{"id":2128,"date":"2024-11-06T13:08:38","date_gmt":"2024-11-06T05:08:38","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2128"},"modified":"2025-12-05T10:49:36","modified_gmt":"2025-12-05T02:49:36","slug":"routine-monitoring-control-and-release-of-ethylene-oxide-sterilization","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2128","title":{"rendered":"Routine Monitoring, Control, and Release of Ethylene Oxide Sterilization"},"content":{"rendered":"\n<div class=\"wp-block-uagb-image uagb-block-49e85672 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\/2024\/10\/tp2.jpg\" alt=\"Ethylene oxide sterilization chamber\" class=\"uag-image-971\" width=\"514\" height=\"358\" title=\"Ethylene role =\"img\" \><\/figure><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-routine-monitoring-and-control\">Roetine monitering en beheer<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Die doel van roetine-monitering en beheer van EO (Etileenoksied) sterilisasie is om te demonstreer dat die bevestigde en gespesifiseerde sterilisasieproses op die produk toegepas is. Data van elke sterilisasiesiklus moet aangeteken en behou word om te bewys dat aan die bevestigde sterilisasieprosesspesifikasies voldoen is. Dit moet ten minste die volgende inhoud insluit:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">a) Bewys dat die omgewingstemperatuur van die produk die minimum bevestigde temperatuur bereik het wanneer die voorbehandeling binnegegaan het (indien gebruik). Dit kan bereik word deur die las vir &#039;n bepaalde minimum tyd by die omgewing te laat akklimatiseer. As die bergingstemperatuur bekend is, is dit nie nodig om die temperatuur van die produk te bepaal voordat dit die voorbehandelingsarea binnegaan nie. Indien die produk aan uiterste temperature blootgestel is, soos tydens vervoer, moet die produk dalk vir &#039;n tydperk gestoor word voor voorbehandeling om sy interne temperatuur en humiditeit binne &#039;n aanvaarbare reeks te stabiliseer.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">b) Monitering en aantekening van die temperatuur en humiditeit in die voorbehandelingsarea (indien gebruik) by gespesifiseerde plekke.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">c) Die begintyd van die voorbehandeling vir elke sterilisasielading en die tyd wat die vrag uit die voorbehandelingsarea verwyder word (indien gebruik).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">d) Die tydsinterval tussen die verwydering van die sterilisasielading uit die voorbehandelingsarea (indien gebruik) en die begin van die sterilisasiesiklus.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">e) Aanwysers van behoorlike werking van die gassirkulasiestelsel in die kamer tydens die gasblootstellingsfase (indien gebruik).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">f) Die temperatuur en druk binne die kamer regdeur die sterilisasiesiklus.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">g) Die humiditeit binne die kamer tydens die verwerkingsfase, soos gemeet deur druk of direk.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">h) Bevestiging dat gasvormige EO in die sterilisasiekamer ingebring is.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">i) Die drukstyging binne die sterilisasiekamer en die hoeveelheid of konsentrasie EO wat gebruik word.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">j) Die verwerkingstyd.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">k) Die blootstellingstyd.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">l) Time, temperature, and pressure changes (if applicable) during the aeration phase and\/or venting operations (if used).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eo-sterilization-release\">EO-sterilisasievrystelling<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-a-biological-indicator-method\">a) Biologiese Aanwyser Metode<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">As biologiese aanwysers (bevestigde EPCD) gebruik word, moet dit deur die sterilisasielading versprei word, insluitend die moeilikste-om-steriliseer-lokasies of plekke wat bekend is dat dit verband hou met hierdie moeilike kolle. Indien voorbehandeling gebruik word, moet die biologiese aanwysers voor die voorbehandeling geplaas word.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Die biologiese aanwysers moet uit die sterilisasielading verwyder word nadat die sterilisasiesiklus beëindig is en so gou as moontlik gekweek word om die biologiese aanwysers te laat herleef. Indien hulle nie betyds gekweek word nie, moet die uitwerking van blootstelling aan oorblywende EO tydens vertraagde herlewing geëvalueer word.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Die groei van die biologiese aanwysers moet ontleed word om te bepaal of die groei nie te wyte is aan die versuim om aan die fisiese prosesspesifikasies te voldoen nie, wat die herhaling van die bevestigingsproses sal vereis.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">b) Parametervrystellingsmetode<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Parametervrystelling berus daarop om te bewys dat alle fisiese prosesparameters voldoen aan die spesifikasies vir vrystelling sonder die gebruik van biologiese aanwysers. Dit is uitsluitlik gebaseer op metings en rekords van fisiese prosesparameters en dien as &#039;n voldoende verklaring van die sterilisasieproses se toereikendheid.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Parametervrystelling is slegs toelaatbaar wanneer alle prosesparameters gespesifiseer, beheer en direk gemonitor word. Daarom, wanneer parametervrystelling gebruik word, moet daar toerusting wees vir direkte meting van temperatuur en humiditeit binne die kamer en vir direkte ontleding van EO-konsentrasie, om die sterilisasieprosesparameters te versamel en aan te teken en te bevestig dat die sterilisasieproses aan die spesifikasies voldoen.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In addition to proving that the sterilization process parameters meet the sterilization specifications, parameter release also requires measuring and recording the following additional data:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Measuring the temperature inside the chamber at least from two locations throughout the sterilization cycle.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Directly measuring the humidity inside the chamber during the processing phase.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Determining the EO concentration by direct analysis of the sterilization chamber&#8217;s gas at specified time intervals, to fully verify that the required conditions are met throughout the exposure period.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more-about-ethylene-oxide-sterilization\">AS JY MEER WIL WEET Oor Etileenoksiedsterilisasie<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Telefoon:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">E-pos:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Plaaslike terrein: Kamer 1202, Caitong Zhongxin, Xiasha-distrik, Hangzhou-stad, Zhejiang-provinsie, China<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Webwerf:<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">zjbocon.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Die doel van roetine-monitering en beheer van EO (Etileenoksied) sterilisasie is om te demonstreer dat die bevestigde en gespesifiseerde sterilisasieproses op die produk toegepas is. Data van elke sterilisasiesiklus moet aangeteken en behou word om te bewys dat aan die bevestigde sterilisasieprosesspesifikasies voldoen is. Dit moet ten minste die volgende inhoud insluit:<\/p>\n","protected":false},"author":234312599,"featured_media":8429,"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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The effectiveness of ethylene oxide gas sterilization lies in its ability to disrupt the cellular structure of microorganisms. Here\u2019s a step-by-step breakdown of how it works: 1.\u00a0Penetration of EO Gas Ethylene oxide gas is highly penetrative, meaning it can easily reach microorganisms even\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\/tp2.jpg?resize=350%2C200&ssl=1","width":350,"height":200},"classes":[]},{"id":2004,"url":"https:\/\/zjbocon.com\/?p=2004","url_meta":{"origin":2128,"position":3},"title":"The Guide to ethylene oxide in sterilization","author":"Bocon Technical Team","date":"2024-10-28","format":false,"excerpt":"ethylene oxide in sterilization Introduction ETO is a colorless gas that is flammable and explosive. 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Ethylene oxide cylinders should be stored separately in a dry, well-ventilated room, with strict prohibition of smoking and open flames. The lighting in the sterilization chamber should be explosion-proof, and any electrical appliances that may cause electric\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\/2024\/10\/Electrical-Scale.png?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":1950,"url":"https:\/\/zjbocon.com\/?p=1950","url_meta":{"origin":2128,"position":5},"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":[]}],"_links":{"self":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2128","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=2128"}],"version-history":[{"count":4,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2128\/revisions"}],"predecessor-version":[{"id":8879,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2128\/revisions\/8879"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/media\/8429"}],"wp:attachment":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2128"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2128"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2128"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}