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Procedure of Integrity Test of Absolute Hapa Filters

The document provides the procedure for integrity testing absolute HEPA filters. The procedure involves testing filters whenever they are changed, damaged, disassembled or moved using poly-alpha-olefin or paraffin oil aerosol as a challenge. Filters are tested for leaks in the media, between the media and frame, and between the frame and duct. Filters exceeding a 0.01% penetration are repaired or replaced if the leakage cannot be repaired.

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Mujib Ur Rehman Malik
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505 views2 pages

Procedure of Integrity Test of Absolute Hapa Filters

The document provides the procedure for integrity testing absolute HEPA filters. The procedure involves testing filters whenever they are changed, damaged, disassembled or moved using poly-alpha-olefin or paraffin oil aerosol as a challenge. Filters are tested for leaks in the media, between the media and frame, and between the frame and duct. Filters exceeding a 0.01% penetration are repaired or replaced if the leakage cannot be repaired.

Uploaded by

Mujib Ur Rehman Malik
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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PROCEDURE OF INTEGRITY TEST OF ABSOLUTE HAPA FILTERS

PURPOSE: To provide detailed procedure for integrity testing of high efficiency particulate air (HEPA) filters serving clean area system, laminar flow hoods, clean benches and miscellaneous equipment.

PROCEDURE: A) Integrity testing of all HEPA filters will be conducted whenever, a filter is changes, damage is observed the unit is disassembled or moved to another location, or when environmental monitoring indicates that there may be a leak in the filter. However, as a general rule, all HEPA filters will be integrity tested atleast once a year. HEPA filter shall be tested to determine leaks. In the filter media In the bond between the filter media and the filter frame Between the filter media and filter mounting frame Between the filter frame and the duct flange, if applicable Poly-alpha-olefin(PAO), commonly known as Emery 3004, will be used as challenge aerosol for integrity testing of Absolute (HEPA) filter. If PAO is not available, Paraffin Oil (may be used as substitute) Following test instruments shall be used for filter integrity testing. Aerosol Photometer Model: 2H Make: ATI- USA Aerosol Generators ( Air Operated) Model: TDA 4B Make: ATI- USA The maximum individual patch size total patching shall be limited as listed below. Patching to be done utilizing 100% silicon caulking.Patch work done on filter.

B)

C)

D)

Class 100 : Any filter that has patching covering greater that 5% of the total surface area, or an individual patch exceeding 1% of the total surface area or a patch that may adversely affect the laminarity of the air flow, quality of the product or container, shall be replaced. Class 10,000 and 100,000 : Any filter that has patching covering greater than 5% of the total surface area, or an individual patch exceeding 3% of the total surface area or a patch that may adversely affect the quality of the product or container shall be replaced. Deviation of the 3% and 5% limit are allowed on a temporary basis in order to continue production operations until the next scheduled shutdown, as long as particulate and / or viable monitoring results show the environmental quality is being maintained. NOTE: The penetration of the seals should be zero %.Any penetration at other locations greater that 0.01% should be repaired. In case of leakage exceeding 0.01% filter should be repaired with silicone caulking as per defined criteria and test repeated. In case of excessive leakage (beyond repair), Filter to be replaced with new one. If you have any further assistance is required, please feel free to contact us. M. Salman Cell:0300-2191813 For Pharma Technology

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