Welcome to ELSIE
The Extractables and Leachables Safety Information Exchange (ELSIE) Consortium is comprised of pharmaceutical, biotechnology, and medical device companies.
The ELSIE Consortium
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Collects, reviews, and compiles toxicological data on leachables and extractables in an information-rich database, enabling rigorous assessments.
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Advances understanding of the impact of extractables and leachables on product quality and process performance.
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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.
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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.
Core Objectives of ELSIE
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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.
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Supports member companies’ regulatory filings.
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Reduces duplication of effort and minimize testing.
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Decreases the risk of substantial, unanticipated delays and associated costs.
For an overview of ELSIE Membership options, see here.