Heating, Ventilation and Air Conditioning (HVAC) System Validation Process

Process:

     1.   Perform Installation Qualification.

     2.   Perform general operational controls verification testing.

     3.   Operate system throughout the range of operating design specifications or range of intended use.

     4.   Integrity test all HEPA filters with dioctylphthalate (DOP) smoke PAO aerosols (0.3 microns).

     5.   Measure the average face velocity of each terminal HEPA filter. Measure the average velocity 1 ft above the work-space exposed product areas, or exposed component areas in all Class 100 laminar flow rooms or areas.

     6.   Verify that system air flows have been balanced to within ±10% of design criteria.

     7.   Verify that directional air flows are consistent with design drawings by verifying relative differential air pressures.

     8.   Verify that each room maintains the design temperature range for three (3) consecutive days.

     9.   Verify that each room maintains the design relative humidity range for three (3) consecutive days.

   10.   Verify that air flow patterns within Class 100 laminar flow areas are non-turbulent and unidirectional by performing smoke‑stick air flow studies and recording the test on videotape.

   11.   Verify that rooms identified with particulate classifications are certified per Federal Standard 209E for their respective classification (Class 100, 10,000, and 100,000).

   12.   Verify that AHUs, fans, and heat exchangers operate per design ratings.

   13.   Record the range of all process or equipment parameters (set points, flow rates, timing sequences, etc.) verified during operational and performance qualifications testing.

Related: HVAC System Validation Tests

Acceptance Criteria:

     1.   The system is installed in accordance with design specifications, manufac­turer recommendations, and cGMPs. Instruments are calibrated, identified, and entered into the calibration program.

     2.   General controls and alarms operate in accordance with design specifica­tions.

     3.   The system operates in accordance with design specifications throughout the operating range or range of intended use.

     4.   HEPA filters are 99.99% efficient when tested with DOP smoke PAO aerosols (0.3 microns).

     5.   All terminal HEPA filter face velocity measurements are within ±30% of the average filter velocity.

     6.   The average face velocity of terminal HEPA filters servicing Class 100 laminar flow rooms is 90 ft/min ±20%, with no points below 75 ft/min or above 105 ft/min.

     7.   All room supply, exhaust, and return flow rates must be within ±10% of design flow rates.

     8.   Directional air flows (as determined by room differential pressure) must be consistent with design drawings.

     9.   Each room must maintain the design temperature range for three (3) consecutive days.

   10.   Each room must maintain the design relative humidity range for three (3) consecutive days.

   11.   Airflow in Class 100 laminar flow areas must be non-turbulent and unidirectional as demonstrated by smoke‑stick studies.

   12.   All classified rooms are certified to meet their particulate classification per Federal Standard 209E.

   13.   AHU, fan, and heat exchanger operations must meet or exceed their respective design ratings.

Also see:

• HEPA Filters Used in Pharmaceuticals
• What is HEPA filter? Its Use in Pharmaceuticals

Get editable documentsView List