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

May 20, 2021

2:00 pm EST

Karen Pieters

Large-volume parenteral drug 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/closure systems. An effective extractables and leachables testing program is needed to determine possible sources of contamination.

In this webcast, learn about the definitions and regulatory requirements for extractables and leachables testing of large-volume parenteral products. Typical sources of extractables and leachables in flexible bag systems for parenteral use will be reviewed and specific challenges associated with large-volume parenteral applications will be highlighted. Case studies on different designs of extractables studies will be discussed.

Key Learning Objectives:

By attending this webinar, attendees will learn:

  1. Regulatory requirements for extractable and leachable testing
  2. Typical sources of extractable and leachable in flexible bag systems for parenteral drugs
  3. Challenges specific to large-volume parenteral drug applications

Who Should Attend:

  • Packaging, QA/QC, Regulatory Affairs, Validation, R&D, Manufacturing/Processing