ISO/TS 23565:2021

Biotechnology - Bioprocessing - General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use

This document 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.

This document 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 involved task, i.e. design, use or maintenance.

This document is applicable to any unit operation system that is used, alone or in combination, for the manufacturing of cells for therapeutic use, meeting user requirements. It is applicable to devices used for the purpose of 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;
 
• biosafety cabinets, general cell culture equipment (such as CO₂ incubators, etc.), and software to control multiple equipment systems or multiple unit operations.