BONFIGLIOLI PHARMA MACHINERY VACUUM TESTER FOR LYOPHILISED VIALS
Until recently Freeze-dried (Lyophilised) vials where checked for vacuum using a spark test which would make the glass glow if a vacuum is present. Due to the relatively long testing time required for energising the vial (especially amber) this method of test became unsuitable as production speeds increased. A revolutionary method has now been developed by analysing the head space pressure inside a vial using Laser Absorption Spectroscopy. Laser absorption spectroscopy is an optical measurement method for rapid and non-destructive gas analysis.
Light from a near-infrared semiconductor laser is tuned to match the internal vibrating frequency of a target molecule. The laser is emitted at the same frequency that will tend to 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 begin to vibrate. The light is then scanned in frequency and detected by a photodetector. The laser absorption signal contains information about the headspace gas concentration and total headspace pressure. If no energy was absorbed then it would mean that the target molecule was not present. The amount of energy absorbed depends on the amount of target molecules present in the container under test. By means of spectroscopy the absorption curve generated will give precise and reliable information of how much vacuum and moisture is present in the vial.
The technology may be supplied as a lab model LF Laser or in line LVA. The LVA machine utilizes one laser head and may achieve outputs of up to 500cpm depending on the type of container. The colour or glass type of the vial under test does not influence the result. An indication of the actual vacuum level is also detemined and dislayed. The LVA machine is fully computerised utilising a SCADA platform. The software is easy to operate and includes utilities such as a products database, Statistical reports etc. A printer is also installed for printing test results and parameters. The machine includes an Auto Self Test system using calibrated Check Vials where by the machine is self challenged as frequently as desired to assure 100% reliability.
The machine is already widely used with several successful installations worldwide.
Further information regards Bonfiglioli Engineering Leak Testers may be obtained from our website www.bonfigliolipharma.com
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Bonfiglioli Engineering S.r.l., Via Rondona 33, 44018 Vigarano, Pieve (Fe), Italy.
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