Navigating USP <382>: What You Need to Know About the New Standards for Elastomeric Closures

How the Upcoming USP Chapter <382> Impacts Parenteral Drug Products—and What to Do Next

Published: June 2025

On December 1, 2025, USP Chapter <382> goes into effect, introducing new requirements for elastomeric closures used in parenteral pharmaceutical products. All new regulatory submissions will need to demonstrate compliance with these standards.

In this on-demand webinar, Alcami experts break down the scope of <382>, outline the testing and instrumentation it requires, and provide actionable strategies for implementation. Whether you’re preparing for a new submission or reassessing current closure systems, this discussion will help your team navigate the regulatory shift with clarity and confidence.

Watch the On-Demand Webinar to Learn:

• How to ensure compliance with USP General Chapter <382>

• The specific testing requirements and instrumentation involved

• How <382> fits within the broader regulatory landscape

• Strategies for developing robust testing programs for elastomeric closures

With the compliance deadline approaching, now is the time to assess your readiness and update your testing protocols.