Cleanroom Particle, Airflow & HEPA Testing

Particle counts and sampling design

Record room area, target classification, particle sizes, occupancy condition and sampling locations. A monitoring trend programme and a classification exercise serve different purposes; a single convenient counter location is not a classification plan.

Airflow and filter integrity

• Airflow visualization examines movement around equipment, doors and interventions; select a tracer compatible with product/process restrictions.
• HEPA leakage testing evaluates the installed filtration system using an agreed aerosol and measurement technique, not merely the filter manufacturer’s label.
• Recovery evaluates clearance after a defined challenge; ventilation velocity/volume and pressure differentials answer separate engineering questions.
• Test order, access, calibrated instruments and post-test cleaning must be agreed with the operator.

Request and reporting inputs

• Provide plans, HVAC zoning, filter schedules, last qualification reports, changes and operating constraints.
• Define acceptance criteria with the responsible quality/engineering team; request measurement uncertainty where relevant, exceptions and sampling diagrams.
• Viable monitoring requires a microbiological plan and is not inferred from particle counts.