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Leak Testing Machine


  • Leak Testing Machine

    • Overview
    We are the agent of Bonfiglioli Engineering from Italy, who is the leader in pharmaceutical industry. All of our products are conformity to GMP, FDA regulation.
    Application:
    ●  Vials
    ●  Ampoules
    ●  IV bags
    ●  Blister
    ●  Pre-syringe
    LEAK TESTING TECHNOLOGY
    IVacuum Decay Method
    100% In-Line and Off-line CCIT:
    ● Vacuum Decay Method (VDM): “Non-invasive, non-destructive physical method for inspecting Packages in a sealed Testing Chamber”
    ●  Patent ID 1225063 (13-9-1988)
    ● Principle of operation according to ASTM F2338
    ● General purpose:
    ● Useful for testing any nonporous package type (Vials, Pre-filled Syringes, BFS, FFS, etc)
    ● Considered as a best practice for leak detection ASTM F2338-09
    ● “Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method”
    ● FDA (CDRH) Recognised Consensus Standard
    ● Recognition Number 14-282
    IIHeadspace Gas Analysis
    Objective:
    Maintenance of sterility and stability in filled and finished Packages
    Total Pressure and H2O / O2 /… concentration measurement in the headspace
    Method: TDLAS
    Applications:
    Glass Packages optically transparent to a NIR laser radiation
    Freeze-dried products
    Oxygen-sensitive liquid products
    Tunable Diode Laser Absorption Spectroscopy:
    Absorption of energy by the gas molecules at one specific wavelength
    If laser beam λ matches the vibrational frequency of the target gas molecule, then energy will be absorbed
    Beam intensity is reduced according to the Lambert 
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