Implementing FDA Guidance: CCI Testing In Lieu Of Sterility Testing

The Food and Drug Administration released guidance in 2008 titled “Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products,” which provides recommendations for replacing sterility testing with alternative test methods as a means to confirm container and closure system integrity The purpose of this application note is to provide recommendations for replacing sterility as a means to confirm container and closure system integrity as a part of the stability protocol.

This application note will detail the requirements laid out in this guidance document, explain the method of operation of Lighthouse’s technology, detail how the method can be used to meet the FDA’s requirements, and detail a case study of a large multinational pharmaceutical company that implemented Lighthouse’s test method in lieu of sterility for their lyophilized drug products.