Understanding how the pending changes to USP 661.1 and USP 661.2 testing apply to your package program is paramount to ensuring that your plastic container systems meet these new regulatory requirements that become effective December 1, 2025
CLIFTON, N.J., May 8, 2024 /PRNewswire-PRWeb/ -- 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 once again 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 Thursday June 20, 2024 at 10:00am through 11:30am EST and will cover all pending and current testing requirements for plastic package systems. This webinar will be hosted by Brandon Zurawlow, Chief Scientific Officer for CS Analytical. The webinar is free of charge and attendees may register here.
"As we have stated previously, over the past few years, the USP 661 chapter has undergone a multitude of revisions that have made the overall test requirements much more complex in many ways. Understanding how these changes apply to your package system is paramount to ensuring that your plastic container and package systems meet these new requirements that become effective December 1, 2025," noted Brandon Zurawlow, CSO. "The goal of this webinar is to provide current updates to the testing requirements and a framework for implementation to help ensure compliance."
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. At this point in time, it is expected that there will be no change to the formal implementation date and companies are expected to be in compliance. With less than 18 months 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.
Media Contact
Brian Mulhall, CS Analytical, 1-888-571-1207, [email protected], https://csanalytical.com/
SOURCE CS Analytical
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