{"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\">Magħkom Kull Pass tat-Triq<\/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>Sabiex tkun konformi ma&#039; EN 1422 &#8211; EN ISO 11135, Standards ISO 13485, u linji gwida GMP, il-protokolli u l-proċeduri tagħna huma maħluqa biex jgħinuk tikkonforma <a href=\"https:\/\/zjbocon.com\/eto-sterilization-2\/\">rekwiżiti ta &#039;validazzjoni u jissodisfaw l-ispeċifikazzjonijiet tal-ħtieġa tiegħek.<\/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 (Speċifikazzjonijiet tar-Rekwiżiti tal-Utent)<\/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>Definizzjoni ta&#039; rekwiżiti biex jiġu sodisfatti t-talbiet tal-proċess. Ġeneralment, URS hija meħtieġa għall-magna sterilizzatur eto qabel ma tagħmel id-disinn.<br \>Sabiex nissodisfaw ir-rekwiżit tal-utent, aħna nagħtu attenzjoni speċjali lill-URS (Speċifikazzjonijiet tar-Rekwiżiti tal-Utent) (bħal daqs tal-kamra, prodott, pakkett, persentaġġ EO, eċċ.)<br \>Maħruġ minn: Utent<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 (Speċifikazzjonijiet tad-Disinn Funzjonali)<\/h2><p>Speċifikazzjoni li fiha t-talbiet tax-xerrej huma trasferiti f&#039;soluzzjoni teknika (mill-perspettiva tal-manifattur)<br \>Maħruġ minn: Manifattur<\/p><\/section><\/section><section class=\"mx-auto sm:max-w-[1200px] w-[95%]\"><section><h2>SPEĊIFIKAZZJONI TA&#039; DISINN (DS)<\/h2><p>Speċifikazzjoni tal-bażi teknika u speċifikazzjoni tal-fatturi li jillimitaw li għandhom jiġu kkunsidrati waqt l-iżvilupp, il-kostruzzjoni u l-assemblaġġ. DS jiżgura li r-rekwiżiti kollha tal-klijenti u l-istandards validi attwali minn CGMP, UE, EN ISO u l-FDA huma sodisfatti.<\/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 \>F&#039;BOCON, qabel il-bejgħ, il-fabbrika tipprovdi lill-klijenti bid-disinn u l-konsultazzjoni dwar it-tagħmir u l-faċilitajiet ġenerali tal-workshop ETO u tassisti fil-formulazzjoni tal-ippjanar ġenerali u t-tqassim tal-workshop ETO. Skont il-karatteristiċi tas-sit tal-klijent u l-prodott, il-materjal, l-ippakkjar, it-trasport u l-iżvilupp futur, aħna nagħżlu l-materjal, il-konfigurazzjoni, il-mod ta &#039;kontroll, il-volum u l-kwantità għall-isterilizzatur. Biex tassisti fil-preparazzjoni tal-proċess ta &#039;sterilizzazzjoni tal-ossidu tal-etilene, skema ta&#039; verifika, regoli u regolamenti ta &#039;ġestjoni tal-workshop ETO, użu u manutenzjoni tat-tagħmir, eċċ Fl-istess ħin biex tipprovdi standards rilevanti, tisħin minn qabel, analiżi residwa, konsultazzjoni tat-teknoloġija tal-ipproċessar, u kooperazzjoni.<\/p><\/section><\/section><section class=\"mx-auto sm:max-w-[1200px] w-[95%]\"><section><h2>DQ, IQ, OQ, PQ<\/h2><p>DQ (Kwalifiki tad-Disinn)<br \><a href=\"https:\/\/zjbocon.com\/iq-in-eto-sterilization-process\/\">IQ (Kwalifikazzjoni ta&#039; Installazzjoni)<\/a><br \><a href=\"https:\/\/zjbocon.com\/oq-in-eto-sterilization-machine\/\">OQ (Kwalifiki Operazzjonali)<\/a><br \><a href=\"https:\/\/zjbocon.com\/ethylene-oxide-sterilization-chamber\/\">PQ (Kwalifikazzjoni tal-Prestazzjoni)<\/a><br \>Mill-ispeċifikazzjonijiet tal-prodott u r-rekwiżiti, għal analiżi tar-riskju, għall-ippjanar u l-eżekuzzjoni tal-passi individwali tal-kwalifika, aħna nieħdu ħsieb dak kollu li teħtieġ l-implimentazzjoni.<\/p><p><strong>Validazzjoni<\/strong>: BOCON jipprovdi validazzjoni tas-softwer. IQ, rapport OQ, u appoġġ ta &#039;PQ wara l-installazzjoni.<\/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\">Rapport 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>Servizzi ta&#039; Kwalifika - 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\/?page_id=1427\" \>\n<meta property=\"og:locale\" content=\"mt_MT\" \>\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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