HVAC Validation
We provide comprehensive HVAC Validation services to ensure controlled environments consistently meet GMP and regulatory requirements. Our experienced validation professionals verify airflow, temperature, humidity, pressure differentials, and air cleanliness through scientifically sound testing, audit-ready documentation, and efficient project execution.
Standard We Follow:
- EU GMP Annex 1
- EU GMP Annex 15
- ISO 14644 Series
- WHO GMP
- PIC/S GMP
- ISPE Good Practice Guides
- US FDA Guidance
- ASHRAE Guidelines (where applicable)
- 21 CFR Part 11 (Electronic Records & Data Integrity)
- Air Velocity, Filter integrity test (PAO Test)
- Non-viable particle count monitoring at static and dynamic state.
- Recovery test
- Light intensity Measurement, Sound Level Measurement.
- Area pressure Balancing
We provide HVAC validation for:
- Cleanrooms (ISO Class 5–9)
- Sterile Manufacturing Areas
- Non-Sterile Manufacturing Areas
- Laboratories
- Microbiology Laboratories
- Sampling Rooms
- Dispensing Areas
- Weighing Booths
- Biosafety Cabinets
- Laminar Airflow (LAF) Units
- Reverse Laminar Airflow (RLAF) Units
- Dynamic Pass Boxes
- Static Pass Boxes
- Air Handling Units (AHUs)
- Terminal HEPA Filters
- HVAC Distribution Systems
- Controlled Storage Areas
Qualification Activities Performed
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Airflow Visualization Studies (Smoke Studies)
- HEPA Filter Integrity Test (PAO/DOP)
- Air Velocity Measurement
- Air Change Rate (ACPH)
- Differential Pressure Verification
- Temperature Mapping
- Relative Humidity Verification
- Non-Viable Particle Count
- Recovery Test
- Room Pressurization Verification
- Airflow Direction Verification
- Noise Level Measurement
- Illumination Level Measurement
- Requalification Studies
Key Deliverables
Each project includes:
- Validation Protocol
- Risk Assessment
- Test Layout Drawings
- Instrument Calibration Certificate
- Raw Data Records
- HEPA Integrity Test Reports
- Air Velocity Data
- ACPH Calculations
- Differential Pressure Records
- Particle Count Reports
- Smoke Study Reports (if applicable)
- Summary Report
- Deviations & Investigations
- Final HVAC Validation Report
Why Choose Cleanstep?
- Advanced HVAC Validation Technology
- Experienced Validation Professionals
- Regulatory-Compliant & Audit-Ready Documentation
- Efficient Project Execution
- Comprehensive HVAC Qualification
- End-to-End Technical Support
Need HVAC Validation Services?
Partner with Cleanstep Pharma and Engineering Solutions for reliable, regulatory-compliant HVAC Validation services. We ensure your controlled environments consistently meet GMP requirements through comprehensive testing, audit-ready documentation, and efficient project execution.
