PQ Tests Used in HVAC Qualification for Pharmaceutical Facilities
Airflow Visualization (Smoke Studies)
Purpose: Confirms airflow patterns, particularly in cleanrooms and critical areas where contamination control is crucial.
Process: Smoke or fog is introduced to visualize the airflow direction, ensuring it moves as intended (e.g., from high to low classification areas) and does not lead to recirculation or contamination risks.
Focus Areas: Laminar flow benches, doors, and areas around equipment or operator stations.
Particle Count Testing
Purpose: Ensures that particulate levels in the air meet the cleanroom classification (e.g., ISO 5 for sterile areas).
Process: Using a particle counter, particulate counts are measured at different locations, especially near critical zones and points where the product is exposed.
Acceptable Limits: Should comply with ISO 14644 standards and facility-specific cleanliness levels.
Temperature and Humidity Mapping
Purpose: Verifies that the HVAC system maintains stable temperature and humidity levels within specified ranges across the room or area.
Process: Multiple sensors are placed in various locations to monitor temperature and humidity over a specified period, both at rest and in operational conditions.
Acceptable Limits: Temperature and humidity should remain within the defined range for the specific area or process.
Room Pressure Differential Testing
Purpose: Confirms that the required pressure differentials are maintained to prevent cross-contamination between rooms of different classifications.
Process: Measurements are taken to ensure that positive or negative pressures are maintained between adjacent areas. For example, aseptic areas typically have positive pressure relative to surrounding rooms.
Acceptable Limits: Should meet facility standards, typically specified in inches of water gauge (e.g., 0.05-0.10 inches for most pharmaceutical cleanrooms).
Air Change Rate (ACH) Verification
Purpose: Ensures that the HVAC system achieves the required air changes per hour to keep contamination levels under control.
Process: Calculations based on airflow rates and room volume, or direct measurement of air changes, to confirm compliance with design specifications (e.g., 20 ACH for certain cleanrooms).
Acceptable Limits: Varies by classification and process, often specified by GMP or ISO standards.
HEPA Filter Integrity Testing (DOP/PAO Testing)
Purpose: Verifies that HEPA filters are free of leaks and perform as required to filter particulates effectively.
Process: A particle aerosol (DOP or PAO) is introduced, and the filter is tested for leaks using a photometer or aerosol generator.
Acceptable Limits: Typically, filters must remove at least 99.97% of particles 0.3 microns or larger without any leaks.
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Resource Person: Mohamed Mahmoud
