{"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\">Me ju në çdo hap të rrugës<\/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>Për të qenë në përputhje me EN 1422 &#8211; EN ISO 11135, Standardet ISO 13485 dhe udhëzimet GMP, protokollet dhe procedurat tona janë krijuar për t&#039;ju ndihmuar të pajtoheni me <a href=\"https:\/\/zjbocon.com\/eto-sterilization-2\/\">kërkesat e vërtetimit dhe plotësoni specifikimet e kërkesave tuaja.<\/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 (Specifikimet e Kërkesave të Përdoruesit)<\/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>Përcaktimi i kërkesave për përmbushjen e kërkesave të procesit. Në përgjithësi, URS kërkohet për makinën sterilizuese eto përpara se të bëhet dizajni.<br \>Për të përmbushur kërkesat e përdoruesit, ne i kushtojmë vëmendje të veçantë URS-së (Specifikimet e Kërkesave të Përdoruesit) (siç janë madhësia e dhomës, produkti, paketa, përqindja e OE, etj.)<br \>Lëshuar nga: Përdoruesi<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 (Specifikimet e dizajnit funksional)<\/h2><p>Specifikimi në të cilin kërkesat e blerësit transferohen në një zgjidhje teknike (nga këndvështrimi i prodhuesit)<br \>Lëshuar nga: Prodhuesi<\/p><\/section><\/section><section class=\"mx-auto sm:max-w-[1200px] w-[95%]\"><section><h2>SPECIFIKIMI I DIZAJNIT (DS)<\/h2><p>Specifikimi i bazës teknike dhe specifikimi i faktorëve kufizues që duhet të merren parasysh gjatë zhvillimit, ndërtimit dhe montimit. DS siguron që të gjitha kërkesat e klientëve dhe standardet aktuale të vlefshme nga CGMP, BE, EN ISO dhe FDA janë të kënaqura.<\/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 \>Në BOCON, përpara shitjes, fabrika u ofron klientëve projektimin dhe konsultimin mbi pajisjet dhe pajisjet e përgjithshme të punishtes ETO dhe ndihmon në formulimin e planifikimit dhe paraqitjes së përgjithshme të punishtes ETO. Sipas karakteristikave të vendit të klientit dhe produktit, materialit, paketimit, transportit dhe zhvillimit të ardhshëm, ne zgjedhim materialin, konfigurimin, mënyrën e kontrollit, vëllimin dhe sasinë për sterilizuesin. Për të ndihmuar në përgatitjen e procesit të sterilizimit të oksidit të etilenit, skemës së verifikimit, rregullave dhe rregulloreve të menaxhimit të punishtes ETO, përdorimit dhe mirëmbajtjes së pajisjeve, etj. Në të njëjtën kohë ofron standardet përkatëse, parangrohjen, analizën e mbetjeve, konsultimin e teknologjisë së përpunimit dhe bashkëpunimin.<\/p><\/section><\/section><section class=\"mx-auto sm:max-w-[1200px] w-[95%]\"><section><h2>DQ, IQ, OQ, PQ<\/h2><p>DQ (Kualifikimi i Dizajnit)<br \><a href=\"https:\/\/zjbocon.com\/iq-in-eto-sterilization-process\/\">IQ (Kualifikimi i instalimit)<\/a><br \><a href=\"https:\/\/zjbocon.com\/oq-in-eto-sterilization-machine\/\">OQ (Kualifikimi Operacional)<\/a><br \><a href=\"https:\/\/zjbocon.com\/ethylene-oxide-sterilization-chamber\/\">PQ (Kualifikimi i Performancës)<\/a><br \>Nga specifikimet e produktit dhe kërkesave, tek analizat e rrezikut, tek planifikimi dhe ekzekutimi i hapave individualë të kualifikimit, ne kujdesemi për gjithçka që kërkon zbatimi.<\/p><p><strong>Vleresimi<\/strong>: BOCON do të siguronte vërtetimin e softuerit. Raporti IQ, OQ dhe mbështetja e PQ pas instalimit.<\/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\">Raporti i 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\" \><\/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>Sherbime Kualifikimi - STERILIZER 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=\"sq_AL\" \>\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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