Introduction: Proving Cleanrooms Perform as Designed
Designing a cleanroom is one thing. Proving it performs according to ISO 14644-3 test methods is another. From airborne particle counting to airflow visualization studies, ISO 14644-3 ensures facilities meet their classification and regulatory expectations.
Part 1: Core Test Categories
Airborne Particle Counts: Calibrated using PSL standards.
Airflow Visualization: Conducted with ultrapure foggers.
Recovery Time Tests: How quickly particle counts return to baseline.
Containment Tests: Ensuring no leaks between pressure cascades.
Part 2: Regulatory Drivers
ISO 14644-3: Defines test methods and frequency.
EU GMP Annex 1: Requires smoke studies in Grade A/B zones.
FDA Guidance: Expects particle data traceable to NIST standards.
Part 3: Tools and Equipment
CRF Cleanroom Foggers: Dense, ultrapure fog for airflow visualization.
AP100 LN₂ Fogger: Long-duration fog for pharma smoke studies.
PSL Particle Standards: Calibration of particle counters.
Calibration Wafers: Semiconductor-specific particle validation.
Part 4: Industry Application
Semiconductor
Particle counting in ISO 3–5 zones.
Fog visualization for wafer transfer systems.
Pharmaceutical
Annex 1 requires full video documentation of smoke studies.
Recovery and containment tests performed routinely.
Medical Devices & Metrology
ISO 7–8 particle monitoring for packaging lines.
Traceability of particle counts via PSL standards.
Conclusion
ISO 14644-3 is the backbone of cleanroom validation. From fog visualization to PSL calibration, it ensures facilities don’t just meet design intent—they prove it. Applied Physics provides the tools to meet every requirement.
