CleanroomProcesses

3.04.2024
Customer Case - Monitoring system for cleanroom application
Jan Wendel
Process Sensing Technologies PST GmbH / rotronic

The medical technology company Thommen Medical AG recently expanded its production site and equipped it with its own clean room. The Rotronic Monitoring System (RMS) was used to reliably measure temperature, humidity and pressure around the clock.

The headquarters of the family-owned company Thommen Medical AG is located 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 so that particularly sensitive products can be packaged with low germ levels. There are strict requirements in this regard, particularly in the medical sector.

Flawless monitoring

It is important that the temperature, pressure and humidity in the cleanroom always remain the same. If one of these values deviates 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 cleanrooms is just as important as stable software. Esra Bal, group manager for germ arm packaging, 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 meet these requirements, which is one of the reasons why they were chosen. They are GMP-certified, an international standard that is required in the pharmaceutical and medical sectors in particular.

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 and 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 whether everything is running smoothly.

The system is equipped with an alarm function in the event of an emergency. This sends notifications to the smartphones of the responsible persons. 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 non-Rotronic devices 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, examine the critical quality attributes and monitor the sensitive process parameters. 

At Thomman Medical, hardware such as digital and analog sensors, data loggers, gateways, Ethernet interfaces and indicator lights (alarm) with cloud software are used in:

- Clean room

- Warehouse 

- Refrigerators

- Heating cabinet

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Jan Wendel
Process Sensing Technologies PST GmbH / rotronic