{"id":7286,"date":"2025-07-29T12:02:12","date_gmt":"2025-07-29T04:02:12","guid":{"rendered":"https:\/\/zjbocon.com\/?p=7286"},"modified":"2025-10-01T19:30:30","modified_gmt":"2025-10-01T11:30:30","slug":"eto-sterilization-re-qualification","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=7286","title":{"rendered":"ETO Sterilization Re-qualification"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements\">ETO zahtjevi za ponovnu kvalifikaciju sterilizacije<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-re-qualification-frequency\">1. Učestalost prekvalifikacije<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Minimalni godišnji zahtjev<\/strong><br>\u2022 At least once per year, verification data, subsequent re-validation data, and routine processing data must be reviewed<br>\u2022 The scope of re-qualification must be determined and documented<br>\u2022 The review procedure shall be documented<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-2-is-re-qualification-needed-if-no-product-changes-occur\">2. Je li potrebna prekvalifikacija ako nema promjena proizvoda?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Da, još uvijek je potrebna prekvalifikacija<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-3-re-qualification-items\">3. Stavke prekvalifikacije<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Na temelju određenih preduvjeta dostupne su sljedeće opcije<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Potpuna prekvalifikacija<\/li>\n\n\n\n<li>Nema potrebe za fizičkom ili mikrobnom ponovnom provjerom<\/li>\n\n\n\n<li>Validacija male mikrobne učinkovitosti<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Preduvjeti za prekvalifikaciju<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a) The following must be reviewed\/tested:<br>b) Bilo koja<strong>značajne promjene<\/strong>&nbsp;koji utječu na sterilnost proizvoda dogodili su se u:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Dizajn proizvoda<\/li>\n\n\n\n<li>Manufacturing\/packaging materials<\/li>\n\n\n\n<li>PCD (Process Challenge Device)<\/li>\n\n\n\n<li>Dobavljači<\/li>\n\n\n\n<li>Manufacturing areas\/facilities<\/li>\n\n\n\n<li>Učitajte konfiguracije ili proizvodne procese<br>c)<strong>Analiza trenda bioopterećenja<\/strong>&nbsp;proizvoda;<br>d) Da li<strong>studije raspodjele temperature<\/strong>&nbsp;i rad sterilizatora pokazuju značajne promjene od zadnje kvalifikacije;<br>e) Da li<strong>raspodjela temperature i provjere recirkulacije<\/strong>&nbsp;u komorama za pretkondicioniranje ili zonama prozračivanja pokazuju značajne promjene od zadnje kvalifikacije;<br>f) Je li sterilizacija ETO<strong> povijest procesa<\/strong>&nbsp;budući da posljednja validacija pokazuje ponovljivost;<br>g) Da li<strong>kontrola promjena i zapisi o preventivnom održavanju<\/strong>&nbsp;potvrditi da nema modifikacija opreme koje utječu na proces;<br>h) Da li<strong>nema izmjena u procesu ETO sterilizacije<\/strong>&nbsp;došlo je do utjecaja na sterilitet;<br>i) Ako<strong>Promijenjene su specifikacije procesa ETO sterilizacije<\/strong>, prekvalifikacija mora uključivati ​​provjeru<strong>Granice rezidua EO<\/strong>&nbsp;usklađenost s regulatornim zahtjevima.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Regulatorni standardi<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ISO 11135:2014<\/strong>&nbsp;<em>(Odjeljak 9.2: Kriteriji prekvalifikacije)<\/em><\/li>\n\n\n\n<li><strong>FDA 21 CFR 211.113<\/strong>&nbsp;<em>(Kontrole procesa sterilizacije)<\/em><\/li>\n\n\n\n<li><strong>EU GMP Dodatak 1:2022<\/strong>&nbsp;<em>(Odjeljak 8.5: Zahtjevi za revalidaciju)<\/em><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements-0\"><strong>ETO zahtjevi za ponovnu kvalifikaciju sterilizacije<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Prekvalifikacija će<strong>uključuju pregled rada komore i godišnje inženjerske promjene<\/strong>&nbsp;to ensure the original IQ\/OQ results remain valid. The review must cover:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Preconditioning zone temperature\/humidity profiles<\/strong>&nbsp;(ako je primjenjivo);<\/li>\n\n\n\n<li><strong>Stvarni profili vlažnosti prazne komore<\/strong>;<\/li>\n\n\n\n<li><strong>Temperature zone prozračivanja<\/strong>&nbsp;(ako je primjenjivo);<\/li>\n\n\n\n<li><strong>Dodatno, čak i ako su zadovoljene specifikacije procesa<\/strong>, inspections must be triggered by:\n<ul class=\"wp-block-list\">\n<li>Nepovoljni trendovi u radu opreme,<\/li>\n\n\n\n<li>kvarovi sterilnosti;<\/li>\n\n\n\n<li>Kako bi se utvrdilo je li ponovna provjera valjanosti opravdana.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Stručnjaci za sterilizaciju<\/strong>&nbsp;će definirati opseg potrebnih<strong>fizička i mikrobna revalidacija<\/strong>&nbsp;na temelju rezultata pregleda.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Kritična razmatranja za prekvalifikaciju sterilizacije<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. Rukovanje značajnim promjenama<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 If&nbsp;<strong>velike promjene<\/strong>&nbsp;are identified during re-qualification, re-execution of IQ\/OQ\/PQ may be required:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>IQ (Kvalifikacija za instalaciju)<\/strong>: Verify modified equipment\/software installation.<\/li>\n\n\n\n<li><strong>OQ (operativna kvalifikacija)<\/strong>: Ponovno testirajte pogođene funkcionalne parametre.<\/li>\n\n\n\n<li><strong>PQ (Kvalifikacija izvedbe)<\/strong>: Ponovno potvrdite učinkovitost sterilizacije u novim uvjetima.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. Dodatni zahtjevi za izdavanje parametara<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Za korištenje objekata<strong>parametarsko otpuštanje<\/strong>&nbsp;(oslanjanje na procesne podatke, a ne na BI testiranje):<br>a)<strong>Učestalost ponovne provjere valjanosti<\/strong>: Mora se izvesti<strong>najmanje godišnje<\/strong>;<br>b)<strong>Opseg ponovne provjere<\/strong>: Mora uključiti<strong>mikrobiološke studije<\/strong>&nbsp;za potvrdu:<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Situations Requiring Full Requalification (IQ\/OQ\/PQ):<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a)<strong>Veliko održavanje sterilizatora<\/strong>;<br>b)<strong>Strukturalne, lokacijske ili promjene okoliša<\/strong>;<br>c)<strong>Neobjašnjivi propusti u sterilnosti<\/strong>;<br>d)<strong>Changes in EO supply\/delivery, diluent, or chamber load configuration<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Izuzeće od fizičke ili mikrobne prekvalifikacije<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Kada su ispunjeni sljedeći uvjeti:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Nema promjena<\/strong>&nbsp;in product, packaging, equipment\/services, or processes;<\/li>\n\n\n\n<li><strong>Pregled rada komore i inženjering<\/strong>&nbsp;su kvalificirani;<\/li>\n\n\n\n<li><strong>Rutinski procesi sterilizacije<\/strong>&nbsp;pouzdano poslovali tijekom razdoblja;<br>?<strong>Profesionalna prosudba<\/strong>&nbsp;može utvrditi da je fizička ili mikrobna prekvalifikacija<strong>nije potrebno<\/strong>&nbsp;do sljedećeg pregleda.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Kvalifikacija mikrobne učinkovitosti ograničenog opsega<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Može biti potrebno u posebnim slučajevima<\/strong>, kao što su:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Provjera kontinuirane prikladnosti BI u odnosu na biološko opterećenje proizvoda;<\/li>\n\n\n\n<li>Pružanje dokaza da br<strong>nenamjerne promjene<\/strong>&nbsp;dogodio od prethodnog (rek)kvalifikacijskog studija nakon definiranog vremenskog intervala.<br>\u2022&nbsp;<strong>Opći zahtjevi (najmanje)<\/strong>:<\/li>\n\n\n\n<li>Jedan<strong>kratki ciklus ili poluciklus rada<\/strong>;<\/li>\n\n\n\n<li>Uključujući<strong>mjerenja temperature i vlažnosti<\/strong>&nbsp;steriliziranih predmeta.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">AKO ŽELITE ZNATI VIŠE<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Telefon:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Email:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Lokalno mjesto: soba 1202, Caitong Zhongxin, okrug Xiasha, grad Hangzhou, provincija Zhejiang, Kina<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Web stranica:<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">zjbocon.com<\/a><\/p>\n\n\n\n<div class=\"wp-block-uagb-image uagb-block-9d7632fc 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\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9-1024x1024.webp\" alt=\"\" class=\"uag-image-8487\" width=\"1024\" height=\"1024\" title=\"eto-sterilizer-9\" role=\"img\" \><\/figure><\/div>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>ETO Sterilization Re-qualification Requirements 1. Re-qualification Frequency \u2022&nbsp;Minimum annual requirement\u2022 At least once per year, verification data, subsequent re-validation data, [&hellip;]<\/p>\n","protected":false},"author":234312599,"featured_media":8487,"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":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[133125,133124],"tags":[],"class_list":["post-7286","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company-news","category-eto-sterilizer"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v28.0) - 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Test Criteria: 1 run\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\/ethylene-oxide-sterilization-57-scaled.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":9080,"url":"https:\/\/zjbocon.com\/?p=9080","url_meta":{"origin":7286,"position":1},"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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Team","date":"2024-10-31","format":false,"excerpt":"PQ is the stage of validation that uses Ethylene oxide sterilization chamber to demonstrate that the Ethylene oxide sterilization equipment consistently operates in accordance with predetermined acceptance criteria and the process yields a product that is sterile and meets the specified requirements.","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-1.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=525%2C300&ssl=1 1.5x, 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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":2138,"url":"https:\/\/zjbocon.com\/?p=2138","url_meta":{"origin":7286,"position":5},"title":"ETO Sterilization Chamber Testing","author":"Bocon Technical Team","date":"2024-11-07","format":false,"excerpt":"The temperature setting range of the ETO Sterilization Chamber should be between 30-60\u00b0C. It is recommended to perform temperature distribution testing of the sterilizer's internal surface and temperature and humidity distribution testing inside the sterilization chamber to ensure the effectiveness of the heating and humidifying systems.","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\/cropped-cropped-hzbocon.png?resize=350%2C200&ssl=1","width":350,"height":200},"classes":[]}],"_links":{"self":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7286","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/users\/234312599"}],"replies":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=7286"}],"version-history":[{"count":12,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7286\/revisions"}],"predecessor-version":[{"id":8613,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7286\/revisions\/8613"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/media\/8487"}],"wp:attachment":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=7286"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=7286"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=7286"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}