USP 797/800 Pharmacy Certification Services
Cleanroom certification for compounding pharmacies, so sterile and hazardous drug spaces stay compliant.
- HEPA Filter Testing
- Airborne Particle Counts
USP 797/800 Pharmacy Certification
USP <797> sets quality standards for anyone who stores, handles, prepares or transports compounded sterile preparations, and USP <800> covers the safe handling of hazardous drugs. Meeting both starts with cleanroom spaces that are tested and certified on schedule.
Integra Testing certifies compounding pharmacy cleanrooms with airborne particle counts, HEPA filter testing and airflow verification, and can support ongoing environmental monitoring to help demonstrate control of your critical areas.
What Certification Covers:
Particle Counts: Airborne non-viable particle counts verify the ISO classification of your room.
HEPA Filter Testing: Verification that filtered air systems perform as installed.
Airflow and Pressure: Room airflow and pressure checks that protect clean spaces.
Documentation: Reports organized for USP <797>, USP <800> and ISO 14644-1.
Contact Integra to schedule pharmacy cleanroom certification or request a quote.