Cleanroom Testing & Qualification

Define the qualification programme

• Document room boundaries, intended ISO particle class, occupancy state (as-built, at-rest or operational), particle sizes and sampling plan.
• Separate commissioning, installation/operational qualification and process-specific performance qualification; agree protocols, acceptance criteria and deviations before testing.
• Include air supply/return layout, pressure cascade, temperature/humidity, equipment and personnel flows and facility change history.

ISO 14644 context and practical tests

ISO 14644-1 concerns classification by airborne particle concentration; ISO 14644-2 concerns monitoring to provide evidence of performance. ISO 14644-3 describes test methods. Verify the edition and applicable scope with the provider. Particle class is not proof of microbiological control or GMP compliance.

• Airborne particle counting and classification: specify particle-size channels, calibrated counters, locations and occupancy conditions.
• Airflow visualization: document smoke/tracer suitability and representative interventions; video alone does not establish aseptic-process validation.
• Installed HEPA filter leakage testing: agree challenge aerosol, scanning method, access and system acceptance criteria.
• Recovery testing: define the challenge, occupancy state and time to a specified particle concentration.
• Viable air/surface/personnel monitoring: risk-based microbiological programme, separate from nonviable particle classification.

Outsource with a usable room brief

• Send room drawings, dimensions, HVAC/filter details, desired classification and relevant manufacturing or research context.
• Specify planned shutdown/access, hazards, cleaning state, test equipment restrictions and whether operations must remain live.
• Agree raw data, calibration traceability, sampling maps, deviations and the report/qualification deliverables; confirm the provider’s actual scope.