Helium Leak Detection On Plastic Ophthalmic Containers

A major global pharmaceutical entity that manufactures and distributes a wide variety of Ophthalmic products requested to utilize the helium leak package testing methods of Packaging Technologies & Inspection/Leak Detection Associates (PTI/LDA) to ascertain the seal quality of their container system. The primary package consisted of a 3 piece container – the 10mL PE bottle, a press fit dispensing nozzle, and the threaded cap closure. Each component interface could be a source of leakage: the nozzle plug seal to the bottle neck ID/land seal and the closure seal to the nozzle open ended tip.

The leak testing method the client previously utilized, a vacuum bubble test, was not sufficient to mitigate the potential for product contamination via microbial ingress. Explore results and conclusions from a series of leak testing projects that highlighted key issues with the plastic containers and demonstrated the capabilities of helium leak testing.