DE102023125415A1 - Method for cleaning a plant, plant with a cleaning system and use of a cleaning system in a plant - Google Patents

Abstract

The invention relates to a method for cleaning a system for producing and/or processing highly effective substances, such as for manufacturing and/or filling pharmaceuticals or biopharmaceuticals, by means of a hand-held cleaning device (10), such as a cleaning lance and/or a cleaning brush. In a cleaning cycle, an actual movement of the cleaning device (10) is detected by means of a sensor device (12), a deviation of the actual movement from a desired movement is determined, and the cleaning cycle is evaluated as a function of the determined deviation. The invention further relates to a system (3) with a cleaning system and to the use of a cleaning system for cleaning a system (3). Finally, the invention relates to a computer program product.

Description

FIELD OF APPLICATION AND STATE OF THE ART

The invention relates to a method for cleaning a system for producing and/or processing highly effective substances, such as for manufacturing and/or filling pharmaceuticals or biopharmaceuticals. The invention further relates to a system with a cleaning system and the use of a cleaning system for cleaning a system. The invention further relates to a computer program product.

For the production and/or processing of highly effective substances, it is known to arrange a filling and/or closing and/or post-processing plant (generally referred to as plant in the application) entirely or partially within an isolator or a RABS, in particular cRABS.

In the context of the registration, isolators refer to decontaminated units that are closed off from their surroundings. Restricted-access barrier systems (RABS) are enclosures that create a barrier between a production area and an operating area, although unlike an isolator, decontamination is not necessarily required. For the processing of highly potent substances, the use of cRABS (closed restricted-access barrier systems) is particularly well-known. For example, cRABS are used in an external washing system to wash the exterior of already closed containers.

After the production and/or processing of highly effective substances, the system must be cleaned. A cleaning process known as "washdown" is used. This involves spraying the system with a cleaning fluid, particularly water and/or water with the addition of detergents, so that the active ingredient dissolves in the cleaning fluid and/or is washed off a surface, allowing the active ingredient to be transported out of the system with the cleaning fluid.

It is known to have an operator manually guide a cleaning lance or hand shower for applying the cleaning fluid and/or a cleaning brush for mechanical cleaning.

To ensure complete cleaning, it is required that the cleaning process be carried out at least essentially the same in each cleaning cycle. Operators must adhere to specified dwell times, possibly defined spray angles, and the like.

To define the cleaning process, it is common practice to spray the system with a fluorescent agent or paint. The system is then cleaned by moving the cleaning lance or brush, and a check is made to ensure that the fluorescent agent or paint has been removed and everything is clean. Depending on the design, further tests may be required to ensure the system has been cleaned properly. The process is then documented using images, text, videos, or similar. The process is repeated several times to establish a standard for how the system should be cleaned.

For a cleaning cycle, the operator must perform the cleaning process according to the established procedure each time. At periodic intervals, the fluorescent agent is used to check whether the cleaning process is being carried out correctly and/or whether the cleaning process needs to be adjusted.

However, when performing the cleaning cycle, controls are limited to a few parameters. For example, the period of time over which a cleaning fluid was dispensed is monitored.

TASK AND SOLUTION

The objects of the invention are to provide a method for cleaning a plant for the production and/or processing of highly effective substances, a plant with a cleaning system and a use of a cleaning system for cleaning a plant and a computer program product which allow an improved verification of a cleaning cycle carried out.

According to a first aspect, a method is provided for cleaning a system for producing and/or processing highly effective substances by means of a hand-held cleaning device, such as a cleaning lance and/or a cleaning brush, wherein in a cleaning cycle an actual movement of the cleaning device is detected by means of a sensor device, a deviation of the actual movement from the desired movement is determined, and the cleaning cycle is evaluated as a function of the determined deviation.

The terms "a,""an,""one," etc., are used in the context of this application only as indefinite articles and not as number words. In particular, in some embodiments, multiple sensor devices may be provided for detecting an actual movement of the cleaning device.

Depending on the application, the movement of the cleaning device is defined as a movement path along which the cleaning device is moved in the room, or the movement path of the cleaning device in the room including dwell positions, dwell times, an orientation of the cleaning device and/or a speed of movement along the movement path.

A handheld cleaning device is a cleaning device, such as a cleaning lance or a cleaning brush, that is operated by an operator. In some embodiments, the operator grasps the cleaning device directly, for example, using a gloved hand on an isolator. In other embodiments, the cleaning device is moved remotely.

By recording the actual movement, the cleaning cycle can be monitored. The actual movement and/or any deviation of the actual movement from the target movement can be electronically logged. The quality of the cleaning cycle can thus be evaluated based on the deviations of the actual movement from the target movement. By evaluating the cleaning cycle based on the detected deviation, it is possible, for example, to release the system for subsequent processes based on quality and/or to open an isolator or a cRABS based on quality.

In some embodiments, the result of the evaluation is displayed by means of a visually perceptible signal, for example by means of a lamp and/or on a monitor.

In one embodiment, a target corridor is specified for the target movement, whereby it is recorded for the evaluation whether the actual movement during the cleaning cycle was within the target corridor. In embodiments, the target corridor can be defined to varying degrees of narrowness or width along the movement path. If the evaluation shows that the actual movement of the cleaning device did not occur within the target corridor over the entire cleaning cycle, release of the system for subsequent processes and/or opening of an isolator or a cRABS can be blocked. Alternatively or additionally, in embodiments, information can be transmitted to an operator indicating where subsequent cleaning is necessary. Depending on the embodiment, the information can be transmitted, for example, as text information and/or as visually perceptible image information.

In one embodiment, the target movement of the cleaning device is taught in by detecting a movement of the cleaning device or a teach-in pendant by means of a sensor device during a calibration cycle and storing the detected movement as the target movement.

A teach-in pendant is an element that corresponds to the cleaning lance and/or cleaning brush in terms of essential properties and is used for teaching. The teach-in pendant of the cleaning lance is designed in some embodiments so that it does not dispense any cleaning fluid. The teach-in pendant is designed in some embodiments so that it dispenses a different fluid, for example, a fluorescent agent. In some embodiments, the teach-in pendant can also be used as a training tool, with which an operator can practice performing the cleaning cycle.

By teaching the target movement, the target movement can be easily specified. Teaching in during a calibration cycle can be performed, for example, by an experienced and diligent operator.

In some embodiments, the sensor device comprises a detection device and a feature arranged permanently or detachably on the cleaning device, wherein movement of the feature is detected by means of the detection device. An element or property that can be detected by the detection device is referred to as a feature, marker, or target. The design of the feature can be suitably selected by a person skilled in the art depending on the design of the detection device and the application. For example, in some embodiments, the detection device is a camera operating in the visible or infrared range, with a corresponding marking applied to the cleaning device. In some embodiments, the marking is selected such that both movement and orientation of the cleaning device can be detected. In some embodiments, the sensor device comprises more than one feature and/or more than one detection device for this purpose. The feature is, in particular, a passive feature that can be sterilized, in particular autoclaved, with or separately from the cleaning device before being introduced into the isolator. The detection device is permanently installed in the system in certain configurations. The detection device In some embodiments, the detection device is arranged stationary and fixedly aligned to a specific area. In other embodiments, the detection device is mounted so as to be pivotable and/or linearly adjustable. Depending on the embodiment, the detection device is arranged inside or outside a housing that at least partially surrounds the system, in particular an isolator or cRABS.

In one embodiment, the target movement of the cleaning device during the cleaning cycle is displayed to an operator on a VR terminal and/or an AR terminal.

In the context of the application, “augmented reality” (AR for short) refers to a representation of the real environment or an image of the real environment supplemented by the display of visually perceptible information. An AR terminal is a terminal that allows the simultaneous superimposed perception of reality or a virtual image, also known as a digital twin, of the real environment and the additional information in real time. The AR device is, for example, glasses or a pane of glass with a transparent field of view on which additional information can be displayed. In embodiments, a transparent section of a wall of the isolator is designed as an AR terminal. In other embodiments, the AR terminal is a terminal with a display surface on which a camera image or the digital twin and the additional information can be displayed.

In the context of the application, "virtual reality" (VR for short) refers to a representation of a virtual image, also known as a digital twin, of the real environment. A VR device is a device that allows the perception of the virtual image in real time, with additional information or representations being able to be overlaid on the virtual image. The VR device is, for example, a pair of glasses. In other embodiments, the VR device is a device with a display surface on which a virtual image of the isolator and the additional information can be overlaid.

By displaying the target movement, the operator can be assisted in carrying out the cleaning process during the cleaning cycle. Depending on the application, additional information can be displayed, for example, areas that have already been cleaned and/or those that still need to be cleaned can be highlighted in color. The target movement is displayed as a green spline on the AR and/or VR device in some configurations.

According to a second aspect, a system for producing and/or processing highly effective substances with a cleaning system is provided, wherein the cleaning system comprises a hand-held cleaning device, in particular a cleaning lance and/or a cleaning brush, a sensor device and a computing unit, wherein the sensor device is configured to detect an actual movement of the cleaning device during a cleaning process, and wherein the computing unit is configured to determine a deviation of the actual movement from the target movement and to evaluate the cleaning cycle depending on the determined deviation.

In embodiments, the computing unit is further configured to log the deviation for validation and/or verification of the cleaning cycle.

In some embodiments, individual elements of the cleaning system, such as the computing unit and/or the sensor device, are also used by other systems provided on the system.

In embodiments of the cleaning system, the computing unit is further configured to specify a target corridor for the target movement and to record for the evaluation whether the actual movement during the cleaning cycle was within the target corridor.

In one embodiment of the cleaning system, it is provided that the sensor device is configured to detect a movement of the cleaning device during a calibration cycle, and wherein the computing unit is configured to store the detected movement as a target movement.

In embodiments of the cleaning system, the computing unit is further configured to determine and store the target corridor for the target movement in the calibration cycle.

In embodiments of the cleaning system, the sensor device comprises a detection device and a feature arranged permanently or detachably on the cleaning device, wherein the detection device is configured to detect movement of the feature. In embodiments, the detection device is permanently installed on the system.

In embodiments, the system comprises a VR terminal and/or AR terminal, wherein the computing unit is configured to control the VR terminal and/or the AR terminal in a cleaning cycle in order to determine a desired movement of the cleaning device on the VR device or the AR device

According to a third aspect, the use of a cleaning system comprising a hand-held cleaning device, in particular a cleaning lance and/or a cleaning brush, for cleaning a system for the production and/or processing of highly effective substances is provided, wherein the cleaning system comprises a sensor device and a computing unit, wherein during a cleaning cycle an actual movement of the cleaning device is detected by means of the sensor device, a deviation of the actual movement from a desired movement is determined by means of the computing unit, and the cleaning cycle is evaluated by means of the computing unit as a function of the determined deviation.

In one embodiment, the use provides that the computing unit for the evaluation detects whether the actual movement during the cleaning cycle was within a predetermined target corridor for the target movement.

In a further embodiment, the use provides that the target movement of the cleaning device is taught in by detecting a movement of the cleaning device or a teach-in pendant by means of the sensor device during a calibration cycle and the detected movement is stored as a target movement in the computing unit, wherein in particular the target corridor for the target movement is detected in the calibration cycle.

In embodiments, the sensor device of the cleaning system comprises a detection device, in particular one permanently installed on the system, and a feature permanently or detachably arranged on the cleaning device, wherein the use provides that a movement of the feature is detected by means of the detection device.

In embodiments, the cleaning system comprises a VR terminal and/or an AR terminal, wherein the use provides that in the cleaning cycle the desired movement of the cleaning device is displayed on the VR terminal and/or the AR terminal.

According to a fourth aspect, a computer program is provided for use with a system comprising a hand-held cleaning device, in particular a cleaning lance and/or a cleaning brush, a sensor device and a computing unit, the computer program comprising instructions which, when the computer program is executed by the computing unit, cause the computing unit to read in an actual movement of the cleaning device detected by the sensor device in a cleaning cycle, to determine a deviation of the actual movement from the desired movement, and to evaluate the cleaning cycle depending on the determined deviation.

In one embodiment, the computer program further comprises instructions which, when the computer program is executed by the computing unit, cause the computing unit to control a human-machine interface and/or a central machine control and/or another device depending on a result of the evaluation.

In one embodiment, the computer program further comprises instructions which, when the computer program is executed by the computing unit, cause the computing unit to record for the evaluation whether the actual movement during the cleaning cycle was within a defined target corridor for the target movement.

Alternatively or additionally, in one embodiment, the computer program further comprises instructions which, when the computer program is executed by the computing unit, cause it to teach the target movement of the cleaning device in a calibration cycle by reading in a movement detected by the sensor device during a movement of the cleaning device or a teach-in pendant and storing the detected movement as a target movement, and in particular instructions which cause the computing unit to determine the target corridor for the target movement in the calibration cycle.

Alternatively or additionally, in one embodiment, the computer program further comprises instructions which, when the computer program is executed by the computing unit, cause the computing unit to generate signals in the cleaning cycle in order to display a desired movement of the cleaning device on a VR terminal and/or an AR terminal.

BRIEF DESCRIPTION OF THE DRAWINGS

• 1 schematisch ein Reinigungssystem zum Reinigen eines Isolators.

Further advantages and aspects of the invention emerge from the claims and from the description of embodiments of the invention, which are explained below with reference to the figure.

• 1 schematic of a cleaning system for cleaning an insulator.

DETAILED DESCRIPTION OF THE EMBODIMENTS

1 shows schematically a cleaning system 1 for cleaning a within an isolator 2 Annex 3, whereby in 1 only a wall 20 and a glove opening 22 are shown for access to the schematically illustrated system 3 arranged in the interior of the isolator 2. Depending on its design, the system 3 arranged in the interior of the isolator 2 comprises different systems (not shown), such as filling, closing and/or feeding and transport systems, which are to be washed by means of the cleaning system 1 after production.

The schematically illustrated cleaning system 1 comprises a cleaning device 10 designed as a cleaning lance with a line 11 for supplying a cleaning fluid. The cleaning device 10 is gripped by an operator 4 via the glove opening 22 and moved to clean the system 3.

The cleaning system 1 shown further comprises a sensor device 12, a computing unit 14 and a VR terminal and/or AR terminal 16.

In the illustrated embodiment, the sensor device 12 comprises a detection device 120 configured as a camera, arranged in the insulator 2, and permanently installed in the insulator 2, and a feature 122 attached to the cleaning device 10 and detectable by the detection device 120. Depending on the design, the feature 122 can be, for example, a color marking detectable by the camera and/or a shape marking. In advantageous embodiments, the feature 122 is configured such that an orientation of the cleaning device 10 can also be detected based on the feature.

The VR terminal and/or AR terminal 16 is schematically depicted in the figure as a monitor, with a virtual or real image of the system 3 with additional information being displayable on the monitor. Instead of the monitor, in other embodiments, the VR terminal and/or AR terminal 16 is designed as glasses. In yet other embodiments, a transparent part of the wall 20 of the isolator 2 is used as the AR terminal 16.

To clean the system 3 using the cleaning device 10, in some embodiments, a target movement of the cleaning device 10 is first learned by detecting a movement of the cleaning device 10 or a not shown teach-in pendant using the sensor device 12 during a calibration cycle and storing the detected movement as a target movement in the computing unit 14. In some embodiments, as shown schematically in 1 shown - a target corridor for the target movement is determined.

For the calibration cycle, some embodiments provide for the interior of the insulator to be sprayed with a fluorescent agent and/or paint, as has been customary up to now. The system 3 is then cleaned by moving the cleaning device 10, and a check is made to determine whether the fluorescent agent or paint has been removed by the cleaning process. The process can be repeated until a desired cleaning effect is achieved, with the movement by which the desired cleaning effect was achieved being saved as the target movement.

It goes without saying that the target movement can be taught in sections.

During a cleaning cycle, an actual movement of the cleaning device 10 is detected by the sensor device 12, a deviation of the actual movement from the target movement is determined, and the cleaning cycle is evaluated based on the determined deviation. For the evaluation, it is determined, in particular, whether the actual movement occurred within the specified target corridor.

By evaluating the cleaning cycle depending on the determined deviation of the actual movement of the cleaning device 10 from a target movement, it is possible, for example, to release the system 3 for subsequent processes and/or to open the isolator 2 depending on the quality.

The deviation is logged in designs and evaluated automatically or by a person for quality control of the cleaning cycle.

In the illustrated embodiment, the target movement can be displayed to an operator on the VR terminal and/or the AR terminal 16. In some embodiments, the target movement is displayed as a target corridor.

In addition, embodiments may provide for additional information to be displayed on the VR terminal and/or the AR terminal 16, which supports the operator in maintaining the actual movement within the target corridor. For example, the operator may be signaled as to the direction in which an angle of the cleaning device 10 should be changed and/or whether the cleaning lance 10 should be moved faster or slower. Alternatively or additionally, embodiments may provide for the operator 4 to be supported by acoustic and/or haptic signals in maintaining the actual movement within the target corridor.

Claims (19)

Method for cleaning a system for the production and/or processing of highly effective substances by means of a hand-held cleaning device (10), such as a cleaning lance and/or a cleaning brush, characterized in that in a cleaning cycle an actual movement of the cleaning device (10) is detected by means of a sensor device (12), a deviation of the actual movement from a desired movement is determined, and the cleaning cycle is evaluated as a function of the determined deviation. Procedure according to Claim 1 , characterized in that a target corridor is specified for the target movement, and for the evaluation it is recorded whether the actual movement during the cleaning cycle was within the target corridor. Procedure according to Claim 1 or 2 , characterized in that the target movement of the cleaning device (10) is taught in by detecting a movement of the cleaning device (10) or of a teach-in pendant by means of the sensor device (12) during a calibration cycle and the detected movement is stored as a target movement, wherein in particular the target corridor for the target movement is detected in the calibration cycle. Procedure according to Claim 1 , 2 or 3 , characterized in that the sensor device (12) comprises a detection device (120) and a feature (122) arranged permanently or detachably on the cleaning device (10), wherein a movement of the feature (122) is detected by means of the detection device (120), wherein in particular the detection device (120) is permanently installed on the system. Method according to one of the Claims 1 until 4 , characterized in that in the cleaning cycle the desired movement of the cleaning device (10) is displayed to an operator (4) on a VR terminal and/or an AR terminal (16). Plant for the production and/or processing of highly effective substances, comprising a cleaning system (1) with a hand-held cleaning device (10), in particular a cleaning lance and/or a cleaning brush, characterized in that the cleaning system (1) comprises a sensor device (12) and a computing unit (14), wherein the sensor device (12) is set up to detect an actual movement of the cleaning device (10) and/or the cleaning brush during a cleaning cycle, and wherein the computing unit (14) is set up to determine a deviation of the actual movement from the target movement and to evaluate the cleaning cycle depending on the determined deviation, wherein in particular the detection device (120) is installed in a stationary manner on the plant. Plant according to Claim 6 , characterized in that the computing unit (14) is arranged to specify a target corridor for the target movement and to detect for the evaluation whether the actual movement during the cleaning cycle was within the target corridor. Plant according to Claim 6 or 7 , characterized in that the sensor device (12) is set up to detect a movement of the cleaning device (10) during a calibration cycle, wherein the computing unit is set up to store the detected movement as a target movement, wherein in particular the computing unit (14) is set up to determine and store the target corridor for the target movement in the calibration cycle. Plant according to Claim 6 , 7 or 8 , characterized in that the sensor device (12) comprises a detection device (120) and a feature (122) arranged permanently or detachably on the cleaning device (10), wherein the detection device (120) is designed to detect a movement of the feature (122), wherein in particular the detection device (120) is permanently installed on the system. System according to one of the Claims 6 until 9 , characterized in that a VR terminal and/or AR terminal (16) is provided, wherein the computing unit (14) is configured to control the VR terminal and/or the AR terminal (16) in a cleaning cycle in order to display a desired movement of the cleaning device (10) on the VR terminal and/or the AR terminal (16), Use of a cleaning system (1) comprising a hand-held cleaning device (10), in particular a cleaning lance and/or a cleaning brush, for cleaning a system for the production and/or processing of highly effective substances, characterized in that the cleaning system (1) comprises a sensor device (12) and a computing unit (14), wherein during a cleaning cycle an actual movement of the cleaning device (10) is detected by means of the sensor device (12), a deviation of the actual movement from a desired movement is determined by means of the computing unit (14), and the cleaning cycle is evaluated by means of the computing unit (14) as a function of the determined deviation. Use according to Claim 11 , characterized in that the computing unit (14) is used for the evaluation to determine whether the actual movement during the cleaning cycle was within a predetermined target corridor for the target movement. Use according to Claim 11 or 12 , characterized in that the target movement of the cleaning device (10) is taught in by detecting a movement of the cleaning device (10) or of a teach-in pendant by means of the sensor device (12) during a calibration cycle and the detected movement is stored as a target movement in the computing unit (14), wherein in particular the target corridor for the target movement is detected in the calibration cycle. Use according to Claim 11 , 12 or 13 , characterized in that the sensor device (12) comprises a detection device (120) and a feature (122) arranged permanently or detachably on the cleaning device (10), wherein a movement of the feature (122) is detected by means of the detection device (120), wherein in particular the detection device (120) is permanently installed on the system. Use according to one of the Claims 11 until 14 , characterized in that the cleaning system (1) comprises a VR terminal and/or an AR terminal (16), wherein in the cleaning cycle the desired movement of the cleaning device (10) is displayed on the VR terminal and/or the AR terminal (16). Computer program for use with a system comprising a hand-held cleaning device (10), in particular a cleaning lance and/or a cleaning brush, a sensor device (12) and a computing unit (14), the computer program comprising instructions which, when the computer program is executed by the computing unit (14), cause the computing unit (14) to read in an actual movement of the cleaning device (10) detected by the sensor device (12) in a cleaning cycle, to determine a deviation of the actual movement from the desired movement, and to evaluate the cleaning cycle as a function of the determined deviation. Computer program according to Claim 16 , further comprising instructions which, when the computer program is executed by the computing unit (14), cause the computing unit (14) to record for the evaluation whether the actual movement during the cleaning cycle was within a defined target corridor for the target movement. Computer program according to Claim 16 or 17 , further comprising instructions which, when the computer program is executed by the computing unit (14), cause it to learn the target movement of the cleaning device (10) in a calibration cycle by reading in a movement detected by the sensor device (12) during a movement of the cleaning device (10) or a teach-in pendant and storing the detected movement as a target movement, and in particular instructions which cause the computing unit (14) to determine the target corridor for the target movement in the calibration cycle. Computer program according to Claim 16 or 17 , further comprising instructions which, when the computer program is executed by the computing unit (14), cause the computing unit (14) to generate signals in the cleaning cycle in order to display a desired movement of the cleaning device (10) on a VR terminal and/or an AR terminal (16).

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