Products
Leak Testing Machine Back
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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