Webinar On Demand: Test Programs for Extractables and Leachables Processing Equipment

Webinar On Demand: Test Programs for Extractables and Leachables Processing Equipment
Part two of the Navigating Extractables & Leachables series examines how to design test programs for processing equipment in pharmaceutical and biopharmaceutical manufacturing.

The session highlights the application of USP <665> and <1665>, risk-based extraction strategies, and analytical workflows used to generate meaningful extractables data. Smithers expert Amy Johnson and Helen Lewis also addressed how extractables studies inform leachables assessments, with practical examples of mitigation strategies for complex formulations.

Recorded on September 25, 2025, Navigating Extractables & Leachables - Test Programs for Processing Equipment is now available on demand. Watch Part 1 - Navigating Extractables & Leachables here.

Webinar Highlights:

  • USP <665> and <1665> Guidance: Frameworks for risk-based assessment and chemical characterization of process components.
  • Risk Assessment Dimensions: How contact time, temperature, process stream chemistry, and component type determine testing needs.
  • Extractables Testing Programs: Solvent selection, extraction durations, and dynamic extraction conditions.
  • Analytical Techniques: Key methods (NVR, UV, GC-MS, LC-MS) to identify and characterize extractables.
  • Leachables Considerations: Assessing cumulative exposure, simulation strategies, and toxicological review.

Access the On-Demand Webinar Below:

Download the slides:

Smithers-Test-Programs-for-Processing-Equipment-Slides-2025
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