{"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\/qualification-services\/","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\">З тобою на кожному кроці<\/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>Щоб відповідати стандарту EN 1422 &#8211; Стандарти EN ISO 11135, ISO 13485 і рекомендації GMP, наші протоколи та процедури створені, щоб допомогти вам дотримуватися <a href=\"https:\/\/zjbocon.com\/eto-sterilization-2\/\">вимоги перевірки та відповідність вашим специфікаціям вимог.<\/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\/qualification_services\/\" 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 (специфікації вимог користувача)<\/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>Визначення вимог щодо виконання вимог процесу. Як правило, URS необхідний для стерилізатора eto перед виготовленням конструкції.<br \>Щоб задовольнити вимоги користувача, ми приділяємо особливу увагу URS (специфікації вимог користувача) (наприклад, розмір камери, продукт, упаковка, відсоток EO тощо).<br \>Видав: Користувач<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 (специфікації функціонального дизайну)<\/h2><p>Специфікація, в якій вимоги покупця передаються в технічне рішення (з точки зору виробника)<br \>Видано: Виробник<\/p><\/section><\/section><section class=\"mx-auto sm:max-w-[1200px] w-[95%]\"><section><h2>СПЕЦИФІКАЦІЯ КОНСТРУКЦІЇ (DS)<\/h2><p>Специфікація технічної бази та специфікація обмежувальних факторів, які необхідно враховувати під час розробки, будівництва та монтажу. DS гарантує, що всі вимоги клієнтів і чинні стандарти CGMP, ЄС, EN ISO та FDA задоволені.<\/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 \>У BOCON перед продажем фабрика надає клієнтам дизайн і консультації щодо загального обладнання та засобів майстерні ETO, а також допомагає у формулюванні загального планування та планування майстерні ETO. Відповідно до характеристик замовника та продукту, матеріалу, упаковки, транспортування та майбутнього розвитку ми вибираємо матеріал, конфігурацію, режим керування, об’єм та кількість для стерилізатора. Допомагати в підготовці процесу стерилізації оксидом етилену, схеми перевірки, правил і положень управління цехом ETO, використання та обслуговування обладнання тощо. Водночас надавати відповідні стандарти, попередній нагрів, аналіз залишків, консультації щодо технології обробки та співпрацю.<\/p><\/section><\/section><section class=\"mx-auto sm:max-w-[1200px] w-[95%]\"><section><h2>DQ, IQ, OQ, PQ<\/h2><p>DQ (Design Qualification)<br \><a href=\"https:\/\/zjbocon.com\/iq-in-eto-sterilization-process\/\">IQ (Кваліфікація встановлення)<\/a><br \><a href=\"https:\/\/zjbocon.com\/oq-in-eto-sterilization-machine\/\">OQ (Операційна кваліфікація)<\/a><br \><a href=\"https:\/\/zjbocon.com\/ethylene-oxide-sterilization-chamber\/\">PQ (Кваліфікація ефективності)<\/a><br \>Від специфікацій продукту та вимог до аналізу ризиків і планування та виконання окремих етапів кваліфікації, ми подбаємо про все, що вимагає впровадження.<\/p><p><strong>Перевірка<\/strong>: BOCON забезпечить перевірку програмного забезпечення. IQ, звіт OQ і підтримка PQ після встановлення.<\/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\">IR OQ PQ звіт<\/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>Кваліфікаційні послуги - ETO STERILIZER<\/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\/qualification-services\/\" \>\n<meta property=\"og:locale\" content=\"uk_UA\" \>\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\/qualification-services\/\" \>\n<meta property=\"og:site_name\" content=\"ETO STERILIZER\" \>\n<meta property=\"article:publisher\" 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