Whitepaper Demonstrates 100% Identification of Defective Blister Packs Using Leak Testing Device

A new whitepaper published by Dr. Dorian Dixon, a leading packaging expert at the University of Ulster in Northern Ireland, has shown that VisionScan, a non-destructive seal and leak detection device for pharmaceutical blister packs, developed by the engineering firm Sepha, can identify 100% of defective pockets across a range of blister pack types. In contrast with traditional, destructive, manual tests such as blue-dye, the VisionScan system uses camera and projection technology, combined with vacuum pressure, allowing for the accurate, non-destructive detection of defects down to 15 μm.

In this latest whitepaper, four blister pack types of various designs and materials were evaluated. Laser drilled holes of 15 or 50 μm were drilled into the foil or paper laminate of 25 of each of the four pack types, creating a total of 200 initial test packs. Only one pocket per pack was laser drilled, leaving the remaining pockets undamaged as control pockets. Scanning electron microscopy (SEM) was used to confirm the dimensions of the laser drilled holes.

On SEM inspection of the initial 200 test packs, it was shown in a number of blister packs that the laser drilled holes were not drilled correctly or were missing. Data from the pockets identified as having defective holes was not included in subsequent analysis, resulting in a total of 170 test packs for final analysis. Once all such incorrectly drilled pockets were removed from the data, the study showed that VisionScan from Sepha correctly identified 100% of both the 15 and 50 μm sized defects in a total of 170 test packs across all four of the blister pack types.

Commenting on the results, Dr. Dixon said: “As the VisionScan is a tool-less, non-destructive test using state-of-the-art vision technology, it removes the possibility of human error and subjectivity, whilst allowing valuable product within defective packs to be recovered. This represents a significant improvement over traditional blue-dye testing, which is both subjective and destructive.”

Sepha CEO John Haran commented: “Dr. Dixon’s study and findings demonstrate the VisionScan’s ability to offer a technologically advanced, non-destructive alternative for the integrity testing of blister packs, whilst delivering quality improvements and cost savings during production for global pharmaceutical manufacturers.”

Sepha Ltd, +44 2890 484848, paul.kelly@sepha.com, www.sepha.com.