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– Reflecting advances in semiconductor and nanotechnology industries, the 2019 edition introduced methods for measuring ultrafine particles (<0.1 µm).
Often considered the most critical test, this procedure uses an aerosol challenge (such as PAO or DEHS) introduced upstream of the HEPA/ULPA filter systems.
Updated requirements for test apparatus used in performance measurements. iso 146443pdf 2021
– ISO 14644-3 requires specific documentation for each test, including apparatus calibration certificates, test conditions, raw data, and calculated results. Missing documentation is a common reason for regulatory observations.
All guidelines regarding the classification of airborne particle concentrations were permanently migrated to ISO 14644-1. Part 3 strictly manages performance metrics . – ISO 14644-3 requires specific documentation for each
– The new edition updated the recommended apparatus and documentation requirements for smoke studies, recognizing advances in fog generation technology.
The heart of the standard lies in its comprehensive test methods. These can be broadly categorized into tests that ensure the cleanroom is built correctly and those that confirm its ongoing operational performance. A summary of the key test methods is presented in the table below. Part 3 strictly manages performance metrics
ISO 14644-1 defines how to classify cleanrooms based on particle concentration. ISO 14644-2 specifies how to monitor cleanrooms to provide evidence of ongoing compliance.
If you only need to reference specific test methods, check if your cleanroom validation software or industry association (e.g., PDA, IEST) offers a bundled standards package.
For anyone validating cleanrooms: