A Holistic Strategy To Ensure Container Closure Integrity Of Sterile Injectable Vial Product

Derek Duncan, Ph.D., Director Product Line, Lighthouse Instruments

Recent regulatory guidance has triggered changes in industry best practices in the area of container closure integrity testing (CCIT). The increasing implementation of deterministic analytical methods for CCIT has enabled deeper insight into the performance of primary packaging with respect to container closure integrity (CCI). However, assuring good CCI of sterile injectable product 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 article describes a framework enabling such a holistic approach to CCI that assures both the primary packaging and the process contribute to good CCI of sterile injectable vial product.