{"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\">ETO Sterilization Re-qualification Requirements<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-re-qualification-frequency\">1. Kasubsob sa Kwalipikasyon<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Minimum nga tinuig nga kinahanglanon<\/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. Kinahanglan ba ang Re-kwalipikasyon kung Walay Pagbag-o sa Produkto?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Oo, gikinahanglan gihapon ang re-qualification<\/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>Base sa pipila ka preconditions, ang mosunod nga mga opsyon anaa<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Bug-os nga re-kwalipikasyon<\/li>\n\n\n\n<li>Dili kinahanglan alang sa pisikal o microbial re-validation<\/li>\n\n\n\n<li>Gagmay nga microbial performance validation<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Mga kinahanglanon para sa Re-qualification<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a) The following must be reviewed\/tested:<br>b) Bisan unsa<strong>mahinungdanon nga mga kausaban<\/strong>&nbsp;Ang nakaapekto sa sterility sa produkto nahitabo sa:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Disenyo sa 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>Pag-load sa mga pagsiguro o mga proseso sa paghimo<br>c)<strong>Bioburden trend analysis<\/strong>&nbsp;sa mga produkto;<br>d) Bisan<strong>mga pagtuon sa pag-apod-apod sa temperatura<\/strong>&nbsp;ug sterilizer nga operasyon nagpakita sa mahinungdanon nga mga kausaban sukad sa katapusang kwalipikasyon;<br>e) Bisan<strong>pag-apod-apod sa temperatura ug pagsusi sa recirculation<\/strong>&nbsp;sa preconditioning chambers o aeration zones nagpakitag mahinungdanong mga kausaban sukad sa kataposang kwalipikasyon;<br>f) Kung ETO Sterilization<strong> kasaysayan sa proseso<\/strong>&nbsp;tungod kay ang katapusang validation nagpakita sa reproducibility;<br>g) Bisan<strong>pagbag-o sa kontrol ug preventive maintenance nga mga rekord<\/strong>&nbsp;pagkumpirma nga walay mga pagbag-o sa kagamitan nga makaapekto sa proseso;<br>h) Bisan<strong>walay mga kausaban sa proseso sa ETO Sterilization<\/strong>&nbsp;nakaapekto sa sterility nahitabo;<br>i) Kung<strong>Ang mga detalye sa proseso sa ETO Sterilization nausab<\/strong>, re-kwalipikasyon kinahanglang maglakip sa verification sa<strong>Mga limitasyon sa nahabilin sa EO<\/strong>&nbsp;pagsunod sa mga kinahanglanon sa regulasyon.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Mga Sumbanan 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 Rekwalipikasyon)<\/em><\/li>\n\n\n\n<li><strong>FDA 21 CFR 211.113<\/strong>&nbsp;<em>(Mga kontrol sa proseso sa sterilization)<\/em><\/li>\n\n\n\n<li><strong>EU GMP Annex 1:2022<\/strong>&nbsp;<em>(Sec. 8.5: Revalidation nga mga kinahanglanon)<\/em><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements-0\"><strong>ETO Sterilization Re-qualification Requirements<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Ang re-kwalipikasyon kinahanglan<strong>naglakip sa usa ka pagrepaso sa performance sa lawak ug tinuig nga mga kausaban 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;(kon magamit);<\/li>\n\n\n\n<li><strong>Aktuwal nga walay sulod nga lawak humidity profile<\/strong>;<\/li>\n\n\n\n<li><strong>Mga temperatura sa aeration zone<\/strong>&nbsp;(kon magamit);<\/li>\n\n\n\n<li><strong>Dugang pa, bisan kung natuman ang mga detalye sa proseso<\/strong>, inspections must be triggered by:\n<ul class=\"wp-block-list\">\n<li>Dili maayo nga mga uso sa pasundayag sa kagamitan,<\/li>\n\n\n\n<li>Mga kapakyasan sa sterility;<\/li>\n\n\n\n<li>Aron mahibal-an kung gikinahanglan ang re-validation.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Mga eksperto sa sterilization<\/strong>&nbsp;maghubit sa sakup sa gikinahanglan<strong>pisikal ug microbial re-validation<\/strong>&nbsp;base sa mga resulta sa pagrepaso.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Mga Kritikal nga Konsiderasyon para sa Sterilization Re-kwalipikasyon<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. Pagdumala sa Mahinungdanon nga mga Kausaban<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 If&nbsp;<strong>dagkong kausaban<\/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-instalar)<\/strong>: Verify modified equipment\/software installation.<\/li>\n\n\n\n<li><strong>OQ (Operational Qualification)<\/strong>: Sulayi pag-usab ang naapektuhan nga mga parameter sa paggana.<\/li>\n\n\n\n<li><strong>PQ (Performance Qualification)<\/strong>: I-validate pag-usab ang pagkaepektibo sa sterilization ubos sa bag-ong mga kondisyon.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. Dugang nga mga Kinahanglanon alang sa Parametric Release<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Alang sa paggamit sa mga pasilidad<strong>parametric nga pagpagawas<\/strong>&nbsp;(nagsalig sa datos sa proseso kaysa pagsulay sa BI):<br>a)<strong>Kadaghanon sa pag-validate<\/strong>: Kinahanglan ipahigayon<strong>labing menos kada tuig<\/strong>;<br>b)<strong>Re-validation scope<\/strong>: Kinahanglan iapil<strong>microbiological nga mga pagtuon<\/strong>&nbsp;sa pagkumpirma:<\/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>Panguna nga pagmentinar sa sterilizer<\/strong>;<br>b)<strong>Pagbag-o sa istruktura, lokasyon, o kalikopan<\/strong>;<br>c)<strong>Wala&#039;y katin-awan nga mga kapakyasan 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 gikan sa Physical o Microbial Re-qualification<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Sa diha nga ang mosunod nga mga kondisyon matuman:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Walay kausaban<\/strong>&nbsp;in product, packaging, equipment\/services, or processes;<\/li>\n\n\n\n<li><strong>Pagpasundayag sa Chamber ug pagrepaso sa engineering<\/strong>&nbsp;mga kuwalipikado;<\/li>\n\n\n\n<li><strong>Kanunay nga mga proseso sa sterilization<\/strong>&nbsp;naglihok nga kasaligan sa panahon;<br>?<strong>Propesyonal nga paghukom<\/strong>&nbsp;mahimong magtino nga ang pisikal o microbial re-kwalipikasyon mao<strong>dili gikinahanglan<\/strong>&nbsp;hangtod sa sunod nga pagrepaso.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Limitado nga Scale Microbial Performance Kwalipikasyon<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Mahimong gikinahanglan sa piho nga mga kaso<\/strong>, sama sa:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Pag-verify sa padayon nga kaangayan sa mga BI kalabot sa bioburden sa produkto;<\/li>\n\n\n\n<li>Naghatag og ebidensya nga dili<strong>wala tuyoa nga mga kausaban<\/strong>&nbsp;nahitabo sukad sa miaging (pag-usab) nga pagtuon sa kwalipikasyon human sa gitakda nga agwat sa panahon.<br>\u2022&nbsp;<strong>Kinatibuk-ang mga kinahanglanon (labing menos)<\/strong>:<\/li>\n\n\n\n<li>Usa<strong>mubo nga siklo o tunga nga siklo nga pagdagan<\/strong>;<\/li>\n\n\n\n<li>Naglakip<strong>pagsukod sa temperatura ug humidity<\/strong>&nbsp;sa sterilized nga mga butang.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">Kung gusto nimo mahibal-an ang dugang<\/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 nga Dapit: 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, 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}]}}