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TR 2018/190: Container Closure Integrity Assessment of the SmartDose Gen I Drug Delivery Platform

Summarizes high voltage leak detection (HVLD) and methylene blue testing results that confirm the SmartDose Gen. I platform achieves the necessary CCI.
Given the unique characteristics of the West SmartDose® Gen. I drug delivery platform, West conducted container closure integrity (CCI) testing in alignment with USP<1207> Package Integrity Evaluation- Sterile Products by performing high voltage leak detection (HVLD) testing on filled samples, as well as methylene blue dye ingress testing.

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