ISO/DIS 23565:2026

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

This document specifies minimum requirements and general considerations for equipment, consisting of hardware, software and consumables used in the manufacturing of cellular therapeutic products. This includes equipment for processing cellular therapeutic products starting from cell isolation/selection, expansion, washing, volume reduction, final formulation and preparation prior to cryopreservation for the storage of cellular therapeutic products.

This document provides guidance on the design, use and maintenance of equipment and equipment systems to both equipment suppliers and equipment users from aspects including the target parties, i.e. equipment supplier or equipment 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 cellular therapeutic products, meeting equipment user requirements. It is applicable to equipment used for the purpose of monitoring equipment status.

It does not apply to:

 
• processing equipment for cellular therapeutic products used at the point of care;
 
• equipment 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.