Tabletop CCI Tester

Tabletop CCI Tester

Quick and sensitive test Compact & maintenance free 3 configurations: BASIC, XL, SY Vacuum and positive pressure testing Applicable to any type of pharmaceutical containers Solutions in place for PFS, LVP, cartridges

Technical Features

  • Container Application: Vials, PFS, Pouches, Strip Packs, Strip, BFS, Cartridges, Ampoules, Carpoules, PFS Nest, Flowpack, Bottles, Filled Pharmaceutical Monobloc Areosol Can, FFS, other Medical devices
  • Products: Lyo, Liquid, Powder, Solid, Semi-solid
  • Container Dimensions: Up to 1000 ml
  • Testing time: From a few seconds to about 1 minute according to container size
  • Technology: CCIT
  • Inspection Features: Non-Invasive, Non-Destructive CCIT based on Vacuum & Pressure Decay Method

 

Additional Benefits
  • Quick format change over
  • Automatic plunger stopping device for PFS
  • Auto-diagnostics verifies optimal working condition of the testing chamber and enables machine start-up
  • Easy, quick and safe remote access
  • Highly functional, intuitive HMI
  • Real time display of testing cycle diagrams, statistical raw data
  • Storage of records: maintenance, production, alarms

 

Technology
  • Container Closure Integrity Testing is a non-destructive measurement technology based on the following testing methods:
  • Vacuum Decay Method
  • Pressure 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.
  • Lid deflection technology can also be implemented to detect leaks on foils of cups or pouches together with Vacuum Decay method.

 

Quality Assurance
  • Equipment test method refers to:
  • FDA 21 CFR part 11 as well as EMA Annex 11
  • 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”
  • Approved industry standard “ASTM F2338-09”: “Standard Test Method for Non-Destructive Detection of Leaks in Packages”

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