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integrity test fails?

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If the sterilization filter fails the integrity test, it may be damaged, but there are other possible reasons for failure, includingInstrument problems,Pipeline tightness,Personnel Operation(such as incorrect assembly, incorrect parameter settings, etc.) andIncomplete wettingand so on. The filter failure investigation and retest procedure shall be documented.

analysis of failure due to inadequate wetting

inadequate wetting may be dueInsufficient flushing of filter, it did not wet all the holes. If it is a test after use, it may be that the filter has adsorbed it.hydrophobic contaminants, orOther formula componentschanges the surface wetting characteristics of the filter membrane. Changes in wetting characteristics may affect integrity test performance. For example, pipe material may enter the product stream and be adsorbed by the filter membrane, or product residues may not be cleaned, affecting the wetting properties of the membrane, causing the integrity test to fail.

In order to obtain suitable integrity test results, the porous structure of the filter should be completely wetted, since the physical nature of the integrity test method relies on the flow of gas through the wetting liquid layer. The wetting of the filter membrane will be affected by the following factors:

membrane polymer: Some polymers are easier to wet than others, depending on the critical surface tension of the membrane.

the size of the hole: The smaller the hole, the more difficult to wet.

wetting fluid: Some wetting fluids may have a repulsive interaction with the polymer matrix.

product residues or contaminants: Product residues or contaminants can change the hydrophilicity of the membrane polymer, repel wetting fluids or reduce surface attraction.

pressure conditions: The manufacturer's pressure recommendations should be followed to achieve complete wetting of the membrane.

temperature conditions: Temperature affects the surface tension of the wetting fluid.

In addition to the above, there may be factors related to the process or application that are not covered by the manufacturer's description of use that affect the integrity test.

distinguish between filter damage and other possible causes of "false failure", the following verification steps should be taken:

has chosen the right integrityTest Method, using the correctTest Parameters?

whether the correctwetting fluidandRunwet procedure?

test systemNo leakage?

filter componentstemperatureremain stable and within specification during testing?

When requiredRepeat test, can refer to the following steps: according to the specification requirementsre-wettingfilter element and repeat test

If the filter integrity testfailed again., you can use the following steps: Applymore powerful wetting conditions, increase the volume/time of flushing, increase the differential pressure and/or apply back pressure