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March 09, 2017

When it Comes to Extractables and Leachables, There Are No "Good" Surprises

When it comes to filing time, the last thing you need is a surprise. The pharmaceutical industry focus on issues of extractables and leachables (E&L) from packaging/delivery systems began during the mid-1990s. Since then, regulatory agency awareness of these issues has increased, while drug product formulations and other drug product contact materials have become more complex. When agency questions on extractables and leachables do arise, the process to evaluate them can seem overwhelming. As a result, many customers are asking: “Do I really need to complete all of the testing requested?”; “What does West already know about the elastomer formulation I am using?” or “Where do I start?”
Lauren Orme

Lauren Orme

Technical Account Manager, TCS

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  • Previous Posts
    Condensers

    December 21, 2016

    West’s Extractables Data Guide    (West EDGe)

    West Pharma

    Erica Tullo, Ph.D.

    Manager, Extractables & Leachables Technology

    Extractabes graphic

    May 09, 2016

    Extractables and Leachables - Assessing Risk in a Complex Landscape

    Lauren Orme

    Lauren Orme, PMP

    Technical Account Manager

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