Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration

Dr. Kelly Waldron, Senior Consultant at ValSource, served as lead author of the recently-published PDA/Biophorum Points to Consider entitled Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration.  She led a team of experts in sterilizing grade filter manufacture and use through an intensive Quality Risk Management (QRM) exercise designed to enable a complete understanding of potential failures and related causal factors associated with the manufacture of sterilizing grade filters and their use by parental drug manufacturers.  The risk assessment outcomes were used to create a sterilizing filtration control strategy aimed at patient protection.

The Points to Consider enables readers to perform a similar assessment using a number of QRM techniques at their own firms, which can improve sterility assurance and enable decisions regarding the inclusion or potential exclusion of commonly debated controls, such as pre-use post-sterilization filter integrity testing (PUPSIT).  Dr. Waldron’s team was comprised of experts from over 25 companies, including both filter manufacturers and sterile drug producers, as of the PDA/BioPhorum Sterilizing Filtration Quality Risk Management Consortium. The Points to Consider document is available through PDA at the link below: