Standard

BS ISO 20404:2023

Biotechnology. Bioprocessing. General requirements for the design of packaging to contain cells for therapeutic use

Current

•

Published:

30 Apr 2023

1 Scope

This document specifies general requirements and considerations for the design of packaging used to contain cells for therapeutic use.

This document is applicable to packaging intended to contain the final products of cells for therapeutic use, as well as their starting and intermediate materials.

This document does not apply to:

a) receptacles used for processing cells in manufacturing processes, e.g. cell culture flask or bag;
b) shipping containers containing packages for transportation;
c) services that utilize packages, e.g. storage services.

NOTE 1 Examples of packaging, packages and shipping containers are illustrated in Annex A.

NOTE 2 The design of packaging includes processes to ensure that the designed packaging is manufactured to a required specification through trial manufacturing, testing and implementation of quality management.

NOTE 3 International, national or regional regulations or requirements can also apply to specific topics covered in this document.

BSI recommends this version of standard for organisations operating in or with the UK. The ISO edition is available here if required.

Product Details

Descriptors

Biotechnology

Design

Packaging

Cells (biology)

Technical requirements

Cell culture

Containers

Storage

ICS Codes

07.080 Biology. Botany. Zoology

Committee

BTI/1

International relationships

Identical to:

ISO 20404:2023

ISBN

978 0 539 15765 9

Publisher

BSI