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Container Closure Integrity Testing (CCIT): a Risk ...
Marco Silvestri Andrea Simonetti Container Closure Integrity Testing (CCIT): a Risk Management Application Omron meets Pharma Milan, January 29th 2014 Process: Container Closure Integrity Testing for Blow-Fill-Seal In line equipment to test 100% of the production: downstream of a Blow-Fill-Seal machine for aseptic primary packaging providing a 60 Container Per Minute (CPM) output rate upstream of a secondary packaging machine Standard ASTM F-2338-09: Standard Test Method for Non-destructive detection of Leaks in Packages by Vacuum Decay FDA (CDRH) Recognised Consensus Standard Bonfiglioli Engineering Leak Testing machine Working principle: a)Vacuuming: the period of vacuum setting within the test chamber b)Stabilization: the time necessary to get a homogeneous vacuum distributio
Process: Container Closure Integrity Testing for Blow-Fill-Seal In line equipment to test 100% of the production: downstream of a Blow-Fill-Seal machine for aseptic primary packaging
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