USP Environmental Monitoring

USP <797> environmental monitoring (EM) requires regular, risk-based assessment of viable airborne and surface microbial contamination in sterile compounding areas to ensure patient safety, with sampling required at least every six months. Key requirements include testing ISO Class 5 Primary Engineering Controls (PECs) and surrounding ISO Class 7/8 areas, with surface monitoring for Category 1 and 2 compounding occurring monthly.

Key Aspects of USP <797> Environmental Monitoring

Purpose: To monitor for microbial contamination in compounding areas to ensure the quality of Compounded Sterile Preparations (CSPs).

Requirements:

Viable Air Sampling: Mandatory in all classified areas (ISO Class 5, 7, and 8).

Surface Sampling: Must be performed using contact plates (24–30 
) or swabs at least monthly for Category 1 & 2 CSPs, or every 6 months for others.

Locations: Each ISO Class 5 PEC, plus immediately adjacent ISO 7 buffer rooms and ISO 8 anterooms.

Monitoring Methods:

Air: Active air samplers (volumetric) or passive air sampling (settle plates).

Surfaces: Contact plates (rodac) or swabs for uneven surfaces.

Personnel: Routine finger dabs and testing of PPE (gowning).

Action Levels: If contamination limits are exceeded, investigation of HVAC, cleaning, and staff training is required.

Action Levels (CFU - Colony Forming Units)

ISO Class 5: >1 CFU (Air), >3 CFU (Surface).

ISO Class 7: >10 CFU (Air), >5 CFU (Surface).

ISO Class 8: >100 CFU (Air), >50 CFU (Surface).

Key References:

USP General Chapter <797> Pharmaceutical Compounding—Sterile Preparations

USP General Chapter <1116> Microbiological Control and Monitoring of Aseptic Processing Environments

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USP Environmental Monitoring

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