Non-Destructive Options For Leak Testing Blister Packages

By Philip Stevenson, Product Manager

Concerns about waste, human error, and cGMP compliance are leading some packaging facilities to seek alternatives to the standard blue-dye leak test for blister packaging.

Leak Testing Blister Packs
The blue-dye test—or methylene blue dye ingress leak test—is the most common method for testing the integrity of pharmaceutical blister packages. It’s been around for decades and the equipment required—essentially a vat, some coloured water, a vacuum pump, and a timer—is inexpensive and easy to use. But there are several newer methods available that have advantages over the simple “dunk-and-bubble” test, including greater quality assurance; accurate, objective, quantifiable test results; compliance with 21 CFR Part 11 and other cGMP standards [1]; and less waste. This article compares the benefits and limitations of four of these alternative leak-testing methods.