NF EN ISO 13408-5

NF EN ISO 13408-5

September 2011
Standard Current

Aseptic processing of health care products - Part 5 : sterilization in place

ISO 13408-5:2006 specifies the general requirements for sterilization in place (SIP) applied to product contact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control. ISO 13408-5:2006 applies to processes where sterilizing agents are delivered to the internal surfaces of equipment that can come in contact with the product.

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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 13408-5

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-117-5

Print number

1 - 18/08/2011

International kinship

ISO 13408-5:2006

European kinship

EN ISO 13408-5:2011
Sumary
Aseptic processing of health care products - Part 5 : sterilization in place

ISO 13408-5:2006 specifies the general requirements for sterilization in place (SIP) applied to product contact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control.

ISO 13408-5:2006 applies to processes where sterilizing agents are delivered to the internal surfaces of equipment that can come in contact with the product.

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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  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Éléments du système qualité
    3
  • 4.1 Généralités
    3
  • 4.2 Responsabilité de la direction
    3
  • 4.3 Contrôle de la conception
    3
  • 4.4 Instruments et systèmes de mesure
    4
  • 5 Caractérisation du procédé et de l'équipement
    4
  • 5.1 Concepts généraux
    4
  • 5.2 Efficacité de la stérilisation sur place (SSP)
    4
  • 5.3 Équipement
    5
  • 6 Caractérisation de l'agent stérilisant
    6
  • 6.1 Choix de l'agent ou des agents stérilisants
    6
  • 6.2 Qualité de l'agent ou des agents stérilisants
    7
  • 6.3 Sécurité et environnement
    7
  • 7 Procédé de SSP
    7
  • 7.1 Paramètres du procédé
    7
  • 7.2 Mise au point du cycle
    7
  • 8 Validation
    8
  • 8.1 Protocole de validation
    8
  • 8.2 Qualification de la conception
    8
  • 8.3 Qualification de l'installation
    8
  • 8.4 Qualification opérationnelle
    8
  • 8.5 Qualification des performances
    9
  • 8.6 Revue et approbation de la validation
    10
  • 8.7 Requalification
    11
  • 9 Surveillance et contrôle de routine
    11
  • 9.1 Contrôle du procédé de SSP
    11
  • 9.2 Modes opératoires
    11
  • 9.3 Enregistrements relatifs au procédé de SSP
    12
  • 9.4 Contrôle des modifications
    12
  • 9.5 Maintenance de l'équipement
    12
  • 10 Formation du personnel
    12
  • Annexe A (informative) Stérilisation à la vapeur fluente
    13
  • Bibliographie
    15
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