Extractables and leachables (E&L) testing is an important part of evaluating the potential chemical interactions between materials, packaging, drug products, and medical devices. Understanding which substances may be released from materials, and under what conditions, can help inform material selection, packaging qualification, chemical characterization, and risk assessment.
In this introductory webinar, Michelle Barnett, Principal Technical Specialist at Smithers, provides an overview of extractables and leachables, the regulatory and standards landscape, and the typical phases of an E&L study. The presentation also examines risk-based approaches to E&L testing and the analytical techniques used to characterize potential extractable and leachable compounds.
Webinar Highlights:
- Extractables and Leachables: Understand the difference between substances released under laboratory conditions and those released during normal use.
- Sources of Leachables: Review potential sources across manufacturing equipment, primary packaging, and secondary and tertiary packaging components.
- Regulations and Standards: Explore key regulations, pharmacopeial chapters, ISO standards, and ICH guidance relevant to E&L assessments.
- E&L Study Planning: Examine how risk assessment, material information, supplier data, and independent testing can help define the scope of an E&L study.
- Extractables Testing: Learn how extracts are generated and characterized using complementary analytical techniques for volatile, semi-volatile, nonvolatile, and elemental impurities.
- Leachables Testing: Review how leachable studies are conducted using samples stored under conditions representative of the drug product shelf life, with testing performed at multiple time points and across multiple batches.
- Risk-Based Assessment: Consider how dosage form, packaging interactions, toxicological evaluation, and chemical characterization contribute to a risk-based E&L strategy.
Access the On-Demand Webinar Below:
Watch the webinar to learn more about the fundamentals of extractables and leachables testing, the regulatory considerations that inform E&L programs, and approaches to chemical characterization and risk assessment.
Presenter: Michelle Barnett, Principal Technical Specialist, Smithers
