HVAC (Heating, Ventilation, and Air Conditioning) systems play a vital role in pharmaceutical manufacturing environments, cleanrooms, laboratories, and healthcare facilities. The proper design, installation, qualification, and maintenance of HVAC systems are crucial to ensuring air quality, contamination control, and temperature/humidity regulation—all of which directly impact product safety, process integrity, and compliance with regulatory guidelines.

At Incredible Pharmaceutical Pvt. Ltd., we specialize in comprehensive HVAC Qualification and Validation services that meet the most stringent international standards, including USFDA, WHO, ISO, GMP, and cGMP. Our HVAC validation solutions are designed to ensure your environment remains consistently compliant, safe, and optimal for critical manufacturing and research processes.

What is HVAC Validation?

HVAC Validation is the process of verifying and documenting that HVAC systems are performing as designed and are capable of maintaining controlled environmental conditions—such as particulate cleanliness, air change rates, pressure differentials, temperature, and humidity—according to industry standards.

Our validation process is a structured and scientific approach that ensures your system:

• Meets the design and operational specifications

• Maintains environmental conditions required for cleanroom or production areas

• Complies with regulatory requirements for cleanliness, microbial control, and system integrity

Our HVAC Validation Services Include:

✅ Design Qualification (DQ)
Review and assessment of HVAC design to ensure it meets regulatory and process requirements.

✅ Installation Qualification (IQ)
Verification of proper installation of ducts, filters, blowers, and controls as per approved design specifications.

✅ Operational Qualification (OQ)
Testing the operation of HVAC system components (AHUs, HEPA filters, sensors) under controlled conditions to ensure they perform as intended.

✅ Performance Qualification (PQ)
Verifying that the HVAC system maintains the desired environmental conditions consistently during routine operations.

✅ HEPA Filter Integrity Testing (DOP/PAO Testing)
Ensures proper filtration efficiency and identifies any leaks or breaches in the filter or housing.

✅ Airflow Velocity and Volume Measurement
Verification of airflow direction, velocity, and volume in critical zones and across filters.

✅ Air Change Rate Testing (ACH)
Confirming that the number of air changes per hour aligns with the required standards for each cleanroom class.

✅ Temperature & Humidity Mapping
Monitoring of temperature and humidity uniformity and stability across defined locations over specified timeframes.

✅ Differential Pressure Monitoring
Testing and verification of pressure gradients between cleanroom areas to prevent cross-contamination.

✅ Recovery Rate Testing
Determines how quickly the environment returns to acceptable levels after contamination.

✅ Particulate Count Testing (Non-Viable Particles)
Measures airborne particles using particle counters in compliance with ISO 14644-1 guidelines.