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A Quality by Design (QbD) Approach to Microbial Retention Validation: Poster Presented at PDA Week 2025
Annie Leahy1, Jennifer Juneau2, Corinne Miller3
1Process Solutions, MilliporeSigma, Burlington, MA, USA; and annie.leahy@milliporesigma.com.
Abstract:
Regulatory and manufacturing requirements exist to perform product-specific microbial retention testing on sterilizing filters. The implementation of a Quality by Design approach to microbial retention testing supports a paradigm that would obviate the need for product-specific testing for early-stage products that do not have the quantity of material required to easily and efficiently perform such testing. Process and product parameters were varied to determine their effect on microbial retention.
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