By taking the time to issue this reminder of the new requirements and the fast-approaching implementation date, we are hopeful that the marketplace will see the value in addressing this issue now as a way to prevent future delays on increasing costs
CLIFTON, N.J., Oct. 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 using this platform to remind current and potential clients that the pending changes to USP 661.2 and 661.2 testing for plastic container and package components will be a direct requirements effective December 1, 2025. In the lead up to this implementation date companies launching products can still comply with the guidelines laid out in the existing USP 661 but as the date is fast approaching, now is the time to consider the new test requirements as no materials will be grandfathered in and retesting to the new standard will be required.
"As we work our way into 2025, we fully expect an onslaught of USP 661.1 and USP 661.2 testing," noted Brian Mulhall, CEO of CS Analytical. "By taking the time to issue this reminder of the new requirements and the fast-approaching implementation date, we are hopeful that the marketplace will see the value in addressing this issue now as a way to prevent future delays and increasing costs."
The numerous changes to USP 661.1 contain more rigorous standards regarding how raw materials are tested and verified as safe to use for health-related product packaging for both topical/oral dose package systems and higher risk injectables, inhalable and suppository type package systems. The requirements focus on direct contact, non-direct contact, and noninteractive materials, and align with a large variety of polymer types. USP 661.1 testing confirms the characteristics of these polymers in four key areas to include Identity of material, biological reactivity with other substances, general physicochemical properties and composition. It should be noted that performing tests under USP 661.1 is not a prerequisite for conducting USP 661.2 tests, however it can provide insights into how materials may fare in the required compliance testing.
USP 661.2 relates to a plastic packaging system as a whole and includes all components that make up that system. For example, the container, the closure, the dropper, the snap cap, etc. Collectively, USP 661.1 and 661.2 provide a comprehensive data package that will facilitate an appropriate evaluation for the correct selection of materials and protect patients more than would be possible with the current 661 test methods.
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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