Advanced Leak Test Methods

By Hemi Sagi, Director, ATC, Inc.

A major pharmaceutical company in North America with manufacturing in the US, Canada and abroad had a problem, which was not unique to them. Their manufacturing process engineers could not reliably verify that their pouch packages were sealed properly and the product could potentially ship with questionable packaging which failed stability testing. They were using the dye ingress testing method, and found it was not only slow and operator dependent (not reliable), causing false accepts. The Dye Ingress test method was also very messy and involved destroying the packages tested, which become costly if done in few hundreds per day.