System for the sterilisation and cleaning of medical and pharmaceutical goods and method for controlling a system

WO2025061467A1PCT designated stage expired Publication Date: 2025-03-27BELIMED LIFE SCI AG
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Patent Information

Application Number
PCT/EP2024/074661
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-09-19
Filing Date
2024-09-04
Publication Date
2025-03-27

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Abstract

The invention relates to a system (18) for the sterilisation and / or cleaning of medical and pharmaceutical goods. The system (18) comprises a chamber (21). The chamber (21) comprises a media introduction means (22) and an actuator control means (23). A physical variable in the chamber (21) can be controlled by the actuator control means (23). A sensor (11, 12) is arranged in the chamber (21). The system (18) has a digital data transmission unit (8, 9). Data of the sensor (11, 12) can be digitally transmitted to a data processing unit (6, 7) by way of the digital data transmission unit (8, 9). The data can be transmitted by the digital data transmission unit (8, 9) in a wireless or wired manner. The data can be exchanged bidirectionally between the digital data transmission unit (8, 9) and the data processing unit (6, 7).
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Description

[0001] Plant for the sterilization and cleaning of medical and pharmaceutical goods and method for controlling a plant

[0002] The present invention relates to a system for the sterilization and cleaning of medical and pharmaceutical goods and to a method for controlling a system.

[0003] Systems for the processing of medical and pharmaceutical goods are well known in the art. During operation, systems such as sterilizers and cleaning systems are continuously monitored by sensors. Since these systems sterilize and / or clean medical and pharmaceutical goods that are then used in the laboratory or directly on patients, it is extremely important to monitor the quality of a system's cleaning or sterilization process in order to ensure high and consistent quality of the sterilization or cleaning process. State-of-the-art systems have the disadvantage that the sensors and the subsequent measuring chains are susceptible to failure and have a high degree of measurement uncertainty.Sensors and measuring technology in a system that are prone to failure are a major disadvantage because, in the event of inaccuracies or measurement errors, a cleaning and sterilization process must be repeated, which means a delay in the process and causes costs.

[0004] The object of the invention is to overcome the disadvantages of the prior art and, in particular, to create a system and a method for controlling a system that can be carried out reliably and with high, consistent quality. This object is achieved by a system for sterilizing and / or cleaning medical and pharmaceutical goods and by a method for controlling a system according to the independent patent claims.

[0005] In particular, the object is achieved by a system for the sterilization and / or cleaning of medical and pharmaceutical goods. The system comprises a chamber. The chamber includes a media inlet and an actuator control. With the actuator control, a physical variable in the chamber can be controlled. The physical variable can be, for example, temperature and / or pressure and / or a conductance. A sensor is arranged in the chamber. A pressure sensor and / or a temperature sensor and / or a conductance sensor can be arranged in the chamber as a sensor. The system has a digital data transmission unit. By means of the digital data transmission unit, data from the sensor can be digitally transmitted to a data processing unit.

[0006] Media can be introduced into the chamber using the media introduction system. Media can be gases and / or liquids. Examples of media include air, water, steam, rinse aid, or cleaning agents. Actuators can be motors or valves, for example. A valve can be a continuous valve. Actuator control can be used to control physical variables such as pressure or temperature in the chamber based on physical values ​​measured by sensors.

[0007] The system can be a sterilizer or a cleaning system for medical and pharmaceutical goods. The chamber can be designed as a washing chamber. The sensor data can be transmitted wirelessly or via cable from the digital data transmission unit to the data processing unit, particularly in real time. It is possible for sensor data to be bidirectionally exchangeable between the digital data transmission unit and the data processing unit.

[0008] Digital transmission of the sensor data via the digital data transmission unit ensures consistent and high transmission quality. This allows the sensor data to be efficiently processed, and the quality of the cleaning and sterilization process can be effectively monitored and documented.

[0009] The system, and in particular the chamber, can be made essentially of stainless steel. It is also possible for the chamber to be made of another material. It is essential that the chamber be made of a heat-resistant, robust, and easy-to-clean material. The chamber can be essentially cuboid-shaped.

[0010] It is possible that several sensors are arranged in the chamber. It is possible that several pressure sensors and / or several temperature sensors and / or several conductivity sensors are arranged in the chamber. The sensor can be a temperature sensor, a pressure sensor, a humidity sensor or a sensor with which a volume flow can be measured. Several of the previously mentioned sensors can also be installed in the system. Sensors that measure other physical quantities can also be installed in the system. The digital transmission unit can be an IO-Link slave. The IO-Link slave can be designed to exchange data with an IO-Link master. The system can be equipped or retrofitted with one or more IO-Link slaves.It is possible to combine several sensors into one sensor unit, with the data from the sensor unit being transmitted to several IO-Link slaves, each sensor being assigned to a 10-Link slave. It is then possible to feed several independent measuring chains with data from the different sensors. One sensor is assigned to one measuring chain. This creates redundancy in the measuring chains if two sensors measure the same physical quantity and are each assigned to a measuring chain. For example, a first measuring chain can be used to control or regulate the pressure and / or temperature in the system chamber. It is possible to use a second measuring chain to measure the same physical quantity as the first measuring chain. The data from the first measuring chain and the data from the second measuring chain can then be compared. This can happen during the cleaning and sterilization process.By comparing the data during the cleaning and sterilization process, the process can be advantageously controlled or regulated. It is also possible to compare the data from the first measuring chain with the data from the second measuring chain after the cleaning and sterilization process.

[0011] The subsequent measurement chain, which connects to another IO-Link slave, can be completely digital. Unlike analog signals, digital signals are less susceptible to interference. By converting analog signals to digital signals as early as possible in the measurement chain, the accuracy and reliability of the measurement chain are increased.

[0012] Wireless data transmission makes it possible to transfer data without the need for complex cables. Wireless transmission thus simplifies data transmission.

[0013] A bidirectional transmission of data between the digital data transmission unit and the data processing unit ensures that data can also be sent from the data processing unit to the digital data transmission unit.

[0014] This makes it possible to calibrate the measuring chain.

[0015] An analog sensor is a sensor that measures data in analog form and forwards the analog data to the further measuring chain. A digital sensor is a sensor that measures data in analog form, converts the data to digital data and feeds the data digitally into the further measuring chain. An analog sensor provides a continuous, analog signal that changes smoothly with changes in the measured quantity. The signal from an analog sensor can therefore take on any value within a certain range. A digital sensor provides a discrete, quantized output signal that represents the measured quantity in a digital format in the form of binary values. A sensor that measures analog data can be equipped with a conversion unit that converts analog data into digital data. A sensor equipped with a conversion unit that provides digital data is a digital sensor.

[0016] A digital sensor is an electronic device that captures measurements or information from the physical environment and outputs them in digital form. Unlike analog sensors, which generate continuous signals, digital sensors generate discrete digital signals or data that are output in the form of binary values ​​(0 and 1) or digital codes. This digital data can be easily processed, transmitted, and analyzed by microcontrollers, computers, and other digital systems. Digital sensors often offer greater precision and accuracy in measuring physical quantities compared to analog sensors. Digital sensors are often smaller and more compact because they require fewer external circuit elements for signal processing. Furthermore, digital signals are less susceptible to interference and noise because they can be protected by error correction mechanisms.Digital sensors can be easily integrated into digital systems and microcontrollers without the need for complex analog-to-digital conversions. Many digital sensors are programmable, allowing users to customize measurement parameters and configurations.

[0017] Digital sensors enable easy integration of sensor data into digital networks and applications.

[0018] It is possible that the sensor, for example the pressure sensor and / or the temperature sensor, is an analog sensor and the sterilizer has a conversion unit by which analog data that can be transmitted between the sensor and the data transmission unit can be converted into digital data.

[0019] The conversion unit can be structurally integrated into the data transmission unit. It is possible for the conversion unit and the data transmission unit to be integrated into a single housing. It is possible for the digital data transmission unit to be an IO-Link slave, and for the conversion unit to be integrated into the IO-Link slave. Data can then be transmitted in analog form from an analog sensor to the IO-Link slave, converted into digital data by the conversion unit in the IO-Link slave, and subsequently transmitted to a data processing unit.

[0020] By installing an IO-Link slave and converting analog signals from the pressure sensor and / or the temperature sensor into digital signals using a conversion unit in the IO-Link slave, systems, such as sterilizers, that contain analog sensors can be easily retrofitted. In retrofitted systems, it is possible to digitally transmit data across a large portion of the measuring chain. This prevents losses in the measuring chain, the data from the sensor, such as the pressure sensor and / or the temperature sensor, can be advantageously processed, and a high, consistent quality of the sterilization process can be ensured.

[0021] It is possible for a system, for example a sterilizer, to have multiple digital data transmission units. It is possible for one conversion unit and / or one digital data transmission unit to be configured for each sensor, for example, for each pressure sensor and / or temperature sensor.

[0022] It is also possible to design several conversion units and / or digital data transmission units for one or more sensors. The digital data transmission unit can be designed as an IO-Link slave. If a digital data transmission unit is designed in the system, for example in the sterilizer, and the sensor, for example the pressure sensor and / or the temperature sensor, is an analog sensor, the data from the sensor is transmitted in analog form to the conversion unit. The data is then converted from analog data into digital data by the conversion unit. The digital data converted by the conversion unit can then be transmitted by the digital data transmission unit and processed in the further measuring chain.It is possible that the digital data transmission unit and / or the conversion unit is structurally connected to the pressure sensor and / or the temperature sensor and / or integrated into a common housing.

[0023] It is possible for the system, which can be designed as a sterilizer, to include a digital sensor. The digital sensor can measure a physical quantity such as temperature and / or pressure. The digital sensor can have a digital data transmission unit. The digital data transmission unit can transmit digital data directly to a data processing unit.

[0024] The design of a digital sensor enables data to be transmitted digitally throughout the entire measurement chain connected to the digital sensor. This allows for extremely reliable data transmission, preventing measurement losses and inaccuracies.

[0025] It is possible for the system to include several digital sensors. It is also possible for the system to include one or more digital sensors and one or more analog sensors. In this case, data from the different sensors can be compared. This way, the accuracy of the measurements can be increased and the function of the sensors can be checked and verified.

[0026] A digital sensor can be, for example, a temperature sensor, a humidity sensor, a light sensor, or a pressure sensor, with the data from the digital sensor being provided digitally in each case. It is also possible for the system to include additional digital sensors that measure other physical variables.It is possible for a system to comprise a digital sensor, wherein a physical quantity, for example the temperature and / or the pressure and / or the conductivity, is measured by the digital sensor and transmitted directly from the digital data transmission unit of the digital sensor to a data processing unit, and for the system to comprise an analog sensor, wherein the data from the analog sensor is sent in analog form to a conversion unit, where it is converted into digital data and then sent to a digital data transmission unit and transmitted from the digital data transmission unit to the data processing unit to which the data from the digital sensor was also transmitted. The digital data from the digital sensor and the data from the analog sensor digitized by the conversion unit can then be compared by the data processing unit.This type of system design makes it possible to compare data measured by different sensors. This allows deviations during sterilization and cleaning within the sterilization and cleaning system to be quickly identified, and a sensor defect can also be quickly identified and rectified. This type of arrangement ensures a high, consistent quality of the sterilization and cleaning process within the system.

[0027] It is possible for the sensor, for example the pressure sensor and / or the temperature sensor and / or the digital sensor, to be designed as a self-monitoring sensor. These sensors can each detect a wide variety of physical variables, as described above.

[0028] In this way, the function of the sensor(s) can be checked at any time and, if defects occur, the respective sensor can be quickly repaired or replaced.

[0029] A self-monitoring or self-calibrating sensor is a sensor that can measure and transmit data about its own status and / or performance without the need for external monitoring. The sensor(s) may be equipped with an integrated microprocessor or microcontroller. Raw data acquired by the sensor may be processed by the microprocessor or microcontroller. The microprocessor or microcontroller may convert the raw sensor data into a format suitable for transmission. Data processing may also include data filtering.

[0030] The sensors, which are designed as self-monitoring sensors, can send a fault signal to the digital data transmission unit, the conversion unit, or the data processing unit in the event of a fault. This allows the sensors to quickly detect a measurement fault in the sterilizer, and any defects can be quickly remedied.

[0031] It is possible that the self-monitoring sensor(s) can perform a calibration check. The self-monitoring sensor(s) can then compare their measurements with a reference value. This allows the self-monitoring sensor(s) to determine whether the required measurement accuracy is maintained.

[0032] It is possible for the sterilizer to have a first data processing unit. It is also possible for the sterilizer to have a second data processing unit. The first data processing unit and / or the second data processing unit can exchange data with the data transmission unit. The first data processing unit and / or the second data processing unit can also exchange data with the data transmission unit. The data exchange between the first data processing unit and / or the second data processing unit and the data transmission unit and / or the data transmission unit can be bidirectional. The first data processing unit and / or the second data processing unit can make data from the digital sensor comparable with data from the sensor.The digital sensor and the sensor can each be a sensor of the type described above. The data can be advantageously processed by forming a first data processing unit and / or a second data processing unit. It is possible for the first data processing unit to be assigned to a first measuring chain and for the second data processing unit to be assigned to a second measuring chain.

[0033] It is possible for the first data processing unit and / or the second data processing unit to be structurally arranged on or in the system. It is also possible for the first data processing unit and / or the second data processing unit to be structurally arranged not on the system, but in its surroundings. It is possible for data from other sterilizers or other systems to be processed in the first data processing unit and / or the second data processing unit.

[0034] By comparing the sensor data with the digital sensor data, it is possible to achieve high measurement accuracy and quickly detect defects and deviations. If the sensors are designed as self-monitoring sensors in addition to the data comparison by the first data processing unit and / or the second data processing unit, this ensures additional redundancy and reliability. This creates an extremely robust and precise overall system that is immune to errors. Should errors and inaccuracies nevertheless occur, they can be quickly detected and corrected.

[0035] It is possible for an analog sensor to send analog data to a conversion unit and for the conversion unit to send digital data to a digital data transmission unit. The data digitized by the conversion unit can then be sent by the digital data transmission unit to a first data processing unit. It is possible for digitally acquired data from the digital sensor to be sent directly from the digital sensor to the first data processing unit. Thus, the first data processing unit contains both digital data from the digital sensor and data from the analog sensor digitized by the conversion unit.

[0036] The first data processing unit can then compare and further process the data from the digital sensor and the analog sensor.

[0037] The first data processing unit and / or the second data processing unit can be configured as an IO-Link master. It is possible for an analog sensor to send analog data to a further conversion unit. From the further conversion unit, the data can be sent to a further digital data transmission unit, and from the further digital data transmission unit to a second data processing unit. This creates a second measuring chain that is independent of the first measuring chain.

[0038] IO-Link is a global communication standard for sensors. The current version is IEC 61131-9:2022.

[0039] It is possible for the system to include a data storage unit. The data storage unit can store sensor data, for example, pressure sensor data and / or temperature sensor data and / or digital sensor data. Data can be transferred between the data storage unit and the second data processing unit. Storing the data makes it possible to document proper sterilization and cleaning, as well as proper functioning of the system.

[0040] It is possible for the system to include multiple data storage units. A data storage unit is specifically designed for data storage. A data storage unit therefore not only stores the data temporarily for processing, but is also capable of storing the input data permanently.

[0041] It is possible for the data to be forwarded from the second data processing unit to a data storage unit and stored there. This makes it possible to save the measurement data and ensure the quality of the measurement and thus the quality of the cleaning and sterilization process.

[0042] It is possible for the system to incorporate a further digital sensor which sends digital data directly to the second data processing unit. The second data processing unit then receives digitized data from an analog sensor and digital data from the further digital sensor. Thus, data can also be compared by the second data processing unit, or both digital data from a digital sensor and digitized data from an analog sensor can be forwarded by the second data processing unit and stored by a data storage unit.

[0043] It is also possible for data to be sent from a sensor, for example from a temperature sensor and / or a pressure sensor and / or the digital sensor, to the first data processing unit and to the second data processing unit. Data from all sensors can then be processed and forwarded by the first data processing unit and by the second data processing unit. The data transmission from the second data processing unit to the data storage unit can take place, for example, via a standard industrial protocol (MQTT, JSON, UPC UA). The data storage unit can be a computer or a server. The data transmission from the digital data transmission unit and / or from the digital sensor to the first data processing unit and / or the second data processing unit can take place via a standard sensor protocol (e.g. IO-Link).

[0044] The use of such well-known transmission technologies ensures reliable, secure transmission.

[0045] It is possible that the system includes a control system. Data can be transferred between the first data processing unit and the control system.

[0046] By developing a control system, it is possible to process the data from the data processing units accordingly and to adapt and control the cleaning or sterilization process accordingly.

[0047] It is possible for a physical quantity, such as the pressure and / or the temperature and / or the conductivity in the chamber, to be controlled by the control based on the data from the sensor, for example the pressure sensor and / or the temperature sensor and / or the digital sensor. It is also possible for a physical quantity, such as the pressure and / or the temperature, in the chamber to be controlled by the control based on the data from the sensor.

[0048] The chamber of the system can be a cleaning and / or sterilization chamber. By regulating a physical variable, for example, by regulating the pressure and / or temperature, in the chamber, or by controlling a physical variable, for example, by controlling the pressure and / or temperature in the chamber, it is possible to control or regulate the cleaning and sterilization process. This ensures a consistently high quality of the cleaning and sterilization process, essentially independent of external conditions.

[0049] The object of the invention is also achieved by a method for controlling, in particular regulating, a system as described above. The method comprises the following steps:

[0050] Measuring a physical quantity, in particular measuring pressure and / or temperature and / or conductivity in the chamber by the sensor, transmitting the data from the sensor to the data transmission unit,

[0051] Digital transmission of the sensor data from the data transmission unit to the first data processing unit.

[0052] Such a process is uncomplicated and can be carried out without disruption and has essentially the same advantages as a system as previously described.

[0053] The procedure may include the following further steps:

[0054] Transmission of the digital data by the first data processing unit to a control system, in particular control of a physical variable and in particular of the temperature and / or the pressure in the system by the control system, in particular tamper-proof storage of the data by a data storage unit.

[0055] Such close control of the cleaning and sterilization process ensures a high, consistent quality of the cleaning and sterilization process. Such a process therefore has essentially the same advantages as a system as described above.

[0056] The procedure may include the following further steps:

[0057] Transmission of digital data from the digital sensor to the first data processing unit by the data transmission unit, transmission of the digital data from the digital sensor from the first data processing unit to the control system.

[0058] These process steps make it possible to compare data from the digital sensor and the other sensors and to control the system accordingly. The system control is thus very resistant to disturbances. The process steps essentially have the same advantages as a system as described above.

[0059] The procedure may include the following further steps:

[0060] Comparison of the digital data of the digital sensor with the data of the sensor by the first data processing unit, If a deviation is detected during the comparison: Sending a deviation signal to the control system, In particular, sending a display signal by the control system to a display device when the control system receives a deviation signal from the first data processing unit,

[0061] In particular, sending a control signal from the controller to the actuator controller when the controller receives a deviation signal.

[0062] By displaying a deviation on a display device, a user can quickly detect the deviation. This allows the user to quickly take further action, such as stopping the system and replacing a sensor.

[0063] It is possible for the first data processing unit to compare the data from the sensor, for example the temperature sensor and / or the pressure sensor and / or the digital sensor, with data from a sterilization program. It is possible for the first data processing unit to send a deviation signal to the controller and / or a display signal to the display device if there is a deviation between the data from the sensor, for example the temperature sensor and / or the pressure sensor and / or the digital sensor, and the data from the sterilization program. It is possible for the controller to send a control signal to the actuator controller based on the deviation signal, which is based on the difference between the sensor data and the data from the sterilization program.

[0064] The procedure may include the following further steps:

[0065] Transfer of the sensor data from the data transmission unit to the second data processing unit,

[0066] Sending the data from the second data processing unit to the data storage unit, storing the data by the data storage unit.

[0067] Such process steps allow data to be stored and the cleaning or sterilization process documented. Such a process thus has the same advantages as a system as described above.

[0068] It is possible that one or more of the above-mentioned process steps will be carried out repeatedly.

[0069] The invention is explained in more detail in the following figures using exemplary embodiments. They show:

[0070] Figure 1 : A sterilizer with a control and a

[0071] Add-on module,

[0072] Figure 2 : a sterilizer with a bus node,

[0073] Figure 3 : a sterilizer with a first digital

[0074] data transmission unit and a second digital data transmission unit,

[0075] Figure 4 : a sterilizer with a first digital

[0076] data transmission unit and a second digital data transmission unit and a digital sensor.

[0077] In order to explain the invention, a sterilizer with the corresponding additional components is shown in each of Figures 1 - 4. However, the invention is not restricted to a sterilizer and can, for example, also comprise a system for cleaning medical and pharmaceutical goods. Figure 1 shows a sterilizer 18 with a control system 3 and an add-on module 4. The first sensor 11 measures data at the measuring point 13. The measuring point is arranged in the chamber 21. The chamber 21 has a media inlet 22 and an actuator control 23. The first sensor 11 is designed as an analog sensor 11. The first sensor 11 is connected to the data storage unit 1 and to the add-on module 4 by means of two analog data transmission paths 14. The add-on module 4 is connected to the control system 3 and structurally connected to the control system 3.The add-on module 4 digitizes analog data from the analog sensor 11, which is transmitted from the analog sensor 11 to the add-on module by means of analog transmission 14, and sends it to the controller 3. The digital data is sent from the controller 3 to the display device 2 by means of digital transmission 15. A second measuring chain 19 is formed, in which data is measured at the measuring point 13 in the chamber 21 by the analog sensor 11 and sent to the data storage unit 1 by means of an analog transmission 14. The second measuring chain 19 serves to store the data recorded by the analog sensor 11 in the data storage unit 1 and to document the sterilization process. The first measuring chain 20, which is independent of the second measuring chain 19, is formed next to the second measuring chain 19.In the first measuring chain 20, data is measured by the analog sensor 11 at the measuring point 13 in the chamber 21 and transmitted to the add-on module 4 via the analog transmission 14. In the add-on module 4, the data in the first measuring chain 20 is digitized and sent to the control system 3. From the control system 3, the data in the first measuring chain 20 is sent digitally to the display device 2 via digital transmission 15. It is possible for the display device 2 to be designed as an operating panel. The display device 2 can then both display data and accept and process user commands. In the first measuring chain 20, the data is thus used to control or regulate the sterilizer 18 and to display the data on the display device 2. Both the first measuring chain 20 and the second measuring chain 19 are located on the calibration section 10.Thus, both the first measuring chain 20 and the second measuring chain 19 can be calibrated.

[0078] Figure 2 shows a sterilizer 18 with a bus node 5. The sterilizer 18 is designed analogously to the sterilizer 18 from Figure 1. Unlike the sterilizer 18 in Figure 1, the sterilizer 18 in Figure 2 comprises a bus node 5. The bus node 5 is located in the first measuring chain 20. The data which is sent by means of analog transmission 14 from the analog sensor 11 to the bus node 5 is digitized by the bus node 5. The data digitized by the bus node 5 is sent by means of digital transmission 15 to the controller 3. The other devices and data transmission paths are designed analogously to the sterilizer 18 in Figure 1.

[0079] Figure 3 shows a sterilizer 18 with a first digital data transmission unit 9 and a second digital data transmission unit 8. The analog sensor 11 collects data at the measuring point 13 in the chamber 21 and sends it to the first digital data transmission unit 9 and to the second digital data transmission unit 8 by means of analog transmission 14. Both the first digital data transmission unit 9 and the second digital data transmission unit 8 are designed as IO-Link slaves. Both the first digital data transmission unit 9 and the second data transmission unit 8 each have an integrated conversion unit (not shown), which can convert analog data into digital data. Both the first data processing unit 7 and the second digital data processing unit 6 are designed as IO-Link masters.The second digital data transmission unit 8 sends the data to the second digital data processing unit 6 via digital transmission 15 using a sensor protocol 17. The second digital data processing unit 6 sends the data to the data storage unit 1 via digital transmission 15 using a standard industry protocol 16.

[0080] The data is sent from the first digital data transmission unit 9 to a first digital data processing unit 7 by means of digital transmission 15 using a sensor protocol 17. The data is sent from the first digital data processing unit 7 to the controller 3 by means of digital transmission 15 using a standard industry protocol 16. The data is sent from the controller 3 to the display device 2 by means of digital transmission 15 using a standard industry protocol 16. The data flow from the analog sensor 11 to the first digital data transmission unit 9, the first data processing unit 7, the controller 3 and the display device 2 forms the first measuring chain 20. The first measuring chain 20 thus serves to control the sterilization process in the sterilizer 18 and to display data on the display device 2, which can additionally be designed as an operating panel.

[0081] The data flow from the analog sensor 11 to the second digital data transmission unit 8, the second data processing unit 6 and the data storage unit 1 forms the second measuring chain 19. The second measuring chain 19 is used to store the data of the analog sensor 11. The first measuring chain 20 and the second measuring chain 19 are designed independently of one another. Both the first measuring chain 20 and the second measuring chain 19 lie on the calibration section 10. Thus, both the first measuring chain 20 and the second measuring chain 19 can be calibrated. Figure 4 shows a sterilizer 18 with a first digital data transmission unit 9, a second digital data transmission unit 8 and a digital sensor 12. The sterilizer 18 in Figure 4 is designed analogously to the sterilizer 18 from Figure 3. Unlike the sterilizer 18 in Figure 3, the sterilizer 18 in Figure 4 has a digital sensor 12.Like the analog sensor 11, the digital sensor 12 measures data at the measuring point 13. The same data is thus collected by the analog sensor 11 and the digital sensor 12. The data measured by the digital sensor 12 is sent to the first data processing unit 7 via digital transmission 15. The first data processing unit 7 thus receives digital data from the digital sensor.

[0082] 12 by means of digital transmission 15 . In addition, the first data processing unit 7 receives data from the analog sensor 11 , which are digitized by the first digital data transmission unit . Thus, the first data processing unit 7 in the first measuring chain 20 receives data from both the analog sensor 11 and the digital sensor 12 . The data from the analog sensor 11 and the data from the digital sensor 12 can thus be compared by the first data processing unit 7 and processed by the control unit 3 . The data at the measuring point

[0083] 13 are thus measured by various sensors 11 , 12 and processed in the first measuring chain 20 .

Claims

Patent claims 1. A system (18) for the sterilization and / or cleaning of medical and pharmaceutical goods, wherein the system (18) comprises a chamber (21), wherein the chamber (21) has a Media introduction (22) and an actuator control (23), wherein a physical variable, in particular the pressure and / or the temperature, in the chamber (21) can be controlled by the actuator control (23), wherein a sensor, in particular a pressure sensor (11, 12) and / or a temperature sensor (11, 12), is arranged in the chamber (21), characterized in that the system (18) has a digital data transmission unit (8, 9) by means of which data from the sensor (11, 12) can be transmitted digitally (15), in particular by cable or wirelessly, preferably bidirectionally, to a data processing unit (6, 7).

2. System (18) according to claim 1, wherein the sensor (11, 12) is an analogue sensor (11) and the system (18) has a conversion unit (8, 9) by means of which analogue data which can be transmitted between the sensor (11, 12) and the data transmission unit (8, 9) can be converted into digital data.

3. System (18) according to one of the preceding claims, wherein the system (18) comprises a digital sensor (12), wherein a physical quantity and in particular the temperature and / or the pressure can be measured by the digital sensor (12), wherein the digital sensor (11) has a digital data transmission unit, by means of which digital data can be transmitted directly to a data processing unit (6, 7).

4. System (18) according to one of the preceding claims, wherein the sensor and / or the digital sensor (12) is designed as a self-monitoring sensor.

5. System (18) according to one of the preceding claims, wherein the system (18) has a first data processing unit (7) and in particular a second data processing unit (6), by means of which data can be exchanged with the data transmission unit (8, 9) and in particular with the data transmission unit, preferably bidirectionally, wherein the first data processing unit (7) in particular exchanges data of the digital sensor (12) with data of the sensor (11, 12) are comparable.

6. System (18) according to claim 5, wherein the system (18) comprises a data storage unit (1) by which data of the sensor (11, 12) and / or data of the digital sensor (12) can be stored, wherein data can be transmitted between the data storage unit (1) and the second data processing unit (6).

7. System (18) according to one of claims 5 to 6, wherein the system (18) comprises a control system (3), wherein data can be transmitted between the first data processing unit (7) and the control system (3).

8. System (18) according to claim 7, characterized in that a physical quantity, in particular the pressure and / or the temperature in the chamber (21), can be controlled, in particular regulated, by the control (3) based on the data of the sensor (11, 12) and / or the digital sensor (12).

9. Methods for controlling, in particular regulating, a plant (18) according to one of claims 1-8 comprising the following steps: - measuring a physical quantity, in particular measuring pressure and / or temperature in the chamber (21) by the sensor (11, 12, - transmission of the data from the sensor (11, 12) to the data transmission unit (8, 9), - Digital transmission (15) of the data of the sensor (11, 12) from the data transmission unit (8, 9) to the first data processing unit (7).

10. The method according to claim 9, comprising the further steps: - transmission (15) of the digital data by the first data processing unit (7) to a control system (3), in particular control of a physical quantity and in particular the temperature and / or the pressure in the system (18) by the control system (3), In particular, tamper-proof storage of the data by a data storage unit (1) .

11. Method according to one of claims 9 to 10, comprising the further steps: - transmission (15) of digital data from the digital sensor (12) to the first data processing unit (7) by the data transmission unit, - Transmission (15) of the digital data of the digital sensor (12) from the first data processing unit (7) to the control system (3).

12. The method according to claim 11, comprising the further steps: - comparing the digital data of the digital sensor (12) with the data of the sensor (11, 12) by the first data processing unit (7), - If a deviation is detected during the comparison: Send a deviation signal to the control ( 3 ), In particular, sending a display signal by the controller (3) to a display device (2) when the controller (3) receives a deviation signal from the first data processing unit (7). In particular, sending a control signal from the controller (3) to the actuator controller (23) when the controller (3) receives a deviation signal.

13. Method according to one of claims 9 to 12, comprising the following steps: - transmission of the data of the sensor (11, 12) from the data transmission unit (8, 9) to the second data processing unit (6), - sending the data from the second data processing unit (6) to the data storage unit (1), - Storing the data by the data storage unit (1) .

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