Sepha
A new whitepaper by a leading packaging expert from the University of Ulster, Dr. Dorian Dixon, into the integrity of pharmaceutical packaging has established that existing methods for testing the seal integrity of blister packs are not as accurate as newer technology-based test equipment. In particular, Dr. Dixon found that the laser-based Blisterscan was capable of detecting 15% more product defects than traditional blue dye test methods used by the majority of the pharmaceutical market.
In his whitepaper study, Dr. Dixon compared the ability of Blisterscan and the blue dye test to detect defective pockets in blister packs with 12 or 20 µm sized holes that were laser drilled in the packs to create defective packs. Ninety pockets were tested for each of the three sample types investigated (defect free, 12 or 20 µm holes). The current industry standard for testing blister pack integrity is blue dye testing, which consists of placing a selection of packs into blue stained water, subjecting the packs to a vacuum of typically 40–600 mBar for several minutes and then removing the vacuum, which allows any defective pockets to take up the dye. Blisterscan is a dry, non-destructive technique, which uses a laser to measure changes in the pack profile that result from applying a vacuum. The lidding material of defective pockets will respond in a different manner to a perfectly sealed pocket when a vacuum is applied.
Building on Dr. Dixon’s initial study where 100% of 15 µm holes were detected, Blisterscan went on to detect 100% of the 20 µm holes and 99% of the 12 µm holes in the final whitepaper study. Conversely, blue dye testing was only capable of detecting 85% of the 15 µm holes, 90% of the 12 µm holes and 99% of the 20 µm holes.
Commenting on the results of the whitepaper, Dr. Dixon said: “Blisterscan testing is a rapid non-destructive test method, which can detect the presence of 12 µm, 15 µm and 20 µm sized defects in pharmaceutical blister packaging with a higher degree of reliability than conventional blue dye testing.” Dr. Dixon went on to conclude that: “The non-subjective nature of Blisterscan testing removes the possibility of human error and reliance on operator judgement, which a key element in the correct identification of small holes using traditional blue dye testing.”
Sepha Ltd, +44 2890 484848, paul.kelly@sepha.com, www.sepha.com.