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/tox assessment of leachables and extractables by supporting and publishing research and participating in the global scientific and regulatory communities.
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.