{"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\">I-ETO Sterilization Re-qualification Izidingo<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-re-qualification-frequency\">1. Imvamisa yokufaneleka kabusha<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Isidingo esincane sonyaka<\/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. Ingabe Ukufaneleka Kabusha Kuyadingeka Uma Lungekho Ushintsho Lomkhiqizo Olwenzekayo?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Yebo, ukufaneleka kabusha kusadingeka<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-3-re-qualification-items\">3. Izinto zokufaneleka kabusha<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Ngokusekelwe kwimibandela ethile, izinketho ezilandelayo ziyatholakala<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Ukufaneleka kabusha okugcwele<\/li>\n\n\n\n<li>Asikho isidingo sokuqinisekiswa kabusha ngokomzimba noma kwe-microbial<\/li>\n\n\n\n<li>Ukuqinisekiswa kokusebenza kwe-microbial encane<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Izimfuneko zokufaneleka kabusha<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a) The following must be reviewed\/tested:<br>b) Noma ngabe ikhona<strong>izinguquko ezibalulekile<\/strong>&nbsp;okuthinta ubunyumba bomkhiqizo kwenzeke ku-:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Umklamo womkhiqizo<\/li>\n\n\n\n<li>Manufacturing\/packaging materials<\/li>\n\n\n\n<li>I-PCD (Process Challenge Device)<\/li>\n\n\n\n<li>Abahlinzeki<\/li>\n\n\n\n<li>Manufacturing areas\/facilities<\/li>\n\n\n\n<li>Layisha ukucushwa noma izinqubo zokukhiqiza<br>c)<strong>Ukuhlaziywa kwethrendi ye-Bioburden<\/strong>&nbsp;kwemikhiqizo;<br>d) Noma<strong>izifundo zokusabalalisa izinga lokushisa<\/strong>&nbsp;kanye nokusebenza kwesibulala-magciwane kukhombisa izinguquko ezibalulekile kusukela ekutholeni iziqu zokugcina;<br>e) Noma<strong>ukusatshalaliswa kwezinga lokushisa kanye namasheke okubuyisela kabusha<\/strong>&nbsp;emakamelweni e-preconditioning noma ezindaweni zokungenisa umoya abonise izinguquko ezibalulekile kusukela ekutholeni iziqu zokugcina;<br>f) Ukuthi i-ETO Sterilization<strong> umlando wokucubungula<\/strong>&nbsp;njengoba ukuqinisekiswa kokugcina kukhombisa ukukhiqiza kabusha;<br>g) Noma<strong>shintsha ukulawula kanye namarekhodi okulondoloza okuvimbela<\/strong>&nbsp;qinisekisa ukuthi akukho ukuguqulwa kwemishini ethinta inqubo;<br>h) Noma<strong>azikho izinguquko kunqubo ye-ETO Sterilization<\/strong>&nbsp;okuthinta inzalo kwenzeke;<br>i) Uma<strong>Ukucaciswa kwenqubo ye-ETO Sterilization kushintshile<\/strong>, ukufaneleka kabusha kufanele kubandakanye ukuqinisekiswa kwe<strong>Imikhawulo yensalela ye-EO<\/strong>&nbsp;ukuhambisana nezidingo zokulawula.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Amazinga Okulawula<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ISO 11135:2014<\/strong>&nbsp;<em>(Isiqephu 9.2: Imibandela yokufaneleka)<\/em><\/li>\n\n\n\n<li><strong>I-FDA 21 CFR 211.113<\/strong>&nbsp;<em>(Izilawuli zenqubo yokuvala inzalo)<\/em><\/li>\n\n\n\n<li><strong>I-EU GMP Isijobelelo 1:2022<\/strong>&nbsp;<em>(Isiqephu 8.5: Izidingo zokuqinisekisa)<\/em><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements-0\"><strong>I-ETO Sterilization Re-qualification Izidingo<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Ukufaneleka kabusha kufanele<strong>hlanganisa ukubuyekezwa kokusebenza kwegumbi kanye nezinguquko zonyaka zobunjiniyela<\/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;(uma kusebenza);<\/li>\n\n\n\n<li><strong>Amaphrofayela wangempela womswakama wegumbi elingenalutho<\/strong>;<\/li>\n\n\n\n<li><strong>Amazinga okushisa endaweni yomoya<\/strong>&nbsp;(uma kusebenza);<\/li>\n\n\n\n<li><strong>Ukwengeza, noma ngabe imininingwane yenqubo iyahlangatshezwa<\/strong>, inspections must be triggered by:\n<ul class=\"wp-block-list\">\n<li>Imikhuba emibi ekusebenzeni kwemishini,<\/li>\n\n\n\n<li>Ukuhluleka kokuzala;<\/li>\n\n\n\n<li>Ukunquma ukuthi ukuqinisekiswa kabusha kuyaqinisekiswa yini.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Ochwepheshe bokuvala inzalo<\/strong>&nbsp;izochaza ububanzi bokudingekayo<strong>ukuqinisekiswa kabusha ngokomzimba namagciwane<\/strong>&nbsp;ngokusekelwe emiphumeleni yokubuyekeza.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Ukucatshangelwa Okubalulekile Kokufaneleka Kabusha Kwenzalo<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. Ukusingatha Izinguquko Ezibalulekile<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 If&nbsp;<strong>izinguquko ezinkulu<\/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>I-IQ (Ukufaneleka Kokufaka)<\/strong>: Verify modified equipment\/software installation.<\/li>\n\n\n\n<li><strong>I-OQ (Ukufaneleka Kokusebenza)<\/strong>: Hlola kabusha amapharamitha wokusebenza athintekile.<\/li>\n\n\n\n<li><strong>I-PQ (Ukufaneleka Kokusebenza)<\/strong>: Qinisekisa kabusha ukusebenza kokuvala inzalo ngaphansi kwezimo ezintsha.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. Izidingo Ezengeziwe Zokukhishwa Kwepharamitha<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Ngezinsiza ezisetshenziswayo<strong>ukukhululwa kwe-parametric<\/strong>&nbsp;(kuncike kwidatha yenqubo esikhundleni sokuhlolwa kwe-BI):<br>a)<strong>Imvamisa yokuqinisekisa kabusha<\/strong>: Kumele kwenziwe<strong>okungenani njalo ngonyaka<\/strong>;<br>b)<strong>Ububanzi bokuqinisekisa kabusha<\/strong>: Kumele ihlanganise<strong>izifundo ze-microbiological<\/strong>&nbsp;ukuqinisekisa:<\/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>Ukugcinwa okuyinhloko kwe-sterilizer<\/strong>;<br>b)<strong>Izinguquko zesakhiwo, indawo, noma imvelo<\/strong>;<br>c)<strong>Ukuhluleka kobunyumba okungachazeki<\/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>Ukukhululwa ekuqeqesheni kabusha ngokomzimba noma kwe-Microbial<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Lapho lezi zimo ezilandelayo zifinyelelwa:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Azikho izinguquko<\/strong>&nbsp;in product, packaging, equipment\/services, or processes;<\/li>\n\n\n\n<li><strong>Ukusebenza kwegumbi nokubuyekezwa kobunjiniyela<\/strong>&nbsp;bafanelekile;<\/li>\n\n\n\n<li><strong>Izinqubo zokuvala inzalo njalo<\/strong>&nbsp;asebenze ngokwethembeka phakathi nalesi sikhathi;<br>?<strong>Ukwahlulela kochwepheshe<\/strong>&nbsp;ingase inqume ukuthi ukufaneleka kabusha ngokomzimba noma kwe-microbial<strong>akudingekile<\/strong>&nbsp;kuze kube yisibuyekezo esilandelayo.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Ukufaneleka Kokusebenza Kwezinto Ezincane Ezilinganiselwe<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Kungase kudingeke ezimweni ezithile<\/strong>, njenge:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Ukuqinisekisa ukuqhubeka kokufaneleka kwama-BI ngokuphathelene nomthwalo wezinto eziphilayo zomkhiqizo;<\/li>\n\n\n\n<li>Ukunikeza ubufakazi bokuthi cha<strong>izinguquko ezingahlosiwe<\/strong>&nbsp;kwenzeke kusukela ocwaningweni lwangaphambilini (kabusha) lweziqu ngemuva kwesikhawu sesikhathi esichaziwe.<br>\u2022&nbsp;<strong>Izidingo ezijwayelekile (okungenani)<\/strong>:<\/li>\n\n\n\n<li>Eyodwa<strong>ukugijima komjikelezo omfushane noma uhhafu womjikelezo<\/strong>;<\/li>\n\n\n\n<li>Kuhlanganisa<strong>izinga lokushisa kanye nomswakama izilinganiso<\/strong>&nbsp;wezinto ezifakwe inzalo.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">UMA UFUNA UKWAZI OKWENGEZIWE<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Ucingo:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">I-imeyili:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Indawo Yendawo: Igumbi 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Iwebhusayithi:<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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https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":7277,"url":"https:\/\/zjbocon.com\/?p=7277","url_meta":{"origin":7286,"position":3},"title":"Performance Qualification(pq)-ppq in eo sterilization","author":"Bocon Technical Team","date":"2025-07-29","format":false,"excerpt":"Physical Performance Qualification (PPQ)\u2022 It shall be demonstrated that all specified acceptance criteria are reproducible throughout the entire process.How many runs should the PPQ process perform?\u2022 To demonstrate process reproducibility, at least 3 runs are required;\u2022 If 3 half-cycles were run during the MPQ process, then at least 1 additional\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-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":2332,"url":"https:\/\/zjbocon.com\/?p=2332","url_meta":{"origin":7286,"position":4},"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, 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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}]}}