International Standard
ISO 20404:2023
Biotechnology — Bioprocessing — General requirements for the design of packaging to contain cells for therapeutic use
Reference number
ISO 20404:2023
Edición 1
2023-04
International Standard
Vista previa
ISO 20404:2023
81477
No disponible en español
Publicado (Edición 1, 2023)

ISO 20404:2023

ISO 20404:2023
81477
Idioma
Formato
CHF 129
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Resumen

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.

Informaciones generales

  •  : Publicado
     : 2023-04
    : Norma Internacional publicada [60.60]
  •  : 1
     : 19
  • ISO/TC 276
    07.080 
  • RSS actualizaciones

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