Filter Integrity Test

LexaMed offers Filtration Efficacy testing used for the validation of filter sterilization of a drug product solution via a Filter Integrity test and Bacterial Retention Testing as recommended in the Food and Drug Administration (FDA) Guidance on Sterile Drug Products Produced by Aseptic Processing. When filtration is used as a method for sterilizing drug product solutions, the filter must be validated to demonstrate that it can reproducibly remove viable organisms from the process stream, and produce a sterile product effluent. Testing is conducted using worst-case processing parameters with direct inoculation of a challenge organism into the drug product to assess the effect of the drug product on the bacterial retention capabilities filter matrix.  In the case of products with inherent bactericidal activity, appropriate alternative methodology is employed.

Marcus Keller

Marcus Keller

Project Manager

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