For validation of single-use bags and assemblies
ATMI, a specialist in single-use bioprocess solutions, has made its proprietary helium integrity testing (HIT) system available for on-site application.
Introduced in 2011 as add-on testing for ATMI bioprocess vessels and manifolds, the HIT system is now also available in an easy-to-use technical transfer format that end-users can apply to standard and custom disposable bags and 3-D single-use assemblies starting from 300L, with plans for application up to 1,200L.
ATMI says the new offer is part of its initiative to promote quality and standardisation in the single-use industry.
‘Though many of our customers liked the idea of executing integrity testing with the HIT system on their products prior to shipping, their ultimate desire was to be able to test single-use bags and manifolds at the point of use,’ said Richard Bhella, Director of Applications for ATMI LifeSciences.
‘In other cases, we found that companies who were not yet ATMI customers wanted access to this level of technology and testing. As these requests continued to come in, we reconfigured the format to enable application at the customer sites just prior to process use.’
The HIT system offers a more sensitive level of testing than standard pressure decay testing, and provides the ability to test the whole assembly rather than just the bag body. During the test, the single-use bag assembly or manifold is placed in a closed test chamber, a vacuum pump removes all the air in the chamber, and then a measured quantity of helium is injected into the assembly. Any helium leakage is measured by a mass spectrometer and the size of any defect is calculated. The test is capable of detecting defects as small as 10µm, which is smaller than the threshold defect size for microbial ingress under typical bioprocess conditions.