Welcome to ELSIE

The Extractables and Leachables Safety Information Exchange (ELSIE) Consortium is comprised of pharmaceutical, biotechnology, and medical device companies.

The ELSIE Consortium


  • Collects, reviews, and compiles toxicological data on leachables and extractables in an information-rich database, enabling rigorous assessments.

  • Advances understanding of the impact of extractables and leachables on product quality and process performance.

  • Provides opportunities to share and leverage experiences, insights, and practices with respect to the potential safety impact of drug product packaging, delivery and manufacturing systems.

  • Advances the state of the art in chemical/toxicological assessment of leachables and extractables by supporting and publishing research and participating in the global scientific and regulatory communities.

Click here to learn about ELSIE's 2020 


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Core Objectives of ELSIE


  • Advances principles of Quality by Design by enhancing the prospects for identifying potential safety issues at the initial stages of the development process, when container-closure materials are being screened and selected.

  • Supports member companies’ regulatory filings.

  • Reduces duplication of effort and minimize testing.

  • Decreases the risk of substantial, unanticipated delays and associated costs.

For an overview of ELSIE Membership options, see here.