Cleanroom testing

Ensure your cleanroom meets stringent regulatory standards. Our testing and qualification services deliver compliance, reliability, and peace of mind for critical environments.

Our Cleanroom testing Capabilities

  • • HEPA filter integrity testing (aerosol challenge)

    • Airborne particle counting

    • Recovery testing (as built and at rest)

    • Microbiological tests (air and surface)

    • Cleanroom classification

    • Lighting & sound testing

    • Airflow visualization

    • Compliance with EU GMP Annex 1, ISO 14644, DIN 1946, ISO 14698, ISPE, PIC standards

    • Air leakage rate measurement to ISO 14644 and GMP standards

    • Leakage path identification

    • Detailed reporting and remedial recommendations

    • Site-specific protocol authoring

    • Data collection & analysis

    • Non-conformance handling

    • Final qualification report

    • Installation qualification

    • Initial balance AHU systems

    • Pressure cascade setup

    • VAV calibration

    • Air velocity measurements

    • Supply & extract volume rates

    • Cleanroom ventilation rate calculation

    • As-built cleanroom measurements

Ready to ensure your cleanroom meets the highest standards?

Cleanroom testing is critical for compliance, performance, and audit readiness. Our comprehensive services validate airflow, pressure, and filtration integrity while ensuring full compliance with EU GMP Annex 1, ISO 14644, and ISPE standards, giving you confidence in every qualification stage.

  • Full compliance with EU GMP Annex 1, ISO 14644, and ISPE standards

  • Validate airflow, pressure, and filtration integrity

  • Support for audits and regulatory approvals

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