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, engage@csanalytical.com,
https://csanalytical.com/
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SOURCE CS Analytical