Standards Development

Scope

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 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 including aspects such as the target parties, i.e. equipment supplier or equipment user, and the phase of the involved task, i.e. design, use, or maintenance.

This document is applicable to any unit operation system, that is intended to be used, either alone or in combination, for the manufacture of cellular therapeutic products by meeting equipment user requirements. It is applicable to equipment used for the purpose of monitoring the equipment status.

This document 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.),;

—     software to control multiple equipment systems or multiple unit operations.