{"id":4110,"date":"2025-05-26T17:13:43","date_gmt":"2025-05-26T09:13:43","guid":{"rendered":"https:\/\/www.leakagetester.com\/?page_id=4110"},"modified":"2025-05-27T08:28:34","modified_gmt":"2025-05-27T00:28:34","slug":"iso-11040-4","status":"publish","type":"page","link":"https:\/\/www.leakagetester.com\/fr\/standards\/iso-11040-4\/","title":{"rendered":"ISO 11040-4"},"content":{"rendered":"
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ISO 11040-4<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Seringues pr\u00e9remplies
Partie 4 : F\u00fbts en verre pour produits injectables et seringues sous-assembl\u00e9es st\u00e9rilis\u00e9es pr\u00eates \u00e0 \u00eatre remplies<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tDemander un devis<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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R\u00e9sum\u00e9 standard<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Le test d'\u00e9tanch\u00e9it\u00e9 de la seringue a pour but de v\u00e9rifier les \u00e9l\u00e9ments suivants r\u00e9sistance aux fuites de liquides des syst\u00e8mes de fermeture de seringues<\/strong> dans des conditions de pression d\u00e9finies. Selon le Annexe G2 de la norme ISO 11040-4<\/em>Ce test simule la surpression interne (typiquement 110 kPa) que les seringues peuvent subir pendant le remplissage ou le transport.<\/p>\n

Ce test \u00e9value \u00e0 la fois les protections d'aiguille<\/strong> et capuchons d'embout<\/strong>Ces fermetures restent s\u00fbres et ne fuient pas sous l'effet du stress.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Cette \u00e9valuation est essentielle pour le contr\u00f4le de la qualit\u00e9 des produits pharmaceutiques, la pr\u00e9vention de la contamination et la pr\u00e9servation de la pr\u00e9cision du dosage.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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M\u00e9thode d'essai de fuite de liquide du syst\u00e8me de fermeture de seringue<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Principales \u00e9tapes de l'essai (conform\u00e9ment \u00e0 l'annexe G2 de la norme ISO 11040-4) :<\/strong><\/p>\n

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  • Pr\u00e9paration des \u00e9chantillons :<\/strong> Utiliser des seringues st\u00e9rilis\u00e9es, sous-assembl\u00e9es et pr\u00eates \u00e0 \u00eatre remplies. \u00c9viter de d\u00e9ranger le bouchon avant le test.<\/li>\n
  • P\u00e9riode d'attente :<\/strong> Il faut attendre au moins 12 heures entre la fixation du bouchon et le test.<\/li>\n
  • Garniture :<\/strong> Remplir la seringue entre 1\/3 et 2\/3 de son volume nominal avec de l'eau distill\u00e9e ou de puret\u00e9 \u00e9quivalente.<\/li>\n
  • Pressurisation :<\/strong> Appliquer 110 kPa<\/strong> pression \u00e0 l'aide d'air comprim\u00e9 ou d'un machine universelle d'essai de traction et de compression<\/strong>. Tenir pour 5 secondes<\/strong>.<\/li>\n
  • Contr\u00f4le :<\/strong> Observez les fuites de liquide pendant et apr\u00e8s le test. Les fuites apparaissent sous forme de gouttelettes visibles sur la surface ext\u00e9rieure de la fermeture.<\/li>\n
  • Crit\u00e8res de r\u00e9ussite :<\/strong> Aucune gouttelette ne doit \u00eatre visible et la fermeture (capuchon ou protection de l'aiguille) doit rester en place.<\/li>\n<\/ul>\n
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    Le test est valable pour les seringues et les sous-ensembles st\u00e9riles. L'inspection visuelle est essentielle pour d\u00e9terminer les r\u00e9sultats de r\u00e9ussite ou d'\u00e9chec.<\/p>\n<\/blockquote>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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    \u00c9quipement essentiel pour le test d'\u00e9tanch\u00e9it\u00e9 des seringues<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    L'\u00e9quipement mis en place pour ce test comprend<\/p>\n

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    • Testeur universel de traction et de compression<\/strong> ou syst\u00e8me de pressurisation de l'air comprim\u00e9<\/strong><\/li>\n
    • Porte-seringue<\/strong> avec un m\u00e9canisme de fermeture s\u00e9curis\u00e9<\/li>\n
    • Manom\u00e8tre ou logiciel<\/strong> capable d'atteindre et de maintenir 110 kPa<\/li>\n
    • Syst\u00e8me d'acquisition de donn\u00e9es \u00e0 haute fr\u00e9quence d'\u00e9chantillonnage<\/strong> (recommand\u00e9 500 Hz pour les mesures de cr\u00eate)<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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      Solutions de Cell Instruments :<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      Effectuer des tests d'\u00e9tanch\u00e9it\u00e9 des seringues conform\u00e9ment \u00e0 la norme ISO 11040-4, Cell Instruments propose des plates-formes de test \u00e0 seringue personnalisables<\/strong>Nos syst\u00e8mes sont compatibles avec les m\u00e9thodes d'application de l'air comprim\u00e9 et de la force m\u00e9canique. Nos syst\u00e8mes garantissent :<\/p>\n

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      • Contr\u00f4le pr\u00e9cis de la pression interne<\/strong><\/li>\n
      • Echantillonnage haute fr\u00e9quence jusqu'\u00e0 500 Hz<\/strong><\/li>\n
      • Conformit\u00e9 totale avec les proc\u00e9dures d'essai ISO<\/strong><\/li>\n
      • Fonctions de documentation automatis\u00e9e<\/strong> pour des rapports pr\u00eats \u00e0 \u00eatre audit\u00e9s<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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        Solutions de Cell Instruments :<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        Effectuer des tests d'\u00e9tanch\u00e9it\u00e9 des seringues conform\u00e9ment \u00e0 la norme ISO 11040-4, Cell Instruments propose des plates-formes de test \u00e0 seringue personnalisables<\/strong>Nos syst\u00e8mes sont compatibles avec les m\u00e9thodes d'application de l'air comprim\u00e9 et de la force m\u00e9canique. Nos syst\u00e8mes garantissent :<\/p>\n

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        • Contr\u00f4le pr\u00e9cis de la pression interne<\/strong><\/li>\n
        • Echantillonnage haute fr\u00e9quence jusqu'\u00e0 500 Hz<\/strong><\/li>\n
        • Conformit\u00e9 totale avec les proc\u00e9dures d'essai ISO<\/strong><\/li>\n
        • Fonctions de documentation automatis\u00e9e<\/strong> pour des rapports pr\u00eats \u00e0 \u00eatre audit\u00e9s<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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          Enregistrement des donn\u00e9es et documentation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          Selon le Annexe G2<\/em>Un rapport d'essai complet doit comprendre<\/p>\n

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          • Pression appliqu\u00e9e<\/strong> (kPa) ou force \u00e9quivalente (N)<\/li>\n
          • Nombre de seringues test\u00e9es<\/strong><\/li>\n
          • Nombre d'\u00e9chantillons r\u00e9ussis\/\u00e9checs<\/strong><\/li>\n
          • Observations visuelles ou d\u00e9viations<\/strong><\/li>\n
          • \n

            Tra\u00e7abilit\u00e9 des param\u00e8tres de configuration<\/strong> (manuellement ou par logiciel)<\/p>\n<\/li>\n<\/ul>\n

            En documentant les conditions d'essai et les r\u00e9sultats, les fabricants d\u00e9montrent leur conformit\u00e9 \u00e0 la norme ISO 11040-4 et s'assurent que tra\u00e7abilit\u00e9 r\u00e9glementaire<\/strong>-un must pour les syst\u00e8mes de qualit\u00e9 pharmaceutiques.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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            Calcul de la force interne<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            Pour les installations appliquant une force m\u00e9canique au lieu d'une pression d'air, le nombre requis de force (F)<\/strong> pour simuler une pression interne de 110 kPa peut \u00eatre calcul\u00e9e en utilisant les formules de la norme ISO 11040-4 :<\/p>\n

            \n

            F = p \u00d7 \u03c0\/4 \u00d7 d\u00b2 \u00d7 10-\u00b3<\/strong>
            O\u00f9 ?<\/p>\n<\/blockquote>\n

              \n
            • F<\/strong> = Force en Newtons<\/li>\n
            • p<\/strong> = Pression (110 kPa)<\/li>\n
            • d<\/strong> = Diam\u00e8tre interne de la seringue (mm)<\/li>\n<\/ul>\n

              Ce calcul permet de garantir r\u00e9plication pr\u00e9cise des tests<\/strong> et l'\u00e9talonnage des appareils.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

              ISO 11040-4 Seringues pr\u00e9rempliesPartie 4 : Barils en verre pour produits injectables et seringues sous-assembl\u00e9es st\u00e9rilis\u00e9es pr\u00eates \u00e0 \u00eatre remplies Demander un devis R\u00e9sum\u00e9 de la norme Le test d'\u00e9tanch\u00e9it\u00e9 des seringues vise \u00e0 v\u00e9rifier la r\u00e9sistance aux fuites de liquide des syst\u00e8mes de fermeture des seringues dans des conditions de pression d\u00e9finies. Selon l'annexe G2 de l'ISO 11040-4, le test simule une surpression interne (typiquement 110 kPa) [...]","protected":false},"author":2,"featured_media":0,"parent":2112,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"_uag_custom_page_level_css":"","footnotes":""},"class_list":["post-4110","page","type-page","status-publish","hentry"],"yoast_head":"\nISO 11040-4 Syringe Leak Test - Closure System Liquid Leakage<\/title>\n<meta name=\"description\" content=\"Syringe leak test per ISO 11040-4 Annex G2 to ensure closure integrity. 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