NF EN ISO 13408-4
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.
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.
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.
- Avant-proposiv
- Introductionv
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1 Domaine d'application1
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2 Références normatives1
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3 Termes et définitions1
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4 Éléments du système qualité2
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4.1 Généralités2
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4.2 Responsabilité de la direction2
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4.3 Contrôle de la conception3
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4.4 Instruments et systèmes de mesure3
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5 Caractérisation du processus et de l'équipement3
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5.1 Concepts généraux3
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5.2 Efficacité du NSP4
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5.3 Équipement4
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6 Caractérisation de l'agent de nettoyage6
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6.1 Sélection des agents de nettoyage6
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6.2 Qualité des agents de nettoyage6
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6.3 Sécurité et environnement6
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7 Processus NSP6
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7.1 Paramètres du processus6
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7.2 Contrôle des processus7
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7.3 Résidus des agents de nettoyage9
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8 Validation9
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8.1 Protocole de validation9
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8.2 Évaluation du processus NSP9
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8.3 Qualification de la conception9
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8.4 Qualification de l'installation9
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8.5 Qualification opérationnelle10
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8.6 Qualification des performances10
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8.7 Revue et approbation de la validation11
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8.8 Requalification11
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9 Surveillance et contrôle de routine11
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9.1 Contrôle du processus NSP11
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9.2 Procédures11
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9.3 Enregistrements du processus NSP12
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9.4 Contrôle des modifications12
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9.5 Maintenance et étalonnage12
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10 Formation du personnel12
- Annexe A (informative) Description des méthodes d'échantillonnage13
- Annexe B (informative) Exemples de calcul des critères d'acceptation14
- Bibliographie15
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