🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
BSI 22/30428167 DC:2022 Edition

BSI 22/30428167 DC:2022 Edition

$13.70

BS ISO 20404. Biotechnology. Bioprocessing. General requirements for the design of packaging to contain cells for therapeutic use

Published By Publication Date Number of Pages
BSI 2022 26
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Category:

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

PDF Catalog

PDF Pages PDF Title
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
11 4 General strategy for packaging
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
4.3 Process of containing cells for therapeutic use into packaging
13 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 Requirements for design input of packaging
5.1 General
5.2 Enclosing process
5.2.1 Explanation of enclosing process
14 5.2.2 Requirements regarding the enclosing process
5.3 Processes from enclosing to usage
5.3.1 General
5.3.2 Requirements regarding disturbances that affect cells for therapeutic use
15 5.3.3 Requirements regarding leakage
5.3.4 Requirements regarding interaction between cells for therapeutic use and packaging
17 5.4 Requirements regarding usage
18 6 Specifics for implementing packaging design
6.1 General
6.2 Shape
6.3 Layer of packaging
19 6.4 Port
6.5 Packaging materials
6.6 Communication between packaging supplier and user
7 Quality management system (QMS)
20 8 Example 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

Related products

BSI 22/30428167 DC
$13.70