USP797 Testing

USP797 Testing

East Coast Laboratory Services offers all the testing requirements needed for you to meet the always changing USP 797.

Testing services for USP797 include the following:

  • Testing and certification of ISO Class 5 Primary Engineering Controls including biological safety cabinets, laminar flow clean benches and clean air devices and isolators.
  • Testing and certification of ISO Class 7 cleanrooms and anterooms including particle counting, airflow volume profiling, air exchange rates, HEPA filter integrity testing, room pressurization monitoring and temperature and humidity monitoring.
  • Videotaped in-situ air pattern analysis (smoke studies) of ISO Class 5 PECs under dynamic conditions for inspection compliance.
  • Isolator Performance Qualification.
  • Airborne and surface microbial environmental monitoring of PECs and SECs including a sample plan development, plate collection, incubation, analysis, growth identification and reporting.