Welcome to ELSIE

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

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ELSIE Risk Management Webinar Series

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This webinar was the second in a series focused on the ELSIE leachables white papers, and engaged participants in the risk management framework through a case study.  The case study considered a component material change, examining material selection considerations, risk assessment, testing approaches, and toxicological considerations throughout the process. Visit our Events page for links to the slides and recording from the webinar. 

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The ELSIE Consortium

 

• 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.

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