{"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 Paggama sa Proseso nga Mga Kagamitan sa Paghagit (PCD)<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Ang Process Challenge Device (PCD) kay usa ka microbiological challenge system nga gigamit sa pagtimbang-timbang sa kill rate sa pinili nga process parameters. Kasagaran kini usa ka aparato o pakete sa pagsulay nga adunay mga biolohikal nga indikasyon (pananglitan, mga spore sa Bacillus atrophaeus nga adunay nahibal-an nga ihap sa spore). Ang pagsukol sa PCD sa proseso sa pag-sterilize kinahanglan nga mas dako o katumbas sa pagsukol sa natural nga microbial load sa labing lisud nga-sterilize nga lugar sa produkto. Ang gidaghanon sa mga PCD kinahanglan makatagbo sa mga kinahanglanon nga gilatid sa Talaan C.3 sa Apendise C sa GB18279.1-2015. Ang mga PCD giklasipikar sa Internal PCDs (IPCD) ug External PCDs (EPCD).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-a-internal-pcd-ipcd-production\">a)Internal nga PCD (IPCD) Production<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Ang mga internal nga PCD kasagarang mga medikal nga himan nga gipili sa kompanya aron magrepresentar sa usa ka pamilya sa produkto. Pinasukad sa disenyo ug materyal nga komposisyon, kini nga mga produkto giisip nga pipila sa labing lisud nga pag-sterilize. Ang mga biolohikal nga indikasyon (BI) gibutang sa pinakalisud nga pag-sterilize nga posisyon sa produkto, pagsiguro nga ang proseso sa sterilization dili makababag sa mga agianan o makabalda sa disenyo sa produkto.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ibutang ang biological indicator (BI) sa pinakalisud nga i-sterilize nga lugar sa produkto, o inoculate ang test microorganism (e.g., Bacillus atrophaeus) sa lokasyon nga adunay pinakalisud nga pagkab-ot sa sterilization nga mga kondisyon. pinakalisud nga i-sterilize nga lokasyon sa produkto.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ang kasagarang mga IPCD naglakip, apan dili limitado sa:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Pagbutang sa kontaminado nga carrier tali sa mga component sama sa mga singsing, piston head, washers, o syringe piston.Pagbutang sa microorganism challenge sa tunga-tunga sa catheter lumen, unya gamita ang adhesive solvents o connectors aron ma-reseal ang catheter ug ibalik ang integridad sa produkto.Pagbutang sa microorganism challenge sa piston interface.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-b-external-pcd-epcd-production\">b)External nga PCD (EPCD) Production<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Ang mga eksternal nga PCD gibutang sa gawas sa gikarga nga produkto. Ang mga EPCD kasagarang gigamit alang sa naandan nga pagproseso ug makuha gikan sa load pagkahuman sa pagtambal. Ang pagsukol sa EPCD sa biological load sa sterilized nga produkto kinahanglang itandi sa resistensya sa IPCD. Ang EPCD kinahanglan usab nga magrepresentar sa pinakalisud nga i-sterilize nga produkto sa load.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ang relasyon tali sa mga EPCD ug kontaminado nga mga sample sa produkto kinahanglan nga regular nga susihon aron masiguro nga walay mga pagbag-o nga nahitabo sa sterilized nga produkto ug nga ang EPCD nagrepresentar gihapon sa pinakalisud nga-sterilize nga produkto sa load.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Kung magbutang ug BI sa usa ka PCD, ang PCD kinahanglan adunay labing menos parehas nga resistensya sa labing lisud nga pag-sterilize nga lokasyon sa produkto.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ang kasagarang mga EPCD naglakip, apan dili limitado sa:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Pagbutang ug biological indicator (BI) sulod sa product packaging o katumbas, sama sa plastic bags, nga ibutang sa sulod sa Manila envelope.Pagbutang ug biological indicator sa baga nga plastic bag nga gipilo sa espesipikong gidaghanon sa mga higayon.Pagbutang sa biological indicator sa lain-laing bahin sa usa ka syringe, sama sa piston washer o piston head.Sealed nga walay mga plastic nga pakete nga adunay sulod.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ang mga PCD nga gihimo sa ibabaw nga paagi giputos gamit ang parehas nga mga pamaagi sama sa regular nga mga produkto sa produksiyon, parehas nga giapod-apod sa sulod sa karga sa produkto, ug giposisyon aron matabonan ang mga bugnaw nga lugar sa sulod sa 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 Partial Cycle (Short Cycle) Testing<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Human mapili ang PCD, ang kaangayan niini mapamatud-an pinaagi sa pagpadagan sa partial cycle. Ang pamaagi sa pagtimbang-timbang mao ang mosunod:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">a) Tinoa ang mga pamaagi sa pagbutang alang sa mga PCD, mga sample sa pagsulay, ug mga sensor base sa mga resulta sa operational evaluation. Kinahanglan nga igo ang gidaghanon ug pag-apod-apod sa mga PCD. Kung ang pinili nga EPCD gigamit alang sa naandan nga pagmonitor sa proseso sa sterilization, kinahanglan kini ibutang sa load sa produkto sumala sa plano ug pamaagi.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">b) Base sa D value, ST time, ug KT time sa biological indicator, magbutang ug mas mubo nga exposure time. Ang ubang mga parameter kinahanglan nga sulayan sa ubos nga limitasyon sa naandan nga mga parameter sa proseso sa sterilization. Ang pamaagi sa pagsulay kinahanglan nga magtumong sa Apendise A sa GB18281.2. Human matapos ang oras sa exposure, kuhaa ang produkto, IPCD, ug EPCD para sa microbial cultivation ug obserbahan ang mga resulta.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ang mga resulta sa pagpananom kinahanglan magpakita nga ang resistensya sa PCD mas dako o katumbas sa biological load resistance sa pinakalisud-sterilize nga lokasyon sa produkto:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ang IPCD ug EPCD kinahanglan nga partially negatibo; ang bug-os nga negatibo o bug-os nga positibo nga resulta magpaila sa kapakyasan sa pagsulay.Ang pagsukol sa IPCD kinahanglan nga mas dako pa kay sa produkto, ug ang pagsukol sa EPCD kinahanglan nga mas dako o katumbas sa sa IPCD.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Kung ang mga resulta wala makaabot sa mga gilauman, susiha ang hinungdan. Kasagaran, kinahanglan ang mga pag-adjust sa resistensya sa PCD o mga parameter sa sterilization, gisundan sa pagsulay pag-usab hangtod nga ang mga resulta nahiuyon sa gipaabut. Kung ang tanan nga tulo (produkto, IPCD, ug EPCD) nagpakita nga walay mikrobyo nga pagtubo, pakunhuran ang oras sa pagkaladlad sa EO sa tukmang paagi ug sulayi pag-usab. Kung ang tanan nagpakita sa pagtubo sa microbial, dugangi ang oras sa pagkaladlad sa EO ug pagsulay pag-usab.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-3-half-cycle-testing\">3.4.1.3 Pagsulay sa Half-Cycle<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Human sa malampuson nga pagkompleto sa mubo nga siklo nga pagsulay, pagpadagan sa tulo ka sunod-sunod nga makanunayon nga half-cycle nga mga pagsulay aron ipakita ang pagka-epektibo (SAL = 10^-6) ug reproducibility sa proseso sa EO sterilization. Ang pamaagi sa pagtimbang-timbang mao ang mosunod:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ibutang ang sterility sa biological indicator isip sumbanan, ug itakda ang ubang mga parameter sa proseso sa sterilization ngadto sa ubos nga limitasyon sa naandan nga sterilization parameters (pananglitan, pre-treatment transfer time sulod sa gitakda nga range). Hinay-hinay nga tungaa ang panahon sa pagkaladlad sa sterilization sa inisyal nga proseso sa sterilization ug kuhaa ang biological indicators gikan sa PCD human sa lain-laing mga panahon sa sterilization. Ugma sila sa usa ka sterile nga palibot hangtod mapamatud-an ang sterility. Ang pinakamubo nga panahon sa sterilization (kritikal nga panahon) sa ingon determinado mao ang katunga sa siklo nga panahon, ug labing menos duha pa ka mga pagsulay kinahanglan nga ipahigayon sa samang pinakamubo nga panahon.<\/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\">Ang resulta sa biological indicator cultivation kinahanglan magpakita sa tanang IPCD ug EPCD negatibo. Kung ang short-cycle nga pagsulay nagpakita nga ang resistensya sa EPCD mas dako kaysa sa IPCD, ang EPCD mahimong magpakita sa partial nga positibo.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Kung ang mga resulta dili makab-ot ang mga gilauman, susiha ang hinungdan ug kasagaran i-adjust ang mga parameter sa sterilization sa dili pa ang pagsulay pag-usab hangtud nga ang mga resulta mahiuyon sa mga gilauman.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Pananglitan:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ibutang ta nga 4 ka oras ang unang tunga sa siklo sa sterilization exposure. Kung sterile, pagpakunhod sa oras sa pagkaladlad ngadto sa 2 ka oras alang sa sunod nga pagsulay; kung mahitabo ang microbial growth, dugangi ang oras sa exposure base sa 4-hour exposure.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ibutang ta nga 2 ka oras ang ikaduhang tunga sa siklo sa sterilization exposure. Kung sterile, pagpakunhod sa oras sa pagkaladlad ngadto sa 1 ka oras alang sa sunod nga pagsulay; kung mahitabo ang pagtubo sa microbial, i-extend ang oras sa pagkaladlad ngadto sa 3 ka oras.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Hunahunaa nga ang ikatulo nga tunga nga siklo sa sterilization exposure oras mao ang 3 ka oras. Kung sterile, balika ang 3 ka oras nga pagsulay sa makaduha. Kung ang tanan nga mga resulta sterile, kumpirmahi ang 3 ka oras nga labing gamay nga epektibo nga oras. Kung mahitabo ang pagtubo sa microbial, balika ang pagsulay nga adunay 4-oras nga pagkaladlad, ug kung ang tanan nga mga resulta sterile, kumpirmahi ang 4 ka oras nga labing gamay nga epektibo nga oras.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-4-full-cycle-testing\">3.4.1.4 Bug-os nga Cycle Testing<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Atol sa bug-os nga cycle testing, ibutang ang EO exposure time sa doble sa tunga sa cycle nga minimum nga epektibong panahon, ug uban pang mga parameter sa taas nga limitasyon sa naandan nga sterilization parameters aron mapamatud-an ang kasaligan ug reproducibility sa proseso sa sterilization.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ang gidaghanon sa mga sensor sa temperatura ug humidity nga gigamit kinahanglan magtagbo sa mga kinahanglanon sa Appendix C sa GB18279.1, parehas nga giapod-apod sa sulod sa pagkarga sa sterilization. Ang mga punto sa pagbutang sa sensor sa temperatura kinahanglan nga maglakip sa bugnaw ug init nga mga lugar sulod sa sterilizer chamber atol sa Operational Qualification (OQ).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Human sa pagsulay, ang mga resulta sa cultivation sa produkto ug EPCD kinahanglan magpakita sa hingpit nga sterility (tanan negatibo).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">Kung gusto nimo mahibal-an ang dugang<\/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 nga Dapit: 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 nga mga aspeto sa ethylene oxide sterilization<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>Ang Process Challenge Device (PCD) kay usa ka microbiological challenge system nga gigamit sa pagtimbang-timbang sa kill rate sa pinili nga process parameters. Kasagaran kini usa ka aparato o pakete sa pagsulay nga adunay mga biolohikal nga indikasyon (pananglitan, mga spore sa Bacillus atrophaeus nga adunay nahibal-an nga ihap sa spore). Ang pagsukol sa PCD sa proseso sa pag-sterilize kinahanglan nga mas dako o katumbas sa pagsukol sa natural nga microbial load sa labing lisud nga-sterilize nga lugar sa produkto. Ang gidaghanon sa mga PCD kinahanglan makatagbo sa mga kinahanglanon nga gilatid sa Talaan C.3 sa Apendise C sa GB18279.1-2015. Ang mga PCD giklasipikar sa Internal PCDs (IPCD) ug External PCDs (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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