The USP 661 chapter has undergone a multitude of revisions that have made the overall test requirements much more complex for plastic components used in container and package systems. Understanding how these changes apply to your product line is paramount to ensuring that your plastic container and package systems meet these new requirements that become effective December 1, 2025
CLIFTON, N.J., Oct. 6, 2025 /PRNewswire/ -- CS Analytical Laboratory, the world's only FDA regulated contract laboratory exclusively dedicated to providing regulatory solutions and qualification testing services specifically for drug product and medical device container systems is pleased to announce that it will be hosting an educational webinar on current requirements for USP 661.1 and USP 661.2 testing, which will become effective on December 1, 2025. The webinar is scheduled for Wednesday October 29, 2025 at 11:00am to 12:00pm EST and will cover all pending and current testing requirements for plastic package systems. This webinar will be hosted by Ronak Patel, Chemistry Services Laboratory Manager with support from Brandon Zurawlow, Chief Operations Officer for CS Analytical. The webinar is free of charge and attendees may register here: https://engage.csanalytical.com/webinar-2-navigating-the-shift-usp-661.1-661.2-compliance-by-december-2025
"The USP 661 chapter has undergone a multitude of revisions that have made the overall test requirements much more complex for plastic components used in container and package systems. Understanding how these changes apply to your product line is paramount to ensuring that your plastic container and package systems meet these new requirements that become effective December 1, 2025," commented Ronak Patel. "The goal of this webinar is to provide current updates to the testing requirements and a framework for implementation to help ensure compliance noting that the old 661 chapters and test requirements will be obsolete."
USP 661.1 is designed to characterize the materials of construction for a packaging system while the USP 661.2 chapter is specific to the actual plastic components used in the packaging system. With less than 45 days to go, now is the time for companies to begin planning the most efficient and effective approach to meeting the new and more comprehensive test requirements. Webinar attendees will gain valuable insight into how best to plan for and implement testing specific to the new USP 661.1 and USP 661.2 guidelines.
About CS Analytical Laboratory
The only FDA regulated, cGMP laboratory dedicated exclusively to the complex world of drug and medical device container and package qualification testing, the CS Analytical Team includes the world's leading experts on all relevant USP and EP requirements and the thought leaders and pioneers on CCI (container closure integrity – CCI) testing. Offering a full suite of laboratory services to include all USP, EP and JP procedures specific to glass, plastic and elastomers as well as complete USP 1207 services that span basic feasibility studies, component qualification programs and advanced method development and validation for helium leak testing, vacuum decay, high voltage and headspace analysis leak testing. CS Analytical is the one source that can ensure your medical product container and package system meets the strict and complex regulatory requirements.
SOURCE CS Analytical

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