USP <797> Testing Services

In 2004, the US Pharmacopeia implemented USP <797> to control the administration and compounding of pharmaceutical products in the United States.  The purpose of the new USP <797> regulation is to increase patient safety by preventing contamination of compounded sterile preparations (csp's).
Triangle Certification is pleased to offer complete USP <797> testing solutions for compounding and hospital pharmacies.  Our combination of NEBB Cleanroom Performance Certification coupled with our NSF Accredited Technicians and CETA Certified Cleanroom Professionals for Sterile Compounding Facilities, allows us to effectively and efficiently execute the complete array of tests prescribed by the USP <797> standard.

  • Complete cleanroom certification - HEPA Filter Integrity, Airflow Volume & Velocity, Air Exchange Rate & Pressurization, and Airborne Particle Counts (non-viable).
  • Full testing and certification service for ISO Class 5 Primary Engineering Controls (PECS) to include biological safety cabinets, laminar flow clean air benches, clean air devices and isolators.
  • Videotaped Airflow Pattern Visualization of ISO Class 5 PECS and cleanrooms.
  • Isolator Performance Qualification in accordance with manufacturer and industry standards.
  • Environmental Monitoring (EM) for both surfaces and air including sample site selection, sample collection, incubation, analysis, and identification.
  • ISO 9001 Accredited Laboratory is used for all EM monitoring to ensure independence of all reported data for EM's.
  • Complete emergency services to include repair services.
  • Training, consultation, and glove testing.

Triangle Certification's technical expertise and industry certifications provide our USP <797> pharmacy and compounding clients with reliable and accurate testing services along with thoroughly documented GLP/cGMP report documentation.

Contact Triangle Certification for more information or to schedule services.
 
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