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Latest Post

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

Previous Posts
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December 29, 2016

West Expands Capabilities in Container Closure Integrity - HVLD

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Philomina Albanese

Director, Laboratory Operations

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December 21, 2016

West’s Extractables Data Guide    (West EDGe)

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Erica Tullo, Ph.D.

Manager, Extractables & Leachables Technology

USP Chapter 1207

July 13, 2016

USP Chapter 1207 Package Integrity Evaluation – Sterile Products

Fran DeGrazio

Fran DeGrazio

VP, Scientific Affairs & Technical Services

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May 09, 2016

Extractables and Leachables - Assessing Risk in a Complex Landscape

Lauren Orme

Lauren Orme, PMP

Technical Account Manager

Blue West logo with Diamond

December 15, 2014

Managing Residual Moisture In Lyophilized Drugs

West Pharma

Lynn Yao

Senior Scientific Affairs Specialist

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