Thommen Medical, a swiss manufacturer for dental implants, has expanded its production site and an in-house cleanroom was built in the new building.
The new cleanroom was designed so that particularly sensitive products can be packaged in low-germ environments to meet the strict requirements of the medical sector.
The specialist in dental implant systems and dental instruments, implemented the Rotronic Monitoring System (RMS) by Process Sensing Technology, which ensures the reliable measurement of temperature, humidity, and pressure around the clock.
Flawless monitoring
It is essential that the temperature, pressure and humidity in the cleanroom always remain the same.
If any of these values deviate from the norm, the room is contaminated and is no longer suitable for packaging sterile products. Thommen Medical is therefore dependent on a reliable, continuous monitoring system and has found this in the Rotronic Monitoring System (RMS).
Also, hardware suitable for cleanrooms is just as important as stable software.
The data logger in the cleanroom must be easy to clean and corrosion-resistant
Esra Bal, Group Leader of Cleanrooms at Thommen Medical, explained: "The data logger in the cleanroom must be easy to clean and corrosion-resistant. It must also not emit any particles and must have a smooth surface."
For Thommen Medical, Rotronic's products fulfill these requirements, which is one of the reasons why they were chosen and they are GMP certified, which is an international standard particularly important in the pharmaceutical and medical sectors.
Alarm system for emergencies
However, the RMS is not only used in the cleanroom, but also in other areas of the new building. For example, the system measures the temperature in various refrigerators, as well as a heating cabinet, and monitors the warehouse for temperature and humidity.
"As part of our own quality controls, we need to monitor the critical areas in real-time and also be able to track all values," said Bal, explaining the use of the RMS.
The system is equipped with an alarm function which is activated in the event of an emergency
Bal can log into the dashboard on her laptop at any time and check that everything is running smoothly.
The system is equipped with an alarm function which is activated in the event of an emergency, sending notifications to the smartphones of responsible individuals.
In addition, an alarm sounds and the indicator lights in the cleanroom start to flash red.
Easily expandable system
The analog or digital implementation of devices that are not from Rotronic is always a challenge when setting up RMS.
In this project, a third-party particle measuring device had to be implemented in the system, which was achieved without any problems after clarification with the manufacturer.
Another big plus point is that it is easy to expand. If we plan to expand again, additional devices can be easily integrated into the existing system
Thommen Medical has been using the RMS for over a year now and is very satisfied with it.
"Another big plus point is that it is easy to expand. If we plan to expand again, additional devices can be easily integrated into the existing system," Bal explained.
Rotronic Monitoring System (RMS)
The Rotronic Monitoring System (RMS) is a GAMP5 Category 4 software in combination with Category 1 hardware that helps our customers to monitor their GxP-compliant applications, analyse the critical quality attributes and monitor the sensitive process parameters.
At Thomman Medical, products such as digital and analog sensors, data loggers, gateways, Ethernet interfaces, and indicator lights (alarm) with cloud software are used in:
- Cleanroom
- Warehouse
- Refrigerators
- Heating cabinet
