Welcome To ELSIE
The Extractables and Leachables Safety Information Exchange (ELSIE) was formed in 2007. ELSIE’s core objective is to establish a comprehensive database that provides a jointly-developed and credible source of (i) Safety information on extractables and leachables and (ii) Extraction profiles and standardized study protocols for a range of materials commonly used in pharmaceutical, biological and device applications and processes (e.g., container closure systems, devices, manufacturing/processing)
The ELSIE Database
- 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.