{"id":1427,"date":"2024-10-17T15:02:09","date_gmt":"2024-10-17T07:02:09","guid":{"rendered":"https:\/\/zjbocon.com\/?page_id=1427"},"modified":"2024-11-08T09:26:22","modified_gmt":"2024-11-08T01:26:22","slug":"qualification-services","status":"publish","type":"page","link":"https:\/\/zjbocon.com\/?page_id=1427","title":{"rendered":"Qualification Services"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1427\" class=\"elementor elementor-1427\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-85c8314 e-flex e-con-boxed e-con e-parent\" data-id=\"85c8314\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7f66526 elementor-widget elementor-widget-heading\" data-id=\"7f66526\" data-element_type=\"widget\" data-e-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\">Contigo en cada paso del camino<\/h2>\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-5867189 e-flex e-con-boxed e-con e-parent\" data-id=\"5867189\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9a68910 elementor-widget elementor-widget-text-editor\" data-id=\"9a68910\" data-element_type=\"widget\" data-e-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>Para cumplir con la norma EN 1422 &#8211; Normas EN ISO 11135, ISO 13485 y directrices GMP, nuestros protocolos y procedimientos se crean para ayudarle a cumplir con <a href=\"https:\/\/zjbocon.com\/eto-sterilization-2\/\">requisitos de validación y cumplir con sus especificaciones de requisitos.<\/a><\/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-86e27d7 e-flex e-con-boxed e-con e-parent\" data-id=\"86e27d7\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e2ee35e elementor-widget elementor-widget-image\" data-id=\"e2ee35e\" data-element_type=\"widget\" data-e-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 fetchpriority=\"high\" decoding=\"async\" data-attachment-id=\"1353\" data-permalink=\"https:\/\/zjbocon.com\/?attachment_id=1353\" data-orig-file=\"https:\/\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services.webp\" data-orig-size=\"971,422\" data-comments-opened=\"1\" data-image-meta=\"{&quot;aperture&quot;:&quot;0&quot;,&quot;credit&quot;:&quot;&quot;,&quot;camera&quot;:&quot;&quot;,&quot;caption&quot;:&quot;&quot;,&quot;created_timestamp&quot;:&quot;0&quot;,&quot;copyright&quot;:&quot;&quot;,&quot;focal_length&quot;:&quot;0&quot;,&quot;iso&quot;:&quot;0&quot;,&quot;shutter_speed&quot;:&quot;0&quot;,&quot;title&quot;:&quot;&quot;,&quot;orientation&quot;:&quot;0&quot;}\" data-image-title=\"Qualification_Services\" data-image-description=\"\" data-image-caption=\"\" data-large-file=\"https:\/\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services.webp\" width=\"971\" height=\"422\" src=\"https:\/\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services.webp\" class=\"attachment-large size-large wp-image-1353\" alt=\"\" srcset=\"https:\/\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services.webp 971w, https:\>\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-91f65a4 e-flex e-con-boxed e-con e-parent\" data-id=\"91f65a4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a54ec2f elementor-widget elementor-widget-heading\" data-id=\"a54ec2f\" data-element_type=\"widget\" data-e-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\">URS (Especificaciones de requisitos del usuario)<\/h2>\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-ebe801e e-flex e-con-boxed e-con e-parent\" data-id=\"ebe801e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-39a745e elementor-widget elementor-widget-text-editor\" data-id=\"39a745e\" data-element_type=\"widget\" data-e-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>Definición de requisitos para cumplir con las demandas del proceso. Generalmente, se requiere URS para la máquina esterilizadora eto antes de realizar el diseño.<br \>Para cumplir con los requisitos del usuario, prestamos especial atención a las URS (Especificaciones de requisitos del usuario) (como el tamaño de la cámara, el producto, el paquete, el porcentaje de EO, etc.)<br \>Emitido por: Usuario<br \><br \><\/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-36326c4 e-flex e-con-boxed e-con e-parent\" data-id=\"36326c4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-51db150 elementor-widget elementor-widget-text-editor\" data-id=\"51db150\" data-element_type=\"widget\" data-e-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<section class=\"mx-auto sm:max-w-[1200px] w-[95%]\"><section><h2>FDS (Especificaciones de diseño funcional)<\/h2><p>Especificación en la que las demandas del comprador se trasladan a una solución técnica (desde el punto de vista del fabricante)<br \>Emitido por: Fabricante<\/p><\/section><\/section><section class=\"mx-auto sm:max-w-[1200px] w-[95%]\"><section><h2>ESPECIFICACIÓN DE DISEÑO (DS)<\/h2><p>Especificación de las bases técnicas y especificación de los factores limitantes que se deben considerar durante el desarrollo, construcción y montaje. DS garantiza que se cumplan todos los requisitos del cliente y las normas vigentes vigentes de CGMP, UE, EN ISO y FDA.<\/p><\/section><\/section><section class=\"mx-auto sm:max-w-[1200px] w-[95%]\"><section><h2>FAT \/ SAT (Factory Acceptance Test \/Site Acceptance Test)<\/h2><p>Documented acceptance tests at the supplier\/customer with test log, test summary, list of open issues, and release certificates.<br \>En BOCON, antes de la venta, la fábrica ofrece a los clientes el diseño y la consulta sobre el equipo y las instalaciones generales del taller de ETO y ayuda en la formulación de la planificación y el diseño generales del taller de ETO. De acuerdo con las características del sitio del cliente y del producto, material, embalaje, transporte y desarrollo futuro, elegimos el material, la configuración, el modo de control, el volumen y la cantidad del esterilizador. Ayudar en la preparación del proceso de esterilización con óxido de etileno, esquema de verificación, reglas y regulaciones de gestión del taller ETO, uso y mantenimiento de equipos, etc. Al mismo tiempo, proporciona estándares relevantes, precalentamiento, análisis de residuos, consulta sobre tecnología de procesamiento y cooperación.<\/p><\/section><\/section><section class=\"mx-auto sm:max-w-[1200px] w-[95%]\"><section><h2>DQ, CI, OQ, PQ<\/h2><p>DQ (calificación de diseño)<br \><a href=\"https:\/\/zjbocon.com\/iq-in-eto-sterilization-process\/\">IQ (Cualificación de instalación)<\/a><br \><a href=\"https:\/\/zjbocon.com\/oq-in-eto-sterilization-machine\/\">OQ (calificación operativa)<\/a><br \><a href=\"https:\/\/zjbocon.com\/ethylene-oxide-sterilization-chamber\/\">PQ (calificación de desempeño)<\/a><br \>Desde las especificaciones de productos y requisitos hasta los análisis de riesgos, pasando por la planificación y ejecución de los pasos de calificación individuales, nos encargamos de todo lo que requiere la implementación.<\/p><p><strong>Validación<\/strong>: BOCON proporcionaría validación del software. IQ, informe OQ y soporte de PQ después de la instalación.<\/p><\/section><\/section>\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-cedf493 e-flex e-con-boxed e-con e-parent\" data-id=\"cedf493\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e63170b elementor-widget elementor-widget-heading\" data-id=\"e63170b\" data-element_type=\"widget\" data-e-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\">Informe IR OQ PQ<\/h2>\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-d00e3ff e-flex e-con-boxed e-con e-parent\" data-id=\"d00e3ff\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7e11248 elementor-arrows-position-inside elementor-pagination-position-outside elementor-widget elementor-widget-image-carousel\" data-id=\"7e11248\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;slides_to_show&quot;:&quot;1&quot;,&quot;navigation&quot;:&quot;both&quot;,&quot;autoplay&quot;:&quot;yes&quot;,&quot;pause_on_hover&quot;:&quot;yes&quot;,&quot;pause_on_interaction&quot;:&quot;yes&quot;,&quot;autoplay_speed&quot;:5000,&quot;infinite&quot;:&quot;yes&quot;,&quot;effect&quot;:&quot;slide&quot;,&quot;speed&quot;:500}\" data-widget_type=\"image-carousel.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-image-carousel-wrapper swiper\" role=\"region\" aria-roledescription=\"carousel\" aria-label=\"Image Carousel\" dir=\"ltr\">\n\t\t\t<div class=\"elementor-image-carousel swiper-wrapper swiper-image-stretch\" aria-live=\"off\">\n\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"1 of 3\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/zjbocon.com\/wp-content\/uploads\/2024\/10\/iq-oq-pq-1.webp\" alt=\"iq oq pq\" \><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"2 of 3\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/zjbocon.com\/wp-content\/uploads\/2024\/10\/iq-oq-pq-2.webp\" alt=\"iq oq pq\" \><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"3 of 3\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/zjbocon.com\/wp-content\/uploads\/2024\/10\/iq-oq-pq-3.webp\" alt=\"iq oq pq\" 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specifications.<\/p>\n","protected":false},"author":234312599,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"full-width-container","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":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","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-5)","background-image":"","background-repeat":"repeat","background-position":"center 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Premium plugin v27.2 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Servicios de Calificación - ESTERILIZADOR ETO<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \>\n<link rel=\"canonical\" href=\"https:\/\/zjbocon.com\/?page_id=1427\" \>\n<meta property=\"og:locale\" content=\"es_ES\" \>\n<meta property=\"og:type\" content=\"article\" \>\n<meta property=\"og:title\" content=\"Qualification Services\" \>\n<meta property=\"og:description\" content=\"n order to comply with EN 1422 - ISO 11135, 13485 Standards, and GMP guidelines, our protocols procedures are created help you validation requirements meet your requirement specifications.\" \>\n<meta property=\"og:url\" content=\"https:\/\/zjbocon.com\/?page_id=1427\" \>\n<meta property=\"og:site_name\" content=\"ETO STERILIZER\" \>\n<meta property=\"article:publisher\" 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