Application Note: CCIT in Lieu of Sterility Testing

The FDA released guidance in 2008 entitled: “Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products”. This guidance provides recommendations for replacing sterility testing, in stability protocols, with alternative CCI testing methods.

This application note describes the requirements in the FDA guidance and how a headspace CCI testing method can be implemented for sterility testing as part of the stability protocol.