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Determining if a sterilizing grade filter is integral can be done via non-destructive integrity testing.
The test parameters for sterilizing grade membrane filters are based on correlating the test parameters with the LRV of the filter against a 107 CFU/cm2 challenge with Brevundimonas diminuta.
The filter cartridges can be tested by industry standard procedures as recommended in PDA Technical Report 26.
The test parameters are dependent on the surface tension of the wetting fluid to be used. Therefore, the parameters used in the procedures, listed below, assume the wetting fluid to be water. For test values using wetting fluids other than water the adjusted parameters have to be determined.
We can carry out and advise on the following integrity test procedures: