{"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> te whakahoromata<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">1.1.Ko te whiwhinga o nga taunakitanga whakamanatanga eto whakahoromata kua whakaratohia, kua whakauruhia nga taputapu mo te whakahoromata ETO kia rite ki tana whakaritenga, ka taea te mahi i roto i nga rohe kua whakaritea, ka mahi tonu i runga i nga paearu kua whakaritea, na reira ka puta nga hua e tutuki ana ki tana whakaritenga.<\/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\">Ko tenei waahanga e whakaatu ana i nga whakaritenga mo te whakawhanaketanga, te whakamana me te whakahaere i nga tikanga o te mahi whakahoromata ETO me te arahi i a ia ki te whakatutuki i nga whakaritenga ture e tika ana penei i te ISO 11135.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-2-scope\">2. Te whānuitanga<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">2.1.Ko nga taputapu e tika ana e whakamahia ana i roto i te whakahoromata ETO(Rua Tuhinga o mua? Sterilizer? Rūma Aeration? Incubator , etc.).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-terms-and-definitions\">3. Nga Kupu me nga Whakamaramatanga<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">3.1.?IQ<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Tohu whakaurunga:IQ<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.2.?OQ<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Tohu mahi: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.:Whakaaetanga<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.5.: He taumahatanga koiora<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.6.:Te tohu koiora<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.7.:Hatanga hautanga<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.8.:Hawhe huringa<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.9.:Te huringa katoa<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.10.PCD: taputapu wero tukanga<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.11.: Hua me te whanau hua<\/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.:Te whakakorikori<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.14.SAL: Taumata whakau<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-4-responsibilities\">4. Nga kawenga<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">4.1 Ko te miihini whakamana eto sterilization te kawenga mo te tuhi i te kawa whakamana, a ko nga kaimahi kua whakangungua me nga whakamahinga te kawenga mo te whakamana me te kohikohi raraunga e tika ana hei awhina i te whakaotinga o te whakamana.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-5-procedure\">5. Tikanga<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Ka mahia 5.1.IQ ki te whakaatu kua tukuna mai nga taputapu whakahoromata me nga mea taapiri i runga i o raatau tohu. I mua i te mahi IQ, ka whakahaerehia e te kaihanga taputapu te FAT me te SAT kia pai ai te tuku o nga taputapu.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-references\">Tohutoro<\/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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