International Standard
ISO 13408-1:2023
Aseptic processing of health care products — Part 1: General requirements
Reference number
ISO 13408-1:2023
Edición 3
2023-08
International Standard
Vista previa
ISO 13408-1:2023
77151
No disponible en español
Publicado (Edición 3, 2023)

ISO 13408-1:2023

ISO 13408-1:2023
77151
Idioma
Formato
CHF 194
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Resumen

This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products.

This document includes requirements and guidance relative to the overall topic of aseptic processing.

Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.

Informaciones generales

  •  : Publicado
     : 2023-08
    : Norma Internacional publicada [60.60]
  •  : 3
     : 72
  • ISO/TC 198
    11.080.01 
  • RSS actualizaciones

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