HEPA Filter Integrity Testing

A procedure will be developed that identifies the certification requirements for all High Efficiency Particulate Air (HEPA) filters in the Injectable facility. This will include HEPA filters mounted in ceilings, flow hoods, biosafety 

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HEPA filter integrity testing is performed at 6-month intervals on level I and level II HEPA filters. HEPA filter testing includes Measuring (Machines, Eilters, Diffusers) Inlet and Outlet Air Velocity or Volume and Integrity Test of HEPA Filters Using Aerosol and Photometer. Refer to (provide reference to attachment no.). 

Filter integrity, including HEPA filter leak test... 

Testing of BSCs involves evaluation of the inflow velocity of air, the downflow velocity of air within the cabinet, and airflow smoke patterns, a HEPA filter leak test, a cabinet leak test, and an electrical connection integrity test (must meet Underwriter s Laboratory requirements), as well as other tests for lighting, vibration, and noise. 

The air quality class determines the type of HEPA filter (see Table 27.4) mounted in the inlet grid and the thereby raised air friction. All HEPA filters should be entered into a maintenance plan at least once a year a leakage test and a filter integrity test should be performed [5]. 

In order to maintain a high level of air qualit), it is necessary to test airflow velocities and HEPA filters for integrity. These tests are described in a variety of standards and recommended practices depending on the use of the airflow bench. 

Measurements in Unmanned Condition 1.1 Integrity testing of HEPA filters... 

The purpose is to check the integrity for HEPA filters by leak test to assure that they are not damaged during installation or operation. 

Adjustments in the air source should be made to obtain a controlled flow of air within the tunnel and across the entrance and exit openings. Air must be particulate-free as it enters the tunnel area therefore, all high efficiency particulate air (HEPA) filters in the tunnel must be integrity tested and certified prior to validation studies. 

Filter leakage tests (To verify filter integrity) All classes 24 months Filter penetration tests to be carried out by a recognized authority to demonstrate filter media and filter seal integrity. Only required on HEPA filters. In accordance with ISO 14644-3 Annex B6 ... 

Integrity test all HEPA filters with dioctylphthalate (DOP) smoke (0.3 ft). 

Upon installation, HEPA filters shall be integrity tested by a suitable method, e.g., cold DOP test... 

The isolator should be designed so that the HEPA filters can be integrity tested in situ. 

Ventilation Hot Exhaust (Zones 1 and 2A combined exhaust) Control of off-site radioactive material releases. 1. Hot exhaust confinement boundary integrity must not be compromised by ventilation system fan mis-operation or malfunction. 2. HCF operators must maintain the required functional performance of confinement controls. 3. HCF operators must verify the functional performance of the hot exhaust HEPA filters. 1. A ventilation system fan sequencing interlock ensures that the backup exhaust fan is automatically started upon loss of the primary operating fan. An aiann alerts the operations staff upon loss of the operating stack exhaust fan. 2. Administrative controls are in place to ensure periodic ventilation system fan sequencing interlock testing. 3. Administrative controls are in place to ensure periodic functional performance and efficiency testing of the HEPA filters. 

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