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BS ISO 20404:2023

BS ISO 20404:2023

$142.49

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

Published By Publication Date Number of Pages
BSI 2023 28
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PDF Catalog

PDF Pages PDF Title
2 National foreword
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
11 4 General strategy for packaging design
4.1 General
12 4.2 Configuration of cells for therapeutic use
4.2.1 General
4.2.2 Suspension of cells
4.2.3 Tissue
13 4.3 Process of containing cells for therapeutic use in packaging
4.4 Disturbances in storage and transportation including contamination
4.5 Impact on external environment when cells for therapeutic use leak from packaging
4.6 Interaction between cells for therapeutic use and packaging
4.7 Usability of packaging in clinical facilities
4.8 Environmental impact
5 Design for packaging
5.1 General
5.2 Enclosing process
5.2.1 Explanation of the enclosing process
14 5.2.2 Packaging for the enclosing process
5.3 Processes from enclosing to usage
5.3.1 Disturbances that affect cells for therapeutic use
15 5.3.2 Leakage
5.3.3 Interactions between cells for therapeutic use and packaging
17 5.4 Usage
18 6 Implementing packaging design
6.1 General
6.2 Shape
19 6.3 Layers
6.4 Ports
6.5 Packaging materials
6.6 Communication between packaging supplier and packaging user
20 7 Quality management
8 Examples of test methods
8.1 General
8.2 Test methods related to disturbance
8.3 Test methods related to leakage
8.4 Test methods related to interaction between cells for therapeutic use and packaging
21 8.5 Other test methods
23 Annex A (informative) Illustrated examples of packaging, packages and shipping containers
26 Bibliography

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BS ISO 20404:2023
$142.49