Continuous monitoring in the cleanroom

The Swiss company Thommen Medical relies on the Rotronic Monitoring System (RMS) in its new building. (Image source: Process Sensing Technologies)

A mini data logger in use for a temperature cabinet from Thommen Medical: For optimal operation, the sensor inside was connected to the data logger via flat ribbon cable. (Image source: Process Sensing Technologies)

The measurement values, here temperature and humidity, can be checked at any time both on the individual data loggers and on the dashboard on the computer. (Image source: Process Sensing Technologies)

The company Thommen Medical AG, active in medical technology, recently expanded its production site and equipped it with its own cleanroom. To reliably monitor temperature, humidity, and pressure around the clock, the company opted for the Rotronic Monitoring System (RMS).

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. Additionally, it develops, packages, and markets these products independently.

In 2022, the production site was expanded, and a proprietary cleanroom was built in the new building to enable sterile packaging of particularly sensitive products. Strict regulations apply in this regard, especially in the medical field.

Flawless Monitoring

It is crucial that temperature, pressure, and humidity in the cleanroom remain constant at all times.

If any of these values deviate from the norm, it indicates contamination of the room, rendering it unsuitable for packaging sterile products. Therefore, Thommen Medical relies on a reliable, continuous monitoring system. The company chose the Rotronic Monitoring System (RMS) for this purpose.

Just as important as stable software is hardware suitable for cleanrooms.

Esra Bal, Group Leader for Aseptic Packaging, explains: "The data logger in the cleanroom must be easy to clean and resistant to corrosion. It must also not emit particles and have a smooth surface." These properties are fulfilled by Rotronic products, which is why the company decided to use them. They are GMP-certified, an international standard required especially in the pharmaceutical and medical sectors.

Emergency Alarm System

The RMS is used not only in the cleanroom but also in other areas of the new building. For example, the system measures the temperature in various refrigerators and a warming cabinet, and monitors the storage area for temperature and humidity. "As part of our own quality controls, we need to monitor critical areas in real time and be able to trace all values," explains Esra Bal about the use of RMS. She can log into the dashboard on her laptop at any time to check if everything is running smoothly.

In case of an emergency, the system is equipped with an alarm function. It sends notifications to the smartphones of responsible personnel. Additionally, an alarm tone sounds, and the indicator lights in the cleanroom start blinking red.

Easy-to-Expand System

One of the challenges when setting up RMS is the integration of analog or digital devices that are not from Rotronic. In this project, an external particle measurement device had to be integrated into the system, which was successfully achieved after clarifications with the manufacturer.

At Thommen Medical, the RMS has been in operation for over a year now, and the company is very satisfied with it. "An additional major advantage is the ease of expansion. If we plan further growth, additional devices can be easily integrated into the existing system," says Esra Bal.

Rotronic Monitoring System (RMS)

The Rotronic Monitoring System (RMS) is software of GAMP®5 category 4 combined with hardware of category 1, helping customers monitor their GxP-compliant applications, investigate critical quality attributes, and monitor sensitive process parameters.

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

– Cleanroom
– Storage
– Refrigerators
– Warming cabinet