A well-designed and qualified HVAC system is essential for maintaining controlled environments, ensuring product quality, and meeting global regulatory requirements. PrimeGMP provides comprehensive HVAC Qualification services covering all stages of the qualification lifecycle to ensure your facility’s air handling systems operate as intended and remain audit-ready.

Our HVAC Qualification Scope

1. URS, DQ & Risk Assessment

• User Requirement Specification (URS) preparation
• Design Qualification (DQ) verification
• Quality Risk Assessment as per ICH Q9
• Review of HVAC schematics, layouts, AHU data sheets

2. Installation Qualification (IQ)

• Verification of AHU installation
• Ducting, dampers, filters, coils, motors, and instrumentation checks
• Calibration of sensors, thermometers, manometers, and differential pressure gauges
• Review of wiring diagrams, utilities, and equipment identification

3. Operational Qualification (OQ)

• Airflow measurements
• HEPA filter integrity testing (DOP/PAO)
• Differential pressure & directionality checks
• Temperature & humidity mapping
• Recovery time tests
• Air change rate (ACPH) verification
• Smoke Study / Airflow Visualization
• Sound level & vibration verification

4. Performance Qualification (PQ)

• Area performance monitoring under dynamic conditions
• Particle count (ISO 14644)
• Microbial monitoring
• Pressure differentials under load
• Environmental monitoring qualification
• HVAC performance trending & evaluation

Documentation Provided

• URS, DQ, IQ, OQ & PQ Protocols
• Summary Reports with observations & CAPA
• Calibration records
• HEPA integrity test reports
• Airflow visualization (smoke study) video documentation
• Temperature & RH mapping reports
• As-built, at-rest & operational qualification summaries

Regulatory Standards We Follow

• WHO TRS 961 / 1019
• EU GMP Annex 1 & Annex 15
• USFDA 21 CFR Parts 210/211
• ISO 14644 (Cleanroom Classification)
• ISPE HVAC Good Practice Guide
• GAMP 5 (for EMS/controls where applicable)

Why Choose PrimeGMP for HVAC Qualification?

• Highly experienced HVAC validation team
• Use of calibrated, traceable instruments
• Detailed and audit-ready documentation
• Strong understanding of sterile & non-sterile facility requirements
• Real-time troubleshooting support
• Capability to integrate with EMS, BMS, and QMS systems