NF EN ISO 13408-1

NF EN ISO 13408-1

April 2024
Standard Current

Aseptic processing of health care products - Part 1 : general requirements

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.

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Main informations

Collections

National standards and national normative documents

Publication date

April 2024

Number of pages

102 p.

Reference

NF EN ISO 13408-1

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-117-1

Print number

1

International kinship

ISO 13408-1:2023

European kinship

EN ISO 13408-1:2024
Sumary
Aseptic processing of health care products - Part 1 : general requirements

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.

Replaced standards (1)
NF EN ISO 13408-1
January 2016
Standard Cancelled
Aseptic processing of health care products - Part 1 : general requirements

ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products. ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Généralités
  • 5 Principes du traitement aseptique
  • 6 Conception et développement du procédé, et gestion des risques
  • 7 Stratégie de contrôle de la contamination (CCS)
  • 8 Démonstration de l'efficacité
  • 9 Libération du produit
  • A Traitement aseptique - Éléments types
  • B Gestion des risques
  • C Zones de traitement types
  • D Comparaison de la classification des chambres stériles et des filtres
  • E Exemple de logigramme de procédé aseptique
  • F Systèmes fermés et robotique
  • G Qualification relative au système d'habillage en chambre stérile
  • H Méthodes microbiologiques rapides et alternatives
  • ZA Relation entre la présente Norme européenne et les exigences générales en matière de sécurité et de performances concernées du Règlement (UE) 2017/745
  • ZB (informative) Relation entre la présente Norme européenne et les exigences générales en matière de sécurité et de performances concernées du Règlement (UE) 2017/746
  • Bibliographie
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