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Leading up to the BioProcess International Event, we'll be highlighting many of the posters you'll be able to find in the hall at the event taking place September 16-19, 2013 in Boston, MA. If you'd like to join us at the event, as a reader of this blog, when you register to join us and mention code BLOG13JP, you'll save 20% off the standard rate! Would you like to submit a poster? Do so here before August 19.Poster: Using Helium Integrity Tester to Increase Assurance of Sterility of Single-use Assemblies
Presenter: Carla Conant, ATMI LifeSciences
About: The rapid adoption of single-use bioprocessing technologies continues to raise concerns about integrity of flexible containers and assemblies. The poster discusses inadequacies of the existing integrity testing methods for flexible containers and presents a novel method, of using helium trace gas for detecting defects down to 10 µm in prior-to –use-mode. A microbial aerosol challenge study conducted on flexible sterile containers revealed that defects as small as 12 µm are capable of causing sterility breach while defects smaller than 10 µm did not show microbial ingress under the test conditions. Data will be presented demonstrating detection of 10 µm defects for single use bags, complex manifolds and assemblies. Relationship between the probability of sterility breach and defect size will be discussed.
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