{"id":2128,"date":"2024-11-06T13:08:38","date_gmt":"2024-11-06T05:08:38","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2128"},"modified":"2025-12-05T10:49:36","modified_gmt":"2025-12-05T02:49:36","slug":"routine-monitoring-control-and-release-of-ethylene-oxide-sterilization","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2128","title":{"rendered":"Routine Monitoring, Control, and Release of Ethylene Oxide Sterilization"},"content":{"rendered":"\n
\"Ethylene<\/figure><\/div>\n\n\n\n

Rutinné monitorovanie a kontrola<\/h2>\n\n\n\n

Účelom rutinného monitorovania a kontroly sterilizácie EO (etylénoxidom) je preukázať, že na produkt bol aplikovaný potvrdený a špecifikovaný proces sterilizácie. Údaje z každého sterilizačného cyklu by sa mali zaznamenať a uchovať, aby sa preukázalo, že boli splnené špecifikácie potvrdeného sterilizačného procesu. To by malo zahŕňať aspoň nasledujúci obsah:<\/p>\n\n\n\n

a) Dôkaz, že okolitá teplota produktu dosiahla minimálnu potvrdenú teplotu pri vstupe do predbežnej úpravy (ak sa používa). Dá sa to dosiahnuť tak, že sa záťaž nechá aklimatizovať na prostredie počas stanoveného minimálneho času. Ak je známa skladovacia teplota, nie je potrebné zisťovať teplotu produktu pred vstupom do priestoru predbežnej úpravy. Ak bol produkt vystavený extrémnym teplotám, napríklad počas prepravy, môže byť potrebné produkt pred predbežnou úpravou uskladniť, aby sa jeho vnútorná teplota a vlhkosť ustálili v prijateľnom rozsahu.<\/p>\n\n\n\n

b) Monitorovanie a zaznamenávanie teploty a vlhkosti v oblasti predbežnej úpravy (ak sa používa) na určených miestach.<\/p>\n\n\n\n

c) Čas začiatku predbežnej úpravy pre každú sterilizačnú náplň a čas, kedy je náplň vybratá z oblasti predbežnej úpravy (ak sa používa).<\/p>\n\n\n\n

d) Časový interval medzi odstránením sterilizačnej náplne z oblasti predbežnej úpravy (ak sa používa) a začiatkom sterilizačného cyklu.<\/p>\n\n\n\n

e) Indikátory správnej činnosti systému cirkulácie plynu v komore počas fázy vystavenia plynu (ak sa používa).<\/p>\n\n\n\n

f) Teplota a tlak vo vnútri komory počas sterilizačného cyklu.<\/p>\n\n\n\n

g) Vlhkosť vo vnútri komory počas fázy spracovania, meraná tlakom alebo priamo.<\/p>\n\n\n\n

h) Potvrdenie, že do sterilizačnej komory bol zavedený plynný EO.<\/p>\n\n\n\n

i) Nárast tlaku vo vnútri sterilizačnej komory a množstvo alebo koncentrácia použitého EO.<\/p>\n\n\n\n

j) Doba spracovania.<\/p>\n\n\n\n

k) Čas expozície.<\/p>\n\n\n\n

l) Time, temperature, and pressure changes (if applicable) during the aeration phase and\/or venting operations (if used).<\/p>\n\n\n\n

Uvoľnenie sterilizácie EO<\/h2>\n\n\n\n

a) Metóda biologického indikátora<\/h3>\n\n\n\n

Ak sa používajú biologické indikátory (potvrdené EPCD), mali by byť rozmiestnené po celej sterilizačnej náplni, vrátane najťažšie sterilizovateľných miest alebo miest, o ktorých je známe, že súvisia s týmito náročnými miestami. Ak sa použije predbežná úprava, biologické indikátory by sa mali umiestniť pred predbežnú úpravu.<\/p>\n\n\n\n

The biological indicators should be removed from the sterilization load after the sterilization cycle ends and cultured as soon as possible to allow the biological indicators to revive. If they are not cultured in a timely manner, the effects of exposure to residual EO during delayed revival should be evaluated.<\/p>\n\n\n\n

The growth of the biological indicators should be analyzed to determine if the growth is not due to failure to meet the physical process specifications, which would require repeating the confirmation process.<\/p>\n\n\n\n

b) Parameter Release Method<\/p>\n\n\n\n

Uvoľňovanie parametrov sa spolieha na preukázanie, že všetky parametre fyzikálneho procesu spĺňajú špecifikácie pre uvoľňovanie bez použitia biologických indikátorov. Vychádza výlučne z meraní a záznamov fyzikálnych parametrov procesu a slúži ako dostatočná deklarácia primeranosti sterilizačného procesu.<\/p>\n\n\n\n

Uvoľnenie parametrov je prípustné len vtedy, keď sú špecifikované, riadené a priamo monitorované všetky parametre procesu. Preto, keď sa používa uvoľňovanie parametrov, malo by existovať zariadenie na priame meranie teploty a vlhkosti vo vnútri komory a na priamu analýzu koncentrácie EO, na zber a zaznamenávanie parametrov sterilizačného procesu a potvrdenie, že proces sterilizácie je v súlade so špecifikáciami.<\/p>\n\n\n\n

In addition to proving that the sterilization process parameters meet the sterilization specifications, parameter release also requires measuring and recording the following additional data:<\/p>\n\n\n\n

Meranie teploty vo vnútri komory aspoň z dvoch miest počas sterilizačného cyklu.<\/p>\n\n\n\n

Priame meranie vlhkosti vo vnútri komory počas fázy spracovania.<\/p>\n\n\n\n

Stanovenie koncentrácie EO priamou analýzou plynu sterilizačnej komory v určených časových intervaloch, aby sa úplne overilo, že požadované podmienky sú splnené počas celej doby expozície.<\/p>\n\n\n\n

AK CHCETE VEDIEŤ VIAC O sterilizácii etylénoxidom<\/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","protected":false},"excerpt":{"rendered":"

Účelom rutinného monitorovania a kontroly sterilizácie EO (etylénoxidom) je preukázať, že na produkt bol aplikovaný potvrdený a špecifikovaný proces sterilizácie. Údaje z každého sterilizačného cyklu by sa mali zaznamenať a uchovať, aby sa preukázalo, že boli splnené špecifikácie potvrdeného sterilizačného procesu. To by malo zahŕňať aspoň nasledujúci obsah:<\/p>\n","protected":false},"author":234312599,"featured_media":8429,"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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Technical Team","author_link":"https:\/\/zjbocon.com\/?author=234312599"},"uagb_comment_info":23,"uagb_excerpt":"The purpose of routine monitoring and control of EO (Ethylene Oxide) sterilization is to demonstrate that the confirmed and specified sterilization process has been applied to the product. Data from each sterilization cycle should be recorded and retained to prove that the confirmed sterilization process specifications have been met. This should include at least the…","jetpack_likes_enabled":true,"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/pgZDV6-yk","jetpack-related-posts":[{"id":3093,"url":"https:\/\/zjbocon.com\/?p=3093","url_meta":{"origin":2128,"position":0},"title":"Introduction to Ethylene Oxide Sterilizers","author":"Bocon Technical Team","date":"2025-02-05","format":false,"excerpt":"Discover how ethylene oxide sterilizers work, their applications, benefits, and safety considerations. Learn why they are essential for medical and industrial sterilization.","rel":"","context":"In "Company News"","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/ethylene-oxide-sterilization-21.webp?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":8958,"url":"https:\/\/zjbocon.com\/?p=8958","url_meta":{"origin":2128,"position":1},"title":"Understanding What is ETO Sterilizers: A Comprehensive Guide","author":"Bocon Technical Team","date":"2025-12-16","format":false,"excerpt":"Discover the essentials of ETO sterilizers and ethylene oxide sterilization, ensuring the highest hygiene standards in healthcare and beyond.","rel":"","context":"In "Company News"","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-3.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-3.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-3.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-3.png?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-3.png?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":3100,"url":"https:\/\/zjbocon.com\/?p=3100","url_meta":{"origin":2128,"position":2},"title":"How Does Ethylene Oxide Gas Sterilization Kill Microorganisms?","author":"Bocon Technical Team","date":"2025-02-05","format":false,"excerpt":"How Does Ethylene Oxide Gas Sterilization Work? The effectiveness of ethylene oxide gas sterilization lies in its ability to disrupt the cellular structure of microorganisms. Here\u2019s a step-by-step breakdown of how it works: 1.\u00a0Penetration of EO Gas Ethylene oxide gas is highly penetrative, meaning it can easily reach microorganisms even\u2026","rel":"","context":"In "Company News"","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/tp2.jpg?resize=350%2C200&ssl=1","width":350,"height":200},"classes":[]},{"id":2004,"url":"https:\/\/zjbocon.com\/?p=2004","url_meta":{"origin":2128,"position":3},"title":"The Guide to ethylene oxide in sterilization","author":"Bocon Technical Team","date":"2024-10-28","format":false,"excerpt":"ethylene oxide in sterilization Introduction ETO is a colorless gas that is flammable and explosive. The four essential parameters (operational ranges) of ethylene oxide in sterilization are: gas concentration (450 to 1200 mg\/l); temperature (37 to 63\u00b0C); relative humidity (40 to 80%)(water molecules carry ETO to reactive sites); and exposure\u2026","rel":"","context":"In "ETO STERILIZER"","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"Industry_ETO_Sterilizer","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Industry_ETO_Sterilizer.webp?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Industry_ETO_Sterilizer.webp?resize=350%2C200 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Industry_ETO_Sterilizer.webp?resize=525%2C300 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Industry_ETO_Sterilizer.webp?resize=700%2C400 2x"},"classes":[]},{"id":2471,"url":"https:\/\/zjbocon.com\/?p=2471","url_meta":{"origin":2128,"position":4},"title":"Safety Requirements for Using Ethylene Oxide in sterilization","author":"Bocon Technical Team","date":"2024-12-23","format":false,"excerpt":"when Ethylene Oxide in sterilization chamber should be equipped with fire prevention facilities. Ethylene oxide cylinders should be stored separately in a dry, well-ventilated room, with strict prohibition of smoking and open flames. The lighting in the sterilization chamber should be explosion-proof, and any electrical appliances that may cause electric\u2026","rel":"","context":"In "Company News"","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Electrical-Scale.png?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":1950,"url":"https:\/\/zjbocon.com\/?p=1950","url_meta":{"origin":2128,"position":5},"title":"eto sterilization process","author":"Bocon Technical Team","date":"2024-10-23","format":false,"excerpt":"Eto Sterilization is conducted using a eto sterilizer located in a dedicated facility.","rel":"","context":"In "ETO STERILIZER"","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"eto sterilization process","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=700%2C400&ssl=1 2x"},"classes":[]}],"_links":{"self":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2128","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/users\/234312599"}],"replies":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2128"}],"version-history":[{"count":4,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2128\/revisions"}],"predecessor-version":[{"id":8879,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2128\/revisions\/8879"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/media\/8429"}],"wp:attachment":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2128"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2128"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2128"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}