NF EN 13824
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.
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.
<p>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.</p> <p>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.</p>
<p>ISO 13408-2:2003 specifies requirements for sterilizing filtration as part of aseptic processing of health care products. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process, to be used for aseptic processing of health care products. </p> <p>ISO 13408-2:2003 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids containing particles as effective ingredient larger than the pore size of a filter (e.g. bacterial whole-cell vaccines). </p>
<p>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.</p>
<p>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.</p> <p>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. </p> <p>ISO 13408-4:2005 is not applicable to processes where equipment is dismantled and cleaned in a washer. </p> <p>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.</p>
<p>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.</p> <p>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.</p>
<p>ISO 13408-6:2005 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products.</p> <p>ISO 13408-6:2005 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.</p> <p>ISO 13408-6:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to national or regional jurisdictions.</p>
- Avant-propos4
- Introduction5
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1 Domaine d'application5
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2 Références normatives6
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3 Termes et définitions6
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4 Systèmes de management de la qualité10
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5 Personnel11
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5.1 Management du personnel11
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5.2 Formation pour la qualification de la ZTA11
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5.3 Conditions sanitaires générales des employés12
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5.4 Surveillance du personnel12
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5.5 Vêtements de travail12
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6 Locaux13
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7 Milieu utilisé pour le procédé13
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7.1 Eau13
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7.2 Autres milieux15
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8 Qualification du matériel et des installations et validation du procédé16
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8.1 Généralités16
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8.2 Requalification et revalidation16
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9 Procédés16
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9.1 Nettoyage et désinfection de la ZTA16
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9.2 Biocharge17
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9.3 Endotoxines17
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9.4 Stérilisation, assemblage et utilisation du matériel et des ustensiles de remplissage18
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9.5 Nettoyage sur place18
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9.6 Stérilisation sur place à la vapeur19
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9.7 Fourniture à la ligne de remplissage de composants de conteneurs et de produit stérilisés19
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9.8 Filtration stérilisante20
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9.9 Suspensions produites de façon aseptique21
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9.10 Procédé de remplissage : interventions, rejets21
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9.11 Lyophilisation22
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9.12 Étanchéité et conditionnement final22
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10 Surveillance de l'environnement et contrôles22
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10.1 Programme de surveillance particulaire22
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10.2 Programme de surveillance microbiologique22
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10.3 Analyse des tendances de la surveillance de l'environnement23
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10.4 Enquêtes et rapports23
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11 Media fill (essais de simulation de procédé)24
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12 Essais de stérilité sur le produit fini24
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12.1 Généralités24
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12.2 Recherche de positifs lors des essais de stérilité24
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12.3 Plans d'échantillonnage24
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13 Libération du produit25
- Annexe A (normative) Salles propres conventionnelles26
- Annexe B (normative) Technologie des isolateurs31
- Annexe C (informative) Suspensions préparées de façon aseptique39
- Annexe D (normative) Lyophilisation40
- Annexe E (normative) Media 1111 (essais de simulation du procédé)44
- Annexe F (informative) Calcul du taux de contamination pour un nombre donné d'unités remplies de milieu de culture52
- Annexe ZA (informative) Articles de cette Norme européenne concernant les exigences essentielles ou les autres dispositions de la Directive du Conseil 90/385/CEE relative aux dispositifs médicaux implantables actifs55
- Annexe ZB (informative) Articles de cette Norme européenne concernant les exigences essentielles ou d'autres dispositions de la Directive du Conseil 93/42/CEE relative aux dispositifs médicaux56
- Bibliographie57
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