Parenteral Drug Associates (PDA) Technical Report (TR) 26 defines the expectations for demonstrating the suitability of sterilizing-grade filters by evaluating both the impact of the product on filter performance and the impact of the filter on product quality.
This webinar presents an integrated, science-based approach that combines filter validation and extractables/leachables (E&L) evaluation. Attendees will learn about the filter validation tests, the respective responsibilities of filter manufacturers and filter users as defined in PDA TR 26, and how extractables, leachables, and toxicological assessments can be integrated, in accordance with USP <665> and USP <1665>, into a comprehensive strategy for evaluating filter suitability and supporting patient safety.
A practical decision tree will be used to demonstrate how each study supports the overall validation strategy and how companies can efficiently establish filter suitability while maintaining compliance and protecting product quality.
Followed by a live Q & A.
Presented by BioPharma Webinars
Learn more about the presenters below.
