Extractables and Leachables Analysis

<h4>VeriSure® Technical Packages</h4>Offer comprehensive data on extractables that customers can access online. These packages are:<ul><li>Designed to provide customers with data to support regulatory submissions, demonstrating compliance with extractables testing guidelines</li><li>A semi-qualitative collection of findings, drawn from extensive data and studies conducted over the years on these formulations.</li></ul>Study variables include:<ul><li>cure conditions</li><li>multiple manufacturing sites, both domestic and international</li><li>multiple component configurations</li><li>post-processing considerations</li></ul>

<h4>E2L Technical Packages</h4>Provides a risk assessment for extractables to determine what leachables a manufacturer may want to focus on for their leachables studies. This Technical Package Includes: <ul><li>A risk assessment report which evaluates each extractable identified in the studyand ranks them in order of “most likely to leach”. </li><li>Explanations of the criteria used to assess the risk </li><li> A color-coded visual reference table that ranks the extractables</li><li>A total risk ranking for each extractable. </li></ul> West’s E2L testing assists our customers with their risk assessment, but it does not remove the need to perform a toxicoligical risk assessment for leachables specific to their drug products.