{"id":2047,"date":"2024-10-30T11:16:45","date_gmt":"2024-10-30T03:16:45","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2047"},"modified":"2025-12-05T11:16:43","modified_gmt":"2025-12-05T03:16:43","slug":"iq-in-eto-sterilization-process","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2047","title":{"rendered":"IQ IN ETO STERILIZATION PROCESS"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Iq in eto 滅菌プロセスは、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<div class=\"wp-block-uagb-image uagb-block-a3122174 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\/Ethylene-Oxide-Sterilizer-Installation-Guide-1-1024x473.webp\" alt=\"\" class=\"uag-image-8475\" width=\"1024\" height=\"473\" title=\"Ethylene-Oxide-Sterilizer-Installation-Guide-1\" role=\"img\" \><\/figure><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-during-iq-the-following-events-need-to-be-further-identified-and-substantiated\">IQ 中に、次の事象をさらに特定し、実証する必要があります。<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a.滅菌工程で使用する設備は、付属品も含めて設計仕様書に準拠する必要があります。対応する文書には、機能設計仕様書、ユーザー要求仕様書、設計図などが含まれます。（設備概略図、エネルギー供給図、電気概略図、システム概略図など）<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">b.すべてのコンポーネント（制御ソフトウェアを含む）が適切に機能していることを確認します。主要な測定器は校正する必要があります。主要なコンポーネント情報を記録する必要があります。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">c.設置および使用環境が安全であり、地域の規制に準拠していることを確認してください。安全性と従業員の健康要件を満たします。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">d. 保守および例外処理文書を含む、安全生産および操作手順文書を作成します。オペレータートレーニングを実施する。オペレーターは資格を取得した後にのみ作業を開始できます。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">e. IQ は、滅菌プロセスに使用される特定の機器に対する 1 回限りの演習である場合があります。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">f.重要なコンポーネントの変更や機能の変更が発生した場合にも、追加の IQ を実行する必要があります。<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more-about-iq-in-eto-sterilization-process\">ETO 滅菌プロセスにおける IQ について詳しく知りたい場合<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">電話：<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">電子メール:<a href=\"mailto:hayley@hzbocon.com\">ヘイリー@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ローカルサイト: 中国浙江省杭州市下沙区財通中新1202号室<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Webサイト：<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">zjbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>a.Equipment to be used in the sterilization process, including any\u00a0ancillary items, shall comply with its design specifications.The corresponding documents include functional design specifications, user requirements specifications, design drawings, etc. (Equipment schematic diagram, energy supply diagram, electrical schematic diagram, system schematic diagram, etc.)<\/p>\n","protected":false},"author":234312599,"featured_media":8475,"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":17,"uagb_excerpt":"a.Equipment to be used in the sterilization process, including any\u00a0ancillary items, shall comply with its design specifications.The corresponding documents include functional design specifications, user requirements specifications, design drawings, etc. (Equipment schematic diagram, energy supply diagram, electrical schematic diagram, system schematic diagram, etc.)","jetpack_likes_enabled":true,"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/pgZDV6-x1","jetpack-related-posts":[{"id":2013,"url":"https:\/\/zjbocon.com\/?p=2013","url_meta":{"origin":2047,"position":0},"title":"Purpose for eto sterilization validation","author":"Bocon Technical Team","date":"2024-10-28","format":false,"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 provided and installed in accordance with its specification and can stably operate within predetermined limits and consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification.\u2026","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"eto sterilization validation","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp?resize=350%2C200 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp?resize=525%2C300 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp?resize=700%2C400 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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":2076,"url":"https:\/\/zjbocon.com\/?p=2076","url_meta":{"origin":2047,"position":2},"title":"PQ in Ethylene oxide sterilization chamber","author":"Bocon Technical 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, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":2064,"url":"https:\/\/zjbocon.com\/?p=2064","url_meta":{"origin":2047,"position":3},"title":"OQ IN ETO STERILIZATION MACHINE","author":"Bocon Technical Team","date":"2024-10-31","format":false,"excerpt":"In OQ, the performance of the relevant auxiliary system should be determined and the software system should be tested by simulating the fault conditions.","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\/Ethylene-Oxide-Sterilizer-Installation-Guide-1-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-Sterilizer-Installation-Guide-1-scaled.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/Ethylene-Oxide-Sterilizer-Installation-Guide-1-scaled.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/Ethylene-Oxide-Sterilizer-Installation-Guide-1-scaled.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/Ethylene-Oxide-Sterilizer-Installation-Guide-1-scaled.webp?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/Ethylene-Oxide-Sterilizer-Installation-Guide-1-scaled.webp?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":2471,"url":"https:\/\/zjbocon.com\/?p=2471","url_meta":{"origin":2047,"position":4},"title":"Safety Requirements for Using Ethylene Oxide in sterilization","author":"Bocon Technical Team","date":"2024-12-23","format":false,"excerpt":"when Ethylene Oxide in sterilization chamber should be equipped with fire prevention facilities. 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