{"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

OQ는 ETO 멸균 기계가 설계 사양의 성능 요구 사항을 충족하는 능력을 입증하기 위해 수행됩니다.<\/h2>\n\n\n\n
\"\"<\/figure>\n\n\n\n

ETO STERILIZATION MACHINE OQ 중에 다음 이벤트를 식별하고 입증해야 합니다.<\/p>\n\n\n\n

\n
<\/path><\/svg><\/span>OQ에서는 관련 보조 시스템의 성능을 결정하고, 결함 조건을 시뮬레이션하여 소프트웨어 시스템을 테스트해야 합니다.<\/span><\/div>\n\n\n\n
<\/path><\/svg><\/span>전처리실, 멸균기, 폭기실의 경우 멸균 부하가 차지할 챔버 전체의 공기 순환 패턴과 환기 용량을 결정해야 합니다. 이는 공기 변화율 계산 및 풍속 측정과 함께 연기 테스트를 통해 수행할 수 있습니다.<\/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>멸균기는 안전성을 보장하기 위해 OQ 전에 누출 테스트를 수행해야 합니다.(저기압 사이클의 경우 진공 상태 또는 초대기압 사이클의 경우 진공 및 압력 상태)<\/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

연간 OQ<\/h2>\n\n\n\n

OQ 검토에는 원래 OQ 결과가 여전히 유효한지 확인하기 위해 해당 연도에 이루어진 장비 성능 및 엔지니어링 변경에 대한 평가가 포함되어야 합니다. 이를 위해 정기적으로 장비의 재인증을 수행하는 것이 일반적이며 다음을 포함해야 합니다.<\/p>\n\n\n\n

    \n
  1. 장비의 IQ 상태 검토;<\/li>\n\n\n\n
  2. 장비 성능 추세 평가;<\/li>\n\n\n\n
  3. 사전 조정 영역의 온도 및 습도 프로파일;<\/li>\n\n\n\n
  4. 챔버 온도 프로파일;<\/li>\n<\/ol>\n\n\n\n

    e. 폭기실의 온도 프로파일<\/p>\n\n\n\n

    ETO 멸균 과정의 IQ에 대해 더 알고 싶다면<\/h2>\n\n\n\n

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

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

    현지 사이트: 중국 절강성 항저우시 샤사구 차이통 중신 1202호<\/p>\n\n\n\n

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

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

    OQ에서는 관련 보조 시스템의 성능을 결정하고, 결함 조건을 시뮬레이션하여 소프트웨어 시스템을 테스트해야 합니다.<\/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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