{"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

Monitoreo y control de rutina<\/h2>\n\n\n\n

El propósito del monitoreo y control de rutina de la esterilización con OE (óxido de etileno) es demostrar que se ha aplicado al producto el proceso de esterilización confirmado y especificado. Los datos de cada ciclo de esterilización deben registrarse y conservarse para demostrar que se han cumplido las especificaciones confirmadas del proceso de esterilización. Éste deberá incluir al menos el siguiente contenido:<\/p>\n\n\n\n

a) Evidencia de que la temperatura ambiental del producto ha alcanzado la temperatura mínima confirmada al ingresar al pretratamiento (si se utiliza). Esto se puede lograr permitiendo que la carga se aclimate al entorno durante un tiempo mínimo específico. Si se conoce la temperatura de almacenamiento, no es necesario determinar la temperatura del producto antes de ingresar al área de pretratamiento. Si el producto ha estado expuesto a temperaturas extremas, como durante el transporte, es posible que sea necesario almacenarlo durante un período antes del tratamiento previo para estabilizar su temperatura interna y humedad dentro de un rango aceptable.<\/p>\n\n\n\n

b) Monitoreo y registro de la temperatura y humedad en el área de pretratamiento (si se usa) en lugares específicos.<\/p>\n\n\n\n

c) La hora de inicio del pretratamiento para cada carga de esterilización y la hora en que se retira la carga del área de pretratamiento (si se utiliza).<\/p>\n\n\n\n

d) El intervalo de tiempo entre la retirada de la carga de esterilización del área de pretratamiento (si se utiliza) y el inicio del ciclo de esterilización.<\/p>\n\n\n\n

e) Indicadores de correcto funcionamiento del sistema de circulación de gas en la cámara durante la fase de exposición al gas (si se utiliza).<\/p>\n\n\n\n

f) La temperatura y presión en el interior de la cámara durante todo el ciclo de esterilización.<\/p>\n\n\n\n

g) La humedad en el interior de la cámara durante la fase de procesamiento, medida por presión o directamente.<\/p>\n\n\n\n

h) Confirmación de que se ha introducido OE gaseoso en la cámara de esterilización.<\/p>\n\n\n\n

i) El aumento de presión dentro de la cámara de esterilización y la cantidad o concentración de OE utilizada.<\/p>\n\n\n\n

j) El tiempo de tramitación.<\/p>\n\n\n\n

k) El tiempo de exposición.<\/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

Liberación de esterilización con OE<\/h2>\n\n\n\n

a) Método del indicador biológico<\/h3>\n\n\n\n

Si se utilizan indicadores biológicos (EPCD confirmado), deben distribuirse a lo largo de la carga de esterilización, incluidos los lugares más difíciles de esterilizar o los lugares que se sabe que están relacionados con estos puntos difíciles. Si se utiliza pretratamiento, los indicadores biológicos deben colocarse antes del pretratamiento.<\/p>\n\n\n\n

Los indicadores biológicos deben retirarse de la carga de esterilización una vez finalizado el ciclo de esterilización y cultivarse lo antes posible para permitir que los indicadores biológicos reaviven. Si no se cultivan de manera oportuna, se deben evaluar los efectos de la exposición al AE residual durante la reactivación tardía.<\/p>\n\n\n\n

El crecimiento de los indicadores biológicos debe analizarse para determinar si el crecimiento no se debe a un incumplimiento de las especificaciones del proceso físico, lo que requeriría repetir el proceso de confirmación.<\/p>\n\n\n\n

b) Método de liberación de parámetros<\/p>\n\n\n\n

La liberación de parámetros se basa en demostrar que todos los parámetros físicos del proceso cumplen con las especificaciones para la liberación sin el uso de indicadores biológicos. Se basa únicamente en mediciones y registros de los parámetros físicos del proceso y sirve como declaración suficiente de la idoneidad del proceso de esterilización.<\/p>\n\n\n\n

La liberación de parámetros solo está permitida cuando todos los parámetros del proceso están especificados, controlados y monitoreados directamente. Por lo tanto, cuando se utiliza la liberación de parámetros, debe haber equipos para la medición directa de la temperatura y la humedad dentro de la cámara y para el análisis directo de la concentración de OE, para recopilar y registrar los parámetros del proceso de esterilización y confirmar que el proceso de esterilización cumple con las especificaciones.<\/p>\n\n\n\n

Además de demostrar que los parámetros del proceso de esterilización cumplen con las especificaciones de esterilización, la liberación de parámetros también requiere medir y registrar los siguientes datos adicionales:<\/p>\n\n\n\n

Medir la temperatura dentro de la cámara al menos desde dos lugares durante todo el ciclo de esterilización.<\/p>\n\n\n\n

Medición directa de la humedad en el interior de la cámara durante la fase de procesamiento.<\/p>\n\n\n\n

Determinar la concentración de EO mediante análisis directo del gas de la cámara de esterilización en intervalos de tiempo específicos, para verificar completamente que se cumplan las condiciones requeridas durante todo el período de exposición.<\/p>\n\n\n\n

Si desea saber más sobre la esterilización de óxido de etileno<\/h2>\n\n\n\n

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

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

Sitio local: Sala 1202, Caitong Zhongxin, distrito de Xiasha, ciudad de Hangzhou, provincia de Zhejiang, China<\/p>\n\n\n\n

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

El propósito del monitoreo y control de rutina de la esterilización con OE (óxido de etileno) es demostrar que se ha aplicado al producto el proceso de esterilización confirmado y especificado. Los datos de cada ciclo de esterilización deben registrarse y conservarse para demostrar que se han cumplido las especificaciones confirmadas del proceso de esterilización. Éste deberá incluir al menos el siguiente contenido:<\/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}]}}