Extractables & Leachables evaluation on Single and Multiple Use Systems – The challenges of the USP <665>

About the lecture 

May 2026 is the deadline for pharmaceutical manufacturers to be in compliance with the USP<665> requirements. The qualification of the Single and Multiple Use Systems (SUS-MUS) in terms of Extractables & Leachables (E&L) is a mandatory aspect for the commercialisation of pharmaceutical products. In this lecture the main impacts of this regulation, the definition of the risk assessment, and the E&L workflow will be explained. The analytical design of the E&L studies will also be addressed in terms of; items to be tested, analytical conditions, and reporting threshold to be applied.

About the speaker

Simone has been working for Eurofins BioPharma Product Testing Italy since 2012, fulfilling the role of Business Unit Manager of the Extractables & Leachables (E&L) and Packaging testing department, and the role of Eurofins E&L Senior Scientific Director. Commencing his academic journey with a degree in biotechnology at the University of Milan in 2005, he built his experience as bio-analytical researcher through developing LC/MS methods for Pharmacokinetics analysis and ADMET profiling. He has led projects in a wide range of areas within analytical chemistry, including method development and validation by LC/MS-GC/MS and drug product impurities characterisation. Over the past decade, his job was focused on E&L testing, providing support to pharmaceutical manufacturing companies in ensuring compliance with regulatory requirements.

About Eurofins

Eurofins BioPharma Product Testing is the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide providing comprehensive laboratory services for the world's largest pharmaceutical, biopharmaceutical and medical device companies.

Their service offerings are fully comprehensive and include testing of drug substance, final product, intermediates, and starting materials for both small and large molecule drug products.