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.