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CCI for Combination Products: Assembling the Package Integrity Profile for Autoinjectors

Due to their complexity, combination products, specifically autoinjection systems, present unique challenges in implementing a container closure integrity (CCI) testing strategy. This is further complicated by a pervasive, though diminishing, tendency for companies to consider CCI only at the final product-package lifecycle stage, an approach where combination products will highlight the pitfalls. 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

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