ISO 20404:2023
p
ISO 20404:2023
81477

Abstract

 Preview

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.


General information 

  •  : Published
     : 2023-04
  •  : 1
     : 19
  •  : ISO/TC 276 Biotechnology
  •  :
    07.080 Biology. Botany. Zoology

Buy this standard

en
Format Language
std 1 124 PDF + ePub
std 2 124 Paper
  • CHF124

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)