Bioprocessing: ISO/TS 23565 – Highlights And Interpretation

ISO/TS 23565 addresses an unmet need in the specification of cell processing systems. The standard applies to all systems used alone or in combination with other equipment including components used for monitoring the status of manufacturing and processing equipment.

ISO/TS 23565 is published as a Technical Specification (TS). Specific aspects of the TS that are relevant to the processing flow path and therefore the selection and specification of single-use components for cell processing systems include sterility, biocompatibility, extractables, particulates, and physical integrity.