Container Closure Integrity Testing – Method Development for Freeze Dried Products Using laser based Headspace Oxygen Analysis

Container Closure Integrity Testing –

Method Development for Freeze Dried Products

Using laser based Headspace Oxygen Analysis

Agenda

• Regulatory expectations

• Scope

• Previous work for CCI method development for FD products and

comparison with alternative methods

• Leaks and positive controls

• Equipment and samples

• Model development and approach

• Results and Discussion – CCI Testing

• Application for CCIT – Take home conclusions