{"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

Monitorizare și control de rutină<\/h2>\n\n\n\n

Scopul monitorizării și controlului de rutină al sterilizării EO (oxid de etilenă) este de a demonstra că procesul de sterilizare confirmat și specificat a fost aplicat produsului. Datele din fiecare ciclu de sterilizare trebuie înregistrate și păstrate pentru a dovedi că au fost îndeplinite specificațiile confirmate ale procesului de sterilizare. Acesta ar trebui să includă cel puțin următorul conținut:<\/p>\n\n\n\n

a) Dovada că temperatura mediului ambiant a produsului a atins temperatura minimă confirmată la intrarea în pretratare (dacă este utilizat). Acest lucru poate fi realizat permițând încărcăturii să se aclimatizeze la mediu pentru un timp minim specificat. Dacă temperatura de depozitare este cunoscută, nu este necesară determinarea temperaturii produsului înainte de a intra în zona de pretratare. Dacă produsul a fost expus la temperaturi extreme, cum ar fi în timpul transportului, este posibil ca produsul să fie depozitat pentru o perioadă înainte de pretratare pentru a-și stabiliza temperatura internă și umiditatea într-un interval acceptabil.<\/p>\n\n\n\n

b) Monitorizarea și înregistrarea temperaturii și umidității în zona de pretratare (dacă este utilizată) în locații specificate.<\/p>\n\n\n\n

c) Ora de începere a pretratării pentru fiecare încărcătură de sterilizare și timpul de îndepărtare a încărcăturii din zona de pretratare (dacă este utilizată).<\/p>\n\n\n\n

d) Intervalul de timp dintre îndepărtarea încărcăturii de sterilizare din zona de pretratare (dacă este utilizată) și începerea ciclului de sterilizare.<\/p>\n\n\n\n

e) Indicatori de funcționare corespunzătoare a sistemului de circulație a gazului în cameră în timpul fazei de expunere la gaz (dacă este utilizat).<\/p>\n\n\n\n

f) Temperatura și presiunea din interiorul camerei pe tot parcursul ciclului de sterilizare.<\/p>\n\n\n\n

g) Umiditatea din interiorul camerei în timpul fazei de prelucrare, măsurată prin presiune sau direct.<\/p>\n\n\n\n

h) Confirmarea că EO gazos a fost introdus în camera de sterilizare.<\/p>\n\n\n\n

i) Creșterea presiunii în interiorul camerei de sterilizare și cantitatea sau concentrația de OE utilizată.<\/p>\n\n\n\n

j) Timpul de prelucrare.<\/p>\n\n\n\n

k) Timpul de expunere.<\/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

Eliberare de sterilizare EO<\/h2>\n\n\n\n

a) Metoda indicatorului biologic<\/h3>\n\n\n\n

Dacă sunt utilizați indicatori biologici (EPCD confirmat), aceștia ar trebui să fie distribuiți în întreaga încărcătură de sterilizare, inclusiv locațiile cele mai greu de sterilizat sau locațiile despre care se știe că sunt legate de aceste puncte dificile. Dacă se utilizează pretratament, indicatorii biologici trebuie plasați înaintea pretratării.<\/p>\n\n\n\n

Indicatorii biologici trebuie scoși din sarcina de sterilizare după încheierea ciclului de sterilizare și cultivați cât mai curând posibil pentru a permite indicatorilor biologici să revină. Dacă nu sunt cultivate în timp util, ar trebui evaluate efectele expunerii la OE reziduală în timpul revigorării întârziate.<\/p>\n\n\n\n

Creșterea indicatorilor biologici ar trebui analizată pentru a determina dacă creșterea nu se datorează neîndeplinirii specificațiilor procesului fizic, ceea ce ar necesita repetarea procesului de confirmare.<\/p>\n\n\n\n

b) Metoda de eliberare a parametrilor<\/p>\n\n\n\n

Eliberarea parametrilor se bazează pe demonstrarea faptului că toți parametrii fizici ai procesului îndeplinesc specificațiile pentru eliberare fără utilizarea indicatorilor biologici. Se bazează exclusiv pe măsurători și înregistrări ale parametrilor fizici ai procesului și servește ca o declarație suficientă a adecvării procesului de sterilizare.<\/p>\n\n\n\n

Eliberarea parametrilor este permisă numai atunci când toți parametrii procesului sunt specificați, controlați și monitorizați direct. Prin urmare, atunci când se utilizează eliberarea parametrilor, ar trebui să existe echipamente pentru măsurarea directă a temperaturii și umidității în interiorul camerei și pentru analiza directă a concentrației de OE, pentru a colecta și înregistra parametrii procesului de sterilizare și a confirma că procesul de sterilizare este conform cu specificațiile.<\/p>\n\n\n\n

Pe lângă demonstrarea faptului că parametrii procesului de sterilizare îndeplinesc specificațiile de sterilizare, eliberarea parametrilor necesită, de asemenea, măsurarea și înregistrarea următoarelor date suplimentare:<\/p>\n\n\n\n

Măsurarea temperaturii din interiorul camerei cel puțin din două locații pe tot parcursul ciclului de sterilizare.<\/p>\n\n\n\n

Măsurarea directă a umidității din interiorul camerei în timpul fazei de procesare.<\/p>\n\n\n\n

Determinarea concentrației de OE prin analiza directă a gazului camerei de sterilizare la intervale de timp specificate, pentru a verifica pe deplin dacă sunt îndeplinite condițiile cerute pe toată perioada de expunere.<\/p>\n\n\n\n

DACĂ VREI SĂ știi mai multe despre sterilizarea cu oxid de etilenă<\/h2>\n\n\n\n

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

E-mail:hayley@hzbocon.com<\/a><\/p>\n\n\n\n

Site local: Camera 1202, Caitong Zhongxin, districtul Xiasha, orașul Hangzhou, provincia Zhejiang, China<\/p>\n\n\n\n

Site:hzbocon.com<\/a>zjbocon.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Scopul monitorizării și controlului de rutină al sterilizării EO (oxid de etilenă) este de a demonstra că procesul de sterilizare confirmat și specificat a fost aplicat produsului. Datele din fiecare ciclu de sterilizare trebuie înregistrate și păstrate pentru a dovedi că au fost îndeplinite specificațiile confirmate ale procesului de sterilizare. Acesta ar trebui să includă cel puțin următorul conținut:<\/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}]}}