Validation & Compliance
HVAC Validation
Cleanroom classification depends on HVAC performance you can prove. Our validation team runs the full set of performance tests on your AHUs and controlled areas, records raw data on calibrated instruments, and delivers reports ready for regulatory inspection.
What's included
Scope of service
AHU performance qualification
End-to-end PQ of air handling units against approved acceptance criteria.
Airflow & air changes
Air velocity, volume and air-change-rate measurement for every room and terminal.
HEPA filter integrity
Aerosol challenge (PAO/DOP) leak testing of terminal and in-line HEPA filters.
Particle count & classification
Non-viable particle counting for ISO 14644 / EU GMP cleanroom classification.
Pressure & recovery studies
Room differential pressure, airflow direction and recovery tests.
Temperature & humidity mapping
Multi-point mapping of rooms, warehouses, stability chambers and cold rooms.
What you receive
- Approved validation protocol
- Raw data sheets signed on site
- Test reports with instrument calibration certificates
- Summary report with deviations and recommendations
How we work
Four steps, fully documented.
- 1
Understand the requirement
Site visit or call to map your instruments, equipment, URS and audit timelines.
- 2
Plan & execute
Approved protocols, calibrated master standards and trained engineers on site.
- 3
Deliver results & reports
Signed certificates, raw data and validation reports in your QA format.
- 4
Ensure compliance
Due-date tracking, re-qualification planning and support during audits.
How often should HVAC systems be re-validated?+
Typically every year, or after any major modification, filter change or failure. Your site SOPs and risk assessment set the final frequency, and we can help you justify it.
Do you provide the test instruments?+
Yes. We bring calibrated anemometers, particle counters, aerosol generators, photometers and data loggers, and their calibration certificates are attached to the report.
Related
Other services
Let's plan your hvac validation.
Tell us what you need. We'll come back with a plan, a timeline and a clear quote, usually within one working day.