A holistic science-based approach to container closure integrity for parenteral products: Lessons learned from a vaccine requiring deep cold storage using a conventional vial system

Abstract

The increasing implementation of deterministic analytical methods for container closure integrity (CCI) testing has enabled deeper insight into the closure performance of parenteral primary packaging. However, a strategy for ensuring CCI of sterile injectable product goes beyond CCI testing. A science-based holistic approach that includes identification of the risk to CCI, robust design of the primary packaging components & qualification of the container sealing/assembly process, and the implementation of appropriate process controls is required. This paper describes the implementation of such an approach for a vaccine stored at deep cold storage and lessons that can be applied to parenteral vial product in general to ensure that both the primary packaging design and the process contribute to assurance of CCI.