NF EN ISO 13408-4

NF EN ISO 13408-4

September 2011
Standard Current

Aseptic processing of health care products - Part 4 : clean-in-place technologies

ISO 13408-4:2005 specifies the general requirements for clean-in-place (CIP) processes applied to product contact surfaces of equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control. ISO 13408-4:2005 is applicable to processes where cleaning agents are delivered to the internal surfaces of equipment designed to be compatible with CIP, which may come in contact with the product. ISO 13408-4:2005 is not applicable to processes where equipment is dismantled and cleaned in a washer. ISO 13408-4:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain to particular national or regional jurisdictions.

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Main informations

Collections

National standards and national normative documents

Publication date

September 2011

Number of pages

29 p.

Reference

NF EN ISO 13408-4

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-117-4

Print number

1 - 18/08/2011

International kinship

ISO 13408-4:2005

European kinship

EN ISO 13408-4:2011
Sumary
Aseptic processing of health care products - Part 4 : clean-in-place technologies

ISO 13408-4:2005 specifies the general requirements for clean-in-place (CIP) processes applied to product contact surfaces of equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control.

ISO 13408-4:2005 is applicable to processes where cleaning agents are delivered to the internal surfaces of equipment designed to be compatible with CIP, which may come in contact with the product.

ISO 13408-4:2005 is not applicable to processes where equipment is dismantled and cleaned in a washer.

ISO 13408-4:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain to particular national or regional jurisdictions.

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
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  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Éléments du système qualité
    2
  • 4.1 Généralités
    2
  • 4.2 Responsabilité de la direction
    2
  • 4.3 Contrôle de la conception
    3
  • 4.4 Instruments et systèmes de mesure
    3
  • 5 Caractérisation du processus et de l'équipement
    3
  • 5.1 Concepts généraux
    3
  • 5.2 Efficacité du NSP
    4
  • 5.3 Équipement
    4
  • 6 Caractérisation de l'agent de nettoyage
    6
  • 6.1 Sélection des agents de nettoyage
    6
  • 6.2 Qualité des agents de nettoyage
    6
  • 6.3 Sécurité et environnement
    6
  • 7 Processus NSP
    6
  • 7.1 Paramètres du processus
    6
  • 7.2 Contrôle des processus
    7
  • 7.3 Résidus des agents de nettoyage
    9
  • 8 Validation
    9
  • 8.1 Protocole de validation
    9
  • 8.2 Évaluation du processus NSP
    9
  • 8.3 Qualification de la conception
    9
  • 8.4 Qualification de l'installation
    9
  • 8.5 Qualification opérationnelle
    10
  • 8.6 Qualification des performances
    10
  • 8.7 Revue et approbation de la validation
    11
  • 8.8 Requalification
    11
  • 9 Surveillance et contrôle de routine
    11
  • 9.1 Contrôle du processus NSP
    11
  • 9.2 Procédures
    11
  • 9.3 Enregistrements du processus NSP
    12
  • 9.4 Contrôle des modifications
    12
  • 9.5 Maintenance et étalonnage
    12
  • 10 Formation du personnel
    12
  • Annexe A (informative) Description des méthodes d'échantillonnage
    13
  • Annexe B (informative) Exemples de calcul des critères d'acceptation
    14
  • Bibliographie
    15
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