Services / Life Sciences

Cleanroom Validation & Qualification

Once a cleanroom is built, it must be proven to perform. NOVTRIQ develops and executes qualification protocols that demonstrate classification, airflow integrity and recovery, producing the documented evidence regulators and auditors expect. This service is validation and qualification focused, and complements our design-led Clean Room Engineering service.

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What we deliver

  • Validation Master Plan (VMP): qualification strategy, scope, roles, acceptance criteria and documentation structure
  • IQ / OQ / PQ Protocols and Reports: installation, operational and performance qualification with executed results and deviations
  • ISO 14644 Classification Testing: airborne particle counts at rest and in operation, with sample point calculation and pass/fail assessment
  • Airflow Visualisation Study: smoke or fog studies documenting unidirectional flow, recovery and containment, with video and reporting
  • Environmental and Recovery Testing: pressure cascade, air change rate, filter integrity (DOP/PAO), recovery time, temperature and humidity mapping
  • Requalification Programme: periodic monitoring and requalification schedule to maintain classified status

Who it is for

  • Pharmaceutical and biotech manufacturers preparing GMP-classified areas for inspection
  • Cleanroom operators in electronics, optics and medical device production
  • Quality and validation teams needing independent qualification and requalification

Standards & regulations

ISO 14644-1:2015ISO 14644-2:2018ISO 14644-3:2019EU GMP Annex 1IEST Recommended PracticesISO 14644-4ISO 14644-5PIC/S GMP Guide

Qualification lifecycle: IQ, OQ, PQ

Installation Qualification confirms the facility and equipment are installed to specification, with calibration and documentation verified. Operational Qualification tests performance under design conditions: airflow, particle counts, pressure cascade, filter integrity and recovery. Performance Qualification demonstrates sustained classification under operational or simulated production loads. Each phase carries defined acceptance criteria and a controlled deviation process.

Particle counts and airflow visualisation

Classification is verified by airborne particle counting to ISO 14644-1, with sample locations and volumes calculated per the standard. Airflow visualisation using smoke or fog studies provides visual evidence of unidirectional flow, absence of turbulence at critical points, and recovery after disturbance, particularly important for GMP Annex 1 Grade A and B environments.

Complementary to design, not duplicate

Where our Clean Room Engineering service designs and specifies the facility, this service proves and maintains it. The two are designed to work together: coordinated acceptance criteria at design stage make qualification faster, cleaner and more likely to pass first time.

Ready to qualify your cleanroom and pass inspection with confidence?

NOVTRIQ delivers rigorous validation and qualification that turns a built cleanroom into documented, defensible performance.

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