USP 797 Testing Services

CRS is pleased to offer expert turn-key USP <797> compliance solutions to pharmaceutical sterile compounding facilities under the direction of CETA-Certified Cleanroom Professionals for Sterile Compounding Facilities. With over 30 years of field experience, CRS offers an unrivaled combination of USP <797> services including primary and secondary engineering control testing and certification to CAG 003 (cleanrooms, biosafety cabinets, LAFWs, isolators), air and surface environmental monitoring and contamination remediation. USP 797 testing services are executed in accordance with CRS standard operating procedures (SOPs) which are updated to remain compliant with current national and international industry standards. Testing results are quality-reviewed and documented in a comprehensive easy-to-follow final report.

CRS USP 797 testing services include:

  • Testing and certification of ISO Class 5 Primary Engineering Controls (PECs) including biological safety cabinets, laminar flow clean benches and clean air devices and isolators.
  • Testing and certification of ISO Class 7 (or better) cleanrooms (buffer areas) 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 (required for isolators outside of buffer areas)
  • Hazardous drug preparation and storage area airflow and pressure testing
  • Airborne and surface microbial environmental monitoring of PECs and SECs including sample plan development, plate collection, incubation, analysis, growth identification, reporting and data trending
  • Cleaning and contamination remediation service of cleanrooms and equipment
  • Contamination investigations and consultation services
  • Full engineering control repair services for biosafety cabinets, clean benches, isolators and cleanrooms

Our vast technical knowledge and experience coupled with our steadfast commitment to quality and the highest standards of customer service, provide our USP 797 pharmacy clients with reliable, accurate and thoroughly documented testing results, ensuring optimal performance of their engineering controls, documented regulatory and quality compliance results, and minimized equipment down time.

With each service call, CRS offers:

  • Trained technical service of the highest quality
  • Customized and quality-reviewed report documentation.
  • On-line access to your equipment inventory and service records
  • Emergency service support.
  • Exceptional customer service.