Integrating E&L Assessment and Filter Validation for Sterilizing Grade Filters used in (Bio-)Pharmaceutical Manufacturing

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.

Presented by Lijun Song, PhD, Scientific Project Manager at Nelson Labs

Lijun Song, PhD is a Scientific Project Manager at Nelson Labs, where she specializes in extractables and leachables (E&L) studies for plastic components and systems used in pharmaceutical and biopharmaceutical manufacturing. Prior to joining Nelson Labs in 2024, she served as a Senior Validation Chemist at the 3M Filter Validation Laboratory, where she focused on chemical compatibility testing and E&L assessments. Lijun earned her PhD in Medicinal Chemistry from Ghent University in 2018 and subsequently joined 3M. Throughout her academic and professional career, she has developed extensive expertise in analytical chemistry, extractables and leachables study design and characterization, and chemical compatibility evaluation for (bio)pharmaceutical applications.

and Peter Cornelis, Senior expert Microbiology and Sterilization at Nelson Labs

Peter Cornelis graduated from the Catholic University of Leuven (Belgium) in 2000 as a Master in Applied Biological Sciences (Major Biotechnology). In 2003 he started working for Toxikon Europe (Now Nelson Labs) as a study director Microbiology and in-vitro Toxicology. From 2007 until 2016, he was department supervisor for Microbiology and in-vitro Toxicology. Since 2016, he is Senior expert Microbiology and Sterilization. Peter is a member of the ISO committees TC198/WG2 Radiation sterilization and WG8 Microbiological Methods and TC 194 WG16, Pyrogenicity and WG 8, Irritation and sensitization. He played a role as an expert for the edit of ISO/TC 194 ISO/DTS 11796:2022(E) Biological evaluation of medical devices — Guidance for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices.

Followed by a live question and answer session

Sponsored by Nelson Labs

Nelson Labs is a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Nelson Labs serves over 3,000 customers across 13 facilities in the United States, Mexico, Asia, and Europe.  We provide our customers with mission-critical testing services, which assess the quality, effectiveness, and end-to-end sterility of products and, ultimately, the impact of the products on patient safety. These services are necessary for our customers’ regulatory approvals, product releases, and ongoing product performance evaluations.  We have over 900 laboratory tests supporting our customers from initial product development and sterilization validation, through regulatory approval and ongoing product testing for sterility, safety, and quality assurance.  Pharmaceutical lab testing services include microbiology, biocompatibility and toxicology assessments, extractables and leachables evaluations of pharmaceutical containers, sterilization validation, sterility assurance, packaging validation and distribution simulation, and facility and process validation.  We also provide expert advisory services to help customers navigate the regulatory requirements applicable throughout their product’s lifecycle. We are regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues.