The USP has initiated the modernization of the packaging chapters with intent to promote a risk-based approach for selecting and qualifying packaging components.  A notice of intent to revise the elastomer standards was published in the USP PF 45 (4) 2019 related to the following: 

  • <381> Elastomeric Closure for Injections
  • <1381> Elastomeric Evaluation of Elastomeric Components Used in Pharmaceutical Packaging/Delivery Systems
  • <382> Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems
  • <1382> Assessment of Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems

The standards below 1000 will provide baseline specifications while chapters above 1000 will provide information to guide qualification of packaging components based on intended use.   This Webinar will explain the baseline requirements for elastomeric physicochemical and functional properties.  Examples to illustrate qualification of components for intended applications will be included.  A strategy for testing the entire packaging and delivery system inclusive of  the drug product is essential.  These USP updates are meant to increase patient safety by reducing risk through more thorough product understanding beyond component level testing, and these significant changes will be highlighted. 

Featured Speakers

Diane Paskiet

Director - Scientific Affairs
West Pharmaceutical Services, Inc.

Diane Paskiet has over twenty five years of experience with qualifying packaging and delivery systems for use with pharmaceutical products. She is Currently Director of Scientific Affairs at West Pharmaceutical Services where she is involved in science and regulatory programs associated with safety and compatibility of packaging systems. Previous to this role she was in charge of site operations for West-Monarch Analytical Laboratories. She is a co-recipient of the United States Pharmacopeia (USP) award for Innovative Response to a Public Health Challenge and awarded the PDA 2019 Packaging Science Award. She serves on the USP Packaging Storage and Distribution Committee and as Chair of Product Quality Research Institute (PQRI) Development Technical Committee (DTC) and Chair of Parenteral and Ophthalmic Drug Product Leachables and Extractables Working Group.

Daniel Bantz

Technology Manager, Packaging & Performance
West Pharmaceutical Services, Inc.

Daniel Bantz has over 25 years practical experience in medical and analytical instrumentation development and testing.  He’s competent in fluid metering product development and testing, combination product testing and device reliability testing.  Additionally, he has been trained in FMEA best practices and has developed product risk mitigation strategies and platforms across multiple organizations.  Daniel implements testing strategies meeting ever-changing regulations in conjunction with customer needs and the competitive landscape.  He earned an MBA in Operations and Technology from Aurora University in Illinois.

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