Welcome to ELSIE

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

Recent ELSIE Webinars:  

Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTC) for Parenteral Extractables and Leachables

This webinar will discuss the TTC and recent work that has been done on this topic within the consortium. Presentations and discussions will include considerations of the recent ELSIE publication as well as regulatory perspectives. The webinar will be open to the public and registration will be free of charge.

Date: 13 September 2022

 

Click here to view the recording and the slides from the webinar.

Framework for Sensitization Assessment for E&Ls and Practical Application 

This webinar will include presentations and discussions on sensitization assessment of E&Ls and an analysis of the ELSIE database. It will also include considerations of their recent ELSIE publication.

Date: 22 September 2022

Click here to view the recording and the slides from the webinar.

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

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Click here for an overview of ELSIE Membership options.