{"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\/?p=2064","title":{"rendered":"OQ IN ETO STERILIZATION MACHINE"},"content":{"rendered":"\n

OQ 旨在证明 ETO 灭菌机满足其设计规范的性能要求的能力。<\/h2>\n\n\n\n
\"\"<\/figure>\n\n\n\n

在 ETO 灭菌机 ​​OQ 期间，需要识别和证实以下事件。<\/p>\n\n\n\n

\n
<\/path><\/svg><\/span>在OQ中，应确定相关辅助系统的性能，并通过模拟故障情况对软件系统进行测试。<\/span><\/div>\n\n\n\n
<\/path><\/svg><\/span>对于预处理室、灭菌室和曝气室，应确定灭菌负荷占用的整个室的空气循环模式和通风能力。这可以通过烟雾测试结合换气率计算和风速测定来执行。<\/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>灭菌器在OQ之前应进行泄漏测试以确保安全。（在真空下进行低于大气压循环或在真空和压力下进行超大气压循环）<\/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 审查应包括对当年进行的设备性能和工程变更的评估，以确保原始 OQ 的结果仍然有效。为此，通常的做法是定期对设备进行重新鉴定，并应包括：<\/p>\n\n\n\n

    \n
  1. 设备IQ状态审核；<\/li>\n\n\n\n
  2. 评估设备性能趋势；<\/li>\n\n\n\n
  3. 预处理区域的温度和湿度分布；<\/li>\n\n\n\n
  4. 室温度曲线；<\/li>\n<\/ol>\n\n\n\n

    e.曝气室的温度曲线；<\/p>\n\n\n\n

    如果您想了解更多关于 ETO 灭菌过程中的 IQ<\/h2>\n\n\n\n

    电话：+86-19975258603<\/a><\/p>\n\n\n\n

    电子邮件：hayley@hzbocon.com<\/a><\/p>\n\n\n\n

    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

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

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

    在OQ中，应确定相关辅助系统的性能，并通过模拟故障情况对软件系统进行测试。<\/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":"\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":2013,"url":"https:\/\/zjbocon.com\/?p=2013","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":"\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 2x"},"classes":[]},{"id":9080,"url":"https:\/\/zjbocon.com\/?p=9080","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. 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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":"\u7c7b\u4f3c\u6587\u7ae0","block_context":{"text":"\u7c7b\u4f3c\u6587\u7ae0","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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