Method and device for analysing a transition state in a barrier system

Abstract

The invention relates to a method and a device for analysing a transition state in a barrier system (10), the barrier system (10) having an interior (16) for processing substances, in particular pharmaceuticals or foodstuffs, and the transition state relating to a batch change between processing of a first substance and processing of a second substance which differs from the first substance.

Description

[0001] Title: Method and device for analyzing a

[0002] Transition state in a barrier system

[0003] Description

[0004] The invention relates to a method and a device for analyzing a transition state in a barrier system, wherein the barrier system has an interior space for processing substances, in particular pharmaceuticals or foodstuffs, wherein the transition state concerns a batch change between processing of a first substance and processing of a second substance different from the first substance. Barrier systems used in the food and pharmaceutical industries, for example isolators, RABS (Restricted Access Barrier Systems), cRABS (closed Restricted Access Barrier Systems), must meet specified purity classes. After completion of a batch with processing of the first substance ("last good container"), a batch change to a different second substance entails a large number of time-consuming and labor-intensive work steps.For example, it is necessary to clear the interior of the barrier system of the first substance and all components specific to the processing of the first substance, e.g., packaging, filling needles, and lines. Furthermore, the interior must be cleaned, and components specific to the processing of the second substance must be installed. If necessary, a decontamination process may follow until the second substance (the "first good container") can finally be processed.

[0005] Many of the aforementioned steps are not automated or are too specific to be worthwhile. Furthermore, particularly in the processing of pharmaceuticals, there are stringent documentation requirements to prove the steps performed during a batch change. In cases of doubt, the inadequate execution of just one step in a batch change can result in not only the defective step but all steps of the batch change having to be repeated. Overall, the effort required by a barrier system operator in terms of time and personnel during a batch change is very high.

[0006] Based on this, the present invention is based on the object of specifying a method and a device for simplifying a batch change.

[0007] This object is achieved according to the invention in a method of the type mentioned at the outset by the features of patent claim 1 and in a device of the type mentioned at the outset by the features of patent claim 9.

[0008] The method according to the invention enables a simplified batch change. For this purpose, at least one target state is defined in the form of a visual representation of the interior.

[0009] The pictorial representation relates to at least one cleaning state in connection with cleaning the interior following processing of the first substance. It is possible for a predetermined position of a cleaning tool within the interior to be assigned to the at least one cleaning state. It is particularly possible for the said position to be assigned to a boundary of the interior and / or a stationary device which remains in the interior throughout the batch change. Additionally or alternatively, it is possible for a predetermined external shape of the cleaning tool to be assigned to the at least one cleaning state, for example a specific fold of a cleaning cloth.

[0010] The pictorial representation of the at least one target state can additionally relate to a desired handover state of the interior which the interior should have when the preparation for processing the second substance begins. In particular, the desired handover state correlates with the first substance and devices for storing and / or processing the first substance preferably being completely removed from the interior. The preparation for processing the second substance comprises setting up and adapting the interior which is necessary for processing the second substance. Devices for storing the first substance are understood to mean all primary packaging materials or packaging bodies which are intended to delimit a storage space for the first substance, i.e. containers such as ampoules, cartridges, syringes, vials and corresponding container closures, e.g. lids or stoppers.Devices for processing the first substance are understood to mean all devices which come into contact with the first substance and / or the aforementioned packaging bodies during the processing of the first substance.

[0011] The pictorial representation of the at least one target state can additionally relate to a preparation state of the interior space which the interior space should have before processing the second substance. In particular, the preparation state correlates with the second substance and / or devices for storing and / or processing the second substance being arranged in the interior space. Devices for storing the second substance are meant all primary packaging materials or packaging bodies which are intended to delimit a storage space for the second substance, i.e. containers such as ampoules, cartridges, syringes, vials and corresponding container closures, for example lids or stoppers. Devices for processing the second substance are meant all devices which come into contact with the second substance and / or the aforementioned packaging bodies during the processing of the second substance.

[0012] In the method according to the invention, at least one image of the interior is further captured by means of an image capture device at at least one point in time during the transition state. The image capture device can be a camera which is used exclusively for carrying out the method according to the invention. It is particularly preferred if the camera also captures operating states of the interior which - before a batch change - are associated with the processing of the first substance and / or which - after a batch change - are associated with the processing of the second substance. According to the invention, this at least one captured image is evaluated and compared with the visual reproduction, and a deviation between the captured image and the visual reproduction is determined.

[0013] The method according to the invention has the advantage that the operator can be supported at least when carrying out partial processes of the batch change. For example, it is possible for a warning signal and / or a work instruction to be issued in the event of an inadmissible deviation. Such signals or instructions make it possible to rectify an inadmissible deviation immediately after a work step has been carried out. It is also possible for a confirmation signal and / or a confirmation instruction to be issued in the event of a non-existent or still permissible deviation, informing the operating personnel that a work step has been carried out as specified.

[0014] The aforementioned signals and instructions can be acoustic and / or optical and can be given, for example, via loudspeakers, lights and / or displays.

[0015] It is possible for the visual representation of the at least one target state to concern a singular state, i.e., a single image, or a sequence of states, i.e., an image sequence. Single images are particularly well-suited for the visual representation of the handover state and the preparation state explained above. Image sequences are particularly well-suited for the visual representation of a sequence of cleaning states, e.g., a cleaning pattern that specifies the positioning and movement of a cleaning tool within the interior.

[0016] Batch changeovers are further simplified if at least one captured image and / or at least one deviation is used to create a batch change report. This also reduces the workload for operating personnel.

[0017] Furthermore, it is possible for the at least one captured image and / or the at least one deviation to be archived in a storage device. This enables simplified long-term documentation of a batch change.

[0018] The invention further relates to a device for analyzing a transition state in a barrier system, in particular for carrying out a method as explained above. The barrier system has an interior space for processing substances, a storage device for storing at least one desired state in the form of a visual representation of the interior space, an image capture device for capturing at least one image of the interior space, and an evaluation device which is configured to evaluate the at least one captured image and compare it with the visual representation and to determine a deviation between the at least one captured image and the visual representation.

[0019] The evaluation, comparison, and determination of deviations can be performed, for example, using image analysis programs. AI (artificial intelligence) support is also preferred.

[0020] It is also possible that the evaluation device and the storage device are components of a self-learning system.

[0021] It is preferred that the image capture device be arranged in an upper region of the interior space when the barrier system is in use. This simplifies the imaging of the interior space or at least a large portion of the interior space; furthermore, the image capture device is arranged in a comparatively low-exposed region of the interior space that does not usually come into direct contact with the substances to be processed.

[0022] In one embodiment of the device it is provided that it comprises an optical marking which can be handled by an operator together with the cleaning tool. This can be, for example, a signal band which an operator wears on the hand or wrist and thus simplifies visual recording of the position and / or movement of the cleaning tool. In a further embodiment of the device it is provided that the device comprises an optical projector which specifies at least one position of the cleaning tool within the interior with an optical projection. This enables in particular the specification of a cleaning pattern which defines the positioning and movement of a cleaning tool within the interior.

[0023] Further features and advantages of the invention are the subject of the following description of preferred embodiments.

[0024] The drawing shows:

[0025] Fig . 1 is a schematic side view of a

[0026] Embodiment of a barrier system with an interior space and an image capture device;

[0027] Fig. 2 is a pictorial representation of a target state of a working area of ​​the interior for a transfer state of the interior which the interior is to have at the start of the preparation for processing the second substance;

[0028] Fig. 3 is a plan view of the work area during processing of a first substance; Fig. 4 is a first image captured by the image capture device during a batch change in preparation for processing a second substance;

[0029] Fig. 5 shows a second image captured by the image capture device during the batch change.

[0030] In Figure 1, a barrier system designed as an isolator for processing various substances, in particular for processing pharmaceuticals, is designated overall by the reference numeral 10. The barrier system 10 is arranged in a clean room 12 that surrounds the barrier system 10.

[0031] The barrier system 10 has a system shell 14 and an interior space 16 with a work area 18 in which different substances are processed.

[0032] An image capture device 20, particularly in the form of a camera, is arranged in an upper region of the interior space 16. The image capture device 20 is coupled to a data processing unit 22, which is preferably arranged in the clean room 12.

[0033] The data processing unit 22 comprises a storage device 24 and an evaluation device 26. Optionally, the data processing unit 22 comprises an output device 28 for the optical and / or acoustic output of signals or instructions. A visual representation 30 of at least one target state of the interior space 16, which the interior space 16 is intended to have during a transition state, is stored in the storage device 24, wherein the transition state concerns a batch change between processing a first substance and processing a second substance that differs from the first substance.

[0034] Fig. 2 shows an example of a pictorial representation 30 of a transfer state of the interior 16, which the interior 16 should have at the beginning of the preparation for processing the second substance. The pictorial representation 30 comprises, for example, an illustration

[0035] - the working area 18 with a filling line 32 along which containers are filled with a substance and sealed,

[0036] - a stationary storage container 34 for storing plugs which are to be placed on filled containers,

[0037] - a stationary plug distributor 36 and

[0038] - stationary plug setting stations 38 .

[0039] During the processing of a first substance, containers 40 filled with the first substance are arranged in the filling line 32, which containers are each closed with a stopper 42 at the stoppering stations 38, see Fig. 3. After completion of the processing of the first substance, the stationary devices (storage container 34, stopper distributor 36, stoppering stations 38) should remain in the interior 16. However, all containers 40 and all stoppers 42 should be removed before the interior is prepared for the processing of a second substance. This desired transfer state during a batch change is defined by the pictorial representation 30 (see Fig. 2).

[0040] During the batch change, the image capture device 20 captures a first image 44, see Fig. 4. At the time the first image 44 is captured, the stationary devices (storage container 34, plug distributor 36, plug placement stations 38) are still arranged in the interior 16. All containers 40 have been removed from the interior 16. However, not all plugs 42 have been removed from the interior; rather, a residual amount of plugs 42 remains in the interior 16.

[0041] The evaluation device 26 compares the first image 44 captured by the image capture device 20 with the image reproduction 30 stored in the memory device 24 and determines an inadmissible deviation. This deviation is output by means of the output device 28 as a warning signal and / or warning notice. This informs an operator that the desired target state of the interior has not (yet) been reached. In particular, it is possible for the warning notice to contain information that undesirable objects (possibly specified as plugs 42) are arranged in the interior 16. In response to the detected, inadmissible deviation, the operating personnel can remove the remaining quantity of plugs 42 from the interior 16. If the image capture device 20 now captures a second image 46 (see Fig. 5), this second image 46 no longer contains any plugs 42.A comparison of the second image 46 with the pictorial representation 30 then results in a non-existent deviation, i.e. a desired match, which can be communicated to the operating personnel by means of the output device 28.

[0042] The first image 44 and the inadmissible deviation corresponding thereto as well as the second image 46 and the non-existent deviation corresponding thereto can be stored in the storage device 24 and / or in an external memory, at least temporarily for the creation of a batch change protocol, preferably also permanently for archiving.

[0043] The visual representation can, for example, also relate to a cleaning pattern 48, which is schematically illustrated in Fig. 1 and which relates to the sequence of cleaning positions of a cleaning tool with which the interior 16 is cleaned during a batch change. A sequence of images captured by the image capture device 20 can be compared, as explained above, with the visual representation of the cleaning pattern 48 for the purpose of determining an impermissible deviation, a still permissible deviation, or a non-existent deviation.

[0044] To simplify the comparison between the visual representation of the cleaning pattern 48 and the sequence of images, it is advantageous if the detection of the sequence of images is supported by an optical marking 50, for example in the form of a signal band 52. The optical marking 50 forms a discrete optical unit which is easily identifiable by the evaluation device 26 and simplifies a comparison with the visual representation of the cleaning pattern 48.

[0045] To further simplify cleaning of the interior 16, it is possible that - preferably in spatial proximity to the image capture device 20 - an optical projector 54 is arranged in the interior 16, which projects the cleaning pattern 48 onto the working area 18 and / or onto a boundary of the interior 16 (e.g. a side wall).

Claims

Patent claims 1. A method for analyzing a transition state in a barrier system (10), wherein the barrier system (10) has an interior space (16) for processing substances, in particular pharmaceuticals or foodstuffs, wherein the transition state relates to a batch change between processing a first substance and processing a second substance different from the first substance, characterized by - Definition of at least one desired state in the form of a pictorial representation (30) of the interior (16), wherein the pictorial representation (30) relates to: at least one cleaning state in connection with a cleaning of the interior (16) following a processing of the first substance, wherein a predetermined position of a cleaning tool within the interior (16) is assigned to the at least one cleaning state and / or wherein a predetermined external shape of the cleaning tool is assigned to the at least one cleaning state, - capturing at least one image (44, 46) of the interior (16) by means of an image capturing device (20) at at least one time point of the transition state, - Evaluation of the at least one captured image (44, 46) and comparison with the pictorial representation (30) to determine a deviation.

2. Method according to claim 1, characterized in that in the event of an inadmissible deviation, a warning signal and / or a work instruction is issued and / or in the event of a non-existent or still permissible deviation, a confirmation signal and / or a confirmation instruction is issued.

3. Method according to one of the preceding claims, characterized in that the pictorial representation (30) relates to a singular state or a sequence of states.

4. Method according to one of the preceding claims, characterized in that the pictorial representation relates to: a desired transfer state of the interior space (16) which the interior space (16) should have at the start of the preparation for the processing of the second substance, and / or a preparation state of the interior space (16) which the interior space (16) should have before processing the second substance.

5. Method according to one of the preceding claims, characterized in that the position of the cleaning element is assigned to a boundary of the interior space (16) and / or a stationary device (34, 36, 38) which remains in the interior space (16) throughout the batch change.

6. Method according to one of the preceding claims, characterized in that the desired Transfer state correlates with the fact that the first substance and devices (40, 42) for storing and / or processing the first substance are removed from the interior space (16).

7. Method according to claim 4 or according to one of claims 5 or 6, each with reference to claim 4, characterized in that the preparation state correlates with the second substance and / or devices for storing and / or processing the second substance being arranged in the interior space (16).

8. Method according to one of the preceding claims, characterized in that the at least one captured image (44, 46) and / or the at least one deviation is or are used to create a batch change protocol and / or that the at least one captured image (44, 46) and / or the at least one deviation is or are archived in a storage device (24).

9. Device for analyzing a transition state in a barrier system (10), in particular for carrying out a method according to one of the preceding claims, wherein the barrier system (10) has an interior space (16) for processing substances, in particular pharmaceuticals or foodstuffs, wherein the transition state is a batch change between processing a first substance and processing a second substance differing from the first substance, with - a storage device (24) for storing at least one desired state in the form of a pictorial representation (30) of the interior (16), wherein the pictorial representation (30) relates to: at least one cleaning state in connection with a cleaning of the interior (16) following a processing of the first substance, wherein a predetermined position of a cleaning tool within the interior (16) is assigned to the at least one cleaning state and / or wherein a predetermined external shape of the cleaning tool is assigned to the at least one cleaning state, - an image capture device (20) for capturing at least one image (44, 46) of the interior (16), - an evaluation device (26) which is set up to evaluate the at least one captured image (44, 46) and to compare it with the pictorial representation (30) and to determine a deviation between the at least one captured image (44, 46) and the pictorial representation (30).

10. Device according to claim 9, characterized in that the image capture device (20) is arranged in an upper region of the interior (16) in the position of use of the barrier system (10).

11. Device according to claim 9 or 10, characterized in that the device comprises an optical Marking (50) which can be handled by an operator together with the cleaning tool.

12. Device according to one of claims 9 to 11, characterized in that the device comprises an optical projector (54) which specifies at least one position of the cleaning tool within the interior (16) with an optical projection.

13. Device according to one of claims 9 to 12, characterized in that the pictorial representation relates to: a desired transfer state of the interior space (16) which the interior space (16) should have at the start of the preparation for processing the second substance, and / or a preparation state of the interior space (16) which the interior space (16) should have before processing the second substance.

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