System and method for carrying out process steps on containers
The system addresses inefficiencies in pharmaceutical container filling and sealing by using a closed cleanroom structure with airlocks and discharge interfaces, ensuring minimal environmental exposure and efficient container handling, thus enhancing safety and reducing costs.
Patent Information
- Application Number
- PCT/EP2025/080797
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-11-12
- Filing Date
- 2025-10-24
- Publication Date
- 2026-04-30
AI Technical Summary
Existing systems for filling and sealing pharmaceutical containers under cleanroom conditions are inefficient and costly, particularly for small batches, and often require extensive decontamination and direct contact with the environment during container insertion and removal.
A system and method utilizing a closed cleanroom structure with an airlock and discharge interface, enabling simultaneous insertion and removal of containers without compromising the sealed interior, using a flow system for decontamination and filtered air, and automated manipulators for handling containers under cleanroom conditions.
Facilitates cost-effective, safe, and efficient filling and sealing of pharmaceutical containers in small batches with minimal environmental exposure, reducing the need for continuous decontamination and allowing simultaneous operations within a closed cleanroom environment.
Smart Images

Figure EP2025080797_30042026_PF_FP_ABST
Abstract
Description
[0001] Equipment and procedures for carrying out process steps on containers
[0002] SCOPE OF APPLICATION AND STATE OF THE ART
[0003] The invention relates to a system and a method for carrying out process steps on containers at least partially under cleanroom conditions, wherein the process steps include at least filling and closing the containers under cleanroom conditions.
[0004] 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.
[0005] The containers in question are primarily pharmaceutical containers, such as vials, syringes, cartridges or ampoules.
[0006] It is known to prepare pharmaceutical containers for filling in a ready-to-use state, particularly pre-sterilized (ENGI). This involves preparing the containers in trays, especially so-called nests or trays. A nest is defined as a tray (e.g., a plate-shaped tray) containing recesses in which the containers can be arranged in several parallel rows. The recesses are designed with a hexagonal offset to achieve high packing density. A tray is defined as 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.
[0007] 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. Devices for filling containers are known, for example, from DE102005006733A1 and DE 10345338 A1.
[0008] 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.
[0009] 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.
[0010] TASK AND SOLUTION
[0011] The object of the invention is to create a system and a method which allows cost-efficient and safe, at least partially automated filling of products under cleanroom conditions, for example in small batches.
[0012] 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 the interior of the enclosure is separated from the environment, and the cleanroom conditions can be met within the interior of the enclosure. A passage with an airlock for introducing containers to be filled into the interior of the enclosure is provided on the enclosure. Alternatively or additionally to the passage, a discharge interface for removing filled and sealed containers from the interior of the enclosure is provided on the enclosure.
[0013] In embodiments of the first aspect, the interior of the housing is closed during operation. The housing features a passage with a sluice gate for introducing containers to be filled into the closed interior. Alternatively or additionally, the housing provides a discharge interface for ejecting filled and sealed containers from the closed interior.
[0014] 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.
[0015] 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 certain 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 called "low-turbulence displacement flow", abbreviated TAV) according to the EU GMP Guide, Annex 1. In particular, the interior is aseptically isolated from the environment when closed. The interior of the housing remains closed even after decontamination during operation. Specifically, filling and sealing of the containers takes place when the interior is closed.
[0016] 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 not through continuously open pass-throughs to the environment.
[0017] 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.
[0018] 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.
[0019] 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.
[0020] For example, one advantage of embodiments of the invention is that the system can be located in a space with minimal requirements, such as those of class D, even during production operations, particularly when filling and sealing are being carried out, since the interior is closed during operation and filling and sealing of the containers is possible within this closed space. In particular, another advantage of embodiments of the invention is that containers can be moved into and / or out of the interior during production operations, especially simultaneously with filling and sealing, by allowing the insertion and / or removal of containers via the airlock and / or the discharge interface without affecting the closed state of the interior.For example, this allows the number of filled and sealed containers to be increased within a given time. In particular, it enables the insertion and / or removal of containers without the need for decontaminating the interior, as the airlock and / or discharge interface allows for the insertion and / or removal of containers without compromising the sealed condition of the interior.
[0021] 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.
[0022] 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 after filling, filled and sealed containers are removed from the interior of the housing via the passage with the sluice.
[0023] 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.
[0024] 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.
[0025] 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 passage while containers with a previous batch of a product are still being filled and / or these containers are being sealed and / or discharged.
[0026] 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.
[0027] The filled and sealed containers, in particular arranged in a microscope slide as a unit, for example in a tray, are dispensed manually via the dispensing interface in certain embodiments. In certain embodiments, the dispensing interface has a discharge device, for example comprising a manipulator, which is configured to dispense filled and sealed containers, in particular units comprising microscope slides and filled and sealed containers arranged therein, for example containers inserted in trays, from the enclosed interior of the housing at least semi-automatically, in particular fully automatically.
[0028] In some configurations, a manipulator is provided inside the housing, which is designed to handle tubs, containers and / or individual containers for application.
[0029] In some embodiments, a manipulator is provided outside the housing, configured to handle trays, containers, and / or individual receptacles for discharge. In other embodiments, the discharge device includes a conveying system located outside the housing, configured to convey trays, containers, and / or individual receptacles for discharge.
[0030] In various configurations, the manipulator designed for application is configured to handle tubs, containers and / or individual containers in the interior space in front of the application interface and / or when passing through the application interface and / or after, in particular immediately after, the application interface.
[0031] For example, the manipulator set up for application is configured to bring tubs, containers and / or individual containers to the application interface and / or through the application interface and / or away from the application interface and / or reposition them after the application interface, for example, to place them in a secondary packaging and / or to bundle them, in particular to stack them.
[0032] In particular, tubs, containers and / or individual containers to be discharged are those tubs, containers and / or individual containers on which the intended process steps have been carried out and which only need to be discharged and / or are in the process of being discharged and / or have been discharged.
[0033] In particular, the ejection device comprises the manipulator located inside and / or outside the housing. A manipulator, as defined above and / or below, is a fully or partially automated single-axis or multi-axis system, in particular a two- to six-axis system, and especially a six-axis system. In certain embodiments, the manipulator is configured for at least translational movement along at least one axis. Alternatively or additionally, in certain embodiments, the manipulator is configured for at least rotational movement along at least one axis. Depending on the specific embodiment, a multi-axis system is configured as a serial mechanism, a parallel kinematic system, or a hybrid mechanism. In certain embodiments, the manipulator is configured as a serial mechanism, in particular as an articulated robot arm, and further, in particular, as a SCARA robot.
[0034] 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.
[0035] 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.
[0036] In some embodiments, containers to be filled can be inserted into the interior of the housing via the opening with the airlock provided at the opening for filling. After filling, filled and sealed containers can be ejected from the interior of the housing via the airlock and chamber. In other embodiments, the filled and sealed containers are ejected from the interior of the housing into the environment via the airlock and chamber. In other embodiments, a container with a rigid and / or flexible wall can be connected to the ejection interface for receiving filled and sealed containers, whereby the filled and sealed containers can be ejected from the interior of the housing into the container without direct contact between the interior of the housing and the environment.It is possible to dispense filled and sealed containers from the interior of the housing into the container 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 chute provided at the dispensing interface and from the chute into the container.
[0037] 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.
[0038] 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.
[0039] In some configurations, an endless bag can be attached to the dispensing interface. An endless bag is defined as a long tube that is closed or sealable at one end, and from which a section with the closed end can be cut off from a supply of tubes as needed. The end remaining on the supply of tubes after the section has been cut off can be sealed, in particular before or during the cutting process. The endless bag has, for example, a length of at least 10 m, in particular at least - IQ -
[0040] 25 m in length. For example, the length of the continuous bag can be up to 100 m, and in some configurations up to 50 m. When dispensing the container, tub, and / or tray, a section of the continuous bag can be drawn off from the hose supply. In some configurations, 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. In some configurations, 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. For example, a beta component is provided with a continuous bag.
[0041] 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.
[0042] In some designs, the filled section is separated manually by an operator.
[0043] In certain configurations, the dispensing interface is designed to tightly package containers to be dispensed, particularly those placed in trays, within a section of the continuous bag. Tight packaging refers specifically to packaging that prevents the containers from being unintentionally moved from the slide and / or ensures the integrity of the container during subsequent handling.
[0044] For example, the dispensing interface is set up to individually pack containers to be discharged, in particular containers placed in tubs, in a section of the continuous bag, and in particular to pack them tightly.
[0045] For example, the dispensing interface is configured to package at least two containers to be dispensed, in particular containers placed in trays, together in one section of the continuous bag, and especially to package them tightly. In some embodiments, the dispensing interface is configured to package containers to be dispensed, in particular containers placed in trays, at least semi-automatically, for example, fully automatically.
[0046] In some designs, a separating device is provided, which is designed to separate a filled section of the continuous bag at a separation point.
[0047] 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.
[0048] 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).
[0049] In some configurations, the separating device is designed to separate the filled section after several containers to be discharged, especially containers placed in a tub, and to close the filled section at the separation point, for example by welding.
[0050] In certain configurations, the separating device is designed to separate the filled section after each container being discharged, in particular after each container being discharged that is placed in a tub, and in particular to separate and close the filled section at the separation point, for example by welding.
[0051] In certain embodiments, at least one stabilizing element, and in particular several stabilizing elements, is / are stored at the dispensing interface, wherein a number of containers, in particular containers used in trays, can be bundled with one, in particular exactly one, stabilizing element, and in particular stacked on a stabilizing element. The stabilizing element allows, in particular, the stabilization of the unit for subsequent handling, in particular for transport to a point of use and / or a storage facility for the products.
[0052] For example, the stabilizing element is removed before the unit is packaged.
[0053] For example, the dispensing interface is set up to package units comprehensively, including the number of containers and one, in particular exactly one, stabilizing element.
[0054] For example, the dispensing interface is designed to introduce units, comprising the number of containers and one, and in particular exactly one, stabilizing element, each as a subassembly into the continuous bag. For example, after the insertion of a unit as a subassembly, a filled section is separated from a supply of hose and, in particular, sealed.
[0055] For example, the dispensing interface is designed to introduce stabilizing elements, particularly individually, into the continuous bag, and to introduce the number of containers, particularly those used in trays, into the continuous bag after the stabilizing element and to bundle them with one, particularly exactly one, stabilizing element in a section of the continuous bag. For example, the containers, particularly those used in trays, are transferred in groups.
[0056] For example, the containers, especially those used in tubs, are moved individually. For example, after the entire unit has been placed in a tubing supply, a filled section is separated and, in particular, sealed. For example, a stabilizing element is then inserted into the continuous bag again.
[0057] For example, the stabilizing element is designed as a flat stabilizing element, in particular as a plate and / or tray and / or pallet. In particular, the flat stabilizing element has a flat contact surface. In particular, the flat stabilizing element has a transverse dimension and a height measured perpendicular to the transverse dimension, and the transverse dimension is greater than the height. In particular, the height is oriented perpendicular to the flat contact surface. For example, the stabilizing element is designed as a container. For example, the stabilizing element is rigid and cannot be deformed, or at least only to an insignificant extent, without causing damage.
[0058] For example, the stabilizing element is deformable within at least a tolerance range. In embodiments of the first aspect, a discharge interface is provided on the housing for ejecting filled and sealed containers from the interior. The interior of the housing is, for example, not necessarily closed in an operating state. In embodiments, a conveying system is provided at the discharge interface, particularly outside the housing, which is designed to transport the ejected containers, especially packaged ones. In particular, the conveying system is designed to transport the ejected containers, comprising microscope slides and containers arranged therein, especially containers placed in trays, especially packaged ones.In particular, the conveying system is designed to transport the units to be discharged, including the number of containers and one, and especially exactly one, stabilizing element, and to transport them, particularly in packaged form. For example, but not necessarily, a passage with an airlock for introducing containers to be filled into the interior of the housing is provided on the housing.
[0059] In some embodiments, the conveying system is configured to transport the containers to be discharged, for example, containers and / or units to be discharged, at least partially at an angle and / or at least approximately vertically, in particular to transport them at least partially at least approximately vertically and / or at an angle through the discharge interface and / or at least partially at an angle away from the discharge interface. In other embodiments, the conveying system is configured to transport the containers to be discharged, for example, containers and / or units to be discharged, at least partially at least approximately horizontally, in particular to transport them at least partially at least approximately horizontally through the discharge interface and / or away from the discharge interface.
[0060] The conveying system is particularly adaptable to an arrangement at the dispensing interface and / or a movement path of the containers during dispensing.
[0061] In certain configurations, the dispensing interface and the conveying system are set up so that the containers to be discharged, for example, containers and / or units, are packaged at the conveying system. For example, the dispensing interface and the conveying system are set up so that the containers to be discharged are brought onto the conveying system in a continuous bag, and the separation takes place there.
[0062] For example, the containers, such as bundles and / or units, packed in a section of the continuous bag are transported away by the conveyor system. In particular, the conveyor system is configured to transport containers to be packaged, such as bundles and / or units, wherein, in some configurations, the containers, such as the bundles and / or units, are packaged on the conveyor system and / or the packaged containers, such as the packaged bundles and / or units, are transported, in particular, removed.
[0063] For example, the conveying system includes a conveyor belt, in particular one that is oriented at least approximately horizontally and / or at an angle. For example, a conveyor belt, in particular one that is oriented at least approximately horizontally and / or at an angle, is advantageous for handling containers, especially those to be packaged, which are discharged along a movement path that is at least approximately horizontal.
[0064] For example, the conveying system includes a lifting system designed to receive containers to be discharged, in particular containers comprising slides and containers arranged therein, especially containers placed in trays.
[0065] For example, a lifting system is configured to move containers, in particular containers comprising slides and containers arranged therein, especially containers placed in trays, along a movement path that is at least approximately vertical, in particular to lower and / or raise them. For example, the lifting system includes a lifting table, wherein containers, in particular those to be packaged, are stacked on the lifting table. For example, the containers are moved onto the lifting table by a movement along a movement path that is at least approximately horizontal.
[0066] For example, the containers are moved onto the lifting table by a movement along a movement path that is at least approximately vertical.
[0067] For example, the containers, especially those used in trays and / or for packaging, are transferred directly to the lifting system upon removal from the housing. Alternatively, the containers, especially those used in trays and / or for packaging, are transferred to a first conveying device, such as a conveyor belt, upon removal from the housing and subsequently transferred to the lifting system for stacking.
[0068] In certain embodiments, the conveying system is configured to transport units comprising a number of containers and one, in particular exactly one, stabilizing element, and / or stacks comprising several containers to be packaged, in particular at least semi-automatically, for example fully automatically. In certain embodiments, the airlock is configured to introduce at least one container comprising a microscope slide and containers arranged therein into the interior. In certain embodiments, the container to be introduced is contained within an outer packaging. The outer packaging comprises, in particular, a tray that receives the container, a film placed on the container, a film sealing the tray with the received container, and / or a bag that receives the container and / or the tray with the received container.If the outer packaging comprises several packaging elements, in some configurations one or more packaging elements are removed before the container is introduced into the airlock. In particular, in some configurations a bag is removed. In other configurations, the container is introduced into the airlock with all packaging elements.
[0069] 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.
[0070] 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 (H₂O₂), also known as vaporized hydrogen peroxide.
[0071] 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.
[0072] 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.
[0073] In particular, a transfer component can be connected to the access opening.
[0074] In particular, the transfer component can be connected to the access opening from the surrounding area.
[0075] 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.
[0076] 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.
[0077] 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.
[0078] 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.
[0079] 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.
[0080] 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.
[0081] 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.
[0082] 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.
[0083] In particular, the containers are closed with a closure element, such as stoppers, caps, snap closures or others.
[0084] For example, the locking mechanism is designed,
[0085] - to close a container with a stopper, and / or
[0086] - to close a container with a cap, and / or
[0087] - to close a container by crimping.
[0088] 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.
[0089] 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.
[0090] 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.
[0091] 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.
[0092] 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.
[0093] 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.
[0094] 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.
[0095] According to a second aspect, a method 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 process steps under cleanroom conditions are carried out, at least partially, in a closed interior space 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 space of the enclosure via a discharge interface on the enclosure.
[0096] 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.
[0097] 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.
[0098] In some embodiments, a sluice gate, in particular with a chamber, is provided at the dispensing interface, whereby filled and sealed containers are dispensed from the closed interior of the housing via the sluice gate.
[0099] 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.
[0100] 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.
[0101] In some embodiments, containers to be discharged, particularly those placed in trays, are tightly packed in a section of the continuous bag, especially in groups or individually in a section of the continuous bag. In some embodiments, packaging is carried out manually. In others, packaging is at least semi-automated, for example, fully automated. In some embodiments, units are formed, each comprising a number of containers and one, in particular exactly one, stabilizing element, with the formed units each being packed as a single unit in a section of the continuous bag.
[0102] In various configurations, containers to be discharged, in particular assemblies comprising microscope slides and containers arranged therein, especially assemblies placed in trays and / or units comprising a number of assemblies and one, in particular exactly one, stabilizing element, are transported away at the discharge interface by a conveying system, in particular at least semi-automated, for example fully automated, and in particular transported away in packaged form. Depending on the application, the conveying system is designed to transport assemblies individually and / or to form stacks during transport.
[0103] 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.
[0104] 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.
[0105] 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.
[0106] 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.
[0107] In particular, a direction within the meaning of this disclosure is at least approximately vertical and / or oblique if that direction is perpendicular to the horizontal direction. For example, a direction within the meaning of this disclosure is oblique if that direction is perpendicular to the horizontal direction and / or perpendicular to the vertical direction.
[0108] For example, a direction within the meaning of this disclosure is at least approximately vertical if the angle between this direction and the vertical direction is at most 30 degrees, for example at most 20 degrees, or in embodiments at most 10 degrees, and / or if a deviation of this direction from the vertical direction is technically irrelevant and / or technically necessary.
[0109] For example, a direction within the meaning of this disclosure is at least approximately horizontal if the angle between this direction and the horizontal direction is at most 30 degrees, for example at most 20 degrees, or in embodiments at most 10 degrees, and / or if a deviation of this direction from the horizontal direction is technically irrelevant and / or technically necessary.
[0110] 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.
[0111] 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.
[0112] BRIEF DESCRIPTION OF THE DRAWINGS
[0113] 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:
[0114] 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;
[0115] Fig. 2: the system according to Fig. 1 during the transfer of a container to a filling station; Fig. 3: the system according to Fig. 1 during cleaning after or before a filling process;
[0116] 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;
[0117] 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;
[0118] Fig. 6 shows an embodiment of a discharge interface of a system for carrying out process steps on containers at least partially under cleanroom conditions; and
[0119] Fig. 7 shows another embodiment of a discharge interface of a system for carrying out process steps on containers at least partially under cleanroom conditions.
[0120] DETAILED DESCRIPTION OF THE EXECUTION EXAMPLES
[0121] Figures 1 to 3 schematically show a first embodiment of a system 1 for carrying out process steps on containers at least partially under cleanroom conditions, wherein the process steps include at least filling and closing the containers under cleanroom conditions. Figure 1 shows the system 1 during a filling process at a filling station 3. Figure 2 shows the system 1 according to Figure 1 during the transfer of a container 5 to the filling station 3. Figure 3 shows the system 1 during cleaning after or before the filling process according to Figure 1.
[0122] The system 1 comprises a cleanroom structure 2, the filling station 3 for filling the container 5 shown schematically in Fig. 1, and a closing station 4 for closing a filled container 5. In the illustrated embodiment, the filling station 3 and the closing station 4 are arranged such that filling and closing take place at a common filling position 30.
[0123] Cleanroom setup 2 comprises an enclosure 20. An interior space of enclosure 20 is separated from the environment of enclosure 20. The required cleanroom conditions for the operation of system 1 can be created within the interior space of enclosure 20 of cleanroom setup 2. The interior space has a main chamber 201 and a sub-chamber 202 separated from the main chamber 201.
[0124] The filling station 3 and the sealing station 4 are located in the separate sub-room 202.
[0125] In the embodiment shown in Fig. 1, exactly one container 5, which is placed in the separated sub-space 202 and arranged at the filling position 30, is filled. In other embodiments, several containers are placed together in the separated sub-space 202 and filled simultaneously or one after the other.
[0126] 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.
[0127] In the illustrated embodiment, the cleanroom structure 2 has a base area that is at least substantially rectangular, with the main chamber 201 and the separated sub-chamber 202 arranged on this base area. In the illustrated embodiment, the separated sub-chamber 202 is located at a corner of the housing 20 and is bounded by two adjacent wall sections 203 and 204 of an outer wall of the housing 20, forming a right angle to each other. In the illustrated embodiment, an access opening 24 is provided in a first wall section 203, and a glove opening 26 is provided in a second wall section 204.
[0128] A cleaning device, in particular a cloth soaked with alcohol and / or another disinfectant, can be introduced into the segregated sub-chamber 202 via the access opening 24. In some embodiments, a cleaning device is introduced into the segregated sub-chamber 202 via a different route, for example, via the main chamber 201. The cleaning device is introduced into the segregated sub-chamber 202, in particular before the cleanroom conditions are established, and in some embodiments, after the cleanroom conditions have already been established. The glove opening 26 allows access to the segregated sub-chamber 202, for example, for manual cleaning of the segregated sub-chamber 202. In some embodiments, a manipulator for semi- or fully automated cleaning of the segregated sub-chamber 202 is provided in the segregated sub-chamber 202. The segregated sub-chamber 202 can be cleaned without decontamination of the main chamber 201.
[0129] 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.
[0130] 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.
[0131] 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.
[0132] In particular, the cleanroom setup 2 includes a flow device. The flow device provides an air supply, preferably via a ceiling of the housing 20, and enables the exhaust of air. Specifically, the flow device forms a "Unidirectional Airflow (UDAF) unit (previously referred to as a Laminar Airflow Unit or LAF)" according to the EC GMP Guide, Annex 1. In some embodiments, a common flow device is provided and configured for the main chamber 201 and for the separate sub-chamber 202. In the illustrated embodiment, an extraction device 6 is provided in the separate sub-chamber 202. In particular, the extraction device 6 provides local air extraction, especially at the filling station 3 and / or sealing station 4.
[0133] The introduction of containers 5 to be filled from the surroundings into the separated sub-chamber 202, as well as the removal of filled and sealed containers from the separated sub-chamber 202 into the surroundings, each takes place via the main chamber 201, as schematically shown in Fig. 2. An inlet 11 and an outlet 12 are provided for transferring the containers 5 into and out of the main chamber 201. Alternatively, in some embodiments, only one passage is provided. In these embodiments, transfer into and out of the main chamber 201 occurs via the common passage. Alternatively or additionally, in some embodiments, an interface is provided on an outer wall of the housing 20, whereby containers 5 can be introduced into and / or removed from the main chamber 201 via this interface.In some embodiments, the inlet 11 and / or the outlet 12 are open for the continuous or semi-continuous transfer of containers 5 and / or other materials into and out of the housing 20. In other embodiments, the inlet 11 and the outlet 12 are closed after decontamination of the interior of the housing 20. In other embodiments, an airlock is provided at the inlet 11 and / or the outlet 12 to allow the introduction of containers 20 into the closed interior of the housing 20.
[0134] 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.
[0135] As schematically shown in Fig. 3, a door 224 is provided in embodiments of the exemplary embodiment, wherein the passage opening 220 is at least covered by the door 224 and, in particular, can be closed. For example, a seal is provided on the door 224 and / or on the passage opening so that the passage opening 220 can be closed fluid-tight with the door 224. The passage opening 220 can be closed, in particular, during the filling and closing of a container and / or for cleaning.
[0136] In the illustrated embodiment, a transport device 7 is provided for the at least partially automated transfer of the containers 5 into or out of the separated sub-compartment 202. In various embodiments, the transport device 7 comprises a schematically depicted manipulator 70, for example, an articulated robot arm. The transport device, in particular the manipulator 70, can be operated as schematically shown in Fig. 2 to move containers 5 to be filled from the main compartment 201 into the separated sub-compartment 202, in particular to the filling position 30 in the separated sub-compartment 202. Specifically, during the transfer of the containers, a transport segment of the transport device 7, for example, a manipulator arm of the articulated robot 70, is located temporarily in the main compartment 201 and temporarily in the separated sub-compartment 202.
[0137] As schematically illustrated in Fig. 1, in certain embodiments, it is provided that during a filling process, particularly before filling and until the container 5 is closed, at least transport segments, for example the manipulator arm, which are located temporarily in the main chamber 201 and temporarily in the separated sub-chamber 202, are located in the main chamber 201. For example, the manipulator 70 is in a retracted position during the filling process, whereby in the retracted position no part of the manipulator 70 engages in the separated sub-chamber 202. In particular, this prevents contamination of the manipulator 70 during the filling process.
[0138] 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.
[0139] In certain embodiments, the transport device 7 comprises at least two transport units, for example, at least two manipulators 70. In particular, a first of the at least two transport units, for example, a first manipulator 70, is located entirely and always within the main chamber 201, and a second of the at least two transport units, for example, a second manipulator 70, is located entirely and always within the separated sub-chamber 202, with all its components. To transfer containers to be filled from the main chamber 201 to the separated sub-chamber 202, the first transport unit transports the container to be filled to a transfer area, in particular to the through-opening 220, and the second transport unit transports the container to be filled from the transfer area to the separated sub-chamber 202, in particular to the filling position.To remove filled and sealed containers from the separated sub-room 202, the second transport unit transports the filled and sealed container, in particular from the sealing and / or filling position 30, to the transfer area, in particular to the passage opening 220, and the first transport unit transports the filled and sealed container from the transfer area into the main room 201.
[0140] In particular, a container is transferred directly from the first transport unit to the second transport unit and / or vice versa within the transfer area. In some configurations, the transfer of a container between the first and second transport units within the transfer area occurs indirectly.
[0141] 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.
[0142] 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.
[0143] 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.
[0144] 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.
[0145] 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.
[0146] 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.
[0147] 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.
[0148] 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.
[0149] 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.
[0150] 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.
[0151] Alternatively or additionally, in some configurations at least partial manual setup of the filling station 3 is possible, in particular via the glove opening 26.
[0152] The filled containers 5 are closed by closure elements 40. In some embodiments, the closure elements 40 are inserted into the separated compartment 202 via the access opening 24. In the illustrated embodiment, a supply 400 of closure elements 40 is provided in the main compartment 201. This supply 400 can be introduced into the main compartment 201, in particular via the inlet 11.
[0153] 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.
[0154] 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.
[0155] 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.
[0156] In certain configurations, the entire facility 1 is first decontaminated.
[0157] Subsequently, containers 5 and closure elements 40 can be fed into the main chamber 201, for example, via inlet 11. In certain configurations, this feeding process is at least partially automated.
[0158] The filling station 3 is set up at least partially manually and / or automatically using a filling needle 32 supplied via the access opening 24, wherein in particular the filling needle 32 is provided in a particularly sterile interior of a transfer component 25.
[0159] In particular, the filling needle 32 is connected via the fluid line to the supply 36 of product to be filled, which is located outside the interior of the transfer component 25.
[0160] In particular, during setup the conveying device 38 is equipped with the fluid line 34, so that the product to be filled can be conveyed from the product supply 36 in a defined manner and filled into a container to be filled via the filling needle 32.
[0161] 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.
[0162] Once the batch of product to be filled has been emptied into the containers, and in particular once the product supply 36 has been used up, the filling needle 32 can be deployed from the separated compartment 202, in particular via the transfer component 25 connected to the access opening 24. The access opening 24 is then closed. The fluid line 34 is removed from the conveying device 38. Subsequently, the separated compartment 202 and the components located therein are cleaned, in particular disinfected.
[0163] 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.
[0164] For example, containers to be filled with the next product can be fed at least partially via the feed device 83 while containers with a previously filled product are still being filled at filling station 3 and / or while sealed containers filled with a previously filled product are being removed via the discharge device 84. In particular, the containers to be filled with the next product are only fed in to the extent that these containers do not come within physical proximity of the sealed containers filled with a previously filled product.
[0165] By cleaning the separated sub-room 202, the risk of cross-contamination between batches can be reduced to at least a tolerable level.
[0166] In particular, by separating the sub-room 202 (in which the filling station 3 and the sealing station 4 are located) from the main room 201, the main room 201 can be kept so clean even when filling and sealing the containers that decontamination of the main room is not required every time a batch of product to be filled is changed and / or every time a product to be filled is changed.
[0167] In particular, this can save resources. For example, a larger quantity of product, especially different products, can be filled into containers in a given time.
[0168] Fig. 4 shows a second embodiment of a system 1 for carrying out process steps on containers 5, at least partially under cleanroom conditions. The system 1 according to Fig. 4 comprises a cleanroom structure 2, a filling station 3 for filling a container 5 (schematically shown in Fig. 4), and a sealing station 4 for sealing a filled container 5. In the illustrated embodiment, the filling station 3 and the sealing station 4 are arranged such that filling and sealing take place at a common filling position 30.
[0169] 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.
[0170] The cleanroom structure 2 shown in Fig. 4 has a "closed interior" during production and / or cleanroom operation. Before decontamination of the interior 200 for operation of the system 1, all pass-throughs and / or openings through which the interior 200 is in direct contact with the environment are closed, in particular sealed to be fluid-tight. Air supply and / or exhaust to the closed interior is provided by a dedicated airflow system.
[0171] For introducing material, in particular containers 5, closure elements 40 and / or consumables, into the enclosed interior space 200, especially after decontamination for a product facility, a passage 13 with an airlock 130 is provided on the housing 20 in the configuration according to Fig. 4. Containers 5, closure elements 40 and / or consumables can be introduced into the interior space 200 via the passage 13 and the airlock 130.
[0172] In some configurations, the passage 13 can also be used to remove material from the enclosed interior space 200.
[0173] In the embodiment according to Fig. 4, a discharge interface 28 is provided on the housing 20 for the discharge of material, in particular of filled and sealed containers, from the enclosed interior space 200. The filled and sealed containers 5 can be removed from the enclosed interior space 200 into the environment via the discharge interface without the enclosed interior space 200 coming into contact with the environment.
[0174] In the embodiment shown in Fig. 4, the dispensing interface 28 is designed as an interface of a transfer system, comprising the dispensing interface 28 and a container 280 that can be detachably connected to it. For example, the dispensing interface 28 is designed as an alpha port and the container 280 as a beta component of an alpha-beta port system.
[0175] Container 280 has a rigid and / or flexible wall and is designed to accommodate filled and sealed containers 5.
[0176] Container 280 can be attached to the discharge interface 28. Inside the attached container 280, the cleanroom conditions of plant 1 are present and / or can be created, and / or a negative pressure prevails inside container 280 that is lower than the pressure prevailing in the interior 200. After the container 280 has been attached to the discharge interface 28, a closable opening of the discharge interface 28 can be opened so that filled and sealed containers 5 can be discharged from the interior 200 of the housing 20 into container 280 without the interior 200 of the housing 20 coming into direct contact with the environment.
[0177] 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.
[0178] The passage 13 with the lock 130 is configured to introduce at least one container (not shown in Fig. 4) comprising a microscope slide and containers 5 to be filled arranged therein into the interior via the lock 130. In some configurations, the containers are packaged in an outer packaging, the removal of which is carried out manually or at least semi-automatically within the interior 200.
[0179] Manual removal of the outer packaging is achieved in some designs via a glove opening 29.
[0180] In certain embodiments, the airlock 130 includes a cleaning unit 131, schematically depicted in Fig. 4, for cleaning, disinfecting, sterilizing, and / or decontaminating the surfaces of objects located in the airlock 130. In certain embodiments, the cleaning unit 131 is designed to decontaminate microbiologically contaminated surfaces. For this purpose, the cleaning unit 131 may include a radiation source, in particular for generating ultraviolet radiation (UV radiation), especially UV-C radiation, and / or an electron accelerator. Alternatively or additionally, in certain embodiments, the cleaning unit 131 may include a fumigation device, in particular for nebulizing an H₂O₂ solution, also referred to as vaporized hydrogen peroxide.
[0181] 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.
[0182] 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.
[0183] 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.
[0184] In the illustrated embodiment, the containers 5 are each individually moved into the filling position. In various embodiments, the system 1 according to Fig. 3 comprises a transfer station 8, shown in Figs. 1 to 3, with a first container position 81 and a second container position 82. At least one container with containers to be filled can be provided at the first container position 81. The containers 5 can be removed individually or in groups from the container located at the first container position 81 and moved into the filling position 30 for a filling operation. After the filled container 5 has been closed, it can be moved from the filling position 30 to the second container position 82, and a slide provided at the second container position 82 can be inserted.The dispensing interface 28 is specifically designed to dispense containers comprising microscope slides and filled and sealed receptacles 5 arranged therein from the enclosed interior 200 of the housing 20. In some embodiments, the containers are placed back into trays after filling and sealing, and then inserted into trays from the interior 200 via the dispensing interface 28.
[0185] In certain embodiments, the handling of the containers 5 to be filled and / or the filled containers 5 is at least partially automated by a transport device 7, schematically depicted in Fig. 4, which includes, in particular, a manipulator not shown in Fig. 4. As schematically shown in Fig. 4, the containers 5 move from the opening 13 towards the filling position 30 along a first transport path 71. The containers 5 move from the filling position 30 towards the dispensing interface along a second transport path 72. The first transport path 71 and the second transport path 72 differ in their configurations, such that the movement of containers 5 along the first transport path 71 and along the second transport path 72 is possible at least partially simultaneously and without collision.
[0186] 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.
[0187] 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.
[0188] In the illustrated embodiment, an access opening 24, designed as a connection opening for a transfer system, is provided for inserting a filling needle 32 into the interior 200. The access opening 24 is specifically designed as an alpha port of an alpha-beta port system. In the illustrated embodiment, a transfer component 25, connectable to the access opening 24, is provided with a feedthrough 250 for a fluid line 34. The filling needle 32 is connected via the fluid line 34 to a reservoir 36 located outside the housing 20. A conveying device 38 is provided on the fluid line 34, through which a defined quantity of fluid can be conveyed from the reservoir 36 to the container 5 for filling the container 5. For in-process control, a control device 9, for example, a scale or an optical control device for detecting a fill level, is further provided at the filling position 30.In some embodiments, the filling station 3 is at least partially automated, and in particular fully automated, by being fitted with the filling needle 32. For example, in some embodiments, a manipulator (not shown in Fig. 4) can be operated to open the access opening 24, remove the filling needle 32 from the connected transfer component 25, and attach the filling needle 32 to a filling needle holder 33. The filling needle 32 is attached to the filling needle holder, in particular, by means of a tool-free quick-release fastener, for example, by means of a snap-fit and / or magnetic connection.
[0189] 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.
[0190] Fig. 5 shows a third embodiment of a system 1 for carrying out process steps on containers 5, at least partially under cleanroom conditions. The system 1 according to Fig. 5 is similar to the system 1 according to Fig. 4. Identical reference numerals are used for identical or similar components, and for a detailed description of the similar or identical components, reference is made to the description of Fig. 4.
[0191] In contrast to the design according to Fig. 4, an endless bag 281 is attached to the dispensing interface 28.
[0192] 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.
[0193] When the container 50 is inserted, the continuous bag 281 is withdrawn from a supply of tubing 282. A filled section of the continuous bag 281 can be separated at a separation point from the tubing 282 remaining at the dispensing interface 28. Separation is effected, in particular, by closing a free end of the tubing 282 remaining at the dispensing interface 28, especially by sealing it fluid-tight, for example, by welding. Separation is effected in embodiments with a schematically depicted separation device 283. In embodiments, the filled section of the continuous bag 281 is separated in such a way that the filled section is also closed, in particular by welding. The separated filled section of the continuous bag 281 then serves as outer packaging for the container 50 with the filled and sealed containers 5.
[0194] In contrast to the embodiment shown in Fig. 4, the embodiment shown in Fig. 5 also includes a glove opening 26 in the area of the filling position 20. The glove opening 26 allows, for example, manual setup of the filling station 3. However, the number and / or position of the glove openings are merely examples. In other embodiments, several glove openings 26, 29 are provided, for example, in the area of the filling station 3 and on another wall of the housing 20.
[0195] Figures 4 and 5 do not show a partition wall (22 cf. Figures 1 to 3). In embodiments of the systems 1 shown in Figures 4 and / or 5, these also include a partition wall and / or an alternative measure by which a main chamber and a separate sub-chamber, in which the filling position 30 is provided, are created in the interior of the housing 20.
[0196] The systems shown in Figures 4 and 5 are also particularly suitable for filling small batches of products. After filling a batch, depending on the application, either the entire interior space 200 or – if separated by suitable measures – only a portion of the interior space containing the filling position can be decontaminated.
[0197] Fig. 6 schematically shows an embodiment of a dispensing interface 28, wherein containers 50, in particular containers inserted into troughs 52, are placed into a continuous bag 281 at the dispensing interface 28, wherein the containers are moved at least approximately in a vertical direction for placement into the continuous bag 281. For example, the dispensing interface 28 is provided on a wall of the housing 2 that is oriented at least approximately horizontally. For example, the dispensing interface 28 is spaced away from a surface so that the containers can be dispensed by moving them towards the surface.
[0198] In the embodiment shown in Fig. 6, a manipulator 284 is provided at the dispensing interface, wherein, for example, the manipulator is designed as a lifting and / or swiveling device. The manipulator 284 is configured to pick up and transfer a container 50, in particular a container inserted in a trough 52. For example, the manipulator 284 has an end effector 2840 with a gripping device. For example, the gripping device comprises suction grippers.
[0199] In the embodiment shown in Fig. 6, the containers, in particular those placed in trays 52, are stacked in the continuous bag 282, for example in a vertical stack. For example, a number of stacked trays 52 are packaged together in one section of the continuous bag 282. In other embodiments, the trays are packaged individually.
[0200] In some embodiments, a conveying system 285 is provided in the vicinity of the housing 2 at the dispensing interface 28 for the removal of the containers, in particular the containers used in tubs 52.
[0201] For example, the conveying system 285 comprises a lifting table 2850, shown schematically in Fig. 6. For example, the lifting table 2850 is movable in the vertical direction, as shown schematically by a double arrow in Fig. 6. For example, the lifting table 2850 is adjustable in increments. For example, after the transfer of a container, in particular a tub 52 containing a container, the lifting table is lowered, in particular by approximately the height of the tub. For example, the lowering is carried out such that when a container is moved into the continuous bag 282, for example by the manipulator 284, the transfer of the container, in particular the container inserted in a tub 52, takes place at at least approximately the same transfer height. For example, lowering the lifting table 2850 results in a section of the continuous bag 282 being pulled from a supply of hose.
[0202] For example, after a defined number of containers, in particular in trays 52, have been placed in the continuous bag 282, the filled section of the continuous bag 282 can be separated from the hose supply and sealed, in particular by welding. For example, the packaged stack is then transported away. For example, after the packaged stack has been transported away, the lifting table 2850 is raised to a starting position so that further stacks can subsequently be formed on the lifting table 2850.
[0203] For example, in some embodiments, the containers, particularly when used in trays 52, are arranged in such a way that two or more adjacent rods are formed. For example, in some embodiments, a stabilizing element (not shown) is inserted into the continuous bag along with the number of containers to stabilize the packaged rod for further handling.
[0204] Fig. 7 schematically shows another embodiment of a dispensing interface 28, wherein containers 50, in particular containers inserted into troughs 52, are introduced into a continuous bag 281 at the dispensing interface 28. For example, the dispensing interface 28 is provided on a wall of the housing 2 that is arranged at least approximately vertically.
[0205] For example, to be placed in the continuous bag 281, the containers 50 are moved at least approximately in a horizontal direction.
[0206] For example, the handling of the containers, in particular the containers used in tubs 52, is carried out at least semi-automatically, in particular fully automatically, for example by a sliding device and / or a manipulator.
[0207] For example, in some configurations the containers, especially in the tubs 52, are individually packaged, as shown schematically in Fig. 7.
[0208] For example, after insertion, a filled section of the continuous bag 281 is separated at a separation point by a schematically depicted separation device 283 from a remaining supply of tubing (not shown in Fig. 7) of the continuous bag 281 at the dispensing interface 28. In particular, the separation is carried out in such a way that the filled section of the continuous bag 281 is separated from the tubing supply without any connection between the interior of the continuous bag and / or the filled section with the environment.
[0209] For example, a free end of the continuous bag 281 and / or the filled section are welded at the separation point.
[0210] In some embodiments, a conveying system 285 is provided in the vicinity of the housing 2 at the dispensing interface 28 for the removal of the packaged containers, in particular the packaged tubs 52 with containers inserted therein.
[0211] For example, the conveying system 285 comprises a conveyor belt 2852, which is shown schematically in Fig. 7. For example, the conveyor belt is, as shown schematically in Fig. 7, at least approximately horizontally oriented, with the packaged tubs 52 being transported in an approximately horizontal plane. In other embodiments, transport takes place in a plane inclined relative to the horizontal plane, so that the packaged tubs 52 are raised or lowered during transport. The packaged tubs 52 are, for example, transported to a stacking device (not shown) and stacked by the stacking device.
[0212] 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.
[0213] The configurations include, in particular, the following combinations of features:
[0214] 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,
[0215] 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,
[0216] 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,
[0217] 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
[0218] 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.
[0219] 2. Plant according to one of the preceding configurations, wherein
[0220] 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,
[0221] the containers are used particularly in tubs. System according to one of the preceding configurations, wherein
[0222] the dispensing interface 28 has a discharge device, in particular comprising a manipulator, which is set up to dispense filled and sealed containers 5, in particular containers comprising microscope slides and filled and sealed containers 5 arranged therein, from the, in particular closed, interior 200 of the housing 20 at least semi-automatically, in particular fully automatically.
[0223] Plant according to one of the preceding configurations, wherein
[0224] 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.
[0225] Plant according to one of the preceding configurations, wherein
[0226] A container 280, 281 with a rigid and / or flexible wall for receiving filled and sealed containers 5 can be connected to the dispensing interface 28, wherein the filled and sealed containers 5 can be dispensed from the interior 200 of the housing 20 into the container 280, 281 without direct contact of the interior 200 of the housing 20 with the environment.
[0227] wherein in particular the container 280, 281 is designed to accommodate container 50 comprising microscope slides 51 and containers 5 inserted therein.
[0228] Plant according to one of the preceding configurations, wherein
[0229] The dispensing interface 28 is designed as an alpha port of an alpha-beta port system.
[0230] Plant according to one of the preceding configurations, wherein
[0231] An endless bag 281 can be attached to the dispensing interface 28.
[0232] Plant according to one of the preceding configurations, wherein
[0233] the dispensing interface 28 is set up to pack containers 50 to be discharged, in particular containers placed in trays, in a section of the continuous bag 281, in particular tightly, in particular as a group or individually in a section of the continuous bag 281, in particular at least semi-automatically, for example fully automatically, and / or
[0234] a separating device 283 is provided which is configured to separate a filled section of the endless bag 281 at a separation point from a hose supply 282 of the endless bag 281 remaining at the dispensing interface, wherein in particular
[0235] - 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
[0236] - the cutting device 283 is configured to weld a free end of the continuous bag 281 and / or the filled section at the cutting point, and / or
[0237] - the separating device 283 is set up to separate the filled section after some and / or after each container(s) 50 to be discharged, in particular container(s) 50 placed in a tub, in particular to separate and weld the filled section at the separation point.
[0238] Plant according to one of the preceding configurations, wherein
[0239] at least one stabilizing element is stored at the dispensing interface 28, wherein a number of containers 50, in particular containers 50 used in troughs, can be bundled with one, in particular with exactly one, stabilizing element, and in particular can be stacked on one stabilizing element,
[0240] particularly
[0241] The dispensing interface 28 is set up to package units comprising the number of containers 50 and one, in particular exactly one stabilizing element, and / or
[0242] The dispensing interface 28 is set up to introduce units comprising the number of containers 50 and one, in particular exactly one stabilizing element, each as an assembly into the continuous bag, and / or
[0243] the dispensing interface 28 is set up to introduce stabilizing elements, in particular individually, into the continuous bag, and the number of containers 50, in particular containers 50 used in tubs, are introduced into the continuous bag after the stabilizing element and bundled with one, in particular with exactly one, stabilizing element in a section of the continuous bag, and / or the stabilizing element is designed as a flat stabilizing element and / or container.
[0244] 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,
[0245] 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 200 of the housing 20 is separated from an environment and the cleanroom condition can be met in the interior 200 of the housing 20 of the cleanroom structure, in particular a system according to one of the preceding embodiments,
[0246] wherein a discharge interface 28 is provided on the housing 20 for discharging filled and sealed containers 5 from the interior 200 of the housing 20, wherein a conveying system is provided at the discharge interface 28, in particular outside the housing 2, which is set up to transport containers 5 to be discharged, in particular containers 50 comprising slides and containers 5 arranged therein, in particular containers 50 inserted in trays and / or units comprising a number of containers 50 and one, in particular exactly one, stabilizing element, in particular to transport them packaged, in particular at least semi-automatically, for example fully automatically,
[0247] in particular the conveying system is set up to transport the containers to be discharged at least section by section at least approximately vertically and / or at an angle.
[0248] Plant according to one of the preceding configurations, wherein
[0249] the conveying system 285 includes a conveyor belt 2852, in particular one that is at least approximately horizontally and / or obliquely aligned.
[0250] Plant according to one of the preceding configurations, wherein
[0251] the conveying system 285 has a lifting system which is set up to receive, and in particular stack, containers 5), in particular containers 50 comprising slides and containers 5), in particular containers 50), to be discharged.
[0252] Plant according to one of the preceding configurations, wherein
[0253] the conveyor system is set up to transport units comprising the number of containers 50 and one, in particular exactly one stabilizing element, and / or stacks comprising some containers to be packaged, in particular at least semi-automatically, for example fully automatically.
[0254] Plant according to one of the preceding configurations, wherein
[0255] the passage 13 is equipped with the lock 130 in order to introduce at least one container 50 comprising a microscope slide and containers arranged therein into the interior 200 via the lock 131,
[0256] in particular the container 50 is packed in an outer packaging.
[0257] Plant according to one of the preceding configurations, wherein
[0258] 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,
[0259] particularly
[0260] Cleaning unit 131 is set up to decontaminate microbiologically contaminated surfaces, and / or
[0261] 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.
[0262] Plant according to one of the preceding configurations, wherein
[0263] the housing 20 has a lockable access opening 24, wherein the access opening 24 is oriented from the housing 20 towards the environment,
[0264] wherein in particular the access opening 24 is accessible from the environment, especially for connecting a transfer component 25.
[0265] Plant according to one of the preceding configurations, wherein
[0266] the access opening is designed as a connection opening of a transfer system, wherein in particular via the opened access opening 24, to which a transfer component is connected, an interior of the connected transfer component is connected to the closed interior space 200 for the transfer of material and / or products and / or for the passage of a fluid line.
[0267] Plant according to one of the preceding configurations, wherein
[0268] 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,
[0269] wherein the transfer component 25 is designed in particular as a beta component of an alpha-beta port system. System according to one of the preceding embodiments, wherein
[0270] in the enclosed interior space 200 a control device 9 for the filling process is arranged,
[0271] 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
[0272] wherein in particular the control device 9 comprises an optical sensor device for detecting a fill level.
[0273] A plant according to one of the preceding configurations and / or a 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
[0274] 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.
[0275] Plant according to one of the preceding configurations, wherein
[0276] a separation of the separated sub-space 202 from the main space 201 is designed to prevent fluids and / or aerosols present in the separated sub-space 202, in particular at least from the beginning of the filling of a container 5 until the completion of the closing of the filled container 5, from the separated sub-space 202 into the main space 201.
[0277] Plant according to one of the preceding configurations, wherein
[0278] in the interior of the housing 20 a partition wall 22 is arranged between the main room 201 and the separated sub-room 202, wherein the partition wall 22 extends at least partially, in particular largely, over an interface between the separated sub-room 202 and the main room 201.
[0279] Plant according to one of the preceding configurations, wherein
[0280] 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.
[0281] System according to one of the preceding embodiments, wherein the at least one through-opening 220 is closable, in particular fluid-tight.
[0282] Plant according to one of the preceding configurations, wherein
[0283] 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.
[0284] Plant according to one of the preceding configurations, wherein
[0285] 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.
[0286] Plant according to one of the preceding configurations, wherein
[0287] a transfer component 25 connectable to the access opening 24 with a feedthrough for a fluid line 34 is provided, wherein a filling needle 32, which is fluidically connected via a fluid line 34 to a product reservoir 36 arranged outside the interior, can be made available for the separated sub-space 202 via the transfer component 25, wherein the transfer component 25 is designed in particular as a beta component of an alpha-beta port system.
[0288] Plant according to one of the preceding configurations, wherein
[0289] The filling station 3 includes a filling needle holder 33.
[0290] Plant according to one of the preceding configurations, wherein
[0291] The closing station 4 comprises a closing device for closing a filled container 5 arranged at a closing position.
[0292] Plant according to one of the preceding configurations, wherein
[0293] A filling position 30 of the filling station and a closing position of the closing station are the same position. System according to one of the preceding configurations, wherein
[0294] the separated sub-space 202 is bounded by at least one wall section 203, 204 of an outer wall of the housing 20, wherein in particular a glove opening 26 and / or the access opening 24 is provided on the at least one wall section 203, 204.
[0295] Plant according to one of the preceding configurations, wherein
[0296] 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°.
[0297] Plant according to one of the preceding configurations, wherein
[0298] The separation of the separated sub-space 202 from the main space 201, in order to prevent fluids and / or aerosols present in the separated sub-space 202 from entering the main space 201, is at least partially achieved through fluid dynamics, in particular by a pressure difference and / or by a directed flow.
[0299] Plant according to one of the preceding configurations, wherein
[0300] the separated sub-room 202 has an extraction device 6,
[0301] Plant according to one of the preceding configurations, wherein
[0302] at least one of the following is provided for:
[0303] that the suction device 6 is designed for local suction at the filling position 30 and / or the closing position; and / or
[0304] that the extraction device 6 is provided in addition to a device for air supply and air extraction at least in the separated sub-room 202.
[0305] Plant according to one of the preceding configurations, wherein
[0306] A transport device 7 is provided, wherein the transport device 7 is configured to transfer containers 5 to be filled from the main chamber 201 into the separated sub-chamber 202 and / or to remove filled and sealed containers 5 from the separated sub-chamber 202 into the main chamber 201, in particular to transfer them in and / or out at least semi-automatically. System according to one of the preceding embodiments, wherein
[0307] the transport device 7 comprises a manipulator 70, which is at least semi-automatically, in particular fully automatically, operable to bring containers 5 to be filled from the main room 201 into the separated sub-room 202, in particular to bring them into a filling position 30 in the separated sub-room 202, and to remove filled and sealed containers 5 from the separated sub-room 202 into the main room 201, in particular to take them from the filling position 30.
[0308] Plant according to one of the preceding configurations, wherein
[0309] The transport device 7 is arranged such that a transport segment of the transport device, which is temporarily located in the main room 201 and temporarily in the separated sub-room 202, is located in the main room at least when filling and / or closing a container, in particular from the beginning of filling a container until the completion of closing the filled container.
[0310] Plant according to one of the preceding configurations, wherein
[0311] in the main room a transfer station 8 with a container position 81, 82 for a container is provided, wherein in particular the transport device 7 is set up to remove containers 5 to be filled individually or in groups from a container provided at the transfer station 8, in particular at the container position 81, 82, and / or wherein in particular the transport device 7 is set up to place filled and closed containers 5 individually or in groups at the transfer station, in particular at the container position 81, 82.
[0312] Plant according to one of the preceding configurations, wherein
[0313] a container feed device is provided for the supply of containers to be filled into the main room, wherein in particular the container feed device is designed to transfer containers to be filled, especially as containers, from the surroundings into a transfer station 8 provided in the main room, in particular to transfer at least semi-automatically.
[0314] Plant according to one of the preceding configurations, wherein
[0315] a container removal device 84 is provided for the removal of filled and sealed containers from the main room 201, wherein in particular the container removal device 84 is designed to transport filled and sealed containers 5, especially as containers, from a transfer station 8 provided in the main room 201 to the surrounding area.
[0316] Plant according to one of the preceding configurations, wherein
[0317] The containers 5 to be filled can be arranged in the separated sub-room 202 at a filling position 30 for filling and closing.
[0318] Plant according to one of the preceding configurations, wherein
[0319] in the separated sub-space 202 a control device 9 for the filling process is arranged, 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.
[0320] Plant according to one of the preceding configurations, wherein
[0321] In the main room 201 a locking device 41 is provided, 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.
[0322] Plant according to one of the preceding configurations, wherein
[0323] a closure insertion device 42 is provided which is designed to move the closure elements 40 into the separated sub-space 202 to the closure station 4.
[0324] 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
[0325] the execution of the process steps under cleanroom conditions takes place at least partially in an enclosed interior space 200 of a housing 20 of a cleanroom setup 2 in cleanroom operation,
[0326] wherein containers 5 to be filled are introduced into the closed interior 200 of the housing 20 via a passage provided on the housing 20 using a lock, and / or
[0327] Filled and sealed containers are dispensed from the enclosed interior 200 of the housing 20 via a dispensing interface 28 on the housing 20.
[0328] Method according to a preceding method and / or on a plant according to one of the preceding configurations, wherein
[0329] A sluice gate, in particular 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 gate.
[0330] Method according to a preceding method and / or on a plant according to one of the preceding configurations, wherein
[0331] 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.
[0332] Method according to a preceding method and / or on a plant according to one of the preceding configurations, wherein
[0333] 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 tube supply 282 of the endless bag 281 remaining at the dispensing interface 28, wherein, in particular, the filled section of the endless bag 281 is separated from the tube supply 282 without any connection between the interior of the endless bag and / or the filled section with the environment, and / or
[0334] wherein in particular a free end of the continuous bag 281 and / or the filled section are welded at the separation point, and / or
[0335] Containers 50 to be discharged, in particular containers placed in trays, are packed tightly in a section of the continuous bag 281, in particular in groups or individually in a section of the continuous bag 281, in particular being packed at least semi-automatically, for example fully automatically, and / or
[0336] Units comprising a number of containers 50 and one, in particular exactly one, stabilizing element, as each unit is packed in a section of the continuous bag 281.
[0337] Method according to a preceding method and / or on a plant according to one of the preceding configurations, wherein
[0338] Containers 5 to be discharged, in particular containers 50 comprising slides and containers 5 arranged therein, in particular containers 50 placed in tubs and / or units comprising the number of containers 50 and one, in particular exactly one stabilizing element, at the discharge interface 28 by a conveying system, in particular arranged outside the housing 2, in particular at least semi-automated, for example fully automated, are transported away, in particular are transported away in packaged form.
[0339] Method according to a preceding method and / or on a plant according to one of the preceding configurations, wherein
[0340] via the airlock at least one container comprising a microscope slide and containers arranged therein is introduced into the interior 200 of the housing 20, wherein in particular the container is introduced into the interior 200 of the housing 20 in an outer packaging.
[0341] Method according to a preceding method and / or on a plant according to one of the preceding configurations, wherein
[0342] 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.
[0343] 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
[0344] the process is carried out under cleanroom conditions, at least partially within an interior of a housing 20 of a cleanroom setup 2, and the interior comprises a main chamber 201 and a separate sub-chamber 202, wherein the filling and sealing of the containers takes place in the separate sub-chamber 202, wherein a batch of a product to be filled is filled into container 5 in the separate sub-chamber 202, and subsequently the separate sub-chamber and the components arranged therein are cleaned, and subsequently a batch of another product to be filled is filled into containers.
[0345] 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.
[0346] Method according to a preceding method and / or on a plant according to one of the preceding configurations, wherein
[0347] 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.
[0348] Reference symbol list
[0349] Attachment
[0350] inlet
[0351] Outlet
[0352] passage
[0353] sluice
[0354] Cleaning unit
[0355] Cleanroom setup
[0356] Housing
[0357] interior
[0358] Main room
[0359] sub-area
[0360] Wall section
[0361] Wall section
[0362] partition
[0363] Passage opening
[0364] T partition wall section
[0365] T partition wall section
[0366] flap
[0367] Access opening
[0368] Transfer component
[0369] implementation
[0370] Glove intervention
[0371] Application interface
[0372] container
[0373] Endless bag
[0374] Hose supply
[0375] Separation device
[0376] Manipulator 2840 End Effector
[0377] 285 Conveyor system
[0378] 2850 Lifting table
[0379] 2852 Conveyor belt
[0380] 29 Glove insertion
[0381] 3 filling stations
[0382] 30 Filling position
[0383] 32 Filling needle
[0384] 33 Filling needle holders
[0385] 34 Fluid line
[0386] 36 product stock
[0387] 38 Funding facility
[0388] 4 locking stations
[0389] 40 locking elements
[0390] 400 stock
[0391] 41 Closure dispensing device 42 Closure insertion device 43 Closure feeding device
[0392] 5 containers
[0393] 50 containers
[0394] 51 slides
[0395] 52 bathtubs
[0396] 6 Extraction device
[0397] 7 transport device
[0398] 70 Manipulator
[0399] 71 T transport path
[0400] 72 T transport path
[0401] 73 T transport path
[0402] 8 Transfer station
[0403] 81 Container position
[0404] 82 Container position
[0405] 83 Container feeding device
[0406] 84 Container discharge device
[0407] 9 Control device
Claims
Patent claims 1. A system for carrying out process steps on containers at least partially under cleanroom conditions, wherein the process steps include at least filling and closing the containers under cleanroom conditions, wherein the system (1) comprises a cleanroom structure (2), a filling station (3) for filling a container and a closing station (4) for closing a filled container, wherein the cleanroom setup (2) comprises an enclosure (20), wherein an interior (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 enclosure (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. System according to claim 1, characterized in 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. System according to claim 1 or 2, characterized in that the dispensing interface (28) has a discharge device, in particular comprising a manipulator, which is configured to dispense filled and sealed containers (5), in particular containers comprising slides and filled and sealed containers (5) arranged therein, from the, in particular closed, interior (200) of the housing (20) at least semi-automatically, in particular fully automatically.
4. Plant according to one of the preceding claims, characterized in that the discharge interface (28) has a lock, in particular a lock with a chamber, wherein the chamber is in particular a closable, in particular fluid-tight closable chamber with at least two closable openings.
5. System according to one of the preceding claims, characterized in 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.
6. System according to one of the preceding claims, characterized in that the dispensing interface (28) is designed as an alpha port of an alpha-beta port system.
7. System according to one of the preceding claims, characterized in that an endless bag (281) can be attached to the dispensing interface (28).
8. Plant according to the preceding claim, characterized in that the dispensing interface (28) is configured to pack containers (50) to be discharged, in particular containers placed in trays, in a section of the continuous bag (281), in particular tightly, especially as a group or individually in a section of the continuous bag (281), in particular at least semi-automatically, for example fully automatically, and / or 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 configured to weld a free end of the continuous bag (281) and / or the filled section at the separation point, and / or - the separating device (283) is set up to after some and / or after each to separate the filled section from the container(s) (50) to be discharged, in particular the container(s) (50) used in a tub, in particular to separate and to weld the filled section at the separation point.
9. Plant according to one of the two preceding claims, characterized in that at least one stabilizing element is stored at the dispensing interface (28), wherein a number of containers (50), in particular containers (50) used in troughs, can be bundled with one, in particular with exactly one, stabilizing element, and in particular can be stacked on one stabilizing element, particularly the dispensing interface (28) is set up to package units comprising the number of containers (50) and one, in particular exactly one, stabilizing element, and / or the dispensing interface (28) is set up to introduce units comprising the number of containers (50) and one, in particular exactly one, stabilizing element, each as an assembly into the continuous bag, and / or the dispensing interface (28) is set up to introduce stabilizing elements, in particular individually, into the continuous bag, and to introduce the number of containers (50), in particular containers (50) used in trays, into the continuous bag after the stabilizing element and to bundle them with one, in particular with exactly one, stabilizing element in a section of the continuous bag, and / or The stabilizing element is designed as a flat stabilizing element and / or container.
0. Equipment 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 a housing (20), wherein an interior space (200) of the housing (20) is separated from an environment and the cleanroom condition can be fulfilled in the interior space (200) of the housing (20) of the cleanroom setup, in particular a system according to one of the preceding claims, wherein the housing (20) has a discharge interface (28) for dispensing filled and a sealed container (5) is provided from the interior (200) of the housing (20), wherein a conveying system is provided at the dispensing interface (28), in particular outside the housing (2), which is set up to transport containers (5), in particular containers (50) comprising slides and containers (5) arranged therein, in particular containers (50) inserted in trays and / or units comprising a number of containers (50) and one, in particular exactly one, stabilizing element, in particular to transport in packaged form, in particular at least semi-automatically, for example fully automatically, in particular the conveying system is set up to transport the containers to be discharged at least section by section at least approximately vertically and / or at an angle.
11. Plant according to the preceding claims, characterized in that the conveying system (285) has a conveyor belt (2852), in particular at least approximately horizontally and / or obliquely oriented.
12. Plant according to one of the two preceding claims, characterized in that the conveying system (285) has a lifting system which is set up to receive, and in particular stack, containers (5) to be discharged, in particular containers (50) comprising slides and containers (5) arranged therein, in particular containers (50) placed in trays.
13. Plant according to one of the three preceding claims, characterized in that the conveying system is set up to transport units comprising the number of containers (50) and one, in particular exactly one stabilizing element, and / or stacks comprising some containers to be packaged, in particular at least semi-automatically, for example fully automatically.
14. System according to one of the preceding claims, characterized in that the passage (13) is equipped with the lock (130) to introduce at least one container (50) comprising a slide and containers arranged therein into the interior (200) via the lock (131), in particular the container (50) is packed in an outer packaging.
15. System according to one of the preceding claims, characterized in that 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 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.
16. System according to one of the preceding claims, characterized in that the housing (20) has a closable 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).
17. Plant according to the preceding claim, characterized in that the access opening is designed as a connection opening of a transfer system, wherein in particular the 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.
18. Plant according to one of the two preceding claims, characterized in that a transfer component (25) connectable to the access opening (24) with a feedthrough for a fluid line (34) is provided, wherein a filling needle (32) which is fluidically connected via a fluid line (34) to a product 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 designed in particular as a beta component of an alpha-beta port system.
19. Plant according to one of the preceding claims characterized by at least one of the following: that the filling station (3) includes a filling needle holder (33); and / or that the closing station (4) comprises a closing device for closing a filled container (5) arranged at a closing position; and / or that a filling position (30) of the filling station and a closing position of the closing station are the same position.
20. Plant according to one of the preceding claims, characterized in that a control device (9) for the filling process is arranged in the closed 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.
21. Method for carrying out process steps on containers at least partially under cleanroom conditions, wherein the process steps include at least filling and closing the containers under cleanroom conditions, wherein the process steps are carried out at least partially under cleanroom conditions in an enclosed interior (200) of a housing (20) of a cleanroom setup (2) that is closed in cleanroom operation, wherein containers (5) to be filled are introduced into the closed interior (200) of the housing (20) via a passage provided on the housing (20) using a lock, and / or Filled and sealed containers are dispensed from the enclosed interior (200) of the housing (20) via a dispensing interface (28) on the housing (20).
22. Method according to the preceding method claim, characterized in that A sluice gate, in particular 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 gate.
23. Method according to one of the preceding method claims, characterized in that A container (280, 281) with a rigid and / or flexible wall for receiving filled and sealed containers (5) is connected to the dispensing interface (28), wherein the filled and sealed containers (5) are dispensed from the interior (200) of the housing (20) into the container without contact between the interior (200) of the housing (20) and the environment.
24. Method according to one of the preceding method claims, characterized in that 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 tube supply (282) without connecting the interior of the continuous bag and / or the filled section with 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, and / or Containers (50) to be discharged, in particular containers placed in trays to be discharged, are packed tightly in a section of the continuous bag (281), in particular in groups or individually in a section of the continuous bag (281), in particular being packed at least semi-automatically, for example fully automatically, and / or Units each comprise a number of containers (50) and one, in particular exactly one, stabilizing element, as one unit is packaged in a section of the continuous bag (281).
25. Method according to one of the preceding method claims, characterized in that Containers (5), in particular containers (50) comprising slides and containers (5) arranged therein, in particular containers (50) placed in tubs and / or units comprising the number of containers (50) and one, in particular exactly one stabilizing element, at the discharge interface (28) are transported away by a conveying system, in particular arranged outside the housing (2), in particular at least semi-automatically, for example fully automatically, in particular packaged.
26. Method according to one of the preceding method claims, characterized in that via the airlock at least one container comprising a microscope slide and containers arranged therein is introduced into the interior (200) of the housing (20), wherein in particular the container is introduced into the interior (200) of the housing (20) in an outer packaging.
7. Method according to one of the preceding method claims, characterized in that In the lock (130) surfaces of objects present in the lock (130) are cleaned, sterilized, disinfected and / or decontaminated, in particular microbiologically contaminated surfaces are decontaminated.
Citation Information
Patent Citations
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