Extractables Testing of Medical Devices Insights into Practical Issues

05th December 2023 | 10:00am EST / 7:00am PST / 3:00pm GMT / 4:00pm CET | Dennis Jenke, Chief Executive Scientist at Triad Scientific Solutions and Pieter Van Wouwe PhD, Senior Expert E&L at Nelson Labs |WATCH FOR FREE

It is a well-known adage that “the devil is in the details.” As authoritative texts and regulatory guidelines that address the chemical characterization of medical devices usually present concepts and generalities and lack granularity, sponsors seeking to design and implement extraction studies for medical devices occasionally struggle to establish and justify critical experimental details that are scientifically sound, practical, achievable, and regulatory compliant.

This presentation provides insights into several of these critical experimental details, addressing concepts that include:

The “It All Comes Out at Once” Paradox
Exhaustive Extractions as a Source of Kinetic Release Data
Predicting Exhaustive Extractions with a Minimum Number of Extraction Steps
A Rational (?) Approach to Quantitation and Managing the AET
Accurate versus Protective Quantitation
What exactly is a “Semi-polar” Solvent?

Presented by Dennis Jenke, Chief Executive Scientist at Triad Scientific Solutions

Dennis Jenke, Chief Executive Scientist at Triad Scientific Solutions presents a webinar on Extractables Testing of Medical Devices Insights into Practical Issues.

Dr. Dennis Jenke is the Chief Executive Scientist at Triad Scientific Solutions LLC, a consulting organization that provides integrated, science-based, and practical E&L solutions to the pharmaceutical, cosmetic, food industries. Dr. Jenke retired as a Distinguished Scientist from Baxter Healthcare Corporation where, for nearly 35 years, he was responsible for developing and defending E&L tactics and strategies. He is widely published on E&L and related topics and is an active member of national and international standard setting organizations.

Extractables and Leachables on Combination Devices

Qualifying injection devices for parenteral administration requires a particular approach when designing studies for extractables and leachables. This presentation will provide an introduction to Medical Device Regulations (ISO 10993 series). It will delve into the distinct practical approaches required for medical devices in comparison to considerations for pharmaceutical packaging, especially in the context of combination products. Several case studies will highlight the critical points in study design and clarify the specific guidelines that must be considered.

Presented by Pieter Van Wouwe PhD, Senior Expert E&L at Nelson Labs

Pieter Van Wouwe PhD, Senior Expert E&L at Nelson Labs on Extractables and Leachables on Combination Devices

Pieter Van Wouwe obtained his Master’s degree and PhD in Bioscience Engineering from the University of Leuven in 2011. In March 2016, he started his role as a project manager at Nelson Labs. Since then, his responsibilities have included overseeing the design of extractable and leachable studies, as well as conducting scientific interpretation and reporting of analytical results. His focus has centered on extractable/leachable projects related to large volume parenteral applications, single-use systems utilized in drug product manufacturing, and infusion devices.

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 4,000 customers across 15 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 800 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.

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