{"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\/?p=2122","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 Paggawa ng Process Challenge Devices (PCD)<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Ang Process Challenge Device (PCD) ay isang microbiological challenge system na ginagamit upang suriin ang rate ng pagpatay ng mga napiling parameter ng proseso. Karaniwan itong isang device o test package na naglalaman ng mga biological indicator (hal., Bacillus atrophaeus spores na may alam na spore count). Ang paglaban ng PCD sa proseso ng isterilisasyon ay dapat na mas malaki kaysa sa o katumbas ng paglaban ng natural na microbial load sa pinaka mahirap i-sterilize na lugar ng produkto. Ang dami ng mga PCD ay dapat matugunan ang mga kinakailangan na nakabalangkas sa Talahanayan C.3 ng Appendix C sa GB18279.1-2015. Ang mga PCD ay inuri sa Internal PCD (IPCD) at External PCD (EPCD).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-a-internal-pcd-ipcd-production\">a) Panloob na Produksyon ng PCD (IPCD).<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Ang mga panloob na PCD ay karaniwang mga medikal na device na pinili ng kumpanya upang kumatawan sa isang pamilya ng produkto. Batay sa disenyo at komposisyon ng materyal, ang mga produktong ito ay itinuturing na ilan sa pinakamahirap i-sterilize. Ang mga biological indicator (BI) ay inilalagay sa pinaka mahirap i-sterilize na posisyon ng produkto, na tinitiyak na ang proseso ng isterilisasyon ay hindi humaharang sa mga channel o makagambala sa disenyo ng produkto.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ilagay ang biological indicator (BI) sa pinaka mahirap i-sterilize na lugar ng produkto, o inoculate ang pansubok na microorganism (hal., Bacillus atrophaeus) sa lokasyong may pinakamahirap na makuhang kondisyon ng isterilisasyon. Kung ang BI o pansubok na microorganism ay hindi mailagay sa lokasyong mahirap i-sterilize, maaaring magdisenyo at maglagay ng alternatibong device sa loob ng sterile barrier na katulad ng resistensya ng sterile. pinakamahirap i-sterilize na lokasyon sa produkto.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Kasama sa mga karaniwang IPCD, ngunit hindi limitado sa:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Paglalagay ng kontaminadong carrier sa pagitan ng mga bahagi gaya ng mga singsing, piston head, washer, o syringe piston. Paglalagay ng microorganism challenge sa gitna ng catheter lumen, pagkatapos ay gumagamit ng adhesive solvents o connectors upang muling isara ang catheter at ibalik ang integridad ng produkto. Paglalagay ng microorganism challenge sa piston interface.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-b-external-pcd-epcd-production\">b) Panlabas na Produksyon ng PCD (EPCD).<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Ang mga panlabas na PCD ay inilalagay sa labas ng na-load na produkto. Ang mga EPCD ay karaniwang ginagamit para sa nakagawiang pagpoproseso at kinukuha mula sa pagkarga pagkatapos ng paggamot. Ang paglaban ng EPCD sa biological load ng isterilisadong produkto ay dapat ihambing sa resistensya ng IPCD. Ang EPCD ay dapat ding kumatawan sa pinaka mahirap i-sterilize na produkto sa load.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ang ugnayan sa pagitan ng mga EPCD at mga kontaminadong sample ng produkto ay dapat na pana-panahong suriin upang matiyak na walang mga pagbabagong naganap sa isterilisadong produkto at ang EPCD ay kumakatawan pa rin sa pinakamahirap na i-sterilize na produkto sa load.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Kapag naglalagay ng BI sa isang PCD, ang PCD ay dapat magkaroon ng hindi bababa sa kaparehong pagtutol sa pinakamahirap na i-sterilize na lokasyon sa produkto.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Kasama sa mga karaniwang EPCD, ngunit hindi limitado sa:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Paglalagay ng biological indicator (BI) sa loob ng packaging ng produkto o katumbas, tulad ng mga plastic bag, na pagkatapos ay inilalagay sa loob ng Manila envelope.Paglalagay ng biological indicator sa isang makapal na plastic bag na natupi nang ilang beses. Paglalagay ng biological indicator sa iba&#039;t ibang bahagi ng syringe, tulad ng sa piston washer o piston head.Sealed na walang mga plastic na packaging na naglalaman ng mga kontaminadong tubo.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ang mga PCD na ginawa sa paraang nasa itaas ay nakabalot gamit ang parehong mga pamamaraan tulad ng mga regular na produkto ng produksyon, pantay na ipinamahagi sa loob ng load ng produkto, at nakaposisyon upang takpan ang mga malamig na spot sa loob ng sterilizer chamber.<\/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 Pagsubok ng Partial Cycle (Short Cycle).<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Pagkatapos piliin ang PCD, ang pagiging angkop nito ay nakumpirma sa pamamagitan ng pagpapatakbo ng isang bahagyang cycle. Ang pamamaraan ng pagsusuri ay ang mga sumusunod:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">a) Tukuyin ang mga paraan ng paglalagay para sa mga PCD, mga sample ng pagsubok, at mga sensor batay sa mga resulta ng pagsusuri sa pagpapatakbo. Dapat sapat ang bilang at pamamahagi ng mga PCD. Kung ang napiling EPCD ay ginagamit para sa regular na pagsubaybay sa proseso ng isterilisasyon, dapat itong ilagay sa load ng produkto ayon sa plano at pamamaraan.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">b) Based on the D value, ST time, and KT time of the biological indicator, set a shorter exposure time. Other parameters should be tested at the lower limit of routine sterilization process parameters. The test method should refer to Appendix A of GB18281.2. After the exposure time ends, remove the product, IPCD, and EPCD for microbial cultivation and observe the results.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The cultivation results should show that the resistance of the PCD is greater than or equal to the biological load resistance of the hardest-to-sterilize location in the product:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ang IPCD at EPCD ay dapat na bahagyang negatibo; ang isang ganap na negatibo o ganap na positibong resulta ay magsasaad ng kabiguan sa pagsubok. Ang paglaban ng IPCD ay dapat na mas malaki kaysa sa produkto, at ang paglaban ng EPCD ay dapat na mas malaki kaysa o katumbas ng paglaban ng IPCD.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Kung ang mga resulta ay hindi nakakatugon sa mga inaasahan, siyasatin ang dahilan. Karaniwan, kailangan ang mga pagsasaayos sa mga parameter ng resistensya ng PCD o isterilisasyon, na sinusundan ng muling pagsusuri hanggang sa umayon ang mga resulta sa mga inaasahan. Kung lahat ng tatlo (produkto, IPCD, at EPCD) ay nagpapakita ng walang microbial growth, bawasan ang oras ng pagkakalantad sa EO nang naaangkop at muling subukan. Kung ang lahat ay nagpapakita ng microbial growth, taasan ang oras ng pagkakalantad sa EO at muling subukan.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-3-half-cycle-testing\">3.4.1.3 Half-Cycle Testing<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Pagkatapos ng matagumpay na pagkumpleto ng short-cycle na pagsubok, magpatakbo ng tatlong magkakasunod na pare-parehong half-cycle na pagsusulit upang ipakita ang pagiging epektibo (SAL = 10^-6) at muling paggawa ng proseso ng isterilisasyon ng EO. Ang pamamaraan ng pagsusuri ay ang mga sumusunod:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Itakda ang sterility ng biological indicator bilang pamantayan, at itakda ang iba pang mga parameter ng proseso ng sterilization sa mas mababang limitasyon ng mga karaniwang parameter ng sterilization (hal., oras ng paglipat bago ang paggamot sa loob ng tinukoy na hanay). Dahan-dahang hatiin sa kalahati ang oras ng pagkakalantad ng isterilisasyon ng paunang proseso ng isterilisasyon at alisin ang mga biological indicator mula sa PCD pagkatapos ng iba&#039;t ibang oras ng isterilisasyon. Linangin ang mga ito sa isang sterile na kapaligiran hanggang sa makumpirma ang sterility. Ang pinakamaikling oras ng isterilisasyon (kritikal na oras) kaya natutukoy ay ang kalahating ikot ng oras, at hindi bababa sa dalawa pang pagsubok ang dapat isagawa sa parehong pinakamaikling oras.<\/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\">Dapat ipakita ng mga resulta ng paglilinang ng biological indicator ang lahat ng negatibong IPCD at EPCD. Kung ang short-cycle test ay nagpapakita na ang resistensya ng EPCD ay mas malaki kaysa sa IPCD, ang EPCD ay maaaring magpakita ng bahagyang positibo.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Kung ang mga resulta ay hindi nakakatugon sa mga inaasahan, siyasatin ang dahilan at karaniwang isaayos ang mga parameter ng isterilisasyon bago muling suriin hanggang ang mga resulta ay umayon sa mga inaasahan.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Halimbawa:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ipagpalagay na ang unang kalahating cycle ng sterilization exposure time ay 4 na oras. Kung sterile, bawasan ang oras ng pagkakalantad sa 2 oras para sa susunod na pagsubok; kung mangyari ang microbial growth, dagdagan ang oras ng pagkakalantad batay sa 4 na oras na pagkakalantad.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ipagpalagay na ang ikalawang kalahating cycle ng sterilization exposure time ay 2 oras. Kung sterile, bawasan ang oras ng pagkakalantad sa 1 oras para sa susunod na pagsubok; kung mangyari ang microbial growth, pahabain ang oras ng exposure sa 3 oras.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ipagpalagay na ang ikatlong kalahating cycle ng sterilization exposure time ay 3 oras. Kung sterile, ulitin ang 3 oras na pagsubok ng dalawang beses. Kung sterile ang lahat ng resulta, kumpirmahin ang 3 oras bilang pinakamababang epektibong oras. Kung nangyari ang microbial growth, ulitin ang pagsubok na may 4 na oras na pagkakalantad, at kung lahat ng resulta ay sterile, kumpirmahin ang 4 na oras bilang pinakamababang epektibong oras.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-4-full-cycle-testing\">3.4.1.4 Buong Cycle Testing<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Sa buong cycle na pagsubok, itakda ang oras ng pagkakalantad sa EO sa dalawang beses sa kalahating ikot na minimum na epektibong oras, at iba pang mga parameter sa pinakamataas na limitasyon ng nakagawiang mga parameter ng isterilisasyon upang ma-verify ang pagiging maaasahan at muling paggawa ng proseso ng isterilisasyon.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ang bilang ng mga sensor ng temperatura at halumigmig na ginamit ay dapat matugunan ang mga kinakailangan ng Appendix C sa GB18279.1, na pantay na ipinamahagi sa loob ng pagkarga ng isterilisasyon. Ang mga punto ng paglalagay ng sensor ng temperatura ay dapat kasama ang parehong malamig at mainit na mga lugar sa loob ng silid ng sterilizer sa panahon ng Operational Qualification (OQ).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Pagkatapos ng pagsubok, ang mga resulta ng paglilinang ng produkto at EPCD ay dapat magpakita ng kumpletong sterility (lahat ng negatibo).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">KUNG GUSTO MONG MALAMAN<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Telepono:<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\">Lokal na Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Website:<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>Microbiological aspects of ethylene oxide sterilization<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>Ang Process Challenge Device (PCD) ay isang microbiological challenge system na ginagamit upang suriin ang rate ng pagpatay ng mga napiling parameter ng proseso. Karaniwan itong isang device o test package na naglalaman ng mga biological indicator (hal., Bacillus atrophaeus spores na may alam na spore count). Ang paglaban ng PCD sa proseso ng isterilisasyon ay dapat na mas malaki kaysa sa o katumbas ng paglaban ng natural na microbial load sa pinaka mahirap i-sterilize na lugar ng produkto. Ang dami ng mga PCD ay dapat matugunan ang mga kinakailangan na nakabalangkas sa Talahanayan C.3 ng Appendix C sa GB18279.1-2015. Ang mga PCD ay inuri sa Internal PCD (IPCD) at External PCD (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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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","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[133124],"tags":[],"class_list":["post-2122","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","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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