{"id":2076,"date":"2024-10-31T11:28:17","date_gmt":"2024-10-31T03:28:17","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2076"},"modified":"2025-12-05T11:11:54","modified_gmt":"2025-12-05T03:11:54","slug":"ethylene-oxide-sterilization-chamber","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2076","title":{"rendered":"PQ in Ethylene oxide sterilization chamber"},"content":{"rendered":"\n
\"Ethylene<\/figure><\/div>\n\n\n\n

PQ es la etapa de validación que utiliza la cámara de esterilización con óxido de etileno para demostrar que el equipo de esterilización con óxido de etileno opera consistentemente de acuerdo con criterios de aceptación predeterminados y que el proceso produce un producto estéril y cumple con los requisitos especificados.<\/p>\n\n\n\n

PQ should be carried out for each new process and\/or product to be validated to demonstrate that the process complies with identified acceptance criteria and is capable of delivering the required SAL to the product.PQ consists of both microbiological and physical performance qualifications and is performed in the Ethylene oxide sterilization equipment used to sterilize the product.<\/p>\n\n\n\n

During PQ process, the package of the product and loading mode of the product\u00a0should be specified;\u00a0Select representative products or materials whose packaging and material composition can cover all the product to be sterilized or the entire product family.<\/p>\n\n\n\n

During PQ process, the package of the product and loading mode of the product\u00a0should be specified;\u00a0Select representative products or materials whose packaging and material composition can cover all the product to be sterilized or the entire product family.<\/p>\n\n\n\n

En general, MPQ y PPQ se realizan simultáneamente. Si PPQ se realiza en paralelo con al menos tres ejecuciones de MPQ, entonces se deberá realizar un mínimo de una ejecución de PPQ adicional utilizando la especificación del proceso de ciclo completo. La PQ física (PPQ) deberá demostrar que los criterios de aceptación especificados se cumplen en toda la carga durante la duración de la especificación del proceso de rutina propuesta.<\/p>\n\n\n\n

La PQ se realizará en la introducción de productos, empaques, configuraciones de carga, cámaras de esterilización con óxido de etileno o parámetros de proceso nuevos o modificados, a menos que se haya documentado la equivalencia con un producto, empaque, configuración de carga, cámara de esterilización con óxido de etileno o proceso previamente validados.<\/p>\n\n\n\n

Verificación PQ Proceso de cámara de esterilización con óxido de etileno<\/h2>\n\n\n\n

El proceso de verificación de PQ es generalmente el siguiente: realizar primero un ciclo fraccionado y probar el estado de esterilidad del producto después.
fraccionario
\u00a0cycle sterilization; compare the EO resistance relationship between IPCD, EPCD and representative products (the expected result is EPCD > IPCD > Product,); Refer to ISO-11737-2 for the test requirements involved in the fractional cycle.<\/p>\n\n\n\n

Realice medio ciclo para demostrar la reproducibilidad del proceso de esterilización y el efecto de esterilización; Si se utiliza el método excesivo, entonces no debería haber IPCD positivo durante el medio ciclo. Los EPCD positivos durante el medio ciclo son aceptables si han demostrado una mayor resistencia que el IPCD proporcionando un
\u201c
desafío del peor de los casos
\u201d
para el procesamiento de rutina.<\/p>\n\n\n\n

Los parámetros de esterilización de rutina generalmente están determinados por los parámetros del ciclo completo, por lo que los desafíos residuales generalmente se realizan durante el ciclo completo para determinar el tiempo de aireación apropiado. Dado que la eficacia del proceso de esterilización se ha demostrado en ciclos fraccionados y medios ciclos, el EPCD puede garantizar el efecto de esterilización.<\/p>\n\n\n\n

Si, en cualquiera de estas ejecuciones, no se cumplen los requisitos de esterilidad o funcionalidad del producto, se debe realizar una investigación para determinar si son necesarias ejecuciones de calificación adicionales. Si los parámetros del proceso no se pueden mantener dentro de los límites definidos, se debe realizar una investigación. Si se realizan modificaciones, deben ser necesarias ejecuciones adicionales.<\/p>\n\n\n\n

PQ anual en el proceso de cámara de esterilización con óxido de etileno<\/h2>\n\n\n\n

Review of PQ should assessment that the sterilization process remains valid for the designated product.Reduced MPQ\/PPQ can be necessary in certain situations, e.g. to verify continued appropriateness of the resistance of the internal PCD in the product load to the resistance of the product bioburden, or, after a defined interval, to provide evidence that there has been no inadvertent change since the previous requalification study. This would typically include, minimally,one fractional or half cycle exposure including load temperature and humidity measurements. Fractional cycles in a developmental chamber can also be used to support a requalification program, but requalification of the production chamber should be performed in the production chamber.<\/p>\n\n\n\n

Evaluación de equivalencia<\/h2>\n\n\n\n

1. ¿Equivalencia del proceso? Equipo de esterilización con óxido de etileno que ofrece los mismos parámetros de proceso, después de haber sido sometido a coeficiente intelectual<\/a> y OQ<\/a>, estará calificado tampoco.<\/p>\n\n\n\n

2. de la misma manera que la cámara original, o utilizando un MPQ reducido que demuestre la entrega del nivel requerido de letalidad microbiológica y PPQ para demostrar la uniformidad de temperatura y humedad de la carga y el control por parte de la cámara de producción. La justificación de esta calificación reducida deberá registrarse y documentarse.<\/p>\n\n\n\n

3. Se determinará la influencia de las distintas ubicaciones geográficas sobre las propiedades del producto o de la carga.<\/p>\n\n\n\n

4. La equivalencia de procesos es un método utilizado para demostrar que el mismo proceso de esterilización validado se realiza mediante dos o más piezas o juegos de equipos de esterilización con óxido de etileno. No requiere que el equipo sea físicamente idéntico. Incluso si los parámetros entregados por el equipo no son estadísticamente idénticos, los procesos entregados aún pueden ser equivalentes si todos son capaces de ejecutar el proceso dentro de los límites de proceso definidos y validados.<\/p>\n\n\n\n

5. La equivalencia del proceso entre múltiples piezas de equipo tiene como objetivo minimizar la cantidad de pruebas necesarias para calificar el proceso. El proceso de esterilización debe validarse en una cámara. El equipo restante puede someterse a una PQ reducida si el equipo restante ha pasado por la calificación de instalación (IQ) y la calificación operativa (OQ) (ver 9.2 y 9.3). La equivalencia también se puede utilizar para reducir la recalificación de varios equipos. El equipo utilizado para realizar un proceso de esterilización comúnmente consta de una cámara o sala y sistemas de control auxiliares. El equipo de proceso de esterilización puede estar ubicado dentro de una instalación de procesamiento determinada o entre varias instalaciones. Este equipo puede usarse de forma independiente para brindar las mismas condiciones de proceso y podría tener exactamente el mismo diseño o podría diferir en tamaño o en la extensión del equipo auxiliar.<\/p>\n\n\n\n

6. La equivalencia del proceso entre múltiples piezas de equipo tiene como objetivo minimizar la cantidad de pruebas necesarias para calificar el proceso. El proceso de esterilización debe validarse en una cámara. El equipo restante puede someterse a una PQ reducida si el equipo restante ha pasado por la calificación de instalación (IQ) y la calificación operativa (OQ) (ver 9.2 y 9.3). La equivalencia también se puede utilizar para reducir la recalificación de varios equipos. El equipo utilizado para realizar un proceso de esterilización comúnmente consta de una cámara o sala y sistemas de control auxiliares. El equipo de proceso de esterilización puede estar ubicado dentro de una instalación de procesamiento determinada o entre varias instalaciones. Este equipo puede usarse de forma independiente para brindar las mismas condiciones de proceso y podría tener exactamente el mismo diseño o podría diferir en tamaño o en la extensión del equipo auxiliar.<\/p>\n\n\n\n

SI QUIERES SABER MÁS <\/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\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

PQ es la etapa de validación que utiliza la cámara de esterilización con óxido de etileno para demostrar que el equipo de esterilización con óxido de etileno opera consistentemente de acuerdo con criterios de aceptación predeterminados y que el proceso produce un producto estéril y cumple con los requisitos 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Project Design Requirements for Ethylene Oxide (EO) Sterilization Logistics This automated project\u2026","rel":"","context":"Similar post","block_context":{"text":"Similar post","link":""},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/Automatic-Sterilizer-Chamber-Conveyor-1.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/Automatic-Sterilizer-Chamber-Conveyor-1.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/Automatic-Sterilizer-Chamber-Conveyor-1.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/Automatic-Sterilizer-Chamber-Conveyor-1.webp?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":2453,"url":"https:\/\/zjbocon.com\/?p=2453","url_meta":{"origin":2076,"position":3},"title":"Microbial Killing Performance of Ethylene Oxide Sterilizers","author":"Bocon Technical Team","date":"2024-12-20","format":false,"excerpt":"Note 1: The Ethylene Oxide sterilization conditions must be obtained through validation confirmation and should be verified with monitoring and routine control during each sterilization cycle. 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