{"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\">Mga Kinakailangan sa Muling Kwalipikasyon ng ETO Sterilization<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-re-qualification-frequency\">1. Dalas ng muling kwalipikasyon<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Minimum na taunang kinakailangan<\/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. Kailangan ba ang Muling Kwalipikasyon kung Walang Nagaganap na Pagbabago sa Produkto?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Oo, kailangan pa rin ang muling kwalipikasyon<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-3-re-qualification-items\">3. Re-qualification Items<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Batay sa ilang mga paunang kundisyon, available ang mga sumusunod na opsyon<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Buong muling kwalipikasyon<\/li>\n\n\n\n<li>Hindi na kailangan para sa pisikal o microbial na muling pagpapatunay<\/li>\n\n\n\n<li>Maliit na sukat na pagpapatunay ng pagganap ng microbial<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Mga kinakailangan para sa Muling kwalipikasyon<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a) The following must be reviewed\/tested:<br>b) Kung mayroon man<strong>makabuluhang pagbabago<\/strong>&nbsp;ang nakakaapekto sa sterility ng produkto ay naganap sa:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Disenyo ng produkto<\/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>Mga supplier<\/li>\n\n\n\n<li>Manufacturing areas\/facilities<\/li>\n\n\n\n<li>I-load ang mga configuration o proseso ng pagmamanupaktura<br>c)<strong>Pagsusuri ng kalakaran ng bioburden<\/strong>&nbsp;ng mga produkto;<br>d) Kung<strong>pag-aaral ng pamamahagi ng temperatura<\/strong>&nbsp;at pagpapatakbo ng sterilizer ay nagpapakita ng mga makabuluhang pagbabago mula noong huling kwalipikasyon;<br>e) Kung<strong>pamamahagi ng temperatura at mga pagsusuri sa recirculation<\/strong>&nbsp;sa mga preconditioning chamber o aeration zone ay nagpapakita ng mga makabuluhang pagbabago mula noong huling kwalipikasyon;<br>f) Kung ETO Sterilization<strong> kasaysayan ng proseso<\/strong>&nbsp;dahil ang huling pagpapatunay ay nagpapakita ng reproducibility;<br>g) Kung<strong>pagbabago ng kontrol at preventive maintenance record<\/strong>&nbsp;kumpirmahin na walang mga pagbabago sa kagamitan na nakakaapekto sa proseso;<br>h) Kung<strong>walang pagbabago sa proseso ng ETO Sterilization<\/strong>&nbsp;naapektuhan ang sterility;<br>i) Kung<strong>Nagbago ang mga detalye ng proseso ng ETO Sterilization<\/strong>, ang muling kwalipikasyon ay dapat magsama ng pagpapatunay ng<strong>Mga limitasyon ng nalalabi sa EO<\/strong>&nbsp;pagsunod sa mga kinakailangan sa regulasyon.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Mga Pamantayan sa Regulasyon<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ISO 11135:2014<\/strong>&nbsp;<em>(Sec. 9.2: Pamantayan sa muling kwalipikasyon)<\/em><\/li>\n\n\n\n<li><strong>FDA 21 CFR 211.113<\/strong>&nbsp;<em>(Mga kontrol sa proseso ng sterilization)<\/em><\/li>\n\n\n\n<li><strong>EU GMP Annex 1:2022<\/strong>&nbsp;<em>(Sec. 8.5: Mga kinakailangan sa muling pagpapatunay)<\/em><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements-0\"><strong>Mga Kinakailangan sa Muling Kwalipikasyon ng ETO Sterilization<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Ang muling kwalipikasyon ay dapat<strong>isama ang isang pagsusuri ng pagganap ng silid at taunang mga pagbabago sa engineering<\/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;(kung naaangkop);<\/li>\n\n\n\n<li><strong>Aktwal na walang laman na mga profile ng halumigmig ng silid<\/strong>;<\/li>\n\n\n\n<li><strong>Mga temperatura ng aeration zone<\/strong>&nbsp;(kung naaangkop);<\/li>\n\n\n\n<li><strong>Bukod pa rito, kahit na natugunan ang mga pagtutukoy ng proseso<\/strong>, inspections must be triggered by:\n<ul class=\"wp-block-list\">\n<li>Mga masamang uso sa pagganap ng kagamitan,<\/li>\n\n\n\n<li>Mga pagkabigo sa sterility;<\/li>\n\n\n\n<li>Upang matukoy kung kinakailangan ang muling pagpapatunay.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Mga eksperto sa sterilization<\/strong>&nbsp;dapat tukuyin ang saklaw ng kinakailangan<strong>pisikal at microbial na muling pagpapatunay<\/strong>&nbsp;batay sa mga resulta ng pagsusuri.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Mga Kritikal na Pagsasaalang-alang para sa Muling Kwalipikasyon ng Sterilization<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. Pangangasiwa ng Mahahalagang Pagbabago<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 If&nbsp;<strong>malalaking pagbabago<\/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 (Kwalipikasyon sa Pag-install)<\/strong>: Verify modified equipment\/software installation.<\/li>\n\n\n\n<li><strong>OQ (Operational Qualification)<\/strong>: Muling subukan ang mga naapektuhang functional na parameter.<\/li>\n\n\n\n<li><strong>PQ (Performance Qualification)<\/strong>: Muling patunayan ang pagiging epektibo ng isterilisasyon sa ilalim ng mga bagong kundisyon.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. Mga Karagdagang Kinakailangan para sa Parametric Release<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Para sa mga pasilidad na gumagamit<strong>parametric release<\/strong>&nbsp;(umaasa sa data ng proseso sa halip na pagsubok sa BI):<br>a)<strong>Dalas ng muling pagpapatunay<\/strong>: Dapat isagawa<strong>kahit taon-taon<\/strong>;<br>b)<strong>Saklaw ng muling pagpapatunay<\/strong>: Dapat isama<strong>microbiological na pag-aaral<\/strong>&nbsp;para kumpirmahin:<\/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>Pangunahing pagpapanatili ng sterilizer<\/strong>;<br>b)<strong>Mga pagbabago sa istruktura, lokasyon, o kapaligiran<\/strong>;<br>c)<strong>Hindi maipaliwanag na pagkabigo sa sterility<\/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>Exemption mula sa Physical o Microbial Re-qualification<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Kapag natugunan ang mga sumusunod na kondisyon:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Walang pagbabago<\/strong>&nbsp;in product, packaging, equipment\/services, or processes;<\/li>\n\n\n\n<li><strong>Pagganap ng silid at pagsusuri sa engineering<\/strong>&nbsp;ay kwalipikado;<\/li>\n\n\n\n<li><strong>Mga karaniwang proseso ng isterilisasyon<\/strong>&nbsp;gumana nang mapagkakatiwalaan sa panahon;<br>?<strong>Propesyonal na paghatol<\/strong>&nbsp;maaaring matukoy na ang pisikal o microbial na muling kwalipikasyon ay<strong>hindi kinakailangan<\/strong>&nbsp;hanggang sa susunod na pagsusuri.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Limited-Scale Microbial Performance Qualification<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Maaaring kailanganin sa mga partikular na kaso<\/strong>, tulad ng:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Pag-verify ng patuloy na pagiging angkop ng mga BI na may kaugnayan sa bioburden ng produkto;<\/li>\n\n\n\n<li>Pagbibigay ng ebidensya na hindi<strong>hindi sinasadyang pagbabago<\/strong>&nbsp;naganap mula noong nakaraang (muling) pag-aaral ng kwalipikasyon pagkatapos ng isang tinukoy na agwat ng oras.<br>\u2022&nbsp;<strong>Pangkalahatang mga kinakailangan (hindi bababa sa)<\/strong>:<\/li>\n\n\n\n<li>Isa<strong>short-cycle o half-cycle run<\/strong>;<\/li>\n\n\n\n<li>Kasama<strong>mga sukat ng temperatura at halumigmig<\/strong>&nbsp;ng mga isterilisadong bagay.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">KUNG GUSTO MONG MALAMAN<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Telepono:<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\">Lokal na Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Website:<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, 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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}]}}