-Autotest in real time
-Easy to validate
-CFR 21 part 11 compliance and 4.0 full integration
-Quick format changeover
-Automatic Drying System, no testing chamber contamination
Technical Features
-Container Application: Small Volume Parenteral, Blow fill Seal (PK-VS SVP)
-Products: Liquid
-Container Dimensions: min: 40 x 40 x 6 mm; max: 150 x 80 x 15 mm
-Speed: Up to 220 strip/BFS or cards per minute
-Technology: CCIT
-Inspection Features: Non-Invasive, Non-Destructive CCIT based on Vacuum Decay Method
-Inspection Capabilities: Microleaks detection
Additional Benefits
-Full batch control testing: fast, reliable and repeatable
-Testing of all nominal production line speed
-MES (Manufacturing Execution System connection) allows remote machine data exchange & download
-Statistical Process Control reduces deviations for a better yield control
-Real time display of testing cycle diagrams, statistical raw data
-Easy, quick and safe remote access
-AHE (Automatic Head Exclusion)
-Easy cleaning
Technology
-Container Closure Integrity Testing is a non-destructive measurement technology based on Vacuum Decay Method.
-Measurement system comprises applying a pressure differential into an airtight testing group enclosing the container.
-The test objective is to detect container leakages by measuring the reached vacuum level as well as the vacuum change over test time.
Quality Assurance
-Equipment test method refers to:
-Approved industry standard “ASTM F2338-09”: “Standard Test Method for Non-Destructive Detection of Leaks in Packages”