Lighthouse Application Notes
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The Effects On Container Closure Integrity Of Freeze Dried Vials
12/26/2018
Non-destructive headspace analysis is a powerful method for monitoring container closure integrity in finished vials of freeze dried product and for building quality into the manufacturing operation.
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Implementing FDA Guidance: CCI Testing In Lieu Of Sterility Testing
12/26/2018
This application note details FDA released guidance titled “Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products."