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.