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June 15, 2013 (Vol. 33 , No. 12)

Single-Use Bag and Assembly Testing

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ATMI LifeSciences

The helium integrity testing (HIT) system is now available in a technical transfer format that end-users can apply to standard and custom disposable bags and 3D single-use assemblies starting from 300 L, with plans for application up to 1,200 L. The system can offer 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. The test is capable of detecting defects as small as 10 µm, which is smaller than the threshold defect size for microbial ingress under typical bioprocess conditions.

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