The test, premiered at last week Interphex in New York, US, involves flooding fully-assembled bioprocess vessels with a prescribed amount of helium and monitoring for any leakage using specialised external sensors.
ATMI CEO Doug Neugold told in-Pharmatechnologist.com that, in contrast with pressure decay-based methods, helium integrity testing (HIT) is highly-sensitive and capable of detecting holes in bioprocess as small as 10 microns in diameter.
Neugold explained that while similar approaches to integrity testing have been attempted before, ATMI is the first firm to develop a method that is reproducible, reliable and fully qualified.
He said that, initially at least, HIT will only be available for ATMI’s range of Integrity single-use bioprocess vessels, explaining that: “We’ve developed the technology as a way to differentiate the products we offer to our customers.”
Neugold also predicted that ATMI’s unique ability to provide this level of quality assurance (QA) will be attractive to the biomanufacturing sector.
“Integrity is something that all of the end users want demonstrated to them. You try to do it through traditional means, but it just doesn’t tell you enough.”