{"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\">Eto sterilizasyon sürecinde Iq, sterilizasyon ekipmanının ve yardımcı öğelerin spesifikasyonlarına uygun olarak tedarik edildiğini ve kurulduğunu göstermek için gerçekleştirilir. IQ gerçekleştirmeden önce ekipman üreticisi, ekipmanın normal şekilde teslim edildiğinden emin olmak için FAT ve SAT işlemlerini gerçekleştirecektir.<\/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 sırasında aşağıdaki olayların daha fazla tanımlanması ve kanıtlanması gerekir.<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a.Yardımcı öğeler de dahil olmak üzere sterilizasyon sürecinde kullanılacak ekipman, tasarım spesifikasyonlarına uygun olacaktır. İlgili belgeler, fonksiyonel tasarım spesifikasyonlarını, kullanıcı gereksinimleri spesifikasyonlarını, tasarım çizimlerini vb. içerir. (Ekipman şematik diyagramı, enerji besleme diyagramı, elektrik şematik diyagram, sistem şematik diyagramı, vb.)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">b.Tüm bileşenlerin (kontrol yazılımı dahil) düzgün çalıştığını doğrulayın; Temel ölçüm cihazlarının kalibre edilmesi gerekir; Anahtar bileşen bilgileri kaydedilmelidir;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">c.Kurulum ve kullanım ortamının güvenli olduğundan ve yerel düzenlemelere uygun olduğundan emin olun. Güvenlik ve personel sağlığı gereksinimlerini karşılayın.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">d.Bakım ve istisna yönetimi belgeleri de dahil olmak üzere güvenli üretim ve işletim prosedürü belgelerini geliştirmek; operatör eğitimi yürütmek; operatörler ancak kalifiye olduktan sonra işe başlayabilirler.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">e. IQ, sterilizasyon işleminde kullanılan spesifik ekipman için tek seferlik bir egzersiz olabilir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">F. Önemli bileşen değişiklikleri veya işlevsel değişiklikler durumunda da ek IQ&#039;nun gerçekleştirilmesi gerekir.<\/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 STERİLİZASYON SÜRECİNDE IQ HAKKINDA DAHA FAZLA BİLGİ ALMAK İSTİYORSANIZ<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Telefon:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">E-posta:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Yerel Site: Oda 1202, Caitong Zhongxin, Xiasha Bölgesi, Hangzhou Şehri, Zhejiang Eyaleti, Çin<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Web sitesi:<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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