Bonfiglioli Pharma Machinery Launch New Vacuum Tester For Lyophilised Vials
Bonfiglioli Pharma Machinery Launch New Vacuum Tester For Lyophilised Vials
7/5/2004
VertMarkets, Inc.
A standard method for checking the vacuum in sealed vials containing freeze-dried (lyophilised) product has been the spark test. In this method the vials are exposed to a high voltage. A resulting glow discharge in the headspace of the vial indicates the presence of some level of vacuum. Drawbacks to this method include a limited measuring range (0 ? 250 mbar) and the possibility that protein-based biological product can be damaged by the high voltage. A revolutionary method has now been developed to quantitatively measure the headspace pressure inside a vial using laser absorption spectroscopy.
Light from a near-infrared semiconductor laser is tuned to match the internal vibrational frequency of a target molecule. The light is passed through the headspace region of a sealed container and some of the laser energy is absorbed by the target molecules. The laser is scanned in frequency and a photodetector records an absorption profile. The laser absorption signal contains information about the headspace gas concentration and the total headspace pressure. The measurement method also incorporates a high sensitivity detection technique known as frequency modulation spectroscopy (FMS). This results in a measurement sensitivity that is 104 greater than traditional direct absorption spectroscopy.
Developed by Lighthouse Instruments LLC, this laser absorption technique solves the drawbacks of the spark test method. Headspace pressure measurements can be made over the full range (0 ? 1 atm). Since the laser light simply passes through the headspace of the vial, there is no affect on the product. Bonfiglioli Pharma Machinery has incorporated the Lighthouse Instruments optical platform to launch a new rapid and non-destructive vacuum tester
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