Quality control is an essential operation in the pharmaceutical industry, especially when it concerns seal integrity and particle inspection. Bonfiglioli provides a solution that saves both time and space, making it one of the most cost-effective solutions on the market.
The PK-V-Vis combination is a fully automatic leak tester and visual inspection machine for ampoules and vials. It may reach an output of 400cpm and vial size can range between 2ml and 100ml. This leak testing method is according to the ASTM and is fully validated. Being equipped with cameras this machine is able to perform particle level and cosmetic inspection.
The container is inserted in an airtight chamber where it is tested by applying vacuum. The PK-V-Vis combination is equipped with software based on the SCADA platform, through which the pressure pattern can be recorded, analysed and compared to a pre-set pattern, thus indicating if container is good or faulty. Having finished this process, the same container is spun, then stopped and several photos are taken. The container is checked for any particles or cracks in the product and for the fill level. Comparison is done between photos and discrimination made between good and bad containers. The machine is already widely used with several successful installations worldwide.
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