{"id":4067,"date":"2025-04-22T13:58:51","date_gmt":"2025-04-22T05:58:51","guid":{"rendered":"https:\/\/www.leakagetester.com\/?page_id=4067"},"modified":"2025-04-22T14:46:01","modified_gmt":"2025-04-22T06:46:01","slug":"iso-8871-5","status":"publish","type":"page","link":"https:\/\/www.leakagetester.com\/es\/standards\/iso-8871-5\/","title":{"rendered":"ISO 8871-5"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"4067\" class=\"elementor elementor-4067\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-40854497 e-con-full e-flex e-con e-parent\" data-id=\"40854497\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-7b6e2650 e-con-full e-flex e-con e-child\" data-id=\"7b6e2650\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1ed62b75 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"1ed62b75\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">ISO 8871-5<\/h1>\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-649c5ca3 e-con-full e-flex e-con e-child\" data-id=\"649c5ca3\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-528d414f elementor-widget elementor-widget-heading\" data-id=\"528d414f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">Piezas elastom\u00e9ricas para parenterales y para dispositivos de uso farmac\u00e9utico<br>Parte 5: Requisitos funcionales y ensayos<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4227f1f3 elementor-tablet-align-center elementor-mobile-align-center elementor-widget__width-inherit elementor-invisible elementor-widget elementor-widget-button\" data-id=\"4227f1f3\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;,&quot;_animation_delay&quot;:200}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"\/es\/contact\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Solicitar cotizaci\u00f3n<\/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<div class=\"elementor-element elementor-element-7f37671f e-flex e-con-boxed e-con e-parent\" data-id=\"7f37671f\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-7479e6a9 e-con-full e-flex e-con e-child\" data-id=\"7479e6a9\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2c1f01b8 elementor-widget elementor-widget-heading\" data-id=\"2c1f01b8\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Resumen est\u00e1ndar<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a7ff4e2 elementor-widget elementor-widget-text-editor\" data-id=\"a7ff4e2\" 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\t\t<p>Mantener la esterilidad de los medicamentos parenterales es una preocupaci\u00f3n cr\u00edtica en las industrias farmac\u00e9utica y de dispositivos m\u00e9dicos. <strong data-start=\"519\" data-end=\"533\">ISO 8871-5<\/strong> proporciona un enfoque de ensayo estructurado para evaluar la integridad funcional de los cierres elastom\u00e9ricos utilizados con viales de inyecci\u00f3n. En concreto, describe procedimientos para determinar <strong data-start=\"713\" data-end=\"749\">vial cierre de goma autosellante<\/strong> rendimiento y estanqueidad de la interfaz cierre-vial en condiciones de tensi\u00f3n simuladas.<\/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<div class=\"elementor-element elementor-element-58d7dfdf e-con-full e-flex e-con e-child\" data-id=\"58d7dfdf\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4aba77f5 elementor-widget elementor-widget-image\" data-id=\"4aba77f5\" 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\t\t\t<a href=\"https:\/\/www.astm.org\/d3078-02r21e01.html\" target=\"_blank\">\n\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"600\" height=\"200\" src=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2025\/04\/ISO-8871-5.webp\" class=\"attachment-medium size-medium wp-image-4076\" alt=\"ISO 8871-5\" srcset=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2025\/04\/ISO-8871-5.webp 600w, https:\/\/www.leakagetester.com\/wp-content\/uploads\/2025\/04\/ISO-8871-5-18x6.webp 18w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\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\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-38d9a2dc e-flex e-con-boxed e-con e-parent\" data-id=\"38d9a2dc\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-22b1040c e-con-full e-flex e-con e-child\" data-id=\"22b1040c\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2c1b4a01 elementor-widget elementor-widget-heading\" data-id=\"2c1b4a01\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Descripci\u00f3n est\u00e1ndar<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2dbe846b elementor-widget elementor-widget-text-editor\" data-id=\"2dbe846b\" 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\t\t<p class=\"\" data-start=\"1055\" data-end=\"1447\"><strong data-start=\"1055\" data-end=\"1069\">ISO 8871-5<\/strong>, titulado <em data-start=\"1078\" data-end=\"1200\">\"Piezas elastom\u00e9ricas para parenterales y para productos de uso farmac\u00e9utico - Parte 5: Requisitos funcionales y ensayos\"<\/em>define los requisitos de rendimiento y los m\u00e9todos de ensayo para los tapones de caucho utilizados en envases m\u00e9dicos est\u00e9riles. Estos cierres a menudo se someten a perforaciones repetidas con agujas hipod\u00e9rmicas y deben preservar la integridad del envase mediante un resellado eficaz.<\/p><p class=\"\" data-start=\"1449\" data-end=\"1719\">Fracaso en <strong data-start=\"1460\" data-end=\"1478\">prueba de fugas en vial<\/strong> pueden comprometer la esterilidad, con el consiguiente riesgo de contaminaci\u00f3n, dosificaci\u00f3n incorrecta o degradaci\u00f3n de la eficacia. Por ello, los fabricantes y los profesionales del control de calidad siguen de cerca esta norma para garantizar el cumplimiento de la normativa y la seguridad del paciente.<\/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<div class=\"elementor-element elementor-element-346b4bef e-con-full e-flex e-con e-child\" data-id=\"346b4bef\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7704d43d elementor-widget elementor-widget-image\" data-id=\"7704d43d\" 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\t\t<img decoding=\"async\" width=\"1020\" height=\"578\" src=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/11\/Bottle-Vacuum-Leak-Test--1400x793.webp\" class=\"attachment-large size-large wp-image-3757\" alt=\"Prueba de fugas de vac\u00edo de botellas\" srcset=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/11\/Bottle-Vacuum-Leak-Test--1400x793.webp 1400w, https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/11\/Bottle-Vacuum-Leak-Test--706x400.webp 706w, https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/11\/Bottle-Vacuum-Leak-Test--768x435.webp 768w, https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/11\/Bottle-Vacuum-Leak-Test--1536x870.webp 1536w, https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/11\/Bottle-Vacuum-Leak-Test--18x10.webp 18w, https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/11\/Bottle-Vacuum-Leak-Test-.webp 1617w\" sizes=\"(max-width: 1020px) 100vw, 1020px\" \/>\t\t\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\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9ee25e2 e-flex e-con-boxed e-con e-parent\" data-id=\"9ee25e2\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-9a921cd e-con-full e-flex e-con e-child\" data-id=\"9a921cd\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5f08225 elementor-widget elementor-widget-heading\" data-id=\"5f08225\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Prueba de fugas en viales, m\u00e1quina de prueba de fugas en viales y explicaci\u00f3n del procedimiento<br>Vial Rubber Closure Self-Sealing and Dye Ingress Testing (Prueba de autosellado y de penetraci\u00f3n de colorantes)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9c9adad elementor-widget elementor-widget-text-editor\" data-id=\"9c9adad\" 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\t\t<p class=\"\" data-start=\"1859\" data-end=\"2099\">La capacidad de autosellado es una de las propiedades m\u00e1s cr\u00edticas evaluadas seg\u00fan la norma ISO 8871-5. El sitio <strong data-start=\"1950\" data-end=\"1986\">vial cierre de goma autosellante<\/strong> simula repetidos pinchazos de aguja y eval\u00faa si el cierre vuelve a cerrar eficazmente bajo presi\u00f3n de vac\u00edo.<\/p><p class=\"\" data-start=\"2101\" data-end=\"2189\">En <strong>Anexos C y D de la norma ISO 8871-5<\/strong>dos principales <strong data-start=\"2145\" data-end=\"2174\">procedimientos de prueba de fugas en viales<\/strong> se especifican:<\/p>\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-6cb75bb e-n-tabs-mobile elementor-widget elementor-widget-n-tabs\" data-id=\"6cb75bb\" data-element_type=\"widget\" data-settings=\"{&quot;tabs_justify_horizontal&quot;:&quot;start&quot;,&quot;horizontal_scroll&quot;:&quot;disable&quot;}\" data-widget_type=\"nested-tabs.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-tabs\" data-widget-number=\"113997243\" aria-label=\"Pesta\u00f1as. Abre elementos con Intro o Espacio, ci\u00e9rralos con Escape y navega con las fechas.\">\n\t\t\t<div class=\"e-n-tabs-heading\" role=\"tablist\">\n\t\t\t\t\t<button id=\"e-n-tab-title-1139972431\" class=\"e-n-tab-title\" aria-selected=\"true\" data-tab-index=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"e-n-tab-content-1139972431\" style=\"--n-tabs-title-order: 1;\">\n\t\t\t\t\t\t<span class=\"e-n-tab-title-text\">\n\t\t\t\tProcedimiento de prueba de autosellado:\t\t\t<\/span>\n\t\t<\/button>\n\t\t\t\t<button id=\"e-n-tab-title-1139972432\" class=\"e-n-tab-title\" aria-selected=\"false\" data-tab-index=\"2\" role=\"tab\" tabindex=\"-1\" aria-controls=\"e-n-tab-content-1139972432\" style=\"--n-tabs-title-order: 2;\">\n\t\t\t\t\t\t<span class=\"e-n-tab-title-text\">\n\t\t\t\tProcedimiento de tensi\u00f3n de la soluci\u00f3n colorante (sin perforaci\u00f3n):\t\t\t<\/span>\n\t\t<\/button>\n\t\t\t\t\t<\/div>\n\t\t\t<div class=\"e-n-tabs-content\">\n\t\t\t\t<div id=\"e-n-tab-content-1139972431\" role=\"tabpanel\" aria-labelledby=\"e-n-tab-title-1139972431\" data-tab-index=\"1\" style=\"--n-tabs-title-order: 1;\" class=\"e-active elementor-element elementor-element-4a09704 e-con-full e-flex e-con e-child\" data-id=\"4a09704\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5218dd8 elementor-widget elementor-widget-text-editor\" data-id=\"5218dd8\" 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\t\t<ol data-start=\"2226\" data-end=\"2729\"><li class=\"\" data-start=\"2226\" data-end=\"2275\"><p class=\"\" data-start=\"2229\" data-end=\"2275\">Llene cada vial limpio con agua libre de part\u00edculas.<\/p><\/li><li class=\"\" data-start=\"2276\" data-end=\"2336\"><p class=\"\" data-start=\"2279\" data-end=\"2336\">Sellar el vial utilizando cierres y tapones de engarce seg\u00fan ISO 8362.<\/p><\/li><li class=\"\" data-start=\"2337\" data-end=\"2441\"><p class=\"\" data-start=\"2340\" data-end=\"2441\">Con agujas hipod\u00e9rmicas nuevas, perforar cada tap\u00f3n de goma <strong data-start=\"2399\" data-end=\"2411\">10 veces<\/strong>variando de posici\u00f3n cada vez.<\/p><\/li><li class=\"\" data-start=\"2442\" data-end=\"2500\"><p class=\"\" data-start=\"2445\" data-end=\"2500\">Sumerja los viales en <strong data-start=\"2466\" data-end=\"2499\">1 g\/L de soluci\u00f3n de azul de metileno<\/strong>.<\/p><\/li><li class=\"\" data-start=\"2501\" data-end=\"2598\"><p class=\"\" data-start=\"2504\" data-end=\"2598\">Coloque los viales sumergidos en un <strong data-start=\"2534\" data-end=\"2552\">c\u00e1mara de vac\u00edo<\/strong> y reducir la presi\u00f3n en 27 kPa durante 10 minutos.<\/p><\/li><li class=\"\" data-start=\"2599\" data-end=\"2669\"><p class=\"\" data-start=\"2602\" data-end=\"2669\">Restablecer la presi\u00f3n atmosf\u00e9rica, mantener sumergido otros 30 minutos.<\/p><\/li><li class=\"\" data-start=\"2670\" data-end=\"2729\"><p class=\"\" data-start=\"2673\" data-end=\"2729\">Enjuague e inspeccione visualmente si hay tinte azul en el interior del vial.<\/p><\/li><\/ol><p class=\"\" data-start=\"2731\" data-end=\"2824\">Esta prueba determina si el cierre mantiene su capacidad de autosellado tras un uso repetido.<\/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<div id=\"e-n-tab-content-1139972432\" role=\"tabpanel\" aria-labelledby=\"e-n-tab-title-1139972432\" data-tab-index=\"2\" style=\"--n-tabs-title-order: 2;\" class=\"elementor-element elementor-element-1f65e67 e-con-full e-flex e-con e-child\" data-id=\"1f65e67\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8d828dd elementor-widget elementor-widget-text-editor\" data-id=\"8d828dd\" 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\t\t<p class=\"\" data-start=\"2885\" data-end=\"3080\">Esto eval\u00faa la integridad de la <strong data-start=\"2921\" data-end=\"2944\">sistema de cierre de viales<\/strong> sin perforaci\u00f3n previa. Los viales se preparan, se sellan, se sumergen en el colorante y se presurizan al vac\u00edo de forma similar, y luego se inspeccionan para detectar la entrada de colorante.<\/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<\/div>\n\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<div class=\"elementor-element elementor-element-fed1035 e-flex e-con-boxed e-con e-parent\" data-id=\"fed1035\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-7873f87 e-con-full e-flex e-con e-child\" data-id=\"7873f87\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-918ea08 e-con-full e-flex e-con e-child\" data-id=\"918ea08\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3f376ab elementor-widget__width-initial elementor-position-top elementor-widget elementor-widget-image-box\" data-id=\"3f376ab\" data-element_type=\"widget\" data-widget_type=\"image-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-image-box-wrapper\"><figure class=\"elementor-image-box-img\"><a href=\"https:\/\/www.leakagetester.com\/es\/lt-02-leak-tester\/\" target=\"_blank\" tabindex=\"-1\"><img decoding=\"async\" width=\"120\" height=\"92\" src=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/10\/LT-02-Vacuum-Leak-Tester.webp\" class=\"attachment-full size-full wp-image-2099\" alt=\"\" \/><\/a><\/figure><div class=\"elementor-image-box-content\"><h3 class=\"elementor-image-box-title\"><a href=\"https:\/\/www.leakagetester.com\/es\/lt-02-leak-tester\/\" target=\"_blank\">Comprobador de fugas LT-02<\/a><\/h3><p class=\"elementor-image-box-description\">La primera generaci\u00f3n de comprobador autom\u00e1tico de fugas dise\u00f1ado por CELL Instruments, que es la unidad m\u00e1s vendida hasta el momento.<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b584e4d elementor-widget__width-initial elementor-position-top elementor-widget elementor-widget-image-box\" data-id=\"b584e4d\" data-element_type=\"widget\" data-widget_type=\"image-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-image-box-wrapper\"><figure class=\"elementor-image-box-img\"><a href=\"https:\/\/www.leakagetester.com\/es\/lt-03-leak-tester\/\" target=\"_blank\" tabindex=\"-1\"><img loading=\"lazy\" decoding=\"async\" width=\"120\" height=\"94\" src=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/10\/LT-03-leak-tester.webp\" class=\"attachment-full size-full wp-image-2095\" alt=\"Comprobador de fugas LT-03 Peque\u00f1o\" \/><\/a><\/figure><div class=\"elementor-image-box-content\"><h3 class=\"elementor-image-box-title\"><a href=\"https:\/\/www.leakagetester.com\/es\/lt-03-leak-tester\/\" target=\"_blank\">Comprobador de fugas LT-03<\/a><\/h3><p class=\"elementor-image-box-description\">El \u00faltimo comprobador de fugas autom\u00e1tico que sigue evolucionando, con un sistema de control avanzado, pantalla y funciones de impresi\u00f3n y software opcionales.<\/p><\/div><\/div>\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<div class=\"elementor-element elementor-element-3384222 e-con-full e-flex e-con e-child\" data-id=\"3384222\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-705671e elementor-widget elementor-widget-heading\" data-id=\"705671e\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Equipo de prueba<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d765a06 elementor-widget elementor-widget-text-editor\" data-id=\"d765a06\" 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\t\t<p class=\"\" data-start=\"3140\" data-end=\"3378\">La ejecuci\u00f3n exacta de la norma ISO 8871-5 exige una regulaci\u00f3n de la presi\u00f3n constante, una temporizaci\u00f3n precisa y un sellado fiable. Cell Instruments recomienda el<strong data-start=\"3283\" data-end=\"3311\">\u00a0Comprobador de fugas en viales<\/strong>dise\u00f1ado espec\u00edficamente para cumplir las normas ISO, incluida la ISO 8871-5.<\/p><p class=\"\" data-start=\"3380\" data-end=\"3393\"><strong>Caracter\u00edsticas principales:<\/strong><\/p><ul><li data-start=\"3396\" data-end=\"3449\">Control autom\u00e1tico de la presi\u00f3n (27 kPa por debajo de la atmosf\u00e9rica)<\/li><li data-start=\"3396\" data-end=\"3449\">Funciones de temporizaci\u00f3n precisas<\/li><li data-start=\"3396\" data-end=\"3449\">Compatible con sistemas de cierre de viales de 13 mm y 20 mm<\/li><li data-start=\"3396\" data-end=\"3449\">Adecuado tanto para m\u00e9todos de autosellado como de penetraci\u00f3n del tinte<\/li><\/ul><p class=\"\" data-start=\"3591\" data-end=\"3775\">Con automatizaci\u00f3n y coherencia, este <strong data-start=\"3629\" data-end=\"3658\">m\u00e1quina de ensayo de fugas en vial<\/strong> reduce los errores de los operarios y garantiza la repetibilidad, algo clave para cumplir la normativa y garantizar la seguridad de los productos.<\/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<div class=\"elementor-element elementor-element-897aaf5 e-flex e-con-boxed e-con e-parent\" data-id=\"897aaf5\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-23d08cc elementor-widget elementor-widget-heading\" data-id=\"23d08cc\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Aplicaciones en los sectores m\u00e9dico y farmac\u00e9utico<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-48e4aa6 elementor-widget elementor-widget-text-editor\" data-id=\"48e4aa6\" 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\t\t<p class=\"\" data-start=\"3844\" data-end=\"3899\">El <strong data-start=\"3848\" data-end=\"3866\">prueba de fugas en vial<\/strong> con arreglo a la norma ISO 8871-5 es crucial para:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-32a66fc e-con-full e-flex e-con e-child\" data-id=\"32a66fc\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-bc8b02f elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"bc8b02f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Medicamentos inyectables multidosis<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cf25ff0 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"cf25ff0\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Contenedores de vacunas<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0ca050f elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"0ca050f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Envasado de medicamentos intravenosos<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6aebdd4 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"6aebdd4\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Viales de diagn\u00f3stico<\/h2>\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-8c1e6fc elementor-widget elementor-widget-text-editor\" data-id=\"8c1e6fc\" 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\t\t<p class=\"\" data-start=\"3997\" data-end=\"4155\"><strong data-start=\"3997\" data-end=\"4026\">Ingenieros de control de calidad<\/strong>, <strong data-start=\"4028\" data-end=\"4046\">Cient\u00edficos de I+D<\/strong>, y <strong data-start=\"4052\" data-end=\"4072\">equipos reguladores<\/strong> conf\u00edan en estas pruebas para validar la integridad del cierre de los envases antes de su comercializaci\u00f3n.<\/p>\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<div class=\"elementor-element elementor-element-75d00f67 e-con-full e-flex e-con e-parent\" data-id=\"75d00f67\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6d8146b5 elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"6d8146b5\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Buenas pr\u00e1cticas de aplicaci\u00f3n de la norma ISO 8871-5<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-68472fc8 elementor-widget__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"68472fc8\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Para ajustarse plenamente a la norma ISO 8871-5:<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4781572a animated-slow elementor-widget-divider--view-line elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"4781572a\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\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\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d671e1c elementor-widget__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"d671e1c\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul data-start=\"4241\" data-end=\"4547\"><li class=\"\" data-start=\"4241\" data-end=\"4299\"><p class=\"\" data-start=\"4243\" data-end=\"4299\">Utilice viales, cierres y juntas de engaste conformes con la norma ISO 8362.<\/p><\/li><li class=\"\" data-start=\"4300\" data-end=\"4354\"><p class=\"\" data-start=\"4302\" data-end=\"4354\">Garantizar entornos de ensayo limpios y libres de part\u00edculas.<\/p><\/li><li class=\"\" data-start=\"4355\" data-end=\"4432\"><p class=\"\" data-start=\"4357\" data-end=\"4432\">Evitar tensioactivos en la soluci\u00f3n de azul de metileno para evitar resultados enga\u00f1osos.<\/p><\/li><li class=\"\" data-start=\"4433\" data-end=\"4471\"><p class=\"\" data-start=\"4435\" data-end=\"4471\">Calibrar peri\u00f3dicamente las c\u00e1maras de vac\u00edo.<\/p><\/li><li class=\"\" data-start=\"4472\" data-end=\"4547\"><p class=\"\" data-start=\"4474\" data-end=\"4547\">Registrar todos los datos de inspecci\u00f3n de acuerdo con los requisitos de documentaci\u00f3n de la norma.<\/p><\/li><\/ul>\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-4828799 elementor-widget__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"4828799\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Cell Instruments no s\u00f3lo suministra equipos, sino tambi\u00e9n <strong data-start=\"4603\" data-end=\"4625\">formaci\u00f3n t\u00e9cnica<\/strong>, <strong data-start=\"4627\" data-end=\"4655\">soluciones de pruebas personalizadas<\/strong>, y <strong data-start=\"4661\" data-end=\"4684\">servicios de automatizaci\u00f3n<\/strong> para ayudar a laboratorios y fabricantes a realizar pruebas conformes con la norma ISO de forma eficaz.<\/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<div class=\"elementor-element elementor-element-563ef868 e-con-full e-flex e-con e-parent\" data-id=\"563ef868\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6a7ad6cf elementor-widget elementor-widget-heading\" data-id=\"6a7ad6cf\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Preguntas frecuentes sobre ISO 8871-5<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7333fe2d e-con-full e-flex e-con e-child\" data-id=\"7333fe2d\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dd759c2 elementor-widget elementor-widget-n-accordion\" data-id=\"dd759c2\" data-element_type=\"widget\" data-settings=\"{&quot;max_items_expended&quot;:&quot;multiple&quot;,&quot;default_state&quot;:&quot;expanded&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Acorde\u00f3n. Abra los enlaces con Intro o Espacio, ci\u00e9rrelos con Escape y navegue con las teclas de flecha.\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2320\" class=\"e-n-accordion-item\" open>\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"true\" aria-controls=\"e-n-accordion-item-2320\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> 1. \u00bfQu\u00e9 comprueba la norma ISO 8871-5? <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2320\" class=\"elementor-element elementor-element-e471aee e-con-full e-flex e-con e-child\" data-id=\"e471aee\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7b578c7 elementor-widget elementor-widget-text-editor\" data-id=\"7b578c7\" 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\t\t<p class=\"\" data-start=\"5395\" data-end=\"5545\">La norma ISO 8871-5 eval\u00faa el autosellado y la integridad del sellado de los cierres elastom\u00e9ricos utilizados en viales farmac\u00e9uticos.<\/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<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2321\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2321\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> 2. \u00bfC\u00f3mo funciona el procedimiento de prueba de fugas en viales? <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2321\" class=\"elementor-element elementor-element-7ce5868 e-con-full e-flex e-con e-child\" data-id=\"7ce5868\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c9878c6 elementor-widget elementor-widget-text-editor\" data-id=\"c9878c6\" 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\t\t<p class=\"\" data-start=\"5547\" data-end=\"5731\">Consiste en pinchar repetidamente los cierres con agujas, sumergirlos en colorante y exponerlos al vac\u00edo para detectar fugas mediante inspecci\u00f3n visual.<\/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<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2322\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2322\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> 3. \u00bfPor qu\u00e9 es importante el autosellado del cierre de goma del vial? <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2322\" class=\"elementor-element elementor-element-dcfefc8 e-con-full e-flex e-con e-child\" data-id=\"dcfefc8\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-72b4879 elementor-widget elementor-widget-text-editor\" data-id=\"72b4879\" 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\t\t<p class=\"\" data-start=\"5733\" data-end=\"5900\">Garantiza que el vial mantenga la esterilidad tras m\u00faltiples pinchazos, especialmente en envases multidosis.<\/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<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2323\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"4\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2323\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> 4. \u00bfQu\u00e9 equipo se necesita para realizar ensayos seg\u00fan la norma ISO 8871-5? <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2323\" class=\"elementor-element elementor-element-0bfbdd9 e-flex e-con-boxed e-con e-child\" data-id=\"0bfbdd9\" 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-34a8313 elementor-widget elementor-widget-text-editor\" data-id=\"34a8313\" 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\t\t<p class=\"\" data-start=\"5902\" data-end=\"6160\">Necesita viales y cierres que cumplan la norma ISO 8362, colorante azul de metileno, agujas hipod\u00e9rmicas y una c\u00e1mara de vac\u00edo. A <strong data-start=\"6090\" data-end=\"6119\">m\u00e1quina de ensayo de fugas en vial<\/strong> como el LSSD-01 simplifica el proceso.<\/p>\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\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2324\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"5\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2324\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> 5. \u00bfPuede Cell Instruments ayudar con la automatizaci\u00f3n y la formaci\u00f3n para estas pruebas? <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2324\" class=\"elementor-element elementor-element-d9b9e08 e-flex e-con-boxed e-con e-child\" data-id=\"d9b9e08\" 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-ccffa35 elementor-widget elementor-widget-text-editor\" data-id=\"ccffa35\" 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\t\t<div class=\"flex max-w-full flex-col grow\"><div class=\"min-h-8 text-message relative flex w-full flex-col items-end gap-2 text-start break-words whitespace-normal [.text-message+&amp;]:mt-5\" dir=\"auto\" data-message-author-role=\"assistant\" data-message-id=\"ac04b2fb-b909-4342-bffc-6922592acb69\" data-message-model-slug=\"gpt-4o\"><div class=\"flex w-full flex-col gap-1 empty:hidden first:pt-[3px]\"><div class=\"markdown prose dark:prose-invert w-full break-words light\"><p class=\"\" data-start=\"6162\" data-end=\"6381\">S\u00ed. Cell Instruments ofrece sistemas personalizables, actualizaciones de automatizaci\u00f3n y formaci\u00f3n experta para ayudar a los clientes a cumplir los requisitos de ensayo ISO.<\/p><\/div><\/div><\/div><\/div>\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\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\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<div class=\"elementor-element elementor-element-3a2b679a e-flex e-con-boxed e-con e-parent\" data-id=\"3a2b679a\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-38014124 elementor-widget elementor-widget-heading\" data-id=\"38014124\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">\u00bfBusca un equipo fiable de detecci\u00f3n de fugas en viales ISO 8871-5?<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-53b530f2 elementor-widget elementor-widget-text-editor\" data-id=\"53b530f2\" 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\t\t<p>\u00a0No pierda la oportunidad de optimizar sus procesos de control de calidad con equipos de \u00faltima generaci\u00f3n.<\/p>\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-5d0c06b6 elementor-mobile-align-center elementor-align-center elementor-widget elementor-widget-button\" data-id=\"5d0c06b6\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"\/es\/contact\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Cont\u00e1ctenos<\/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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6021db4e e-flex e-con-boxed e-con e-parent\" data-id=\"6021db4e\" 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-474e3b4e elementor-widget elementor-widget-heading\" data-id=\"474e3b4e\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Informaci\u00f3n relacionada<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6ba2452d elementor-posts__hover-none elementor-grid-2 elementor-grid-tablet-2 elementor-grid-mobile-1 elementor-posts--thumbnail-top elementor-widget elementor-widget-posts\" data-id=\"6ba2452d\" data-element_type=\"widget\" data-settings=\"{&quot;cards_row_gap&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:80,&quot;sizes&quot;:[]},&quot;cards_row_gap_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:71,&quot;sizes&quot;:[]},&quot;cards_row_gap_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:30,&quot;sizes&quot;:[]},&quot;cards_columns&quot;:&quot;2&quot;,&quot;cards_columns_tablet&quot;:&quot;2&quot;,&quot;cards_columns_mobile&quot;:&quot;1&quot;}\" data-widget_type=\"posts.cards\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-posts-container elementor-posts elementor-posts--skin-cards elementor-grid\">\n\t\t\t\t<article class=\"elementor-post elementor-grid-item post-2253 post type-post status-publish format-standard hentry category-vacuum-leak-test tag-astm-d3078 tag-astm-d4991 tag-vacuum-leak-tester\">\n\t\t\t<div class=\"elementor-post__card\">\n\t\t\t\t<div class=\"elementor-post__text\">\n\t\t\t\t<h4 class=\"elementor-post__title\">\n\t\t\t<a href=\"https:\/\/www.leakagetester.com\/es\/lt-02-leak-tester\/\" >\n\t\t\t\tComprobador de fugas LT-02\t\t\t<\/a>\n\t\t<\/h4>\n\t\t\t\t<div class=\"elementor-post__excerpt\">\n\t\t\t<p> El <strong>Comprobador de fugas LT-02<\/strong> es una soluci\u00f3n de prueba de vac\u00edo autom\u00e1tica de alto rendimiento dise\u00f1ada espec\u00edficamente para detectar fugas en envases flexibles, en particular en aplicaciones donde hay gas en el espacio de cabeza. Este equipo se utiliza com\u00fanmente en las industrias de alimentos, bebidas, farmac\u00e9utica y otras donde la confiabilidad del envasado es fundamental para mantener la calidad del producto.<\/p>\n\t\t<\/div>\n\t\t\n\t\t<a class=\"elementor-post__read-more\" href=\"https:\/\/www.leakagetester.com\/es\/lt-02-leak-tester\/\" aria-label=\"Read more about LT-02 Leak Tester\" tabindex=\"-1\" >\n\t\t\tLeer m\u00e1s\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t<article class=\"elementor-post elementor-grid-item post-2179 post type-post status-publish format-standard hentry category-vacuum-leak-test tag-astm-d3078 tag-astm-d4991 tag-vacuum-leak-tester\">\n\t\t\t<div class=\"elementor-post__card\">\n\t\t\t\t<div class=\"elementor-post__text\">\n\t\t\t\t<h4 class=\"elementor-post__title\">\n\t\t\t<a href=\"https:\/\/www.leakagetester.com\/es\/lt-03-leak-tester\/\" >\n\t\t\t\tComprobador de fugas LT-03\t\t\t<\/a>\n\t\t<\/h4>\n\t\t\t\t<div class=\"elementor-post__excerpt\">\n\t\t\t<p>El comprobador de fugas LT-03 es un dispositivo de \u00faltima generaci\u00f3n dise\u00f1ado para evaluar rigurosamente la integridad del sellado de los envases en diversas industrias. Este equipo es fundamental para verificar que el embalaje mantenga sus capacidades de protecci\u00f3n, lo que salvaguarda la calidad y la seguridad del producto. El LT-03 es especialmente adecuado para aplicaciones que involucran envases flexibles, pero tambi\u00e9n se puede adaptar para probar materiales r\u00edgidos y no flexibles gracias a su dise\u00f1o personalizable.<\/p>\n\t\t<\/div>\n\t\t\n\t\t<a class=\"elementor-post__read-more\" href=\"https:\/\/www.leakagetester.com\/es\/lt-03-leak-tester\/\" aria-label=\"Read more about LT-03 Leak Tester\" tabindex=\"-1\" >\n\t\t\tLeer m\u00e1s\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t<\/div>\n\t\t\n\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>ISO 8871-5 Elastomeric parts for parenterals and for devices for pharmaceutical usePart 5:Functional requirements and testing Request a Quote Standard Summary Maintaining the sterility of parenteral drugs is a critical concern in the pharmaceutical and medical device industries. ISO 8871-5 provides a structured testing approach for assessing the functional integrity of elastomeric closures used with [&#8230;]","protected":false},"author":2,"featured_media":0,"parent":2112,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-blank.php","meta":{"_uag_custom_page_level_css":"","footnotes":""},"class_list":["post-4067","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>ISO 8871-5 Vial Leak Test for Vial Rubber Closure Self-Sealing - Leakage Tester<\/title>\n<meta name=\"description\" content=\"Understand ISO 8871-5 for evaluating vial rubber closure self-sealing using the vial leak test procedure. 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