Environmental Monitoring
Per USP 797 regulations, sterile drug compounding pharmacies must develop and implement a microbial monitoring program for their sterile drug compounding suites [Clean room] and compounding hoods. Schedules for viable air sampling programs plus mandated microbial alert and action count levels are specified in detail by the regulations.
Unlike other compliance vendors, Microtest earned its reputation as a leading environmental testing laboratory first. No other vendor has the experience, expertise, and resources to efficiently, cost-effectively deliver environmental air monitoring compliance programs.
Microtest environmental monitoring services include:
- Clean- room validation
- Hood validation
- Risk-level Category ISO-class air monitoring of clean room, compounding hood, aseptic compounding isolators
- Air (viable organisms and particulate)
- Surfaces (viable organisms)
- Personnel (viable organisms)
Among recognized USP 797 compliance vendors, only Microtest offers both viable and nonviable air monitoring programs. That’s why Microtest is the total solution to USP 797 environmental monitoring compliance. |