Cleanroom classification is only as strong as the HVAC evidence behind it. Before an inspection, make sure your validation package covers each of these tests, with raw data recorded on calibrated instruments.
1. Airflow velocity and volume
Measure air velocity at each terminal filter and calculate the supply air volume. This is the basis for every air-change calculation that follows.
2. Air changes per hour
Calculate air changes for every room from the measured supply volume and the room volume. Compare against the design and your acceptance criteria.
3. HEPA filter integrity
Challenge each terminal and in-line HEPA filter with an aerosol (PAO/DOP) and scan for leaks with a photometer. Document the upstream concentration and any repairs.
4. Non-viable particle count
Count particles at the defined locations to classify the room to ISO 14644-1 and EU GMP grade limits, at rest and in operation as required.
5. Differential pressure and airflow direction
Record room-to-room pressure differentials and confirm airflow moves from cleaner to less clean areas, including smoke-pattern visualisation where your SOPs require it.
6. Recovery
Show how quickly the room returns to its classified state after a particle challenge.
7. Temperature and humidity
Map temperature and relative humidity against the product and process requirements.
What auditors check in the report
- An approved protocol, signed before execution
- Raw data sheets signed on site
- Calibration certificates for every test instrument used
- Deviations recorded and closed, with impact assessment
- A summary report with a clear conclusion
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