IQ/OQ/PQ Validation Services for Cleanrooms & Regulated Facilities
Validation is your documented proof that your cleanroom, HVAC system, and critical equipment consistently perform within specification. Our validation specialists produce the evidence your regulator demands and your quality team relies on.
A well-executed validation programme protects your product, your manufacturing licence, and your organisation's reputation.
Installation Qualification — IQ
Documented verification that your cleanroom, HVAC system, or laboratory equipment has been installed correctly, completely, and in accordance with approved design specifications, drawings, and manufacturer requirements.
Operational Qualification — OQ
Documented verification that your installed system operates consistently within defined parameters across its full operating range, including challenge testing under worst-case conditions.
Performance Qualification — PQ
Documented verification that your system consistently performs in accordance with defined specifications under actual or simulated production conditions over a defined time period.
Cleanroom ISO Classification Testing
ISO 14644-1 particle count testing and cleanroom classification verification at rest and in operation with full statistical analysis and documentary evidence of classification status.
HVAC System Qualification
Air change rate verification, HEPA filter integrity testing, pressure differential mapping, temperature and humidity testing, airflow visualisation, and recovery time testing documented to GMP standards.
Revalidation & Periodic Review
Scheduled revalidation services after changes, maintenance activities, or as part of periodic review programmes to maintain your facility's validated status.
Validation Documentation
- Validation Master Plan
- User Requirements Specification
- Design Qualification documentation
- IQ, OQ, PQ protocols and reports
- Deviation and non-conformance records
- Final Validation Summary Report
Documented Proof, Not Assumptions
We provide comprehensive IQ/OQ/PQ validation services for cleanrooms, HVAC and air handling systems, laboratory equipment, and environmental monitoring systems — producing regulatory-grade validation packages that satisfy SAHPRA, PIC/S GMP, and ISO 14644 requirements.
