In December 2025, new USP chapter <382> will go into effect. This new chapter changes testing for elastomeric enclosures viewing them as part of an entire packaging system versus individual entities previously seen in USP <381>.
As such, functionality testing is expanded to ensure that the elastomeric enclosure can provide a sterile barrier in the specific packaging system in which it will be utilized. To do so, your container system will need to be broken down into testing groups to ensure the overall system is able to safely store and deliver sterile drug products. This webinar will look at the inherent integrity and functionality testing changes and help the user determine what is needed for closure testing when USP <382> is effective.
During this webinar, you will learn: