Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about the regulatory and manufacturing hurdles facing rare disease drug developers.
News|Articles|January 5, 2024
Determining the best approach for your Container Closure Integrity Testing needs
Author(s)Eurofins
Container-Closure Integrity (CCI) is essential for ensuring the stability and safety of drug products over time. The USP recommends deterministic methods over older probabilistic ones like dye ingress, emphasizing the need to assess the significance of leakage in relation to product quality. Eurofins can assist in choosing and validating appropriate CCI testing methods tailored to specific product and closure system configurations, as there is no one-size-fits-all solution outlined in the USP.
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