Apr 23 2013
ATMI, Inc., a global technology company and leader in single-use bioprocess solutions, today announced that its proprietary helium integrity testing (HIT™) system has been made available to end-users for on-site application.
Originally 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 300 Liters, with plans for application up to 1,200 Liters. The new offer is part of ATMI's initiative to promote the advancement of quality and standardization in the single-use industry. ATMI will exhibit an HIT system and feature the technology behind it in presentations held from April 23rd-–25th during INTERPHEX trade show in New York, NY at the ATMI LifeSciences booth #3319.
"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," offered Director of Applications for ATMI LifeSciences, Richard Bhella. "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. We fully advocate open advancement in the single-use industry, so this is a step we are happy to take."
The HIT system offers a much 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.
"This type of testing is the most advanced of its kind and addresses a real quality gap in the market," commented Senior Vice President and General Manager of ATMI LifeSciences, Mario Philips. "Drug products accrue value at an exponential rate as they move downstream, with batch costs reaching into the millions of dollars. 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."
The new, innovative HIT platform is currently available for purchase. All transactions come with support from dedicated ATMI application specialists who also scale the technology to individual customer needs. For customers that do not wish to acquire the technology for on-site use, ATMI continues to offer integrity testing with the HIT system as an add-on test for ATMI vessels and systems.
To learn more about the HIT system, please visit ATMI at booth #3319 during INTERPHEX, or email Richard Bhella directly at [email protected].
Source: http://www.atmi.com/