{"id":2013,"date":"2024-10-28T10:57:16","date_gmt":"2024-10-28T02:57:16","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2013"},"modified":"2024-11-06T14:09:45","modified_gmt":"2024-11-06T06:09:45","slug":"eto-sterilization-2","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2013","title":{"rendered":"Purpose for eto sterilization validation"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\" id=\"h-1-purpose-for-validation-eto-sterilization\">1.<strong>Purpose\u00a0for validation<\/strong> thiab sterilization<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">1.1.the tau txais cov ntaub ntawv pov thawj ntawm eto sterilization validation uas cov cuab yeej siv rau ETO sterilization tau muab thiab ntsia raws li nws cov specification thiab muaj peev xwm ruaj khov nyob rau hauv predetermined txwv thiab tsis tu ncua ua raws li cov txheej txheem predetermined thiab yog li yields khoom raws li nws specification.<\/p>\n\n\n\n<div class=\"wp-block-uagb-image uagb-block-4162e3c7 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\"><a class=\"\" href=\"https:\/\/zjbocon.com\/qualification-services\/\" target=\"\" rel=\"noopener\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp\" alt=\"eto sterilization validation\" class=\"uag-image-1359\" width=\"800\" height=\"400\" title=\"Qualification_Services (2)\" role=\"img\" \><\/a><\/figure><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">1.2<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Qhov no qhia meej txog cov kev cai rau kev txhim kho, kev siv tau thiab kev tswj hwm niaj hnub ntawm ETO sterilization txheej txheem thiab muab kev taw qhia rau nws kom ua raws li cov kev cai tswj hwm xws li ISO 11135.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-2-scope\">2. Scope<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">2.1.Cov cuab yeej siv hauv ETO kom tsis muaj menyuam (chav ua ntej?Sterilizer?Aeration room?Incubator, thiab lwm yam).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-terms-and-definitions\">3. Cov ntsiab lus thiab cov lus txhais<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">3.1. IQ Ib<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Installation kev tsim nyog: IQ<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.2.o QH<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Kev tsim nyog ua haujlwm: OQ<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.3.?PQ(MPQ\/PPQ)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Performance qualification:PQ(Microbiological PQ\/Physical PQ )<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.4.: Requalification<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.5.: Bioburden<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.6.:Biological taw qhia<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.7.: Fractional voj voog<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.8.: Ib nrab voj voog<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.9.: Tag nrho lub voj voog<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.10.PCD: txheej txheem kev sib tw ntaus ntawv<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.11.: Khoom thiab khoom tsev neeg<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.12.?: Usable volume\/Product load volume<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.13.: Sterility<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.14.SAL: qib kev ruaj ntseg<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-4-responsibilities\">4. Lub luag haujlwm<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">4.1 Lub eto sterilization validation engineer yog lub luag hauj lwm rau kev sau cov txheej txheem validation, thiab cov neeg ua hauj lwm cob qhia thiab cov kev siv yog lub luag hauj lwm rau ua qhov validation thiab sau cov ntaub ntawv tseem ceeb los pab nyob rau hauv ua kom tiav cov validation.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-5-procedure\">5. Cov txheej txheem<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">5.1.IQ tau lees paub los ua kom pom tias cov cuab yeej ua kom tsis muaj menyuam thiab lwm yam khoom ntxiv tau muab thiab ntsia raws li lawv qhov tshwj xeeb. Ua ntej ua IQ, cov chaw tsim khoom lag luam yuav ua FAT thiab SAT kom ntseeg tau tias cov khoom tau raug xa tuaj ib txwm.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-references\">Ntawv Sawv cev<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.iso.org\/obp\/ui\/#iso:std:iso:11135:ed-2:v1:en\">ISO 11135:2014&nbsp;Sterilization of health-care products \u2014 Ethylene oxide \u2014 Requirements for the development, validation and routine control of a sterilization process for medical devices<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>1.Purpose\u00a0for validation eto sterilization 1.1.the obtain of eto sterilization validation evidence that the equipment used for ETO sterilization has been [&hellip;]<\/p>\n","protected":false},"author":234312599,"featured_media":1974,"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":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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Technical Team","author_link":"https:\/\/zjbocon.com\/?author=234312599"},"uagb_comment_info":23,"uagb_excerpt":"1.Purpose\u00a0for validation eto sterilization 1.1.the obtain of eto sterilization validation evidence that the equipment used for ETO sterilization has been [&hellip;]","jetpack_likes_enabled":true,"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/pgZDV6-wt","jetpack-related-posts":[{"id":8776,"url":"https:\/\/zjbocon.com\/?p=8776","url_meta":{"origin":2013,"position":0},"title":"How to Test ETO Gas Sterilization Test Materials","author":"Bocon Technical Team","date":"2025-11-25","format":false,"excerpt":"When it comes to ETO gas sterilization, testing is an essential part of ensuring the effectiveness and safety of the sterilization process. 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Re-qualification Frequency \u2022\u00a0Minimum annual requirement\u2022 At least once per year, verification data, subsequent re-validation data, and routine processing data must be reviewed\u2022 The scope of re-qualification must be determined and documented\u2022 The review procedure shall be documented 2. Is Re-qualification Needed if No Product Changes\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\/eto-sterilizer-9.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":8772,"url":"https:\/\/zjbocon.com\/?p=8772","url_meta":{"origin":2013,"position":4},"title":"ETO STERILIZATION Safety Guidelines: Best Practices for Using Ethylene Oxide as a Sterilant","author":"Bocon Technical Team","date":"2025-11-25","format":false,"excerpt":"Ethylene oxide (ETO STERILIZATION) is widely used as a low-temperature sterilant in industries like healthcare, pharmaceuticals, and biotechnology. 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