What is ISO/TS 23565 about?
ISO/TS 23565 discusses biotechnology and specifies minimum requirements and general considerations for equipment, consisting of hardware, software, and consumables, used in the manufacturing of cells for therapeutic use. This includes equipment for processing cells for therapeutic use starting from cell isolation/selection, expansion, washing, and volume reduction, from cell finish through to cryopreservation for the storage of cells for therapeutic use.
ISO/TS 23565 gives guidance on the design, use, and maintenance of equipment and equipment systems to both suppliers and users from aspects including the target parties, i.e., supplier or user, and phase of the involved task, i.e., design, use, or maintenance
ISO/TS 23565 applies to any unit operation system that is used, alone or in combination, for the manufacturing of cells for therapeutic use, meeting user requirements. It applies to devices used for monitoring equipment status.
It does not apply to processing equipment for cells for therapeutic use used at the point of care, devices used for analytical purposes, and biosafety cabinets, general cell culture equipment (such as CO2 incubators, etc.), and software to control multiple equipment systems or multiple unit operations
Who is ISO/TS 23565 for?
ISO/TS 23565 on biotechnology is useful for-
- Biotechnology laboratories
- Manufacturers of equipment systems used in the manufacturing of cells for therapeutic use
- Targeted parties i.e., suppliers and customers of cells for therapeutic use
Why should you use ISO/TS 23565?
Cells for therapeutic use is a product containing cells as active substances. Equipment systems for manufacturing cells for therapeutic use generally comprise three distinct components that entail different approaches to quality assurance and risk management: hardware, software, and consumables. A high level of assessment should encompass the whole equipment system as the sum of the individual components and together with the implications of upstream and downstream processes for the complete workflow.
ISO/TS 23565 guideline provide minimum requirements and general considerations for equipment and equipment systems, used in the manufacturing of cells for therapeutic use and cell processing equipment, and ensures a suitable operating environment is there while operating.
