Understand Critical Changes for Implementation
The USP has initiated the modernization of the packaging chapters with intent to promote a risked 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 on the following:
• <381> Elastomeric Components in Injectable Pharmaceutical Product Packaging/Delivery Systems
• <1381> Assessment of Elastomeric Components Used in Injectable Pharmaceutical Product Packaging/Delivery Systems
• <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems
• <1382> Assessment of Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems
The standards below 1000 will provide baseline specifications while chapters above 1000 will provides information to guide qualification of packaging components based on intended use. It is important to understand the critical changes that will occur in on the effective date and the new requirements in 2025.
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 systems 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.
Presented by
Diane Paskiet,
Director of Scientific Affairs
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 L. Bantz,
Principle Scientist, Manager, Scientific Communications, Self Injection Systems
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. Daniel identifies, designs, and execute studies to understand performance of devices and components, device-drug interactions, system interfaces and fundamental combination product performance.
