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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.
“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.”