Environmental Monitoring Program (Cleanroom)

Routine cleanroom inspection template for viable and nonviable environmental monitoring in classified areas, including alert/action level review, excursion response, and corrective action documentation.

Inspection Details

• Inspection date and time recorded
• Cleanroom area, room ID, or suite identified
• Inspector name and role documented
• Monitoring event type
• Applicable SOP or monitoring plan reference

Area Conditions and Sampling Readiness

• Area classification and status confirmed before sampling
• Temperature and relative humidity within established limits
• Differential pressure within alert limits
• Doors, pass-throughs, and material transfer points controlled
• Sampling location map and sequence followed

Nonviable Particle Monitoring

• Nonviable particle count at rest or in operation recorded
• Sample volume and duration documented
• Nonviable result within alert level
• Nonviable result within action level
• Instrument calibration status verified

Viable Monitoring

• Viable monitoring method used
• Viable sample location and identifier recorded
• Viable count recorded
• Viable result within alert level
• Viable result within action level

Excursion Review and Immediate Response

• Any excursion identified during review
• Excursion classified as alert or action level
• Immediate containment or area hold initiated
• Investigation owner or competent person assigned
• Product impact assessment completed

Corrective Actions and Attestation

• Corrective actions documented for any non-conformance
• Follow-up verification date assigned
• Inspector signature