The Bioprocess Systems Alliance published its first component quality test matrices in 2007. The state purpose of this work was to “help guide users when making their selections and (to) facilitate qualification, validation, and use of single-use products.”
This 2015 document is an update to the original publication necessitated by the increase in the number of components the are currently incorporated into single-use assemblies as well as the introduction of new single-use products to the market. For example, single use sensors and chromatography column products were not a part of the 2007 matrices publication. This update also accounts for changes to common practices followed by single-use component and assembly providers.
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