USP 797 and USP 800 Cleanroom Certification

Allometrics USP 797 and USP 800

Our USP 797 and USP 800 cleanroom certification and testing services include:

  • Certification and testing for ISO Class 5 Primary Engineering Controls (PECs) that include biological safety cabinets, clean air devices, laminar flow clean benches and isolators.
  • Certification of buffer areas and anterooms. Our testing and certification include airborne particle counting (non-viable), air exchange rates, temperature, and humidity monitoring, airflow volume and velocity profiling, room pressurization monitoring, and HEPA filter integrity testing.
  • Onsite videotaped airflow pattern visualization (smoke studies) of ISO Class 5 PECs under dynamic conditions.
  • Isolator Performance Qualification. Our tests are modified to comply with all manufacturer and industry standards.
  • Airflow and pressure testing for hazardous drug preparation and storage areas
  • Environmental Monitoring (EM) of PECs and SECs of both air and surfaces including sample plan development, sample collection, incubation, analysis, growth identification, and reporting
  • Repair services for biosafety cabinets, clean benches, isolators, and cleanrooms

USP 797 and USP
800 Cleanroom

USP 797 and USP 800 compliant cleanrooms play a vital role in creating and maintaining contamination free production environments for the pharmaceutical sterile compounding industry.

Allometrics employs NSF Accredited Technicians, and CETA Registered Cleanroom Certification Professionals (RCCP-SCF) for all USP 797 and USP 800 cleanroom certification and testing services.

USP 797 is a regulatory document issued by the United States Pharmacopoeia which specifies both the procedures and environmental requirements for compounded sterile preparations (CSPs).

The USP 797 standard was created to ensure the quality and safety of compounded products. Its focus is on providing patients with medications that are of equal:

  • Strength
  • Quality
  • Purity
  • Consistency

USP 797 also details additional factors, including:

  • HVAC Systems
  • Cleanroom Requirements
  • Humidity, Temperatures and Pressure Factors
  • Equipment Requirements
  • Personnel Training
  • Equipment Maintenance Specifications
  • Approved Cleaning Solutions
  • Testing Procedures
  • Standard Operating Procedures

USP 797 safeguards sterile compounding for consumer protection, but concerns about the well-being of healthcare manufacturing personnel led to the creation of USP 800.

While USP 797 prioritizes patient safety, USP 800 focuses on protecting healthcare workers handling hazardous drugs.

NIOSH defines a hazardous drug as displaying characteristics such as carcinogenicity, teratogenicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or resembling existing hazardous drugs in humans or animals.

USP 797 Certification and Testing

USP 797 standards came into effect in 2004. Allometrics has provided pharmaceutical laboratories with USP 797 cleanroom certification and testing services from day one.

Thanks to our unique combination of field experience, our NSF Accredited Technicians and CETA Registered Cleanroom Certification Professionals for Sterile Compounding Facilities, we can provide a wide range of cleanroom testing and certification solutions for compounding pharmacies and pharmaceutical manufacturers.

Our cleanroom certification and testing program provides accurate, reliable, and thorough documentation of testing results.

At Allometrics, our USP 797 and USP 800 cleanroom certification program ensures accurate, reliable, and comprehensive documentation of test results, essential for proper maintenance, operation, and regulatory compliance.