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:

• An overview of new USP <382>
• Key testing differences between USP <381> & USP <382>
• Influence of inherent integrity and USP <1207>
• Integrity and functionality testing changes for elastomeric enclosures

Presenters:

	Leonard Harris Manager – Chemistry and Container Testing Eurofins Medical Device Testing
As Manager of Chemistry and Container Testing at Eurofins Medical Device Testing, Mr. Harris oversees the chemical testing of medical devices. With 25 years of industry experience in pharmaceuticals and medical device chemical testing, and seven years specifically in ethylene oxide residual testing, Mr. Harris is experienced in GMP and ISO test methods and validations, investigations, protocol validations, and data analysis. Mr. Harris holds a B.S. degree in chemistry from Shippensburg University.
	Andrea DeVoe Manager – Package Testing Eurofins Medical Device Testing
As a Manager of Package Testing at Eurofins Medical Device Testing, Ms. DeVoe is responsible for leading transport simulation, shelf life, package integrity and mechanical testing in compliance with ASTM, ISO, and ISTA standards. Ms. DeVoe has more than 25 years of experience, spanning both the medical device and biopharmaceutical industries. She has a strong background in compendial testing for both raw materials and drug products, data analysis, and investigations.