ISO 20404:2023

INTERNATIONAL ISO
STANDARD 20404
First edition
2023-04
Biotechnology — Bioprocessing —
General requirements for the design
of packaging to contain cells for
therapeutic use
Biotechnologie — Bioprocédés — Exigences générales pour la
conception d'emballages destinés à contenir des cellules à usage
thérapeutique
Reference number
© ISO 2023
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Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General strategy for packaging design . 3
4.1 General . 3
4.2 Configuration of cells for therapeutic use . 4
4.2.1 General . 4
4.2.2 Suspension of cells . 4
4.2.3 Tissue. 4
4.3 Process of containing cells for therapeutic use in packaging . 5
4.4 Disturbances in storage and transportation including contamination . 5
4.5 Impact on external environment when cells for therapeutic use leak from
packaging . 5
4.6 Interaction between cells for therapeutic use and packaging . 5
4.7 Usability of packaging in clinical facilities . 5
4.8 Environmental impact . 5
5 Design for packaging .5
5.1 General . 5
5.2 Enclosing process . 5
5.2.1 Explanation of the enclosing process . 5
5.2.2 Packaging for the enclosing process . 6
5.3 Processes from enclosing to usage . 6
5.3.1 Disturbances that affect cells for therapeutic use. 6
5.3.2 Leakage . 7
5.3.3 Interactions between cells for therapeutic use and packaging . 7
5.4 Usage . 9
6 Implementing packaging design .10
6.1 General . 10
6.2 Shape . 10
6.3 Layers . 11
6.4 Ports . 11
6.5 Packaging materials. 11
6.6 Communication between packaging supplier and packaging user . 11
7 Quality management .12
8 Examples of test methods .12
8.1 General .12
8.2 Test methods related to disturbance .12
8.3 Test methods related to leakage .12
8.4 Test methods related to interaction between cells for therapeutic use and
packaging . 12
8.5 Other test methods .13
Annex A (informative) Illustrated examples of packaging, packages and shipping
containers .15
Bibliography .18
iii
Foreword
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electrotechnical standardization.
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This document was prepared by Technical Committee ISO/TC 276, Biotechnology.
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iv
Introduction
Medicinal products containing cells as active substances, which are employed in cell therapy or gene
therapy, are expected to deliver novel therapeutic value to patients who are currently untreated or
under-treated. These products have potential capabilities to repair, replace or regenerate tissues
affected by disease or injury. Development of such products is at the forefront of scientific innovation.
Therefore, manufacturers of cells for therapeutic use are expected to maintain product quality
throughout the product life cycle by continuously improving their ability to process cells with advanced
technology.
Cells for therapeutic use are complex products, as compared with conventional pharmaceuticals.
They are produced in a variety of culture systems, such as a system in which cells are suspended
in a medium, or a system in which tissue formed by cells is immersed in a medium. At the point of
their administration, various methods such as surgery or infusion are applied. In addition, special
attention is taken in their storage and transportation, which is not always considered in conventional
pharmaceuticals. This includes the need to store products in a precisely controlled, closed environment
to prevent contamination by foreign substances (viruses, bacteria, mycoplasmas, etc.) at a certain
temperature, such as culture environment or at a cryogenic temperature. Even with these complexities,
it is indispensable to maintain the quality of cells for therapeutic use from manufacturing to usage.
Packaging is important for cells for therapeutic use to keep their quality. Therefore, a standard for
packaging to contain cells for therapeutic use is necessary. Existing standards, such as ISO 3826-1,
however, do not provide information for handling cells for therapeutic use.
This document provides general requirements to design packaging intended to contain cells for
therapeutic use. It provides useful information for packaging suppliers to manufacture packaging with
consideration given to the specific configurations needed for cells for therapeutic use. It is also useful
for packaging users when they need to consult with packaging suppliers for custom-made packaging.
This document is intended to help packaging suppliers to design and manufacture packaging in
consideration of enclosing, storage, transportation, and utilization processes of cells for therapeutic
use. This document is also intended to help packaging users to design and employ packaging in
consideration of the above-mentioned processes.
v
INTERNATIONAL STANDARD ISO 20404:2023(E)
Biotechnology — Bioprocessing — General requirements
for the design of packaging to contain cells for therapeutic
use
1 Scope
This document specifies general requirements and considerations for the design of packaging used to
co
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