LDB

Leak Tester

100% Off-line Machine for Non-Invasive, Non-Destructive Integrity Inspection a for hermetically form filled package systems.

Highlights

  • Zero alteration of container features
  • High machine adaptability & stability
  • Adjustable force level check
  • Easy management
  • Low energy consumption
  • Low & Ease of maintenance: free access to all moving parts
  • Full integration in Industry 4.0 Environment

Tech Specification and Features

Technical Features

  • Container Application: IV Bags, Liquid Forms
  • Container Dimensions: IV Bags with ports from 50ml to 1liter
  • Speed: Up to 16 cpm
  • Technology: CCIT
  • Inspection Features: Non-Invasive, Non-Destructive based on Force Decay Method
  • Inspection Capabilities: Microleaks detection

Additional Plus

  • 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)

Technology

  • 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).

Quality Assurance

  • 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