Bonfiglioli Pharma, together with their representatives Genesis Packaging Technologies, will be at Pack Expo Chicago from 9-13 November 2008 at booth 1059, south hall. The event will showcase the new automatic PKI-LVA combi-machine for leak-testing vials and detecting headspace vacuum pressure in lyophilised vials.
The PKI-LVA can reach an output of 750cph, making it ideal for batch-testing. The vial first passes through a headspace pressure analyzer using laser absorption spectroscopy. Laser absorption spectroscopy is an optical measurement method for rapid and non-destructive gas analysis. The laser is emitted at the same frequency as that of the moisture molecule. The light is passed through the headspace region of a container. Energy from the laser is absorbed by the target molecules and thus begins to vibrate.
The light is then scanned in frequency and detected by a photo-detector. The laser absorption signal contains information about the headspace gas concentration and total headspace pressure. The amount of energy absorbed depends on the amount of target molecules present in the container under test.
Using spectroscopy, the absorption curve generated gives precise and reliable information on the amount of vacuum and moisture present in the vial. The vials lacking the required amount of vacuum are automatically rejected. Following this headspace test, the vial then proceeds to be leak-tested according to the ASTM procedure, where it is inserted into an airtight chamber and tested by applying a vacuum. The machine is equipped with software based on SCADA platform, through which the pressure pattern can be recorded, analysed and compared to a pre-set pattern, thus indicating if the container is good or faulty.
Bonfiglioli also supply this test for higher outputs reaching 36,000cph. All systems are validated and already widely used with several successful installations worldwide.