Validation & Performance Testing

Comprehensive Validation

Validation is not just a formality — it is the proof that your cleanroom performs as designed. Our validation engineers follow GAMP 5 principles and provide complete IQ/OQ/PQ documentation packages accepted by regulatory auditors worldwide.

Testing Scope

1. Particle count testing — ISO 14644-1 classification (at rest and in operation)
2. HEPA filter integrity — DOP/PAO aerosol challenge per ISO 14644-3
3. Airflow velocity & uniformity — Anemometer traverse per ISO 14644-3
4. Pressure differential — Multi-point manometer mapping across all zones
5. Temperature & humidity mapping — 24-hour data-logging at grid points
6. Recovery test — Time to return to classification after contamination event
7. Sound level measurement — Compliance with occupational limits
8. Lighting level measurement — EN 12464-1 compliance

Deliverables

Bound validation report with raw data, calibration certificates, deviation management, and summary of compliance. Re-qualification schedules recommended per ISO 14644-2.