Method for manipulating a container part in a controlled environment

Abstract

The invention relates to a method for manipulating a container part (3) in a controlled environment (4), and to a closing device (1) for carrying out the method, wherein the container part (3) is stored in a stock (5) which has a homogeneous bulk material density (6) of the container part (3), characterised in that the container part (3) is received, preferably individually, from the stock (5) by means of a preferably automated removal instrument (7).

Description

[0001] Method for manipulating a container part in a controlled environment

[0002] The invention relates to a method for manipulating a container part in a controlled environment, wherein the container part is stored in a supply which has a homogeneous bulk density of the container part.

[0003] The invention further relates to a method for attaching a container part, wherein the preferably filled container is arranged in a controlled environment, wherein the container part, in particular closure element, is stored in a supply which is connected to the controlled environment from the outside via a port.

[0004] The invention further relates to a method for attaching a container part, in particular a closure element, to a container, wherein the preferably filled container is arranged in a controlled environment, wherein the container part, in particular a closure element, is stored in a supply.

[0005] The invention further relates to a closure device for attaching a container part to a container in a controlled environment.

[0006] The object of the invention is to improve the manipulation and attachment of container parts in controlled environments. The object of the invention is further or alternatively to improve closure devices for attaching container parts to containers in controlled environments.

[0007] To achieve the stated objects, the features of claim 1 are provided according to the invention. In particular, in a method of the type described at the outset, it is proposed according to the invention that the container part is picked up from the supply using a removal instrument. This can, for example, make it possible for the container part to be made available for a work step in the controlled environment. It can preferably be provided that the container part is picked up from the supply using an automated removal instrument. The automated removal instrument can, for example, be a gripper on a handling system or robot. It can preferably be provided that the container part is picked up individually from the supply. This can, for example, make it possible for only the container part to be picked up which is presented in the supply in such a way that it is not potentially contaminated or soiled by the picking.It may also be possible to pick up the container part that is most advantageous to grasp. Gripping can also be achieved, for example, by selecting the parts so that the shortest path is chosen over the exposed container parts and / or so that air flow in an artificially overflowing system is disrupted as little as possible. This, for example, reduces the risk of contaminants being transferred from the removal instrument to container parts in the supply.

[0008] A homogeneous bulk density can be a density distribution that develops when a substance is poured into a container that is large compared to the container components. Local changes in the bulk density may be possible depending on the position in a bag or the container. Container components can include, for example, stoppers, plungers, caps, vials, cartridges, syringe bodies, syringe attachments, or other pharmaceutical containers.

[0009] In general, the supply can be made available in a controlled zone, for example in a bag or a container, which can be closed off from the controlled environment, for example via a port or a cover.

[0010] In general, a controlled space can be formed by a containment, such as an isolator. The controlled environment can, in particular, define a substance input and / or output based on quantity and / or quality.

[0011] A preferred application of the invention provides that the container part has at least one surface that can be wetted by the contents of the container. The container part can, for example, be a plug and / or plunger that has a surface that comes into contact with a liquid, for example. This wettable surface must not be touched when taken from the supply in order to prevent potential contamination. Alternatively, it is provided that the container part is not wetted by the contents of the container during use. This can, for example, define an area at which the container part can be gripped without potentially contaminating it.

[0012] A preferred application of the invention provides that the container part consists of an elastic material. As a result, the container part can be designed as a well-sealing closure element. Alternatively or additionally, it is provided that the container part is designed as a closure element. As a result, the closure element can, for example, close a container. The closure element can be automatically and individually taken from the supply and made available for closing a container. Alternatively or additionally, it is provided that the container part is part of a pharmaceutical container. Pharmaceutical containers can, for example, be medicament-containing devices for the provision and / or application of preferably defined medicament dispensations.For example, pharmaceutical containers can be designed as vials, syringes, cylinder ampoule syringes, optionally with associated closure means, or injectors or devices with automated drug delivery. This can, for example, make it possible for parts of pharmaceutical containers or the entire container to be taken from a supply.

[0013] A preferred application of the invention provides for one or more container parts picked up by the removal instrument to be removed from the supply by the removal instrument. This makes it possible, for example, to provide the closure elements for closing containers, such as pharmaceutical containers. Intermediate storage, transfer, or presentation of the closure elements for collection is thus dispensable.

[0014] In this case, the removal instrument can, for example, remove several closure elements simultaneously and / or one after the other while maintaining the general position of the removal instrument and / or one after the other by moving the removal instrument.

[0015] A preferred application of the invention provides that the supply has a removal area and a storage area. In the removal area of ​​the supply, the container parts can be advantageously presented and received. In the storage area of ​​the supply, the container parts can be kept ready and provide a supply for the removal area.

[0016] A preferred application of the invention provides for the removal instrument to be attached to a handling system or robot. The handling system or robot can, for example, be configured to manage a material flow from one location to the next. This can, for example, ensure that removal from the supply is efficient, error-free, and free of contamination.

[0017] Alternatively or additionally, it can be provided that the removal instrument is moved, preferably in a controlled manner, along at least three, preferably at least four, or at least five, or at least six axes for picking up. This can, for example, make it possible for the removal instrument to be moved in a controlled manner along multiple axes in order to pick up a container part in many orientations from a supply. The mobility along multiple axes is advantageous because the position and orientation of the container parts is random, making them easier to pick up.

[0018] A preferred application of the invention provides that the removal instrument receives the container part on a side facing away from the surface or a surface that can be wetted by the container contents. This can for example ensure that the surface that can be wetted by the container contents is not contacted by the removal instrument and therefore cannot be contaminated. Alternatively or additionally, it can be provided that the removal instrument receives the container part on a side that is spaced away from the surface or a surface that can be wetted by the container contents. This can for example ensure that the removal instrument receives the container part not on the wettable surface but at a distance from it, and the wettable surface is not contaminated. In particular, it is provided that the container part is gripped.This allows the container part to be safely picked up, held, transported, and / or set down or positioned. Alternatively or additionally, the container part can be suctioned in. This can be achieved by a suction device in the removal instrument. This advantageously eliminates the need for a gripping device, for example. Suction can also result in hygienic advantages, since there are fewer moving parts compared to a gripping device.

[0019] Alternatively or additionally, the features of the first independent claim directed to a method are provided to achieve the stated object. In particular, it is therefore proposed in the method that the container part is removed from the supply through the port using the or a removal instrument. This can, for example, make it possible for the removal instrument to be moved through the port into the supply in order to pick up a container part there. This means, for example, that there does not have to be a removal area for the container part in the controlled environment. Because the removal instrument can remove through the port, a separate and, in particular, preparatory transfer of container parts from a supply through the port into the controlled environment is not necessary. A port can, for example, be characterized as a device for the contamination-free introduction of container parts.For example, a port can be designed as an RTP (Rapid Transfer Port) with an associated, connectable container. This reduces preparation time and eliminates the need to clean slides or other transfer devices within the controlled environment, which were previously used in the usual container parts provisioning procedures to prevent uncontrolled contact with potentially contaminated areas.

[0020] The port can also be designed as a door that closes an opening designed for docking tubs or other containers, preferably containers with a controlled zone. In this case, the door can also have a decontamination unit for external decontamination of a cover of the tub or container.

[0021] A port can be designed with or without an active decontamination system, even as part of a lock. The invention makes it possible to ensure the provision and processing of container parts that are to be introduced or introduced via a port, while eliminating the need for otherwise conventional safety measures with regard to potentially contaminated port interfaces, such as cover films or slides. This significantly shortens the provisioning time.

[0022] The container part can in particular be a closure element. This can be designed to close containers. The container part is preferably removed individually from the supply through the port. This can advantageously result in better control over the removal process. In particular, it is provided that the container is filled. This can, for example, result in a liquid, a solid or a gas being stored in the container and being enclosed in the container by the container part.

[0023] A preferred application of the invention provides for the removal instrument to be moved at a distance from a boundary and / or a potentially contaminated interface of the port. The boundary of the port can be a frame. A potentially contaminated interface of the port can, for example, be a "ring of concern," for example, an area where contamination of an external surface cannot be ruled out with certainty due to inevitably occurring manufacturing tolerances.

[0024] This can, for example, ensure that the removal instrument and the goods to be transferred (container parts) do not come into contact with the port's boundary. Thus, contamination can be prevented.

[0025] Alternatively or additionally, it can be provided that the supply is spatially separated from the controlled environment by the port. This can, for example, ensure that the supply does not extend into the controlled environment. The limitation can, for example, be characterized by the supply being separated from the controlled environment when the port is closed and / or that the port can allow and block access to the supply from the controlled environment and / or that access to the supply from the controlled environment must proceed via the port.

[0026] The controlled environment can, for example, comprise spatial areas that are inaccessible from the outside if all closable openings (particularly ports) that may be present are closed. A supply, which is brought into a separate controlled zone, for example in a sterilized bag, container, or sack, can be coupled to such a controlled environment via a port. The invention makes it possible to remove container parts from the supply without having to take additional measures against possible contamination of the container parts during the removal process due to the remaining deficiencies in the coupling.

[0027] Alternatively or additionally, the features of the second independent claim directed to a method are provided to achieve the stated object. In particular, it is therefore proposed in the method that the container part is removed from the supply in a removal area using the or a removal instrument and that the supply is fed into the removal area. In this way, it can be achieved, for example, that the container part is presented in a removal area and can be picked up from the supply by the removal instrument. Container parts are fed from the supply so that sufficient container parts are presented in the removal area to be picked up by the removal instrument.

[0028] A preferred application of the invention provides that the refilling takes place when the fill level runs out of a withdrawal area of ​​the supply. This can, for example, make it possible for the withdrawal area to be filled when the fill level falls below a level defined by a user. Alternatively or additionally, it can be provided that the refilling causes a return of one or the fill level to the or a withdrawal area of ​​the supply. This can, for example, make it possible for a fill level to be reached, wherein the withdrawal instrument can advantageously pick up container parts from the withdrawal area.

[0029] A return and follow-up movement can also or alternatively be carried out in order to reorient the container parts in the removal area.

[0030] A filling level can, for example, be characterized as a boundary region of a bulk material with a homogeneous bulk density, at which the homogeneous bulk density ends and the bulk material can be removed.

[0031] A removal area can be characterized, for example, as a spatially fixed area in which the removal instrument can remove container parts from the supply, in particular under monitoring by the sensor or a sensor system, preferably an optical identification device.

[0032] A withdrawal area can alternatively or additionally be characterized, for example, as a part of the supply at which the filling level is formed.

[0033] A storage area can, for example, be considered a part of the supply from which the withdrawal area can be refilled, particularly for adjusting a filling level. The storage area can be spatially separated from the withdrawal area—preferably if the bulk material density matches—or can merge into it—preferably if the bulk material density remains constant.

[0034] Alternatively or additionally, the features of the third independent claim directed to a method are provided to achieve the stated object. In particular, the method proposes that the container part be identified in a supply using a sensory identification device, preferably arranged outside the controlled environment, and that it be removed from the supply using the removal instrument or instruments. The sensory identification device can be used to detect the position of container parts in the supply. This position detection is advantageous for advantageously picking up the container part.

[0035] In general it can be said that the controlled environment can serve to protect a product from contamination during the process which is to take place in the controlled environment. Transfers which are necessary for the process and through which contamination could be introduced are particularly sensitive if something has to be introduced from outside, for example container parts. The invention is concerned with reducing the risk of contamination or eliminating it altogether. The number of moving parts in the controlled environment can thus be minimized, as a result of which particle generation can be minimized. This also leads to a reduction in potential or actual contamination. Potential contamination can be characterized, for example, by the fact that contamination cannot be reliably ruled out in a process step due to the circumstances.In this case, it is not necessary that actual contamination has been proven; it is sufficient if process safety can no longer be guaranteed.

[0036] The invention also simplifies the transfer or supply of container parts, as fewer cleaning / sterilization / decontamination steps are required. Furthermore, the less wettable surfaces of the container parts are no longer in contact with as many other surfaces, since the movement of the container parts can be controlled from a selection in the supply.

[0037] Advantageous retrieval can mean that the container part is retrieved in such a way that it is not contaminated, for example, through uncontrolled contact with potentially contaminated surfaces, and / or that it is available for a subsequent work step. Advantageous retrieval can also mean that other container parts from the supply are not potentially contaminated when a container part is retrieved, for example, through abrasion of moving parts.

[0038] The sensory identification device is preferably arranged outside the controlled environment. This can, for example, ensure that the controlled environment is not contaminated by the identification device or that the controlled environment remains free of contamination. Alternatively or additionally, it can be provided that the identification unit and / or the optical control station do not have to meet the high (particularly material) requirements as other parts within the controlled environment. This can, for example, relate to the generation of abrasion of moving parts or outgassing of materials or resistance to aggressive decontamination agents. This can reduce manufacturing costs.

[0039] In particular, it can be provided that the container part is identified in a supply using an optical identification device. The optical identification device can be a camera which, in conjunction with image processing software, is set up to detect the position of container parts in a supply, in particular in the removal area. This has the advantage that such cameras are cost-effective. However, an identification device based on a runtime analysis is also conceivable, for example radar, lidar, laser or ultrasound. Identification in the sense of the application can be understood as distinguishing from a remainder and / or recognizing a location / position. The identification device can also use structured light to detect the position of the container parts in the supply.Structured light can, for example, be characterized as a method of projecting a known pattern onto a scene, capturing the resulting pattern in the scene, and thus obtaining three-dimensional information about the scene.

[0040] S ce to calculate .

[0041] A preferred application of the invention provides that an optical identification device, for example the one already mentioned, is directed through the controlled environment to a port leading to the supply. This allows the optical identification device to be arranged, for example, at a location desired by a user outside the controlled environment. The controlled environment can have walls that are at least partially transparent, preferably partial glass panes, which allows the optical identification device to see through the controlled environment. In particular, it can be provided that the optical identification device is directed through the controlled environment to a port leading to the supply, for detecting container parts in a removal area. This allows, for example, the container parts in a removal area to be identified.Alternatively or additionally, the optical identification device can be directed through the controlled environment toward a port leading to the supply, for detecting the fill level of the supply. This can, for example, make it possible for the optical identification device to detect the fill level of the supply through the controlled environment.

[0042] Alternatively or additionally, the features of the fourth independent claim directed to a method are provided to achieve the stated object. In particular, it is therefore proposed in the method that the container part is removed from the supply using a removal instrument and that the container parts are reoriented in the supply. This can, for example, result in a container part being available for reception as a result of the reorientation. In particular, it is provided that the container part is a closure element. Preferably, the container parts are removed individually from the supply. In particular, it is provided that the bulk material density remains the same during the reorientation. This can result in an advantageous presentation of the container parts. In particular, it is provided that the container parts are reoriented when no container part can be removed using the removal instrument.This makes it possible to detect when no container part can be picked up by the removal instrument and to reorientate it in order to provide a container part for picking up.

[0043] A preferred application of the invention provides that the reorientation is brought about by an external influence on the container parts. This can achieve that the container parts are reoriented and made ready for reception by the removal instrument. In particular, it can be provided that the influence is brought about from outside a bag or container holding the supply. This can achieve, for example, that the container parts are not contaminated during reorientation. Preferably, the reorientation is brought about by a local change to the supply. This can achieve, for example, that an influence only needs to be exerted on a certain part of the supply and not the entire supply has to be influenced. Alternatively or additionally, it can be provided that the reorientation is brought about by shaking the supply.

[0044] By shaking, for example, the container parts can be reoriented quickly and easily. Alternatively or additionally, the reorientation can be effected by acting on a bag or container holding the supply. This can, for example, make it possible for the action to be taken directly on the bag or container and for the container parts to remain in the bag or container for reorientation. A container can, for example, also be designed as a closed tub, wherein a closure of the tub is opened after docking at a port.

[0045] In a bag, for example, a flexible wall can be deformed from the outside to reorient the container parts inside or to cause them to slide. In a container, for example, rigid wall sections can be repositioned or shaken to reorient the container parts inside or to cause them to slide.

[0046] A preferred application of the invention provides that by moving the container part from the supply into the removal area, a reorientation of at least individual container parts is brought about. This can, for example, result in the container parts being reoriented in the removal area and advantageously being made available for pickup with the removal instrument. Alternatively or additionally, it can be provided that a reorientation of the fill level or a fill level of the supply is brought about. This can, for example, result in the fill level of the supply being such that a container part is presented for pickup.

[0047] Alternatively or additionally, the features of the fifth independent claim directed to a method are provided to achieve the stated object. In particular, the method proposes that the container part is removed from the supply using the or a removal instrument and is inspected using sensors. This allows, for example, the container part to be checked for its quality, shape, size and structure. In particular, the sensory inspection can be carried out optically. This allows the container part to be inspected without contact, which reduces the risk of contamination of the product to be sealed, preferably a pharmaceutical.

[0048] Alternatively or additionally, it can be provided that the container part is subjected to a processing step. This processing step can take place within the controlled environment and / or after removal from the supply. This can, for example, achieve that the container part is changed from an undesirable state to a desired state. In particular, the container part can be subjected to sterilization. This can, for example, achieve that an existing substance, for example a germ load, on the container part is brought below a threshold value or is reduced to preferably zero.

[0049] Alternatively or additionally, the container part can be subjected to decontamination. This can, for example, result in a depletion of a substance, such as a microbial contamination, on the container part.

[0050] A preferred application of the invention provides that an image of the closure element is recorded for the optical inspection. This allows the inspection to be carried out, for example, on an image and in real time or with a time delay. If the image is saved, the inspection can also be repeated. It can preferably be provided that the image is two-dimensional. This can, for example, make it possible for the image to have a small file size and be processed quickly. It can preferably be provided that the container part is held on the removal instrument. This can, for example, make it possible for the inspection to be carried out very quickly because the container part does not have to be specially stored for the inspection. Alternatively or additionally, it can be provided that the optical inspection serves to assess shape stability.This can, for example, make it possible for container parts that do not have the required shape to be identified and / or sorted out / treated separately. Alternatively or additionally, the optical inspection can be used to assess contamination. This can, for example, make it possible for a contaminated container part to be identified. The optical inspection can be carried out at an optical inspection station, where an image can be captured using a sensor, e.g., a camera.

[0051] A preferred application of the invention provides that contaminated container parts can be detected. Contamination can be understood as particulate contamination and / or microbial contamination. Alternatively or additionally, it can be provided that the optical inspection serves to assess integrity. This can, for example, make it possible to detect container parts that are not intact, for example broken or holey. Alternatively or additionally, it can be provided that the optical inspection serves to assess a gripping position. This can, for example, make it possible to detect the positioning of the container part on the removal instrument and to detect whether the container part is suitable for closing a container in this position. If necessary, a correction can be made or planned for a subsequent step.

[0052] Alternatively or additionally, the optical inspection may detect an incorrect geometry and / or a wrong body and / or a different format. Furthermore, the optical inspection may detect an incorrect color and / or a wrong material used, in particular an incorrect material.

[0053] A preferred application of the invention provides for the contamination of the container part to be determined by means of biofluorescence. This can, for example, make it possible to use excitation radiation to irradiate the container part, and filter the reaction radiation emitted by the container part during an analysis to assess the contamination.

[0054] A preferred application of the invention provides that, after contamination of the container part has been detected, a cleaning step is carried out. This can, for example, achieve that the contamination on the container part is removed. In particular, the cleaning step can be a decontamination step. This can, for example, achieve that the container part exhibiting the contamination is decontaminated.

[0055] A preferred application of the invention provides for the container part to be attached to the container with the removal instrument. This makes it possible, for example, for the container part to be picked up from the supply and attached to the container in a single step. It is also advantageous that the container part can, for example, close the container.

[0056] A preferred application of the invention provides that surfaces on a virtual model of the container part, which can be touched by the removal instrument, are marked. This can, for example, enable a robot or handling system to learn how to pick up the container part using the virtual model. A shape of a gripper or generally relevant parts of the removal instrument can also be stored in a virtual model in order to be able to analyze and / or verify potential effects of an air flow over the removal instrument on the presented container parts.

[0057] Another advantage is that, for example, surfaces can be identified where contact with the removal instrument is permitted. This can, for example, prevent contamination of the pharmaceutical product caused by the gripper coming into contact with wettable container parts.

[0058] A preferred application of the invention provides that the removal instrument has a positive-locking gripper. This can, for example, make it possible for the container part to be picked up securely in a positive-locking manner, for example with a fork tine or a shovel. Alternatively or additionally, it can be provided that the removal instrument has a force-locking gripper. This can, for example, make it possible for the container part to be gripped securely in a force-locking manner, for example with pliers or a suction cup.

[0059] A preferred application of the invention provides that the controlled environment is an isolator or RABS or a glove box. Open and closed RABS can be used here. This makes it possible to apply a previously described method in an isolator or RABS (restricted access barrier system). The simplification of the assembly method according to the invention is particularly advantageous in systems that require complex cleaning and / or decontamination because internal structures for transferring supplies of container parts through a port or opening into the controlled environment can be largely dispensed with. Alternatively or additionally, it can be provided that a gas flow, preferably an air flow, is generated at least locally in the controlled environment.This makes it possible to ensure that particles that are unintentionally generated, for example due to mechanical movement, are transported in a defined manner. In particular, the gas flow is generated in such a way that a preferred flow direction is defined. This can, for example, ensure that the gas flows in a defined direction and particles are transported in this direction and cannot move against this direction. For example, the preferred flow direction in the insulator runs from top to bottom.

[0060] A preferred application of the invention provides that the removal instrument and the supply are arranged in such a way that the potential transport of contaminants from the removal instrument to the supply is kept to a minimum with respect to a preferred flow direction, for example the one already mentioned. In this way, it can be achieved, for example, that the preferred flow direction flows over the supply in such a way that contaminants coming from the removal instrument only impair the supply to a minimal extent. Alternatively or additionally, it can be provided that the removal instrument is guided in such a way that the potential transport of contaminants from the removal instrument to the supply is kept to a minimum with respect to a preferred flow direction.For example, a shape of a relevant part of the sampling instrument, for example a gripper, in particular a localization of potential particle sources on the sampling instrument, can be stored and / or taken into account.

[0061] This can, for example, make it possible for

[0062] Contaminants coming from the extraction instrument are kept away from the reservoir by the preferential flow direction. In particular, it can be provided that the extraction instrument for receiving a container part is guided in such a way that the potential transport of contaminants from the extraction instrument to the reservoir is kept to a minimum with respect to a preferential flow direction. This can, for example, ensure that when the container part is received, the preferential flow ensures that contamination of the reservoir is kept to a minimum.

[0063] In particular, it is intended to prevent the transport of contaminants from the extraction instrument to the reservoir with respect to a preferred flow direction. This can, for example, ensure that the preferred flow direction flows over the reservoir in such a way that contaminants coming from the extraction instrument do not impair or reach the reservoir. The preferred flow direction can help keep contamination of the reservoir and the container components as low as possible.

[0064] A preferred application of the invention provides that the container parts to be removed from the supply are selected in such a way that the distance traveled by the removal instrument over the supply is minimized. This can, for example, make it possible to minimize and / or avoid the distance and time traveled by the removal instrument over the supply of the container parts exposed in the removal point or the removal area, and thus also the potential contamination of the supply by the removal instrument. Alternatively or additionally, it can be provided that the overshadowed area traveled by the removal instrument over the supply is minimized. This can, for example, make it possible to

[0065] The area that the extraction instrument describes above the supply is minimized, and thus also potential contamination. Alternatively or additionally, it is provided that the container parts to be removed from the extraction area are selected in such a way that the distance that the extraction instrument covers above the extraction area is minimized. This can, for example, make it possible for the extraction area to be potentially less contaminated, since the distance and time that the extraction instrument covers above the extraction area are shorter or smaller. Alternatively or additionally, it can be provided that the container parts to be removed from the extraction area are selected in such a way that the overshadowing area that the extraction instrument describes above the supply is minimized.This can, for example, make it possible to minimize the area that the sampling instrument describes over the sampling area and thus also potential contamination.

[0066] A preferred application of the invention provides that the container part is deposited at an intermediate station for attachment to the container. This can, for example, make it possible to correct the positioning of the container part for attachment to the container. Alternatively or additionally, it can be provided that the container part is held at an intermediate station for attachment to the container. This can, for example, make it possible to inspect the container part.

[0067] A preferred application of the invention provides that the container is fed with a magnetically levitated transport unit before the container part is attached. This can, for example, make it possible for the remaining container, for example a container part to be filled, to be brought into a position that is suitable for the attachment of the closing container part. Alternatively or additionally, it can be provided that the container is transported away with a magnetically levitated transport unit after the closing container part has been attached or is made available to such a transport unit for further processing. This can, for example, make it possible for the container closed with the container part to be brought to a position desired by a user.

[0068] A preferred application of the invention provides that a decontamination step is carried out before the supply is opened. This can, for example, make it possible for the controlled environment to be decontaminated, for example with hydrogen peroxide. In particular, it can be provided that a port through which the supply is to be accessible is released after the decontamination step has been carried out. This can, for example, make it possible for the port to be opened only after decontamination and upon release. The release should preferably take place automatically. This can, for example, make it possible for the end of the decontamination phase to be detected automatically and the port to then be released. This can make human interaction unnecessary and save costs.

[0069] A preferred application of the invention provides that before picking up the container part, its position is automatically determined. This can, for example, achieve that only a container part is picked up whose position, for example the distance of the container part to an edge of the supply, preferably the removal area, is suitable for picking up. Alternatively or additionally, it can be provided that before picking up the container part, its orientation is determined. This can, for example, achieve that only a container part is picked up whose

[0070] Orientation, for example which surface of the

[0071] Container part is presented for receiving, is suitable for receiving.

[0072] Furthermore, it can be provided that, before the container part is picked up, a control of the removal instrument is automatically calculated from its position and / or orientation.

[0073] A preferred application of the invention provides for the container to be filled in the controlled environment before, during, or after the attachment of the container part. This makes it possible, for example, for the filling of the container and the attachment of the container part to take place sequentially or simultaneously.

[0074] To achieve the object stated at the outset, the invention provides the features of the independent claim directed to a closing device. In particular, it is proposed that the closing device be configured to attach a container part to a container in a controlled environment, with means for carrying out the method described above. This can, for example, make it possible to carry out the method described above, i.e., for example, the closing device can pick up the container part from the supply in the controlled environment with the removal instrument and attach it to the container.Alternatively or additionally, it is provided that the closing device for attaching the container part to the container in the controlled environment is designed with individual or multiple elements from the group consisting of a movable removal instrument, a handling system, a controlled environment, a port, an optical identification device, a closing station or an optical control station. The container part can, for example, be picked up with the removal instrument. The removal instrument can preferably move in multiple axes. This can, for example, make it possible for the container part to be picked up in different layers and positions. Alternatively or additionally, it can be provided that the removal instrument is controllable. This can, for example, make it possible for control commands to be transmitted to the removal instrument.The handling system can, for example, make it possible for the container part to be picked up, transported and / or set down in a defined position. Alternatively or additionally, a robot can be provided. This can, for example, make it possible for the removal instrument to be attached to the robot and for the container to be picked up from a supply and closed. The controlled environment can protect a process taking place within it from contamination, whereby the controlled environment can be an isolator or RABS. Container parts can, for example, be transferred from the outside into the interior of the controlled environment through the port. A bag can preferably be connected to the port. This can, for example, make it possible for the container parts to be stored in the bag.The optical identification device can, for example, recognize the position, shape and orientation of the container parts and process this information so that the removal instrument can pick up a container part. The closing station can, for example, enable the container to be closed with the container part. The optical inspection station can, for example, detect contamination, for example bacterial contamination and / or a change in shape and / or damage to the container part. The optical inspection can also be used to assess a gripping position. In particular, the optical inspection station can be a device for taking an image. This device can, for example, be an optical camera. This can, for example, make it possible to take the images cost-effectively. The device preferably takes two-dimensional images.This can, for example, make it possible for them to require only a small amount of storage space and be processed quickly. In particular, the closing device is designed and / or configured to carry out a method according to one of the claims described above. This can, for example, make it possible for the closing device to carry out the method.

[0075] The removal instrument can be designed as a multiple removal instrument. The removal instrument can thus, for example, pick up several, in particular two, container parts from the supply. The removal instrument can place several container parts that it has picked up from the supply, for example two plugs, directly onto two containers in order to close the containers. In this case, it can be provided that the container parts in the supply are at a different distance from one another than the containers onto which the container parts are to be placed. It can therefore be provided that the removal instrument can change the distance between two gripped container parts so that the two container parts can be placed on two or more containers.

[0076] It may be provided that several sampling instruments are arranged in the controlled environment, which simultaneously or alternately remove container parts from the supply. The sampling instruments can be arranged in or next to the sampling area.

[0077] The removal instrument can remove the container parts according to the “First

[0078] Air" principle from the supply. The term "First Air" means that fluid, in particular air, which escapes from a terminal (HEPA) filter in a controlled environment, preferably an isolator, directly hits or passes over objects, in particular their surfaces, which are subsequently exposed to direct product contact, or those surfaces which have contact with an object with later direct product contact.

[0079] In particular, this means that the fluid does not touch or pass over any surface other than those surfaces which are later exposed to direct or indirect product contact.

[0080] Such objects and / or surfaces are in particular the product itself, (internal) surfaces of a container, preferably a vial, a syringe or carpule (cylindrical ampoule), the surfaces of closure means such as stoppers or plungers that later face the product, or components that are located nearby, in particular above the objects that have not yet been closed. This particularly refers to containers along a processing line, as used in filling machines in the "Aseptic Fill Finish" area. The container parts can therefore be picked up from the supply by the removal instrument in such a way that the side of the container part that later comes into contact with a product is not touched by the removal instrument or swept over by it.

[0081] The process sequence for picking up the container part from the stock can proceed as follows: The identification device, for example a camera, takes a picture of the container parts in the stock, with the position of the container parts being calculated by a computer program. One or more container parts can then be identified that are suitable for removal by the removal instrument. These container parts suitable for removal can be removed by the removal instrument. It is not necessary to take a new picture of the container parts after each removal. This can save computing time and speed up removal. However, a new picture can also be taken after each removal, although for example it is only checked whether a container part that was previously suitable for removal is still suitable for removal.In this case, the computer program's calculation can be limited to a partial section of the stock, thus saving computing time. If it turns out that the container part intended for removal is, contrary to assumption, not suitable for removal, the remaining image section can be analyzed to identify suitable container parts.

[0082] The identification device can be located outside and / or inside the controlled environment. The identification device can also be encapsulated within the controlled environment. The identification device can, for example, be integrated directly into the sampling instrument, i.e., arranged close to the robot's gripper. The identification device can also be arranged in the port of the controlled environment. The identification unit can also be designed to be suitable for cleanroom use, easy to clean, and / or resistant to decontaminants, preferably resistant to H2O2.

[0083] The identification device can control one or more sampling instruments. The identification device can be directed at one or more sampling areas.

[0084] After picking up the container part from the supply, the removal instrument can deposit the container part on an intermediate station. The intermediate station can be, for example, a closing station or a magnetically levitable transport unit for depositing or transporting the container part to a further process station. Levitable transport units are known from practice, for example as part of a planar motor, such as the "Xplanar" system from Beckhof f Automation GmbH & Co. KG in Verl, Germany, or the "ctrlX FLOW6D" system from Bosch Rexroth AG in Lohr am Main, Germany, and are used, for example, to move and / or hold a payload in a controlled manner.

[0085] The invention will now be described in more detail using an exemplary embodiment, but is not limited to the exemplary embodiment. Further exemplary embodiments result from combining the features of one or more claims with one another and / or with one or more features of the exemplary embodiment.

[0086] It shows

[0087] Fig. 1 shows a closing device in a side view in a first method step (identification of a container part),

[0088] Fig. 2 shows the closing device in a further side view in a further process step (approaching the removal instrument),

[0089] Fig. 3 shows the closing device from Fig. 1 in a further side view in a further process step (picking up a container part),

[0090] Fig. 4 shows the closing device from Fig. 1 in a further side view in a further process step (presentation on an optical

[0091] control station),

[0092] Fig. 5 shows the closing device from Fig. 1 in a further side view in a further process step (closing a container),

[0093] Fig. 6 shows a further closing device with modified air flow in a side view,

[0094] Fig. 7 shows an empty opened container and a container part in a side view,

[0095] Fig. 8 the empty opened container and the container part in a further side view for marking wettable surfaces,

[0096] Fig. 9 shows a filled open container and a container part in a side view,

[0097] Fig. 10 shows a filled closed container and the container part in a side view,

[0098] Fig. 11 shows another closure device with a multiple removal instrument,

[0099] Fig. 12 shows a further closing device with a further variant of a port with a shaking unit,

[0100] Fig. 13 shows another closing device with a lock and a supply presented in the controlled environment in a container, in particular a tub,

[0101] Fig. 14 shows a supply in a controlled zone inside a bag before docking to a port,

[0102] Fig. 15 shows the supply from Fig. 13 in docked position,

[0103] Fig. 16 shows the supply from Fig. 13 with the port open,

[0104] Fig. 17 shows another closing device with a removal instrument with several grippers and

[0105] Fig. 18 shows a further closing device in a plan view with several handling systems.

[0106] Figure 1 shows a closure device 1 for manipulating 2 a container part 3 in a controlled environment 4. The container part 3 is stored in a supply 5 having a homogeneous bulk density 6. The container part 3 can be removed individually from the supply 5 using an automated removal instrument 7. The removal of a container part 3, which in the illustrated embodiment is a closure element 8, is shown in Fig. 3.

[0107] Container parts 3 and container 9 are shown in Figs. 7-10. There, it can be seen that the container parts 3 have a surface 11 that can be wetted by the container contents 10. On one of the wettable surfaces 11, the container parts 3 also have a non-wetted surface 12 that is not wetted by the container contents 10 during use.

[0108] The container part 3 consists of an elastic material and is designed as a closure element 8 and is part of a pharmaceutical container 9. In this embodiment, the container part 3 can securely close a pharmaceutical container 9. The closure element 8 is designed here as a plug. As a result, the container part 3 has a surface that can be wetted by a container content 10. One or more closure elements 8 can be removed from the supply 5 using the removal instrument 7. This enables efficient working because many closure elements 8 can be processed quickly.

[0109] In the drawing, a removal instrument 7 is designed to remove a single closure element 8.

[0110] In further embodiments, the removal instrument

[0111] 7 for the simultaneous removal of several closure elements

[0112] 8, for example by forming several receiving positions or by several handling units which remove the same or from an identical supply of container parts.

[0113] In further embodiments, the removal instrument 7 can be configured for the successive removal of multiple closure elements 8 by successively bringing multiple receiving positions into the working position. This can be achieved, for example, by maintaining a general position of the removal instrument, such as its center of gravity and / or a central position of the receiving positions, or by relocating this general position.

[0114] In further embodiments, for example, an outer attachment part of a pharmaceutical container 9 which is not wetted by a container content 10 during use, for example an aluminum cap or a medical device, is processed.

[0115] The supply 5 has a removal area 13 and a storage area 14. The removal area 13 is the area in which the container parts 3 can be received. The supply 4 is the area in which the container parts 3 are kept.

[0116] The removal instrument 7 is attached to a handling system 15 and can be moved in a controlled manner on at least three axes 30 to pick up a container part 3. In an exemplary embodiment not shown, the removal instrument 7 is attached to another robot. The removal instrument 7 picks up the container part 3 on the side 16 facing away from the surface 11 that can be wetted by the container contents 10. In the exemplary embodiment shown, the container part 3 is sucked in. In an exemplary embodiment not shown, the container part 3 is gripped. In an exemplary embodiment not shown, the container part 3 is picked up on a side that is spaced apart from the surface 11 that can be wetted by the container contents 10. The picking up of a container part 3 with the removal instrument 7 is shown in Fig. 3.

[0117] 1-6 show a method for attaching the container part 3, which is designed as a closure element 8, to the filled container 9 in the controlled environment 4. The closure element 8 is stored in the supply 5, which is connected to the controlled environment 4 from the outside via a port 17. The container part 3 is removed individually from the supply 5 through the port 17 for attachment. This method step is shown in Fig. 3, where the removal instrument 7 reaches through the port 17 into the supply 5 to receive a container part 3.

[0118] The sampling instrument 7 is moved at a distance from a boundary 18 of the port 17. The reservoir 5 is spatially separated from the controlled environment 4. The boundary 18 is to be understood here as the frame of the port 17.

[0119] The method for attaching the container part 3 also includes feeding the supply 5 into the removal area 13. The feeding takes place when the fill level 19 runs out of the removal area 13 of the supply 5. The feeding thus causes the fill level 19 to return to the removal area 13 of the supply 5. This ensures that sufficient container parts 3 are presented for reception in the removal area 13 and can thus be picked up by the removal instrument 7.

[0120] The container part 3 picked up by the removal instrument 7 is identified in the supply 5 by an optical identification device 20 arranged outside the controlled environment 4 (Fig. 1). The optical identification device 20 views the supply through an inspection window 39.

[0121] A movement sequence for the removal instrument 7 is determined and executed with the aid of a computer (Fig. 2). The movement sequence begins with the selection of a container part 3, to which the removal instrument 7 must pass through as few other container parts 3 of the supply 5 as possible. This reduces the risk of transferring contamination from the removal instrument 7 to the supply 5. In this case and when calculating the movement sequence, the air flow 40, which potentially causes a transfer of contamination, is taken into account.

[0122] The container part 3 can then be removed individually from the supply 5 by the removal instrument 7 (Fig. 3). The optical identification device 20 is directed through the controlled environment 4 onto the port 17 leading to the supply 5 in order to detect the container parts 3 in the removal area 13. The identification device 20 can also be used to detect the fill level 19 of the supply 5. In the embodiment shown in Fig. 17, the identification unit is positioned in the handling system itself. In further embodiments, the identification device can be positioned at other suitable locations inside or outside.

[0123] When no more container parts 3 can be removed from the supply 5, the container parts 3 are reoriented while the bulk material density 6 remains the same. This can happen when the container parts 3 have assumed a position in which they can no longer be picked up by the removal instrument 7. The reorientation can be brought about by an external influence 21 on the container parts 3. A local change to the supply 5 is brought about on the bag 22 in which the container parts 3 are stored, for example by shaking or an external influence 21. By feeding the container parts 3 from the supply 5 into the removal area 13, a reorientation of at least individual container parts 3 and an adjustment of the fill level of the supply 5 is brought about.

[0124] The container parts 3 removed with the removal instrument 7 are optically inspected after removal from the supply 5 and, if necessary, subjected to a processing step, for example sterilization and / or decontamination (Fig. 4). For the optical inspection, a two-dimensional image of the container part 3 held on the removal instrument 7 is taken. This optical inspection serves to assess the shape retention, contamination, integrity and gripping position of the container part 3. The contamination can be determined, for example, by means of biofluorescence. After contamination is detected, a cleaning step is carried out on the container part 3, which

[0125] Decontamination step can be carried out. The optical inspection is carried out using an optical inspection station 28. The optical inspection station 28 has a camera as an optical sensor.

[0126] In Fig. 5 it can be seen that the container part 3 with the removal instrument 7 is attached to the container 9.

[0127] On a virtual model of the container part 3, surfaces 12 are marked at which contact by the removal instrument 7 is permitted.

[0128] The removal instrument 7 has a force-locking gripper for receiving the container part 3. In an embodiment not shown, the removal instrument 7 has a form-locking gripper for receiving it.

[0129] In the illustrated embodiment, the controlled environment 4 is an isolator 23 in which a local gas flow 24, here an air flow, is generated, which defines a preferred flow direction 25. The gas flow 24 flows through the isolator 23 in the preferred flow direction 25. A potential transport of contaminants from the sampling instrument 7 to the reservoir, with respect to the preferred flow direction 25, is thus avoided. The particles potentially falling from the sampling instrument 7 are deflected away from the reservoir 5 by the gas flow 23.

[0130] During the removal process, the container parts 3 are selected from the supply 5 in such a way that a distance and / or an overshadowing area that the removal instrument 7 travels or describes above the supply 5 is minimized. The shorter the distance the removal instrument 7 is moved above the supply 5, the smaller the probability that it can contaminate the supply 5 with falling particles. The same naturally also applies to other parts of the handling system, for example the robot arm.

[0131] In the embodiment shown in Fig. 17, the container part 3 is placed and / or held at an intermediate station 42 for attachment to the container 9.

[0132] Before the container part 3 is attached to the container 9, the container is fed with a magnetically levitated transport unit. After the container part 3 is attached, the container is transported away with the magnetically levitated transport unit 26.

[0133] A decontamination step of the controlled environment is carried out at least before the first opening of the supply 5, wherein a release of the port 17 is accessible via the supply 5 and takes place automatically after the decontamination step has been carried out.

[0134] Before picking up the container part 3, its position and orientation are automatically determined. This allows it to be determined whether the container part 3 is suitable for picking up with the removal instrument 7.

[0135] The container 9 can be in the controlled environment 4 before, during or after the container part 9 is attached.

[0136] The closing device 1 for attaching the container part 3 to the container 9 in a controlled environment 4 comprises the multi-axis movable and controllable removal instrument 7, the handling system 15 or a robot, the controlled environment 4, the port 17 designed to connect the bag 22, the optical identification device 20, a closing station 27 at which the container 9 is closed, the optical control station 27 for recording a two-dimensional image.

[0137] Figs. 7-10 show the container 9 and the container part 3, which is attached to the container 9 to close it. The wettable surface 11 of the container part 3 faces the container contents 10, for example a liquid. The surface 12 is not in contact with the container contents 10, since that is the side 16 where the removal instrument 7 receives the container part 3.

[0138] In Fig. 8, the dashed line represents the imaginary liquid film that may adhere to the wettable surface. This area must not be touched under any circumstances.

[0139] Figure 11 shows a further closure device 1. Components and functional units that are structurally and / or functionally similar or identical to the preceding embodiments are shown in a comparable manner and / or are designated by the same reference numerals. The statements regarding the preceding figures therefore apply accordingly to Figure 11.

[0140] The embodiment according to Figure 11 differs by the use of a gripper 30 designed as a double gripper on the removal instrument 7.

[0141] The movement sequence can be set up for the simultaneous reception of several container parts 3 or for the successive reception of individual container parts 3.

[0142] Figure 12 shows a further closure device 1 according to the invention. Again, functionally and / or structurally similar and / or identical components and functional units are shown identically and designated by the same reference symbols. The statements regarding the preceding figures therefore apply accordingly to Figure 12.

[0143] The embodiment according to Figure 12 has a transport unit 26 that is magnetically coupled to a magnetic field generator 38 through the insulator 23. The magnetic field generator 38 is configured to generate a moving magnetic field through which the transport unit 26 can be moved in a targeted manner, by suitable energization of coils and / or suitable movement of permanent magnets and / or by other measures.

[0144] The embodiment according to Figure 12 also has a shaking unit 37, which can be used to act on the supply 5 from the outside through the bag 22. This can also be used effectively with non-deformable containers 41. The shaking unit 37 can also shake using ultrasound.

[0145] In a further embodiment, the external influence can also be effected using a magnetically levitated transport system.

[0146] Port 17 is designed as an RTP ( rapid transfer port ) , which is described in more detail in Figures 14 - 16 .

[0147] The differences or modifications of the embodiment according to Figure 12 compared to the preceding embodiments can also be used in the other embodiments in a corresponding modification.

[0148] The embodiment according to Figure 13 shows a further closure device 1 according to the invention. Components and functional units that are functionally and / or structurally similar and / or identical to the preceding embodiments are again designated by the same reference numerals and / or depicted in a corresponding manner.

[0149] The explanations given in the previous examples therefore apply here accordingly.

[0150] In the embodiment according to Figure 13, the port 17 is part of a lock 40.

[0151] Containers 41 can be introduced through the lock 40. A controlled zone 32 is formed inside the containers 41, in which the supply 5 with the container parts 3 is transferred.

[0152] For transfer, transport units 26 are again provided, which are magnetically coupled to the magnetic field generators 38 already described in Figure 12. These transport units 26 are thus magnetically levitated.

[0153] In the lock 40, the container 41, here a tab with a covering layer, is decontaminated on the outside.

[0154] The container 41 is then opened, for example with the removal instrument 7, in order to then carry out the removal of the container parts 3 through the created opening.

[0155] The differences or modifications of the embodiment according to Figure 13 compared to the preceding embodiments can also be used in the other embodiments with corresponding modifications.

[0156] Figures 14-16 show a simplified sequence of movements when presenting a supply 5 of container parts 3.

[0157] The supply 5 is sterilized and protected from external influences and contamination in a bag 22, so that a controlled zone 32 is created inside the bag 22 (which in other embodiments can also be a container 41). This zone is closed by a lid 34. In a first step (Figure 15), the lid 34 is docked to the port 17. As a result, a door 33 covers the lid 34 and, in particular, its outer contaminated surface as completely as possible.

[0158] It is already apparent from the drawing that at interface 31 there remains an area called "ring of concern" (known to the person skilled in the art) in which contamination could not be completely covered.

[0159] This becomes apparent when the lid with the door 33 is pivoted inwards ( Figure 16 ).

[0160] The movement sequence for removing the container parts 3 is now controlled in such a way that a distance is maintained from these potentially contaminated areas, so that they do not have to be covered or bridged after opening the port 17, as was previously the case.

[0161] In Fig. 13, the supply 5 is arranged in a container 41, wherein the container stands on a magnetically levitable transport unit 26. Should the identification device 20 determine that no or insufficient container parts 3 are available for removal by the removal instrument 7, the magnetically levitable transport unit 26 can shake the container 41 and thus realign the container parts 3.

[0162] Fig. 17 shows a closing device 1 in a side view. In this exemplary embodiment, the removal instrument 7 comprises three grippers 30 which can remove the container parts 3 one after the other or simultaneously from the supply 5. To check the orientation of the container parts 3, the identification device 20 is arranged on the handling unit 15. However, the identification device 20 can also be arranged directly on the removal instrument 7. A change 43 in the distance between the grippers 30 to one another is possible. In this way, the removal instrument 7 can adapt flexibly to the arrangement of the container parts 3 in the removal area 13 and / or can set the picked up container parts 3 at a defined distance and pass the container parts 3 on in this way. In the exemplary embodiment, the container parts 3 are deposited on the intermediate station 42 after removal.

[0163] Fig. 18 shows a plan view of a closing device 1, wherein the side walls have not been shown in order to clarify that the controlled environment 4 extends even further. The controlled environment 4 can be open or closed. In the exemplary embodiment, the controlled environment 4 has two handling systems 15 which, controlled by an identification unit (not shown), successively or simultaneously pick up container parts 3 from the removal area 13 of the supply 5. The container parts 3 are deposited on the intermediate station 42. From there, the container parts 3 can be placed on containers 9 located on transport units 26.

[0164] A method for manipulating a container part 3 in a controlled environment 4 and a closing device 1 for carrying out the method are proposed, wherein the container part 3 is stored in a supply 5 which has a homogeneous bulk density 6 of the container part 3, characterized in that the container part 3 is picked up from the supply 5 with a, preferably automated, removal instrument 7, preferably individually.

[0165] / List of reference symbols List of reference symbols

[0166] Manipulating the locking device

[0167] Container part

[0168] Controlled environment

[0169] stock

[0170] Pour well dense

[0171] Collection instrument

[0172] locking element

[0173] container

[0174] Retains contents wettable surface non-wetted surface removal area

[0175] Storage area handling system

[0176] Page

[0177] port

[0178] Limitation

[0179] Fill level

[0180] Identification device impact

[0181] bag

[0182] I insulator

[0183] Gas flow

[0184] Preferred flow direction Transport unit Closing station Optical control station Axis

[0185] Gripper

[0186] Interface controlled zone door 34 cover

[0187] 35 Supply air opening

[0188] 36 Exhaust air opening

[0189] 37 Shaking unit 38 Magnetic field generator

[0190] 39 inspection windows

[0191] 40 Lock

[0192] 41 containers

[0193] 42 Intermediate station 43 Distance change

[0194] / Claims

Claims

Claims 1. Method for manipulating (2) a container part (3) in a controlled environment (4), wherein the container part (3) is stored in a supply which has a homogeneous bulk density (6) of the container part (3), characterized in that the container part (3) is picked up from the supply (5) with a preferably automated removal instrument (7), preferably individually.

2. Method according to claim 1, characterized in that the container part (3) has at least one surface (11) wettable by a container content (10) or that the container part (3) is not wetted by a container content (10) during use.

3. Method according to one of the preceding claims, characterized in that the container part (3) consists of an elastic material and / or is designed as a closure element (8) and / or that the container part (3) is part of a pharmaceutical container (9).

4. Method according to one of the preceding claims, characterized in that one or more container parts (3) picked up by the removal instrument (7) are removed by the latter from the supply (5).

5. Method according to one of the preceding claims, characterized in that the removal instrument (7) removes at least two container parts (3) from the supply (5) in one removal process, preferably simultaneously.

6. Method according to one of the preceding claims, characterized in that the supply (5) has a removal area (13) and a storage area (14).

7. Method according to one of the preceding claims, characterized in that the removal instrument (7) is attached to a Handling system (15) or robot is attached and / or that the removal instrument (7) is moved for receiving on at least three, preferably at least four or at least five or at least six, axes (29), preferably in a controlled manner.

8. Method according to one of the preceding claims, characterized in that the removal instrument (7) receives, in particular grips and / or sucks in, the container part (3) on a side (16) facing away from and / or spaced from the surface (11) that can be wetted by a container content (10).

9. Method for attaching a container part (3), in particular a closure element (8), to a container (9), in particular according to the preamble of claim 1 or according to one of the preceding claims, wherein the preferably filled container (9) is arranged in a controlled environment (4), wherein the container part (3), in particular a closure element (8), is stored in a supply (5) which is connected to the controlled environment (4) from the outside via a port (17), characterized in that the container part (3), in particular a closure element (8), is removed from the supply (5) through the port with the or a removal instrument (7), preferably individually.

10. Method according to one of the preceding claims, characterized in that the removal instrument (7) is moved at a distance from a boundary (18) and / or a potentially contaminated interface (31) of the port (17) and / or that the supply (5) is spatially separated from the controlled environment (4) by the port (17).

11. Method for attaching a container part (3), in particular a closure element (8), to a container (9), in particular according to the preamble of claim 1 or 9 or according to one of the preceding claims, wherein the preferably filled container (9) is arranged in a controlled environment (4), wherein the container part (3), in particular closure element (8), is stored in a supply (5), characterized in that the container part (3), in particular closure element (8), is removed from the supply (5) with the or a removal instrument (7) in a removal area (13), preferably individually, and that the supply (5) is fed into the removal area (13).

12. Method according to one of the preceding claims, characterized in that the adjustment takes place when the filling level (19) runs out of the removal area (13) of the supply (5) and / or that the adjustment causes a return of one or the filling level (19) into the or a removal area (13) of the supply (5).

13. Method for attaching a container part (3), in particular a closure element (8), to a container (9), in particular according to the preamble of one of claims 1, 9 or 11 or according to one of the preceding claims, wherein the preferably filled container (9) is arranged in a controlled environment (4), wherein the container part (3), in particular a closure element (8), is stored in a supply (5), characterized in that the container part (3), in particular a closure element (8), is identified in a supply (5) with a sensory, in particular optical, identification device (20), preferably arranged outside the controlled environment (4), and is removed from the supply (5) with the or a removal instrument (7), preferably individually.

14. Method according to one of the preceding claims, characterized characterized in that one or the optical identification device (20) is directed through the controlled environment (4) to a port (17) leading to the supply (5), in particular for detecting container parts (3) in a removal area (13) and / or a filling level (19) of the supply.

15. Method for attaching a container part (3), in particular a closure element (8), to a container (9), in particular according to the preamble of one of claims 1, 9, 11 or 13 or according to one of the preceding claims, wherein the preferably filled container (9) is arranged in a controlled environment (4), wherein the container part (3), in particular a closure element (8), is stored in a supply (5), characterized in that the container part (3), in particular a closure element (8), is removed from the supply (5) using a removal instrument (7), preferably individually, and that the container parts (3), in particular closure elements (8), are reoriented in the supply (5), in particular while the bulk material density (6) remains the same, in particular when no container part (3) can be removed using the removal instrument (7).

16. Method according to one of the preceding claims, characterized in that the reorientation is brought about by an action (21) from outside on the container parts (3), in particular from outside a bag (22) or container receiving the supply (5), preferably by a local change to the supply (5), and / or by shaking the supply (5), and / or that the reorientation is brought about by an action (21) on a bag (22) receiving the supply (5).

17. Method according to one of the preceding claims, characterized in that by tracking the container part (3) from the supply (5) into the removal area (13) a reorientation of at least individual container parts (3) and / or a tracking of the or a filling level (19) of the supply (5) is effected.

18. Method for attaching a container part (3), in particular a closure element (8), to a container (9), in particular according to the preamble of one of claims 1, 9, 11, 13 or 15 or according to one of the preceding claims, wherein the preferably filled container (9) is arranged in a controlled environment (4), wherein the container part (3), in particular a closure element (8), is stored in a supply (5), characterized in that the container part (3), in particular a closure element (8), is removed from the supply (5) with the or a removal instrument (7), preferably individually, and is checked by sensors, in particular optically, and / or is subjected to a processing step, in particular sterilization and / or decontamination.

19. Method according to one of the preceding claims, characterized in that for the optical inspection a preferably two-dimensional image of the container part (3), in particular the closure element (8), preferably held on the removal instrument (7), is recorded and / or that the optical inspection serves to assess a shape retention and / or contamination and / or integrity and / or a gripping position of the container part (3).

20. Method according to one of the preceding claims, characterized in that the contamination of the container part (3) is determined by means of biofluorescence.

21. Method according to one of the preceding claims, characterized in that after detecting contamination of the container part (3), a cleaning step is carried out on the container part (3), in particular a decontamination step, is carried out.

22. Method according to one of the preceding claims, characterized in that the container part (3) with the removal instrument (7) is attached to the container (9).

23. Method according to one of the preceding claims, characterized in that surfaces (12) on which contact by the removal instrument (7) is permitted are marked on a virtual model of the container part (3).

24. Method according to one of the preceding claims, characterized in that the removal instrument (7) has a positive and / or non-positive gripper (30).

25. Method according to one of the preceding claims, characterized in that the controlled environment (4) is an isolator (23) or RABS and / or that in the controlled environment (4) at least locally a gas flow (24), in particular air flow, is generated, in particular such that a preferred flow direction (25) is defined.

26. Method according to one of the preceding claims, characterized in that the removal instrument (7) and the supply (5) are arranged relative to one another and / or the removal instrument (7), in particular for receiving a container part (3), is guided in such a way that a potential transport of contaminants from the removal instrument (7) to the supply (5) is kept to a minimum, in particular avoided, with respect to one or the preferred flow direction (25).

27. Method according to one of the preceding claims, characterized in that the container parts (3) to be removed from the supply (5) and / or the removal area (13) are be selected such that a distance and / or an overshadowing area that the removal instrument (7) travels over the supply (5) and / or the removal area (13) is minimized.

28. Method according to one of the preceding claims, characterized in that the container part (3) is placed and / or held at an intermediate station (42) for attachment to the container (9).

29. Method according to one of the preceding claims, characterized in that the container (9) is supplied with a magnetically levitated transport unit (26) before the container part (3) is attached and / or that the container (9) is transported away with a magnetically levitated transport unit (26) after the container part (3) has been attached.

30. Method according to one of the preceding claims, characterized in that a decontamination step is carried out before opening the supply (5), in particular wherein a port (17) through which the supply (5) is to be accessible is released, preferably automatically, after carrying out the decontamination step.

31. Method according to one of the preceding claims, characterized in that before picking up the container part (3) its position and / or orientation is automatically determined.

32. Method according to one of the preceding claims, characterized in that the container (9) is filled before, during or after the attachment of the container part (3) in the controlled environment (4).

33. Closing device (1) for attaching a container part (3), in particular closure element (8), on a, preferably pharmaceutical, container (9) in a controlled environment (4), with means for carrying out a method according to one of the preceding claims and / or with individual or with several elements from a group of - a removal instrument (7) which is preferably movable and / or controllable in multiple axes, - a handling system (15) and / or a robot, - a controlled environment (4) , - a port (17), preferably designed to connect a bag (22), - an optical identification device (20), - a closing station (27), - an optical control station (28), in particular a device for recording an image, preferably a two-dimensional image, in particular wherein the closing device (1) is designed and / or configured to carry out a method according to one of the preceding claims. / Summary

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