Container Dimensions: IV Bags with ports from 50ml to 1liter
Speed: Up to 16 cpm
Inspection Features: Non-Invasive, Non-Destructive based on Force Decay Method
Inspection Capabilities: Microleaks detection
Low investment cost
Reliability guaranteed above 99%
Enhanced easy-to-use HMI integrated functions
Quick format change
HMI real time display of statistics and raw data
Noise levels well within allowed limits
Suitable for installation in clean areas for less critical phases of sterile product fabrication (Class C and D)
Container Closure Integrity Testing is a non-destructive measurement technology based on the Force Decay method, which analyses the force level variation following container mechanical pressing works on a broad range of hermetically form filled package systems This method is accomplished by:
Container mechanical pressing.
Container reaction according to its status.
Reactive force level acquisition with a force sensor.
Decision making (approval or rejection).
Equipment test method refers to:
Approved industry standard “ASTM F2338-09”: “Standard Test Method for Non-Destructive Detection of Leaks in Packages”
FDA 21 CFR part 11 as well as EMA Annex 11
The Machine Qualification and Validation complies with requirements stated in EU Annex 15