Detects leaks from holes as small as 10 microns in single-use bioprocess vessels
ATMI, a US specialist in materials handling, has introduced Helium Integrity Testing (HIT) on its single-use Integrity bioprocess vessels.
The company says the deployment of HIT to confirm product integrity is unique in the industry and its application to fully assembled bags takes quality assurance to a new level.
The HIT process involves flooding a fully assembled vessel with a prescribed amount of helium and noting the escape of any helium that can be detected. Specialised helium sensors that are exterior to the vessel can detect holes as small as 10 microns.
After extensive development of the technology for adaptation to widespread application, HIT is being piloted on ATMI’s 2-D Integrity bags at its North American life sciences manufacturing facility in Bloomington, MN.
The company plans to deploy HIT across its full Integrity line of single-use technologies in a phased approach.
‘The integrity of sterile vessels used in biopharmaceutical processes is of critical importance,’ said Jeffery Craig, global director, business development and marketing at ATMI LifeSciences.
‘Leaks in the bags obviously compromise the quality of the product so, by starting to deploy HIT, we are providing customers with additional peace of mind beyond our already stringent integrity testing, and continuing to ensure that ATMI employs the most cutting-edge integrity testing standards in the market.’
ATMI manufactures in Class V space with vertical laminar air flow to minimise particle count, and executes 100% integrity testing of fully assembled bags.
‘The addition of HIT to our integrity testing procedures allows us to provide unprecedented quality assurance,’ Craig added.
Not all manufacturers have stringent processes in place to ensure the quality and integrity of their single-use technologies. In cases where testing does occur, the preferred method is pressure decay testing. This test, however, is not known to be sensitive enough to detect very small leaks. Additionally, this and other methods typically test only the bag chamber and not the fully assembled vessel with fittings, tubings and connectors attached.
Products tested by HIT will initially be marketed to specific application areas within the bioprocessing industry, for example, biopharma downstream processing, final fill and finish, cell therapies and personalised medicine.