Qualification / Validation Services

Download Validation Leaflet

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