1.1 This practice describes the requirements for development, qualification, and routine application of a procedure for the effective liquid extraction of particulate matter from the surfaces of single-use components and assemblies designed for use in biopharmaceutical manufacturing processes. The extraction generates a suspension of particulate matter in liquid which makes the particulate matter readily available for analytical characterization.

Product Details

Published:

03/01/2020

Number of Pages:

12

File Size:

1 file , 240 KB