{"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 Produzzjoni ta&#039; Apparat ta&#039; Sfida tal-Proċess (PCD)<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">A Process Challenge Device (PCD) huwa sistema ta &#039;sfida mikrobijoloġika użata biex tevalwa r-rata ta&#039; qtil tal-parametri tal-proċess magħżula. Tipikament huwa apparat jew pakkett tat-test li jkun fih indikaturi bijoloġiċi (eż., spori ta’ Bacillus atrophaeus b’għadd ta’ spori magħruf). Ir-reżistenza tal-PCD għall-proċess ta &#039;sterilizzazzjoni għandha tkun akbar minn jew ugwali għar-reżistenza tat-tagħbija mikrobjali naturali fiż-żona l-aktar diffiċli biex tiġi sterilizzata tal-prodott. Il-kwantità ta &#039;PCDs għandha tissodisfa r-rekwiżiti deskritti fit-Tabella C.3 tal-Appendiċi C f&#039;GB18279.1-2015. Il-PCDs huma kklassifikati f&#039;PCDs Interni (IPCD) u PCDs Esterni (EPCD).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-a-internal-pcd-ipcd-production\">a)Produzzjoni Interna tal-PCD (IPCD).<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Il-PCDs interni huma tipikament apparati mediċi magħżula mill-kumpanija biex jirrappreżentaw familja ta&#039; prodotti. Ibbażat fuq id-disinn u l-kompożizzjoni tal-materjal, dawn il-prodotti huma kkunsidrati bħala wħud mill-aktar diffiċli biex jiġu sterilizzati. L-indikaturi bijoloġiċi (BI) jitqiegħdu fl-iktar pożizzjoni diffiċli biex tiġi sterilizzata tal-prodott, u jiżguraw li l-proċess ta &#039;sterilizzazzjoni ma jimblokkax il-kanali jew jinterferixxi mad-disinn tal-prodott.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Poġġi l-indikatur bijoloġiku (BI) fl-iktar żona diffiċli biex tiġi sterilizzata tal-prodott, jew inokula l-mikroorganiżmu tat-test (eż., Bacillus atrophaeus) fil-post bl-aktar kundizzjonijiet ta’ sterilizzazzjoni diffiċli biex jinkisbu. istess reżistenza bħall-post l-aktar diffiċli biex jiġi sterilizzat fil-prodott.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">IPCDs komuni jinkludu, iżda mhumiex limitati għal:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Tqegħid it-trasportatur ikkontaminat bejn komponenti bħal ċrieki, irjus tal-pistun, woxers, jew pistuni tas-siringi. Tqegħid l-isfida tal-mikroorganiżmu fin-nofs ta &#039;lumen tal-kateter, imbagħad tuża solventi adeżivi jew konnetturi biex tissiġilla mill-ġdid il-kateter u tirrestawra l-integrità tal-prodott. It-tqegħid tal-isfida tal-mikroorganiżmu fl-interface tal-pistun.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-b-external-pcd-epcd-production\">b) Produzzjoni esterna tal-PCD (EPCD).<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">PCDs esterni jitqiegħdu fuq barra tal-prodott mgħobbi. EPCDs huma tipikament użati għall-ipproċessar ta &#039;rutina u huma rkuprati mit-tagħbija wara t-trattament. Ir-reżistenza tal-EPCD għat-tagħbija bijoloġika tal-prodott sterilizzat għandha titqabbel mar-reżistenza tal-IPCD. L-EPCD għandu wkoll jirrappreżenta l-aktar prodott diffiċli biex jiġi sterilizzat fit-tagħbija.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ir-relazzjoni bejn l-EPCDs u l-kampjuni tal-prodott kontaminat għandha tiġi riveduta perjodikament biex jiġi żgurat li ma jkun seħħ l-ebda tibdil fil-prodott sterilizzat u li l-EPCD għadu jirrappreżenta l-aktar prodott diffiċli biex jiġi sterilizzat fit-tagħbija.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Meta tpoġġi BI f&#039;PCD, il-PCD għandu jkollu mill-inqas l-istess reżistenza bħall-post l-aktar diffiċli biex jiġi sterilizzat fil-prodott.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">EPCDs komuni jinkludu, iżda mhumiex limitati għal:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Tqegħid ta &#039;indikatur bijoloġiku (BI) ġewwa l-ippakkjar tal-prodott jew ekwivalenti, bħal boroż tal-plastik, li mbagħad jitqiegħed ġewwa envelope ta&#039; Manila. Tqegħid ta &#039;indikatur bijoloġiku f&#039;borża tal-plastik ħoxna li tkun ġiet mitwija numru speċifikat ta&#039; drabi. Tqegħid tal-indikatur bijoloġiku f&#039;diversi partijiet ta &#039;siringa, bħal fil-washer tal-pistun jew ras tal-pistun.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Il-PCDs prodotti bil-mod ta &#039;hawn fuq huma ppakkjati bl-użu tal-istess metodi bħal prodotti ta&#039; produzzjoni regolari, imqassma b&#039;mod uniformi fit-tagħbija tal-prodott, u pożizzjonati biex ikopru l-punti kesħin fil-kamra tal-isterilizzatur.<\/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 Ittestjar ta&#039; Ċiklu Parzjali (Ċiklu Qasir).<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Wara l-għażla tal-PCD, l-adegwatezza tiegħu hija kkonfermata billi jitħaddem ċiklu parzjali. Il-metodu ta&#039; evalwazzjoni huwa kif ġej:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">a) Iddetermina l-metodi ta &#039;tqegħid għal PCDs, kampjuni tat-test, u sensuri bbażati fuq ir-riżultati tal-evalwazzjoni operattiva. In-numru u d-distribuzzjoni tal-PCDs għandhom ikunu biżżejjed. Jekk l-EPCD magħżul jintuża għall-monitoraġġ tal-proċess ta &#039;sterilizzazzjoni ta&#039; rutina, għandu jitqiegħed fuq it-tagħbija tal-prodott skont il-pjan u l-proċedura.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">b) Ibbażat fuq il-valur D, il-ħin ST, u l-ħin KT tal-indikatur bijoloġiku, issettja ħin ta &#039;espożizzjoni iqsar. Parametri oħra għandhom jiġu ttestjati fil-limitu aktar baxx tal-parametri tal-proċess ta &#039;sterilizzazzjoni ta&#039; rutina. Il-metodu tat-test għandu jirreferi għall-Appendiċi A ta&#039; GB18281.2. Wara li jintemm il-ħin tal-espożizzjoni, neħħi l-prodott, l-IPCD, u l-EPCD għall-kultivazzjoni tal-mikrobi u osserva r-riżultati.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ir-riżultati tal-kultivazzjoni għandhom juru li r-reżistenza tal-PCD hija akbar minn jew ugwali għar-reżistenza tat-tagħbija bijoloġika tal-post l-aktar diffiċli biex jiġi sterilizzat fil-prodott:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">L-IPCD u l-EPCD għandhom ikunu parzjalment negattivi; riżultat kompletament negattiv jew pożittiv għal kollox jindika falliment tat-test. Ir-reżistenza tal-IPCD għandha tkun akbar mill-prodott, u r-reżistenza tal-EPCD għandha tkun akbar minn jew ugwali għal dik tal-IPCD.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Jekk ir-riżultati ma jissodisfawx l-aspettattivi, investiga l-kawża. Tipikament, huma meħtieġa aġġustamenti għar-reżistenza tal-PCD jew il-parametri tal-isterilizzazzjoni, segwiti minn ittestjar mill-ġdid sakemm ir-riżultati jallinjaw mal-aspettattivi. Jekk it-tlieta (prodott, IPCD, u EPCD) ma juru l-ebda tkabbir mikrobjali, naqqas il-ħin tal-espożizzjoni tal-EO b&#039;mod xieraq u erġa&#039; ttestja. Jekk kollha juru tkabbir mikrobjali, żid il-ħin ta &#039;espożizzjoni EO u erġa&#039; ittestja.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-3-half-cycle-testing\">3.4.1.3 Ittestjar ta&#039; Nofs Ċiklu<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Wara li tlesti b&#039;suċċess l-ittestjar ta &#039;ċiklu qasir, agħmel tliet testijiet ta&#039; nofs ċiklu konsistenti konsekuttivi biex turi l-effettività (SAL = 10^-6) u r-riproduċibilità tal-proċess ta &#039;sterilizzazzjoni EO. Il-metodu ta&#039; evalwazzjoni huwa kif ġej:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Issettja l-isterilità tal-indikatur bijoloġiku bħala l-istandard, u ssettja parametri oħra tal-proċess ta &#039;sterilizzazzjoni għal-limitu aktar baxx ta&#039; parametri ta &#039;sterilizzazzjoni ta&#039; rutina (eż., ħin ta &#039;trasferiment ta&#039; qabel it-trattament fil-medda speċifikata). Gradwalment tnaqqas bin-nofs il-ħin ta &#039;espożizzjoni ta&#039; sterilizzazzjoni tal-proċess ta &#039;sterilizzazzjoni inizjali u neħħi l-indikaturi bijoloġiċi mill-PCD wara żminijiet differenti ta&#039; sterilizzazzjoni. Ikkultivahom f&#039;ambjent sterili sakemm tiġi kkonfermata l-isterilità. L-iqsar ħin ta &#039;sterilizzazzjoni (ħin kritiku) hekk determinat se jkun il-ħin tan-nofs ċiklu, u mill-inqas żewġ testijiet oħra għandhom isiru bl-istess iqsar ħin.<\/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\">Ir-riżultati tal-kultivazzjoni tal-indikatur bijoloġiku għandhom juru l-IPCDs u l-EPCDs kollha negattivi. Jekk it-test ta &#039;ċiklu qasir juri li r-reżistenza tal-EPCD hija akbar minn dik tal-IPCD, l-EPCD jista&#039; juri pożittività parzjali.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Jekk ir-riżultati ma jissodisfawx l-aspettattivi, investiga l-kawża u ġeneralment aġġusta l-parametri ta &#039;sterilizzazzjoni qabel ma terġa&#039; tittestja sakemm ir-riżultati jallinjaw mal-aspettattivi.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Eżempju:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Assumi li l-ewwel nofs ċiklu ħin ta &#039;espożizzjoni ta&#039; sterilizzazzjoni huwa ta &#039;4 sigħat. Jekk sterili, naqqas il-ħin ta&#039; espożizzjoni għal sagħtejn għat-test li jmiss; jekk iseħħ tkabbir tal-mikrobi, żid il-ħin ta &#039;espożizzjoni abbażi tal-espożizzjoni ta&#039; 4 sigħat.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Assumi li l-ħin ta &#039;espożizzjoni għall-isterilizzazzjoni tat-tieni nofs ċiklu huwa ta&#039; sagħtejn. Jekk sterili, naqqas il-ħin ta&#039; espożizzjoni għal siegħa għat-test li jmiss; jekk iseħħ tkabbir mikrobjali, estendi l-ħin ta &#039;espożizzjoni għal 3 sigħat.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Assumi li l-ħin ta &#039;espożizzjoni għall-isterilizzazzjoni tat-tielet nofs ċiklu huwa ta&#039; 3 sigħat. Jekk sterili, irrepeti t-test ta&#039; 3 sigħat darbtejn. Jekk ir-riżultati kollha huma sterili, ikkonferma 3 sigħat bħala l-ħin effettiv minimu. Jekk iseħħ tkabbir mikrobjali, irrepeti t-test b&#039;espożizzjoni ta&#039; 4 sigħat, u jekk ir-riżultati kollha huma sterili, ikkonferma 4 sigħat bħala l-ħin effettiv minimu.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-4-full-cycle-testing\">3.4.1.4 Ittestjar taċ-Ċiklu Sħiħ<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Matul l-ittestjar taċ-ċiklu sħiħ, issettja l-ħin ta &#039;espożizzjoni EO għad-doppju tal-ħin effettiv minimu ta&#039; nofs ċiklu, u parametri oħra sal-limitu ta &#039;fuq tal-parametri ta&#039; sterilizzazzjoni ta &#039;rutina biex tivverifika l-affidabilità u r-riproduċibilità tal-proċess ta&#039; sterilizzazzjoni.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In-numru ta &#039;sensuri tat-temperatura u l-umdità użati għandhom jissodisfaw ir-rekwiżiti tal-Appendiċi C f&#039;GB18279.1, imqassma b&#039;mod uniformi fit-tagħbija ta&#039; sterilizzazzjoni. Il-punti tat-tqegħid tas-sensorju tat-temperatura għandhom jinkludu kemm il-punti kesħin kif ukoll dawk sħan fil-kamra tal-isterilizzatur matul il-Kwalifikazzjoni Operattiva (OQ).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Wara t-test, ir-riżultati tal-kultivazzjoni tal-prodott u l-EPCD għandhom juru sterilità sħiħa (kollha negattiva).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">Jekk trid tkun taf aktar<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Telefon:<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\">Sit Lokali: Kamra 1202, Caitong Zhongxin, Distrett Xiasha, Belt Hangzhou, Provinċja ta &#039;Zhejiang, Ċina<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Websajt:<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 mikrobijoloġiċi tal-isterilizzazzjoni tal-ossidu tal-etilene<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>A Process Challenge Device (PCD) huwa sistema ta &#039;sfida mikrobijoloġika użata biex tevalwa r-rata ta&#039; qtil tal-parametri tal-proċess magħżula. Tipikament huwa apparat jew pakkett tat-test li jkun fih indikaturi bijoloġiċi (eż., spori ta’ Bacillus atrophaeus b’għadd ta’ spori magħruf). Ir-reżistenza tal-PCD għall-proċess ta &#039;sterilizzazzjoni għandha tkun akbar minn jew ugwali għar-reżistenza tat-tagħbija mikrobjali naturali fiż-żona l-aktar diffiċli biex tiġi sterilizzata tal-prodott. Il-kwantità ta &#039;PCDs għandha tissodisfa r-rekwiżiti deskritti fit-Tabella C.3 tal-Appendiċi C f&#039;GB18279.1-2015. Il-PCDs huma kklassifikati f&#039;PCDs Interni (IPCD) u PCDs 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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It is typically a device or test package containing biological indicators (e.g., Bacillus atrophaeus spores with known spore count). 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Re-qualification Frequency \u2022\u00a0Minimum annual requirement\u2022 At least once per year, verification data, subsequent re-validation data, and routine processing data must be reviewed\u2022 The scope of re-qualification must be determined and documented\u2022 The review procedure shall be documented 2. 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Note 2: This testing method is also applicable to A class Ethylene\u2026","rel":"","context":"In &quot;Company News&quot;","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"eto sterilizer","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/banner__.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/banner__.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/banner__.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/banner__.webp?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":9276,"url":"https:\/\/zjbocon.com\/?p=9276","url_meta":{"origin":2122,"position":5},"title":"Sterilization Compatibility of Sterile Barrier Systems","author":"Bocon Technical Team","date":"2026-02-06","format":false,"excerpt":"Sterilization Compatibility of Sterile Barrier Systems Technical White Paper 1. Introduction The compatibility between sterile barrier systems (SBS) and sterilization processes is a critical engineering consideration in medical device packaging design. Inappropriate material-process combinations may lead to insufficient sterilant penetration, material degradation, or loss of microbial barrier integrity. 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