USP 797/800


CERTS  systematic approach to USP 797/800 testing helps customers minimize downtime, while meeting all the required regulatory standards affecting their various types of facilities. CERTS USP 797 testing and certification services includes a comprehensive gap analysis and are performed by CETA certified technicians. To help pharmacists and other pharmacy personnel understand the requirements under USP 797/800 compliance, CERTS also offers comprehensive compliance training/consulting services.

USP 797/800 testing includes:

  • Non-viable airborne particulate counting
  • Room air exchange rate calculation and pressurization measurement
  • Ceiling HEPA filter integrity testing
  • Clean bench or laminar flow device testing and certification
  • Biosafety cabinet and isolator testing and certification
  • Calibration of room pressure gauges and other critical devices
  • Airflow visualization studies
  • Viable (Microbial) testing and analysis
  • Gowning certification
  • Testing for chemotherapeutic and cytotoxic drug surface contamination