IQ/OQ/PQ Qualification for Cleanroom & Laboratory Equipment

What is IQ/OQ/PQ?

IQ/OQ/PQ is a three-stage qualification process that documents equipment is installed, operates and performs correctly. IQ (Installation Qualification) verifies correct installation; OQ (Operational Qualification) verifies it operates within specification; PQ (Performance Qualification) verifies it performs under real conditions.

Why it matters

For regulated environments — pharmaceutical, biotech, hospital — qualification documentation is essential for audits and GMP compliance. It proves your biosafety cabinet, laminar flow hood or cleanroom meets its required standard.

Our service

ADS Laminaire performs on-site installation, HEPA filter integrity testing, airflow verification, particle counts and full IQ/OQ/PQ qualification, delivering audit-ready dossiers. See our biosafety cabinets and modular cleanrooms.

What each phase verifies

After design qualification (DQ), IQ confirms the equipment is installed exactly as specified — correct model, utilities, location and documentation. OQ confirms it operates within its parameters: airflow velocities, HEPA filter integrity (DOP/PAO), alarms and controls. PQ confirms it performs under real conditions with your actual process and load.

Who performs it and what you receive

Qualification is carried out by an accredited technician against written protocols. You receive the protocols, raw test data, any deviations and a signed final report. For biosafety cabinets this typically aligns with NSF 49 field certification.

Requalification

Equipment should be requalified periodically (commonly annually) and after any relocation or major maintenance. Our equipment is built to be qualified on site — see our biosafety cabinets and laminar flow hoods.

Frequently Asked Questions

Questions about your project?

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