While the financial world focuses on NY-based Pfizer’s efforts to purchase London-based AstraZeneca, Pfizer has selected a nondestructive inspection device for blister packs, called Visionscan, as its preferred global standard for blister packaging inspection. Visionscan was developed by the Northern Ireland-based packaging engineering firm Sepha Ltd., and is distributed in the U.S. and Canada by Service Industries. In 2013, Sepha was purchased by TASI, a manufacturer of leak test and measurement equipment.
Visionscan will help Pfizer, one of the world's leading biopharmaceutical companies, reduce inspection costs and drive up accuracy levels as compared to traditional test methods.
The endorsement of Visionscan by Pfizer comes after several months of trials that have demonstrated that Visionscan eliminates some of the known disadvantages of the blue dye test while increasing limit-of-detection capabilities in terms of pinhole size.
Scientists in Pfizer's Process Analytical Technologies (PAT) team validated Visionscan's test cycle, which is capable of non-destructively assessing blister integrity for multiple sizes, shapes, cavity configurations, and materials of construction. The test is relatively fast (about 1 min/test cycle), empirical, and provides pass/fail results eliminating the need for human-visual analysis of samples and associated subjectivity.
The Pfizer team tested a statistically significant number of packs during the trial period, across multiple product materials, and from production sites worldwide. They used Visionscan to apply cycles of both positive pressure and vacuum to blisters, while a high-resolution camera captured images of the blisters at the different pressure/vacuum stages. They then utilized the image analysis algorithms to compare the images and identify subtle deformations in each blister pocket. The results highlight the objective differences in good and bad blister pockets during Pfizer’s non-destructive inspection process with Visionscan.
Commenting on the return on investment for Pfizer with Visionscan in the European Pharmaceutical Review publication, Pfizer's PAT team states, "Considering some of the financial statistics, these systems can achieve favorable and appealing numbers, especially if matched for use with blister products exhibiting relatively high volume and/or high manufacturing costs per unit."
Pfizer also found Visionscan relatively simple to install as well as operate, with low complexity of system hardware. With cost reduction and economic pressures continuing to play a key role in the pharmaceutical industry, the team concluded that technology with a purpose (such as Visionscan) can help improve quality, reduce rejected product, lower manufacturing costs, and can help create a competitive advantage.
Paul Kelly, Head of Sales and Marketing at Sepha Ltd., says, "Pfizer's independent validation of Visionscan as their preferred inspection method of blister packs justifies the investment Sepha has made in developing and bringing to market this blister inspection technology. It also reflects the change we expect to continue to see in the global blister inspection market as it moves away from destructive inspection methods such as blue dye. Pfizer, along with a number of other global pharmaceutical multinationals, are already making that move.”
