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Testing of Packaging Systems for Large-Volume Parenteral Drugs: Extractables Study Design and Challenges

Large-volume parenteral (LVP) applications are characterized by high-volume doses of a drug product, which are administered intravenously. Flexible-bag systems, which contain a combination of different materials, are often used as container or closure systems. First in this webinar, definitions and regulatory requirements for extractables and leachables (E&L) testing of LVP products will be highlighted. Then, typical sources of E&L in flexible-bag systems for parenteral use will be listed. Specific challenges associated with LVP applications will be emphasized. Finally, case studies on different designs of extractables studies will be discussed.

By reading this whitepaper, you can expect to learn about the following:

  • Regulatory requirements for E&L testing.
  • Typical sources of E&L in flexible-bag systems for parenterals.
  • Challenges of LVP applications.
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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