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ON-DEMAND WEBINAR

ON-DEMAND WEBINAR

Extractables & Leachables Testing of Single-Use Systems for Production

Published Date: June 23, 2022

Leachables in pharmaceutical products could originate from manufacturing items (filters, bioreactors, etc.) used in the production process.

With the increasing use of disposables in the pharma industry, the concern in E&L has also developed considerably. Biopharma industry groups (BPSA, BPOG) have published recommendations when and how to perform E&L studies for these materials. More over, the USP has released chapter <665> and <1665>, which ad dress E&L for production materials in the (bio)
pharmaceutical industry.

The different steps in the assessment of the E&L impact of a production line will be outlined In this presentation. In addition, the recommendations of BPOG and USP for these materials will be discussed.

Learn more about the presenter below.

Karen Pieters

Karen Pieters

Large Volume Parenterals, Ophthalmics, and Disposables
Senior E&L Expert

Karen Pieters graduated as a bioengineer in chemistry in 2006. Karen joined Nelson Labs Europe in 2010 as a Study Director for different applications. She now leads a team of study directors with a focus on Large Volume Parenterals, Ophthalmics, and Disposables. She has presented on the set-up and challenges of extractables and leachables studies...

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