USP Monitoring & Compliance Support
Legacy Environmental Laboratory provides comprehensive microbiological testing and documentation services to help compounding pharmacies meet the rigorous requirements of USP <797>. From viable surface and air sampling to personnel competency support, we offer accurate testing, fast turnaround, and unmatched reporting tools.
What We Offer
We support both initial certification and ongoing routine monitoring required under USP <797> for sterile compounding environments.
Test Type | Description |
|---|---|
Single Plate Surface Testing | TSA agar for both total bacterial and fungal counts, genus ID, and speciation |
Dual Plate Surface Testing | TSA and SabDex plated separately for separate counts and ID of bacteria and fungi |
Viable Air Sampling | Impaction-based sampling onto TSA or SabDex plates; counts and ID of airborne microbes |
Glove Fingertip Testing | Post-hand hygiene and garbing assessment for CFU detection on gloved fingertips |
Media Fill (Process Simulation) | Broth-based simulation to evaluate aseptic technique and contamination risk |
What Makes Us Different
No other lab provides the level of insight and ease-of-use we offer for personnel monitoring and ongoing compliance:
✅ Custom Yearly Trending Summary
Track performance across your cleanroom year over year, by area, and test type — ideal for inspections and internal reviews.
✅ Personnel Competency Report
We compile all required test results (glove fingertip, surface sampling, media fill) into a single summary with clear Pass/Fail status for both initial qualification and routine monitoring — so you don’t have to.
✅ Comparative Glove Fingertip Report
A clean, standalone report per person that shows all glove fingertip test results comparing both hands, pass/fail determinations — ready for your inspection binder.
We Work With
– 503A and 503B compounding pharmacies
– Hospital cleanrooms and infusion centers
– Outpatient surgical centers
– Sterile product manufacturers
– Compliance consultants and QA teams