CASE STUDY: Pfizer elects Sepha’s blister packs inspection device as global standard

Sepha’s Visionscan, a non-destructive inspection device for blister packs, has been selected by Pfizer as its preferred global standard for blister packaging inspection. Visionscan is claimed to be the world’s first, non-destructive, tool-less inspection device for blister packs and was developed by the Northern Ireland-based packaging engineering firm Sepha. Visionscan can help Pfizer reduce inspection costs and drive up accuracy levels compared with traditional test methods.

The endorsement of Sepha’s 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 whilst 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 minute per test cycle), empirical and provides pass/fail results, eliminating any 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 across the globe. It 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. The team then utilised the bespoke 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.

Taking into consideration ROI, Pfizer’s PAT team was of the opinion that the Visionscan could achieve favourable 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.

Commenting on this significant endorsement of Visionscan by one of the world’s premier biopharmaceutical companies, Paul Kelly, Sepha head of sales and marketing, said: “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 innovative 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 outdated, destructive inspection methods such as blue dye. Pfizer, along with a number of other global pharmaceutical multinationals are already making that move. We believe Visionscan will become the best practice, global non-destructive test method for blister packs over the coming years.”

Visionscan is distributed globally by Sepha through a number of international agents. In 2013, Sepha was purchased by US company TASI, a manufacturer of leak test and measurement equipment. In recent years, Sepha has been recognised for its international marketing and exporting achievements with a number of awards including NI Exporter of the Year.

Sepha Ltd, www.sepha.com.