{"id":310,"date":"2023-01-09T05:42:47","date_gmt":"2023-01-09T05:42:47","guid":{"rendered":"https:\/\/www.maryatech.com\/?post_type=product&p=310"},"modified":"2023-01-11T06:41:30","modified_gmt":"2023-01-11T06:41:30","slug":"equipamento-de-isolamento-asseptico","status":"publish","type":"product","link":"https:\/\/www.maryatech.com\/pt\/product\/aseptic-isolation-equipment\/","title":{"rendered":"Equipamento de isolamento ass\u00e9ptico"},"content":{"rendered":"

1. Introdu\u00e7\u00e3o<\/b><\/h1>\n

O equipamento de isolamento ass\u00e9ptico \u00e9 especialmente projetado e fabricado de acordo com o padr\u00e3o de gerenciamento de qualidade de produ\u00e7\u00e3o de medicamentos (GMP) e \u00e9 usado em produtos de sa\u00fade e requer um n\u00edvel mais alto de sistema de barreira de prote\u00e7\u00e3o ambiental. O sistema de isolador farmac\u00eautico pode maximizar a polui\u00e7\u00e3o da preven\u00e7\u00e3o e do controle do produto, para proteger a seguran\u00e7a do operador e evitar que ele seja ferido por subst\u00e2ncias t\u00f3xicas. Bons fabricantes de isoladores farmac\u00eauticos podem fornecer solu\u00e7\u00f5es perfeitas de tecnologia de controle ambiental para testes ass\u00e9pticos, produ\u00e7\u00e3o ass\u00e9ptica e prote\u00e7\u00e3o da produ\u00e7\u00e3o de medicamentos altamente alerg\u00eanicos e t\u00f3xicos.<\/p>\n

O equipamento de isolamento \u00e9 vedado ou tem um sistema de filtragem microbiol\u00f3gica (HEPA) para fornecer ar e \u00e9 autopurificador. Quando vedado, use somente a superf\u00edcie interna limpa ou use o canal de transfer\u00eancia r\u00e1pida para a transfer\u00eancia de materiais. Quando aberto, os materiais s\u00f3 podem entrar e sair por aberturas espec\u00edficas que foram projetadas e validadas para eliminar a transfer\u00eancia de contamina\u00e7\u00e3o. Pode ser usado para isolar misturas ativas durante opera\u00e7\u00f5es ass\u00e9pticas ou para tratamentos de esteriliza\u00e7\u00e3o e isolamento.<\/p>\n

De acordo com o uso, o isolador pode ser dividido em isolador de inspe\u00e7\u00e3o ass\u00e9ptica, isolamento de pesagem ass\u00e9ptica, isolador de alimenta\u00e7\u00e3o ass\u00e9ptica, isolador API, etc;<\/p>\n

2. Recurso de desempenho<\/b><\/h1>\n
    \n
  • Todo o projeto da linha, o material, a fabrica\u00e7\u00e3o, a montagem, a depura\u00e7\u00e3o e assim por diante atenderam aos novos requisitos de especifica\u00e7\u00e3o de produ\u00e7\u00e3o farmac\u00eautica GMP.<\/li>\n
  • \u00c9 poss\u00edvel escolher o material de a\u00e7o inoxid\u00e1vel, a estrutura da m\u00e1quina e a plataforma de opera\u00e7\u00e3o no topo de todo o projeto da estrutura fechada, o sistema de esteriliza\u00e7\u00e3o, a unidade de controle integrada, a entrada e a sa\u00edda do sistema de ar e a unidade de filtragem de ar, mais bonitos e f\u00e1ceis de limpar e manter;<\/li>\n
  • O corpo da m\u00e1quina adota bordas e cantos suaves, e o local de soldagem \u00e9 polido sem rebarbas. Design de \u00e2ngulo de arco interno, f\u00e1cil de limpar;<\/li>\n
  • Cada c\u00e2mara, de acordo com os requisitos funcionais de design, luvas com tamanho padr\u00e3o, sem opera\u00e7\u00e3o de ponto cego, pode ser adotado um design especial de vestu\u00e1rio para o busto do casco;<\/li>\n
  • O projeto do m\u00f3dulo do equipamento isolador usa a conex\u00e3o de orif\u00edcios para ratos entre cada m\u00f3dulo, cada parte tem \u00e1reas importantes de gradiente de press\u00e3o diferencial \u00f3bvias para garantir que a quantidade de diferen\u00e7a de press\u00e3o em rela\u00e7\u00e3o a outras \u00e1reas para press\u00e3o positiva;<\/li>\n
  • O equipamento isolador pode ser projetado de acordo com a necessidade de dois tipos de opera\u00e7\u00e3o em um lado ou em dois lados; o equipamento tem dois m\u00e9todos de projeto: tipo dividido e tipo integrado;<\/li>\n
  • O isolador pode, de acordo com a fun\u00e7\u00e3o, aumentar a carca\u00e7a do tanque de amortecimento, o m\u00f3dulo de sa\u00edda ou outros chanbers foram combinados com o casco principal, fabricando um sistema de isolamento personalizado;<\/li>\n
  • Dispositivo de exaust\u00e3o do equipamento, remova o excesso de decomposi\u00e7\u00e3o do per\u00f3xido de hidrog\u00eanio e evite res\u00edduos;<\/li>\n
  • N\u00edveis de res\u00edduos de VHP: < 1 PPM (n\u00edvel de res\u00edduo determinado pelos requisitos tecnol\u00f3gicos).<\/li>\n
  • Veda\u00e7\u00e3o da c\u00e2mara: a taxa de vazamento da c\u00e2mara n\u00e3o \u00e9 superior a 5% em 10 minutos sob press\u00e3o de 500 pa;<\/li>\n
  • Sistema de detec\u00e7\u00e3o de vazamento on-line de luvas configur\u00e1vel, que pode ser usado para a detec\u00e7\u00e3o de integridade on-line de v\u00e1rias luvas ao mesmo tempo;<\/li>\n
  • Pode configurar diferentes prateleiras para diferentes usos;<\/li>\n
  • O isolador pode ser equipado com v\u00e1rias pistolas de \u00e1gua para limpeza, o meio de limpeza pode ser \u00e1gua (medicamentos altamente ativos podem usar solvente inativado) e ar comprimido;<\/li>\n
  • Sistema configur\u00e1vel de entrada\/sa\u00edda de saco (BIBO), filtros de substitui\u00e7\u00e3o seguros, garantem a seguran\u00e7a das pessoas e do processo de mudan\u00e7a do ambiente;<\/li>\n
  • Sistema de gerador de VHP integrado configur\u00e1vel sem gerador de VHP externo, melhor evaporado em g\u00e1s, o l\u00edquido de per\u00f3xido de hidrog\u00eanio para obter um melhor efeito de esteriliza\u00e7\u00e3o, temperatura programada de esteriliza\u00e7\u00e3o, acusado de \u00famido.<\/li>\n
  • Pode ser configurado para monitorar a concentra\u00e7\u00e3o de per\u00f3xido de hidrog\u00eanio do g\u00e1s, part\u00edculas de poeira e porta de bact\u00e9rias planct\u00f4nicas;<\/li>\n
  • V\u00e1lvula RTP configur\u00e1vel, permite a transfer\u00eancia ass\u00e9ptica de materiais;<\/li>\n
  • O dispositivo de carregamento autom\u00e1tico de per\u00f3xido de hidrog\u00eanio do equipamento pode ser configurado e o fluido pode ser adicionado automaticamente de acordo com as condi\u00e7\u00f5es de esteriliza\u00e7\u00e3o;<\/li>\n
  • Sistema configur\u00e1vel de detec\u00e7\u00e3o de alta e baixa concentra\u00e7\u00e3o, detec\u00e7\u00e3o da concentra\u00e7\u00e3o de per\u00f3xido de hidrog\u00eanio no processo de esteriliza\u00e7\u00e3o;<\/li>\n
  • O sistema de desumidifica\u00e7\u00e3o configur\u00e1vel faz com que o ar circule pelo dispositivo de desumidifica\u00e7\u00e3o dentro do isolador, reduzindo a umidade relativa dentro do isolador e a efici\u00eancia da esteriliza\u00e7\u00e3o VHP;<\/li>\n
  • Fun\u00e7\u00f5es do sistema de controle: controle autom\u00e1tico da press\u00e3o do g\u00e1s, controle autom\u00e1tico do conte\u00fado de \u00e1gua e oxig\u00eanio, circula\u00e7\u00e3o de ar de limpeza autoadaptativa, velocidade vari\u00e1vel cont\u00ednua, dicas de seguran\u00e7a, diagn\u00f3stico de falhas, armazenamento de dados, prote\u00e7\u00e3o por senha e outras fun\u00e7\u00f5es;<\/li>\n<\/ul>\n
      \n
    • O sistema de isolador est\u00e9ril no setor farmac\u00eautico pode ser acoplado a diferentes equipamentos, acess\u00f3rios e integra\u00e7\u00e3o, realizando as v\u00e1rias fun\u00e7\u00f5es e requisitos tecnol\u00f3gicos, com design personalizado;<\/li>\n<\/ul>","protected":false},"excerpt":{"rendered":"

      Os isoladores farmac\u00eauticos ass\u00e9pticos s\u00e3o totalmente vedados para controlar e processar produtos farmac\u00eauticos e biol\u00f3gicos em um estado est\u00e9ril. Uma opera\u00e7\u00e3o completa pode exigir um sistema de isoladores para separar todo o processo de poss\u00edveis fontes de contamina\u00e7\u00e3o, como equipamentos e operadores ao redor.<\/p>","protected":false},"featured_media":588,"template":"","meta":{"om_disable_all_campaigns":false,"_templately_pack_id":"","_templately_imported_at":"","_templately_source":"","_templately_import_session_id":"","site-sidebar-layout":"default","site-content-layout":"default","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":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}}},"product_brand":[],"product_cat":[83,15],"product_tag":[],"class_list":["post-310","product","type-product","status-publish","has-post-thumbnail","product_cat-aseptic-isolation-equipment","product_cat-uncategorized","desktop-align-left","tablet-align-left","mobile-align-left","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"\nAseptic isolation equipment - Shanghai Marya<\/title>\n<meta name=\"description\" content=\"Aseptic pharmaceutical isolators is fully sealed to control and process pharmaceuticals and biological products into a sterile state.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.maryatech.com\/pt\/produto\/equipamento-de-isolamento-asseptico\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Aseptic isolation equipment\" \/>\n<meta property=\"og:description\" content=\"High-end sterile pharmaceutical filling lines manufacturer, with core strengths in complying with EU GMP\/FDA certification, serving multinational pharmaceutical companies.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.maryatech.com\/pt\/produto\/equipamento-de-isolamento-asseptico\/\" \/>\n<meta property=\"og:site_name\" content=\"Shanghai Marya Pharmaceutical Engineering & Project Co., Ltd.\" \/>\n<meta property=\"article:modified_time\" content=\"2023-01-11T06:41:30+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.maryatech.com\/wp-content\/uploads\/2023\/01\/Aseptic-isolation-equipment.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"750\" \/>\n\t<meta property=\"og:image:height\" content=\"750\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:site\" content=\"@Shanghai_Marya\" \/>\n<meta name=\"twitter:label1\" content=\"Est. tempo de leitura\" \/>\n\t<meta name=\"twitter:data1\" content=\"4 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.maryatech.com\\\/ar\\\/product\\\/aseptic-isolation-equipment\\\/\",\"url\":\"https:\\\/\\\/www.maryatech.com\\\/ar\\\/product\\\/aseptic-isolation-equipment\\\/\",\"name\":\"Aseptic isolation equipment - 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