{"id":2013,"date":"2024-10-28T10:57:16","date_gmt":"2024-10-28T02:57:16","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2013"},"modified":"2024-11-06T14:09:45","modified_gmt":"2024-11-06T06:09:45","slug":"eto-sterilization-2","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2013","title":{"rendered":"Purpose for eto sterilization validation"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\" id=\"h-1-purpose-for-validation-eto-sterilization\">1.<strong>Purpose\u00a0for validation<\/strong> eto sterilizácia<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">1.1.získanie dôkazu o validácii sterilizácie eto, že zariadenie používané na sterilizáciu ETO bolo poskytnuté a nainštalované v súlade s jeho špecifikáciou a môže stabilne fungovať v rámci vopred stanovených limitov a konzistentne funguje v súlade s vopred stanovenými kritériami, a teda poskytuje produkt spĺňajúci jeho špecifikáciu.<\/p>\n\n\n\n<div class=\"wp-block-uagb-image uagb-block-4162e3c7 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\"><a class=\"\" href=\"https:\/\/zjbocon.com\/qualification-services\/\" target=\"\" rel=\"noopener\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp\" alt=\"eto sterilization validation\" class=\"uag-image-1359\" width=\"800\" height=\"400\" title=\"Qualification_Services (2)\" role=\"img\" \><\/a><\/figure><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">1.2<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Táto časť špecifikuje požiadavky na vývoj, validáciu a rutinnú kontrolu procesu sterilizácie ETO a poskytuje návod na to, aby vyhovoval príslušným regulačným požiadavkám, ako je ISO 11135.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-2-scope\">2. Rozsah pôsobnosti<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">2.1. Príslušné vybavenie používané pri sterilizácii ETO (miestnosť na prípravu? Sterilizátor? Prevzdušňovacia miestnosť? Inkubátor atď.).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-terms-and-definitions\">3. Pojmy a definície<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">3.1.?IQ<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Inštalačná kvalifikácia: IQ<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.2.?OQ<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Prevádzková kvalifikácia: OQ<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.3.?PQ(MPQ\/PPQ)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Performance qualification:PQ(Microbiological PQ\/Physical PQ )<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.4.:Rekvalifikácia<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.5.: Biozáťaž<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.6.:Biologický indikátor<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.7.: Zlomkový cyklus<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.8.: Polovica cyklu<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.9.:Úplný cyklus<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.10.PCD: zariadenie na výzvu procesu<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.11.:Produkt a skupina produktov<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.12.?: Usable volume\/Product load volume<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.13.:Sterilita<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.14.SAL: Úroveň zabezpečenia sterility<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-4-responsibilities\">4. Zodpovednosti<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">4.1 Inžinier pre validáciu sterilizácie eto je zodpovedný za návrh validačného protokolu a vyškolený personál a použitia sú zodpovední za vykonanie validácie a zber relevantných údajov, ktoré pomôžu pri dokončení validácie.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-5-procedure\">5. Postup<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">5.1. IQ sa zaväzuje preukázať, že sterilizačné zariadenie a všetky pomocné položky boli dodané a nainštalované v súlade s ich špecifikáciou. Pred vykonaním IQ výrobca zariadenia vykoná FAT a SAT, aby sa uistil, že zariadenie bolo dodané normálne.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-references\">Referencie<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.iso.org\/obp\/ui\/#iso:std:iso:11135:ed-2:v1:en\">ISO 11135:2014&nbsp;Sterilization of health-care products \u2014 Ethylene oxide \u2014 Requirements for the development, validation and routine control of a sterilization process for medical devices<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>1.Purpose\u00a0for validation eto sterilization 1.1.the obtain of eto sterilization validation evidence that the equipment used for ETO sterilization has been [&hellip;]<\/p>\n","protected":false},"author":234312599,"featured_media":1974,"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":23,"uagb_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 [&hellip;]","jetpack_likes_enabled":true,"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/pgZDV6-wt","jetpack-related-posts":[{"id":8776,"url":"https:\/\/zjbocon.com\/?p=8776","url_meta":{"origin":2013,"position":0},"title":"How to Test ETO Gas Sterilization Test Materials","author":"Bocon Technical Team","date":"2025-11-25","format":false,"excerpt":"When it comes to ETO gas sterilization, testing is an essential part of ensuring the effectiveness and safety of the sterilization process. ETO GAS STERILIZATION TEST MATERIALS","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\/ethylene-oxide-sterilization-68.webp?resize=350%2C200&ssl=1","width":350,"height":200},"classes":[]},{"id":2332,"url":"https:\/\/zjbocon.com\/?p=2332","url_meta":{"origin":2013,"position":1},"title":"Terms and definitions of eto gas sterilization","author":"Bocon Technical Team","date":"2024-11-26","format":false,"excerpt":"For the purposes of this document, the following terms and definitions apply in ethylene oxide sterilization 3.1 Aeration part of the eto gas sterilization process during which ethylene oxide and\/or its reaction products desorb from the medical device until predetermined levels are reached \u00a0 Note 1 to entry: This can\u2026","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-11.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":1950,"url":"https:\/\/zjbocon.com\/?p=1950","url_meta":{"origin":2013,"position":2},"title":"eto sterilization process","author":"Bocon Technical Team","date":"2024-10-23","format":false,"excerpt":"Eto Sterilization is conducted using a eto sterilizer located in a dedicated facility.","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"eto sterilization process","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":7286,"url":"https:\/\/zjbocon.com\/?p=7286","url_meta":{"origin":2013,"position":3},"title":"ETO Sterilization Re-qualification","author":"Bocon Technical Team","date":"2025-07-29","format":false,"excerpt":"ETO Sterilization Re-qualification Requirements 1. 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":8772,"url":"https:\/\/zjbocon.com\/?p=8772","url_meta":{"origin":2013,"position":4},"title":"ETO STERILIZATION Safety Guidelines: Best Practices for Using Ethylene Oxide as a Sterilant","author":"Bocon Technical Team","date":"2025-11-25","format":false,"excerpt":"Ethylene oxide (ETO STERILIZATION) is widely used as a low-temperature sterilant in industries like healthcare, pharmaceuticals, and biotechnology. 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