Cleanrooms and controlled environments are tested to established methods and standards. Our basic tests include; total particle counts, HEPA filter airflow measurement, room air-change calculation, room pressurization, and supply HEPA filter leak tests are used to establish room performance.
Additional tests such as air pattern visualization, room temperature / humidity level measurement, air / surface environmental monitoring (microbial) testing, room recovery, compressed air tests, and other services are available for your applications.
Regulatory Guidance / Test Methods:
- FDA: Guidance for Industry Sterile Drug Produced by Aseptic Processing
- FDA: Quality System Regulation: Medical Device
- European Union: Manufacture of Sterile Medicinal Products Annex 1
- United States Pharmacopeia
- Parenteral Drug Association
- ISO 14644
- ISO 14698
- IEST Contamination Control RPs
NOTE: We have ISO 21501-4 compliant equipment available.