EP4263144A1

EP4263144A1 - Device for handling closures inside a clean room, a clean room comprising a corresponding device, and a method for handling closures inside a clean room

Info

Publication number: EP4263144A1
Application number: EP21823495.3A
Authority: EP
Inventors: Stefan Nagler; Ulrich Krauss; Markus Ilgenfritz; Juergen Leidig; Patrick Holl
Original assignee: Syntegon Technology GmbH
Current assignee: Syntegon Technology GmbH
Priority date: 2020-12-15
Filing date: 2021-11-29
Publication date: 2023-10-25
Also published as: CN116583383A; US20240001568A1; DE102020133609A1; WO2022128421A1; CA3196739A1

Abstract

The invention relates to a device (10) for handling closures (12) inside a clean room, in particular in a sterile environment, to a clean room comprising a corresponding device (10) and to a method for handling closures (12) inside a clean room, in particular in a sterile environment.

Description

Title : Device for handling closures within a clean room, a clean room comprising a corresponding device and a method for handling closures within a clean room

description

The invention relates to a device for handling closures within a clean room with the features of the preamble of claim 1, a clean room with a corresponding device with features of claim 8 and a method for handling closures within a clean room with features of claim 9 . Medicinal active ingredients are filled in special filling and sealing systems. Particularly in the case of aseptic filling and filling of toxic and highly potent active substances, the filling is carried out under strict sterility requirements in an isolator or clean room .

In filling and capping systems, oscillating conveyors or centrifugal conveyors are usually used to feed and align loose capping components. The closure components are guided in lanes and sorted via baffles.

When feeding closure components with an oscillating conveyor or a centrifugal conveyor, malfunctions may occur due to closure components jamming on the feed line.

These faults must be remedied by operator intervention. For this purpose, a glove grip is usually provided on the insulator, through which an operator can gain manual access and rectify the fault. It is not possible to eliminate the fault automatically, since the locking components can jam at any point on the conveyor and the fault can therefore occur at different points.

The object of the present invention is a device for handling closures within a clean room, a clean room with a corresponding To provide a device and a method for handling closures within a clean room, with which the closures can be handled reliably and can be applied to a container, for example.

This object is achieved by a device for handling closures within a clean room (e.g. an isolator of a pharmaceutical machine), in particular in a sterile environment, according to claim 1. The device includes:

A receptacle for accommodating at least one closure, in particular a large number of closures.

A handling device, in particular a robot arm, with a tool. The tool is designed to be able to handle at least one closure.

The tool can be a vacuum suction device, an electrically or pneumatically driven gripper, or a contact surface on the end effector equipped with a microstructured polymer film (gecko effect).

A sensor device that is designed to detect a position, a type (e.g. different size and/or color), an orientation and/or possible damage to the closure within the receptacle. It is also conceivable that the sensor device monitors the fill level of the receptacle. With In other words, the sensor device can be set up to detect the number of closures received in the receptacle.

The device also has a vibration device. This is designed to cause the holder to vibrate in such a way that the orientation and/or position of the closure held in the holder, in particular a majority, in particular all, of the closures held in the holder, is changed due to the vibration or is moved . will .

It is conceivable that the orientation and/or position of the closure received in the receptacle can only be changed in part of the receptacle, but in particular in the entire receptacle, due to the vibration. The vibration device can be designed in order to set the receptacle directly in vibration (by means of direct contact). It is also conceivable that the vibration device can be designed to cause the receptacle to vibrate indirectly (indirectly), in particular by means of at least one intermediate coupling element (without direct contact).

The number of individual components of the device can vary. It can e.g. B. several, in particular two, receptacles, handling devices and/or sensor devices can also be used. The device can be used in a barrier system. All components used can be designed in such a way that they can be used in a sterile pharmaceutical environment.

A clean room in the present sense can be a barrier system, e.g. B. RABS (Reduced Access Barrier System), an isolator (z. B. aseptic or cytotoxic isolator) or a biosafety cabinet (biosafety cabinet). A clean room in this sense can be pressurized to prevent the ingress of contamination or to minimize the risk of ingress. A clean room in this sense can alternatively also be operated under negative pressure in order to prevent the escape of any toxic or otherwise dangerous substances to be handled in the clean room.

The closures can be moved, in particular poured, out of a bunker system (e.g. linear conveyor, bag, container) or manually onto the receptacle.

The receptacle can, for example, be in the form of a tablet. The receptacle can be essentially rectangular. The recording can be made in one piece. The receptacle can have a flat receptacle surface. The receptacle can in particular be designed in such a way that the closures can move freely in the entire receptacle or its receptacle surface. The recording can have an edge that delimits the recording area. The edge can protrude from an extension plane of the receiving surface. The edge can at least partially, in particular completely, enclose the receiving surface. The edge can be oriented orthogonally to the extension plane of the receiving surface. The handling device can be designed in order to be able to move the tool in relation to the direction of gravity over the entire recording surface, in particular over the entire recording. The handling device can be designed in particular to be able to move the tool within a plane parallel to the plane of extension of the receiving surface. In particular, the handling device is designed in such a way that it takes closures at different, in particular arbitrary, locations of the receptacle or record or can grasp .

In the present case, “handle” can mean gripping, fixing, releasing, holding and/or transporting. Gripping can mean a clamping fixation in all three spatial directions.

In particular, the handling device is designed in such a way that it removes closures from the receptacle or can absorb the recording surface and transport it to another location and deliver it there.

It is conceivable that the handling device has several, in particular two, tools. The multiple tools can be coupled to one another in such a way that all tools are moved simultaneously and in the same way by means of the handling device. It is also conceivable that the handling device has an adjustment device with which the multiple tools can be moved relative to one another

According to a development, the sensor device can have at least one lighting device. This can be designed to illuminate the recording. The lighting device is advantageously one or more LEDs (light-emitting diodes), which are arranged in particular on the sensor device and/or in the immediate vicinity of the sensor device. The lighting device can be aligned in such a way that the receptacle and/or the closures received in the receptacle are illuminated, in particular illuminated from above. With such an illumination, the detection of the closures or whose position, type, orientation and/or possible damage are optimized.

The lighting device can be designed to be static (i.e. immobile) and in particular to be arranged above the receptacle in relation to the direction of gravity. It is also conceivable that the lighting device is designed to be movable, in particular in relation to the direction of gravity above the receptacle. This allows the lighting device optimally adjusted to illuminate the closures.

The sensor device can have at least one camera for detecting the closure. This can be designed to record images and/or videos in the visible and/or non-visible spectral range (e.g. infrared, ultraviolet) of the recording or of the closure (or several closures) recorded in the recording .

It is conceivable that the sensor device is designed to be static (i.e. immovable) and is arranged above the receptacle, in particular in relation to the direction of gravity. It is also conceivable that the sensor device is designed to be movable, in particular in relation to the direction of gravity above the receptacle.

The sensor device can be designed to be able to record (detect) at least part of the recording, in particular the entire recording. The sensor device can be designed to be able to record (detect) all of the closures accommodated in the receptacle, in particular at the same time.

The receptacle can be in the form of a plate.

This can have an edge and / or in particular shell-like or. be trough-like. A receptacle can thus be provided in a simple structural manner be that the closure or can safely accept the closures .

The recording can have a structure. This can be designed to influence the position and/or orientation of the closure (or the closures) during the vibration of the receptacle. The structure can, for example, as a depression / depressions and / or as an increase / elevations. be slit-like. The structure can have indentations designed to be complementary to the closures; in particular, the indentations are complementary to the closures in such a way that a closure is only held in one orientation in one of the indentations. In particular, the device can comprise one or more corresponding closures.

The device can include a control device. This can be coupled to the handling device and/or the sensor device by means of connections (eg by means of a connecting cable or wirelessly). The control device can be designed to move the handling device and/or the tool of the handling device depending on the detection of the sensor device. In other words, the controller can handle the unit or. place the tool in a position where the tool can handle the detected occlusion (or occlusions) . For example, the tool can be positioned directly over a detected closure. In this way, the detected closure can be handled safely. The control device can be designed in the form of a computer.

At least one element of the device, in particular all elements of the device, can be H2O2 (hydrogen peroxide) resistant, autoclavable and/or waterproof. This allows decontamination using H2O2 or an autoclave to be implemented. This can be easily and safely decontaminated or disinfected, which optimizes the use of the device in a sterile environment. The waterproof elements are suitable for washing out (wash-down) the device with water.

The problem to be solved is further solved by a clean room with the features of claim 8 . The clean room includes a device with the features described above.

With regard to the advantages that can be achieved with the clean room, reference is made to the relevant statements on the device. The measures described in connection with the device can serve to further develop the clean room.

The problem to be solved is further illustrated by a method for handling closures within a clean room (e.g.

B. an isolator of a pharmaceutical machine), in particular in a sterile environment, according to claim 9. The procedure consists of the following steps: Capturing at least one shutter in a shot. For this purpose, the closures can be moved, in particular poured, out of a bunker system (eg linear conveyor, bag, container) or manually onto the receptacle. The closures can be distributed over the entire recording.

Vibrating the receptacle in such a way that the orientation and/or position of the closure received in the receptacle is changed due to the vibration. Due to the vibration, at least individual closure components "jump" into a defined position (e.g. from lying sideways to an upright position with the closure opening downwards). The closures can "jump" back and forth within the entire recording as a result, the closures are distributed over the entire receptacle (or receptacle surface), in particular chaotically.

Detecting position, type, orientation and/or possible damage of the closure within the receptacle. In particular, a sensor device can be used for this purpose.

Moving the handling device to a position from which handling of the detected closure is possible. Such a position is preferably located directly above the detected closure, so that the closure can be gripped from above (e.g. by means of a gripper). But it is also conceivable that such a position is arranged laterally to a detected closure, so that the closure can be gripped laterally by means of a gripper, for example. In particular, the handling device can be moved over the receptacle, in particular the entire receptacle, in relation to the direction of gravity.

Handling of the closure by means of a handling device. This can include transferring the closure to a further handling device, placing the closure in a nest, closing a corresponding container with the closure and/or transporting the closure further.

The above process steps are preferably carried out in succession in the order listed. However, it is also conceivable that in each case two or three of these method steps are carried out simultaneously or that all method steps listed are carried out at the same time. A process step can also be repeated several times in succession.

Due to the fact that the closures are already gripped/handled in the desired orientation, there is no need to change hands when handling the closures, for which a further handling device and/or further tool would possibly be required.

However, it is conceivable that an optional gripping of the closures can be provided, e.g. B. if the closures due to an unfavorable center of gravity with oriented upside down instead of upside down as desired.

According to a development, the receptacle and/or the closure received by means of the receptacle can be illuminated, in particular by means of an illumination device. In this way, the detection of the position, the type, the orientation and/or possible damage to the closure can be optimized.

According to a development, a device with the features described above can be used to carry out the method. Alternatively, the method can be carried out in a clean room with the features described above.

With regard to the advantages that can be achieved with the method, reference is made to the relevant statements on the device or Referred to the clean room. For further development of the method, in connection with the device or the measures described in the clean room are used.

It is conceivable that the recording can be used as a shelf for a nest with closures. Such a nest could, for example, be placed on the containers complete with all the closures. It is also conceivable that the closures are picked individually from the nest and placed on the containers. In this way, the sensor device, in particular a camera, could be used to check whether all closures are present in the nest and/or whether the correct closures (or components) are in the nest . It is conceivable that this check can be carried out if the nest with closures is not placed on the recording, but z. B. is held with the robotic arm in the detection field of the sensor device (or recording window of the camera) .

Further features, details and advantages of the invention result from the wording of the claims and from the following description of the exemplary embodiment with reference to the drawing. It shows :

Fig. 1 is a perspective view of a device.

FIG. 1 shows a perspective view of a device 10 for handling closures 12 within a clean room. The device 10 has a receptacle 14 .

In the present case, the receptacle 14 is designed as a plate 28 with an edge 27 . In other words, the receptacle 14 is trough-shaped or. shell-shaped. Recording 14 or the plate 28 is presently rectangular. The edge 27 runs along the four edges of the plate 28 . in other words, the rim 27 encloses the plate 28 .

The receptacle 14 can securely accommodate a large number of closures 12 . The device 10 also has a handling device 16 . In the present case, this is designed in the form of a robot arm 17 . The handling device 16 has a tool 18 . This is designed to be able to handle a closure 12 .

The holder 14 can optionally be automatically upgraded with the robot arm 17 .

The receptacle 14 can be format-dependent. In other words, the receptacle 14 can be designed depending on the type, size, shape of the closures 12 to be accommodated in it.

The receptacle 14 can be designed in such a way that it can be exchanged manually.

FIG. 1 shows a state of the device 10 in which the tool 18 is handling a closure 12 . In other words, a closure 12 is held by the tool 18 .

The device 10 also has a sensor device 20 . In the present case, this is designed in the form of a camera 26 . An illumination device 24 is arranged around the camera 26 . In other words, the camera 26 is arranged inside the lighting device 24 . It is conceivable that the lighting device 24 is designed separately from the camera 26 , in particular is arranged at a distance from the camera 26 . For example, the lighting device 24 can illuminate the receptacle 14 obliquely from the side.

In the present case, the sensor device 20 or the camera 26 and the lighting device 24 are arranged above the receptacle 14 and corresponding to the receptacle 14 or aligned in the direction of the receptacle 14 . In this way, the receptacle 14 and the closures 12 accommodated therein can be optimally illuminated and their position, type, orientation and/or possible damage can be reliably detected. It is conceivable that the lighting device 24 can be set/changed in its position relative to the receptacle 14 for better illumination.

The device 10 also has a vibration device 22 . This is designed to cause the receptacle 14 to vibrate. The individual closures 12 "jump" back and forth and thereby change their position or orientation.

The vibration device 22 is arranged directly below the receptacle 14 . In the present case, the vibration device 22 is cuboid. The receptacle 14 is arranged on the vibrating device 22 so that the vibrating device 22 constitutes a base (supporting base) for the receptacle 14 . In order to influence the "jumping behavior" of the individual closures 12 or the orientation in which the individual closures "jump", the receptacle 14 has a structure 29 . In the present case, the structure 29 is in the form of elongated, slot-shaped depressions 30 . These are indicated only schematically in FIG.

In the present case, the depressions 30 are designed in such a way that the closures 12 can only "jump" into the depressions 30 in a specific orientation (e.g.

B. with the locking opening down) . The indentations 30 are designed to complement the closures 12 . Different types of structures, in particular complementary ones, are conceivable, for example projections or elevations designed to complement the closures 12 can also be provided. Various structures or Elevations and / or depressions may be provided, for example. are matched to different types of closures 12.

The device 10 also has a control device 30 . In the present case, this is coupled to the handling device 16 and the sensor device 20 by means of connections 32 . Both the control device 30 and the connections 32 are shown only schematically in FIG. The connections 32 can be cable connections. However, wireless connections (e.g. radio, optical connections) can also be provided.

The mode of operation of the device 10 can be described as follows:

A plurality of closures 12 are placed on the receptacle 14 . Here are closures 12 of the same type or. format shown. However, it is also conceivable for closures 12 of different types to be placed in the receptacle 14 at the same time.

The vibration device 22 causes the receptacle 14 to vibrate so that the closures 12 jump back and forth in the receptacle 14 . In the process, the closures 12 change their position and/or their orientation. The closures 12 can be distributed over the entire receptacle 14 .

After the vibration process, the camera 26 searches the nest 14 for the closures 12 of the desired type (eg, vial stoppers) and in the desired orientation. If none of the closures 12 are detected in the desired orientation, the vibration process can be restarted. It is conceivable that if the desired orientation could not be detected even after a specific number of repetitions of a vibration process, an interference signal is output. Alternatively or additionally, further closures 12 can be inserted into the receptacle 14 be introduced and/or removed. E.g. the receptacle 14 can be completely emptied.

The position of the closures 12 of the desired type and orientation is communicated to the controller 30 . This controls the handling device 16 or the tool 18 so that the handling device 16 or the tool 18 is moved to a position from which a closure 12 of the desired type and orientation is handled or can be gripped .

It is conceivable that the camera 26 already detects the closures 12 while the receptacle 14 is vibrating and sends corresponding signals to the control device 30, so that the control device 30 controls the handling device 16 or the tool 18 is likewise already being moved while the receptacle 14 is vibrating.

The closures 12 can then be further processed. A next step can e.g. B. the placement of the closure 12 on a container (not shown) directly by the handling device 16 or the transfer to a further handling device (not shown). The closures 12 can also be placed in a receptacle (e.g. nest or tray) or in a parking position.

Because the closures 12 are already being gripped/handled in the desired orientation, a change of direction when handling the closures 12 is required for which if necessary, an additional handling device and/or additional tool would be required, unnecessary.

It is conceivable that the camera 26 checks the closures 12 for damage. By changing the orientation of the closures 12 when the holder 14 vibrates, the closures 12 are recorded by the camera 26 from as many sides as possible, in particular from all sides. Repositioning the camera 26 and/or changing the alignment of the camera 26 (and/or the lighting device 20) in order to record the closures 12 from as many sides as possible is therefore superfluous but can also be provided in order to speed up the process or make it more reliable to design .

If a closure 12 is found to be damaged, the damaged closure 12 can be sorted out by means of the handling device 16 . It is also conceivable that a further handling device (not shown) can be provided for sorting out damaged closures 12 .

In the event of a malfunction or after the end of a run (batch), the receptacle 14 can be emptied automatically. Emptying of receptacle 14 may be performed by handler 16, other handler (not shown), or by means of the vibratory platform. This means that there is no manual intervention by an operator in the barrier system required. The receptacle 14 can, for example, also be tilted for emptying.

Claims

22

Claims Device (10) for handling closures

(12), within a clean room, in particular in a sterile environment, comprising: a receptacle (14) for receiving at least one closure (12), a handling device (16), in particular a robot arm (17), with a tool (18) , wherein the tool (18) is designed to be able to handle at least one closure (12), a sensor device (20) which is designed a position, a type, an orientation and/or a possible damage of the closure (12) inside to detect the receptacle (14), characterized in that the device (10) further comprises a vibration device (22) which is designed to vibrate the receptacle (14) in such a way that the in the receptacle (14) on taken closure (12) is changed due to the vibration in its orientation and / or position. Device (10) according to Claim 1, characterized in that the sensor device (20) has at least one lighting device (24) has, which is designed to illuminate the recording (14). Device (10) according to Claim 1 or Claim 2, characterized in that the sensor device (20) for detecting the closure (12) has at least one camera (26). Device (10) according to one of the preceding

Claims, characterized in that the receptacle (14) is in the form of a plate (28), in particular with a raised edge (27), is in particular in the form of a shell. Device (10) according to one of the preceding

Claims characterized in that the receptacle (14) has a structure (29) which is designed to influence the position and/or orientation of the closure (12) during vibration of the receptacle (14). Device (10) according to one of the preceding

Claims, characterized in that the device (10) comprises a control device (30), which is coupled to the handling device (16) and/or the sensor device (20) by means of connections (32) and is designed to control the handling device (16 ) and/or to move the tool (18) of the handling device (16) as a function of the detection of the sensor device (20). Device (10) according to any one of the preceding

Claims, characterized in that at least one element of the device (10), and in particular all elements of the device (10), are H2O2 resistant, autoclavable and/or waterproof. Clean room with a device (10) according to one of

Claims 1 to 7. A method for handling closures (12), within a clean room, in particular in a sterile environment, comprising the steps:

receiving at least one closure (12) in a receptacle (14),

Vibrating the receptacle (14) in such a way that the orientation and/or position of the closure (12) received in the receptacle (14) is changed due to the vibration,

Detecting a position, a type, an orientation and/or possible damage to the closure (12) within the receptacle (14), in particular by means of a sensor device (20),

Moving the handling device (16) to a position from which handling of the detected closure (12) is possible,

Handling of the closure (12) by means of a handling device (16). 25 according to claim 9, characterized in that the receptacle (14) and/or the closure (12) received by means of the receptacle is illuminated, in particular by means of an illumination device (24). experienced according to Claim 9 or Claim 10, characterized in that a device (10) according to one of Claims 1 to 7 is used to carry out the method, or the method is carried out in a clean room according to Claim 8.