E&L and Beyond: Qualifying Plastic Materials for Contaminants and Failure

Jun 19, 2018

Register Free: http://www.pharmtech.com/pt_s/plastic

In a complex, costly bioprocessing operation, failure of a single-use component is not an option. Failure of a single plastic part can shut down an entire process, resulting in lost product and production time. The difference between good performance and long life—and failure—can be a seemingly small difference in the variables that affect plastics properties.

While extractable and leachables studies identify potential contaminations in plastic materials, they do not reveal chemical resistance of polymeric materials under operating conditions. Understanding why plastic parts fail—through fractures or other methods—is crucial for the selection of materials and components; independent failure mode testing is crucial.

In this presentation, materials and analysis experts will explain how to detect—prior to material qualification and selection—the potential for materials to fail, as well as the potential for contaminants to leach from the materials into the process stream.

The discussion will cover the scope of testing requirements for single-use systems, the challenges of characterizing materials from multiple sources, standard test protocols, and compendia and regulatory requirements.


Key Learning Objectives:

In this webcast you will:

  • Gain insight into regulatory requirements for failure and safety analysis testing of plastics
  • Review the serviceability of standardized extraction protocols as per USP <1665/665>
  • Understand the boundary between failure mode studies and extractables and leachables study designs as shown in practical examples



Andreas Nixdorf, Business Development Manager, SGS Life Sciences


Date and Time:

Live: North America: Tuesday, June 19, 2018 at 11 am EDT | 10 am EDT | 8 am PDT

Europe: Tuesday, 26 June, 2018 at 0900 BST | 1000 CEST

After the final airing of the webcast on 26 June, 2018 it will be available on demand until 26 June, 2019. 

Sponsor: SGS Life Science Services

Register Free: http://www.pharmtech.com/pt_s/plastic    

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