United States Pharmacopeia 797 (USP 797) Compliant Pharmacy Cleanroom Certification

USP 797 Compliant Pharmacy Cleanrooms play a critical role in maintaining contamination free production environments for Pharmaceutical Sterile Compounding.  A well-executed USP 797 compliant cleanroom certification and testing program is essential to proper cleanroom maintenance, operation, and regulatory compliance.

 

In accordance with regulatory standards, Primary and Secondary Engineering Controls shall be certified at least every 6 months.

Mandatory USP 797 Compliant Cleanroom Tests (must pass to be certified)

Testing of Primary Engineering Controls (PEC)

• Biological Safety Cabinets – see certification section for testing procedures
  • In addition USP 797 requires: Non-viable airborne particle count testing
  • In addition USP 797 requires: Class II, Type A2 Biological Safety Cabinets must have canopy style exhaust connection
  • In addition USP 797 requires: Biological Safety Cabinet exhaust fan(s) must be direct drive type
• Laminar Flow Benches – see certification section for testing procedures
• All ISO 5 or cleaner devices

Testing of Secondary Engineering Controls (SEC)

• Non-Viable Airborne Particle Count Testing
• Airborne & Surface Viable Particle Sampling
• Airflow Velocity / Volume Testing
• Room Air Change Rate(s)
• Room Differential Pressure Testing
• Smoke Pattern Testing
• HEPA Filter Leak / Challenge Testing

  

Additional Cleanroom Tests (Annual or Semi-Annual)

• Temperature / Relative Humidity Testing
• Room Differential Pressure Gauge Calibration

 

Detailed Summary Report:

Standards Utilized:

All performance testing datasheets contain reference number, testing standard used, date of test, and person who performed the testing. A comprehensive computer generated report will be furnished indicating any required recommendations. As part of our comprehensive report we provide drawings of cleanroom space(s) with location of HEPA filters, equipment, gauges, direction of room pressures, and non-viable airborne particle count testing locations. Prepare and submit a budgetary proposal for any items deemed defective and/or requiring repair.

CETA, Controlled Environmental Testing Association IEST, Institute of Environmental Science and Technology ISO 14644, International Organization for Standardization Customer specifications