{"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 is undertaken to demonstrate the ability of the ETO STERILIZATION MACHINE to meet the performance requirements of its design specification.<\/h2>\n\n\n\n
\"\"<\/figure>\n\n\n\n

During ETO STERILIZATION MACHINE OQ the following events need to be identified and substantiated.<\/p>\n\n\n\n

\n
<\/path><\/svg><\/span>In OQ, the performance of the relevant auxiliary system should be determined and the software system should be tested by simulating the fault conditions.<\/span><\/div>\n\n\n\n
<\/path><\/svg><\/span>For the preconditioning room , sterilizer and aeration room, the pattern of air circulation and ventilation capacity throughout the chamber to be occupied by the sterilization load(s) should be determined. This can be performed by smoke tests in combination with the calculation of air change rates and anemometric determinations.<\/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>The sterilizer should do leak test before OQ to ensure safety.(under vacuum for subatmospheric cycles or under vacuum and at pressure for super atmospheric cycles)<\/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

Annual OQ<\/h2>\n\n\n\n

Review of OQ should include an assessment of the equipment performance and engineering changes that were made during the year to ensure that the results from the original OQ are still valid. In order to do so, it is common practice to perform periodic requalification of equipment and should include:<\/p>\n\n\n\n

    \n
  1. review of IQ status of equipment;<\/li>\n\n\n\n
  2. assessment of trends in equipment performance;<\/li>\n\n\n\n
  3. temperature and humidity profiles of the preconditioning areas;<\/li>\n\n\n\n
  4. chamber temperature profile;<\/li>\n<\/ol>\n\n\n\n

    e.temperature profile of the aeration room;<\/p>\n\n\n\n

    IF YOU WANT TO KNOW MORE ABOUT IQ IN ETO STERILIZATION PROCESS<\/h2>\n\n\n\n

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

    Email: hayley@hzbocon.com<\/a><\/p>\n\n\n\n

    Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China<\/p>\n\n\n\n

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

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

    In OQ, the performance of the relevant auxiliary system should be determined and the software system should be tested by simulating the fault conditions.<\/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\/?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":"In "ETO STERILIZER"","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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Below\u2026","rel":"","context":"In "Company News"","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\/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\/?p=9744","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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