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Leading the Way with Scientific Expertise
In the current regulatory climate, information on extractables and leachables (E&L) is essential. West collaborates with our clients to tackle the complex regulatory environment by designing and implementing E&L studies.
Particle characterization and identification capabilities:
In addition, the Particle Lab has the capability to perform particle counting and sizing for sub-visible and visible particles using:
Pharma and biotech companies needs to combine the containment system or combination product with analytical expertise to meet agency expectations and quickly progress through the extractables and leachables process. In order to help our customers, West has developed two technical packages; VeriSure® Technical Packages, specifically for our 4040/40, 4023/50 Gray and 4432/50 Gray formulations, and E2L testing services to support their extractables risk assessment. The VeriSure® technical packages and the E2L risk assessment can help customers move efficiently through the first stage of the extractables and leachables process for their packaging components.
<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.
VeriSure™ is trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
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