

Description

SCOPE OF APPLICATION AND STATE OF THE ART

[0001] The invention relates to 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.

[0002] As a process step on an object, in particular on a container, any form of handling, processing and / or treatment of an object and / or its contents is defined here, 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 of the object and / or its contents, in particular optical inspection.

[0003] The containers in question are primarily pharmaceutical containers, such as vials, syringes, cartridges or ampoules.

[0004] It is known to prepare pharmaceutical containers for filling in a ready-to-use state, particularly pre-sterilized. This involves preparing the containers in trays, especially so-called nests or trays. A nest is a tray (for example, a plate-shaped tray) containing recesses in which the containers can be arranged in several parallel rows. The recesses are typically designed with a hexagonal offset to achieve 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 slide and objects arranged within it is called a container.

[0005] For example, the containers grouped in the microscope slides are sterilized beforehand using suitable methods and then packaged in an outer packaging designed as a sterile barrier.

[0006] For example, devices for filling containers are known from DE102005006733A1 and DE 10345338 A1.

[0007] 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 comprising a cleanroom setup are known. A cleanroom setup comprises an enclosure, wherein an interior of the enclosure is separated from the environment and a cleanroom condition is created within the interior of the cleanroom setup.

[0008] 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 the VDI 2083 guideline 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. For example, Annex 1 of the EU GMP Guide defines isolators and restricted access barrier systems (RABS).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 EC GMP Guide, Annex 1, especially classes A, B, and C. In particular, the cleanroom condition required for filling and sealing the containers is class A. TASK AND SOLUTION

[0009] The purpose of the invention is to create a system that allows for cost-efficient and safe, at least partially automated filling of products under cleanroom conditions, for example in small batches.

[0010] According to a first aspect, a system for carrying out process steps on containers is created, at least partially, under cleanroom conditions, wherein the process steps include at least filling and sealing the containers under cleanroom conditions. The system comprises a cleanroom structure, a filling station for filling a container, and a sealing station for sealing a filled container. The cleanroom structure comprises an enclosure, wherein an interior of the enclosure is separated from the environment, and the cleanroom conditions can be met within the interior of the enclosure. The interior of the enclosure is closed in an operating state. A passage with an airlock for introducing containers to be filled into the closed interior of the enclosure is provided on the enclosure.Alternatively or in addition to the passage, a discharge interface is provided on the housing for dispensing filled and sealed containers from the closed interior of the housing.

[0011] 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 arranged at a filling position simultaneously or sequentially. In these configurations, it is provided that only exactly one container is arranged at a filling position for each filling and sealing operation.

[0012] To meet cleanroom requirements, the interior of the cleanroom structure is decontamination. This interior is sealed off from the environment for decontamination purposes. Following decontamination, and especially after the removal of a decontamination medium, air is supplied via a flow system within the cleanroom structure. The interior, when sealed, is decontaminated, particularly with a fluid, at least partially gaseous decontamination medium such as hydrogen peroxide. The flow system supplies air to the interior of the cleanroom structure, specifically via a ceiling of the enclosure, and supplies filtered air, for example, Class A clean air. The flow system also allows for air exhaust.In its various configurations, the flow device is a “Unidirectional Airflow (UDAF) unit (previously referred to as a Laminar Airflow Unit or LAF)” (“Unidirectional Airflow” in German also “low-turbulence displacement flow”, abbreviated TAV) according to the EC GMP Guide, Annex 1. In particular, the interior is aseptically isolated from the environment when closed.

[0013] The interior of the housing remains closed even after decontamination and is in an operational state. In particular, filling and sealing of the containers takes place when the interior is closed.

[0014] In the context of the application, the term "closed interior space in an operating state" refers to an interior space design in which the interior space does not have a continuously open pass-through to the environment during cleanroom operation, for example, for continuous or semi-continuous material transfer. In particular, material can only enter and exit the closed interior space via auxiliary devices, such as alpha-beta port systems, but cannot pass through continuously open pass-throughs to the environment.

[0015] The interior is designed to be fluid-tight, particularly in certain configurations. The cleanroom structure is designed as a closed isolator in accordance with Annex 1 of the EU GMP Guide.

[0016] In particular, while the unit is closed, the interior is decontaminated with a fluid, at least partially gaseous, decontamination medium such as hydrogen peroxide. After decontamination, the decontamination medium is removed from the interior, and the interior remains closed for subsequent operation. Specifically, no continuous opening is created between the exterior and the interior.

[0017] The insertion of containers to be filled and the removal of filled and sealed containers take place after decontamination into and from the closed interior of the housing, without direct contact between the interior of the housing and the environment. The environment and the interior of the housing can remain fluidically separated during the insertion of containers to be filled and the removal of filled and sealed containers; that is, insertion and / or removal is possible without any fluid from the environment entering the interior or from the interior entering the environment.

[0018] For example, one advantage of embodiments of the invention is that the system can also be located in a space with minimal requirements, such as class D requirements, for production operations, especially when filling and sealing are carried out, since the interior is closed in the operating state and filling and sealing of the containers is possible in the closed interior.

[0019] A particular advantage of embodiments of the invention is that, even in a production plant, containers can be introduced into and / or removed from the interior, especially simultaneously with filling and sealing, by enabling the insertion and / or removal of containers via the airlock and / or the discharge interface without compromising the closed state of the interior. For example, the quantity of filled and sealed containers can thus be increased within a given time. In particular, the insertion and / or removal of containers is possible without the need for decontaminating the interior, since the airlock and / or the discharge interface allows for this without affecting the closed state of the interior.

[0020] In some embodiments, a passage with an airlock is provided for inserting containers to be filled. Specifically, the airlock has a closable, and in particular fluid-tight, chamber with at least two closable openings. A first of the at least two closable openings opens to the interior of the housing, and a second of the at least two closable openings opens to an adjoining space, in particular to the environment. The openings cannot be opened simultaneously during operation. The airlock has, in particular, devices through which a fluid can be supplied to the chamber or an existing fluid can be discharged from the chamber when it is closed, in order to create the cleanroom conditions of the cleanroom setup within the chamber. In some embodiments, monitoring devices are provided on the airlock for monitoring the atmosphere prevailing in the chamber.In certain configurations, opening an opening (especially the first opening of the chamber) to the interior is only possible if a defined cleanroom condition is met in the chamber of the airlock.

[0021] In some configurations, the passage can be used bidirectionally, whereby containers to be filled are introduced into the interior of the housing via the passage with the sluice for filling, and filled and sealed containers are removed from the interior of the housing via the passage with the sluice after filling.

[0022] In advantageous embodiments, the passage is provided with the sluice for introducing the containers to be filled, and the discharge interface for discharging the filled and sealed containers is provided separately from the passage.

[0023] For example, one advantage of the separately designed devices for inserting and removing the containers is that containers can be introduced into the interior of the housing via the airlock, and simultaneously, already filled and sealed containers can be removed via the discharge interface. In particular, some embodiments provide that containers to be filled are cleaned, especially disinfected and / or decontaminated and / or sterilized, when being inserted via the airlock, and that simultaneously, filled and sealed containers can be removed via the discharge interface. In some embodiments, no cleaning of the filled and sealed containers is necessary when removing them.

[0024] For example, one advantage of the separately designed loading and unloading devices is that containers for filling a batch of one product can be inserted into the housing via the airlock, while simultaneously, already filled and sealed containers of another batch can be unloaded via the unloading interface. The containers for products from different batches, which are simultaneously loaded into and unloaded from the housing, can be moved along separate, spatially distinct paths. In some configurations, containers to be filled with a different batch of product are only loaded into the housing after all containers previously filled with a particular batch of product have been sealed and, in particular, unloaded from the housing.For example, containers that are to be filled with a batch of another product are already placed in the chamber of the pass-through while containers with a previous batch of a product are still being filled and / or these containers are being sealed and / or discharged.

[0025] In certain configurations, the dispensing interface is designed to allow the removal of containers, including microscope slides and filled and sealed receptacles arranged within them, from the enclosed interior of the housing. In some configurations, the container can be placed inside a tub within the housing and removed from the housing along with the tub. The dispensing interface is dimensioned sufficiently large for this purpose.

[0026] The filled and sealed containers, in particular arranged in a microscope slide as a container, for example in a tub, are manually dispensed via the dispensing interface in various configurations.

[0027] In some configurations, a manipulator is provided inside the housing, which is designed to handle tubs, containers and / or individual containers for application.

[0028] 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.

[0029] In certain embodiments, the dispensing interface features a sluice, in particular a sluice with a chamber. The chamber is, in particular, a closable, especially fluid-tight, chamber with at least two closable openings.

[0030] One of the at least two closable openings of the dispensing interface's airlock opens specifically to the interior of the housing, and a second of the at least two closable openings opens to an adjoining space, specifically to the environment. The openings cannot be opened simultaneously during operation. The airlock includes, in particular, devices through which, in a closed state, a fluid can be added to the chamber or an existing fluid can be discharged from the chamber in order to create the cleanroom conditions of the cleanroom setup within the chamber. In some embodiments, the airlock is equipped with monitoring devices that allow the atmosphere within the airlock chamber to be monitored. In some embodiments, opening an opening (especially the first opening of the chamber) to the interior is only possible if a defined cleanroom condition is met within the airlock chamber.Depending on the product being processed, in some designs, opening an opening (especially the second opening of the chamber) to the environment is only possible if a defined condition is met in the chamber of the airlock.

[0031] In some configurations, containers to be filled can be inserted into the interior of the housing via the opening with the airlock provided at the opening. After filling, filled and sealed containers can be ejected from the interior of the housing via the airlock and chamber. In other configurations, the filled and sealed containers are ejected from the interior of the housing into the surrounding environment via the airlock and chamber.

[0032] In some embodiments, a container with a rigid and / or flexible wall can be connected to the dispensing interface for receiving filled and sealed containers. The filled and sealed containers can be dispensed from the interior of the housing into the container without direct contact between the interior of the housing and the environment. Dispensing filled and sealed containers from the interior of the housing into the container is possible without any fluid from the environment entering the interior or from the interior into the environment. In some embodiments, filled and sealed containers can be moved directly from the interior into the container. In other embodiments, the containers can be moved from the interior into a sluice gate provided at the dispensing interface and from the sluice gate into the container.

[0033] A container is defined as an object with a rigid and / or flexible wall that contains a cavity. In some configurations, the wall is fluid-tight to isolate the cavity, at least partially, from its surroundings. In some configurations, the container has at least a partially rigid wall and is designed, for example, as a transport container or similar. In other configurations, the container has at least a partially flexible wall and is designed, for example, as a bag or sack.

[0034] In some configurations, the dispensing interface is designed as an alpha port of an alpha-beta port system. Specifically, an alpha-beta port system, also known as a rapid transfer port, is a transfer system that allows a material and / or product to be quickly and without contamination moved into and out of the cleanroom enclosure. The alpha port is integrated into an outer wall of the cleanroom enclosure and / or located at an opening of an airlock provided at the dispensing interface. 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 dispensing the containers. In some configurations, the beta component is a container with a cavity-shaped interior.

[0035] In certain configurations, an endless bag can be attached to the dispensing interface. An endless bag is defined as a long hose that is closed or sealable at one end, and from which a section with the closed end can be cut off as needed from a supply of hose. The end remaining on the hose supply after the section has been cut off can be sealed, particularly before or during the cutting process. The endless bag has, for example, a length of at least 10 m, and in particular at least 25 m. For example, the length of the endless bag can be up to 100 m, and in some configurations up to 50 m. When dispensing the container, tub, and / or trough, a section of the endless bag can be pulled off from the hose supply.The length of the continuous bag is selected such that no bag change is necessary between two decontamination processes of the cleanroom setup, or at least the number of bag changes is reduced. The continuous bag is made of plastic. In particular, the plastic is selected such that the interior of the housing at the dispensing interface is fluid-tightly sealed by the connected and closed continuous bag.

[0036] In certain embodiments, a filled section of the continuous bag can be separated from a remaining supply of tubing attached to the housing in such a way that a free end of the remaining tubing is immediately sealed upon separation, without the interior of the housing coming into contact with the environment via this free end. In particular, in certain embodiments, the section is separated by welding at least the free end of the remaining tubing.

[0037] In some designs, the filled section is separated manually by an operator.

[0038] In some designs, a separating device is provided which is designed to separate a filled section of the continuous bag at a separation point.

[0039] In some configurations, the separating device is designed so that an operator can manually perform the separation. In other configurations, the separating device is designed to perform the separation at least semi-automatically.

[0040] The separating device is specifically designed to separate the filled section of the continuous bag without any contact between the interior of the tubing reservoir and / or the interior of the filled section with the environment. When the filled section is separated, the interior of the housing remains sealed via the continuous bag. In certain embodiments, the separating device is configured to weld the continuous bag and / or the filled section at the separation point. This welding seals the continuous bag at the separation point. When the filled section is subsequently separated, the interior of the housing remains sealed. Sealing the filled section also ensures that no fluid escapes from the interior of the housing into the environment when the containers are deployed, but rather that the fluid is contained within the filled section along with the deployed container(s).

[0041] In some embodiments, the airlock is designed to introduce at least one container, comprising a microscope slide and containers arranged therein, into the interior. In some embodiments, the container to be introduced is enclosed in an outer packaging. This outer packaging includes, in particular, a tray that holds the container, a film placed on the container, a film sealing the tray containing the container, and / or a bag that holds the container and / or the tray containing the container. If the outer packaging comprises several packaging elements, in some embodiments one or more packaging elements are removed before the container is introduced into the airlock. In particular, in some embodiments, a bag is removed. In other embodiments, the container is introduced into the airlock with all packaging elements.

[0042] In some configurations, the container is placed inside the housing with an outer packaging, which in particular includes a tray. In some configurations, the outer packaging is removed at least partially manually inside the housing, for example, by opening a glove. In other configurations, a manipulator is provided for at least semi-automated removal of the outer packaging.

[0043] The airlock, in its various configurations, includes a cleaning unit for cleaning, in particular disinfection, sterilization, and / or decontamination, at least the surfaces of objects present in the airlock, especially objects introduced into the airlock chamber. Specifically, the cleaning unit is designed to clean objects introduced into the airlock from the surrounding environment in such a way that introducing the object into the interior does not compromise the required cleanroom conditions. The cleaning unit can be designed to suit specific requirements by a person skilled in the art. In some configurations, the cleaning unit is designed to decontaminate microbiologically contaminated surfaces.The cleaning unit is specifically designed to clean, and in particular decontaminate, the surface of an outer packaging of a container before the container and its outer packaging are placed inside the housing under cleanroom conditions. In various configurations, the cleaning unit comprises a radiation source, particularly for generating ultraviolet radiation (UV radiation), especially UV-C radiation, and / or an electron accelerator, and / or a fumigation device, particularly for nebulizing a hydrogen peroxide solution.

[0044] The passage with the airlock can be used in various configurations to introduce additional materials, such as auxiliary materials, closure elements or other consumables, for example cleaning cloths or the like, into the interior of the closed housing.

[0045] In addition to or as an alternative to the passage with the airlock for introducing containers to be filled and other materials into the enclosed interior of the housing, and / or to the discharge interface for dispensing filled and sealed containers from the enclosed interior of the housing, the housing may, in certain configurations, have a lockable access opening. In some configurations, the access opening is located in a wall section that defines the interior. Specifically, the access opening is oriented from the interior towards the surroundings of the system and is accessible from the surroundings. The lockable access opening allows, in particular, the introduction of material and / or products into the interior without the material and / or product passing through the passage with the airlock.

[0046] In particular, a transfer component can be connected to the access opening. Specifically, the transfer component can be connected to the access opening from the environment.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] In some embodiments, an alternative or additional transfer component with a feedthrough for a fluid line is provided, connectable to the access opening. This transfer component allows a filling needle, fluidically connected via a fluid line to a product reservoir located outside the interior, to be supplied to the filling station. In some embodiments, the transfer component is designed as the beta component of an alpha-beta port system.

[0051] 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 at least partially equipped with the filling needle manually, particularly by operating a gloved hand. In other configurations, the filling station is at least partially automated. For example, a manipulator is provided for equipping the filling station with the filling needle.

[0052] In some configurations, an access opening is provided in addition to the passage with the airlock. A particular advantage of this additional access opening is that a fluid line can be routed through it from the product supply located outside the interior to the filling station. Furthermore, if the filling station is equipped with a filling path, containers to be filled can be introduced into the interior through this passage. Specifically, a product supply cannot be introduced into the interior through the airlock, as cleaning the surface of the container holding the product supply, which is required for cleanroom conditions, would pose a risk of damaging the product being filled.For example, one advantage of the additional access opening is that the filling station can be equipped with a filling needle supplied via the access opening and / or the filling station can be converted for a subsequent batch after filling one batch, while containers to be filled simultaneously are introduced via the sluice and, in particular, cleaned, especially disinfected and / or decontaminated and / or sterilized when introduced via the sluice.

[0053] In some configurations, an access opening is provided in addition to the dispensing interface. A particular advantage of this additional access opening is that a fluid line can be routed through it from the product reservoir located outside the interior to the filling station. When the filling station is thus equipped with a filling path, containers can be filled and sealed, and the product dispensed from the interior via the dispensing interface while other containers are being filled. For example, this eliminates the need for the accumulation of filled and sealed containers, especially batches of filled and sealed containers, within the interior.For example, one advantage of the additional access opening is that the filling station can be equipped with a filling needle supplied via the access opening and / or the filling station can be converted for a subsequent batch after filling one batch, while simultaneously filled and sealed containers are dispensed via the dispensing interface.

[0054] 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.

[0055] In particular, the containers are closed with a closure element, such as stoppers, caps, snap closures or others.

[0056] For example, the locking mechanism is designed, - to close a container with a stopper, and / or - to close a container with a cap, and / or - to close a container by crimping.

[0057] In certain embodiments, the containers to be filled can be arranged at the same position, which serves as both a filling and a closing 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 disruption during transport. It also eliminates the need for a transport device for moving containers between the filling and closing stations. Furthermore, it minimizes the number of components that need to be cleaned at the filling station during batch changes.In certain embodiments, a transport device, particularly one that is at least partially automated, is provided for moving the containers into the filling position and moving them out of the closing position. In these embodiments, the transport device includes a manipulator that is at least partially automated, and in particular fully automated, and is configured, for example, to move containers to be filled into a filling position and to remove filled and closed containers from the closing position.

[0058] In particular, the transport device is designed to transport containers to be filled, especially at least semi-automatically and, for example, fully automatically, from a transfer station to the filling position. In particular, the transfer station is configured to remove containers to be filled from a slide, especially at least semi-automatically and, for example, fully automatically.

[0059] In particular, the transport device is designed to transport filled and sealed containers from the sealing position at least in the direction of the dispensing interface. In particular, the transport device is designed, in particular at least semi-automatically and, for example, fully automatically, to transport the filled and sealed containers to a transfer station. In particular, the transfer station is configured to arrange filled and sealed containers into a slide, in particular at least semi-automatically and, for example, fully automatically.

[0060] Depending on the application, the transport device, for example 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 from the closing position and transporting them further.

[0061] The containers are each closed, in particular, with at least one closure element such as a plug, a cap, a snap closure, or other device. In some configurations, the closure elements for closing the containers can be inserted into the interior of the housing via the opening with the airlock. In some configurations, a transport device is provided for moving the closure elements to the closing station. In other configurations, the closure elements are moved manually or at least semi-automatically through the access opening into the interior of the housing and to the closing station.

[0062] In certain embodiments, a control device is provided for in the interior. 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 one, especially 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.

[0063] 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.

[0064] A method for performing process steps on containers, at least partially, under cleanroom conditions is disclosed, wherein the process steps include at least filling and sealing the containers under cleanroom conditions. The process steps under cleanroom conditions are performed, at least partially, in a closed interior of a cleanroom enclosure. Containers to be filled are introduced via an airlock through a passage provided in the enclosure. Alternatively or additionally, filled and sealed containers are ejected from the closed interior of the enclosure via a discharge interface on the enclosure.

[0065] In some configurations, the containers to be filled are inserted at least partially simultaneously with the removal of filled and sealed containers. To prevent the transfer of material into or out of the housing's interior during a filling process, insertion and / or removal occur particularly during the setup, dismantling, and / or conversion of a filling station for filling the containers and / or a sealing station for sealing the containers.

[0066] In some configurations, the containers are ejected from the enclosed interior of the housing as a unit comprising microscope slides and filled, sealed containers arranged within them. For this purpose, the units are placed in trays in some configurations.

[0067] In some designs, a sluice gate is provided at the discharge interface, whereby filled and sealed containers are discharged from the closed interior of the housing via the sluice gate.

[0068] In some configurations, a container with a rigid and / or flexible wall is connected to the dispensing interface to receive filled and sealed containers. The filled and sealed containers are dispensed from the interior of the housing into the container without direct contact between the interior of the housing and the environment.

[0069] In some embodiments, filled and sealed containers are placed into a receptacle designed as a continuous bag. After placement, a filled section of the continuous bag is separated at a separation point from a remaining portion of the continuous bag's tubing at the dispensing interface. Specifically, the filled section of the continuous bag is separated from the tubing without direct contact between the interior of the continuous bag and / or the interior of the filled section with the environment. In some embodiments, a free end of the continuous bag and / or the filled section is welded at the separation point. In other embodiments, both a free end of the remaining tubing at the dispensing interface and the filled section are sealed at the separation point.This ensures that neither fluid from the environment enters the interior of the housing nor fluid from the interior of the housing escapes into the environment.

[0070] Inserting the containers via the airlock allows them to be brought into the enclosed interior, particularly after decontamination of the interior and / or during setup or changeover of the filling station. The containers are typically inserted as units within outer packaging.

[0071] In some configurations, the surfaces of objects located in the airlock are cleaned, sterilized, disinfected, and / or decontaminated. In others, microbiologically contaminated surfaces are decontaminated. In some configurations, several containers, particularly those in outer packaging, are simultaneously introduced into the airlock and cleaned, sterilized, disinfected, and / or decontaminated there.

[0072] 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.

[0073] 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.

[0074] 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.

[0075] 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. BRIEF DESCRIPTION OF THE DRAWINGS

[0076] 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: Fig. 1: a first embodiment of a system for carrying out process steps on containers at least partially under cleanroom conditions during a filling process; Fig. 2: the facility according to Fig. 1 when a container is moved to a filling station; Fig. 3: the facility according to Fig. 1 during cleaning after or before a filling process; 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 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; DETAILED DESCRIPTION OF THE EXECUTION EXAMPLES

[0077] Fig. Figures 1 to 3 schematically show a first embodiment of a plant 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. Fig. Figure 1 shows the system 1 during a filling process at a filling station 3. Fig. 2 shows Annex 1 according to Fig. 1 when a container 5 is moved to the filling station 3. Fig. Figure 3 shows the system 1 during cleaning after or before the filling process according to Fig. 1.

[0078] The system 1 comprises a cleanroom structure 2, the filling station 3 for filling the schematically in Fig. 1. Container 5 as shown 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.

[0079] 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 within the interior space of enclosure 20 of cleanroom setup 2.

[0080] The interior space comprises a main room 201 and a sub-room 202 separated from the main room 201.

[0081] The filling station 3 and the sealing station 4 are located in the separate sub-room 202.

[0082] In the Fig. In the embodiment shown in Figure 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.

[0083] 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.

[0084] 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. 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.

[0085] 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.

[0086] The separated sub-room 202 can be cleaned without decontaminating the main room 201.

[0087] 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.

[0088] 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.

[0089] 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.

[0090] In particular, the cleanroom setup 2 includes a flow device. The flow device provides an air supply, preferably via a ceiling of the enclosure 20, and enables the exhaust of air. Specifically, the flow device forms a "Unidirectional Airflow (UDAF) unit (previously referred to as a Laminar Airflow Unit or LAF)" according to the EC GMP Guide, Annex 1. In certain embodiments, a common flow device is provided and implemented for the main room 201 and for the separate sub-room 202.

[0091] In the illustrated embodiment, an extraction device 6 is provided in the separated sub-compartment 202. In particular, the extraction device 6 effects local air extraction, especially at the filling station 3 and / or sealing station 4.

[0092] The process of introducing containers 5 to be filled from the surroundings into the separated sub-room 202, as well as the removal of filled and sealed containers from the separated sub-room 202 into the surroundings, is carried out as schematically shown in Fig. Figure 2 shows the main chamber 201. 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 a single opening is provided. In these embodiments, transfer into and out of the main chamber 201 occurs via the shared opening. Alternatively or additionally, in some embodiments, an interface is provided on an outer wall of the housing 20, allowing containers 5 to be inserted 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 continuous or semi-continuous transfer of the 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 an interior area of ​​the housing 20.In some configurations, a lock is provided at the inlet 11 and / or at the outlet 12 to allow containers 20 to be brought into the closed interior of the housing 20.

[0093] 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.

[0094] As schematically in Fig. Figure 3 shows that in embodiments of the exemplary embodiment a door 224 is provided, 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.

[0095] For the at least partially automated transfer of the containers 5 into or out of the separated sub-compartment 202, a transport device 7 is provided in the illustrated embodiment. In some embodiments, the transport device 7 comprises a schematically depicted manipulator 70, for example, an articulated robot arm. The transport device 7, in particular the manipulator 70, is shown schematically in Fig. 2 shown to be operable for moving containers 5 to be filled from the main chamber 201 into the separated sub-chamber 202, in particular to moving them to the filling position 30 in the separated sub-chamber 202. In particular, during the movement of the containers, a transport segment of the transport device 7, for example a manipulator arm of the manipulator 70 designed as an articulated robot, is located temporarily in the main chamber 201 and temporarily in the separated sub-chamber 202.

[0096] As schematically in Fig. Figure 1 shows that in certain embodiments, 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 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.

[0097] 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.

[0098] 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-chamber 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 chamber 201. Specifically, a container in the transfer area is transferred directly from the first transport unit to the second transport unit and / or vice versa. In some configurations, the transfer of a container in the transfer area between the first and second transport units occurs indirectly.

[0099] 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.

[0100] 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.

[0101] 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.

[0102] 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.

[0103] 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.

[0104] 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.

[0105] 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.

[0106] 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.

[0107] 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.

[0108] 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.

[0109] Alternatively or additionally, in some configurations at least partial manual setup of the filling station 3 is possible, in particular via the glove access 26.

[0110] The filled containers 5 are closed by closure elements 40. In some embodiments, the closure elements 40 are inserted into the separate 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.

[0111] 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.

[0112] 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.

[0113] 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.

[0114] In certain configurations, the entire system 1 is first decontaminated. Subsequently, containers 5 and closure elements 40 can be fed into the main chamber 201, for example, via inlet 11. In some configurations, this feeding process is at least partially automated.

[0115] 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 the filling needle 32 is provided, in particular, in a sterile interior of a transfer component 25. Specifically, the filling needle 32 is connected via the fluid line to the supply 36 of product to be filled, which is located outside the interior of the transfer component 25. During setup, the conveying device 38 is connected to the fluid line 34 so that the product to be filled can be conveyed from the product supply 36 in a defined manner and filled into a container via the filling needle 32.

[0116] 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.

[0117] 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 then disconnected from the conveying device 38.

[0118] Subsequently, the separated sub-room 202 and the components arranged therein are cleaned, in particular disinfected.

[0119] 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.

[0120] 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 such an extent that they do not come within physical proximity of the sealed containers filled with a previously filled product.

[0121] By cleaning the separated sub-room 202, the risk of cross-contamination between batches can be reduced to at least a tolerable level.

[0122] In particular, because the separate sub-chamber 202 (in which the filling station 3 and the sealing station 4 are located) is separated from the main chamber 201, the main chamber 201 can be kept so clean even during the filling and sealing of containers that decontamination of the main chamber is not required every time a batch of product to be filled changes and / or every time a product to be filled changes. This can save resources. For example, a larger quantity of product to be filled, especially different products, can be filled into containers in a given time.

[0123] Fig. Figure 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 setup 2, a filling station 3 for filling a schematically in Fig. The illustrated container 5 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.

[0124] 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.

[0125] The in Fig. Cleanroom setup 2, as depicted in section 4, features a "closed interior" during production and / or cleanroom operation. Prior to decontamination of interior space 200 for operation of system 1, all pass-throughs and / or openings through which interior space 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 space is provided via a dedicated airflow system.

[0126] For the introduction of material, in particular containers 5 as well as closure elements 40 and / or consumables, into the closed interior space 200, especially after decontamination for a product operation, the design according to Fig. 4. A passage 13 with a lock 130 is provided on the housing 20. Containers 5, closure elements 40 and / or consumables can be brought into the interior 200 via the passage 13 with the lock 130.

[0127] In some configurations, the passage 13 can also be used to remove material from the enclosed interior space 200.

[0128] In the design according to Fig. 4 For the discharge of material, in particular from filled and sealed containers, from the enclosed interior space 200, a discharge interface 28 is provided on the housing 20. The filled and sealed containers 5 can be discharged 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.

[0129] In the Fig. In the embodiment shown in Figure 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.

[0130] Container 280 has a rigid and / or flexible wall and is designed to accommodate filled and sealed containers 5.

[0131] 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, which 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 dispensed 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. 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.

[0132] Passage 13 with lock 130 is designed to allow at least one [ship / object] to enter the [river / lake / etc.] via lock 130. Fig. 4. A container (not shown) comprising a microscope slide and containers 5 arranged therein to be filled is to be introduced into the interior. In some embodiments, the containers are packaged in an outer packaging, the removal of which is carried out manually or at least semi-automatically in the interior 200. In some embodiments, manual removal of the outer packaging is achieved via a glove opening 29.

[0133] In its design, lock 130 features a Fig. Figure 4 schematically depicts a cleaning unit 131 for cleaning, disinfecting, sterilizing, and / or decontaminating the surfaces of objects located in the airlock 130. The cleaning unit 131 is configured to decontaminate microbiologically contaminated surfaces. For this purpose, the cleaning unit 131 includes, in some configurations, a radiation source, in particular for generating ultraviolet radiation (UV radiation), especially UV-C radiation, and / or an electron accelerator. Alternatively or additionally, the cleaning unit 131 includes, in some configurations, a fumigation device, in particular for nebulizing an H₂O₂ solution, also referred to as vaporized hydrogen peroxide.

[0134] 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.

[0135] 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.

[0136] 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.

[0137] In the illustrated embodiment, the containers 5 are each individually moved into the filling position. In various configurations, Annex 1 includes, according to Fig. 3 one in Fig. The transfer station 8, shown in Figures 1 to 3, has 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 to 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 microscope 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 the filled and closed containers 5 arranged therein from the closed interior 200 of the housing 20.

[0138] In some configurations, the containers are placed back in trays after filling and closing, and inserted into trays from the interior 200 via the dispensing interface 28.

[0139] In some configurations, the handling of the containers 5 to be filled and / or the filled containers is at least partially automated using a system that is Fig. 4 schematically represented transport device 7 comprising in particular a in Fig. 4 manipulators not shown. As schematically shown in Fig. As shown in Figure 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.

[0140] 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.

[0141] 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.

[0142] 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.

[0143] 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 Fig. 4. A manipulator (not shown) 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.

[0144] 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.

[0145] Fig. Figure 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 Annex 1 according to Fig. 4. For identical or similar components, matching reference numerals are used, and for a detailed description of the similar or identical components, reference is made to the description at Fig. 4 referred.

[0146] In contrast to the design according to Fig. 4 An endless bag 281 is attached to the dispensing interface 28.

[0147] 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.

[0148] 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 remaining tubing 282 of the continuous bag 281 at the dispensing interface 28. Separation is effected, in particular, by closing a free end of the remaining tubing 282 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.

[0149] In some embodiments, the filled section of the continuous bag 281 is separated in such a way that the filled section is also sealed, in particular welded. The separated filled section of the continuous bag 281 serves as outer packaging for the container 50 with the filled and sealed containers 5.

[0150] In contrast to the design according to Fig. 4 is in the design according to Fig. 5. In addition, a glove opening 26 is provided in the area of ​​the filling position 20. Manual setup of the filling station 3 is possible, for example, via the glove opening 26. However, the number and / or position of the glove openings is merely an example. In various 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.

[0151] In Fig. 4 and Fig. 5 is not a partition wall in either case (22 cf. Fig. 1 to 3). In various forms of the in Fig. The facilities 1 shown in 4 and / or 5 also include a partition wall and / or an alternative measure by which a main room and a sub-room separated from it, in which the filling position 30 is provided, are created in the interior of the housing 20.

[0152] Even those in Fig. 4 and Fig. The five illustrated systems 1 are 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.

[0153] 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.

[0154] The configurations include, in particular, the following combinations of features: 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 sealing station 4 for sealing a filled container, 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, 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 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. 2. Plant according to one of the preceding configurations, wherein the dispensing interface 28 is designed to comprehensively dispense containers, slides and to remove the filled and sealed containers 5 arranged therein from the closed interior 200 of the housing 20, the containers are used particularly in tubs. 3. System according to one of the preceding embodiments, wherein the discharge interface 28 has a lock with a chamber, wherein the chamber is in particular a lockable, in particular fluid-tight lockable chamber with at least two lockable openings. 4. System according to one of the preceding embodiments, wherein 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, wherein in particular the container 280, 281 is designed to accommodate container 50 comprising microscope slides 51 and containers 5 inserted therein. 5. System according to one of the preceding configurations, wherein the dispensing interface 28 is designed as an alpha port of an alpha-beta port system. 6. System according to one of the preceding embodiments, wherein an endless bag 281 can be attached to the dispensing interface 28. 7. A system according to one of the preceding embodiments, wherein a separating device 283 is provided which is configured to separate a filled section of the continuous bag 281 at a separation point from a hose supply 282 of the continuous bag 281 remaining at the dispensing interface, wherein in particular - 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 - 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. 8. Plant according to one of the preceding configurations, wherein Passage 13 is equipped with lock 130 to allow passage via lock 131 to introduce at least one container 50 comprising a microscope slide and containers arranged therein into the interior space 200, in particular the container 50 is packed in an outer packaging. 9. System according to one of the preceding embodiments, wherein 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, particularly Cleaning unit 131 is set up to decontaminate microbiologically contaminated surfaces, and / or 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. 10. Plant according to one of the preceding configurations, wherein the housing 20 has a lockable access opening 24, wherein the access opening 24 is oriented from the housing 20 towards the environment, wherein in particular the access opening 24 is accessible from the environment, especially for connecting a transfer component 25. 11. System according to one of the preceding embodiments, wherein the access opening is designed as a connection opening of a transfer system, wherein in particular an interior of the connected transfer component is connected to the closed interior space 200 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. 12. Plant according to one of the preceding configurations, wherein 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, where the transfer component 25 is specifically designed as a beta component of an alpha-beta port system. 13. Plant according to one of the preceding embodiments, wherein a control device 9 for the filling process is arranged in the enclosed interior space 200, 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. 14. 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, 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 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 room 201 and a sub-room 202 separated from the main room 201, wherein the filling station 3 and the closing station 4 are arranged in the separated sub-room 202. 15. System according to one of the preceding embodiments, wherein the separated sub-space 202 is designed to separate from the main space 201 in order 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. 16. System according to one of the preceding embodiments, wherein a partition wall 22 is arranged in the interior of the housing 20 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. 17. Plant according to one of the preceding configurations, wherein 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. 18. System according to one of the preceding embodiments, wherein the at least one through-opening 220 is closable, in particular fluid-tight. 19. System according to one of the preceding embodiments, wherein 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. 20. System according to one of the preceding embodiments, wherein 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. 21. System according to one of the preceding embodiments, wherein a transfer component 25 connectable to the access opening 24 is provided with a feedthrough for a fluid line 34, 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 subspace 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. 22. System according to one of the preceding embodiments, wherein the filling station 3 comprises a filling needle holder 33. 23. System according to one of the preceding embodiments, wherein the closing station 4 comprises a closing device for closing a filled container 5 arranged at a closing position. 24. System according to one of the preceding embodiments, wherein a filling position 30 of the filling station and a closing position of the closing station are the same position. 25. System according to one of the preceding embodiments, wherein the separated subspace 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. 26. System according to one of the preceding embodiments, wherein the separated subspace 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°. 27. System according to one of the preceding embodiments, wherein 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 realized by flow engineering, in particular by a pressure difference and / or by a directed flow. 28. System according to one of the preceding embodiments, wherein the separated sub-space 202 has an extraction device 6, 29. Plant according to one of the preceding configurations, wherein at least one of the following is provided: 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 additionally includes a device for an air supply and Air extraction is provided at least in the separated sub-room 202. 30. Plant according to one of the preceding embodiments, wherein a transport device 7 is provided, wherein the transport device 7 is configured 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 bring them out at least semi-automatically. 31. Plant according to one of the preceding embodiments, wherein the transport device 7 comprises a manipulator 70 which is at least semi-automatically, in particular fully automatically, operable to transfer containers 5 to be filled from the main chamber 201 into the separated sub-chamber 202, in particular to transfer them to a filling position 30 in the separated sub-chamber 202, and to transfer filled and sealed containers 5 from the separated sub-chamber 202 into the main chamber 201, in particular to take them from the filling position 30. 32. System according to one of the preceding embodiments, wherein the transport device 7 is arranged such that a transport segment of the transport device, which is temporarily located in the main chamber 201 and temporarily in the separated sub-chamber 202, is located in the main chamber 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. 33. Plant according to one of the preceding embodiments, wherein 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 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. 34. Plant according to one of the preceding embodiments, wherein a container feed device is provided for feeding containers to be filled into the main room, wherein in particular the container feed device is designed 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. 35. Plant according to one of the preceding embodiments, wherein 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, in particular as containers, from a transfer station 8 provided in the main room 201 to the surrounding area. 36. System according to one of the preceding embodiments, wherein the containers 5 to be filled can be arranged in the separated subspace 202 at a filling position 30 for filling and closing. 37. System according to one of the preceding embodiments, wherein 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 a weight of the containers 5 to be filled, in particular for recording a weight before and / or after filling, and / or wherein in particular the control device 9 comprises an optical sensor device for recording a filling level. 38. System according to one of the preceding embodiments, wherein a locking device 41 is provided in the main room 201, wherein in particular the locking device is designed to take locking elements individually or in groups from a supply provided in the main room, and to provide the locking elements at a locking dispensing position, wherein in particular the locking dispensing position is provided in a transfer area between the main room and the separated sub-room. 39. System according to one of the preceding embodiments, wherein a closure insertion device 42 is provided which is designed to move the closure elements 40 into the separated subspace 202 to the closure station 4. 40. 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 the process steps are carried out under cleanroom conditions, at least partially, in an enclosed interior space 200 of a housing 20 of a cleanroom setup 2, wherein the containers 5 to be filled are connected via a port provided on the housing 20 A passage with a lock is introduced into the closed interior 200 of the housing 20, and / or Filled and sealed containers are dispensed from the enclosed interior 200 of the housing 20 via a dispensing interface 28 on the housing 20. 41. Procedure according to a preceding procedure and / or on a plant according to one of the preceding configurations, wherein A sluice with a chamber is provided at the discharge interface 28, wherein the filled and sealed containers 5 are discharged from the interior 200 of the housing 20 via the sluice. 42. Procedure according to a preceding procedure and / or on a plant according to one of the preceding configurations, wherein 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 of the interior 200 of the housing 20 with the environment. 43. Procedure according to a preceding procedure and / or on a plant according to one of the preceding configurations, wherein 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 continuous bag 281 is separated from the tubing supply 282 without any connection between the interior of the continuous bag and / or the filled section and the environment, and / or wherein in particular a free end of the continuous bag 281 and / or the filled section are welded at the separation point. 44. Procedure according to a preceding procedure and / or on a plant according to one of the preceding configurations, wherein via the sluice 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 in an outer packaging is placed in the interior 200 of the housing 20. 45. Procedure according to a preceding procedure and / or on a plant according to one of the preceding configurations, wherein 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. 46. ​​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 the process is carried out under cleanroom conditions, at least partially, in an interior space of a housing 20 of a cleanroom setup 2, and the interior space comprises a main space 201 and a separate subspace 202, wherein the filling and sealing of the containers takes place in the separate subspace 202. wherein a batch of a product to be filled is filled into container 5 in the separated sub-space 202 and subsequently the separated sub-space and the components arranged therein are cleaned and subsequently a batch of another product to be filled is 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. 47. Procedure according to a preceding procedure and / or on a plant according to one of the preceding configurations, wherein 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. Reference symbol list 1 Annex 11 Admission 12 Outlet 13 Passage 130 Lock 131 Cleaning unit 2 Cleanroom setup 20 cases 200 interior 201 Main Room 202 sub-area 203 Wall section 204 Wall section 22 Partition wall 220 Through opening 221 Partition wall section 222 Partition wall section 224 flap 24 Access opening 25 Transfer component 250 execution 26 Glove insertion 28 Dispensing interface 280 containers 281 continuous bags 282 hose supply 283 Separating device 29 Glove insertion 3 filling stations 30 Filling position 32 Filling needle 33 Filling needle holders 34 Fluid line 36 product stock 38 Funding facility 4 locking stations 40 locking elements 400 stock 41 Locking device 42 Closure insertion device 43 Closure feeder 5 containers 6 Extraction device 7 Transport device 70 Manipulator 71 Transport route 72 Transport route 73 Transport route 8 Transfer station 81 Container position 82 Container position 83 Container feeding device 84 Container discharge device 9 Control device QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] DE 102005006733A1

[0006] DE 10345338 A1

[0006] Cited non-patent literature

[0000] The Rules Governing Medicinal Products in the European Union, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use“ (EG-GMP-Leitfaden), Annex 1 (zur Zeit: Volume 4 vom 22. August 2022

[0008]

Claims

[1] 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, 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 (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, wherein the interior (200) of the housing (20) is closed in an operating state, wherein the housing (20) has a passage with a lock for introducing containers (5) to be filled into the closed interior (200) of the housing (20), and / or 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). [2] Plant according to claim 1, characterized by , that 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), the containers are used particularly in tubs. [3] Plant according to claim 1 or 2, characterized by that the discharge interface (28) has a lock, in particular a lock with a chamber, wherein the chamber is in particular a lockable, in particular fluid-tight lockable chamber with at least two lockable openings. [4] Plant according to claim 1, 2 or 3, characterized by, that 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, wherein in particular the container (280, 281) is designed to receive containers (50) comprising microscope slides (51) and containers (5) inserted therein. [5] Plant according to any of the preceding claims, characterized by , that the dispensing interface (28) is designed as an alpha port of an alpha-beta port system. [6] Plant according to any of the preceding claims, characterized by , that an endless bag (281) can be attached to the dispensing interface (28). [7] Plant according to claim 6, characterized by, that a separating device (283) is provided which is configured to separate a filled section of the continuous bag (281) at a separation point from a hose supply (282) of the continuous bag (281) remaining at the dispensing interface, wherein in particular - 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 and the environment, and / or - 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. [8] Plant according to any of the preceding claims, characterized by, that the passage (13) is equipped with the lock (130) to introduce at least one container (50) comprising a microscope slide and containers arranged therein into the interior (200) via the lock (131), wherein in particular the container (50) is packed in an outer packaging. [9] Plant according to any of the preceding claims, characterized by , that the airlock (130) has a cleaning unit (131) for cleaning, in particular disinfection, sterilization and / or decontamination, of surfaces of objects present in the airlock (130), particularly the cleaning unit (131) is set up to decontaminate microbiologically contaminated surfaces, and / or the cleaning unit (131) comprises a radiation source, in particular for generating ultraviolet radiation and / or an electron accelerator, and / or a fumigation device, in particular for nebulizing an H2-O2 solution. [10] Plant according to any of the preceding claims, characterized by that the housing (20) has a lockable access opening (24), wherein the access opening (24) is oriented from the housing (20) to the environment, wherein in particular the access opening (24) is accessible from the environment, especially for connecting a transfer component (25). [11] Plant according to claim 10, characterized by , that the access opening is designed as a connection opening of a transfer system, wherein in particular an interior of the connected transfer component is connected to the closed interior (200) 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. [12] Plant according to claim 10 or 11, characterized by, that a transfer component (25) connectable to the access opening (24) is provided with a feedthrough for a fluid line (34), 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), wherein the transfer component (25) is in particular designed as a beta component of an alpha-beta port system. [13] 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 locking station (4) is a locking device for locking a a filled container arranged in a closing position (5) comprises; and / or that a filling position (30) of the filling station and a closing position of the closing station are the same position. [14] Plant according to any of the preceding claims, characterized by , that a control device (9) for the filling process is arranged in the enclosed interior space (200), 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.

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