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/toxilogical 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 2018 accomplishments 

ELSIE Year in Review.JPG

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.

@2019 Extractables & Leachables Safety Information Exchange

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