Description:

BPSA published the first component quality test matrices in 2007, with a subsequent update in 2015. This 3rd edition, updated in 2023, is necessitated by the increase in the number of components that are currently incorporated into single-use assemblies. The updates also account for changes to common practices followed by single-use component and assembly providers as well as sterilization process compatibility, pre-use treatment, as well as sterilization (irradiation and thermal) exposure to test samples.