ISO 14644 defines the test methods for the classification of airborne particulate cleanliness and for evaluating the performance of cleanrooms and clean zones. The standard applies to both unidirectional and non-unidirectional airflow cleanrooms and specifies testing under three occupancy states:

• As-Built

• At-Rest

• Operational

The test methods outlined in ISO 14644 recommend appropriate test apparatus and procedures to determine cleanroom performance parameters. Where testing is influenced by cleanroom type or operational conditions, alternative methods are suggested to suit specific application requirements.

These procedures are used to demonstrate compliance with user-defined performance criteria during installation and for periodic requalification. The selection and sequence of tests are mutually agreed upon between the customer and supplier to ensure efficiency and to minimize rework in case of non-compliance.

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Testing, Commissioning & Validation Scope

We carry out comprehensive cleanroom testing and validation, including:

• Air velocity measurement

• HEPA/ULPA filter integrity (leak) testing

• Non-viable particle count testing

• Recovery time testing

• Airflow pattern (smoke) testing

• Temperature and humidity testing

• Differential pressure testing

• Sound level testing

• Light intensity (lux level) testing

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Documentation & Compliance

We provide complete validation documentation in line with ISO 14644 and cGMP guidelines, including:

• DQ, IQ, OQ, and PQ documentation

• Detailed test reports

• Material test certificates

• Calibration certificates for instruments such as magnehelic gauges, sensors, and monitoring devices

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Note: All test results are verified to meet approved design specifications, regulatory standards, and customer requirements.