{"id":2064,"date":"2024-10-31T11:05:10","date_gmt":"2024-10-31T03:05:10","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2064"},"modified":"2025-12-05T11:13:13","modified_gmt":"2025-12-05T03:13:13","slug":"oq-in-eto-sterilization-machine","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/oq-in-eto-sterilization-machine\/","title":{"rendered":"OQ IN ETO STERILIZATION MACHINE"},"content":{"rendered":"\n

OQ旨在證明ETO滅菌機能夠滿足其設計規範嘅性能要求。<\/h2>\n\n\n\n
\"\"<\/figure>\n\n\n\n

在ETO STERILIZATION MACHINE OQ期間，需要識別和證實以下事件。<\/p>\n\n\n\n

\n
<\/path><\/svg><\/span>在OQ中，應確定相關輔助系統嘅性能，並透過模擬故障條件嚟測試軟件系統。<\/span><\/div>\n\n\n\n
<\/path><\/svg><\/span>對於預處理室、滅菌器和曝氣室，應確定滅菌負荷所佔據的整個腔室的空氣循環和通風能力模式。 可以透過煙霧測試以及換氣率嘅計算同風速測定嚟執行。<\/span><\/div>\n\n\n\n
<\/path><\/svg><\/span>Temperature and humidity should be monitored throughout the\u00a0preconditioning area over a period long enough to demonstrate that values\u00a0are maintained within the desired ranges. The temperature and humidity in\u00a0a number of locations distributed throughout the preconditioning\u00a0area should be determined;<\/span><\/div>\n<\/div><\/div>\n\n\n\n
\n
<\/path><\/svg><\/span>Temperature should be monitored throughout the\u00a0heated aeration\u00a0area over a period long enough to demonstrate that values\u00a0are maintained within the desired ranges. The temperature in\u00a0a number of locations distributed throughout the aeration area should be determined;<\/span><\/div>\n\n\n\n
<\/path><\/svg><\/span>滅菌器應喺OQ前進行洩漏測試，以確保安全。 （在真空下進行低於大氣壓的循環，或在真空和壓力下進行超大氣壓循環）<\/span><\/div>\n\n\n\n
<\/path><\/svg><\/span>For sterilizer,a chamber wall temperature study should be completed to verify adequate\u00a0temperature uniformity provided by the jacket heating system. The study\u00a0should characterize the temperature profile for comparison on a periodic\u00a0basis to ensure the system continues to operate effectively.<\/span><\/div>\n<\/div><\/div>\n\n\n\n
\n
<\/path><\/svg><\/span>Repetition cycles shall be performed (at least three times) to demonstrate reproducibility of control and operation effects;The temperature of the injected EO-gas should be within the volatizer specification or above the boiling point of EO (10,7\u00b0C at atmospheric pressure);<\/span><\/div>\n\n\n\n
<\/path><\/svg><\/span>In empty chamber OQ exercises, the recorded temperature range, within\u00a0the usable chamber volume during EO or inert gas exposure, of
\u00b13?of\u00a0the average recorded chamber temperature at each time point should be\u00a0obtained after an equilibration period. When the OQ exercise is carried\u00a0out using a loaded chamber, then the\u00b13?\u00a0tolerance might not be\u00a0achievable.<\/span><\/div>\n\n\n\n
<\/path><\/svg><\/span>………<\/span><\/div>\n<\/div><\/div>\n\n\n\n

年度OQ<\/h2>\n\n\n\n

OQ嘅審核應包括對當年所做嘅設備性能同工程變更嘅評估，以確保原始OQ嘅結果仍然有效。 為此，通常嘅做法係定期對設備進行認證番，並且應包括：<\/p>\n\n\n\n

    \n
  1. 審查設備嘅IQ狀態;<\/li>\n\n\n\n
  2. 設備性能趨勢評估;<\/li>\n\n\n\n
  3. 預處理區域嘅溫度同濕度曲線;<\/li>\n\n\n\n
  4. 腔室溫度曲線;<\/li>\n<\/ol>\n\n\n\n

    e.曝氣室的溫度曲線;<\/p>\n\n\n\n

    如果您想了解更多關於ETO滅菌過程中嘅IQ嘅信息<\/h2>\n\n\n\n

    電話:+8619975258603<\/a><\/p>\n\n\n\n

    電子郵件：hayley@hzbocon.com<\/a><\/p>\n\n\n\n

    本地站點：中國浙江省杭州市下沙區蔡通中新1202室<\/p>\n\n\n\n

    網站：hzbocon.com<\/a>zjbocon.com<\/a><\/p>\n\n\n\n

    <\/p>\n","protected":false},"excerpt":{"rendered":"

    在OQ中，應確定相關輔助系統嘅性能，並透過模擬故障條件嚟測試軟件系統。<\/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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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 "Company News"","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/category\/company-news\/"},"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":2013,"url":"https:\/\/zjbocon.com\/eto-sterilization-2\/","url_meta":{"origin":2064,"position":1},"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 "ETO STERILIZER"","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/category\/eto-sterilizer\/"},"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 2x"},"classes":[]},{"id":9080,"url":"https:\/\/zjbocon.com\/essential-utilities-and-service-requirements-for-eto-sterilizers\/","url_meta":{"origin":2064,"position":2},"title":"Essential Utilities and Service Requirements for ETO Sterilizers","author":"Bocon Technical Team","date":"2026-01-20","format":false,"excerpt":"The successful operation of an Ethylene Oxide (ETO) sterilizer requires more than just the machine itself; it demands a robust infrastructure of essential utilities, safety systems, and ongoing technical support. Ensuring these requirements are met is critical for process efficiency, operator safety, and regulatory compliance (such as ISO 11135). Below\u2026","rel":"","context":"In "Company News"","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/category\/company-news\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-4.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-4.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-4.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-4.png?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-4.png?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":9744,"url":"https:\/\/zjbocon.com\/advanced-automation-safety-systems-hzbocon-eto-sterilization\/","url_meta":{"origin":2064,"position":3},"title":"Advanced Automation & Safety Systems: HZBOCON ETO Sterilization","author":"Bocon Technical Team","date":"2026-07-06","format":false,"excerpt":"Advanced Automation & Safety Systems: HZBOCON ETO Sterilization Deep dive into the sophisticated automation, safety protocols, and comprehensive validation support provided by HZBOCON. 5. Intelligent Automation & Data Management Our systems utilize an industrial-grade SIMENS PLC platform (No. 49) coupled with an advanced HMI that provides graphical process visualization (No.\u2026","rel":"","context":"Similar post","block_context":{"text":"Similar post","link":""},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2026\/03\/eto-sterilizer-25.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2026\/03\/eto-sterilizer-25.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2026\/03\/eto-sterilizer-25.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2026\/03\/eto-sterilizer-25.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2026\/03\/eto-sterilizer-25.webp?resize=1050%2C600&ssl=1 3x, 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Team","date":"2024-10-21","format":false,"excerpt":"advantage:\u00a0This\u00a0is\u00a0a\u00a0cost-effective,\u00a0widely-used\u00a0sterilization\u00a0method\u00a0that\u00a0has\u00a0been\u00a0common\u00a0for\u00a0many\u00a0years, when you buy the machine, you can sterilize by yourself, and the cost is very cheap.large volume (1-36pallet) (around 1-35ton spice one time, depending on the density Of spice ) disadvantage:\u00a0ETO\u00a0is\u00a0a\u00a0heavily-regulated, gas.\u00a0And\u00a0will\u00a0take\u00a0more\u00a0time\u00a0than\u00a0the other\u00a0two\u00a0sterilization\u00a0way(you can install a pre-heating room and aeration room to solve this problem).","rel":"","context":"In "ETO STERILIZER"","block_context":{"text":"ETO 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