{"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\">Kröfur um endurhæfingu ETO ófrjósemisaðgerðar<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-re-qualification-frequency\">1. Endurhæfistíðni<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Lágmarks árleg krafa<\/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. Er þörf á endurhæfingu ef engar vörubreytingar eiga sér stað?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Já, enn er krafist endurhæfingar<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-3-re-qualification-items\">3. Endurhæfisatriði<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Miðað við ákveðnar forsendur eru eftirfarandi valkostir í boði<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Fullt endurhæfi<\/li>\n\n\n\n<li>Engin þörf á líkamlegri eða örveruendurstaðfestingu<\/li>\n\n\n\n<li>Löggilding á frammistöðu örvera í litlum mæli<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Forsendur fyrir endurhæfingu<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a) The following must be reviewed\/tested:<br>b) Hvort einhver<strong>verulegar breytingar<\/strong>&nbsp;sem hafa áhrif á ófrjósemi vöru hefur komið fram í:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Vöruhönnun<\/li>\n\n\n\n<li>Manufacturing\/packaging materials<\/li>\n\n\n\n<li>PCD (Process Challenge Device)<\/li>\n\n\n\n<li>Birgjar<\/li>\n\n\n\n<li>Manufacturing areas\/facilities<\/li>\n\n\n\n<li>Hlaða stillingar eða framleiðsluferli<br>c)<strong>Bioburden þróun greining<\/strong>&nbsp;af vörum;<br>d) Hvort<strong>rannsóknir á hitadreifingu<\/strong>&nbsp;og notkun dauðhreinsunartækis sýna verulegar breytingar frá síðasta hæfi;<br>e) Hvort<strong>eftirlit með hitadreifingu og endurrás<\/strong>&nbsp;í formeðferðarhólfum eða loftræstingarsvæðum sýna verulegar breytingar frá síðasta hæfi;<br>f) Hvort ETO ófrjósemisaðgerð<strong> ferli sögu<\/strong>&nbsp;síðan síðasta staðfesting sýnir fram á endurgerðanleika;<br>g) Hvort<strong>breytingaeftirlit og fyrirbyggjandi viðhaldsskrár<\/strong>&nbsp;staðfesta engar breytingar á búnaði sem hafa áhrif á ferlið;<br>h) Hvort<strong>engar breytingar á ETO dauðhreinsunarferlinu<\/strong>&nbsp;sem hefur áhrif á ófrjósemi hefur átt sér stað;<br>i) Ef<strong>Forskriftir ETO ófrjósemisferlis breytt<\/strong>, endurhæfi verður að fela í sér sannprófun á<strong>EO leifarmörk<\/strong>&nbsp;samræmi við kröfur reglugerðar.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Reglugerðarstaðlar<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ISO 11135:2014<\/strong>&nbsp;<em>(Grein 9.2: Endurhæfisskilyrði)<\/em><\/li>\n\n\n\n<li><strong>FDA 21 CFR 211.113<\/strong>&nbsp;<em>(Stýringar á ófrjósemisferli)<\/em><\/li>\n\n\n\n<li><strong>ESB GMP viðauki 1:2022<\/strong>&nbsp;<em>(Kafli 8.5: Framlengingarkröfur)<\/em><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements-0\"><strong>Kröfur um endurhæfingu ETO ófrjósemisaðgerðar<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Endurhæfi skal<strong>fela í sér endurskoðun á frammistöðu deildarinnar og árlegar verkfræðilegar breytingar<\/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;(ef við á);<\/li>\n\n\n\n<li><strong>Raunveruleg rakastig í tómu hólfinu<\/strong>;<\/li>\n\n\n\n<li><strong>Hitastig loftræstingarsvæðis<\/strong>&nbsp;(ef við á);<\/li>\n\n\n\n<li><strong>Þar að auki, jafnvel þó að vinnsluforskriftir séu uppfylltar<\/strong>, inspections must be triggered by:\n<ul class=\"wp-block-list\">\n<li>Óhagstæð þróun í frammistöðu búnaðar,<\/li>\n\n\n\n<li>Ófrjósemisbilun;<\/li>\n\n\n\n<li>Til að ákvarða hvort endurfullgilding sé réttlætanleg.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Ófrjósemisaðgerðir sérfræðingar<\/strong>&nbsp;skal skilgreina umfang krafist<strong>líkamlega og örvera endurfullgildingu<\/strong>&nbsp;byggt á niðurstöðum endurskoðunar.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Mikilvægar athugasemdir við endurhæfingu ófrjósemisaðgerða<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. Meðhöndlun mikilvægra breytinga<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 If&nbsp;<strong>meiri háttar breytingar<\/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 (uppsetningarhæfi)<\/strong>: Verify modified equipment\/software installation.<\/li>\n\n\n\n<li><strong>OQ (Rekstrarhæfi)<\/strong>: Endurprófaðu hagnýtar færibreytur sem hafa áhrif.<\/li>\n\n\n\n<li><strong>PQ (Performance Qualification)<\/strong>: Endurstaðfesta virkni dauðhreinsunar við nýjar aðstæður.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. Viðbótarkröfur fyrir færibreytuútgáfu<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Fyrir aðstöðu að nota<strong>parametric losun<\/strong>&nbsp;(að treysta á vinnslugögn frekar en BI prófun):<br>a)<strong>Endurstaðfestingartíðni<\/strong>: Verður að framkvæma<strong>að minnsta kosti árlega<\/strong>;<br>b)<strong>Umfang endurmats<\/strong>: Verður að innihalda<strong>örverufræðilegar rannsóknir<\/strong>&nbsp;til að staðfesta:<\/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>Mikilvægt viðhald á dauðhreinsunartækinu<\/strong>;<br>b)<strong>Skipulags-, staðsetningar- eða umhverfisbreytingar<\/strong>;<br>c)<strong>Óútskýrð ófrjósemisbrestur<\/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>Undanþága frá líkamlegri eða örverufræðilegri endurhæfingu<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Þegar eftirfarandi skilyrði eru uppfyllt:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Engar breytingar<\/strong>&nbsp;in product, packaging, equipment\/services, or processes;<\/li>\n\n\n\n<li><strong>Afköst stofu og verkfræðileg endurskoðun<\/strong>&nbsp;eru hæfir;<\/li>\n\n\n\n<li><strong>Venjuleg dauðhreinsunarferli<\/strong>&nbsp;hafa starfað áreiðanlega á tímabilinu;<br>?<strong>Faglegt mat<\/strong>&nbsp;getur ákveðið að líkamlegt eða örverufræðilegt endurhæfi sé<strong>ekki krafist<\/strong>&nbsp;fram að næstu endurskoðun.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Árangurshæfni fyrir örverur í takmörkuðum mæli<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Getur verið krafist í sérstökum tilvikum<\/strong>, eins og:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Staðfesta áframhaldandi hæfi BI miðað við líffræðilegan byrði vöru;<\/li>\n\n\n\n<li>Að leggja fram sannanir fyrir því að nr<strong>ófyrirséðar breytingar<\/strong>&nbsp;occurred since the previous (re)qualification study after a defined time interval.<br>\u2022&nbsp;<strong>General requirements (at minimum)<\/strong>:<\/li>\n\n\n\n<li>One&nbsp;<strong>short-cycle or half-cycle run<\/strong>;<\/li>\n\n\n\n<li>Including&nbsp;<strong>temperature and humidity measurements<\/strong>&nbsp;of sterilized items.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">EF ÞÚ VILT VITA MEIRA<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Sími:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Netfang:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Staðbundin staður: Herbergi 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, Kína<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Vefsíða:<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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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, 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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}]}}