Integrity test helps assure no flaws in single-use systems, says ASI

08-Apr-2014 - Last updated on 09-Apr-2014 at 14:08 GMT

ASI has developed a last-chance confidence test for single-use biomanufacturers looking for assurance there are no flaws in their bioreactor bags.

At Interphex New York last month, Biopharma-Reporter.com spoke to a number of experts regarding the trends in biomanufacturing, and whilst stainless steel multi-use systems remain abundant within the industry there was a general consensus that single-use plastic systems had positioned themselves in the mainstream.

However, for manufacturers using such disposable systems, a flaw in the bag could spell financial disaster. Though a manufacturing flaw in the plastic is a very rare occurrence, Amber Martin-Sherrick, Marketing Manager at ASI Life Science, said “it is vital that nothing has occurred through manipulation of the bag, or loading or shipping.”

Talking with Biopharma-Reporter.com on the show floor, she told us ASI had developed the inSITE Inflation & Integrity Test System for bio-therapeutic manufacturing in order to serve as “a last chance to have a little confidence” before beginning batch manufacture.

“It’s truly point-of-use which means that you can do it in your container which then again limits the amount of manipulations you’re doing to the bag,” she told us, and works with all bag types.

By placing the bag in the bottom of the system’s tank and doing “a pressure controlled inflation” with air that’s rendered sterile through a filter, it is possible to detect any flaws with the component however small, she continued.

Plastic sometimes less than fantastic

A gross-leak test detects bigger things, she said, for example making sure that a hose isn’t off, by using “the pressure decay method.” This fills the bag with air to a set point, measuring any decay over a set time.

However, for less obvious issues “there’s a fine leak test that allows you to test even smaller potential flaws in the bag, that you definitely wouldn’t be able to see with the naked eye,” she told us.

As for industry’s uptake of such equipment, Martin-Sherrick said ASI had sold the system to a lot of manufacturers. “Though they have the confidence in the bags and the confidence in the process it just gives them some added assurance.”

Furthermore, she added, the results of the tests can be printed out “showing them their bag was fine when they filled it with their product and that can go along with their documentation cycle.”