USP 797 Compounding Cleanroom Verification

Inspection template for sterile compounding cleanroom verification, including particle counts, pressure differentials, surface sampling, and personnel qualification.

Inspection Setup and Scope

• Inspection date, time, and suite identifier documented
• Inspection scope includes ante-area, buffer room, and any classified support spaces
• Current SOP or verification protocol available to inspector
• Environmental monitoring records reviewed for prior non-conformances

Cleanroom Physical Conditions

• Surfaces are clean, intact, and free of visible dust, residue, or damage
• HEPA supply diffusers, ceilings, walls, and floors show no visible compromise
• Cleaning logs for the cleanroom and ante-area are current
• No unauthorized storage, cardboard, or clutter observed in controlled areas

Pressure Differentials and Airflow

• Ante-area to buffer room pressure differential
• Buffer room to adjacent uncontrolled area pressure differential
• Pressure monitoring device is calibrated and within current calibration date
• Airflow patterns support unidirectional flow and do not show turbulence at critical work zones

Particle Counts and Environmental Monitoring

• Nonviable particle count at rest in classified area
• Nonviable particle count during dynamic conditions in classified area
• Sampling location and method documented for particle count testing
• Environmental monitoring results reviewed against action limits

Surface Sampling and Microbial Controls

• Surface sampling performed at required locations and frequency
• Surface sampling results are within established action limits
• Sampling media, incubation, and chain-of-custody documented
• Any contamination excursion has documented investigation and corrective action

Personnel Qualification and Aseptic Technique

• All personnel performing sterile compounding are currently qualified
• Media-fill test completion is current for compounding personnel
• Gloved fingertip or glove print testing is current
• Gowning and hand hygiene competency records are current