1.1 This practice provides a standardized approach for testing the integrity of single-use systems consisting of single-use components used in pharmaceutical development and manufacturing notably biotechnology. 1.2 It is not intended to provide practice on how to make risk assessments on processes with regard to minimal requirements on system integrity notably the distinction between bioburden controlled and sterile operation.
Keywordstesting, integrity, single-use systems, biopharmaceuticals
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
Draft Under Development