Chapters 4 and 5 of this standard focus on tangential flow filtration membranes and membrane cassettes/devices, and elaborate on the manufacturing, quality control, and inspection and release aspects of tangential flow filtration membranes and membrane cassettes/devices from the perspective of the manufacturer. requirements. It can also provide a reference for users to select and manage tangential flow filtration membranes and membrane cassettes/devices and their suppliers; Chapter 6 explains the use and maintenance process of tangential flow filtration membranes and membrane cassettes/devices from the user's perspective. focus of attention. This standard can be used to guide manufacturers and users on the production quality management of tangential flow filtration membranes and membrane packages/devices to ensure drug quality and safety and better promote the development of the biopharmaceutical industry.
T/SHPPA 025-2024 history
2024T/SHPPA 025-2024 Guidance for the manufacturing quality management of tangential flow filtration membrane and cassettes/devices