Free Webinar – Extractables & Leachables: Regulatory aspects, risk assessment and design of experiment


A drug product container-closure system should not release chemicals that can accumulate in the drug in quantities sufficient to present a risk of toxicity, or to affect its stability or efficacy. As substances may migrate from different materials the patients may be exposed through different routes of administration it is important to evaluate the potential for various chemicals to migrate. FDA and international regulators require testing to identify any risks of product adulteration associated with extractables and leachables. Failure to demonstrate material safety results in failure to receive regulatory approval for a product.

The evaluation of the container closure system and single use systems (SUS) is fundamental to guarantee the safety of pharmaceutical products. Consequently, E&L studies are now a crucial component of product release. Regulatory authorities require the execution of analytical activities according to specific experimental designs. The implementation of an adequate risk assessment, the definition of testing conditions and extracting solvents, the selection of analytical techniques, and reporting threshold to be applied as well as a proper toxicological evaluation are among the most important aspects to consider.

This webinar aims to provide a comprehensive overview of the most relevant and critical aspects, technical considerations and strategies for establishing an extractables study design that provides meaningful data for the pharma industry.

Participants will gain valuable insights from keynote experts of Eurofins BioPharma Product Testing Italy, E&L center of excellence within the Eurofins network, on how to correctly approach risk assessment and toxicological evaluation by also recommending testing options that are up to current industry standards and expectations.

  • Regulatory overview impacting Extractables and Leachables:
    • USP 1663-1664 USP665-1665
    • The BPOG Update

Speaker: Davide Tartaglione

  • Extractables – Design of Experiment:
    • Identification of the extractable components of the container/packaging
    • Selection of the appropriate extracting solvent
    • Definition of optimal extraction conditions (exhaustive extraction)
    • Selection of the appropriate analytical techniques (evaluation of relative response factors)
    • Configuration of the Analytical Evaluation Threshold (AET)

Speaker: Simone Carrara

  • Toxicological Evaluation – Design of Experiment:
    • Toxicological risk assessment to determine the toxicological relevance of E&L

Speaker: Davide Tartaglione

  • R&D Managers
  • CQ Managers
  • QA Managers
  • Regulatory Managers
  • Production Managers
  • Packaging Managers
  • CMC Managers
  • Validation Managers


Simone holds a Biotechnology degree from the University of Milan and has a vast experience as bio-analytical researcher, through LC/MS method development for Pharmacokinetics analysis and ADMET profiling. In his previous role as Project Leader he has successfully managed different projects including analytical method development and validation with LC/MS-GC/MS, and drug product impurities characterization. In the last 7 years he has been focusing on extractables & leachables studies to support drugmanufacturing companies to fulfill regulatory requirements. He is currently the E&L Business Unit Manager, in Eurofins BioPharma Product Testing Italy.


Senior Consultant Pharma division in Eurofins BioPharma Product Testing Italy.

** Israel Time Zone



Start Time

3:00 pm

March 17, 2021

Finish Time

5:00 pm

March 17, 2021


On-Line Meeting

Event Participants