Michell Instruments Ltd (A PST Brand)

Continuous Monitoring In Clean Rooms

04-04-2024

The medical technology company Thommen Medical AG recently expanded its production site and, as part of the development, installed a clean room. The implementation of the Rotronic Monitoring System (RMS) ensures the reliable measurement of temperature, humidity and pressure around the clock.

Thommen Medical AG is a family-run company with headquarters in Grenchen, Solothurn. Founded over 20 years ago, the company specializes in dental implant systems and dental instruments. It also develops, packages and markets these independently.

In 2022, the production site was expanded, and an in-house clean room was built in the new building, meaning that particularly sensitive products can be packaged in low-germ environments to meet the strict requirements of the medical sector.

Flawless monitoring

It is essential that the temperature, pressure and humidity in the clean room always remain the same. If any of these values deviate from the norm, the room is contaminated and is, therefore, no longer suitable for packaging sterile products. Thommen Medical is therefore dependent on a reliable, continuous monitoring system. The company has found this in the Rotronic Monitoring System (RMS).

Hardware suitable for clean rooms is just as important as stable software. Esra Bal, Group Leader Cleanroom, explains: "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." Rotronic's products fulfil these requirements, which is one of the reasons why they were chosen. They are GMP certified – GMP is an international standard which is particularly important in the pharmaceutical and medical sectors.

Alarm system for emergencies

However, the RMS is not only used in the clean room, 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," says Esra Bal, explaining the use of the RMS. She 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 clean room 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.

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," says Esra Bal.

Rotronic Monitoring System (RMS)

The Rotronic Monitoring System (RMS) is a GAMP©5 Category 4 software in combination with Category 1 hardware that helps our customers to monitor their GxP-compliant applications, analyze 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: