{"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> エト滅菌<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">1.1. ETO 滅菌に使用される機器が仕様に従って提供および設置され、所定の制限内で安定して動作し、所定の基準に従って一貫して動作し、それによって仕様を満たす製品が得られることを示す ETO 滅菌検証証拠を取得すること。<\/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\">この部分では、ETO 滅菌プロセスの開発、検証、日常管理の要件を指定し、ISO 11135 などの関連規制要件に準拠するためのガイダンスを提供します。<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-2-scope\">2. 範囲<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">2.1.ETO滅菌に使用される関連設備(プレコンディションルーム?滅菌器?曝気室?インキュベーターなど)。<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-terms-and-definitions\">3. 用語と定義<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">3.1.?IQ<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">設置資格:IQ<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.2.?Q<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">運用資格：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.:再認定<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.5.: バイオバーデン<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.6.:生物学的指標<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.7.:分数サイクル<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.8.:半サイクル<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.9.:フルサイクル<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.10.PCD: プロセスチャレンジデバイス<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.11.:製品と製品ファミリー<\/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.:無菌性<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.14.SAL: 無菌保証レベル<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-4-responsibilities\">4. 責任<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">4.1 eto 滅菌検証エンジニアは検証プロトコルの起草に責任を負い、訓練を受けた担当者と使用者は検証の実行と検証の完了を支援する関連データの収集に責任を負います。<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-5-procedure\">5. 手順<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">5.1.IQ は、滅菌装置および付属品が仕様に従って供給および設置されていることを実証するために実施されます。 IQ を実行する前に、機器メーカーは FAT および SAT を実施して、機器が正常に納入されたことを確認します。<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-references\">参考文献<\/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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