{"id":7286,"date":"2025-07-29T12:02:12","date_gmt":"2025-07-29T04:02:12","guid":{"rendered":"https:\/\/zjbocon.com\/?p=7286"},"modified":"2025-10-01T19:30:30","modified_gmt":"2025-10-01T11:30:30","slug":"eto-sterilization-re-qualification","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=7286","title":{"rendered":"ETO Sterilization Re-qualification"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements\">Kërkesat e rikualifikimit të sterilizimit ETO<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-re-qualification-frequency\">1. Frekuenca e rikualifikimit<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Kërkesa minimale vjetore<\/strong><br>\u2022 At least once per year, verification data, subsequent re-validation data, and routine processing data must be reviewed<br>\u2022 The scope of re-qualification must be determined and documented<br>\u2022 The review procedure shall be documented<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-2-is-re-qualification-needed-if-no-product-changes-occur\">2. A nevojitet rikualifikim nëse nuk ndodhin ndryshime në produkti?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Po, kërkohet ende rikualifikim<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-3-re-qualification-items\">3. Artikujt e rikualifikimit<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Bazuar në disa parakushte, opsionet e mëposhtme janë të disponueshme<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Rikualifikim i plotë<\/li>\n\n\n\n<li>Nuk ka nevojë për rivlerësim fizik ose mikrobik<\/li>\n\n\n\n<li>Vlefshmëria e performancës mikrobike në shkallë të vogël<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Parakushtet për rikualifikim<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a) The following must be reviewed\/tested:<br>b) Nëse ndonjë<strong>ndryshime të rëndësishme<\/strong>&nbsp;që ndikojnë në sterilitetin e produktit kanë ndodhur në:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Dizajni i produktit<\/li>\n\n\n\n<li>Manufacturing\/packaging materials<\/li>\n\n\n\n<li>PCD (Pajisja e sfidës së procesit)<\/li>\n\n\n\n<li>Furnizuesit<\/li>\n\n\n\n<li>Manufacturing areas\/facilities<\/li>\n\n\n\n<li>Ngarkoni konfigurimet ose proceset e prodhimit<br>c)<strong>Analiza e tendencës së biobarrës<\/strong>&nbsp;e produkteve;<br>d) Nëse<strong>studimet e shpërndarjes së temperaturës<\/strong>&nbsp;dhe funksionimi i sterilizuesit demonstron ndryshime të rëndësishme që nga kualifikimi i fundit;<br>e) Nëse<strong>shpërndarjen e temperaturës dhe kontrollet e riqarkullimit<\/strong>&nbsp;në dhomat e parakushtimit ose në zonat e ajrimit shfaqin ndryshime të rëndësishme që nga kualifikimi i fundit;<br>f) Nëse Sterilizimi ETO<strong> historia e procesit<\/strong>&nbsp;meqenëse vërtetimi i fundit demonstron riprodhueshmëri;<br>g) Nëse<strong>ndryshimi i të dhënave të kontrollit dhe mirëmbajtjes parandaluese<\/strong>&nbsp;konfirmoni asnjë modifikim të pajisjes që ndikon në proces;<br>h) Nëse<strong>asnjë ndryshim në procesin e Sterilizimit ETO<\/strong>&nbsp;kanë ndodhur që ndikojnë në sterilitetin;<br>i) Nëse<strong>Ndryshuan specifikimet e procesit të sterilizimit me ETO<\/strong>, rikualifikimi duhet të përfshijë verifikimin e<strong>Kufijtë e mbetjeve të OE<\/strong>&nbsp;pajtueshmërinë me kërkesat rregullatore.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Standardet Rregullatore<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ISO 11135:2014<\/strong>&nbsp;<em>(Sek. 9.2: Kriteret e rikualifikimit)<\/em><\/li>\n\n\n\n<li><strong>FDA 21 CFR 211.113<\/strong>&nbsp;<em>(Kontrollet e procesit të sterilizimit)<\/em><\/li>\n\n\n\n<li><strong>BE GMP Aneksi 1:2022<\/strong>&nbsp;<em>(Sek. 8.5: Kërkesat e rivlerësimit)<\/em><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements-0\"><strong>Kërkesat e rikualifikimit të sterilizimit ETO<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Rikualifikimi do të<strong>përfshijnë një rishikim të performancës së dhomës dhe ndryshimeve vjetore inxhinierike<\/strong>&nbsp;to ensure the original IQ\/OQ results remain valid. The review must cover:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Preconditioning zone temperature\/humidity profiles<\/strong>&nbsp;(nëse është e aplikueshme);<\/li>\n\n\n\n<li><strong>Profilet aktuale të lagështisë së dhomës së zbrazët<\/strong>;<\/li>\n\n\n\n<li><strong>Temperaturat e zonës së ajrimit<\/strong>&nbsp;(nëse është e aplikueshme);<\/li>\n\n\n\n<li><strong>Për më tepër, edhe nëse plotësohen specifikimet e procesit<\/strong>, inspections must be triggered by:\n<ul class=\"wp-block-list\">\n<li>Tendenca të pafavorshme në performancën e pajisjeve,<\/li>\n\n\n\n<li>Dështimet e sterilitetit;<\/li>\n\n\n\n<li>Për të përcaktuar nëse rivalidimi është i garantuar.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Ekspertët e sterilizimit<\/strong>&nbsp;do të përcaktojë fushën e kërkuar<strong>rivalidimi fizik dhe mikrobial<\/strong>&nbsp;bazuar në rezultatet e rishikimit.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Konsiderata kritike për rikualifikimin e sterilizimit<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. Trajtimi i ndryshimeve të rëndësishme<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 If&nbsp;<strong>ndryshime të mëdha<\/strong>&nbsp;are identified during re-qualification, re-execution of IQ\/OQ\/PQ may be required:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>IQ (Kualifikimi i instalimit)<\/strong>: Verify modified equipment\/software installation.<\/li>\n\n\n\n<li><strong>OQ (Kualifikimi Operacional)<\/strong>: Ritestoni parametrat funksionalë të ndikuar.<\/li>\n\n\n\n<li><strong>PQ (Kualifikimi i Performancës)<\/strong>: Rivlerësoni efikasitetin e sterilizimit në kushte të reja.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. Kërkesa Shtesë për Lirimin Parametrik<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Për objektet që përdorin<strong>lëshimi parametrik<\/strong>&nbsp;(duke u mbështetur në të dhënat e procesit dhe jo në testimin e BI):<br>a)<strong>Frekuenca e rivlerësimit<\/strong>: Duhet të kryhet<strong>të paktën çdo vit<\/strong>;<br>b)<strong>Shtrirja e rivlerësimit<\/strong>: Duhet të përfshijë<strong>studimet mikrobiologjike<\/strong>&nbsp;për të konfirmuar:<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Situations Requiring Full Requalification (IQ\/OQ\/PQ):<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a)<strong>Mirëmbajtja e madhe e sterilizuesit<\/strong>;<br>b)<strong>Ndryshime strukturore, vendndodhjeje ose mjedisore<\/strong>;<br>c)<strong>Dështime të pashpjegueshme të sterilitetit<\/strong>;<br>d)<strong>Changes in EO supply\/delivery, diluent, or chamber load configuration<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Përjashtim nga Rikualifikimi Fizik ose Mikrobik<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Kur plotësohen kushtet e mëposhtme:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Nuk ka ndryshime<\/strong>&nbsp;in product, packaging, equipment\/services, or processes;<\/li>\n\n\n\n<li><strong>Rishikimi i performancës së dhomës dhe inxhinierisë<\/strong>&nbsp;janë të kualifikuar;<\/li>\n\n\n\n<li><strong>Proceset rutinë të sterilizimit<\/strong>&nbsp;kanë funksionuar në mënyrë të besueshme gjatë periudhës;<br>?<strong>Gjykimi profesional<\/strong>&nbsp;mund të përcaktojë se rikualifikimi fizik ose mikrobial është<strong>nuk kërkohet<\/strong>&nbsp;deri në shqyrtimin tjetër.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Kualifikimi i performancës mikrobiale në shkallë të kufizuar<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Mund të kërkohet në raste specifike<\/strong>, të tilla si:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Verifikimi i përshtatshmërisë së vazhdueshme të BI-ve në lidhje me ngarkesën biologjike të produktit;<\/li>\n\n\n\n<li>Dhënia e provave se nr<strong>ndryshime të padëshiruara<\/strong>&nbsp;ka ndodhur që nga studimi i mëparshëm (ri)kualifikues pas një intervali kohor të përcaktuar.<br>\u2022&nbsp;<strong>Kërkesat e përgjithshme (në minimum)<\/strong>:<\/li>\n\n\n\n<li>Një<strong>vrapim me cikël të shkurtër ose gjysmë cikli<\/strong>;<\/li>\n\n\n\n<li>duke përfshirë<strong>matjet e temperaturës dhe lagështisë<\/strong>&nbsp;e sendeve të sterilizuara.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">NËSE DËSHIRONI TË DINI MË SHUMË<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Telefoni:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Email:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Vendi lokal: Dhoma 1202, Caitong Zhongxin, Distrikti Xiasha, Qyteti Hangzhou, Provinca Zhejiang, Kinë<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Faqja e internetit:<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">zjbocon.com<\/a><\/p>\n\n\n\n<div class=\"wp-block-uagb-image uagb-block-9d7632fc wp-block-uagb-image--layout-default wp-block-uagb-image--effect-static wp-block-uagb-image--align-none\"><figure class=\"wp-block-uagb-image__figure\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9-1024x1024.webp\" alt=\"\" class=\"uag-image-8487\" width=\"1024\" height=\"1024\" title=\"eto-sterilizer-9\" role=\"img\" \><\/figure><\/div>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>ETO Sterilization Re-qualification Requirements 1. Re-qualification Frequency \u2022&nbsp;Minimum annual requirement\u2022 At least once per year, verification data, subsequent re-validation data, [&hellip;]<\/p>\n","protected":false},"author":234312599,"featured_media":8487,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","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":"","ast-breadcrumbs-content":"","ast-featured-img":"","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":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[133125,133124],"tags":[],"class_list":["post-7286","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company-news","category-eto-sterilizer"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v28.0) - 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Test Criteria: 1 run\u2026","rel":"","context":"In &quot;Company News&quot;","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":9080,"url":"https:\/\/zjbocon.com\/?p=9080","url_meta":{"origin":7286,"position":1},"title":"Essential Utilities and Service Requirements for ETO Sterilizers","author":"Bocon Technical Team","date":"2026-01-20","format":false,"excerpt":"The successful operation of an Ethylene Oxide (ETO) sterilizer requires more than just the machine itself; it demands a robust infrastructure of essential utilities, safety systems, and ongoing technical support. 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Team","date":"2024-10-31","format":false,"excerpt":"PQ is the stage of validation that uses Ethylene oxide sterilization chamber to demonstrate that the Ethylene oxide sterilization equipment consistently operates in accordance with predetermined acceptance criteria and the process yields a product that is sterile and meets the specified requirements.","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=525%2C300&ssl=1 1.5x, 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apply in ethylene oxide sterilization 3.1 Aeration part of the eto gas sterilization process during which ethylene oxide and\/or its reaction products desorb from the medical device until predetermined levels are reached \u00a0 Note 1 to entry: This can\u2026","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":2138,"url":"https:\/\/zjbocon.com\/?p=2138","url_meta":{"origin":7286,"position":5},"title":"ETO Sterilization Chamber Testing","author":"Bocon Technical Team","date":"2024-11-07","format":false,"excerpt":"The temperature setting range of the ETO Sterilization Chamber should be between 30-60\u00b0C. It is recommended to perform temperature distribution testing of the sterilizer's internal surface and temperature and humidity distribution testing inside the sterilization chamber to ensure the effectiveness of the heating and humidifying systems.","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/cropped-cropped-hzbocon.png?resize=350%2C200&ssl=1","width":350,"height":200},"classes":[]}],"_links":{"self":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7286","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/users\/234312599"}],"replies":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=7286"}],"version-history":[{"count":12,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7286\/revisions"}],"predecessor-version":[{"id":8613,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7286\/revisions\/8613"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/media\/8487"}],"wp:attachment":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=7286"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=7286"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=7286"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}