ATMI Offers Helium Integrity Testing System

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Evaluation system for single-use bags and assemblies is now available for onsite testing.

ATMI’s proprietary helium integrity testing (HIT) system is now available to end-users for on-site application, announced the company in a press release. The testing system was originally introduced in 2011 as add-on testing for ATMI bioprocess vessels and manifolds prior to shipping. End-users of both ATMI and other single-use systems can now apply the new technical-transfer format to standard and custom disposable bags and three-dimensional, single-use assemblies.

“We reconfigured the format to enable application at the customer sites just prior to process use. We fully advocate open advancement in the single-use industry, so this is a step we are happy to take,” said Richard Bhella, director of applications for ATMI LifeSciences, in the press release.

The HIT system offers a more sensitive level of testing than standard pressure-decay testing. The system also 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.

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“Drug products accrue value at an exponential rate as they move downstream, with batch costs reaching into the millions of dollars,” commented Mario Phillips, senior vice-president and general manager of ATMI LifeSciences. “Batch failure due to leakage or sterility breach can represent great financial loss and, as the reliance on single-use technologies has grown in the bioprocess industry, the need to guarantee their integrity has also grown. This technology transfer for on-site customer use is about giving customers access to innovative solutions in a format that fits their specific needs.”