{"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

    \n
  • 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

          \n
        • 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 Prefilled syringesPart 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling Request a Quote Standard Summary The syringe leak test aims to verify the liquid leakage resistance of syringe closure systems under defined pressure conditions. According to Annex G2 of ISO 11040-4, the test simulates internal overpressure (typically 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. Discover the test method, apparatus.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.leakagetester.com\/fr\/standards\/iso-11040-4\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 11040-4 Syringe Leak Test - Closure System Liquid Leakage\" \/>\n<meta property=\"og:description\" content=\"Syringe leak test per ISO 11040-4 Annex G2 to ensure closure integrity. 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