{"id":2122,"date":"2024-11-06T11:41:22","date_gmt":"2024-11-06T03:41:22","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2122"},"modified":"2025-12-05T10:51:11","modified_gmt":"2025-12-05T02:51:11","slug":"production-of-process-challenge-devices-in-eo-sterilization","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/production-of-process-challenge-devices-in-eo-sterilization\/","title":{"rendered":"Production of Process Challenge Devices in eo sterilization"},"content":{"rendered":"\n<div class=\"wp-block-uagb-image uagb-block-5b40b406 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\/Turnkey-EO-Sterilisation-Project-1-1024x724.webp\" alt=\"\" class=\"uag-image-8216\" width=\"768\" height=\"1024\" title=\"Turnkey-EO-Sterilisation-Project\" role=\"img\" \><\/figure><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-1-production-of-process-challenge-devices-pcd\">3.4.1.1 Hanganga o nga Pūrere Wero Tukatuka (PCD)<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Ko te Pūrere Wero Tukatuka (PCD) he punaha wero microbiological e whakamahia ana ki te arotake i te reiti mate o nga tawhā tukanga kua tohua. Ko te tikanga he taputapu, he kete whakamatautau ranei kei roto nga tohu koiora (hei tauira, nga puaa Bacillus atrophaeus me te tatauranga o te pua). Ko te parenga o te PCD ki te tukanga whakahoromata kia nui ake, kia rite ranei ki te parenga o te kawenga microbial taiao i roto i te waahi tino uaua-ki-whakahoroi o te hua. Me tutuki te rahinga o nga PCD ki nga whakaritenga kua tuhia ki te Ripanga C.3 o te Apiti C i GB18279.1-2015. Kua whakarōpūhia nga PCD ki roto PCD roto (IPCD) me PCD waho (EPCD).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-a-internal-pcd-ipcd-production\">a)Whakaputa PCD-roto (IPCD).<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Ko nga PCD o roto he taputapu rongoa i tohua e te kamupene hei tohu mo te whanau hua. I runga i te hoahoa me te hanganga rauemi, ko enei hua ka kiia ko etahi o nga mea tino uaua ki te whakahoromata. Ko nga tohu koiora (BI) ka whakanohohia ki te waahi tino uaua-ki-whakahoroi o te hua, kia kore ai te mahi whakahoromata e arai i nga awa, e pokanoa ranei ki te hoahoa hua.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Whakanohoia te tohu koiora (BI) ki te waahi tino uaua ki te whakakorikori o te hua, ka werohia ranei te microorganism whakamatautau (hei tauira, Bacillus atrophaeus) ki te waahi me nga tikanga whakahoromata tino uaua ki te whakatutuki. te waahi tino uaua ki te whakamakuku i roto i te hua.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ko nga IPCD noa kei roto, engari kaore i te iti ki:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Te whakanoho i te kaikawe kua poke i waenga i nga waahanga penei i nga mowhiti, i nga upoko piston, i nga kaihoroi, i nga piston syringe ranei.Te whakanoho i te wero moroiti ki waenganui o te catheter lumen, ka whakamahi i nga whakarewa whakapiri, i nga hononga hono ranei hei hiri i te catheter me te whakahoki i te pono o te hua.Te tuu i te wero microorganism ki te atanga piston.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-b-external-pcd-epcd-production\">b)Whakaputa PCD waho (EPCD).<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Ka whakanohoia nga PCD o waho ki waho o te hua kua utaina. Ka whakamahia nga EPCD mo te tukatuka o ia ra, ka tangohia mai i te kawenga i muri i te maimoatanga. Ko te parenga o te EPCD ki te kawenga koiora o te hua whakahoromata me whakataurite ki te parenga o te IPCD. Me tohu ano te EPCD i te hua tino uaua ki te whakamakuku i roto i te kawenga.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ko te hononga i waenga i nga EPCD me nga tauira hua poke me arotake i ia wa kia kore ai he huringa i puta ki te hua kua whakahoroa me te tohu tonu ko te EPCD te hua tino uaua ki te whakamakuku i roto i te uta.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">I te wa e whakatakoto ana i te BI ki roto i te PCD, me rite te iti rawa o te parenga o te PCD ki te waahi uaua-ki-whakahoroi i roto i te hua.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Kei roto i nga EPCD noa, engari kaore i te whakawhāitihia ki:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Te whakatakoto i te tohu koiora (BI) ki roto i te kete hua, te rite ranei, penei i te peeke kirihou, katahi ka tuu ki roto i te envelope Manila.Te tuu i te tohu koiora ki roto i te peeke kirihou matotoru kua takai mo te maha o nga waa.Te whakanoho i te tohu koiora ki nga waahi rereke o te syringe, penei i te piston moriori, upoko piston ranei.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ko nga PCD i hangaia i runga ake nei ka kohia ma te whakamahi i nga tikanga rite ki nga hua whakangao o ia ra, ka tohatoha i roto i te uta o nga hua, ka tuu ki te uhi i nga waahi makariri i roto i te ruma whakahoromata.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-2-partial-cycle-short-cycle-testing\">3.4.1.2 Whakamātautau Waahanga Porowhita (Porohiko).<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Whai muri i te kowhiringa i te PCD, ka whakamanahia tona tika ma te whakahaere i tetahi huringa wahanga. Ko te tikanga arotake e whai ake nei:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">a) Whakatauhia nga tikanga whakaurunga mo nga PCD, nga tauira whakamatautau, me nga puoro i runga i nga hua o te aromatawai whakahaere. Me rawaka te maha me te tohatoha o nga PCD. Mena ka whakamahia te EPCD kua tohua mo te aro turuki i nga mahi whakahoromata, me whakanoho ki runga i te uta o nga hua e ai ki te mahere me te tikanga.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">b) I runga i te uara D, te wa ST, me te wa KT o te tohu koiora, whakaritea he wa poto ake. Me whakamatau etahi atu tawhā i te tepe o raro o nga tawhā tukanga whakahoromata. Ko te tikanga whakamatautau me titiro ki te Apiti A o GB18281.2. Ka mutu te wa whakakitenga, tangohia te hua, IPCD, me te EPCD mo te maara moroiti me te titiro ki nga hua.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ko nga hua maara me whakaatu he nui ake, he rite ranei te parenga o te PCD ki te atete kawenga koiora o te waahi tino uaua ki te whakamakuku i roto i te hua:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ko te IPCD me te EPCD me noho kino; he tino kino, he hua tino pai ranei ka tohu i te korenga o te whakamatautau.Ko te parenga o te IPCD kia nui ake i te hua, a ko te parenga o te EPCD kia nui ake, kia rite ranei ki tera o te IPCD.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ki te kore nga hua e tutuki i nga tumanakohanga, tirotirohia te take. Ko te tikanga, ka hiahiatia nga whakarereketanga ki te aukati PCD me nga tawhā whakahoromata, ka whai i te whakamatautau ano kia rite nga hua ki nga tumanako. Mēnā karekau ngā hua e toru (hua, IPCD, me te EPCD) karekau he tipu moroiti, whakaitihia te wa whakamohiotanga o te EO me te whakamatau ano. Mena ka whakaatu te katoa i te tipu microbial, whakanuia te wa whakakitenga EO ka whakamatau ano.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-3-half-cycle-testing\">3.4.1.3 Whakamātautau Haurua<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Whai muri i te oti pai o te whakamatautau huringa-poto, whakahaerehia nga whakamatautau haurua-huringa e toru karapīpiti hei whakaatu i te whai huatanga (SAL = 10^-6) me te tukuruatanga o te tukanga whakahoromata EO. Ko te tikanga arotake e whai ake nei:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Tautuhia te whakakorikori o te tohu koiora hei paerewa, me te whakarite i etahi atu tawhā tukanga whakahoromata ki te tepe o raro o nga tawhā whakahoromata (hei tauira, te wa whakawhiti i mua i te maimoatanga i roto i te awhe kua tohua). Whakatataa ki te haurua te wa whakamaaramatanga o te whakahoromatatanga tuatahi me te tango i nga tohu koiora mai i te PCD i muri i nga waa rerekee. Whakatokia ki roto i te taiao parakore tae noa ki te whakapumautanga. Ko te wa whakamaoritanga poto rawa (te wa tino nui) ka whakatauhia ko te wa haurua o te huringa, a kia rua atu nga whakamatautau me whakahaere i te wa poto rawa atu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">All three test results should show complete inactivation of all biological indicators (initial colony count no less than 1\u00d710^6) to confirm the minimum effective EO exposure time. The exposure time in the routine sterilization process should be at least twice this minimum time.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ko nga hua maara tohu koiora me whakaatu he kino nga IPCD me nga EPCD katoa. Mena ka whakaatuhia e te whakamatautau huringa-poto he nui ake te parenga o te EPCD i tera o te IPCD, ka whakaatu pea te EPCD i te ahua pai.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ki te kore nga hua e tutuki i nga tumanakohanga, tirotirohia te take me te whakarite i nga tawhā whakahoromata i mua i te whakamatautau ano kia rite nga hua ki nga tumanakohanga.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Tauira:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Me whakaaro ko te haurua o te huringa tuatahi o te whakahoromatatanga he 4 haora. Mena he horomata, whakaitihia te wa whakakitenga ki te 2 haora mo te whakamatautau ka whai ake; ki te tupu te tipu o te moroiti, whakanuia te wa whakamohiotanga i runga i te whakaaturanga 4-haora.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Me whakaaro ko te haurua tuarua o te huringa whakahoromatatanga he 2 haora. Mēnā he horomata, whakaitihia te wā whakakitenga ki te 1 hāora mō te whakamātautau ka whai ake; ki te tupu te tipu o te moroiti, whakaroahia te wa whakakitenga ki te 3 haora.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Me whakaaro ko te toru o nga haora te whakamaaramatanga o te haurua o te huringa whakahoromata he 3 haora. Mena he horomata, tuaruatia te whakamatautau 3-haora kia rua. Mēnā he horomata ngā hua katoa, whakaūhia kia 3 hāora te wā whai hua. Mena ka tupu te tipu o te moroiti, whakahoki ano i te whakamatautau me te 4-haora ka kitea, a ki te mea he horomata nga hua katoa, whakaūhia kia 4 haora te waa whai hua.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-4-full-cycle-testing\">3.4.1.4 Whakamatau Porohita Katoa<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">I roto i nga whakamatautau huringa katoa, whakatauhia te wa whakakitenga EO kia rua te haurua-hurihuri te wa whai hua iti rawa, me etahi atu tawhā ki te tepe o runga o nga tawhā whakahoromata hei manatoko i te pono me te whakahoki ano o te tukanga whakahoromata.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ko te maha o nga pūoko pāmahana me te haumākū e whakamahia ana me tutuki nga whakaritenga o te Tāpiritanga C i roto i te GB18279.1, ka tohatohahia i roto i te kawenga whakahoromata. Ko nga waahi tuunga pukoro pāmahana me whakauru nga waahi makariri me nga waahi wera i roto i te ruma whakahoromata i te wa o te Tohu Whakahaere (OQ).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">I muri i te whakamatautau, ko nga hua maara o te hua me te EPCD me whakaatu i te koretake katoa (he kino katoa).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">Mena kei te hiahia koe ki te mohio atu<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Waea:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Īmēra:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Pae Rohe: Room 1202, Caitong Zhongxin, Takiwa Xiasha, Hangzhou City, Zhejiang Province, Haina<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">paetukutuku:<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">zjbocon.com<\/a><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><th>ISO 11135: 2014<\/th><td>Sterilization of health-care products \u2013 Ethylene oxide \u2013 Requirements for the development, validation and routine control of a sterilization process for medical devices<\/td><\/tr><tr><th>ISO 14161:2009<\/th><td>Sterilization of health care products \u2014 Biological indicators \u2014 Guidance for the selection, use and interpretation of results<\/td><\/tr><tr><th>ISO 10993-7:2008<\/th><td>Biological evaluation of medical devices \u2014 Part 7: Ethylene oxide sterilization residuals<\/td><\/tr><tr><th>ISO 11737-1:2018<\/th><td>Sterilization of health care products \u2014 Microbiological methods \u2013 Part 1: Determination of a population of microorganisms on products<\/td><\/tr><tr><th>ISO 11737-2:2009<\/th><td>Sterilization of medical devices \u2014 Microbiological methods \u2014 Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process<\/td><\/tr><tr><th>AAMI TIR16:2017<\/th><td>Ko nga ahuatanga microbiological o te whakahoromatatanga o te ethylene oxide<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>Ko te Pūrere Wero Tukatuka (PCD) he punaha wero microbiological e whakamahia ana ki te arotake i te reiti mate o nga tawhā tukanga kua tohua. Ko te tikanga he taputapu, he kete whakamatautau ranei kei roto nga tohu koiora (hei tauira, nga puaa Bacillus atrophaeus me te tatauranga o te pua). Ko te parenga o te PCD ki te tukanga whakahoromata kia nui ake, kia rite ranei ki te parenga o te kawenga microbial taiao i roto i te waahi tino uaua-ki-whakahoroi o te hua. Me tutuki te rahinga o nga PCD ki nga whakaritenga kua tuhia ki te Ripanga C.3 o te Apiti C i GB18279.1-2015. Kua whakarōpūhia nga PCD ki roto PCD roto (IPCD) me PCD waho (EPCD).<\/p>\n","protected":false},"author":234312599,"featured_media":8417,"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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https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Te whakaputanga o nga taputapu Wero Tukatuka i roto i te whakahoromata - ETO STERILIZER<\/title>\n<meta name=\"description\" content=\"A Process Challenge Device (PCD) is a microbiological challenge system used to evaluate the kill rate of selected process parameters.\" \>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \>\n<link rel=\"canonical\" href=\"https:\/\/zjbocon.com\/production-of-process-challenge-devices-in-eo-sterilization\/\" \>\n<meta property=\"og:locale\" content=\"en_US\" \>\n<meta property=\"og:type\" content=\"article\" \>\n<meta property=\"og:title\" content=\"Production of Process Challenge Devices in eo sterilization\" \>\n<meta property=\"og:description\" content=\"A Process Challenge Device (PCD) is a microbiological challenge system used to evaluate the kill rate of selected process parameters.\" \>\n<meta property=\"og:url\" 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