Commissioning environmental monitoring in a cleanroom
Installing, calibrating and qualifying a temperature and humidity monitoring system in a GMP cleanroom.
The situation
A GMP cleanroom whose temperature and humidity records feed quality decisions. The monitoring system is a computerised system in its own right, so it has to be qualified before anyone relies on what it says.
What had to be shown
Before go live the client needed to show that every sensor reads correctly, that alarms reach the right people when a limit is crossed, and that the record cannot be quietly changed. A sensor that drifts or an alarm that never fires is worse than no system, because it looks like evidence.
How I did it
- Agreed the sensor positions with the client’s quality team, from the room’s critical areas and any earlier mapping.
- Installed and commissioned the sensors and the recording system, then calibrated each sensor on site against reference equipment traceable to national standards.
- Ran the qualification: IQ to show it was installed as specified, OQ to test alarms, delays, the audit trail and behaviour on power or communications loss, and PQ to show it records correctly in normal operation.
- Trained the users who would answer the alarms and review the data, and stayed their contact for queries after handover.
What the client got
A system handed over with its signed IQ, OQ and PQ, a calibration certificate for every sensor and users who knew what to do when it alarmed. The client could rely on the record, and show an inspector why.
Written from the work, with no client named and no client figures quoted.