{"id":2059,"date":"2025-04-22T02:54:20","date_gmt":"2025-04-22T02:54:20","guid":{"rendered":"https:\/\/www.pharmacopoeiatest.com\/?p=2059"},"modified":"2025-04-22T03:29:50","modified_gmt":"2025-04-22T03:29:50","slug":"flange-breakage-resistance-iso-11040-4","status":"publish","type":"post","link":"https:\/\/www.pharmacopoeiatest.com\/fr\/flange-breakage-resistance-iso-11040-4\/","title":{"rendered":"R\u00e9sistance \u00e0 la rupture des brides - ISO 11040-4 Annexe C1"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"2059\" class=\"elementor elementor-2059\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-99d088f e-flex e-con-boxed e-con e-parent\" data-id=\"99d088f\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-43cc8ff elementor-widget elementor-widget-heading\" data-id=\"43cc8ff\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">R\u00e9sistance \u00e0 la rupture de la bride<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f9d7284 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"f9d7284\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1129df5 elementor-widget elementor-widget-heading\" data-id=\"1129df5\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4 Annexe C1<\/h2>\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<div class=\"elementor-element elementor-element-b7ccfb2 e-flex e-con-boxed e-con e-parent\" data-id=\"b7ccfb2\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-254e154 elementor-widget elementor-widget-text-editor\" data-id=\"254e154\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"477\" data-end=\"932\"><em data-start=\"477\" data-end=\"505\">R\u00e9sistance \u00e0 la rupture de la bride<\/em> est un attribut de qualit\u00e9 essentiel dans la fabrication des seringues pr\u00e9remplies. Ce test d\u00e9termine la r\u00e9sistance m\u00e9canique de la collerette du corps de la seringue - la partie qui doit r\u00e9sister aux forces appliqu\u00e9es pendant l'utilisation clinique. \u00c0 mesure que les r\u00e9glementations en mati\u00e8re de soins de sant\u00e9 se durcissent \u00e0 l'\u00e9chelle mondiale, le respect des normes de performance m\u00e9canique d\u00e9crites dans la norme <a href=\"https:\/\/www.pharmacopoeiatest.com\/fr\/flange-breakage-resistance-iso-11040-4\/\"><strong data-start=\"819\" data-end=\"843\">ISO 11040-4 Annexe C1<\/strong><\/a> est essentiel pour les fabricants de seringues en verre et de seringues st\u00e9rilis\u00e9es sous-assembl\u00e9es.<\/p><p class=\"\" data-start=\"934\" data-end=\"1146\">Cell Instruments, leader dans le domaine des \u00e9quipements d'essai de pr\u00e9cision, propose des solutions robustes pour garantir que vos <em data-start=\"1037\" data-end=\"1054\">test \u00e0 la seringue<\/em> est conforme aux normes internationales tout en maximisant la pr\u00e9cision et l'efficacit\u00e9 op\u00e9rationnelle.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ededb4f elementor-widget elementor-widget-heading\" data-id=\"ededb4f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4 et son application au contr\u00f4le des seringues<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a1f63cd elementor-widget elementor-widget-text-editor\" data-id=\"a1f63cd\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"1223\" data-end=\"1586\"><a href=\"https:\/\/www.pharmacopoeiatest.com\/fr\/iso-11040-4\/\"><strong data-start=\"1223\" data-end=\"1238\">ISO 11040-4<\/strong><\/a> r\u00e9git les barils de verre pour les produits injectables, en mettant l'accent sur l'int\u00e9grit\u00e9 structurelle et la fonctionnalit\u00e9. Dans le cadre de la <em data-start=\"1346\" data-end=\"1368\">ISO 11040-4 Annexe C1<\/em>Des lignes directrices sp\u00e9cifiques sont \u00e9tablies pour l'\u00e9valuation des <em data-start=\"1418\" data-end=\"1446\">r\u00e9sistance \u00e0 la rupture de la bride<\/em>. L'objectif de ce test est de simuler les conditions dans lesquelles la collerette d'une seringue peut se rompre lors de la manipulation ou des processus de remplissage automatis\u00e9s.<\/p><p class=\"\" data-start=\"1588\" data-end=\"1752\">La norme s'applique non seulement aux seringues finales, mais aussi aux seringues sous-assembl\u00e9es st\u00e9rilis\u00e9es pr\u00eates \u00e0 \u00eatre remplies, ce qui garantit la coh\u00e9rence tout au long de la cha\u00eene d'approvisionnement.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d261813 elementor-widget elementor-widget-heading\" data-id=\"d261813\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">L'importance des essais de r\u00e9sistance \u00e0 la rupture des brides<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3f45136 elementor-widget elementor-widget-text-editor\" data-id=\"3f45136\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"1811\" data-end=\"2112\">Les seringues subissent de nombreuses contraintes m\u00e9caniques pendant le transport, le stockage, le remplissage et l'administration. La collerette, un \u00e9l\u00e9ment structurel situ\u00e9 \u00e0 l'extr\u00e9mit\u00e9 du corps de la seringue, est un point faible connu. Une d\u00e9faillance de la collerette peut compromettre la st\u00e9rilit\u00e9, la pr\u00e9cision du dosage et, en fin de compte, la s\u00e9curit\u00e9 du patient.<\/p><p class=\"\" data-start=\"2114\" data-end=\"2168\">Pr\u00e9cision <em data-start=\"2123\" data-end=\"2151\">r\u00e9sistance \u00e0 la rupture de la bride<\/em> les tests sont utiles :<\/p><ul><li data-start=\"2171\" data-end=\"2216\">Valider les processus de conception et de fabrication<\/li><li data-start=\"2171\" data-end=\"2216\">Respecter la conformit\u00e9 r\u00e9glementaire<\/li><li data-start=\"2171\" data-end=\"2216\">R\u00e9duire le risque de d\u00e9faillance du produit sur le terrain<\/li><li data-start=\"2171\" data-end=\"2216\">\u00c9tablir la confiance avec les organismes de r\u00e9glementation et les clients<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3fd48bf elementor-widget elementor-widget-heading\" data-id=\"3fd48bf\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4 Annexe C1 M\u00e9thode d'essai de r\u00e9sistance \u00e0 la rupture des brides<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ef26935 e-con-full e-flex e-con e-child\" data-id=\"ef26935\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-25fc654 e-con-full e-flex e-con e-child\" data-id=\"25fc654\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1372d22 elementor-widget elementor-widget-heading\" data-id=\"1372d22\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Test de r\u00e9sistance \u00e0 la rupture des brides requis<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c3c025e elementor-widget elementor-widget-text-editor\" data-id=\"c3c025e\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"2399\" data-end=\"2565\">La m\u00e9thode d\u00e9crite dans <strong data-start=\"2422\" data-end=\"2446\">ISO 11040-4 Annexe C1<\/strong> consiste \u00e0 appliquer une force de compression contr\u00f4l\u00e9e \u00e0 la bride du cylindre de la seringue jusqu'\u00e0 ce qu'elle c\u00e8de. Voici comment proc\u00e9der :<\/p><ul data-start=\"2590\" data-end=\"2834\"><li class=\"\" data-start=\"2590\" data-end=\"2707\"><p class=\"\" data-start=\"2592\" data-end=\"2707\"><strong data-start=\"2592\" data-end=\"2645\">Machine universelle d'essai de traction et de compression<\/strong> (par exemple, Cell Instruments <em>Testeur de seringues<\/em>)<\/p><\/li><li class=\"\" data-start=\"2708\" data-end=\"2766\"><p class=\"\" data-start=\"2710\" data-end=\"2766\"><strong data-start=\"2710\" data-end=\"2728\">Porte-seringue<\/strong> en mat\u00e9riau appropri\u00e9 tel que le PEEK<\/p><\/li><li class=\"\" data-start=\"2767\" data-end=\"2834\"><p class=\"\" data-start=\"2769\" data-end=\"2834\"><strong data-start=\"2769\" data-end=\"2784\">Goupille de chargement<\/strong>de pr\u00e9f\u00e9rence en polyac\u00e9tale avec un noyau en acier inoxydable<\/p><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a1e99e9 elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"a1e99e9\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"488\" height=\"1024\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-488x1024.webp\" class=\"attachment-large size-large wp-image-2048\" alt=\"Test d&#039;\u00e9tanch\u00e9it\u00e9 des seringues ISO 11040-4\" srcset=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-488x1024.webp 488w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-143x300.webp 143w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-768x1613.webp 768w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-731x1536.webp 731w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-975x2048.webp 975w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-scaled.webp 1219w\" sizes=\"(max-width: 488px) 100vw, 488px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d45498c e-con-full e-flex e-con e-child\" data-id=\"d45498c\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-91d25ab elementor-widget elementor-widget-heading\" data-id=\"91d25ab\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4 Annexe C1 Proc\u00e9dure d'essai<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-922228a elementor-widget elementor-widget-text-editor\" data-id=\"922228a\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"2858\" data-end=\"2884\"><strong data-start=\"2858\" data-end=\"2882\">1. Pr\u00e9paration des \u00e9chantillons d'essai<br \/><\/strong><span style=\"font-size: 16px;\">\u00c9viter les chocs avant le test. Inspecter visuellement chaque seringue et son support pour v\u00e9rifier qu'ils ne sont pas endommag\u00e9s.<\/span><\/p><p class=\"\" data-start=\"2975\" data-end=\"2986\"><strong data-start=\"2975\" data-end=\"2984\">2. Configuration de la machine d'essai<br \/><\/strong><span style=\"font-size: 16px;\">Placez le corps de la seringue dans le support. Alignez la broche de chargement pr\u00e8s de l'\u00e9paule de la seringue comme indiqu\u00e9 dans le tableau ci-dessous. <\/span><strong style=\"font-size: 16px;\" data-start=\"3091\" data-end=\"3105\">Figure C.2<\/strong><span style=\"font-size: 16px;\"> de la norme ISO.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1c20220 elementor-widget__width-inherit elementor-widget elementor-widget-image\" data-id=\"1c20220\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"451\" height=\"297\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Annex-C1.png\" class=\"attachment-large size-large wp-image-2064\" alt=\"ISO 11040-4 Annexe C1 r\u00e9sistance \u00e0 la rupture de la bride\" srcset=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Annex-C1.png 451w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Annex-C1-300x198.png 300w\" sizes=\"(max-width: 451px) 100vw, 451px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0bc0e73 elementor-widget elementor-widget-text-editor\" data-id=\"0bc0e73\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"3131\" data-end=\"3151\"><strong data-start=\"3131\" data-end=\"3149\">3. Ex\u00e9cution des tests<\/strong><\/p><ul><li data-start=\"3131\" data-end=\"3151\">R\u00e9gler la vitesse de la machine sur <strong data-start=\"3182\" data-end=\"3196\">100 mm\/min<\/strong> (ou par accord).<\/li><li data-start=\"3131\" data-end=\"3151\">Lancer l'essai et appliquer la force jusqu'\u00e0 ce que la bride se brise.<\/li><li data-start=\"3131\" data-end=\"3151\">Enregistrer <strong style=\"font-size: 16px;\" data-start=\"3302\" data-end=\"3328\">force en fonction du d\u00e9placement<\/strong><span style=\"font-size: 16px;\"> pour cr\u00e9er une courbe.<\/span><\/li><\/ul><p class=\"\" data-start=\"3131\" data-end=\"3151\"><strong data-start=\"3352\" data-end=\"3369\">4. Analyse des donn\u00e9es<br \/><\/strong>Identifiez la force maximale sur la courbe - cette valeur repr\u00e9sente la <em data-start=\"3442\" data-end=\"3470\">r\u00e9sistance \u00e0 la rupture de la bride<\/em>.<\/p><p class=\"\" data-start=\"3478\" data-end=\"3493\"><strong data-start=\"3478\" data-end=\"3491\">5. Rapports<br \/><\/strong><span style=\"font-size: 16px;\">Inclure la vitesse d'essai, le nombre d'\u00e9chantillons, les valeurs maximales et toute anomalie. Veiller \u00e0 ce que la documentation r\u00e9ponde aux exigences de tra\u00e7abilit\u00e9 ISO.<\/span><\/p>\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\t\t<div class=\"elementor-element elementor-element-a9006f3 elementor-widget elementor-widget-heading\" data-id=\"a9006f3\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Testeur de seringue de Cell Instruments<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e501b92 e-con-full e-flex e-con e-child\" data-id=\"e501b92\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-7a2147d e-con-full e-flex e-con e-child\" data-id=\"7a2147d\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-67dcd66 elementor-widget elementor-widget-heading\" data-id=\"67dcd66\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Machine d'essai de seringues Avantages principaux<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fb2553c elementor-widget elementor-widget-text-editor\" data-id=\"fb2553c\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul><li data-start=\"4049\" data-end=\"4092\">Compatible avec les fixations sp\u00e9cifiques aux seringues<\/li><li data-start=\"4049\" data-end=\"4092\">Repr\u00e9sentation graphique en temps r\u00e9el de la force et du d\u00e9placement<\/li><li data-start=\"4049\" data-end=\"4092\">Vitesses et plages de charge r\u00e9glables<\/li><li data-start=\"4049\" data-end=\"4092\">Micro-imprimante int\u00e9gr\u00e9e et port RS232 en option pour une exportation transparente des donn\u00e9es<\/li><\/ul><p class=\"\" data-start=\"4258\" data-end=\"4427\">La modularit\u00e9 du syst\u00e8me en fait un outil id\u00e9al pour les entreprises qui s'engagent dans des projets globaux de d\u00e9veloppement durable. <em data-start=\"4336\" data-end=\"4353\">test \u00e0 la seringue<\/em>, y compris <em data-start=\"4365\" data-end=\"4393\">r\u00e9sistance \u00e0 la rupture de la bride<\/em> et d'autres \u00e9valuations m\u00e9caniques.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9b6dbd6 e-con-full e-flex e-con e-child\" data-id=\"9b6dbd6\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2c4684f elementor-widget elementor-widget-heading\" data-id=\"2c4684f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Meilleures pratiques pour les machines \u00e0 tester les seringues<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f42b687 elementor-widget elementor-widget-text-editor\" data-id=\"f42b687\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul><li data-start=\"4495\" data-end=\"4556\"><strong data-start=\"4495\" data-end=\"4526\">Utiliser l'\u00e9chantillonnage \u00e0 haute fr\u00e9quence<\/strong> (\u2265500 Hz) pour une pr\u00e9cision maximale<\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4559\" data-end=\"4584\">V\u00e9rifier l'alignement du test<\/strong><span style=\"font-size: 16px;\"> avant chaque ex\u00e9cution pour \u00e9viter les fausses lectures<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4629\" data-end=\"4655\">Remplacer les composants us\u00e9s<\/strong><span style=\"font-size: 16px;\"> (broche de chargement, support) r\u00e9guli\u00e8rement pour maintenir la coh\u00e9rence<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4716\" data-end=\"4739\">Tout documenter<\/strong><span style=\"font-size: 16px;\">les \u00e9carts, m\u00eame mineurs, afin d'am\u00e9liorer la tra\u00e7abilit\u00e9<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4792\" data-end=\"4822\">Collaborer avec les clients<\/strong><span style=\"font-size: 16px;\"> se mettre d'accord sur les vitesses d'essai et l'\u00e9talonnage des \u00e9quipements<\/span><\/li><\/ul>\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\t\t<div class=\"elementor-element elementor-element-20579e3 elementor-widget elementor-widget-text-editor\" data-id=\"20579e3\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"4897\" data-end=\"5170\">Le test de r\u00e9sistance \u00e0 la rupture des brides n'est pas seulement une case \u00e0 cocher de conformit\u00e9 - c'est un \u00e9l\u00e9ment essentiel de l'assurance qualit\u00e9 des produits pour les fabricants de seringues. En alignant les pratiques de test sur les normes de <strong data-start=\"5075\" data-end=\"5099\"><a href=\"https:\/\/www.iso.org\/standard\/82222.html\" target=\"_blank\" rel=\"noopener\">ISO 11040-4<\/a> Annexe C1<\/strong>vous pouvez garantir la durabilit\u00e9, la s\u00e9curit\u00e9 et l'acceptation r\u00e9glementaire du produit.<\/p><p class=\"\" data-start=\"5172\" data-end=\"5418\"><a href=\"https:\/\/www.pharmacopoeiatest.com\/fr\/\" target=\"_blank\" rel=\"noopener\"><strong data-start=\"5172\" data-end=\"5192\">Instruments cellulaires<\/strong><\/a> est votre partenaire de confiance pour atteindre l'excellence en mati\u00e8re de tests. Nos services <strong>Testeur de seringues<\/strong>\u00a0permet de rationaliser les flux de travail des tests de seringues tout en garantissant la pr\u00e9cision et la conformit\u00e9 exig\u00e9es par les normes de soins de sant\u00e9 modernes.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b3e233b elementor-widget elementor-widget-text-editor\" data-id=\"b3e233b\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"5420\" data-end=\"5503\">Laissez-nous vous aider \u00e0 mettre au point des produits performants et conformes \u00e0 la r\u00e9glementation.<\/p>\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\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Flange Breakage Resistance ISO 11040-4 Annex C1 Flange breakage resistance is a critical quality attribute in prefilled syringe manufacturing. This test determines the mechanical strength of the syringe barrel\u2019s flange\u2014the portion that must withstand applied forces during clinical use. As healthcare regulations tighten globally, meeting the mechanical performance standards outlined in ISO 11040-4 Annex C1 [&hellip;]<\/p>","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"categories":[26],"tags":[],"class_list":["post-2059","post","type-post","status-publish","format-standard","hentry","category-blog"],"acf":[],"uagb_featured_image_src":{"full":false,"thumbnail":false,"medium":false,"medium_large":false,"large":false,"1536x1536":false,"2048x2048":false,"trp-custom-language-flag":false},"uagb_author_info":{"display_name":"pharmacopoeiatest","author_link":"https:\/\/www.pharmacopoeiatest.com\/fr\/author\/pharmacopoeiatest\/"},"uagb_comment_info":0,"uagb_excerpt":"Flange Breakage Resistance ISO 11040-4 Annex C1 Flange breakage resistance is a critical quality attribute in prefilled syringe manufacturing. This test determines the mechanical strength of the syringe barrel\u2019s flange\u2014the portion that must withstand applied forces during clinical use. As healthcare regulations tighten globally, meeting the mechanical performance standards outlined in ISO 11040-4 Annex C1\u2026","_links":{"self":[{"href":"https:\/\/www.pharmacopoeiatest.com\/fr\/wp-json\/wp\/v2\/posts\/2059","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/fr\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/fr\/wp-json\/wp\/v2\/comments?post=2059"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/fr\/wp-json\/wp\/v2\/posts\/2059\/revisions"}],"predecessor-version":[{"id":2072,"href":"https:\/\/www.pharmacopoeiatest.com\/fr\/wp-json\/wp\/v2\/posts\/2059\/revisions\/2072"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/fr\/wp-json\/wp\/v2\/media?parent=2059"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/fr\/wp-json\/wp\/v2\/categories?post=2059"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/fr\/wp-json\/wp\/v2\/tags?post=2059"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}