{"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\/es\/flange-breakage-resistance-iso-11040-4\/","title":{"rendered":"Resistencia a la rotura de bridas - ISO 11040-4 Anexo 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\">Resistencia a la rotura de bridas<\/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 Anexo 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\">Resistencia a la rotura de la brida<\/em> es un atributo de calidad cr\u00edtico en la fabricaci\u00f3n de jeringuillas precargadas. Esta prueba determina la resistencia mec\u00e1nica de la brida de la jeringa, la parte que debe soportar las fuerzas aplicadas durante el uso cl\u00ednico. A medida que las normativas sanitarias se hacen m\u00e1s estrictas en todo el mundo, el cumplimiento de las normas de rendimiento mec\u00e1nico descritas en <a href=\"https:\/\/www.pharmacopoeiatest.com\/es\/flange-breakage-resistance-iso-11040-4\/\"><strong data-start=\"819\" data-end=\"843\">ISO 11040-4 Anexo C1<\/strong><\/a> es esencial para los fabricantes de jeringuillas de vidrio y jeringuillas subensambladas esterilizadas.<\/p><p class=\"\" data-start=\"934\" data-end=\"1146\">Cell Instruments, l\u00edder en equipos de ensayo de precisi\u00f3n, ofrece soluciones robustas para garantizar que su <em data-start=\"1037\" data-end=\"1054\">pruebas con jeringa<\/em> cumple las normas internacionales al tiempo que maximiza la precisi\u00f3n y la eficacia operativa.<\/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 y su aplicaci\u00f3n en los ensayos con jeringuillas<\/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\/es\/iso-11040-4\/\"><strong data-start=\"1223\" data-end=\"1238\">ISO 11040-4<\/strong><\/a> rige los barriles de vidrio para inyectables, centr\u00e1ndose especialmente en la integridad estructural y la funcionalidad. En <em data-start=\"1346\" data-end=\"1368\">ISO 11040-4 Anexo C1<\/em>se establecen directrices espec\u00edficas para evaluar <em data-start=\"1418\" data-end=\"1446\">resistencia a la rotura de la brida<\/em>. El objetivo de este ensayo es simular las condiciones en las que podr\u00eda romperse la brida de una jeringa durante su manipulaci\u00f3n o en procesos de llenado automatizados.<\/p><p class=\"\" data-start=\"1588\" data-end=\"1752\">La norma se aplica no s\u00f3lo a las jeringuillas finales, sino tambi\u00e9n a las jeringuillas subensambladas esterilizadas listas para su llenado, lo que garantiza la coherencia en toda la cadena de suministro.<\/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\">Por qu\u00e9 son importantes las pruebas de resistencia a la rotura de bridas<\/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\">Las jeringuillas est\u00e1n sometidas a numerosas tensiones mec\u00e1nicas durante su transporte, almacenamiento, llenado y administraci\u00f3n. La brida, un componente estructural situado en el extremo de la jeringa, es un punto d\u00e9bil conocido. Si la brida falla, puede comprometer la esterilidad, la precisi\u00f3n de la dosificaci\u00f3n y, en \u00faltima instancia, la seguridad del paciente.<\/p><p class=\"\" data-start=\"2114\" data-end=\"2168\">Preciso <em data-start=\"2123\" data-end=\"2151\">resistencia a la rotura de la brida<\/em> las pruebas ayudan:<\/p><ul><li data-start=\"2171\" data-end=\"2216\">Validar los procesos de dise\u00f1o y fabricaci\u00f3n<\/li><li data-start=\"2171\" data-end=\"2216\">Cumplir la normativa<\/li><li data-start=\"2171\" data-end=\"2216\">Reduzca el riesgo de fallo del producto sobre el terreno<\/li><li data-start=\"2171\" data-end=\"2216\">Generar confianza con los organismos reguladores y los clientes<\/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 Anexo C1 M\u00e9todo de ensayo de resistencia a la rotura de bridas<\/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\">Comprobador de resistencia a la rotura de bridas necesario<\/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\">El m\u00e9todo descrito en <strong data-start=\"2422\" data-end=\"2446\">ISO 11040-4 Anexo C1<\/strong> consiste en aplicar una fuerza de compresi\u00f3n controlada a la brida de la jeringa hasta que falle. As\u00ed es como se hace:<\/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\">M\u00e1quina universal de ensayos de tracci\u00f3n y compresi\u00f3n<\/strong> (por ejemplo, Cell Instruments' <em>Comprobador de jeringuillas<\/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\">Soporte para jeringuillas<\/strong> de un material adecuado, como 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\">Pasador de carga<\/strong>preferiblemente poliacetal con n\u00facleo de acero inoxidable<\/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=\"Prueba de fugas en jeringas 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 Anexo C1 Procedimiento de ensayo<\/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. Preparar las muestras de ensayo<br \/><\/strong><span style=\"font-size: 16px;\">Evite los choques previos a la prueba. Inspeccione visualmente cada jeringa y soporte en busca de da\u00f1os.<\/span><\/p><p class=\"\" data-start=\"2975\" data-end=\"2986\"><strong data-start=\"2975\" data-end=\"2984\">2. Configuraci\u00f3n de la m\u00e1quina de ensayo<br \/><\/strong><span style=\"font-size: 16px;\">Coloque la jeringa en el soporte. Alinee el pasador de carga cerca del hombro de la jeringa seg\u00fan <\/span><strong style=\"font-size: 16px;\" data-start=\"3091\" data-end=\"3105\">Figura C.2<\/strong><span style=\"font-size: 16px;\"> de la norma 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 Anexo C1 resistencia a la rotura de la brida\" 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. Ejecuci\u00f3n de las pruebas<\/strong><\/p><ul><li data-start=\"3131\" data-end=\"3151\">Ajuste la velocidad de la m\u00e1quina a <strong data-start=\"3182\" data-end=\"3196\">100 mm\/min<\/strong> (o por acuerdo).<\/li><li data-start=\"3131\" data-end=\"3151\">Inicie la prueba y aplique fuerza hasta que se produzca la rotura de la brida.<\/li><li data-start=\"3131\" data-end=\"3151\">Registro <strong style=\"font-size: 16px;\" data-start=\"3302\" data-end=\"3328\">fuerza vs. desplazamiento<\/strong><span style=\"font-size: 16px;\"> para crear una curva.<\/span><\/li><\/ul><p class=\"\" data-start=\"3131\" data-end=\"3151\"><strong data-start=\"3352\" data-end=\"3369\">4. 4. An\u00e1lisis de datos<br \/><\/strong>Identifique la fuerza m\u00e1xima de la curva: este valor representa la <em data-start=\"3442\" data-end=\"3470\">resistencia a la rotura de la brida<\/em>.<\/p><p class=\"\" data-start=\"3478\" data-end=\"3493\"><strong data-start=\"3478\" data-end=\"3491\">5. Informes<br \/><\/strong><span style=\"font-size: 16px;\">Incluya la velocidad de la prueba, el n\u00famero de muestras, los valores m\u00e1ximos y cualquier anomal\u00eda. Aseg\u00farese de que la documentaci\u00f3n cumple los requisitos de trazabilidad 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\">Comprobador de jeringas 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\">Principales ventajas de la m\u00e1quina de ensayo con jeringa<\/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 con accesorios espec\u00edficos para jeringas<\/li><li data-start=\"4049\" data-end=\"4092\">Gr\u00e1fico en tiempo real de fuerza-desplazamiento<\/li><li data-start=\"4049\" data-end=\"4092\">Velocidades y rangos de carga ajustables<\/li><li data-start=\"4049\" data-end=\"4092\">Microimpresora integrada y puerto RS232 opcional para exportar datos sin problemas<\/li><\/ul><p class=\"\" data-start=\"4258\" data-end=\"4427\">La modularidad del sistema lo hace ideal para las empresas que se dedican a la <em data-start=\"4336\" data-end=\"4353\">pruebas con jeringa<\/em>incluyendo <em data-start=\"4365\" data-end=\"4393\">resistencia a la rotura de la brida<\/em> y otras evaluaciones mec\u00e1nicas.<\/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\">Pr\u00e1cticas recomendadas para m\u00e1quinas de ensayo con jeringuillas<\/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\">Utilizar el muestreo de alta frecuencia<\/strong> (\u2265500 Hz) para precisi\u00f3n de pico<\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4559\" data-end=\"4584\">Verificar la alineaci\u00f3n de la prueba<\/strong><span style=\"font-size: 16px;\"> antes de cada ejecuci\u00f3n para evitar lecturas err\u00f3neas<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4629\" data-end=\"4655\">Cambiar los componentes desgastados<\/strong><span style=\"font-size: 16px;\"> (pasador de carga, soporte) con regularidad para mantener la coherencia<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4716\" data-end=\"4739\">Docum\u00e9ntelo todo<\/strong><span style=\"font-size: 16px;\">incluso peque\u00f1as desviaciones, para mejorar la trazabilidad<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4792\" data-end=\"4822\">Colaborar con los clientes<\/strong><span style=\"font-size: 16px;\"> acordar la velocidad de las pruebas y la calibraci\u00f3n de los equipos<\/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\">Las pruebas de resistencia a la rotura de bridas no son s\u00f3lo una casilla de verificaci\u00f3n de conformidad, sino una parte vital de la garant\u00eda de calidad del producto para los fabricantes de jeringuillas. Alineando las pr\u00e1cticas de ensayo con <strong data-start=\"5075\" data-end=\"5099\"><a href=\"https:\/\/www.iso.org\/standard\/82222.html\" target=\"_blank\" rel=\"noopener\">ISO 11040-4<\/a> Anexo C1<\/strong>puede garantizar la durabilidad del producto, su seguridad y la aceptaci\u00f3n de la normativa.<\/p><p class=\"\" data-start=\"5172\" data-end=\"5418\"><a href=\"https:\/\/www.pharmacopoeiatest.com\/es\/\" target=\"_blank\" rel=\"noopener\"><strong data-start=\"5172\" data-end=\"5192\">Instrumentos celulares<\/strong><\/a> es su socio de confianza para lograr la excelencia en las pruebas. Nuestra <strong>Comprobador de jeringuillas<\/strong>\u00a0ayuda a agilizar los flujos de trabajo de las pruebas con jeringuillas al tiempo que ofrece la precisi\u00f3n y el cumplimiento exigidos por las normas sanitarias modernas.<\/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\">Perm\u00edtanos ayudarle en su camino hacia productos de alto rendimiento que cumplan la normativa.<\/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\/es\/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&hellip;","_links":{"self":[{"href":"https:\/\/www.pharmacopoeiatest.com\/es\/wp-json\/wp\/v2\/posts\/2059","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/es\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/es\/wp-json\/wp\/v2\/comments?post=2059"}],"version-history":[{"count":4,"href":"https:\/\/www.pharmacopoeiatest.com\/es\/wp-json\/wp\/v2\/posts\/2059\/revisions"}],"predecessor-version":[{"id":2072,"href":"https:\/\/www.pharmacopoeiatest.com\/es\/wp-json\/wp\/v2\/posts\/2059\/revisions\/2072"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/es\/wp-json\/wp\/v2\/media?parent=2059"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/es\/wp-json\/wp\/v2\/categories?post=2059"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/es\/wp-json\/wp\/v2\/tags?post=2059"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}