{"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 trong quá trình khử trùng bằng eto được thực hiện để chứng minh rằng thiết bị khử trùng và mọi hạng mục phụ trợ đã được cung cấp và lắp đặt theo đúng đặc điểm kỹ thuật của chúng. Trước khi thực hiện IQ, nhà sản xuất thiết bị sẽ tiến hành FAT và SAT để đảm bảo thiết bị được giao nhận bình thường.<\/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\">Trong quá trình IQ, các sự kiện sau đây cần được xác định và chứng minh thêm.<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a.Thiết bị được sử dụng trong quá trình khử trùng, bao gồm mọi hạng mục phụ trợ, phải tuân thủ các thông số kỹ thuật thiết kế của nó. Các tài liệu tương ứng bao gồm thông số kỹ thuật thiết kế chức năng, thông số kỹ thuật yêu cầu của người dùng, bản vẽ thiết kế, v.v. (Sơ đồ thiết bị, sơ đồ cung cấp năng lượng, sơ đồ điện, sơ đồ hệ thống, v.v.)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">b.Xác minh rằng tất cả các thành phần (bao gồm cả phần mềm điều khiển) đều hoạt động bình thường; Các dụng cụ đo chính cần được hiệu chuẩn; Thông tin thành phần chính cần được ghi lại;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">c.Đảm bảo môi trường lắp đặt và sử dụng an toàn và tuân thủ các quy định của địa phương. Đáp ứng các yêu cầu về an toàn và sức khoẻ con người.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">d.Xây dựng các tài liệu về quy trình sản xuất và vận hành an toàn, bao gồm các tài liệu về bảo trì và xử lý ngoại lệ; tiến hành đào tạo người vận hành; người vận hành chỉ có thể bắt đầu công việc sau khi họ đủ điều kiện.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">đ. IQ có thể là bài tập một lần đối với thiết bị cụ thể được sử dụng cho quy trình khử trùng.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">f. IQ bổ sung cũng cần được thực hiện trong trường hợp có thay đổi đáng kể về thành phần hoặc thay đổi chức năng.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more-about-iq-in-eto-sterilization-process\">NẾU BẠN MUỐN BIẾT THÊM VỀ IQ TRONG QUY TRÌNH Tiệt Trùng ETO<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Điện thoại:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">E-mail:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Địa điểm địa phương: Phòng 1202, Caitong Zhongxin, Quận Xiasha, Thành phố Hàng Châu, Tỉnh Chiết Giang, Trung Quốc<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Trang web:<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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