{"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

Venjulegt eftirlit og eftirlit<\/h2>\n\n\n\n

Tilgangur reglubundins eftirlits og eftirlits með EO (etýlenoxíð) dauðhreinsun er að sýna fram á að staðfesta og tilgreinda dauðhreinsunarferlið hafi verið beitt á vöruna. Skrá skal og varðveita gögn frá hverri dauðhreinsunarlotu til að sanna að staðfestar forskriftir um ófrjósemisaðgerðir hafi verið uppfylltar. Þetta ætti að innihalda að minnsta kosti eftirfarandi efni:<\/p>\n\n\n\n

a) Vísbendingar um að umhverfishiti vörunnar hafi náð staðfestu lágmarkshitastigi þegar farið er í formeðferð (ef hún er notuð). Þetta er hægt að ná með því að leyfa álaginu að aðlagast umhverfinu í tiltekinn lágmarkstíma. Ef geymsluhitastig er þekkt er engin þörf á að ákvarða hitastig vörunnar áður en farið er inn á formeðferðarsvæðið. Ef varan hefur verið útsett fyrir miklum hita, eins og við flutning, gæti þurft að geyma vöruna í nokkurn tíma fyrir formeðferð til að koma á stöðugleika innra hitastigs og raka innan viðunandi marka.<\/p>\n\n\n\n

b) Vöktun og skráning á hitastigi og rakastigi á formeðferðarsvæði (ef það er notað) á tilgreindum stöðum.<\/p>\n\n\n\n

c) Upphafstími formeðferðar fyrir hvert dauðhreinsunarálag og tíminn sem farmurinn er fjarlægður af formeðferðarsvæðinu (ef það er notað).<\/p>\n\n\n\n

d) Tímabilið frá því að sótthreinsunarálagið er fjarlægt af formeðferðarsvæðinu (ef það er notað) og þar til dauðhreinsunarferlið hefst.<\/p>\n\n\n\n

e) Vísbendingar um rétta virkni gashringrásarkerfisins í hólfinu á meðan á gasútsetningu stendur (ef það er notað).<\/p>\n\n\n\n

f) Hitastig og þrýstingur inni í hólfinu í gegnum dauðhreinsunarferlið.<\/p>\n\n\n\n

g) Raki inni í hólfinu á meðan á vinnslu stendur, mældur með þrýstingi eða beint.<\/p>\n\n\n\n

h) Staðfesting á því að loftkennt EO hafi verið sett í dauðhreinsunarhólfið.<\/p>\n\n\n\n

i) Þrýstihækkun inni í dauðhreinsunarhólfinu og magn eða styrkur EO sem notað er.<\/p>\n\n\n\n

j) Afgreiðslutíminn.<\/p>\n\n\n\n

k) Lýsingartíminn.<\/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

EO ófrjósemisaðgerð<\/h2>\n\n\n\n

a) Líffræðileg vísiraðferð<\/h3>\n\n\n\n

Ef líffræðilegir vísbendingar (staðfest EPCD) eru notaðir, ætti að dreifa þeim um ófrjósemisaðgerðina, þar á meðal á þeim stöðum sem erfiðast er að sótthreinsa eða staði sem vitað er að tengjast þessum erfiðu blettum. Ef formeðferð er notuð skal setja líffræðilegu vísbendingar fyrir formeðferðina.<\/p>\n\n\n\n

Fjarlægja skal líffræðilegu vísana úr dauðhreinsunarálaginu eftir að dauðhreinsunarlotunni lýkur og rækta þær eins fljótt og auðið er til að líffræðilegu vísarnir geti endurlífgað sig. Ef þau eru ekki ræktuð tímanlega ætti að meta áhrif útsetningar fyrir leifar EO við seinkun á endurlífgun.<\/p>\n\n\n\n

Greina skal vöxt líffræðilegra vísbendinga til að ákvarða hvort vöxturinn sé ekki vegna þess að ekki uppfyllir eðlisfræðilega ferlislýsingarnar, sem myndi krefjast endurtekningar á staðfestingarferlinu.<\/p>\n\n\n\n

b) Aðferð til að losa færibreytur<\/p>\n\n\n\n

Útgáfa færibreytu byggir á því að sanna að allar eðlisfræðilegar ferlibreytur uppfylli forskriftir fyrir losun án þess að nota líffræðilegar vísbendingar. Það er eingöngu byggt á mælingum og skrám yfir eðlisfræðilegar ferlibreytur og þjónar sem fullnægjandi yfirlýsing um að dauðhreinsunarferlið sé fullnægjandi.<\/p>\n\n\n\n

Slepping færibreytu er aðeins leyfileg þegar allar ferlibreytur eru tilgreindar, stjórnað og beint eftirlit. Þess vegna, þegar færibreytulosun er notuð, ætti að vera búnaður til að mæla hitastig og rakastig inni í hólfinu beint og fyrir beina greiningu á styrk EO, til að safna og skrá færibreytur dauðhreinsunarferlisins og staðfesta að dauðhreinsunarferlið sé í samræmi við forskriftirnar.<\/p>\n\n\n\n

Auk þess að sanna að færibreytur dauðhreinsunarferlisins uppfylli dauðhreinsunarforskriftirnar, krefst losun breytu einnig að mæla og skrá eftirfarandi viðbótargögn:<\/p>\n\n\n\n

Mæla hitastigið inni í hólfinu að minnsta kosti frá tveimur stöðum í gegnum dauðhreinsunarferlið.<\/p>\n\n\n\n

Bein mæling á rakastigi inni í hólfinu á meðan á vinnslu stendur.<\/p>\n\n\n\n

Ákvörðun EO styrks með beinni greiningu á gasi dauðhreinsunarhólfsins með tilteknu millibili, til að fullvissa að tilskilin skilyrði séu uppfyllt allan váhrifatímann.<\/p>\n\n\n\n

EF ÞÚ VILT VITA MEIRA Um etýlenoxíð ófrjósemisaðgerð<\/h2>\n\n\n\n

Sími:+8619975258603<\/a><\/p>\n\n\n\n

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

Staðbundin staður: Herbergi 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, Kína<\/p>\n\n\n\n

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

Tilgangur reglubundins eftirlits og eftirlits með EO (etýlenoxíð) dauðhreinsun er að sýna fram á að staðfesta og tilgreinda dauðhreinsunarferlið hafi verið beitt á vöruna. Skrá skal og varðveita gögn frá hverri dauðhreinsunarlotu til að sanna að staðfestar forskriftir um ófrjósemisaðgerðir hafi verið uppfylltar. Þetta ætti að innihalda að minnsta kosti eftirfarandi efni:<\/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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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}]}}