ISO/PWI 26833

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

Scope

This document specifies minimum requirements and general considerations for bioreactor
equipment, consisting of hardware, software and connectors, used in the manufacturing of cells
for therapeutic use. This includes equipment used for growth/expansion, differentiation including
stir tanks, fixed beds, rocking platforms, and hollow fiber systems.
This document gives guidance on the design, use and maintenance of bioreactor 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 bioreactors using real time monitoring, automation, and closed
systems.