Subject matter experts from the SFQRM Consortium has prepared this strategy roadmap with suggested actions and considerations to support the implementation of an effective risk-based approach:
Sterile Filtration Quality Risk Management
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SFQRM: The use of scientific data to assess and control risks associated with sterilizing filtration: a PDA and BioPhorum collaboration
It is generally recognized that post-use filter integrity testing is sufficient to detect filter failure and ensure patient safety unless there is a possibility that a filter passing the post-use test could have allowed bacterial penetration during filtration. This possibility is the phenomenon referred to as filter “flaw masking”, hypothesized to occur when, for example, a filter is damaged during sterilization such that it allows bacterial penetration, but that the damage becomes plugged during the filtration process to such an extent that it allows the filter to exhibit a passing post-use integrity test result. Two workstreams within the SFQRM consortium were designed specifically to evaluate the risk of this filter flaw masking and to understand in what conditions it might occur: Masking Studies, and Bacterial Challenge Test (BCT) Data Mining.