Codes & Standards - Purchase
ISO 20404:2023
Biotechnology — Bioprocessing — General requirements for the design of packaging to contain cells for therapeutic use
SKU: iso_081477_184703
Published by ISO
Publication Year 2023
1 Edition
19 pages
Product Details
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.
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.