Article

Extractables And Leachables – Assessing Risk In A Complex Landscape

By Lauren Orme, West Pharmaceutical Services

westextractables

Within the medical device market, there is still confusion on the topics of extractable and leachable testing, as well as the process of making sense of and reporting the data to the regulatory authorities. This article offers an outlined process for extractable and leachable analysis which starts with the optimal component selection, assesses extractable information gaps and design fit, and defines the leachables testing plan. For more on the steps of this valuation and questions to consider for each step, download the full paper.

VIEW THE ARTICLE!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Pharmaceutical Online? Subscribe today.

Subscribe to Pharmaceutical Online X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.

or

Subscribe to Pharmaceutical Online

West Pharmaceutical Services, Inc.