Production and Cleanroom Monitoring

Cleanroom monitoring is complex. We make it easy.

The monitoring of cleanrooms is a complex project. It requires a disciplined approach and advanced planning and integration with the cleanroom builder. Whether they are in laboratories or production facilities, in cleanrooms the products are in an unpackaged state and are therefore particularly vulnerable. The entire system must also be qualified and cleanly documented. The requirements defined in the GMP guidelines are correspondingly high. You must monitor various parameters, ensure the data are processed correctly, and then transferred to other systems. For example, consider the following:

• Temperature and humidity in the cleanroom

• Relative humidity and CO² in incubators

• Pressure, pressure differential and door openings in access locks

• Number of particles in supply air, room and exhaust air (particle counter)

• The status of the cleanroom should be clearly visible to personnel at all times. Clear displays with clear sensor statuses are therefore elementary.

• The alarm behavior should be able to distinguish between different operating states (day, night, cleaning) and transfer the events to the building management system (BMS)

• The raw data of all sensors must be transferred completely to higher batch management databases for archiving

• All system components, especially the software, must be FDA CFR 21 Part 11 compliant

• All sensors must be calibrated regularly according to the ISO 17025 standard