Filter validation - Good to know
The following sub-pages should highlight some aspects about filter validation and provide an overview. Further information can also be found in our Blog about filter validation, where updates will be posted from time to time.
In this article the requirements for filter validation according to the PDA 26 report are presented.
This articles provides an abstract about the information provided by the filter suplliers in their validation guides. This includes bacterial retention in medium, the values of the filter integrity test, the influence of the sterilization method, chemical compatibility and extractables, particles and fibers as well as TOC, conductivity, oxidizable substances, bacterial endotoxins and toxicity tests.
Here, studies are described which have to be performed by the filter user e.g. the pharmaceutical company itself. This compromises determinations about viability of Brevundimonas diminuta in preparation for the product specific bacterial retention test, a product specific filter integrity test, studies about the release of particles, fibers, leachables by the filter material in contact with the product solution to be tested as well as adsorption of product components to the filter membrane and if required an evaluation of multiple filtrations.
Shortly, the mode of action of the three main non-destructive filter integrity tests are summarized: bubble point test, diffusion test (forward flow test and pressure hold test) and water flow test.
In this article the performance of the bacterial retention test according to ASTM F838-15a is described.