This document provides the terms and definitions of space-enclosed systems (cell preparation isolators and supporting culture systems) used in the production of cell therapy products, and includes considerations for equipment configuration, equipment qualification, aseptic process simulation, production process verification, and system risk control. , biosafety control and other aspects to provide suggestions to reduce the risks of exogenous contamination, cross-contamination, confusion and error, and biosafety risks that may arise in the production of cell therapy products, improve the sterility guarantee level of the production process, and improve medication safety.
T/SHQAP 003-2023 history
2024T/SHQAP 003-2023 Guidelines for application of space separative closed systems for cell therapies production