{"id":2122,"date":"2024-11-06T11:41:22","date_gmt":"2024-11-06T03:41:22","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2122"},"modified":"2025-12-05T10:51:11","modified_gmt":"2025-12-05T02:51:11","slug":"production-of-process-challenge-devices-in-eo-sterilization","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2122","title":{"rendered":"Production of Process Challenge Devices in eo sterilization"},"content":{"rendered":"\n<div class=\"wp-block-uagb-image uagb-block-5b40b406 wp-block-uagb-image--layout-default wp-block-uagb-image--effect-static wp-block-uagb-image--align-none\"><figure class=\"wp-block-uagb-image__figure\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/Turnkey-EO-Sterilisation-Project-1-1024x724.webp\" alt=\"\" class=\"uag-image-8216\" width=\"768\" height=\"1024\" title=\"Turnkey-EO-Sterilisation-Project\" role=\"img\" \><\/figure><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-1-production-of-process-challenge-devices-pcd\">3.4.1.1 Produção de Dispositivos de Desafio de Processo (PCD)<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Um Dispositivo de Desafio de Processo (PCD) é um sistema de desafio microbiológico usado para avaliar a taxa de eliminação de parâmetros de processo selecionados. Normalmente é um dispositivo ou pacote de teste contendo indicadores biológicos (por exemplo, esporos de Bacillus atrophaeus com contagem de esporos conhecida). A resistência do PCD ao processo de esterilização deve ser maior ou igual à resistência da carga microbiana natural na área mais difícil de esterilizar do produto. A quantidade de PCDs deve atender aos requisitos descritos na Tabela C.3 do Apêndice C em GB18279.1-2015. Os PCDs são classificados em PCDs Internos (IPCD) e PCDs Externos (EPCD).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-a-internal-pcd-ipcd-production\">a) Produção interna de PCD (IPCD)<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Os PCDs internos são normalmente dispositivos médicos selecionados pela empresa para representar uma família de produtos. Com base no design e na composição do material, esses produtos são considerados alguns dos mais difíceis de esterilizar. Os indicadores biológicos (BI) são colocados na posição de maior dificuldade de esterilização do produto, garantindo que o processo de esterilização não obstrua os canais nem interfira no design do produto.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Coloque o indicador biológico (BI) na área do produto mais difícil de esterilizar, ou inocule o microrganismo de teste (por exemplo, Bacillus atrophaeus) no local com as condições de esterilização mais difíceis de alcançar. local mais difícil de esterilizar no produto.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">IPCDs comuns incluem, mas não estão limitados a:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Colocar o transportador contaminado entre componentes como anéis, cabeças de pistão, arruelas ou pistões de seringa. Colocar o desafio do microrganismo no meio do lúmen do cateter e, em seguida, usar solventes adesivos ou conectores para selar novamente o cateter e restaurar a integridade do produto. Colocar o desafio do microrganismo na interface do pistão.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-b-external-pcd-epcd-production\">b) Produção externa de PCD (EPCD)<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">PCDs externos são colocados na parte externa do produto carregado. EPCDs são normalmente usados ​​para processamento de rotina e são recuperados da carga após o tratamento. A resistência do EPCD à carga biológica do produto esterilizado deve ser comparada com a resistência do IPCD. O EPCD também deve representar o produto mais difícil de esterilizar na carga.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A relação entre EPCDs e amostras de produtos contaminados deve ser revista periodicamente para garantir que não ocorreram alterações no produto esterilizado e que o EPCD ainda representa o produto mais difícil de esterilizar na carga.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ao colocar um IB em um PCD, o PCD deve ter pelo menos a mesma resistência que o local mais difícil de esterilizar no produto.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">EPCDs comuns incluem, mas não estão limitados a:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Colocar um indicador biológico (BI) dentro da embalagem do produto ou equivalente, como sacos plásticos, que depois é colocado dentro de um envelope de Manila. Colocar um indicador biológico em um saco plástico grosso que foi dobrado um determinado número de vezes. Colocar o indicador biológico em várias partes de uma seringa, como na arruela do pistão ou na cabeça do pistão.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Os PCDs produzidos da maneira acima são embalados usando os mesmos métodos que os produtos de produção regulares, distribuídos uniformemente dentro da carga do produto e posicionados para cobrir os pontos frios dentro da câmara do esterilizador.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-2-partial-cycle-short-cycle-testing\">3.4.1.2 Teste de Ciclo Parcial (Ciclo Curto)<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Depois de selecionar o PCD, a sua adequação é confirmada através da execução de um ciclo parcial. O método de avaliação é o seguinte:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">a) Determinar os métodos de colocação de PCDs, amostras de teste e sensores com base nos resultados da avaliação operacional. O número e a distribuição dos PCD deverão ser suficientes. Se o EPCD selecionado for utilizado para monitoramento rotineiro do processo de esterilização, ele deverá ser colocado na carga do produto de acordo com o plano e procedimento.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">b) Com base no valor D, tempo ST e tempo KT do indicador biológico, defina um tempo de exposição menor. Outros parâmetros devem ser testados no limite inferior dos parâmetros do processo de esterilização de rotina. O método de teste deve consultar o Apêndice A de GB18281.2. Após o término do tempo de exposição, retire o produto, IPCD e EPCD para cultivo microbiano e observe os resultados.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Os resultados do cultivo devem mostrar que a resistência do PCD é maior ou igual à resistência à carga biológica do local mais difícil de esterilizar no produto:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">IPCD e EPCD deverão ser parcialmente negativos; um resultado totalmente negativo ou totalmente positivo indicaria falha no teste. A resistência do IPCD deve ser maior que a do produto, e a resistência do EPCD deve ser maior ou igual à do IPCD.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Se os resultados não atenderem às expectativas, investigue a causa. Normalmente, são necessários ajustes na resistência do PCD ou nos parâmetros de esterilização, seguidos de novos testes até que os resultados estejam alinhados com as expectativas. Se todos os três (produto, IPCD e EPCD) não apresentarem crescimento microbiano, reduza o tempo de exposição ao OE de forma adequada e teste novamente. Se todos mostrarem crescimento microbiano, aumente o tempo de exposição ao OE e teste novamente.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-3-half-cycle-testing\">3.4.1.3 Teste de meio ciclo<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Depois de concluir com êxito os testes de ciclo curto, execute três testes consecutivos e consistentes de meio ciclo para demonstrar a eficácia (SAL = 10^-6) e a reprodutibilidade do processo de esterilização por EO. O método de avaliação é o seguinte:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Defina a esterilidade do indicador biológico como padrão e defina outros parâmetros do processo de esterilização para o limite inferior dos parâmetros de esterilização de rotina (por exemplo, tempo de transferência de pré-tratamento dentro do intervalo especificado). Reduza gradualmente pela metade o tempo de exposição à esterilização do processo de esterilização inicial e remova os indicadores biológicos do PCD após diferentes tempos de esterilização. Cultive-os em ambiente estéril até que a esterilidade seja confirmada. O menor tempo de esterilização (tempo crítico) assim determinado será o tempo de meio ciclo, devendo ser realizados pelo menos mais dois testes com o mesmo menor tempo.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">All three test results should show complete inactivation of all biological indicators (initial colony count no less than 1\u00d710^6) to confirm the minimum effective EO exposure time. The exposure time in the routine sterilization process should be at least twice this minimum time.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Os resultados do cultivo dos indicadores biológicos devem mostrar todos os IPCDs e EPCDs negativos. Se o teste de ciclo curto mostrar que a resistência do EPCD é maior que a do IPCD, o EPCD pode apresentar positividade parcial.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Se os resultados não atenderem às expectativas, investigue a causa e geralmente ajuste os parâmetros de esterilização antes de repetir o teste até que os resultados estejam alinhados com as expectativas.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Exemplo:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Suponha que o tempo de exposição do primeiro meio ciclo de esterilização seja de 4 horas. Se estéril, reduzir o tempo de exposição para 2 horas para o próximo teste; se ocorrer crescimento microbiano, aumente o tempo de exposição com base na exposição de 4 horas.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Suponha que o tempo de exposição à esterilização do segundo meio ciclo seja de 2 horas. Se estéril, reduzir o tempo de exposição para 1 hora para o próximo teste; se ocorrer crescimento microbiano, estenda o tempo de exposição para 3 horas.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Suponha que o tempo de exposição à esterilização do terceiro meio ciclo seja de 3 horas. Se estéril, repita o teste de 3 horas duas vezes. Se todos os resultados forem estéreis, confirme 3 horas como o tempo mínimo eficaz. Se ocorrer crescimento microbiano, repita o teste com exposição de 4 horas e, se todos os resultados forem estéreis, confirme 4 horas como o tempo mínimo eficaz.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-4-full-cycle-testing\">3.4.1.4 Teste de ciclo completo<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Durante o teste de ciclo completo, defina o tempo de exposição ao EO para o dobro do tempo efetivo mínimo de meio ciclo e outros parâmetros para o limite superior dos parâmetros de esterilização de rotina para verificar a confiabilidade e a reprodutibilidade do processo de esterilização.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">O número de sensores de temperatura e umidade utilizados deve atender aos requisitos do Apêndice C em GB18279.1, distribuídos uniformemente na carga de esterilização. Os pontos de colocação do sensor de temperatura devem incluir os pontos frios e quentes dentro da câmara do esterilizador durante a Qualificação Operacional (OQ).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Após o teste, os resultados do cultivo do produto e do EPCD deverão apresentar esterilidade completa (todos negativos).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">SE VOCÊ QUER SABER MAIS<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Telefone:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">E-mail:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Local: Sala 1202, Caitong Zhongxin, distrito de Xiasha, cidade de Hangzhou, província de Zhejiang, China<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Site:<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">zjbocon.com<\/a><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><th>ISO 11135:2014<\/th><td>Sterilization of health-care products \u2013 Ethylene oxide \u2013 Requirements for the development, validation and routine control of a sterilization process for medical devices<\/td><\/tr><tr><th>ISO 14161:2009<\/th><td>Sterilization of health care products \u2014 Biological indicators \u2014 Guidance for the selection, use and interpretation of results<\/td><\/tr><tr><th>ISO 10993-7:2008<\/th><td>Biological evaluation of medical devices \u2014 Part 7: Ethylene oxide sterilization residuals<\/td><\/tr><tr><th>ISO 11737-1:2018<\/th><td>Sterilization of health care products \u2014 Microbiological methods \u2013 Part 1: Determination of a population of microorganisms on products<\/td><\/tr><tr><th>ISO 11737-2:2009<\/th><td>Sterilization of medical devices \u2014 Microbiological methods \u2014 Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process<\/td><\/tr><tr><th>AAMI TIR16:2017<\/th><td>Aspectos microbiológicos da esterilização por óxido de etileno<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>Um Dispositivo de Desafio de Processo (PCD) é um sistema de desafio microbiológico usado para avaliar a taxa de eliminação de parâmetros de processo selecionados. Normalmente é um dispositivo ou pacote de teste contendo indicadores biológicos (por exemplo, esporos de Bacillus atrophaeus com contagem de esporos conhecida). A resistência do PCD ao processo de esterilização deve ser maior ou igual à resistência da carga microbiana natural na área mais difícil de esterilizar do produto. A quantidade de PCDs deve atender aos requisitos descritos na Tabela C.3 do Apêndice C em GB18279.1-2015. Os PCDs são classificados em PCDs Internos (IPCD) e PCDs Externos (EPCD).<\/p>\n","protected":false},"author":234312599,"featured_media":8417,"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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