Did You Really Seal Your Blister Packaging - A Seal Integrity Testing Method for Blister Packaging

[Abstract] As blister packages for pharmaceutical drugs become more popular because of their many benefits, such as protecting drugs over long shelf-life, portability, and being tamper resistant. All of these benefits are based on that the blister packages are sealed well. But did you really seal your blister packaging? Do you know how to identify if your blister packages are sealed well? This article will introduce a simple and precise seal integrity testing method for blister packaging.
[Keywords] Blister Packages, Blister packaging, sealing Performance of blister packaging, Seal integrity testing, Seal integrity testing method

As blister packages for pharmaceutical drugs become more popular because of their many benefits, such as protecting drugs over long shelf-life, portability, and being tamper resistant. For a quality and process engineer, the common characteristics of a blister package provide a challenge. The good news is that blister packaging lines should never require 100% testing, as the process can be controlled in ways such that random defects do not occur. But laboratory tests are indispensable.

One of essential characteristic of blister package is seal integrity. It is the primary characteristic of blister packaging as a protection of drugs. Now, manufacturers can use a test instrument, like the Labthink MFY-01 Leak tester, to identify if their blister packages are sealed perfectly in laboratory. This is an automotive, easy-operated and user-friendly instrument.

Current Standard
The current industry standard for blister packaging leak test is bubble emission method, which is a gross leak testing method. In this method, submerge the blister package spcimen in an immersion fluid in a vacuum chamber, and then evacuate the vacuum chamber to form differential pressure between the inside and outside of blister package specimen. The leakage property could be obtained by observing the steady progression of bubbles from the specimen and how the specimen expands and restores to its original shape after vacuum release.