The BlisterScan technology can detect leaks in blister packs as small as 7 microns in diameter in a non-destructive protocol that has been adopted by a number of European and US drugmakers as a replacement for traditional methylene blue dye testing.
In Japan however, such technologies have yet to make a big impact, largely because the strict rules that govern manufacture have made it difficult for non-Japanese firms to enter the market, despite it being the fifth largest worldwide for blister packaging.
This situation is changing according to Sepha marketing manager Gillian Parker who suggested that since the Pharmaceutical and Medical Devices Agency (PMDA) was set up in 2004 a growing number of non-Japanese companies have entered the market increasing demand for innovative testing technologies.
Parker told in-PharmaTechnologist that: “With more global pharmaceutical players able to enter the Japanese market, Sepha is now better able to leverage its existing relationships with these multinationals to enter the market.”
She also argued that, while capital spending is down worldwide as a result of the economic downturn, there is a strong interest in manufacturing and analysis technologies that generate cost savings.
Sepha’s competition will come from domestic producers of deblistering machines, although the firm is convinced that the non-destructive testing capacity provided by its platform is “unique in the Japanese market.”
Parker went on to say that entry into the Japanese market is part of a wide-ranging global expansion programme that has seen Sepha find agents in Germany, France and Italy and demonstrate its leak testing technology at events in Mexico and Brazil.
CEO Aubery Sayer suggested that: “As the economic downturn forces global consolidation of the pharmaceutical industry and puts the focus on projects that achieve cost savings…we believe the time is right to introduce BlisterScan in Asia.”
He reiterated that the ability to reduce waste and save both time and money during routine testing is becoming “increasingly important within the pharmaceutical industry.”