PK-A

In-line Ampoules and Cartridges CCI Tester

Non-Invasive, Non-Destructive, 100% in-line Integrity Inspection System at high production speed.

Highlights

  • Autotest in real time
  • Easy to validate
  • CFR 21 part 11 compliance and 4.0 full integration
  • Quick format changeover
  • Easy cleaning

Tech Specification and Features

Technical Features

  • Container Application: Ampoules, Cartridges
  • Products: Liquid
  • Container Dimensions: Standard ampoule from 1 to 50 ml
  • Speed: Up to 600 cpm
  • Technology: CCIT
  • Inspection Features: Non-Invasive, Non-Destructive CCIT based on Vacuum & Pressure Decay Method
  • Inspection Capabilities: Microleaks detection; Tip Inspection integrity

Additional Plus

  • 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)

Technology

  • Container Closure Integrity Testing is a non-destructive measurement technology based on the following testing methods:
    • Vacuum Decay Method
    • Pressure Decay Method (suggested)
  • 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 GMP Medicinal 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