Cleanroom Daily Audit

ISO 14644-aligned daily cleanroom audit for ISO 7/8 environments. Verifies particle count, gowning compliance, environmental monitoring, and material flow.

Inspection Details

• Inspection date and time recorded
• Cleanroom identifier and classification confirmed
  Enter the room ID and classification (ISO 7 or ISO 8).
• Inspector name and role documented
• Reference SOP or audit checklist used

Environmental Conditions

• Differential pressure within approved range
  Record the measured differential pressure and confirm it remains within site acceptance limits.
• Temperature within approved range
  Record the room temperature and verify it is within the validated operating range.
• Relative humidity within approved range
  Record the room relative humidity and verify it is within the validated operating range.
• Environmental monitoring alarms normal
  No active excursions, unresolved alarms, or out-of-limit conditions on the environmental monitoring system.
• Monitoring devices present and in service
  Sensors, displays, and indicators are powered, readable, and functioning as intended.

Particle Monitoring

• Calibrated particle counter used for the audit
  Confirm the particle counter is within calibration and suitable for the cleanroom classification being audited.
• Particle count result recorded
  Enter the measured particle count or the site-defined daily verification result.
• Particle count within ISO 7/8 acceptance limit
  Measured results meet the approved acceptance criteria for the room classification.
• Sampling location and duration match approved procedure
  Sampling points, flow rate, and duration follow the validated cleanroom monitoring plan.

Gowning and Personnel Compliance

• Authorized personnel only in the cleanroom
  All occupants are approved for entry and listed on the authorized access roster or work assignment.
• Gowning complies with room classification requirements
  Garments, hood, mask, gloves, shoe covers, and other PPE match the approved gowning procedure for the room classification.
• No exposed skin, hair, or jewelry observed
  Personnel appearance is consistent with cleanroom contamination control requirements.
• Aseptic or low-particle behavior maintained
  Personnel movement, talking, and handling practices do not create avoidable contamination risk.

Material and Personnel Flow

• Material transfer follows approved pass-through or airlock process
  Incoming materials are transferred using the validated route and contamination control steps.
• No unapproved items present in the cleanroom
  No cardboard, paper, personal items, or other prohibited materials are observed in the controlled area.
• Waste containers closed and removed per procedure
  Waste handling does not compromise cleanliness or airflow and follows the site procedure.
• Traffic patterns do not compromise clean zone segregation
  Personnel and material movement remain segregated to prevent cross-contamination between zones.

Housekeeping and Corrective Actions

• Visible debris or spills present
  Indicate whether any visible debris, residue, or spills were observed in the cleanroom.
• Non-conformances documented with corrective action
  Record any deficiencies, immediate containment, and assigned corrective actions.