ISOLATOR SYSTEM AND METHOD

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a Continuation application of International patent application PCT/EP2023/079676, filed Oct. 24, 2023, which claims the priority of German patent application DE 10 2022 128 726.2, filed Oct. 28, 2022. Both applications PCT/EP2023/079676 and DE 10 2022 128 726.2 are herewith incorporated by reference in their entireties.

FIELD

The present invention generally relates to a barrier system, such as an isolator system, comprising a restricted-access environment, a feeding apparatus for feeding closure elements into the restricted-access environment, a sealing station for sealing containers by means of the fed closure elements, and a handling device for transferring the fed closure elements. The present invention also generally relates to a method for processing closure elements in the restricted-access environment.

BACKGROUND

A barrier system is to be understood as a system that provides a physical and aerodynamic barrier, e.g., by means of positive air pressure, between an external environment, for example an external cleanroom environment, and a working process. In particular, a barrier system provides a restricted-access environment in which the working process can be carried out. Various barrier systems are known in the prior art. A barrier system may comprise, for example, an isolator or a restricted access barrier, a so-called RABS (“Restricted Area Barrier System”). The RABS may be an open RABS or a closed RABS.

The present disclosure primarily relates to aseptic isolators as barrier systems. However, the present disclosure may also be applied in other barrier systems, such as in an open or closed RABS.

The term “isolator” generally refers to a container that is hermetically and gas-tight sealed from the surrounding working space. A defined atmosphere can be generated within an isolator for processing sensitive or hazardous products.

In this context, isolators are commonly used in biopharmaceutical process engineering, for example as part of a filling system with multiple processing and handling stations, in order to create a high-purity or sterile, i.e., germ-free environment.

In such filling systems, containers, e.g., vials, cartridges, flasks, syringes and/or the like, may be filled with a product, e.g., a pharmaceutical or cosmetic product, in particular a liquid or a powder, and then sealed with a closure element, e.g., a stopper or a crimp cap.

To handle the containers and/or the closure elements, one or more handling devices, e.g., handling robots, may be arranged within the isolator. A filling station may be provided within the isolator for filling the containers. One or more sealing stations, e.g., a stoppering station and/or a crimping station, may be arranged within the isolator for sealing the containers. In a sealing station, each container is sealed with a closure element after filling. In particular, in a stoppering station, a stopper can be placed onto the container. In the crimping station, a crimp cap can be applied, in particular crimped, onto the container.

Feeding apparatuses can be used within the isolator for introducing or feeding closure elements into the isolator. For example, the closure elements may be provided in a transfer lock or a supply container, e.g., a beta container filled with closure elements, outside the isolator. This supply container can then be coupled from the outside to a port, e.g., an alpha-beta port, of the isolator. The feeding apparatus may comprise a chute or a pipe which can accordingly be coupled from the inside to the port. The closure elements can then, for example, be guided from the transfer lock into a collection container within the isolator via the chute or the pipe. From the collection container, the closure elements can then be conveyed, in particular individually, to the sealing station.

For example, printed publication DE 10 2021 101 384 B3 discloses a system for transporting sterile bulk closure elements from an environment of an isolator into an interior of the isolator, comprising a container for storing a supply quantity of closure elements in the environment of the isolator, an isolator opening, and a collecting device for collecting the closure elements and for providing the closure elements in the interior of the isolator, with a metering device for controlling a target quantity of closure elements to be transported from the container through the isolator opening into the collecting device.

Furthermore, printed publication EP 3 581 339 B1 discloses a transfer system for a sealed housing, wherein the sealed housing defines a first closed volume and comprises at least one sealed connection device which is intended to connect the first closed volume to a second closed volume, wherein the transfer system is intended to be arranged in the housing, wherein the transfer system comprises at least one arm which is intended to be rotatably mounted to a wall of the sealed housing via a first rotary joint having a first axis of rotation, wherein the transfer system comprises a chute, wherein the chute comprises a docking edge and a discharge edge, wherein the docking edge is configured to interact with the sealed connection device, wherein the transfer system comprises a second rotary joint between the arm and the chute, wherein the second rotary joint has a second axis of rotation.

Furthermore, printed publication WO 2021/214809 A1 discloses a device for filling containers with a powdery material, comprising a feeding station arranged for feeding a plurality of the containers; a filling station arranged downstream of the feeding station and comprising a metering arrangement configured to fill each container with a measured amount of powdery material; a sealing station arranged downstream of the filling station; and at least one handling arrangement that is movable to transport at least one container from one station to a subsequent station.

Furthermore, printed publication EP 2 801 828 A1 discloses a method for sealing vessels containing biological samples. The method comprises providing a cap supply with a plurality of caps for the vessels within compartments in a predefined geometric arrangement. The cap supply is introduced into a pre-analytical system via an interface comprising a housing. For this purpose, it is reversibly docked to a feeding device in order to introduce the cap supply into the pre-analytical system and to remove it therefrom. A cap is then removed from the supply by a robotic manipulator and transported to a workstation holding the vessels. A vessel is then sealed using the manipulator. The steps from introducing the cap supply into the pre-analytical system to sealing a vessel are then repeated a certain number of times or until all caps from the supply have been removed. Finally, the cap supply is retrieved from the pre-analytical system.

Furthermore, feeding devices are known in filling systems in which the closure elements can be inspected and defective or incorrect closure elements can be rejected. Such feeding devices comprise a conveying path or a feeding rail along which the closure elements are conveyed or guided individually. If defective closure elements are detected, they are removed or rejected from the conveying path or feeding rail.

For example, printed publication DE 10 2008 047 286 A1 discloses a device for manufacturing containers comprising a transport device which transports the containers along a predefined transport path, at least one treatment device which treats the containers in a predefined manner, a sealing device which is arranged in a transport direction of the containers downstream of the treatment device and which seals the containers with closures, and a feeding device which feeds the closures to the sealing device. In a transport direction of the closures upstream of the feeding device, an inspection device is provided which inspects the closures and which outputs at least one signal characteristic of a physical condition of the closures.

Furthermore, printed publication EP 2 733 111 A2 discloses a device for feeding container closures to a sealer in a beverage filling plant, comprising a sorting unit, an elevation conveyor, and an inspection device, wherein the inspection device is arranged upstream of the elevation conveyor.

Furthermore, printed publication DE 10 2012 216 163 A1 discloses a device for feeding closure elements, comprising a feeding rail on which the closure elements can be fed in a successive row, an optical inspection device for checking the closure elements, wherein the optical inspection device is arranged on the feeding rail, and a rejection device for ejecting closure elements identified as unsuitable.

However, the known isolator systems and methods for processing closure elements in isolators still leave room for improvement, particularly with regard to the inspection and handling of the closure elements.

SUMMARY

Against this background, it is an object of the present disclosure to provide an improved barrier system, such as an isolator system, as well as an improved method for processing closure elements in a restricted-access environment, such as one in which the processing of the closure elements is improved.

According to a first aspect, a barrier system is provided, the barrier system comprising a restricted-access environment, a feeding apparatus for feeding closure elements into the restricted-access environment, a sealing station for sealing containers using the closure elements, and a handling device for transferring the closure elements, wherein the sealing station and the handling device are arranged within the isolator, the handling device is configured to transfer a fed closure element from the feeding apparatus to an inspection position within the restricted-access environment, wherein the barrier system further comprises an inspection device, wherein the inspection device is configured to inspect the closure element at the inspection position and to determine whether the closure element has a defect, and wherein the handling device is configured to transfer the closure element from the inspection position to the sealing station when the closure element has no defect. The barrier system may be an isolator system, wherein the restricted-access environment is an isolator. Alternatively, the barrier system may also be an open or closed RABS.

According to a second aspect, a method for processing closure elements in a restricted-access environment, in particular in an isolator, is provided, the method comprising the following steps:

• • feeding the closure elements into the restricted-access environment by means of a feeding apparatus;
  • first transferring a fed closure element from the feeding apparatus to an inspection position within the restricted-access environment by means of a handling device;
  • inspecting the closure element at the inspection position by means of an inspection device, wherein the inspection device determines whether the closure element has a defect;
  • second transferring the closure element from the inspection position to a sealing station within the restricted-access environment by means of the handling device when the closure element has no defect; and
  • sealing a container in the sealing station by means of the closure element transferred to the sealing station.

The method according to the second aspect may be carried out in the barrier system according to the first aspect.

The barrier system may be an isolator system. The isolator system may preferably be part of a filling system with multiple processing and handling stations. The filling system may be, for example, a system for filling and sealing containers with a pharmaceutical or cosmetic substance. The system may comprise a filling station and at least one sealing station in the isolator. In the system, the containers are filled in the filling station and sealed in the at least one sealing station.

The isolator may comprise an interior. The isolator is preferably an aseptic isolator. An aseptic isolator comprises a high-purity or sterile, i.e., germ-free, environment in the interior. In the isolator, in the interior of the isolator, the feeding apparatus, the sealing apparatus, and the handling device are arranged.

The isolator system may comprise a transfer system via which the closure elements can be introduced into the isolator. The transfer system may comprise, for example, an isolator opening. The isolator opening may be closable by means of a door. A transfer lock can be coupled to the isolator opening from the outside. The closure elements can be arranged in the transfer lock. Preferably, the transfer lock is coupled to the isolator opening with the door closed, and the door is only opened in the coupled state. For example, the transfer system may be designed as a port system, in particular as an alpha-beta port system. The port system may comprise a port, also referred to as an alpha port, which is integrated into the isolator. The alpha port may comprise the isolator opening and the door. The transfer lock may be designed accordingly as a beta port or beta container, which can be coupled to the alpha port. The beta port or beta container may be, for example, a sterile bag or a rigid transport container, e.g., a stainless steel container, a plastic container or an aluminum container.

The feeding apparatus is used for feeding closure elements into the isolator. The closure elements may be, for example, stoppers or closure caps, in particular crimp caps. In other words, the feeding apparatus introduces the closure elements into the isolator and provides the closure elements in the isolator for the subsequent process steps. The feeding apparatus may be couplable to the port, in particular to the isolator opening, in order to introduce the closure elements from the transfer lock into the interior of the isolator and to provide them in the interior. For this purpose, the feeding apparatus may comprise, for example, a feeding unit and a collecting unit, for example a container, a plate or a vibrating plate. The feeding unit may preferably comprise a pipe or a chute. The feeding unit may, for example, be couplable to the port, in particular to the isolator opening, from the inside in order to introduce the closure elements from the transfer lock into the isolator and to feed them to the collecting unit. The closure elements are then provided on or in the collecting unit.

The handling device is used to transfer the fed closure elements. For this purpose, the handling device may pick up the fed closure elements, in particular those provided by means of the feeding apparatus, and move them within the isolator. The handling device may be designed as a handling robot. The handling device may comprise, for example, a multi-axis arm and an end effector. The end effector is arranged at one end of the arm. The end effector is movable by means of the arm. A drive unit may be provided, for example, for moving the arm. The end effector may be a gripping tool comprising one or more, in particular two, grippers. By means of the gripping tool, at least one closure element, one closure element per gripper, can be picked up or gripped and moved, in particular transferred, within the isolator. In particular, the handling device may handle or transfer the closure elements individually or in pairs. In particular, the handling device may transfer a fed closure element from the feeding apparatus to the sealing station.

The sealing station may be a stoppering station or a crimping station. In the sealing station, filled containers may be sealed with the fed closure elements. For this purpose, the sealing station may comprise, for example, a sealing apparatus, such as a stoppering device or a crimping device, by means of which the containers are sealed with the closure elements. The fed closure elements thus serve to seal the containers.

The sealing station may further comprise additional components. For example, the sealing station may comprise a storage device or a transfer station, such as an intermediate storage or a feeding rail, which is used for temporarily storing, buffering, or transferring the closure elements. Furthermore, the sealing station may also comprise a further handling device which, for example, picks up the closure elements from the intermediate storage or the transfer station and then places them onto the filled containers.

A filling station may further be arranged in the isolator in which the containers can be filled before sealing. In particular, the containers may be filled with the pharmaceutical or cosmetic substance in the filling station. One or more further handling devices may also be arranged in the isolator for handling the containers and/or the closure elements. For example, one handling device may be configured to transfer filled containers to the sealing station.

In principle, it is possible that closure elements fed into the isolator have a defect. Such a defect can occur during the production of the closure elements, the transport of the closure elements, or the handling of the closure elements during feeding. A defect may be, for example, damage or deformation of the closure element, in particular a crack, dent, bulge or a deviation from a predetermined shape. Such defects may result in the sealing station being unable to properly seal the containers with the closure elements. In other words, defective closure elements may not be processed at all or only incorrectly in the sealing station.

According to the disclosure, inspection of the closure elements on the transfer path from the feeding apparatus to the sealing station is now carried out by means of the inspection device. For this purpose, the handling device first transfers a fed closure element from the feeding apparatus to an inspection position within the interior of the isolator. In particular, the handling device may transfer the closure elements individually or in pairs to the inspection position. Preferably, the handling device may arrange each closure element transferred to the inspection position at the inspection position in a defined alignment or orientation. Alternatively, the closure element may also be arranged at the inspection position successively in different positions and/or orientations. At the inspection position, each closure element transferred to the inspection position is then inspected by means of the inspection device. In particular, the inspection device determines whether the respective closure element arranged at the inspection position has a defect. If the inspection reveals that the closure element has no defect, the handling device transfers the inspected closure element further to the sealing station.

This ensures that only closure elements that have no defect are transferred to the sealing station. This ensures that the containers are not sealed incorrectly or not at all due to defective closure elements. This increases process reliability. In particular, defective closure elements do not need to be rejected at a later stage. Furthermore, inspection on the transfer path from the feeding apparatus to the sealing station is relatively easy to carry out. In addition, the inspection is carried out after the closure elements have been fed into the isolator, in particular shortly before the sealing station. This also allows detection of defects that only occur during the feeding process or during handling, in particular gripping, of the closure elements by means of the handling device. In this way, the processing of the closure elements is improved.

In one refinement of the aspects, the feeding apparatus may be configured to provide the closure elements on a surface, in particular in a defined position and/or in a defined number, wherein the handling device is configured to transfer the closure element from the surface to the inspection position.

In particular, the handling device may be configured to transfer the closure elements individually or in pairs from the surface to the inspection position. For this purpose, the handling device may, for example, grip one of the closure elements provided on the surface and transfer it to the inspection position. In particular, a defined number of closure elements may be provided on the surface. This may be at least one. Preferably, the defined number is two or greater than two. In particular, the closure elements may also be provided on the surface in a defined position. The defined position may be a defined location or area and/or a defined orientation in space. This simplifies the handling of the closure elements by the handling device.

In particular, the feeding apparatus may comprise a vibrating plate, wherein the vibrating plate comprises the surface. By vibrating the vibrating plate, the closure elements can then be provided on the surface in the defined position. Furthermore, the feeding apparatus may be configured to feed the defined number of closure elements onto the vibrating plate in order to provide closure elements on the surface in the defined number. Feeding in a defined number may be carried out, for example, by means of a controlled conveyor, e.g., by means of a further upstream vibrating plate or a metering device.

In a further refinement of the aspects, the barrier system may further comprise a disposal device for disposing of defective closure elements, wherein the handling device is configured to transfer the closure element from the inspection position to the disposal device when the closure element has a defect.

In particular, the handling device may be configured to transfer the inspected closure element from the inspection position to the disposal device when the inspection has shown that the closure element has a defect. The disposal device serves to dispose of defective closure elements. The disposal device may be arranged within the isolator. The disposal device may comprise a collection container within the isolator. The collection container serves to collect the closure elements within the interior of the isolator. In order to dispose of the closure elements, they may be collected in the collection container, for example.

In particular, the handling device may hold and release defective closure elements over the collection container in order to feed them to the collection container, i.e., to transfer them to it. The inspection position may be arranged directly above the collection container in a vertical direction. In this case, the handling device may simply release the closure element at the inspection position when the inspection has shown that the closure element has a defect.

In a further refinement of the aspects, the barrier system may comprise a control device for controlling the handling device.

In particular, the control device controls the handling device according to the result of the inspection by the inspection device. If the inspection has shown that the closure element has no defect, the control device controls the handling device in such a way that the inspected closure element is transferred to the sealing station. If the inspection has shown that the closure element has a defect, the control device controls the handling device in such a way that the inspected closure element is transferred to the disposal device.

In a further refinement of the aspects, the inspection device may comprise the control device, wherein the control device is further configured to determine whether the closure element has a defect.

In this refinement, in addition to controlling the handling device, the control device also carries out the inspection of the closure element for a defect. The control device is thus part of the inspection device and carries out the determination as to whether the closure element has a defect.

In an alternative refinement of the aspects, the inspection device may comprise a further control device, wherein the further control device is configured to determine whether the closure element has a defect.

In this refinement, the inspection device comprises a separate, in particular further, control device. This separate control device carries out the inspection of the closure element for a defect. In particular, this separate control device determines whether the closure element arranged at the inspection position has a defect. The result of the determination is then transmitted to the control device of the isolator system so that it can then control the handling device accordingly.

In a further refinement of the aspects, the inspection device may comprise a camera system, wherein the camera system is configured to capture at least one image of the closure element at the inspection position, wherein the inspection device, in particular the control device or the further control device, is configured to determine, on the basis of the at least one captured image, whether the closure element has a defect.

The camera system may comprise one or more cameras for this purpose. Each camera may be configured to capture an image of the closure element at the inspection position. In particular, the control device or the further control device may control the image capture by the camera system. The captured image can then be evaluated by the control device or the further control device to determine whether the closure element has a defect. Based on the result of this determination, the control device can then control the handling device accordingly.

In particular, the handling device may arrange each closure element at the inspection position in a defined orientation or successively in several defined orientations. In this way, the image evaluation can be simplified, since the closure elements are always arranged in the same orientation.

In a further refinement of the aspects, the closure elements may be formed with a substantially circular cross-section, wherein the inspection device is configured to inspect the closure element at the inspection position for its roundness.

The closure elements may be designed or manufactured substantially in the same shape and size. In particular, the closure elements may have a substantially circular cross-section perpendicular to an axial direction. In other words, the closure elements may have a round outer contour perpendicular to the axial axis. In particular, they may be designed or manufactured to be rotationally symmetrical about an axis parallel to the axial direction. The closure elements may be, for example, substantially cylindrical or conical. The defect to be inspected may, in this case, be insufficient roundness. Insufficient roundness may be present, for example, when the closure element is bent or deformed, for example has an elliptical instead of circular outer contour, or has deformations such as dents or bulges on the outer contour. By means of the captured image, it can be determined whether the outer contour is round or deviates from a round outer contour. If the outer contour is not, in particular not substantially, round, the inspected closure element has insufficient roundness and is thus defective.

In particular, the handling device may arrange the closure element at the inspection position in such a way that an image plane of the captured image extends perpendicular to the axial direction of the closure element. In this way, the image of the closure element in the captured image is a projection perpendicular to the axial direction. If the closure element has a round outer contour in cross-section, the image of the closure element in the captured image is also round or circular. Deviations from the round outer contour result in the image of the closure element in the captured image also deviating from the circular shape, e.g., due to bulges, dents or other deformations.

In a further refinement of the aspects, the inspection device, in particular the control device or the further control device, may be configured to determine, on the basis of the at least one captured image, a parameter indicating a measure of the roundness of the closure element, and to determine, on the basis of a comparison of the determined parameter with a threshold value, whether the closure element has a defect.

In this way, it can be determined whether the closure element has insufficient roundness as a defect. To determine the roundness of the closure element shown in the captured image at the inspection position, for example, an edge or an outer contour of the closure element in the captured image can be considered. In particular, the outer contour, especially image points of the outer contour, can be determined in the captured image. A circle can be fitted to the outer contour, for example. The quality of the fit can then be considered. The quality is maximal if the outer contour is circular. The more the outer contour deviates from the circle, the lower the quality becomes. Alternatively, a curve can be fitted to the outer contour. For a curve, the variation, i.e., variance, of the curvature along the curve can be considered. For a circular shape, the curvature is constant and the variation is therefore minimal, in particular zero. The more the outer contour deviates from the circular shape, the greater the variation. Alternatively, a reference image may be used to determine the roundness, in which a round closure element is shown. The deviation of the image of the closure element in the captured image from the image of the round closure element in the reference image is then the greater, the more the closure element deviates from the circular shape. The quality of a fitted circle, the variation of the curvature of a fitted curve, or the deviation of the image of the closure element in the captured image from the image of a round closure element in a reference image may be used as the parameter for the measure of roundness. The threshold value is determined in advance. The threshold value defines a limit as to how far the closure element may deviate from the circular shape. A defect is present if the parameter is lower—e.g., in the case of the quality of a fitted circle—or greater—e.g., in the case of curvature variation or deviation from the reference image—than the threshold value.

In a further refinement of the aspects, the inspection device, in particular the control device, may be configured to determine whether an outer edge of the closure element lies within a tolerance range in the captured image.

In particular, to inspect roundness, it may be determined whether an outer contour or an outer edge of the closure element in the captured image lies within a tolerance range between a first circle and a second circle. The first circle and the second circle are arranged concentrically around a common center point. The first circle is larger than the second circle. The area between the first circle and the second circle may be referred to as a tolerance range or tolerance band. If the outer edge of the closure element to be inspected lies completely within the tolerance range, the closure element is sufficiently round and is thus not defective. If the outer edge of the closure element to be inspected lies partially or completely outside the tolerance range, the closure element is not sufficiently round and is thus defective. The size of the tolerance range can be used to define the desired requirement for the roundness. The smaller or narrower the tolerance range, the higher the requirement for the roundness of the closure elements. In order to determine whether the outer edge lies within the tolerance range, the area of the image around the center point may be subdivided circumferentially into segments. For each segment, it can then be determined whether an image point of the outer edge in the segment lies within the tolerance range. If an image point of the outer edge lies within the tolerance range in all segments, the closure element is not defective. However, if there is no image point within the tolerance range in at least one segment, the closure element is defective. The accuracy of the determination of roundness can be adjusted via the number of segments. The more segments are used, the more precise the determination of roundness will be. For example, the area around the center point may be divided into 10 or more segments, 100 or more segments, or 1000 or more segments.

In a further refinement of the aspects, the sealing station may be a crimping station, wherein the closure elements are crimp caps.

Crimp caps may have a substantially circular cross-section perpendicular to an axial direction. In particular, crimp caps are designed or manufactured to be substantially cylindrical. Especially in the case of crimp caps, the inspection of roundness is advantageous. Crimp caps that are not round or bent may be processed incorrectly or not at all in the crimping station and may in particular lead to faulty crimping.

In a further refinement of the aspects, in the feeding step, the feeding apparatus may provide the closure elements on a surface, in particular in a defined position and/or in a defined number, wherein in the first transferring step, the handling device transfers the closure element from the surface to the inspection position.

In particular, the handling device may be configured to transfer the closure elements individually or in pairs from the surface to the inspection position. For this purpose, the handling device may, for example, grip one of the closure elements provided on the surface and transfer it to the inspection position. In particular, a defined number of closure elements may be provided on the surface. This may be at least one. Preferably, the defined number is two or greater than two. In particular, the closure elements may also be provided on the surface in a defined position. The defined position may be a defined location or area and/or a defined orientation in space. This simplifies the handling of the closure elements by the handling device.

In a further refinement of the aspects, the method may further comprise the following steps

• • third transferring the closure element from the inspection position to a disposal device within the restricted-access environment by means of the handling device when the closure element has a defect; and
  • disposing of the closure element transferred to the disposal device by means of the disposal device.

In particular, the handling device may be configured to transfer the inspected closure element from the inspection position to the disposal device when the inspection has shown that the closure element has a defect. The disposal device serves to dispose of defective closure elements. The disposal device may be arranged within the isolator. The disposal device may comprise a collection container within the isolator. The collection container serves to collect the closure elements within the interior of the isolator. To dispose of the closure elements, they may be collected in the collection container, for example.

In a further refinement of the aspects, in the inspection step, a camera system of the inspection device may capture at least one image of the closure element at the inspection position and the inspection device may determine, on the basis of the at least one captured image, whether the closure element has a defect.

The camera system may comprise one or more cameras for this purpose. Each camera may be configured to capture an image of the closure element at the inspection position. In particular, the control device or the further control device may control the image capturing of the camera system. The captured image may then be evaluated by the control device or the further control device to determine whether the closure element has a defect. Based on the result of this determination, the control device may then control the handling device accordingly.

In a further refinement of the aspects, the closure elements may be formed with a substantially circular cross-section, wherein in the inspection step, the inspection device inspects the closure element at the inspection position for its roundness.

The closure elements may be designed or manufactured substantially in the same shape and size. In particular, the closure elements may have a substantially circular cross-section perpendicular to an axial direction. In other words, the closure elements may have a round outer contour perpendicular to the axial axis. In particular, they may be designed or manufactured to be rotationally symmetrical about an axis parallel to the axial direction. The closure elements may be, for example, substantially cylindrical or conical. The defect to be inspected may, in this case, be insufficient roundness. Insufficient roundness may be present, for example, when the closure element is bent or deformed, for example has an elliptical instead of circular outer contour, or has deformations such as dents or bulges on the outer contour. By means of the captured image, it can be determined whether the outer contour is round or deviates from a round outer contour. If the outer contour is not substantially round, the inspected closure element has insufficient roundness and is thus defective.

In a further refinement of the aspects, the inspection device may determine, on the basis of the at least one captured image, a parameter indicating a measure of the roundness of the closure element, and may determine, on the basis of a comparison of the determined parameter with a threshold value, whether the closure element has a defect.

In this way, it can be determined whether the closure element has insufficient roundness as a defect. To determine the roundness of the closure element shown in the captured image at the inspection position, for example, an edge or outer contour of the closure element in the captured image can be considered. In particular, the outer contour, especially image points of the outer contour, can be determined in the captured image. A circle may be fitted to the outer contour, for example. The quality of the fit can then be evaluated. The quality is maximal if the outer contour is circular. The more the outer contour deviates from the circular shape, the lower the quality becomes. Alternatively, a curve may be fitted to the outer contour. In the case of a curve, the variation, i.e., variance, of the curvature along the curve may be considered. For a circular shape, the curvature is constant and the variation is therefore minimal, in particular zero. The more the outer contour deviates from the circular shape, the greater the variation. Alternatively, a reference image in which a round closure element is shown may be used to determine the roundness. The deviation of the image of the closure element in the captured image from the image of the round closure element in the reference image is then the greater, the more the closure element deviates from the circular shape. The quality of a fitted circle, the variation of the curvature of a fitted curve, or the deviation of the image of the closure element in the captured image from the image of a round closure element in a reference image may be used as the parameter for the measure of roundness. The threshold value is determined in advance. The threshold value defines a limit as to how far the closure element may deviate from the circular shape. A defect is present if the parameter is lower, for example in the case of the quality of a fitted circle, or greater, in the case of curvature variation or deviation from the reference image, than the threshold value.

In a further refinement of the aspects, the inspection device may determine whether an outer edge of the closure element lies within a tolerance range in the captured image.

In particular, as already described above, to inspect roundness, it may be determined whether an outer contour or outer edge of the closure element in the captured image lies within a tolerance range between a first circle and a second circle.

It is understood that the features mentioned above and those yet to be explained below can be used not only in the respective combination specified, but also in other combinations or in isolation, without departing from the scope of the present invention.

DRAWINGS

Exemplary embodiments of the disclosure are illustrated in the drawings and are explained in more detail in the following description. The figures show:

FIG. 1 a schematic view of a first embodiment of an isolator system;

FIG. 2 an isometric view of a second embodiment of an isolator system;

FIG. 3 a side view of the isolator system from FIG. 2 showing an inspection position;

FIG. 4A a schematic view of a closure element with a circular outer contour;

FIG. 4B a schematic view of a closure element with an elliptical outer contour;

FIG. 4C a schematic view of a closure element with a dented outer contour;

FIG. 4D a schematic view of a closure element with a crack;

FIG. 5A a schematic view of a round closure element;

FIG. 5B a schematic view of a dented closure element; and

FIG. 6 a schematic view of an embodiment of a method for processing closure elements in an isolator.

DETAILED DESCRIPTION

FIG. 1 shows a first embodiment of an isolator system as a barrier system, designated in its entirety by reference numeral 10.

The isolator system 10 comprises an isolator 12. The isolator is a restricted-access environment. The isolator 12 comprises an interior 14. The isolator 12 further comprises a transfer system 16. The transfer system 16 may be configured as an alpha-beta port system. The transfer system 16 comprises a port 18. The port 18 may be an alpha port. The port 18 is arranged on a wall of the isolator 12 that separates the interior 14 from an external environment. The port 18 may comprise an isolator opening and an isolator door. The isolator door may be arranged at the isolator opening. By means of the isolator door, the isolator opening can be opened or closed. From the outside, a transfer chamber 20 can be coupled to the port 18. The transfer chamber 20 may be configured as a beta container or beta port. Closure elements 22 may be arranged or provided in the transfer chamber 20.

The isolator system 10 comprises in the interior 14 of the isolator 12 a feeding device 24, a sealing station 34, a disposal device 42, and a handling device 46. The feeding device 24 serves to feed the closure elements 22 into the isolator 12. The handling device 46 serves to transfer the closure elements 22 within the isolator 12. The sealing station 34 serves to seal containers using, in particular, non-defective closure elements 22. The disposal device 42 serves to dispose of, in particular, defective closure elements 22.

The isolator system 10 may further comprise in the interior 14 a filling station, not shown. In this filling station, the containers can be filled, for example with a pharmaceutical or cosmetic substance, before they are sealed in the sealing station 34. The isolator system 10 may further comprise additional, not shown, handling devices in the interior 14 for handling the closure elements and/or the containers. These may be used, for example, to transfer the containers from the filling station to the sealing station 34.

By means of the feeding device 24, the closure elements 22 can be fed into the interior 14 of the isolator 12. The closure elements 22 can be provided outside the isolator in the transfer chamber 20 and then introduced into the isolator 12 via the port 18 and the feeding device 24. The feeding device 24 comprises a surface 26. The feeding device 24 may comprise, for example, a feeding unit 28, a first vibrating plate 30, and a second vibrating plate 32.

The feeding unit 28 may serve to feed the closure elements 22 from the port 18 onto the first vibrating plate 30. The feeding unit 28 may, for example, be connectable to the port 18 from the inside. In particular, by means of the feeding unit 28, closure elements can be introduced from a transfer chamber 20 into the isolator 12 via the port 18 and the feeding unit 28 and be fed to the first vibrating plate 30.

The first vibrating plate 30 may serve to convey the closure elements 22 onto the second vibrating plate 32. For this purpose, the first vibrating plate 30 may comprise a first drive unit and a first plate. The first plate serves as a support surface for the closure elements 22. In particular, the closure elements 22 can be fed onto the first plate and conveyed on it. The first drive unit is configured to move the first plate. In particular, the first drive unit is configured to tilt and vibrate the first plate. The conveying of the closure elements may be carried out by vibrating the first plate.

The second vibrating plate 32 may serve to arrange the closure elements 22 on the second vibrating plate 32 in a defined position, in particular to orient them. For this purpose, the second vibrating plate 32 may comprise a second drive unit and a second plate. The second plate serves as a support surface for the closure elements 22. In particular, the closure elements 22 can be fed onto the second plate and moved thereon. The second drive unit is configured to move the second plate. In particular, the second drive unit is configured to vibrate the second plate. The arrangement or orientation of the closure elements in the defined position can be achieved by vibrating the plate. In this way, the closure elements are provided in the defined position on the second vibrating plate 32. Closure elements 22 provided in this defined position can then be picked up by the handling device 46 and transferred to the sealing station 34. The surface 26 can thus be a surface of the second plate of the second vibrating plate 32.

In the sealing station 34, containers filled with a product are sealed with the fed closure elements 22. For sealing the containers, the sealing station 34 comprises a sealing device 36. The sealing device 36 may be a crimping device, by means of which crimp caps can be applied to the containers as closure elements. Alternatively, the sealing device 36 may also be a stopper placing device, by means of which stoppers can be placed onto the containers as closure elements. The sealing station 34 may additionally comprise a storage device 38 in which the closure elements can be temporarily stored or held prior to sealing. The sealing station 34 may further comprise a separate handling device 40 by means of which the closure elements 22 can be picked up from the storage device 38 and placed onto the containers.

The disposal device 42 can be used to dispose of defective closure elements 22. For this purpose, the disposal device 42 may comprise a collection container 44. Defective closure elements 22 can be collected in the collection container 44.

The handling device 46 serves to handle the closure elements 22 within the interior 14 of the isolator 12. In particular, the handling device 46 can pick up the fed closure elements 22 individually or in pairs from the feeding device 24, in particular from the surface 26, and transfer them to the sealing station 34 or to the disposal device 42. The handling device 46 is preferably configured as a handling robot. The handling device 46 may comprise a multi-axis arm 48 and an end effector 50. The end effector 50 is arranged at one end of the arm 48. The arm 48 can be moved by means of a drive unit. The end effector may comprise a gripping tool, for example one or more grippers, by means of which one or more closure elements 22 can be gripped for transfer, in particular picked up and held, preferably one per gripper.

The isolator system 10 may further comprise a camera system 52. The camera system 52 is preferably arranged on a ceiling of the isolator 12. For example, the camera system 52 may be mounted on the ceiling of the isolator 12. Using the camera system 52, images can be captured. To capture the images, the camera system 52 may comprise one or more cameras 54. The camera system 52 may also comprise a lighting unit by means of which at least the area to be captured during image acquisition is illuminated. The camera system 52 may in particular be arranged such that the feeding device 24, the sealing station 34, the disposal device 42, and a working area of the handling device 46 lie within the field of view of the camera system 52. For example, the camera system 52 may be configured to capture an image of the closure elements on the first and/or second vibrating plate 30, 32. Furthermore, the camera system 52 may be configured to capture an image of the closure elements 22 during the transfer of the closure elements, i.e., in the working area of the handling device 46.

The isolator system 10 may further comprise a control unit 56. The control unit 56 serves to control the handling device 46. In particular, the control unit 56 controls the transfer of the closure elements 22 from the feeding device 24 to the sealing station 34 or to the disposal device 42. The control unit 56 may further be configured to control the first and/or second vibrating plate 30, 32 to provide the closure elements 22 on the surface 26, i.e., on the second vibrating plate 32, in a defined quantity and/or in a defined position, in particular orientation.

The control unit 56 may be configured to control the camera system 52. In particular, the control unit 56 may control the image acquisition of the camera system 52 for capturing images. The control unit 56 controls the handling device 46 and optionally also the vibrating plates 30, 32 based on the captured images, i.e., based on the image data, of the camera system 52. In particular, the control unit 56 may be configured to evaluate the captured images. For example, the control unit 56 may determine based on the captured images whether a closure element 22 is arranged on the second vibrating plate in the defined position.

For this purpose, the control unit 56 may comprise various subunits, each of which performs control of a component and/or processing of data. For example, the control unit may comprise a control unit that controls the handling device 46, the camera system 52, or optionally also the vibrating plates 30, 32. The control unit may send control commands to the respective components for controlling them. Furthermore, the control unit may comprise a data processing unit configured to evaluate the captured images of the camera system. The data processing unit may, for example, determine the position of closure elements on the second vibrating plate 32 based on the captured images.

The control unit 56 may be connected to or comprise a non-volatile data memory in which a computer program is stored. In some embodiments, the control unit 56 is a general-purpose computer, such as a commercially available personal computer running Windows®, Linux, or macOS, and the computer program from memory includes program code designed and configured to implement control and determination steps. In an alternative embodiment, the control unit 56 is a logic circuit, such as a field-programmable gate array (FPGA), an application-specific integrated circuit (ASIC), a microcontroller, or any other suitable programmable electronic circuit. In such a logic circuit, control and determination steps can be implemented. Any suitable programming language or hardware description language, such as C, VHDL, or the like, can be used for implementing the control and determination steps in the logic circuit.

The isolator system 10 further comprises a control device 66. The control device 66 serves to inspect a closure element 22 at an inspection position 58 within the isolator 12 and to determine whether the closure element 22 has a defect. The inspection position 58 is arranged in a working area of the handling device 46. Preferably, the control device 66 comprises the control unit 56 of the isolator system 10. In particular, the control unit 56 may be configured to determine whether a closure element 22 arranged at the inspection position has a defect.

The handling device 46 is configured to transfer the closure elements individually or in pairs from the feeding device 24 to the inspection position 58. The transfer to the inspection position 58 is illustrated in FIG. 1 by the arrow with reference numeral 60. At the inspection position, the control device 66 then determines whether the closure element 22 transferred to the inspection position 58 has a defect. If the inspection determines that the closure element 22 has no defect, the closure element 22 is further transferred to the sealing station 34. The transfer to the sealing station 34 is illustrated in FIG. 1 by the arrow with reference numeral 62. If the inspection determines that the closure element 22 has a defect, the closure element 22 is transferred to the disposal device 42. The transfer to the disposal device 42 is illustrated in FIG. 1 by the arrow with reference numeral 64.

The camera system 52 may be part of the control device 66. In particular, the camera system 52 may be configured to capture at least one image of a closure element 22 at the inspection position 58. In particular, the inspection position 58 may be arranged below the camera system 52 within the field of view of the camera system 52. The control device 66 may then determine, based on the at least one captured image, whether a closure element 22 arranged at the inspection position 58 has a defect. In particular, the control unit 56 may be configured to determine, based on the at least one captured image of the camera system, whether the closure element 22 has a defect. Based on the result of this determination, the control unit 56 may then control the handling device 46 accordingly.

FIG. 2 shows a second embodiment of the isolator system 10 as a barrier system. The isolator system of the second embodiment essentially corresponds to the isolator system 10 of the first embodiment from FIG. 1. Identical elements are designated with identical reference numerals and are not explained further.

In the isolator system 10 of the second embodiment, the sealing station 34 is configured as a crimping station, and the sealing device 36 is configured as a crimping device. Accordingly, the closure caps 22 are configured as crimp caps. Furthermore, the camera system 52 is arranged in the isolator 12 on the ceiling. In particular, the collection container 44 is arranged adjacent to the feeding device. In particular, the camera system 52 is arranged above the collection container 44 and the feeding device 24.

FIG. 3 shows, by way of example, the position of the inspection position 58 in the isolator system 10 from FIG. 2. In particular, the camera system 52 is arranged in a vertical direction 68 above the collection container 44. Between the camera system 52 and the collection container 44, the inspection position 58 is arranged in the vertical direction 68. The inspection position 58 is in particular arranged above the collection container 44 in the vertical direction.

As previously explained in connection with the isolator system 10 of the first embodiment, each closure element 22 is first transferred by the handling device 46 to the inspection position 58 in order to be inspected there by the control device 68. For this purpose, the camera system 52 may capture an image of the respective closure element 22 arranged at the inspection position 58 from above. The control unit 56 may then determine, based on the captured image, whether the closure element 22 has a defect. If the inspection reveals that the closure element 22 has no defect, the handling device 46 transfers the closure element 22 further to the sealing station 34. If the inspection reveals that the closure element 22 has a defect, the handling device 46 transfers the closure element 22 further to the disposal device 42. For this purpose, the handling device 46 may simply release the defective closure element 22 and let it drop into the collection container 44 arranged below the inspection position 58.

FIG. 4A shows, by way of example, a top view in the axial direction of a closure element 70 with a circular cross-sectional geometry perpendicular to the axial direction. The outer contour is round or circular in this case.

FIG. 4B shows, by way of example, a top view in the axial direction of a deformed closure element 72 with an elliptical cross-sectional geometry perpendicular to the axial direction. The outer contour in this case is not round but elliptical with an eccentricity greater than zero. Such an outer contour may result, for example, if a round closure element is gripped with a gripper and slightly compressed in the process.

FIG. 4C shows, by way of example, a top view in the axial direction of a deformed closure element 74 that has an essentially circular cross-sectional geometry, wherein the closure element 74 has a dent 76 on the outside. In the region of the dent 76, the cross-sectional geometry deviates from the circular shape.

FIG. 4D shows, by way of example, a top view in the axial direction of a closure element 78 with a circular cross-sectional geometry perpendicular to the axial direction. The closure element 78 has a crack 80 on the top side.

The control device 66 of the first and second embodiments of the isolator system 10 can inspect the closure elements 22 for one or more defects. The one or more defects are preferably an insufficient roundness of the closure element and/or a crack in the closure element.

The closure elements 22, in particular crimp caps, are formed with an essentially circular cross section perpendicular to the axial direction, i.e. with a round outer contour. The control device 66 may then be configured to inspect each closure element 22 at the inspection position 58 for its roundness. The camera system then captures at least one image of the closure element 22 at the inspection position 58. The control unit 56 then determines, based on the at least one captured image, a parameter that indicates a measure of the roundness of the closure element. The control unit 56 then determines, based on a comparison of the determined parameter with a threshold value, whether the closure element has a defect.

Preferably, the handling device 46 arranges each closure element 22 to be inspected at the inspection position 58 in a defined orientation, in particular in such a way that an image plane of the captured image is perpendicular to the axial direction of the closure element.

To inspect the roundness, the control unit 56 may in particular first determine an outer contour of the closure element 22 in the captured image and fit a circle to the outer contour. Then the control unit 56 can determine the quality of the fit of the circle, wherein the quality is a measure of the roundness of the closure element. If the quality is lower than the threshold value, the closure element has a defect, i.e. insufficient roundness.

Alternatively, to inspect the roundness, the control unit 56 may determine an outer contour of the closure element 22 in the captured image and fit a closed curve to the outer contour. Then the control unit 56 may determine the variation, i.e. variance, of the curvature along the closed curve, wherein the variation is a measure of the roundness of the closure element. If the variation is greater than the threshold value, the closure element has a defect, i.e. insufficient roundness.

Alternatively, to inspect the roundness, a reference image showing a round closure element may be used, see for example FIG. 4A. The deviation of the outer contour of the image of the closure element 22 in the captured image from the outer contour of the image of the round closure element in the reference image may then be used as a measure of the roundness of the closure element. The control unit 56 can then determine this deviation by image comparison. If the deviation is greater than the threshold value, the closure element 22 has a defect, i.e. insufficient roundness.

To inspect the closure element 22 for a crack, a reference image of a closure element without a crack may also be used, for example. The control unit 56 can then also determine whether the closure element 22 has a crack by comparing the captured image with the reference image.

Alternatively, to inspect the roundness, it can also be determined whether an outer contour or an edge of the closure element 22 in the captured image lies within a tolerance range between a first circle 82 and a second circle 84. This is illustrated by way of example in FIGS. 5A and 5B.

The first circle 82 and the second circle 84 are arranged concentrically around a common center. The first circle 82 is larger than the second circle 84. The area between the first circle 82 and the second circle 84 may be referred to as a tolerance range or tolerance band. If the outer edge of the closure element 22 to be inspected lies completely within the tolerance range, the closure element is sufficiently round and thus not defective. If the outer edge of the closure element 22 to be inspected lies partially or completely outside the tolerance range, the closure element is not sufficiently round and thus defective.

In FIG. 5A, a closure element is shown whose outer edge 86 lies completely within the tolerance range. This closure element is therefore not defective. In FIG. 5B, a closure element is shown whose outer edge 90 lies partially outside the tolerance range. This closure element is therefore defective.

To determine whether the outer edge lies within the tolerance range, the area of the image around the center may be divided into segments 88. In FIGS. 5A and 5B, the area is divided into sixteen segments 88-1, 88-2, . . . , 88-16. The individual segments are shown as dashed lines. For each segment 88, it is determined whether a pixel of the outer edge in the segment lies within the tolerance range. If a pixel of the outer edge lies within the tolerance range in all segments 88, the closure element is not defective. However, if there is no pixel within the tolerance range in at least one segment 88, the closure element is defective.

In FIG. 5A, a pixel of the outer edge 86 lies within the tolerance range in each segment 88. In FIG. 5B, no pixel of the outer edge 86 lies within the tolerance range in segments 88-1 and 88-2.

FIG. 6 shows an embodiment of a method for processing closure elements 22 in an environment with restricted access, in particular in an isolator 12, designated in its entirety with reference numeral 100. The method 100 can be carried out using the isolator system 10 according to the first or second embodiment.

In a first step 102 of the method 100, the closure elements 22 are fed into the isolator 12 by means of the feeding device 24.

In a further step 104 of the method 100, a fed closure element 22 is transferred by means of a handling device 46 from the feeding device 24 to the inspection position 58.

In a further step 106 of the method 100, the closure element 22 transferred to the inspection position 58 is inspected at the inspection position 58 by means of the control device 66, wherein the control device 66 determines whether the closure element 22 has a defect.

In a further step 108 of the method 100, the inspected closure element 22 is transferred by means of the handling device 46 from the inspection position 58 to the sealing station 34, if the closure element 22 has no defect.

In a further step 110 of the method 100, a container is sealed in the sealing station 34 by means of the closure element 22 transferred to the sealing station 34.

In a further step 112 of the method 100, the inspected closure element 22 is transferred by means of the handling device 46 from the inspection position 58 to the disposal device 42, if the closure element 22 has a defect.

In a further step 114 of the method 100, the closure element 22 transferred to the disposal device 42 is disposed of by means of the disposal device 42.

It is to be understood that the foregoing is a description of one or more preferred exemplary embodiments of the invention. The invention is not limited to the particular embodiment(s) disclosed herein, but rather is defined solely by the claims below. Furthermore, the statements contained in the foregoing description relate to particular embodiments and are not to be construed as limitations on the scope of the invention or on the definition of terms used in the claims, except where a term or phrase is expressly defined above. Various other embodiments and various changes and modifications to the disclosed embodiment(s) will become apparent to those skilled in the art. All such other embodiments, changes, and modifications are intended to come within the scope of the appended claims.

As used in this specification and claims, the terms “for example,” “e.g.,” “for instance, “such as,” and “like,” and the verbs “comprising,” “having,” “including,” and their other verb forms, when used in conjunction with a listing of one or more components or other items, are each to be construed as open-ended, meaning that the listing is not to be considered as excluding other, additional components or items. Other terms are to be construed using their broadest reasonable meaning unless they are used in a context that requires a different interpretation.