In-line Flowpacks and Pouches Leak Tester

In-line Flowpacks and Pouches Leak Tester

Autotest in real time Easy to validate CFR 21 part 11 compliance and 4.0 full integration Quick format changeover High installation flexibility

Technical Features

  • Container Application:IV Bags, Flowpacks & Pouches
  • Products: Semi-solid, Powder, Liquid
  • Container Dimensions: 40 x 40 x 10 mm (min); 150 x 150 x 50 mm (max)
  • Speed: Up to 180 Cpm
  • 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 pressure level as well as the pressure 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”
  • United States Pharmacopoeia – USP General Chapter «1207» “Packaging Integrity Evaluation”
  • EU Guidelines to GMPMedicinal Products for Human and Veterinary Use –Annex 1 “Manufacture of Sterile Medicinal Products”
  • PDA Technical Report No. 27 “Pharmaceutical Package Integrity”
  • FDA 21 CFR part 11 as well as EMA Annex 11

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