{"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 Produzzione di Dispositivi di Sfida di Prucessu (PCD)<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Un Dispositivu di Sfida di Processu (PCD) hè un sistema di sfida microbiologica utilizatu per valutà a rata di uccisione di parametri di prucessu selezziunati. Hè tipicamenti un dispositivu o un pacchettu di teste chì cuntene indicatori biologichi (per esempiu, spore di Bacillus atrophaeus cun cuntu di spore cunnisciutu). A resistenza di u PCD à u prucessu di sterilizazione deve esse più grande o uguale à a resistenza di a carica microbiana naturale in l&#039;area più difficiuli di sterilizà di u pruduttu. A quantità di PCD deve risponde à i requisiti delineati in a Table C.3 di l&#039;Appendice C in GB18279.1-2015. I PCD sò classificati in PCD interni (IPCD) è PCD esterni (EPCD).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-a-internal-pcd-ipcd-production\">a) Produzione interna di PCD (IPCD).<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">I PCD interni sò tipicamente dispositi medichi scelti da a cumpagnia per rapprisintà una famiglia di prudutti. Basatu nantu à u disignu è a cumpusizioni di materiale, questi prudutti sò cunsiderati alcuni di i più difficiuli di sterilizà. L&#039;indicatori biologichi (BI) sò posti in a pusizione più difficiuli di sterilizà di u pruduttu, assicurendu chì u prucessu di sterilizazione ùn impedisce micca i canali o interferiscenu cù u disignu di u produttu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Pone l&#039;indicatore biologicu (BI) in l&#039;area più difficiuli di sterilizà di u pruduttu, o inoculate u microorganismu di prova (per esempiu, Bacillus atrophaeus) in u locu cù e cundizioni di sterilizazione più difficiuli di ottene. Se u BI o u microorganismu di prova ùn pò micca esse piazzatu in u locu più difficiuli di sterilizà, un sistema alternativu pò esse cuncepitu in un sistema di barriera sterile. a stessa resistenza cum&#039;è u locu più difficiuli di sterilizà in u pruduttu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">L&#039;IPCD cumuni includenu, ma ùn sò micca limitati à:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Pone u trasportatore contaminatu trà cumpunenti cum&#039;è anelli, capi di pistoni, rondelle, o pistoni di siringa. Pone a sfida di u microorganismu in u mezu di un lumen di cateteru, dopu utilizendu solventi adesivi o connettori per reseal the cateter è restaurà l&#039;integrità di u pruduttu.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-b-external-pcd-epcd-production\">b) Produzione PCD Esterna (EPCD).<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">I PCD esterni sò posti nantu à l&#039;esternu di u pruduttu carricu. L&#039;EPCD sò tipicamente usati per u processamentu di rutina è sò recuperati da a carica dopu à u trattamentu. A resistenza di l&#039;EPCD à a carica biologica di u pruduttu sterilizatu deve esse paragunata cù a resistenza di l&#039;IPCD. L&#039;EPCD deve ancu rapprisintà u pruduttu più difficiuli di sterilizà in a carica.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A relazione trà l&#039;EPCD è i campioni di produtti contaminati deve esse rivisitata periodicamente per assicurà chì ùn ci sò micca cambiamenti in u pruduttu sterilizatu è chì l&#039;EPCD rapprisenta sempre u pruduttu più difficiuli di sterilizà in a carica.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Quandu si mette un BI in un PCD, u PCD deve avè almenu a stessa resistenza cum&#039;è u locu più difficiuli di sterilizà in u pruduttu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">I EPCD cumuni includenu, ma ùn sò micca limitati à:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Pone un indicatore biologicu (BI) in l&#039;imballaggio di u produttu o equivalente, cum&#039;è sacchetti di plastica, chì hè poi piazzatu in una busta di Manila. Pone un indicatore biologicu in un saccu di plastica grossa chì hè stata piegata un certu numaru di volte. Pone l&#039;indicatore biologicu in diverse parti di una siringa, cum&#039;è in a rondella di pistone o testa di pistone.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">I PCD pruduciuti in u modu sopra sò imballati cù i stessi metudi di i prudutti di produzzione regulare, distribuiti uniformemente in a carica di u produttu, è posizionati per copre i punti friddi in a camera di sterilizzatore.<\/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 Testing di Ciclu Parziale (Ciculu Cortu).<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Dopu à a selezzione di u PCD, a so adattabilità hè cunfirmata da eseguisce un ciclu parziale. U metudu di valutazione hè cusì:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">a) Determinate i metudi di piazzamentu per i PCD, i campioni di teste è i sensori nantu à i risultati di a valutazione operativa. U numeru è a distribuzione di PCD deve esse abbastanza. Se l&#039;EPCD sceltu hè utilizatu per u monitoraghju di u prucessu di sterilizazione di rutina, deve esse postu nantu à a carica di u produttu secondu u pianu è a prucedura.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">b) Basatu nantu à u valore D, u tempu ST è u tempu KT di l&#039;indicatore biologicu, stabilisce un tempu di esposizione più brevi. L&#039;altri paràmetri anu da esse pruvati à u limitu minimu di i paràmetri di u prucessu di sterilizazione di rutina. U metudu di prova deve riferite à l&#039;Appendice A di GB18281.2. Dopu chì u tempu d&#039;esposizione finisci, sguassate u pruduttu, IPCD è EPCD per u cultivo microbicu è osservate i risultati.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">I risultati di u cultivo duveranu dimustrà chì a resistenza di u PCD hè più grande o uguale à a resistenza di carica biologica di u locu più difficiuli di sterilizà in u pruduttu:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">IPCD è EPCD deve esse parzialmente negativu; un risultatu cumplettamente negativu o cumplettamente pusitivu indicà un fallimentu di teste. A resistenza di l&#039;IPCD deve esse più grande di u pruduttu, è a resistenza di l&#039;EPCD deve esse più grande o uguale à quella di l&#039;IPCD.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Se i risultati ùn rispondenu micca à l&#039;aspettattivi, investigate a causa. Di genere, l&#039;aghjustamenti à i paràmetri di resistenza à u PCD o di sterilizazione sò necessarii, seguitu da riprova finu à chì i risultati alignanu cù l&#039;aspettattivi. Sì tutti i trè (pruduttu, IPCD è EPCD) ùn mostranu micca crescita microbiana, riduce u tempu di esposizione à l&#039;EO in modu adattatu è pruvate di novu. Sì tutti mostranu crescita microbiana, aumentate u tempu d&#039;esposizione à l&#039;EO è ritestate.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-3-half-cycle-testing\">3.4.1.3 Testu di a mità di ciclu<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Dopu avè finitu cù successu a prova di u ciclu curtu, eseguite trè teste consecutivi di a mità di ciculu consistente per dimustrà l&#039;efficacità (SAL = 10^-6) è a riproducibilità di u prucessu di sterilizazione EO. U metudu di valutazione hè cusì:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Pone a sterilità di l&#039;indicatore biologicu cum&#039;è u standard, è stabilisce altri paràmetri di prucessu di sterilizazione à u limitu più bassu di i paràmetri di sterilizazione di rutina (per esempiu, u tempu di trasferimentu di pre-trattamentu in u intervallu specificatu). Diminuisce gradualmente u tempu d&#039;esposizione di sterilizazione di u prucessu di sterilizazione iniziale è sguassate l&#039;indicatori biologichi da u PCD dopu diversi tempi di sterilizazione. Cultivate in un ambiente sterile finu à chì a sterilità hè cunfirmata. U tempu di sterilizazione più brevi (tempu criticu) cusì determinatu serà u tempu di a mità di u ciculu, è almenu duie altre teste deve esse realizatu cù u listessu tempu più cortu.<\/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\">I risultati di a cultura di l&#039;indicatore biologicu duveranu vede tutti i IPCD è EPCD negativi. Se a prova di ciculu curtu mostra chì a resistenza di l&#039;EPCD hè più grande di quella di l&#039;IPCD, l&#039;EPCD pò mostrà positività parziale.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Se i risultati ùn scontranu micca l&#039;aspettattivi, investigate a causa è di solitu aghjustate i paràmetri di sterilizazione prima di ritestà finu à chì i risultati alignanu cù l&#039;aspettattivi.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Esempiu:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Assumite chì u primu tempu d&#039;esposizione à a sterilizazione di a mità di ciclu hè di 4 ore. Sè sterile, riduce u tempu di esposizione à 2 ore per a prussima prova; se si sviluppa una crescita microbica, aumenta u tempu di esposizione basatu annantu à l&#039;esposizione di 4 ore.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Assumite chì u tempu d&#039;esposizione à a seconda mità di u ciclu di sterilizazione hè di 2 ore. Sè sterile, riduce u tempu d&#039;esposizione à 1 ora per a prussima prova; se a crescita microbica si trova, allargà u tempu di esposizione à 3 ore.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Assumite chì u terzu tempu d&#039;esposizione di sterilizazione di a mità di ciclu hè di 3 ore. Sè sterile, repite a prova di 3 ore duie volte. Sì tutti i risultati sò sterili, cunfirmà 3 ore cum&#039;è u tempu minimu efficace. In casu di crescita microbiana, ripetite a prova cù l&#039;esposizione di 4 ore, è se tutti i risultati sò sterili, cunfirmà 4 ore cum&#039;è u tempu minimu efficace.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-4-full-cycle-testing\">3.4.1.4 Test di Ciclu Full<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Durante a prova di u ciclu cumpletu, stabilisce u tempu d&#039;esposizione à l&#039;EO à duie volte u tempu d&#039;effettu minimu di a mità di ciclu, è altri parametri à u limitu superiore di i parametri di sterilizazione di rutina per verificà l&#039;affidabilità è a riproducibilità di u prucessu di sterilizazione.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">U numaru di sensori di temperatura è umidità utilizati deve risponde à i requisiti di l&#039;Appendice C in GB18279.1, distribuitu uniformemente in a carica di sterilizazione. I punti di posizionamentu di u sensoru di temperatura duveranu include i punti friddi è caldi in a camera di sterilizzatore durante a Qualificazione Operativa (OQ).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Dopu à a prova, i risultati di cultivazioni di u produttu è EPCD deve mustrà sterilità cumpleta (tutti negativu).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">SE VOGLIA SAPERNE DI PIÙ<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Telefonu:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">E-mail:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Situ lucale: Room 1202, Caitong Zhongxin, District Xiasha, Hangzhou City, Zhejiang Province, China<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">situ web:<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>Aspetti microbiologichi di a sterilizazione di l&#039;ossidu di etilene<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>Un Dispositivu di Sfida di Processu (PCD) hè un sistema di sfida microbiologica utilizatu per valutà a rata di uccisione di parametri di prucessu selezziunati. Hè tipicamenti un dispositivu o un pacchettu di teste chì cuntene indicatori biologichi (per esempiu, spore di Bacillus atrophaeus cun cuntu di spore cunnisciutu). A resistenza di u PCD à u prucessu di sterilizazione deve esse più grande o uguale à a resistenza di a carica microbiana naturale in l&#039;area più difficiuli di sterilizà di u pruduttu. A quantità di PCD deve risponde à i requisiti delineati in a Table C.3 di l&#039;Appendice C in GB18279.1-2015. I PCD sò classificati in PCD interni (IPCD) è PCD esterni (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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