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Assessing PFAS extractables from sterilizing-grade filters
Evolving PFAS regulations have intensified the need for transparent protocols to measure and test extractables and leachables from materials used in biopharmaceutical manufacturing. This white paper compares selected PES- and PVDF-based sterilizing-grade filters using a USP <665>-based extraction approach. It examines extractable organic fluorine and 102 targeted PFAS under worst-case conditions, providing evidence to support risk assessment and filter selection.
Key Learning Objectives:
- Compare EOF profiles across selected PES- and PVDF-based sterilizing-grade membrane filters.
- Review targeted PFAS findings from filters tested under worst-case extraction conditions
- Assess how membrane material and PFAS-based surface modifications relate to extractables
