Stefatos offers full Clean Room qualification/validation testing and documentation to ISO 14644-1 and EU GMP requirements.
Key features
- Design Qualification (DQ)
- Preparation of protocols (IQ, OQ, PQ)
- IQ execution
- OQ execution
- Temperature and humidity checks
- HEPA filter integrity testing (DEHS test)
- Airflow particle count analysis
- Media Gases Piping
- Airflow differential pressures
- Airflow volumes and air change rates
- Noise and light lux testing
- Airflow visualization display analysis
- Submittal of completed IQ, OQ protocols
- PQ execution
- Support services during audits