{"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\">С вами на каждом этапе пути<\/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>Чтобы соответствовать EN 1422 &#8211; EN ISO 11135, стандарты ISO 13485 и руководящие принципы GMP, наши протоколы и процедуры создаются, чтобы помочь вам соблюдать <a href=\"https:\/\/zjbocon.com\/eto-sterilization-2\/\">Требования к валидации и соответствовать вашим требованиям.<\/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 (спецификации требований пользователя)<\/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>Определение требований для удовлетворения требований процесса. Как правило, URS требуется для машины стерилизатора ETO перед созданием дизайна.<br \>Чтобы удовлетворить требования пользователя, мы уделяем особое внимание URS (спецификации требований пользователя) (например, размер камеры, продукт, пакет, процент EO и т. Д.)<br \>Выдано: Пользователь<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 (спецификации функциональных проектов)<\/h2><p>Спецификация, в которой требования покупателя передаются в техническое решение (с точки зрения производителя)<br \>Выдано: производитель<\/p><\/section><\/section><section class=\"mx-auto sm:max-w-[1200px] w-[95%]\"><section><h2>Спецификация дизайна (DS)<\/h2><p>Спецификация технической основы и спецификации ограничивающих факторов, которые должны учитываться во время разработки, строительства и сборки. DS гарантирует, что все требования клиентов и текущие действительные стандарты CGMP, ЕС, EN ISO и FDA удовлетворены.<\/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 \>В Bocon, до продажи, завод предоставляет клиентам дизайн и консультации по общему оборудованию и средствам мастерской ETO и помогает в составе общего планирования и планировки семинара ETO. Согласно характеристикам сайта клиента и продукта, материала, упаковки, транспортировки и будущей разработки, мы выбираем материал, конфигурацию, режим управления, объем и количество для стерилизатора. Чтобы помочь в приготовлении процесса стерилизации этиленоксида, схемы проверки, правил и правил управления семинаром ETO, использования и технического обслуживания оборудования и т. Д. В то же время обеспечивает соответствующие стандарты, предварительное нагревание, остаточный анализ, консультации по технологии обработки и сотрудничество.<\/p><\/section><\/section><section class=\"mx-auto sm:max-w-[1200px] w-[95%]\"><section><h2>DQ, IQ, OQ, PQ<\/h2><p>DQ (квалификация дизайна)<br \><a href=\"https:\/\/zjbocon.com\/iq-in-eto-sterilization-process\/\">IQ (квалификация установки)<\/a><br \><a href=\"https:\/\/zjbocon.com\/oq-in-eto-sterilization-machine\/\">OQ (оперативная квалификация)<\/a><br \><a href=\"https:\/\/zjbocon.com\/ethylene-oxide-sterilization-chamber\/\">PQ (квалификация производительности)<\/a><br \>От спецификаций продукта и требований до анализа рисков, до планирования и выполнения отдельных квалификационных этапов, мы заботимся обо всем, что требуется.<\/p><p><strong>Валидация<\/strong>: Bocon обеспечит проверку программного обеспечения. IQ, OQ Report и поддержка PQ после установки.<\/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\">IQ White PQ Report<\/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\" \><\/figure><\/div>\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-swiper-button elementor-swiper-button-prev\" role=\"button\" tabindex=\"0\">\n\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-eicon-chevron-left\" viewBox=\"0 0 1000 1000\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M646 125C629 125 613 133 604 142L308 442C296 454 292 471 487 504 296 521 308 533L604 854C617 867 629 875 646 663 679 871 692 858 704 846 713 829 812 796 708 779 767L438 225C700 217 204 187 171 154 142 675 129 125Z\"><\/path><\/svg>\t\t\t\t\t<\/div>\n\t\t\t\t\t<div class=\"elementor-swiper-button elementor-swiper-button-next\" role=\"button\" tabindex=\"0\">\n\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-eicon-chevron-right\" viewBox=\"0 0 1000 1000\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M696 533C708 521 713 504 487 471 708 454 696 446L400 146C388 133 375 125 354 338 325 129 313 142 300 154 292 171 187 204 296 221 308 233L563 492 304 771C292 783 288 800 817 833 850 863 321 871 875 371 388 867 400 854L696 533Z\"><\/path><\/svg>\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t<div class=\"swiper-pagination\"><\/div>\n\t\t\t\t\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>n order to comply with EN 1422 &#8211; EN ISO 11135, ISO 13485 Standards, and GMP guidelines, our protocols and procedures are created to help you comply with validation requirements and meet your requirement 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>Квалификационные услуги - стерилизатор 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=\"ru_RU\" \>\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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