Monitoring device for a manipulation in a controlled environment

Abstract

The invention relates to a monitoring device (1) which automatically detects a manipulation, in particular an insertion action (2), in a controlled environment (3) by means of a sensor, in particular a light barrier (4), and which can automatically detect who or what has carried out this manipulation; the monitoring device (1) automatically detects a beginning and an end of the manipulation.

Description

[0001] PC 24 0584 C 26 August 2024

[0002] Monitoring device for manipulation of a controlled environment

[0003] The invention relates to a monitoring device that automatically detects manipulation, in particular interference, in a controlled environment with a sensor, in particular a light barrier, and can automatically identify who or what carried out this manipulation.

[0004] The object of the invention is to improve monitoring devices for controlled environments.

[0005] To solve the aforementioned problem, the features of claim 1 are particularly provided. In particular, to solve the aforementioned problem in a monitoring device of the type described above, it is proposed that the monitoring device automatically detects the beginning and the end of the manipulation.

[0006] This makes it possible, for example, to record who or what performed the manipulation of the controlled environment, when this manipulation began and ended, and thus also how long this manipulation lasted. A manipulation can be, for example, an intrusion into the controlled environment, such as an isolator or RABS, using a glove. A manipulation can also be the attachment of a device, such as a glove tester or glove stretcher. A manipulation can also be the attachment or fastening of an intrusion protection device, which is then detected. Other types of manipulation can include the replacement of agar plates, unlocking, cleaning, and the insertion of pumps. For processes that occur on and / or in the controlled environment, see PC 24 0584 C 2 / 25, August 26, 2024.

[0007] In an environment where manipulation occurs, it is important to know who or what carried it out and when. Automatic detection can mean that a user does not need to take any steps themselves, allowing for the detection or identification of the user or device and the determination of the start and end times of the manipulation.

[0008] To solve the aforementioned problem, the features of an independent claim directed to a comparison device are also provided. Thus, a monitoring device can be provided that automatically detects manipulation, in particular an intrusion, on a controlled environment using a sensor, especially a light barrier, and can automatically identify who or what carried out this manipulation. A comparison device is designed that compares a detected manipulation act with a predefined list and outputs a signal in case of a deviation. This makes it possible, for example, to identify a manipulation act taking place on the controlled environment as "permitted" or "not permitted" and to output a signal in case of deviation or match, so that a user can refrain from an accidentally carried-out manipulation.

[0009] In an advantageous embodiment of the invention, an identification device, which can determine who or what carried out the manipulation, can be activated by a sensor, for example, a light barrier. This makes it possible, for example, to ensure that the identification device does not have to be permanently activated, which results in undesirably high energy consumption, but only when a PC 24 0584 C 3 / 25 26. August 2024

[0010] Manipulation occurs and the sensor detects this manipulation. Alternatively or additionally, the identification device can be deactivated by the sensor. This allows, for example, the identification device to be switched off or put into a power-saving mode when the sensor no longer detects manipulation, thus saving energy. The light barrier can be, for example, an infrared light barrier. Of course, other known light barriers are also conceivable, such as laser light barriers or light barriers operating in the visible light spectrum. The light barrier can consist of a transmitter and a receiver (one-way light barrier), although systems with the transmitter and receiver in a single housing (reflective light barrier) are also conceivable. Light grids or light curtains are also possible.To minimize the risk of reflections from adjacent reflective surfaces, whose scattered light can interfere with the light barrier's receiver, the light barrier can be power-limited to reduce the light intensity. Alternatively or additionally, the light barrier's detection cone can be aligned so that reflections from the nearest wall surfaces are not detected. The light barrier can be positioned so that it does not necessarily detect a hand itself during an intervention, but rather a separating material moved by the hand between a hand section and the edge of an intervention glove. It can also be advantageous to use multiple light barriers to achieve the best possible coverage of an intervention opening while simultaneously avoiding the need for overly precise alignment of the monitoring device.

[0011] The sensor can also be a Hall sensor or an infrared sensor.

[0012] It must be a proximity sensor that can detect when a device is brought into the PC 24 0584 C 4 / 25 26. August 2024 controlled environment. The identification device can consist, for example, of a transponder, such as an RFID chip, and an RFID antenna. Alternatively or additionally, an RFID chip can also be worn by a user, for example, on their wrist.

[0013] In an advantageous embodiment, the identification device may read a signal from a passive transmitter. This may, for example, enable the identification device to identify a user or a device. In particular, it may be possible to read a signal from a passive transmitter, especially a passive RFID transponder. This may, for example, allow the passive RFID transponder to consume less energy. Alternatively or additionally, the identification device may read a signal from an active transmitter, especially an active RFID transponder, Bluetooth, or WLAN transmitter. This may, for example, allow reading over greater distances compared to the passive transmitter.

[0014] In an advantageous embodiment, the sensor can be automatically switched on and off at time intervals. This can, for example, make it possible to use the sensor in a very energy-efficient manner. Of course, it is also conceivable that the sensor could be permanently switched on.

[0015] In an advantageous embodiment, the monitoring device may include at least one signal receiver. A signal receiver may, for example, be an RFID receiver and / or a Hall sensor. This may, for example, make it possible to ensure that the PC 24 0584 C 5 / 25 26. August 2024

[0016] The monitoring device can receive signals, for example, from a transponder. Alternatively or additionally, the monitoring device can include a radio unit. This allows the monitoring device to transmit signals, such as radio signals to a PC / laptop / network in the vicinity. Advantageously, the radio unit can only be activated once the sensor has detected tampering. Alternatively or additionally, the monitoring device can include a storage unit. This allows signals, for example, from the sensor and / or an RFID chip, to be stored. Alternatively or additionally, the monitoring device can include a display unit.This allows, for example, a user to receive a notification when interacting with the controlled environment. The display unit can be a screen integrated into a glove access system, for instance. Upon user identification at the glove access system, the display unit can provide feedback, such as indicating whether the manipulation is authorized or not. Alternatively, the identification device can include the aforementioned components: a signal receiver, a radio unit, a storage unit, and / or a display unit. The advantages have been described previously. A display unit can also be used to issue tasks, instructions, and / or warnings to a user.The display unit can provide feedback as soon as the light barrier is interrupted and / or an RFID chip is read. The display unit can also include an input option, such as a touchscreen, allowing for user input. This enables a user to specify the type of manipulation being performed, either before or during the process (PC 24 0584 C 6 / 25 26. August 2024). The monitoring device can interact with a glove management system as a higher-level control system. This system allows for the subsequent recording and commentary of manipulations. For example, it can record which manipulation was performed and add missing information (e.g., if the user could not be identified). However, the data in the original database is not modified; instead, it is transferred to and supplemented in a separate database.The user can then create a batch report in this higher-level control, which is necessary for the complete documentation of the batch.

[0017] The monitoring and / or identification device can include the comparison device. The comparison device can store a list of planned manipulations locally, which can be updated at predefined intervals, for example, once a day. This has the advantage that a manipulation can be compared with the locally stored list more quickly and energy-efficiently. Thus, no connection to an external storage device is required to compare the manipulation. The comparison device can also be implemented decentrally on a PC or laptop.

[0018] In an advantageous embodiment, the identification device can receive information from a user and / or a device and send this information to a computing and storage unit. This allows, for example, the information to be stored in a database and / or compared with information in a database (PC 24 0584 C 7 / 25 26. August 2024), for instance, to determine whether the user and / or a device is authorized to perform a manipulation. Preferably, this information is transmitted wirelessly, which has the advantage that the identification device can be wireless. This, in turn, has the advantage that the user's field of vision remains unobstructed and that cleaning of a glass pane into which the monitoring device may be embedded is easier.

[0019] In an advantageous embodiment, the monitoring device may include an independent energy storage unit. The monitoring device can thus have a self-sufficient power supply. This allows, for example, the monitoring device to operate independently of any other power supply. Preferably, the energy storage unit is rechargeable. This allows, for example, the energy storage unit to have a battery that can be charged wirelessly. Of course, the energy storage unit can also be charged via a cable.

[0020] In an advantageous embodiment, the monitoring device can be operated with an energy storage device. This can, for example, enable the monitoring device to operate autonomously and not require any other wired power supply. Thus, a monitoring device can be implemented, for instance, that can be mounted centrally on a glass pane of an insulator or RABS without the need for any cables. This provides the user with an unobstructed view. Furthermore, cleaning the glass surface is facilitated. PC 24 0584 C 8 / 25 26. August 2024

[0021] In an advantageous embodiment, a signal may be emitted in the event of an undesired manipulation. Undesired manipulation can be manipulation that is not recorded, i.e., not stored in a database, or manipulation that occurs while a process is running in the controlled environment. For example, this could be an interference with the controlled environment while a process is in progress. This could, for instance, ensure that a user perceives the signal and refrains from the undesired manipulation. Alternatively or additionally, the signal could be visual and / or audible. This could, for example, enable a visual signal to be emitted via a display unit or a light on the monitoring device and / or in the controlled environment.An acoustic signal can be emitted via an audio output unit at the monitoring device and / or in the controlled environment. Acoustic and visual signals can be used to draw a user's attention. It is also possible for the signals to differ depending on the type of manipulation. For example, a signal for undesired manipulation can differ from a signal for desired manipulation. Signals can also be emitted for desired manipulation. A signal can also be displayed on a screen of the monitoring device.

[0022] In an advantageous embodiment, the energy storage device of the monitoring unit can be charged with a further energy storage device. This can, for example, make it possible to add another

[0023] Energy storage can transfer energy to the energy storage of the monitoring device. This can be done, for example, with a glove testing device, a PC 24 0584 C 9 / 25 26. August 2024

[0024] Glove stretchers or a protective device are used. Gloves worn in controlled environments such as isolators or RABS must be checked for functionality, e.g., leak tightness, at regular intervals. For this purpose, a glove testing device is attached to the controlled environment and the glove. In addition to the leak test, energy can advantageously be transferred to the energy storage device of the monitoring unit. Alternatively or additionally, it can be provided that data can be transferred to or from the monitoring unit in this way. Preferably, the energy storage device of the monitoring unit is charged without contact. This can, for example, ensure that the additional energy storage device does not have to touch the monitoring unit and therefore cannot become contaminated, and that energy can be transferred wirelessly.

[0025] In an advantageous design, the monitoring device can be configured to automatically terminate a process running in the controlled environment in the event of unwanted manipulation. This can, for example, serve as a safety precaution to protect the user carrying out the unwanted manipulation. It can also protect the process from changes that unwanted manipulation could cause by terminating the process, thus preventing a user and / or device from influencing an ongoing process.

[0026] In an advantageous embodiment, the controlled environment can be defined by an isolator. An isolator can create a protected environment in which a process can take place hermetically and gas-tightly sealed off from the surroundings. Once any manipulation is carried out on the isolator, it can be detected by PC 24 0584 C 10 / 25 26 August 2024

[0027] The monitoring device can detect tampering. Alternatively or additionally, the sensor can be configured to detect tampering via glove access. This allows, for example, a user to work more easily inside an isolator. To perform a tampering, such as an access attempt, the user can reach inside the glove and trigger the sensor, for example, the light barrier. This activates the identification device, which then receives a signal to identify the user, for example, from an RFID chip. The termination of a tampering attempt can also be registered.

[0028] In one embodiment of the invention, a transponder and / or an RFID reader may be provided. This makes identification easy.

[0029] Alternatively or additionally, a permanent magnet can be incorporated. This makes detecting an approach, for example to activate the identification device, easy. For instance, the sensor, particularly a Hall sensor, can be triggered by the permanent magnet. This allows for easy handling and identification of who or what is approaching.

[0030] Alternatively or additionally, the features of the dependent claim, which relates to a method for automatic process documentation, are provided according to the invention to solve the aforementioned problem. In particular, a method is thus proposed to solve the aforementioned problem in a monitoring device of the type described above, wherein a manipulation of a controlled environment is automatically detected and wherein a start and an end of the manipulation can be automatically recorded and these can be automatically linked to recorded time points with time points of a process sequence. This can, for example, make it possible for the process documentation to enable temporal traceability of manipulations of the controlled environment.In particular, such process documentation allows for tamper-proof documentation of interventions in the controlled environment, whereby the monitoring system can automatically save a detection of a manipulation in a database that is inaccessible to the user. It is also easy to trace who or what carried out a manipulation at a specific point in a process within a controlled environment.

[0031] Alternatively or additionally, to solve the aforementioned problem, the features of the subsidiary claim, which relates to a method for the automatic detection of manipulation with a monitoring device, are provided according to the invention.In particular, to solve the aforementioned problem in a monitoring device of the type described above, a method is proposed comprising at least two of the following steps: Activating a sensor, in particular a light barrier and / or a Hall sensor, at time intervals to detect tampering; Activating an identification device when the sensor sends a signal or when a signal is absent, in particular when the light barrier is blocked and / or the Hall sensor detects a magnetic field; Reading information from a user or a device; Sending the information to a computing and storage unit; Evaluating the information in the computing and storage unit; Receiving information from a computing and storage unit; Displaying the information. Of course, a PC 24 0584 C 12 / 25 26. August 2024.

[0032] Manipulation can also be detected if a user or device does not provide any information for reading. In other words, the automatic manipulation detection method also works if a user does not wear an RFID chip for identification or if a device is brought near that does not carry any identification information. Consequently, information indicating the absence of this information is stored. This makes it possible, for example, to detect manipulation of a user or device even if not all steps of the previously described procedure are carried out.

[0033] Alternatively or additionally, the features of the dependent claim, which relates to a method for maintaining a monitoring device, are provided according to the invention to solve the aforementioned problem. In particular, it is thus proposed that, to solve the aforementioned problem in a monitoring device of the type described above, the energy storage device can be charged with a further rechargeable energy storage device. This can, for example, make it possible to provide a method by which the monitoring device can be supplied with energy so that it can operate autonomously. Preferably, the charging is carried out without contact and / or wirelessly, which has the advantage that no contaminants can be transferred to the energy storage device and / or the monitoring device and / or that no cables are required that obstruct the view into the monitored environment.Alternatively or additionally, it may be provided that information is read from the monitoring device. This may, for example, make it possible to avoid the need for long-distance radio transmission from the monitoring device to a receiving unit, but rather to transmit the information over short distances (a few centimeters). Preferably, this is described in PC 24 0584 C 13 / 25 26. August 2024.

[0034] Information transmission is contactless and / or wireless. This can, for example, eliminate the need for additional components such as cables, and allow for easy cleaning of the surfaces of the monitoring device or the glove grip unit.

[0035] A preferred use of potentially independent inventive quality in a monitoring device according to the invention, in particular as described above and / or claimed below, and / or in a method according to the invention, in particular as described above and / or claimed below, provides that a transponder, for example the one already mentioned, is preferably worn on a wrist in a manner that prevents replacement.

[0036] Exchange-proof can mean, for example, that an exchange of the carrier is registered in a tamper-proof manner by the transponder.

[0037] The invention will now be described in more detail using an exemplary embodiment, but is not limited to this embodiment. Further exemplary embodiments result from combining the features of one or more claims with each other and / or with one or more features of the exemplary embodiment.

[0038] They show

[0039] Fig. 1 shows a monitoring device in a side sectional view.

[0040] Fig. 2 shows the monitoring device from Fig. 1, where a user starts / ends a manipulation of a controlled environment.

[0041] Fig. 3 the monitoring device from Fig. 1-2, wherein the PC 24 0584 C 14 / 25 26 August 2024

[0042] Users can manipulate a controlled system

[0043] environment

[0044] Fig. 4 shows the monitoring device from Figs. 1-3, wherein a glove testing device is brought forward and

[0045] Fig. 5 shows the monitoring device from Fig. 1-4, with the glove testing device attached and

[0046] Fig. 6 shows the monitoring device from Fig. 1-5, with a glove stretcher attached.

[0047] Figures 1-6 show the monitoring device 1, designated in its entirety as 1. The monitoring device 1 can automatically detect a manipulation, in this case an intrusion 2, into a controlled environment 3 using a light barrier 4. The monitoring device 1 can also automatically detect who or what carried out this intrusion 2. Furthermore, the monitoring device 1 can automatically detect the beginning and end of the intrusion 2.

[0048] The monitoring device 1 has a comparison device 30 that compares a detected manipulation action with a predefined list and outputs a signal 29 in case of a deviation. The comparison device 30 is shown as part of the monitoring device 1 in Figures 1-6. In an embodiment not shown, the comparison device 30 is arranged decentrally, for example on a PC or laptop.

[0049] The monitoring device 1 has an identification device 5 with which it can be determined who or what carried out the intervention 2. The identification device 5 can be activated and deactivated by the light barrier 4 PC 24 0584 C 15 / 25 26. August 2024.

[0050] The identification device 5 reads a signal 12 from a passive transmitter, in the example shown a transponder 18, 24, 27.

[0051] The light barrier 4 of the monitoring device 1 is automatically switched on and off at time intervals, which saves energy.

[0052] In the illustrated embodiment, the monitoring device 1 comprises two signal receivers 6, a radio unit 7, a storage unit 8, and a display unit 9. The signal receivers shown are an RFID antenna and a Hall sensor. In an embodiment not shown, the identification device comprises the signal receiver 6, the radio unit 7, the storage unit 8, and the display unit 9.

[0053] The identification device 5 wirelessly receives information from a user 10 and sends this information to a computing and storage unit (not shown).

[0054] The monitoring device 1 includes an independent, rechargeable energy storage device 11 that supplies energy to the monitoring device 1.

[0055] The monitoring device 1, the identification device 5 and the radio unit 7 can be operated with the energy storage device 11.

[0056] In the event of an unwanted intrusion 2, as exemplified in Figure 3, a visual and / or acoustic signal 29 is output. The visual signal 29 is output via the display unit 9 and the acoustic signal 29 via an acoustic output unit, for example a PC 24 0584 C 16 / 25 26. August 2024

[0057] Loudspeaker. Both signals 29 are simplified and summarized in Figure 3.

[0058] Figure 4 shows the approach of a glove testing device 14 to the controlled environment 3, wherein the monitoring device 1 detects this manipulation with its sensors, the Hall sensor and identifies it with the RFID antenna, and automatically records the beginning and end of this manipulation. The glove testing device 14 comprises a transponder 24 and a magnet 25 which interact with the two sensors.

[0059] The energy storage device 11 of the monitoring device 1 can be charged contactlessly with another energy storage device 13. The second energy storage device 13 is enclosed by a glove testing device 14. The glove testing device 14 has a handle 22, which is used to attach it to the glove opening 15 (Fig. 4). A seal 23 of the glove testing device 14 seals the glove 17, which is placed inside the controlled environment 3, so that it can be pressurized compared to the environment outside the controlled environment 3. In this position (Fig. 5), the glove testing device 14 can charge the energy storage device 11 of the monitoring device 1 contactlessly and wirelessly. Data can also be exchanged between the glove testing device 14 and the monitoring device 1.

[0060] Figure 6 shows a glove stretcher 26 attached to the controlled environment 3, wherein the monitoring device 1 detects this manipulation with its sensors, the Hall sensor, and identifies it with the RFID antenna, automatically recording the beginning and end of this manipulation. In the illustrated embodiment, the glove stretcher has a transponder 27 and a magnet 28. PC 24 0584 C 17 / 25 26 August 2024

[0061] In the event of an unwanted interference 2, the monitoring device 1 automatically terminates a process taking place in the controlled environment 3.

[0062] The controlled environment 3 is defined as an isolator. The light barrier 4 is configured to detect an intervention 2 via a glove opening 15. The glove opening 15 is located on, or embedded in, a glass pane 16 of the controlled environment 3. The glove opening 15 comprises a glove 17 with which a user 10 can access the controlled environment 3 to work there. The monitoring device 1 is part of the glove opening 15. Fig. 1 shows a state in which the glove 17 hangs outside the controlled environment 3. In this state, the light barrier 4 is not interrupted, which is why the identification device is not active. In Fig. 2, a user 10 reaches into the glove 17 and blocks the light barrier 4. The light barrier 4 consists of an IR emitter 20 and an IR receiver 21.The identification device 5 is then activated and reads a signal 12 provided by the user 10. This signal 12 is emitted by a transponder 18 worn by the user 10 on their wrist 19. The transmitted information can be sent to a computing and storage unit or stored locally in the monitoring device 1. Fig. 3 shows the state in which the user 10 enters the controlled environment 3 to perform a task. When the glove 17 is removed from the controlled environment 3, the end of the intervention 2 is detected and recorded.

[0063] In a procedure for an automatic

[0064] Process documentation, where an intervention 2 into a controlled environment 3 is automatically detected, is a PC 24 0584 C 18 / 25 26 . August 2024

[0065] The beginning and end of the intervention are automatically recorded and automatically linked to recorded timestamps with timestamps of a process flow.

[0066] A method for the automatic detection of an intrusion 2 with a monitoring device 1 comprises the following steps: Activating the light barrier 4 at time intervals to detect an intrusion 2; Activating the identification device 5 when the light barrier 4 is blocked; Reading information from a user 10; Sending the information to a computing and storage unit; Evaluating the information 10 in the computing and storage unit; Receiving information from a computing and storage unit; Displaying the information.

[0067] For the maintenance of a monitoring device 1, it is provided that the energy storage device 11 is charged contactlessly and wirelessly with another rechargeable energy storage device 13, and that information from the monitoring device 1 is read out contactlessly and wirelessly. Naturally, information can also be transmitted to the monitoring device 1 in this way.

[0068] A monitoring device 1 is proposed which automatically detects an intrusion 2 into a controlled environment 3 with a light barrier 4 and can automatically detect who carried out this intrusion 2, characterized in that the monitoring device 1 automatically detects a beginning and an end of the intrusion 2.

[0069] / Reference list PC 24 0584 C 19 / 25 26 August 2024

[0070] Reference symbol list

[0071] 1 monitoring device

[0072] 2 intervention

[0073] 3 Controlled environment

[0074] 4 light barriers

[0075] 5 Identification device

[0076] 6 signal receivers

[0077] 7 radio unit

[0078] 8 storage units

[0079] 9 Display unit

[0080] 10 users

[0081] 11 Energy storage

[0082] 12. User / device signal

[0083] 13 additional energy storage devices

[0084] 14 Glove testing device

[0085] 15 Glove entry

[0086] 16 glass panes

[0087] 17 Glove

[0088] 18 transponders

[0089] 19 Wrist

[0090] 20 IR emitters

[0091] 21 IR receivers

[0092] 22 Grip

[0093] 23 Seal

[0094] 24 transponders of the glove testing device

[0095] 25 Magnet of the glove testing device

[0096] 26 glove stretchers

[0097] 27 glove stretcher transponders

[0098] 28 Glove stretcher magnet

[0099] 29 Signal in case of unwanted manipulation

[0100] 30 Comparative Institution

[0101] / Claims

Claims

PC 24 0584 C 20 / 25 August 26, 2024 Claims 1. Monitoring device (1) which automatically detects a manipulation, in particular an intervention (2) , on a controlled environment (3) with a sensor, in particular a light barrier (4) , and can automatically identify who or what carried out this manipulation, characterized in that the monitoring device (1) automatically detects a beginning and / or an end of the manipulation.

2. Monitoring device according to the preamble of claim 1 or according to claim 1, characterized in that a comparison device (30) is designed which compares a detected manipulation act with a predetermined list and outputs a signal (29) in case of deviation.

3. Monitoring device (1) according to the preamble of claim 1 or according to claim 1, characterized in that an identification device (5) with which it is possible to determine who or what has carried out the manipulation, in particular the intervention (2), can be activated and / or deactivated by the sensor, in particular the light barrier (4).

4. Monitoring device (1) according to one of the preceding claims, characterized in that the identification device (5) reads a signal (12) from a passive transmitter, in particular a passive RFID transponder, and / or that the identification device (5) reads a signal (12) from an active transmitter, in particular an active REID transponder, Bluetooth or WLAN transmitter. PC 24 0584 C 21 / 25 August 26, 2024 5. Monitoring device (1) according to one of the preceding claims, characterized in that the sensor, in particular the light barrier (4), is automatically switched on and off at time intervals.

6. Monitoring device (1) according to one of the preceding claims, characterized in that the monitoring device (1) and / or identification device (5) comprises at least one signal receiver (6) and / or one radio unit (7) and / or one storage unit (8) and / or one display unit (9).

7. Monitoring device (1) according to one of the preceding claims, characterized in that the identification device (5) receives information from a user (10) and / or from a device and sends this information, preferably wirelessly, to a computing and storage unit.

8. Monitoring device (1) according to one of the preceding claims, characterized in that the monitoring device (1) comprises an independent, preferably rechargeable, energy storage device (11).

9. Monitoring device (1) according to one of the preceding claims, characterized in that the monitoring device (1), in particular the identification device (5), and / or a radio unit (7) can be operated with the, preferably rechargeable, energy storage device (11).

10. Monitoring device (1) according to one of the preceding claims, characterized in that in the event of an unwanted manipulation, in particular an intervention PC 24 0584 C 22 / 25 August 26, 2024 (2) , a signal (29) , in particular a visual and / or acoustic signal (29) , is emitted.

11. Monitoring device (1) according to one of the preceding claims, characterized in that the energy storage device (11) the monitoring device (1) is rechargeable with a further energy storage device (13), preferably contactless.

12. Monitoring device (1) according to one of the preceding claims, characterized in that the monitoring device (1) automatically terminates a process taking place in the controlled environment (3) in the event of an unwanted manipulation, in particular an intervention (2).

13. Monitoring device (1) according to one of the preceding claims, characterized in that the controlled environment (3) is defined by an isolator and / or that the sensor, in particular the light barrier (4), is used to detect manipulation, in particular an intervention. (2) , in a controlled environment (3) , in particular via a gloved intervention (15) .

14. Monitoring device (1) according to one of the preceding claims, characterized in that a transponder (18, 24) and / or an RFID reader is / are designed and / or that a permanent magnet is designed, in particular with which the sensor, in particular a Hall sensor, can be triggered.

15. Method for automatic process documentation, involving manipulation of a controlled environment (3) , in particular an intrusion (2) into a controlled environment (3) , is automatically detected and wherein a PC 24 0584 C 23 / 25 August 26, 2024 The beginning and end of the intervention (2) can be automatically recorded and these can preferably be automatically linked to times of a process flow on recorded times.

16. Method for automatically detecting manipulation, in particular an intrusion (2) , with a monitoring device (1) according to one of the preceding claims comprising at least two of the following steps: - Switching on a sensor, in particular a light barrier (4) and / or a Hall sensor at time intervals to detect an intervention (2). - Switching on an identification device (5) when the sensor emits a signal or when a signal is not received, in particular when the light barrier (4) is blocked and / or the Hall sensor detects a magnetic field , - Reading information from a user (10) or a device - Sending the information to a computing and storage unit - Evaluating the information in the computing and storage unit - Receiving information from a computing and storage unit - Presenting the information 17. Method for maintaining a monitoring device (1) according to one of the preceding claims, characterized in that the energy storage device (11) is charged with a further rechargeable energy storage device (13), preferably contactlessly and / or wirelessly, and / or that information is read out of the monitoring device (1), preferably contactlessly and / or wirelessly. PC 24 0584 C 24 / 25 August 26, 2024 18. Use of a monitoring device (1) according to one of claims 1 to 14 and / or in a method according to one of claims 15 to 17, characterized in that the transponder or transponders (18) are preferably worn on a wrist in a manner that prevents replacement. / Summary

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