T/SHPPA 025-2024 Guidance for Quality Management of Production of Tangential Flow Membrane and Membrane Pack/Apparatus

Scope

Scope: This standard specifies the requirements for the production, quality control, inspection and release, and use of tangential flow filtration membranes and membrane packages/devices, and is applicable to manufacturers and users in the management of the production quality of tangential flow filtration membranes and membrane packages/devices. Main technical content: Chapters 4 and 5 of this standard focus on tangential flow filtration membranes and membrane packages/devices, and from the manufacturer's perspective, they elaborate on the requirements for the production, quality control, and inspection and release of tangential flow filtration membranes and membrane packages/devices. They can also provide reference for users to screen and manage tangential flow filtration membranes and membrane packages/devices and their suppliers; Chapter 6, from the user's perspective, elaborates on the key points of attention in the use and maintenance of tangential flow filtration membranes and membrane packages/devices. This standard can be used to guide manufacturers and users in the management of the production quality of tangential flow filtration membranes and membrane packages/devices, so as to ensure the quality and safety of drugs and better promote the development of the biomedical industry.

Development Information

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