1.1 This practice provides a standardized approach for determining particulates burden from single-use systems for applications in pharmaceutical development and manufacturing, notably biotechnology. 1.2 It describes what information is required to be able to assess impact of these particulates to the pharmaceutical manufacturing process.
Keywordsparticulates, single-use, biopharmaceuticals, impact, manufacturing
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
Draft Under Development