{"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
\"\"<\/figure><\/div>\n\n\n\n

3.4.1.1 Výroba zariadení na testovanie procesov (PCD)<\/h2>\n\n\n\n

Process Challenge Device (PCD) je mikrobiologický testovací systém, ktorý sa používa na vyhodnotenie miery usmrtenia vybraných parametrov procesu. Typicky je to zariadenie alebo testovací balíček obsahujúci biologické indikátory (napr. spóry Bacillus atrophaeus so známym počtom spór). Odolnosť PCD voči sterilizačnému procesu by mala byť väčšia alebo rovnaká ako odolnosť prirodzenej mikrobiálnej záťaže v najťažšie sterilizovateľnej oblasti produktu. Množstvo PCD by malo spĺňať požiadavky uvedené v tabuľke C.3 v dodatku C v GB18279.1-2015. PCD sa delia na interné PCD (IPCD) a externé PCD (EPCD).<\/p>\n\n\n\n

a)Interná výroba PCD (IPCD).<\/h3>\n\n\n\n

Interné PCD sú zvyčajne zdravotnícke pomôcky vybrané spoločnosťou, aby reprezentovali produktovú skupinu. Na základe dizajnu a materiálového zloženia sa tieto produkty považujú za jedny z najťažšie sterilizovateľných. Biologické indikátory (BI) sú umiestnené na mieste produktu, ktoré je najťažšie sterilizovateľné, čím zaisťujú, že proces sterilizácie neblokuje kanály ani nezasahuje do dizajnu produktu.<\/p>\n\n\n\n

Umiestnite biologický indikátor (BI) do najťažšie sterilizovateľnej oblasti produktu alebo naočkujte testovaný mikroorganizmus (napr. Bacillus atrophaeus) na miesto s najťažšie dosiahnuteľnými sterilizačnými podmienkami. Ak BI alebo testovaný mikroorganizmus nie je možné umiestniť na najťažšie sterilizovateľné miesto, je možné navrhnúť alternatívne zariadenie a umiestniť ho do rovnakého systému odolnosti. najťažšie sterilizovateľné miesto v produkte.<\/p>\n\n\n\n

Bežné IPCD zahŕňajú, ale nie sú obmedzené na:<\/p>\n\n\n\n

Umiestnenie kontaminovaného nosiča medzi komponenty, ako sú krúžky, hlavy piestov, podložky alebo piesty injekčnej striekačky. Umiestnite mikroorganizmus do stredu lúmenu katétra, potom pomocou lepiacich rozpúšťadiel alebo konektorov opätovne utesnite katéter a obnovte integritu produktu. Umiestnite mikroorganizmový podnet na rozhranie piestu.<\/p>\n\n\n\n

b)Externá výroba PCD (EPCD).<\/h3>\n\n\n\n

Externé PCD sú umiestnené na vonkajšej strane vloženého produktu. EPCD sa zvyčajne používajú na rutinné spracovanie a po ošetrení sa získavajú z nákladu. Odolnosť EPCD voči biologickej záťaži sterilizovaného produktu by sa mala porovnať s odolnosťou IPCD. EPCD by tiež mal predstavovať najťažšie sterilizovateľný produkt v náklade.<\/p>\n\n\n\n

Vzťah medzi EPCD a kontaminovanými vzorkami produktu by sa mal pravidelne prehodnocovať, aby sa zabezpečilo, že v sterilizovanom produkte nenastali žiadne zmeny a že EPCD stále predstavuje najťažšie sterilizovateľný produkt v náklade.<\/p>\n\n\n\n

Pri umiestnení BI do PCD by mal mať PCD aspoň rovnakú odolnosť ako najťažšie sterilizovateľné miesto v produkte.<\/p>\n\n\n\n

Bežné EPCD zahŕňajú, ale nie sú obmedzené na:<\/p>\n\n\n\n

Umiestnenie biologického indikátora (BI) do obalu produktu alebo jeho ekvivalentu, ako sú plastové vrecká, ktoré sa potom vložia do manilskej obálky. Umiestnenie biologického indikátora do hrubého plastového vrecka, ktoré bolo preložené stanoveným počtom krát. Umiestnenie biologického indikátora do rôznych častí injekčnej striekačky, napríklad do podložky piestu alebo hlavy piestu. Utesnené plastové skúmavky obsahujúce kontaminované nosiče, s dodatočným obalom alebo bez neho.<\/p>\n\n\n\n

PCD vyrobené vyššie uvedeným spôsobom sa balia pomocou rovnakých metód ako bežné výrobné produkty, rovnomerne rozložené v náklade produktu a umiestnené tak, aby pokryli studené miesta v komore sterilizátora.<\/p>\n\n\n\n

3.4.1.2 Testovanie čiastočného cyklu (krátky cyklus).<\/h2>\n\n\n\n

Po výbere PCD sa jeho vhodnosť potvrdí spustením čiastkového cyklu. Metóda hodnotenia je nasledovná:<\/p>\n\n\n\n

a) Na základe výsledkov prevádzkového hodnotenia určte metódy umiestnenia PCD, skúšobných vzoriek a snímačov. Počet a distribúcia PCD by mala byť dostatočná. Ak sa vybraný EPCD používa na rutinné monitorovanie procesu sterilizácie, mal by sa umiestniť na náplň produktu podľa plánu a postupu.<\/p>\n\n\n\n

b) Na základe hodnoty D, času ST a času KT biologického indikátora nastavte kratší čas expozície. Ostatné parametre by sa mali testovať na spodnej hranici parametrov rutinného sterilizačného procesu. Skúšobná metóda by mala odkazovať na prílohu A k GB18281.2. Po uplynutí času expozície odstráňte produkt, IPCD a EPCD na mikrobiálnu kultiváciu a sledujte výsledky.<\/p>\n\n\n\n

Výsledky kultivácie by mali ukázať, že odolnosť PCD je väčšia alebo rovná odolnosti voči biologickému zaťaženiu najťažšie sterilizovateľného miesta v produkte:<\/p>\n\n\n\n

IPCD a EPCD by mali byť čiastočne negatívne; úplne negatívny alebo úplne pozitívny výsledok by znamenal zlyhanie testu. Odolnosť IPCD by mala byť väčšia ako odolnosť produktu a odolnosť EPCD by mala byť väčšia alebo rovnaká ako odpor IPCD.<\/p>\n\n\n\n

Ak výsledky nespĺňajú očakávania, zistite príčinu. Zvyčajne sú potrebné úpravy odolnosti PCD alebo parametrov sterilizácie, po ktorých nasleduje opätovné testovanie, kým sa výsledky nezhodujú s očakávaniami. Ak všetky tri (produkt, IPCD a EPCD) nevykazujú žiadny mikrobiálny rast, primerane skráťte čas expozície EO a otestujte znova. Ak všetky vykazujú mikrobiálny rast, predĺžte expozičný čas EO a zopakujte test.<\/p>\n\n\n\n

3.4.1.3 Testovanie v polovici cyklu<\/h2>\n\n\n\n

Po úspešnom dokončení testovania s krátkym cyklom vykonajte tri po sebe idúce konzistentné testy s polovičným cyklom, aby ste preukázali účinnosť (SAL = 10^-6) a reprodukovateľnosť procesu sterilizácie EO. Metóda hodnotenia je nasledovná:<\/p>\n\n\n\n

Sterilitu biologického indikátora nastavte ako štandard a ostatné parametre sterilizačného procesu nastavte na spodnú hranicu parametrov rutinnej sterilizácie (napr. čas prenosu pred ošetrením v rámci špecifikovaného rozsahu). Postupne znížte čas sterilizačnej expozície počiatočného sterilizačného procesu na polovicu a po rôznych časoch sterilizácie odstráňte biologické indikátory z PCD. Kultivujte ich v sterilnom prostredí, kým sa nepotvrdí sterilita. Takto stanovený najkratší čas sterilizácie (kritický čas) bude polcyklový čas a mali by sa vykonať aspoň dva ďalšie testy s rovnakým najkratším časom.<\/p>\n\n\n\n

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

Výsledky kultivácie biologických indikátorov by mali ukázať všetky IPCD a EPCD negatívne. Ak test s krátkym cyklom ukáže, že odpor EPCD je väčší ako odpor IPCD, EPCD môže vykazovať čiastočnú pozitivitu.<\/p>\n\n\n\n

Ak výsledky nespĺňajú očakávania, preskúmajte príčinu a zvyčajne upravte parametre sterilizácie pred opakovaným testovaním, kým sa výsledky nezhodujú s očakávaniami.<\/p>\n\n\n\n

Príklad:<\/p>\n\n\n\n

Predpokladajme, že doba expozície prvej polovice cyklu sterilizácie je 4 hodiny. Ak ste sterilný, skráťte čas expozície na 2 hodiny na ďalší test; ak dôjde k rastu mikróbov, predĺžte expozičný čas na základe 4-hodinovej expozície.<\/p>\n\n\n\n

Predpokladajme, že doba expozície sterilizácie v druhej polovici cyklu je 2 hodiny. Ak ste sterilný, skráťte čas expozície na 1 hodinu pre ďalší test; ak dôjde k rastu mikróbov, predĺžte dobu expozície na 3 hodiny.<\/p>\n\n\n\n

Predpokladajme, že čas expozície sterilizácie v treťom polcykle je 3 hodiny. Ak ste sterilný, zopakujte 3-hodinový test dvakrát. Ak sú všetky výsledky sterilné, potvrďte 3 hodiny ako minimálny účinný čas. Ak dôjde k rastu mikróbov, zopakujte test so 4-hodinovou expozíciou a ak sú všetky výsledky sterilné, potvrďte 4 hodiny ako minimálny účinný čas.<\/p>\n\n\n\n

3.4.1.4 Testovanie celého cyklu<\/h2>\n\n\n\n

Počas testovania celého cyklu nastavte čas expozície EO na dvojnásobok minimálneho efektívneho času polovice cyklu a ostatné parametre na hornú hranicu parametrov bežnej sterilizácie, aby ste overili spoľahlivosť a reprodukovateľnosť sterilizačného procesu.<\/p>\n\n\n\n

Počet použitých snímačov teploty a vlhkosti by mal spĺňať požiadavky prílohy C v GB18279.1, rovnomerne rozložené v sterilizačnej náplni. Body umiestnenia snímača teploty by mali zahŕňať studené aj horúce miesta v komore sterilizátora počas prevádzkovej kvalifikácie (OQ).<\/p>\n\n\n\n

Po teste by výsledky kultivácie produktu a EPCD mali vykazovať úplnú sterilitu (všetky negatívne).<\/p>\n\n\n\n

AK CHCETE VEDIEŤ VIAC<\/h2>\n\n\n\n

Telefón:+8619975258603<\/a><\/p>\n\n\n\n

Email:hayley@hzbocon.com<\/a><\/p>\n\n\n\n

Miestna lokalita: Izba 1202, Caitong Zhongxin, okres Xiasha, mesto Hangzhou, provincia Zhejiang, Čína<\/p>\n\n\n\n

Webstránka:hzbocon.com<\/a>zjbocon.com<\/a><\/p>\n\n\n\n

ISO 11135:2014<\/th>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>
ISO 14161:2009<\/th>Sterilization of health care products \u2014 Biological indicators \u2014 Guidance for the selection, use and interpretation of results<\/td><\/tr>
ISO 10993-7:2008<\/th>Biological evaluation of medical devices \u2014 Part 7: Ethylene oxide sterilization residuals<\/td><\/tr>
ISO 11737-1:2018<\/th>Sterilization of health care products \u2014 Microbiological methods \u2013 Part 1: Determination of a population of microorganisms on products<\/td><\/tr>
ISO 11737-2:2009<\/th>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>
AAMI TIR16:2017<\/th>Mikrobiologické aspekty sterilizácie etylénoxidom<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"

Process Challenge Device (PCD) je mikrobiologický testovací systém, ktorý sa používa na vyhodnotenie miery usmrtenia vybraných parametrov procesu. Typicky je to zariadenie alebo testovací balíček obsahujúci biologické indikátory (napr. spóry Bacillus atrophaeus so známym počtom spór). Odolnosť PCD voči sterilizačnému procesu by mala byť väčšia alebo rovnaká ako odolnosť prirodzenej mikrobiálnej záťaže v najťažšie sterilizovateľnej oblasti produktu. Množstvo PCD by malo spĺňať požiadavky uvedené v tabuľke C.3 v dodatku C v GB18279.1-2015. PCD sa delia na interné PCD (IPCD) a externé 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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