{"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

Pemantauan dan Pengendalian Rutin<\/h2>\n\n\n\n

Tujuan pemantauan dan pengendalian sterilisasi EO (Ethylene Oxide) secara rutin adalah untuk menunjukkan bahwa proses sterilisasi yang dikonfirmasi dan ditentukan telah diterapkan pada produk. Data dari setiap siklus sterilisasi harus dicatat dan disimpan untuk membuktikan bahwa spesifikasi proses sterilisasi yang dikonfirmasi telah dipenuhi. Ini harus mencakup setidaknya konten berikut:<\/p>\n\n\n\n

a) Bukti bahwa suhu lingkungan produk telah mencapai suhu minimum yang dikonfirmasi saat memasuki pretreatment (jika digunakan). Hal ini dapat dicapai dengan membiarkan beban menyesuaikan diri dengan lingkungan untuk waktu minimum yang ditentukan. Jika suhu penyimpanan diketahui, tidak perlu menentukan suhu produk sebelum memasuki area pretreatment. Jika produk terkena suhu ekstrem, seperti selama pengangkutan, produk mungkin perlu disimpan selama beberapa waktu sebelum perlakuan awal untuk menstabilkan suhu dan kelembapan internal dalam kisaran yang dapat diterima.<\/p>\n\n\n\n

b) Pemantauan dan pencatatan suhu dan kelembaban di area pretreatment (bila digunakan) pada lokasi tertentu.<\/p>\n\n\n\n

c) Waktu mulai pra-perlakuan untuk setiap muatan sterilisasi dan waktu pemindahan muatan dari area pra-perawatan (jika digunakan).<\/p>\n\n\n\n

d) Interval waktu antara pelepasan beban sterilisasi dari area pra-perlakuan (jika digunakan) dan dimulainya siklus sterilisasi.<\/p>\n\n\n\n

e) Indikator berfungsinya sistem sirkulasi gas di dalam ruangan selama fase pemaparan gas (jika digunakan).<\/p>\n\n\n\n

f) Suhu dan tekanan di dalam ruangan selama siklus sterilisasi.<\/p>\n\n\n\n

g) Kelembapan di dalam ruang selama tahap pemrosesan, yang diukur dengan tekanan atau secara langsung.<\/p>\n\n\n\n

h) Konfirmasi bahwa gas EO telah dimasukkan ke dalam ruang sterilisasi.<\/p>\n\n\n\n

i) Kenaikan tekanan di dalam ruang sterilisasi dan jumlah atau konsentrasi EO yang digunakan.<\/p>\n\n\n\n

j) Waktu pemrosesan.<\/p>\n\n\n\n

k) Waktu pemaparan.<\/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

Pelepasan Sterilisasi EO<\/h2>\n\n\n\n

a) Metode Indikator Biologis<\/h3>\n\n\n\n

Jika indikator biologis (EPCD yang dikonfirmasi) digunakan, indikator tersebut harus didistribusikan ke seluruh beban sterilisasi, termasuk lokasi yang paling sulit untuk disterilkan atau lokasi yang diketahui terkait dengan titik-titik sulit tersebut. Jika pretreatment digunakan, indikator biologis harus ditempatkan sebelum pretreatment.<\/p>\n\n\n\n

Indikator biologis harus dikeluarkan dari beban sterilisasi setelah siklus sterilisasi berakhir dan dibiakkan sesegera mungkin agar indikator biologis dapat hidup kembali. Jika mereka tidak dikultur pada waktu yang tepat, efek dari paparan sisa EO selama kebangkitan yang tertunda harus dievaluasi.<\/p>\n\n\n\n

Pertumbuhan indikator biologis harus dianalisis untuk menentukan apakah pertumbuhan tersebut bukan disebabkan oleh kegagalan memenuhi spesifikasi proses fisik, yang memerlukan pengulangan proses konfirmasi.<\/p>\n\n\n\n

b) Metode Pelepasan Parameter<\/p>\n\n\n\n

Pelepasan parameter bergantung pada pembuktian bahwa semua parameter proses fisik memenuhi spesifikasi pelepasan tanpa menggunakan indikator biologis. Hal ini hanya didasarkan pada pengukuran dan catatan parameter proses fisik dan berfungsi sebagai pernyataan yang memadai mengenai kecukupan proses sterilisasi.<\/p>\n\n\n\n

Pelepasan parameter hanya diperbolehkan ketika semua parameter proses ditentukan, dikontrol, dan dipantau secara langsung. Oleh karena itu, ketika pelepasan parameter digunakan, harus ada peralatan untuk pengukuran langsung suhu dan kelembaban di dalam ruangan dan untuk analisis langsung konsentrasi EO, untuk mengumpulkan dan mencatat parameter proses sterilisasi dan memastikan bahwa proses sterilisasi sesuai dengan spesifikasi.<\/p>\n\n\n\n

Selain membuktikan bahwa parameter proses sterilisasi memenuhi spesifikasi sterilisasi, pelepasan parameter juga memerlukan pengukuran dan pencatatan data tambahan sebagai berikut:<\/p>\n\n\n\n

Mengukur suhu di dalam ruangan setidaknya dari dua lokasi sepanjang siklus sterilisasi.<\/p>\n\n\n\n

Mengukur langsung kelembapan di dalam ruangan selama tahap pemrosesan.<\/p>\n\n\n\n

Penentuan konsentrasi EO dengan analisis langsung gas ruang sterilisasi pada interval waktu tertentu, untuk memverifikasi sepenuhnya bahwa kondisi yang diperlukan terpenuhi sepanjang periode pemaparan.<\/p>\n\n\n\n

JIKA ANDA INGIN TAHU LEBIH LANJUT Tentang Sterilisasi Etilen Oksida<\/h2>\n\n\n\n

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

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

Situs Lokal: Kamar 1202, Caitong Zhongxin, Distrik Xiasha, Kota Hangzhou, Provinsi Zhejiang, Tiongkok<\/p>\n\n\n\n

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

Tujuan pemantauan dan pengendalian sterilisasi EO (Ethylene Oxide) secara rutin adalah untuk menunjukkan bahwa proses sterilisasi yang dikonfirmasi dan ditentukan telah diterapkan pada produk. Data dari setiap siklus sterilisasi harus dicatat dan disimpan untuk membuktikan bahwa spesifikasi proses sterilisasi yang dikonfirmasi telah dipenuhi. Ini harus mencakup setidaknya konten berikut:<\/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}]}}