NF EN ISO 13408-3

NF EN ISO 13408-3

September 2011
Standard Current

Aseptic processing of health care products - Part 3 : lyophilization

ISO 13408-3:2006 specifies requirements for, and offers guidance on, equipment, processes, programmes and procedures for the control and validation of lyophilization as an aseptic process. It does not address the physical/chemical objectives of a lyophilization process.

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Main informations

Collections

National standards and national normative documents

Publication date

September 2011

Number of pages

25 p.

Reference

NF EN ISO 13408-3

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-117-3

Print number

1 - 18/08/2011

International kinship

ISO 13408-3:2006

European kinship

EN ISO 13408-3:2011
Sumary
Aseptic processing of health care products - Part 3 : lyophilization

ISO 13408-3:2006 specifies requirements for, and offers guidance on, equipment, processes, programmes and procedures for the control and validation of lyophilization as an aseptic process. It does not address the physical/chemical objectives of a lyophilization process.

Replaced standards (1)
NF EN 13824
March 2005
Standard Cancelled
Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

Le présent document spécifie les exigences relatives à la conception et au fonctionnement des installations de traitement aseptique et à la validation et au contrôle de routine des procédés aseptiques en vue de la préparation de dispositifs médicaux liquides stériles. Il ne s'applique pas aux produits pharmaceutiques pour lesquels les exigences relatives aux bonnes pratiques de fabrication appropriées s'appliquent.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Éléments du système qualité
    1
  • 4.1 Généralités
    1
  • 4.2 Responsabilité de la direction
    2
  • 4.3 Contrôle de la conception
    2
  • 4.4 Instruments et/ou systèmes de mesure
    2
  • 5 Définition du produit
    2
  • 6 Définition du processus
    2
  • 7 Exigences d'utilisateur
    3
  • 7.1 Généralités
    3
  • 7.2 Caractérisation de l'équipement
    3
  • 7.3 Manipulation du produit
    4
  • 7.4 Surveillances microbiologique et particulaire environnementale
    4
  • 7.5 Nettoyage et stérilisation
    5
  • 7.6 Système de filtres-évents
    5
  • 7.7 Essai d'étanchéité du lyophilisateur
    5
  • 8 Validation
    6
  • 8.1 Généralités
    6
  • 8.2 Qualification de la conception
    6
  • 8.3 Qualification de l'installation
    6
  • 8.4 Qualification opérationnelle
    7
  • 8.5 Qualification des performances
    8
  • 8.6 Validation du processus
    8
  • 8.7 Revue et approbation de la validation
    9
  • 9 Surveillance et contrôle de routine
    9
  • 9.1 Généralités
    9
  • 9.2 Formation de l'opérateur
    10
  • 9.3 Procédures normalisées
    10
  • 9.4 Requalification
    10
  • 9.5 Maintenance de l'équipement
    10
  • 9.6 Contrôle des modifications
    10
  • Bibliographie
    11
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