CCI for Combination Products

Due to the complexity of combination products, specifically autoinjection systems, unique challenges are faced in implementing a container closure integrity (CCI) testing strategy. These types of products can only be tested in the final stage of their lifecycle. No one leak test technology is intended for all use cases. Each technology has advantages and limitations, and choosing the correct method is a function of what is feasible given the product, the package, and the unique study goals being considered at the time. This article seeks to discuss the unique challenges of CCIT on combination products, and how to overcome them using a modern, risk management approach to CCI in line with current guidance and regulation: development of a package integrity profile. This study gives a case example of how three unique technologies can be used in support of developing an autoinjector’s package integrity profile.