A Science-Based Approach For Ensuring Container Closure Integrity Of Sterile Vials

Recent regulatory guidance has triggered changes in industry best practices in the area of container closure integrity (CCI) testing. The increasing implementation of deterministic analytical methods for CCI testing has enabled deeper insight into the performance of primary packaging with respect to CCI. However, ensuring good CCI goes beyond CCI testing. A more science-based holistic approach that includes robust design & qualification of the process and the implementation of appropriate process controls is required. This webinar will describe a framework to enable such a holistic approach to CCI that assures both the primary packaging and the process contribute to good CCI of sterile injectable vial product.