{"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 — это этап проверки, на котором используется стерилизационная камера с оксидом этилена для демонстрации того, что оборудование для стерилизации оксидом этилена постоянно работает в соответствии с заранее определенными критериями приемки, и в результате процесса получается продукт, который является стерильным и соответствует указанным требованиям.<\/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

Как правило, MPQ и PPQ выполняются одновременно. Если PPQ выполняется параллельно как минимум с тремя прогонами MPQ, то должен быть выполнен как минимум один дополнительный прогон PPQ с использованием спецификации процесса полного цикла. Физический PQ (PPQ) должен демонстрировать, что указанные критерии приемки соблюдаются на протяжении всей нагрузки в течение всего срока действия предлагаемой стандартной спецификации процесса.<\/p>\n\n\n\n

PQ должно проводиться при вводе новых или модифицированных продуктов, упаковки, конфигурации загрузки, камеры для стерилизации оксидом этилена или параметров процесса, если не документально подтверждена эквивалентность ранее проверенному продукту, упаковке, конфигурации загрузки. Камера для стерилизации оксидом этилена или процесс.<\/p>\n\n\n\n

Проверка качества процесса в камере стерилизации оксидом этилена<\/h2>\n\n\n\n

Процесс проверки качества качества обычно выглядит следующим образом: сначала выполните дробный цикл, а затем проверьте статус стерильности продукта.
дробный
\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

Выполните полуцикл, чтобы доказать воспроизводимость процесса стерилизации и эффекта стерилизации; Если используется метод overkill, то в течение полупериода не должно быть положительных значений IPCD. Положительные значения EPCD в течение полупериода допустимы, если они продемонстрировали большую устойчивость, чем IPCD, обеспечивающие
\u201c
вызов наихудшего случая
\u201d
для рутинной обработки.<\/p>\n\n\n\n

Параметры плановой стерилизации обычно определяются параметрами полного цикла, поэтому остаточные испытания обычно выполняются в течение всего цикла, чтобы определить подходящее время аэрации. Поскольку эффективность процесса стерилизации доказана при дробном цикле и полуциклах, эффект стерилизации может быть обеспечен с помощью EPCD.<\/p>\n\n\n\n

Если в каком-либо из этих циклов требования к стерильности или функциональности продукта не соблюдены, следует провести расследование, чтобы определить, необходимы ли дополнительные квалификационные испытания. Если параметры процесса невозможно поддерживать в установленных пределах, следует провести расследование. Если внесены изменения, потребуются дополнительные прогоны.<\/p>\n\n\n\n

Ежегодный контроль качества в камере стерилизации оксидом этилена<\/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

Оценка эквивалентности<\/h2>\n\n\n\n

1. Эквивалентность процесса? Оборудование для стерилизации оксидом этилена, обеспечивающее те же параметры процесса, прошедшее IQ<\/a> и ОК<\/a>, также должны быть квалифицированы.<\/p>\n\n\n\n

2. таким же образом, как и в исходной камере, или с использованием уменьшенного ПДК, демонстрирующего обеспечение необходимого уровня микробиологической летальности, и ППК для демонстрации однородности температуры и влажности загрузки и контроля со стороны производственной камеры. Обоснование такой пониженной квалификации должно быть записано и задокументировано.<\/p>\n\n\n\n

3. Должно быть определено влияние различных географических положений на свойства продукции или груза.<\/p>\n\n\n\n

4. Эквивалентность процесса – это метод, используемый для демонстрации того, что один и тот же проверенный процесс стерилизации осуществляется с помощью двух или более единиц или комплектов оборудования для стерилизации оксидом этилена. Физически идентичность оборудования не требуется. Даже если параметры, предоставляемые оборудованием, не являются статистически идентичными, поставляемые процессы все равно могут быть эквивалентными, если все они способны выполнять процесс в определенных, проверенных пределах процесса.<\/p>\n\n\n\n

5. Эквивалентность процесса среди нескольких единиц оборудования призвана свести к минимуму объем испытаний, необходимых для квалификации процесса. Процесс стерилизации должен валидироваться в одной камере. Оставшееся оборудование может пройти пониженное PQ, если оставшееся оборудование прошло аттестацию установки (IQ) и эксплуатационную квалификацию (OQ) (см. 9.2 и 9.3). Эквивалентность также может использоваться для сокращения переаттестации нескольких единиц оборудования. Оборудование, используемое для проведения процесса стерилизации, обычно состоит из камеры или помещения и вспомогательных систем управления. Оборудование для процесса стерилизации может быть расположено на одном технологическом предприятии или на нескольких объектах. Это оборудование может использоваться независимо для обеспечения одних и тех же условий процесса и может иметь абсолютно одинаковую конструкцию или может отличаться по размеру или объему вспомогательного оборудования.<\/p>\n\n\n\n

6. Эквивалентность процесса среди нескольких единиц оборудования призвана свести к минимуму объем испытаний, необходимых для квалификации процесса. Процесс стерилизации должен валидироваться в одной камере. Оставшееся оборудование может пройти пониженное PQ, если оставшееся оборудование прошло аттестацию установки (IQ) и эксплуатационную квалификацию (OQ) (см. 9.2 и 9.3). Эквивалентность также может использоваться для сокращения переаттестации нескольких единиц оборудования. Оборудование, используемое для проведения процесса стерилизации, обычно состоит из камеры или помещения и вспомогательных систем управления. Оборудование для процесса стерилизации может быть расположено на одном технологическом предприятии или на нескольких объектах. Это оборудование может использоваться независимо для обеспечения одних и тех же условий процесса и может иметь абсолютно одинаковую конструкцию или может отличаться по размеру или объему вспомогательного оборудования.<\/p>\n\n\n\n

ЕСЛИ ВЫ ХОТИТЕ УЗНАТЬ БОЛЬШЕ <\/h2>\n\n\n\n

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

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

Локальное место: комната 1202, Цайтонг Чжунсинь, район Сяша, город Ханчжоу, провинция Чжэцзян, Китай<\/p>\n\n\n\n

Веб-сайт:hzbocon.com<\/a>zjbocon.com<\/a><\/p>\n\n\n\n

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

PQ — это этап проверки, на котором используется стерилизационная камера с оксидом этилена для демонстрации того, что оборудование для стерилизации оксидом этилена постоянно работает в соответствии с заранее определенными критериями приемки, и в результате процесса получается продукт, который является стерильным и соответствует указанным требованиям.<\/p>\n","protected":false},"author":234312599,"featured_media":8489,"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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