Run USP 797 Compounding Cleanroom Verification — Free

Inspection Setup and Scope

Inspection date, time, and suite identifier documented

Inspection scope includes ante-area, buffer room, and any classified support spaces critical (required)

Yes No N/A

Current SOP or verification protocol available to inspector critical (required)

Yes No N/A

Environmental monitoring records reviewed for prior non-conformances

Yes No N/A

Cleanroom Physical Conditions

Surfaces are clean, intact, and free of visible dust, residue, or damage critical (required)

Yes No N/A

HEPA supply diffusers, ceilings, walls, and floors show no visible compromise critical (required)

Yes No N/A

Cleaning logs for the cleanroom and ante-area are current

Yes No N/A

No unauthorized storage, cardboard, or clutter observed in controlled areas critical (required)

Yes No N/A

Pressure Differentials and Airflow

Ante-area to buffer room pressure differential critical (required)

Buffer room to adjacent uncontrolled area pressure differential critical (required)

Pressure monitoring device is calibrated and within current calibration date critical (required)

Yes No N/A

Airflow patterns support unidirectional flow and do not show turbulence at critical work zones critical (required)

Yes No N/A

Particle Counts and Environmental Monitoring

Nonviable particle count at rest in classified area critical (required)

Nonviable particle count during dynamic conditions in classified area critical (required)

Sampling location and method documented for particle count testing critical (required)

Yes No N/A

Environmental monitoring results reviewed against action limits critical (required)

Yes No N/A

Surface Sampling and Microbial Controls

Surface sampling performed at required locations and frequency critical (required)

Yes No N/A

Surface sampling results are within established action limits critical (required)

Yes No N/A

Sampling media, incubation, and chain-of-custody documented

Yes No N/A

Any contamination excursion has documented investigation and corrective action critical (required)

Yes No N/A

Personnel Qualification and Aseptic Technique

All personnel performing sterile compounding are currently qualified critical (required)

Yes No N/A

Media-fill test completion is current for compounding personnel critical (required)

Yes No N/A

Gloved fingertip or glove print testing is current critical (required)

Yes No N/A

Gowning and hand hygiene competency records are current critical (required)

Yes No N/A

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Run: USP 797 Compounding Cleanroom Verification

Inspection Setup and Scope

Cleanroom Physical Conditions

Pressure Differentials and Airflow

Particle Counts and Environmental Monitoring

Surface Sampling and Microbial Controls

Personnel Qualification and Aseptic Technique

Get your results