HVAC Validation & Cleanroom Qualification Services India
Validated airflow, filtration, pressure and cleanroom classification for GMP facilities.
Ranucal provides HVAC validation and cleanroom qualification services in India for pharmaceutical, healthcare and food facilities. We qualify air handling units, filters, airflow, pressure cascades, and temperature and humidity control, and verify cleanroom classification to ISO 14644-1, with documented evidence for GMP inspection.
What We Offer
HVAC Design Review
Review of the HVAC design against user requirements, cleanroom classes and pressure cascade philosophy before installation (Design Qualification).
Installation Qualification (IQ)
Verification that air handling units, ducting, filters, dampers, fans and controls are installed as specified, with documented component and drawing checks.
Operational Qualification (OQ)
Testing of airflow velocity, pressure differentials, temperature and humidity control, alarms and recovery under defined operating conditions.
HEPA Filter Integrity Testing
In-situ integrity testing of HEPA and terminal filters using an aerosol challenge, with leak locations identified and reported.
Cleanroom Classification
Particle count testing, air change rate verification and recovery tests to classify cleanrooms against ISO 14644-1 and the applicable GMP grade.
Performance Qualification & Requalification
Monitoring of particle counts, differential pressure and temperature and humidity over time, plus requalification after major changes or repairs.
Our Execution Approach
- 1
Planning — URS review, cleanroom classes, pressure cascade and acceptance criteria
- 2
Design and Installation Review — drawings, equipment and component verification
- 3
Operational Testing — airflow, pressure differentials, temperature and humidity control
- 4
Filter Integrity and Classification — HEPA testing, particle counts and recovery tests
- 5
Final Report — qualification report, deviations, corrective actions and requalification schedule
Key Benefits
Frequently Asked Questions
What is HVAC validation and why is it required?▼
HVAC validation demonstrates that the air handling system consistently provides the airflow, filtration, pressure differentials, temperature and humidity that a cleanroom or controlled area needs. GMP regulations, including EU GMP Annex 1, expect these systems to be qualified before use and monitored thereafter.
What is the difference between HVAC validation and temperature mapping?▼
HVAC validation qualifies the air handling system and cleanroom environment, covering airflow, filtration, pressure and particles. Temperature mapping measures the temperature distribution inside a storage area, chamber or room. We perform both, and they often run together during a facility qualification.
What is HEPA filter integrity testing?▼
Integrity testing checks that installed HEPA filters have no leaks. An aerosol challenge is applied upstream and measured downstream, and any leak is located and documented so it can be repaired and retested.
How often should HVAC systems be requalified?▼
Requalification frequency depends on the cleanroom classification, your risk assessment and your SOPs. Many classified cleanrooms are requalified annually, and requalification is also needed after major changes, repairs or filter replacements.
Do you classify cleanrooms against ISO 14644?▼
Yes. We carry out particle count testing, air change rate verification and recovery testing to classify cleanrooms under ISO 14644-1, and we assess the results against the GMP grade your process requires.
How long does HVAC validation take?▼
Timelines depend on the number of air handling units and cleanroom classes. A single suite typically takes two to four weeks on site, including reporting. Large facilities are planned in phases.
Need HVAC Validation for your facility?
Tell us your requirement and our team will respond within 24 hours.