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Filter Integrity



Bubble point: The measured differential gas pressure which a wetting liquid (e.g., water, alcohol, product) is pushed out of the largest pores of a wetted porous membrane and a steady stream of gas bubbles or bulk gas flow is detected.

Bubble point test: A test to indicate the maximum pore size of a filter. The differential gas pressure at which a liquid (usually water) is pushed out of the largest pores and a steady stream of gas bubbles is detected from a previously wetted filter under specific test conditions. Used to test filter integrity with specific, validated, pressure values, wetting liquids and temperatures for specific pore-size (and type of) filters.

Water intrusion test/ HydroCorr test : The HydroCorr test is based on the fact that water is repelled by the pores Hydrophobic filters by surface tension and capillary forces. The HydroCorr test is a highly sensitive, non-alcohol, water flow integrity test for hydrophobic membrane filters. The minimum pressure required to force liquid into the largest pores is called the water intrusion pressure.

Integrity testing failure analysis-

1. If a sterilizing grade filter fails for integrity test, it could be due to damaged filter, incorrect assembly, incomplete wetting and possible test problems (but not limited to).
2. Damaged filter could possibly result in non-sterile filtrate while other test problems may produce sterile filtrate.
3. Integrity testing failure analysis shall be carried out to distinguish filter damage and possible test problems to take necessary corrective action and preventive action.
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