Temperature and humidity limits depend on products, processes and personnel. There is no universal temperature–humidity pair for every cleanroom.
Define process needs
Specify permitted ranges, operating modes and control locations. EU GMP Annex 1 addresses sterile manufacture; the cited WHO HVAC guidance concerns non-sterile products.
Provide design inputs
- Equipment heat gains and occupancy.
- Moisture from outdoor air and production activities.
- Operating schedules, alarms and recording needs.
Verify performance
Check sensor accuracy, placement and trends. Acceptable readings in an empty room do not demonstrate satisfactory performance during production.