ISO-14644-3-Test-Methods-Airborne-Particles-Flow-and-Visualization-Studies.-Technicians-performing-cleanroom-validation

ISO 14644-3 Test Methods: Airborne Particles, Flow, and Visualization Studies

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


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.

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About Applied Physics USA

Since 1992, Applied Physics Corporation has been a leading global provider of precision contamination control and metrology standards. We specialize in airflow visualization, particle size standards, and cleanroom decontamination solutions for critical environments.

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