{"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\">进行 eto 灭菌过程中的 Iq 是为了证明灭菌设备和任何辅助物品已按照其规格提供和安装。在进行IQ之前，设备制造商会进行FAT和SAT，以确保设备已正常交付。<\/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\">在 IQ 期间，需要进一步识别和证实以下事件。<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a.灭菌过程中使用的设备，包括任何附属物品，应符合其设计规范。相应的文件包括功能设计规范、用户要求规范、设计图纸等（设备原理图、供能图、电气图）原理图、系统原理图等）<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">b.验证所有组件（包括控制软件）功能正常；关键测量仪器需要校准；应记录关键部件信息；<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">c.确保安装和使用环境安全并符合当地法规。满足安全和人员健康要求。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">d.制定安全生产和操作规程文件，包括维护和异常处理文件；进行操作员培训；操作人员考核合格后方可上岗作业。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">e. IQ 可能是对灭菌过程中使用的特定设备的一次性测试。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">f.如果发生重大组件更改或功能更改，也需要执行额外的 IQ<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more-about-iq-in-eto-sterilization-process\">如果您想了解更多关于 ETO 灭菌过程中的 IQ<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">电话：<a href=\"https:\/\/wa.me\/8619975258603\">+86-19975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">电子邮件：<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">办公室地址:浙江省杭州市下沙财通中心1202

工厂地址：浙江省嘉兴市嘉善县罗星同济未来邨6幢厂房 <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">网站：<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":"\u5728\u201cETO STERILIZER\u201d\u4e2d","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":"\u5728\u201cCompany News\u201d\u4e2d","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":"\u5728\u201cETO STERILIZER\u201d\u4e2d","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":"\u5728\u201cETO STERILIZER\u201d\u4e2d","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. Ethylene oxide cylinders should be stored separately in a dry, well-ventilated room, with strict prohibition of smoking and open flames. The lighting in the sterilization chamber should be explosion-proof, and any electrical appliances that may cause electric\u2026","rel":"","context":"\u5728\u201cCompany News\u201d\u4e2d","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Electrical-Scale.png?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":8776,"url":"https:\/\/zjbocon.com\/?p=8776","url_meta":{"origin":2047,"position":5},"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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