Container Closure Integrity Testing In Lieu Of Sterility by Dye Ingress Method Using Uv-Visible Spectroscopy

Abstract

Container Closure Integrity is crucial for ensuring and maintaining the sterility and stability of Pharmaceutical products. This study involves the application of dye ingress method validated using UV- Visible Spectroscopy as an alternative for sterility testing in stability studies. The research emphases on developing standard analytical method validation criteria and assessing the effectiveness of the Packaging Integrity Apparatus. The method‟s sensitivity and reliability in detecting micro leaks is confirmed by performing specificity, limit of detection (LOD), linearity, and precision assessments. The outcomes of this method support to the liable practice of Container Closure Integrity Testing (CCIT) in compliance with regulatory guidelines, ensuring product sterility and quality throughout its shelf life.