HVAC Qualification Process
Design Qualification (DQ)
The DQ phase involves verifying that the HVAC system is designed according to the requirements of the facility, production process, and regulatory guidelines (e.g., WHO, EU GMP, FDA). It should ensure that:
Room classification: Cleanrooms and controlled environments are designed to meet the required cleanliness level, such as ISO 7 or ISO 8.
Airflow patterns: Proper design of airflows to prevent cross-contamination (unidirectional airflow in critical areas, for example).
Temperature and humidity control: The HVAC system must meet the specific ranges of temperature and humidity required for product stability and worker comfort.
Filtration system: Use of HEPA (High-Efficiency Particulate Air) filters where necessary, especially in sterile or aseptic production areas.
Room pressure differentials: Ensure that proper pressure gradients (positive or negative) are maintained to control the flow of air between rooms and prevent contamination.
Installation Qualification (IQ)
IQ involves documenting and verifying that the HVAC system and all its components are installed per the design and vendor specifications. Key activities include:
Component Verification: Checking each component (filters, ducting, dampers, sensors, etc.) against the engineering drawings and vendor documentation.
Calibration: Verifying the proper installation and calibration of control and monitoring devices (thermostats, pressure gauges, airflow sensors, etc.).
As-built Documentation: Confirming that the “as-built” system matches the design specifications. Any deviations must be documented.
Typical documents for IQ:
- Equipment manuals.
- Drawings of HVAC layouts and components.
- Calibration certificates for critical devices.
Operational Qualification (OQ)
OQ ensures the HVAC system functions according to the intended operational parameters under various conditions. The following tests are performed:
Airflow velocity tests: Measure the velocity of airflow in different rooms to ensure uniform and adequate distribution.
Temperature uniformity tests: Verify that temperature is maintained consistently across different parts of the facility within the specified range.
Humidity control tests: Ensure humidity levels meet the desired set points and are stable.
Room pressure differential tests: Check that positive or negative pressure is maintained as required to prevent cross-contamination.
Filter integrity tests: Verify that HEPA filters are functioning properly, ensuring no leaks or inefficiencies in air filtration.
Alarm tests: Verify that the HVAC system alarms (temperature, humidity, airflow) work correctly when critical thresholds are exceeded.
Performance Qualification (PQ)
During PQ, the HVAC system is tested under real or simulated production conditions to demonstrate consistent performance over time. The tests conducted during PQ include:
Particulate count tests: Measure the number of airborne particles in the air to ensure it meets the cleanroom classification.
Microbial monitoring: Microbiological sampling in sterile areas to ensure the system is controlling contamination effectively.
Environmental monitoring: Continuous monitoring of temperature, humidity, and differential pressure to ensure they are within acceptable ranges during actual production.
Air exchange rate: Testing the number of air changes per hour (ACH) in the room to ensure sufficient ventilation and air filtration.
Regulatory Expectations
Regulatory bodies such as the FDA, EMA, and WHO emphasize the qualification and validation of HVAC systems to maintain product quality and safety. Some key standards and guidelines include:
ISO 14644: This international standard provides guidance on the classification of air cleanliness in cleanrooms.
EU GMP Annex 1: Provides guidelines for sterile manufacturing, specifying HVAC requirements for cleanroom classification, airflow patterns, and filtration.
FDA Guidance for Industry: Includes guidelines on HVAC design, qualification, and performance requirements in facilities producing sterile drugs.
WHO TRS 961: Offers guidance on HVAC systems for pharmaceutical manufacturing, emphasizing contamination control and environmental monitoring.
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Resource Person: Mohamed Mahmoud
