METHOD FOR MONITORING CONDITION AND MOVEMENT Sequence in an Aseptic Workroom of a Containment

Description

Application area of ​​the invention

[0001] The present invention relates to a method for monitoring the condition and movement sequence in an aseptic work chamber of a containment located in a storage room, with at least one work glove projecting into the work chamber, worn by an operator. Each work glove can be extended within the work chamber to a maximum gripping range along the three xyz axes. Each work glove could hold one object, or two work gloves together could hold one object, thus resulting in a maximally extended range of action along the three xyz axes. Containers that are temporarily filled with substances, or that are to be filled or emptied, may be located in the work chamber. State of the art

[0002] Metall+Plastik GmbH, D-78315 Radolfzell / Germany, is known to use cameras to film the interiors of isolators for monitoring operations from various angles. Nuaire, Plymouth, MN 55447 / USA, also uses cameras for continuous recording inside isolators (see https: / / www.nuaire.com / learn / general-technicalbulletins / camera-useage-in-a-biosafety-cabinet-pharmacy-isolator ; Internet extract dated 30.09.2019).

[0003] Ortner Reinraumtechnik GmbH, A-9500 Villach / Austria, uses an intercom system with a surveillance camera for the same purpose (see https: / / www.ortner-group.com / produkte / isoline / aseptic-isolator.15f08.php; internet extract dated 30.09.2019).

[0004] The use of cameras for continuous recording of filling processes in isolators is known from Bausch+Ströbel Maschinenfabrik IIshofen GmbH+Co. KG, D-74532 IIshofen / Germany (see ISPE November 2018 "Remote Observation Technologies - Revolutionizing the Pharma Manufacturing Space", at https: / / ispe.org / pharmaceutical-engineering / novemberdecember-2018 / remote-observation-technologies-revolutionizing; internet extract from 30.09.2019).

[0005] The journal article by Jorge Usabiaga et al.: Global hand pose estimation by multiple camera ellipse tracking. In: Machine Vision and Applications, Springer Verlag Berlin, Vol. 21, No. 1, May 24, 2008, pp. 1-15, discloses a system for monitoring the state and movement sequence in an aseptic work chamber of a containment located in a storage room, with at least one work glove extending into the work chamber. The respective work glove can be extended within the work chamber to a maximum reach in the three spatial axes. The system includes a tracking system whose recordings serve for the continuous three-dimensional localization of the at least one work glove and are stored in a computer unit.

[0006] WO 2019 / 173 678 A1 describes a system in which an operator, wearing a work glove, enters a room. The glove surface is equipped with an array of strain sensors arranged in a complementary pattern to the individual hand and finger joints. A camera captures the positions of the strain sensors, and thus the hand and finger joints, in real time. A computer unit stores restricted areas within the monitored space, defined by their 3D coordinates. If the operator enters these restricted areas with the glove, for example, into hazardous zones, a warning is triggered by comparing the current positions of the strain sensors with the restricted areas defined in the computer unit. Object of the invention

[0007] Based on the prior art, the invention aims to create an advanced method for monitoring the condition and movement sequence in an aseptic work chamber of a containment. The goal is to ensure safe guidance for the operator's actions at the containment, while simultaneously enabling the rapid detection of operator errors and malfunctions, and minimizing resulting losses. Overview of the invention

[0008] The method is designed for monitoring the condition and movement sequence in an aseptic work chamber of a containment located in an installation room. It includes at least one work glove extending into the work chamber, worn by an operator, and: a) the respective work glove can extend within the work chamber up to a maximum gripping range in the three spatial axes; and b) a tracking system is installed, the recordings of which serve for the continuous three-dimensional localization of the at least one work glove and are stored in a computer unit. The following steps are characteristic: definition of at least one three-dimensional or two-dimensional restricted area within the work chamber; at least individual surface sections of the containment are defined as restricted areas; a restricted area is established around machines installed in the work chamber that pose a danger to the operator; the coordinates of the at least one restricted area are stored in the computer unit; and the operator is alerted if the at least one work glove enters the at least one restricted area.

[0009] Specific embodiments of the invention are described below: A warning zone adjacent to the at least one three-dimensional or two-dimensional restricted area is defined. The at least one area section comprises the entire floor of the containment as the restricted area. A warning zone is established in front of the restricted area around the machines installed in the work chamber that pose a danger to the operator. The coordinates of the restricted area and the warning zone are stored in the computer unit. The operator is alerted when the operator enters the warning zone wearing at least one work glove.

[0010] Each work glove holds one object, or two work gloves together hold one object, resulting in a maximally extended range of action in all three spatial axes. The tracking system continuously records the three-dimensional location of both the at least one work glove and the at least one object. The operator is alerted if an object enters the warning or restricted area.

[0011] The computer unit records the instantaneous spatial positions of work gloves and objects within the xyz coordinate system defined by the three spatial axes, along with a timestamp. The computer unit then performs a real-time comparison with the restricted areas and optional warning zones defined within it.

[0012] The work chamber may temporarily contain containers filled with substances, or requiring filling or emptying. The computer unit then records the spatial positions of these containers within the xyz coordinate system defined by the three spatial axes, along with a timestamp. This allows for the detection of any unplanned container positions, potential container breakage and its extent of spillage, and the area of ​​uncontrolled substance leakage in the event of an accident.

[0013] The operator can be equipped with virtual reality glasses designed to: to display to him the restricted areas and optional warning areas defined in the computer unit as graphic elements; and to display to him an area to be cleaned according to the cleaning and disinfection program stored in the computer unit.

[0014] The tracking system includes at least the following: a) a first camera with a first field of view; and b) a second camera with a second field of view; wherein: the first camera with its first field of view monitors two spatial axes and the second camera with its second field of view monitors the third spatial axis; the first field of view and the second field of view overlap so that all areas in the work chamber are monitored; and the recorded states and movements are stored in the computer unit as 3D data and / or video streams.

[0015] If the work chamber is large, a third camera with its third viewing angle is installed, and depending on the size of the work chamber, further cameras with their respective viewing angles are installed; whereby: The first camera, with its first detection angle, monitors the first spatial axis; the second camera, with its second detection angle, monitors the second spatial axis; and the third camera, with its third detection angle, monitors the third spatial axis; the detection angles overlap in such a way that all areas in the work chamber are monitored; and the recorded states and movements are stored in the computer unit as 3D data and / or video streams.

[0016] A signaling unit is provided, which alerts an operator intervening in the work chamber and / or a supervisor: a) in the event of unauthorized entry into a restricted area, an alarm is triggered acoustically and / or visually and / or by vibration acting on the body of the operator and / or the monitoring person; and b) in the case of established warning zones, an alarm is triggered acoustically and / or visually and / or by vibration acting on the body of the operator and / or the monitoring person in the event of critical entry into a warning zone as an approach to a restricted area.

[0017] Further rules can be defined in the computer unit, namely: a) operators authorized to access the work chamber; b) objects permitted in the work chamber, e.g. tools, and permitted, compatible components, e.g. molded parts on filling machines, and the proper installation of such molded parts with regard to plant-technical allocation and positioning; c) maximum permissible speed of the work gloves or objects moving in the work chamber; and d) a cleaning and disinfection program.

[0018] The tracking system is additionally equipped to recognize the biometric characteristics of an operator positioned at the containment.

[0019] The virtual reality glasses show the operator the prescribed intensity of surface cleaning, e.g., as one or more wipings with a minimum contact pressure, according to the cleaning and disinfection program stored in the computer unit, and the fulfillment of this requirement, e.g., as a color change from red to green when fulfillment has been achieved.

[0020] At least one work glove is provided with systematically distributed marking points, and the solid body formed by the work glove is captured as a CAD wireframe model by the tracking system based on these marking points.

[0021] The object, held by at least one work glove, is marked with systematically distributed marker points, and the solid body formed by the object is captured as a CAD wireframe model by the tracking system based on these marker points. Brief description of the attached drawings

[0022] They show: Figure 1A – the work chamber of a containment with two protruding work gloves, a held object in the form of a tool, and two cameras, in top view; Figure 1B – the setup according to Figure 1A , in side view; Figure 2 - a work glove with tool with a multitude of systematic marking points for creating a CAD wireframe model; Figure 3A - the setup according to Figure 1A , with three cameras and the first work glove with a stretching device, in top view; Figure 3B - the setup according to Figure 3A , with a user standing in front of the containment, in side view; Figure 4A - the setup according to Figure 1A , each work glove with tool, for the basic illustration of the gripping and action areas, in top view; Figure 4B - the structure according to Figure 4A , in side view; Figure 5A - the structure according to Figure 1A, the second work glove with tool for the basic illustration of warning and prohibition areas, in top view; Figure 5B - the setup according to Figure 5A , in side view; Figure 6A - the structure according to Figure 5A , for the basic illustration with the first work glove in the engagement of the first prohibited area, in top view; and Figure 6B - the setup according to Figure 6A , for the basic illustration of disturbed laminar flow, in side view. Example of implementation

[0023] With reference to the accompanying drawings, the detailed description below of the inventive method for monitoring the condition and movement sequence in an aseptic working chamber of a containment is given.

[0024] The following rule applies to the entire subsequent description. If a figure contains reference numerals for the purpose of graphical clarity, and it is clearly recognizable from the drawing that these are "recurring" components, but this is not explained in the immediately associated descriptive text, then, in the interest of brevity, reference is made to their explanation in preceding figure descriptions. Figures 1A and 1B

[0025] This is located in a setup room 99 positioned containment 9 is from the case 90 surrounding which the work chamber 91 encompasses. Into the Chamber of Labor 91 protrude - as shown in the stretched state - a first work glove 1 and a second work glove 2 inside. These work gloves 1,2 are available for intervention by an authorized operator 8 certain (see Figure 3B ). To create a tracking system C1-C2are a first camera C1, which provide a first detection angle α1 has, and a second camera C2 with its second detection angle α2 planned. The first camera C1 Monitoring and capturing the two spatial axes x,y and the second camera C2 the third spatial axis z, where the first detection angle α1 and the second detection angle α2 overlap, so that all areas in the work chamber 91 are recorded by the monitoring system. The recorded states and movements are stored in the computer unit. 5 stored as 3D data and / or video streams.

[0026] A tracking system C1-C2 can be used instead of cameras C1,C2 formed by an apparatus that operates based on optical systems, laser, radar, ultrasound or infrared technology.

[0027] Every work glove 1,2Each object can 7 hold or two work gloves 1,2 holding together an object 7, For example, a tool. In the workshop 91 Can containers be temporarily used? 4 Containers that are filled with substances, or that are to be filled or emptied with such substances. Outside the containment 9 are the computer unit 5 as well as the signal unit 6 provided for and a supervisor 8' can be assigned. The supervisor 8' The process flow at the containment is integrated as needed. 9 intervention.

[0028] The recordings of the tracking system C1-C2 in the computer unit 5 They serve both for the continuous three-dimensional localization of work gloves 1,2 as well as the objects associated with them 7 in the three spatial axes x,y,zformed xyz coordinate system with timestamp.

[0029] In the computer unit 5 The spatial positions of the containers will also be determined. 4 within the space defined by the three spatial axes x,y,z The xyz coordinate system is recorded with a timestamp to identify the unplanned position of a container in the event of an accident. 4, a possible breakage of a container 4 to determine its spread area and the spread area of ​​any uncontrolled leakage of the substance. Examples of such serious incidents include plastic or glass containers that have shattered into splinters, as well as spilled liquids or powders. Figure 2

[0030] The work glove 1 is equipped with a large number of systematically distributed marker points P1-P9 Provided. Based on the aforementioned marking points. P1-P9 will be the one from the work glove 1The solid bodies formed as CAD wireframe models are tracked by the tracking system. C1-C2 Captured. With the work glove 1 can an object 7 to be guided, which also includes marker points PM-PN for position detection using the tracking system C1-C2 exhibits. Figures 3A and 3B

[0031] In the case of a large spatial extent of the work chamber 91 is a third camera C3 with its third detection angle α3 installed. The first camera C1 with their first detection angle α1 The first spatial axis is monitored and captured. x, the second camera C2 with its second detection angle α2 the second spatial axis y and the third camera C3 with its third detection angle α3 the third spatial axis z. Depending on the size of the chamber of labor 91 Can additional cameras be used? Cwith the respective detection angles α This would be practical. Here too, it is advisable that the detection angles... α1-an overlap to cover all areas in the workroom 91 to be captured by surveillance.

[0032] In the computer unit 5 Regulations can be defined, namely: to the intervention in the labor chamber 91 authorized operators 8; in the Chamber of Labor 91 permitted objects 7, e.g. tools, and permitted, compatible components, e.g. molded parts on filling machines, and the proper installation of such molded parts with regard to plant-technical assignment and positioning; maximum permissible speed of the components in the working chamber 91 moving work gloves 1,2 or objects 7; and a cleaning and disinfection program.

[0033] The tracking system C1-C3 In addition to facial recognition, FR with the recording of the biometric characteristics of a person at containment 9 positioned operator 8 equip to record the operator's personal details 8 to log and / or his authorization for access to the work gloves 1,2 to determine and only release if affirmed, as embodied in the two European patent applications Nos. 19 405 011.8 and 19 405 012.6.

[0034] During the decontamination of the work chamber 91 It is also important to ensure that the work gloves 1,2 with their sometimes narrow areas, especially between the fingers, they can be completely decontaminated, which might not be guaranteed when they are turned inside out and hanging loosely. For the complete expansion of the work gloves 1,2 It is common practice to use a stretching device for the decontamination phase. 3 into the respective work glove 1,2to insert.

[0035] The operator is advantageous. 8 with virtual reality glasses 80 equipped, which may be intended, among other things, to assist the operator 8 according to the computer unit 5 The cleaning and disinfection program specifies the prescribed intensity for surface cleaning, e.g., as one or more passes with a minimum contact pressure, and indicates its proper fulfillment, e.g., as a color change from red to green when fulfillment has been achieved. Figures 4A and 4B

[0036] The respective one in the Chamber of Labour 91 protruding work glove 1,2 is up to a maximum gripping range R1,R2 in the three spatial axes x,y,z Extendable. Are worn by work gloves? 1,2 objects 7 Held, this results in a maximally extended action range. R1',R2' in the three spatial axes x,y,z. Figures 5A to 6B

[0037] In the Chamber of Labor 91 is at least a three-dimensional or two-dimensional exclusion zone V1,V2 defined, to which a warning zone W1,W2 can border on individual sections of land or the entire ground. 92 of containment 9 can be designated as a restricted area V1,V2 be defined. Around machines that are in the work chamber 91 are installed and for the operator 8 a danger can be a restricted area V1,V2 and possibly a warning zone in front of it W1,W2 be set up.

[0038] The coordinates of the restricted area V1,V2 and warning area W1,W2 in the three spatial axes x,y,z with xV1,yV1,zV1 until xV1',yV1',zV1' example of the first restricted area V1 and xW1,yW1,zW1 until xW1',yW1',zW1' example of the first warning zone W1 are in the computer unit 5saved. In the restricted area V1,V2 May work gloves be worn 1,2 No intervention should occur while in the warning area W1,W2 with the work gloves 1,2 No intervention should be undertaken. The same applies to an object. 7, with which also not into the restricted area V1,V2 Entry is permitted, while this applies to the warning area. W1,W2 This should not happen. In the computer unit 5 A real-time comparison is performed with the data in the computer unit. 5 designated restricted areas V1,V2 and any warning zones W1,W2.

[0039] With the tracking system C1-C3 It can also be detected and logged, although not directly in a restricted area. V1 Intervention occurs, but over a restricted area V1 through a work glove that extends over it 1 the laminar flow may be disrupted to a critical extent.

[0040] The virtual reality glasses 80, which of the operators 8 It is specifically designed to assist the operator 8 the computer unit 5 defined restricted areas V1,V2 and any warning zones W1,W2 to display as graphic elements.

[0041] The signal unit belonging to the arrangement 6 its purpose is to bring someone into the Chamber of Labor 91 intervening operator 8 and / or a supervisor 8' in case of unauthorized entry into a restricted area V1,V2 acoustic and / or visual and / or through sensation to the operator's body 8 and / or the supervisor 8' to trigger an alarm due to vibration.

[0042] Are warning areas W1,W2 The signal unit is set up and serves as a signal unit 6 to prevent critical entry into a warning zone W1,W2 as an approach to a restricted area V1,V2acoustic and / or visual and / or through sensation to the operator's body 8 and / or the supervisor 8' to report any vibrations that may be acting upon it.

Claims

1. Process for monitoring a state and movement sequence in an aseptic work chamber (91) of a containment (9) located in an installation room (99), having at least one work glove (1,2) which projects into the work chamber (91) and is worn by an operator (8), wherein: a) the respective work glove (1,2) can be extended in the work chamber (91) as far as a maximum gripping range (R1,R2) in the three spatial axes (x,y,z); and b) a tracking system (C1-C3) is installed, the recordings of which are used for continuous three-dimensional localization of the at least one work glove (1,2) and are stored in a computer unit (5), characterized by the following steps: c) definition of at least one three-dimensional or two-dimensional prohibited region (V1,V2) in the work chamber (91); d) at least some individual surface sections of the containment (9) are defined as a prohibited region (V1,V2); e) a prohibited region (V1,V2) is arranged set up around machines which are installed in the work chamber (91) and which represent a hazard for the operator (8); f) the coordinates of the at least one prohibited region (V1,V2) are stored in the computer unit (5); g) the operator (8) is warned when intervening with the at least one work glove (1,2) into the at least one prohibited region (V1,V2).

2. Process as claimed in claim 1, characterized in that a) a warning region (W1,W2) is defined which is adjoined to the at least one prohibited region (V1,V2), wherein: b) the at least one surface section comprises the entire bottom (92) of the containment (9) as a prohibited region (V1,V2); c) around the machines which are installed in the work chamber (91) and which represent a hazard for the operator (8) a warning region (W1,W2) is arranged in front of prohibited region (V1,V2); d) the coordinates of the prohibited region (V1,V2) and warning region (W1,W2) are stored in the computer unit (5); and e) the operator (8) is warned when intervening with the at least one work glove (1,2) into the warning region (W1,W2).

3. Process as claimed in claims 1 and 2, characterized in that a) each work glove (1,2) may respectively hold an object (7) or two work gloves (1,2) together may hold an object (7), so that there is a maximally extended action range (R1',R2') in the three spatial axes (x,y,z); b) the recordings of the tracking system (C1-C3) are used for continuous three-dimensional localization both of the at least one work glove (1,2) and of the at least one object (7); and c) the operator (8) is warned when an object (7) is intervening into the warning region (W1,W2) or the prohibited region (V1,V2).

4. Process as claimed in the claims 1 to 3, characterized in that a) the spatial positions of work gloves (1,2) and objects (7) within the xyz coordinate system formed by the three spatial axes (x,y,z) are recorded with a timestamp in the computer unit (5); and b) a real-time comparison with the prohibited regions (V1,V2) and optional warning regions (W1,W2) established in the computer unit (5) is carried out in the computer unit (5).

5. Process as claimed in at least one of claims 1 to 4, characterized in that a) containers (4) which are filled with substances, are to be filled therewith or are to be emptied, are temporarily located in the work chamber (91); wherein b) the spatial positions of the containers (4) within the xyz coordinate system formed by the three spatial axes (x,y,z) are recorded with a timestamp in the computer unit (5) in order, in the event of an accident, to establish an unplanned position of a container (4), possible breakage of a container (4) with its spreading region and the spreading region of uncontrolledly emerging substance.

6. Process as claimed in at least one of claims 1 to 5, characterized in that the operator (8) is equipped with virtual reality glasses (80), which are intended: a) to display the prohibited regions (V1,V2) and optional warning regions (W1,W2) defined in the computer unit (5) to them as graphics elements; and b) to display to them a surface to be cleaned according to the cleaning and disinfection program saved in the computer unit (5).

7. Process as claimed in at least one of claims 1 to 6, characterized in that the tracking system (C1-C3) comprises at least: a) a first camera (C1), which has a first acquisition angle (α1); and b) a second camera (C2), which has a second acquisition angle (α2); wherein: c) the first camera (C1) with its first acquisition angle (α1) monitoringly records two spatial axes (x,y) and the second camera (C2) with its second acquisition angle (α2) monitoringly records the third spatial axis (z); d) the first acquisition angle (α1) and the second acquisition angle (α2) overlap so that all regions in the work chamber (91) are recorded by the monitoring; and e) the recorded states and movement sequences are stored as 3D data and / or video streams in the computer unit (5).

8. Process as claimed in claim 7, characterized in that in the case of a large spatial extent of the work chamber (91), a third camera (C3) with its third acquisition angle (α3) and, depending on the size of work chamber (91), further cameras (C) with the respective acquisition angles (α) are installed; wherein: a) the first camera (C1) with its first acquisition angle (α1) monitoringly records the first spatial axis (x), the second camera (C2) with its second acquisition angle (α2) monitoringly records the second spatial axis (y) and the third camera (C3) with its third acquisition angle (α3) monitoringly records the third spatial axis (z); b) the acquisition angles (α1-α3) overlap in such a way that all regions in the work chamber (91) are recorded by the monitoring; and c) the recorded states and movement sequences are stored as 3D data and / or video streams in the computer unit (5).

9. The arrangement as claimed in at least one of claims 2 to 8, characterized in that a signal unit (6) is provided, which for an operator (8) intervening in the work chamber (91) and / or a monitoring person (8'): a) in the event of unallowed penetration into a prohibited region (V1,V2), alerts them acoustically and / or optically and / or by a vibration acting on the body of the operator (8) and / or of the monitoring person (8'); and b) if warning regions (W1,W2) are set up, in the event of critical penetration into a warning region (W1,W2) as an approach to a prohibited region (V1,V2), informs them acoustically and / or optically and / or by a vibration acting on the body of the operator (8) and / or of the monitoring person (8').

10. Process as claimed in at least one of claims 1 to 9, characterized in that further rules are defined in the computer unit (5), namely: a) operators (8) authorized to intervene in the work chamber (91); b) objects (7), for example tools, allowed in the work chamber (91) and allowed fittable components, for example shaped parts for filling machines, and the specification-compliant installing of such shaped parts in respect of plant-technological allocation and positioning; c) maximum allowed speed of the work gloves (1,2) or objects (7) moved in the work chamber (91); and d) a cleaning and disinfection program.

11. Process as claimed in claim 10, characterized in that the tracking system (C1-C3) is additionally configured to detect the biometric features of an operator (8) positioned at the containment (9).

12. Process as claimed in claim 6, characterized in that the virtual reality glasses (80) display to the operator (8), according to the cleaning and disinfection program saved in the computer unit (5), the prescribed intensity for the surface cleaning, for example as single or multiple wiping to be carried out with a minimum application pressure, and the fulfillment thereof, for example as a color change from red to green when reaching fulfillment.

13. The arrangement as claimed in at least one of claims 1 to 12, characterized in that a) the at least one work glove (1,2) is provided with systematically distributed marking points (P1-P9); and b) with the aid of said marking points (P1-P9), the volume body formed by the work glove (1,2) can be recorded as a CAD wire model by the tracking system (C1-C3).

14. The arrangement as claimed in at least one of claims 3 to 13, characterized in that a) the object (7) held by the at least one work glove (1,2) is provided with systematically distributed marking points (Pm-Pn); and b) with the aid of said marking points (Pm-Pn) the volume body formed by the object (7) can be recorded as a CAD wire model by the tracking system (C1-C3).