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Cleanroom Validation

Cleanroom Validation

Line-Link® provides professional cleanroom validation and certification to meet GMP, FDA, EU GMP and ISO 14644-1 standards.

① IQ / OQ / PQ Qualification
Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) with complete documentation and on-site validation to ensure system integrity and regulatory readiness.

② Pressure & Airflow Validation
Verification of room pressure differentials, airflow velocity, distribution uniformity, and containment performance to ensure stable directional airflow and contamination control in compliance with ISO cleanroom standards.

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  • What is included in cleanroom validation (IQ / OQ / PQ)?

    • Cleanroom validation typically includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This process verifies that all cleanroom systems are correctly installed, operate according to design parameters, and consistently perform under real production conditions. Full documentation and on-site testing are provided to ensure compliance with GMP, FDA, EU GMP, and ISO 14644-1 requirements.

  • How often should cleanroom validation be performed?

    • Validation frequency depends on regulatory requirements, facility classification, and process criticality. In general, cleanroom requalification is recommended annually or after any major modification, maintenance, or system upgrade. Critical parameters such as airflow, pressure differential, and particle counts should also be monitored regularly as part of an ongoing environmental control program.

  • What parameters are tested during cleanroom performance validation?

    • Key performance parameters include air pressure differentials between zones, airflow velocity and uniformity, HEPA/ULPA filter integrity (including MPPS testing), particle concentration levels, temperature and humidity stability, and cleanroom recovery time. These tests ensure that the controlled environment consistently meets required ISO classification standards.

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