{"id":171525,"date":"2025-03-07T07:41:03","date_gmt":"2025-03-07T07:41:03","guid":{"rendered":"https:\/\/www.maryatech.com\/?post_type=product&p=171525"},"modified":"2025-03-07T07:41:07","modified_gmt":"2025-03-07T07:41:07","slug":"sistema-de-formulacao-farmaceutica","status":"publish","type":"product","link":"https:\/\/www.maryatech.com\/pt\/product\/pharmaceutical-formulation-system\/","title":{"rendered":"Sistema de formula\u00e7\u00e3o farmac\u00eautica"},"content":{"rendered":"

Classifica\u00e7\u00e3o do sistema de prepara\u00e7\u00e3o\uff1a<\/h2>\n

1\uff09Sistema de prepara\u00e7\u00e3o geral: \u00c9 usado para a prepara\u00e7\u00e3o qu\u00edmica geral de pequenas mol\u00e9culas, como inje\u00e7\u00e3o aquosa, inje\u00e7\u00e3o de p\u00f3 liofilizado e assim por diante.<\/p>\n

2\uff09Sistema de prepara\u00e7\u00e3o complexa: \u00c9 usado na produ\u00e7\u00e3o de prepara\u00e7\u00f5es com processos complexos, como suspens\u00f5es, emuls\u00f5es, lipossomos, microesferas e outras prepara\u00e7\u00f5es especiais.<\/p>\n

3\uff09Sistema de prepara\u00e7\u00e3o biol\u00f3gica: \u00c9 usado para a prepara\u00e7\u00e3o de todos os tipos de produtos que aplicam a tecnologia de engenharia biol\u00f3gica, como a prepara\u00e7\u00e3o semiacabada de anticorpos, vacinas, produtos sangu\u00edneos, prote\u00ednas recombinantes e assim por diante, e tamb\u00e9m pode ser usado para a produ\u00e7\u00e3o de meio de cultura, tamp\u00e3o de purifica\u00e7\u00e3o e outras prepara\u00e7\u00f5es l\u00edquidas auxiliares.<\/p>\n

4\uff09Sistema de esta\u00e7\u00e3o CIP: \u00c9 usado para auxiliar na limpeza on-line de tanques e tubula\u00e7\u00f5es de v\u00e1rios sistemas de prepara\u00e7\u00e3o e biorreatores, e pode ser controlado separadamente ou integrado a outros sistemas.<\/p>\n

Caracter\u00edsticas de desempenho do sistema de prepara\u00e7\u00e3o\uff1a<\/strong><\/h5>\n

Sistema de prepara\u00e7\u00e3o geral<\/h3>\n
    \n
  1. O sistema pode ser totalmente autom\u00e1tico, com design modular, e seu acompanhamento de instala\u00e7\u00e3o e manuten\u00e7\u00e3o \u00e9 conveniente.<\/li>\n
  2. O sistema de controle autom\u00e1tico de CIP e SIP pode ser ativado por uma tecla, que pode detectar automaticamente o fim da limpeza e da esteriliza\u00e7\u00e3o, com gerenciamento de receitas, assinatura eletr\u00f4nica, registros eletr\u00f4nicos, rastreamento de auditoria e outras fun\u00e7\u00f5es de computador.<\/li>\n
  3. Quando o equipamento est\u00e1 em funcionamento, ele pode realizar a produ\u00e7\u00e3o control\u00e1vel dos principais par\u00e2metros de processo dos medicamentos (como temperatura, oxig\u00eanio dissolvido, PH, etc.) e pode detect\u00e1-los automaticamente e emitir um alarme quando houver condi\u00e7\u00f5es especiais fora dos par\u00e2metros definidos, de modo a evitar problemas de qualidade dos medicamentos.<\/li>\n
  4. O sistema segue os conceitos de projeto ASME BPE e GMP, atende aos requisitos de canto cego 3D e permite a produ\u00e7\u00e3o cont\u00ednua e com poucos res\u00edduos.<\/li>\n
  5. Antes de fabricar o equipamento em nossa f\u00e1brica, realizamos um projeto tridimensional individual para racionalizar a disposi\u00e7\u00e3o de tubula\u00e7\u00f5es, v\u00e1lvulas, instrumentos etc. no sistema, a fim de tornar a opera\u00e7\u00e3o do equipamento mais f\u00e1cil de usar.<\/li>\n<\/ol>\n

     <\/p>\n

    Sistema de prepara\u00e7\u00e3o complexo<\/h3>\n
      \n
    1. Usaremos o software de an\u00e1lise de fluidos ANSYS para simular a situa\u00e7\u00e3o real do fluido no tanque e, com base nisso, selecionar agitadores e tesouras adequados, para garantir que o processo de laborat\u00f3rio possa ser transferido sem problemas para a produ\u00e7\u00e3o em larga escala.<\/li>\n
    2. Usaremos bombas de transfer\u00eancia de fase de \u00f3leo e \u00e1gua de alta precis\u00e3o para controlar rigorosamente a propor\u00e7\u00e3o de mistura da fase de \u00f3leo e \u00e1gua para garantir o efeito de emulsifica\u00e7\u00e3o.<\/li>\n
    3. Se houver mat\u00e9rias-primas perigosas para a produ\u00e7\u00e3o de produtos farmac\u00eauticos, instalaremos isoladores na \u00e1rea de alimenta\u00e7\u00e3o do sistema de prepara\u00e7\u00e3o para garantir a esterilidade do processo de alimenta\u00e7\u00e3o de API e a prote\u00e7\u00e3o do pessoal.<\/li>\n
    4. Os tanques de mistura est\u00e3o dispon\u00edveis em projetos com formatos especiais para atingir volumes m\u00ednimos de mistura muito baixos.<\/li>\n
    5. Para produtos em suspens\u00e3o, adotaremos o projeto de tubula\u00e7\u00e3o circulante para evitar a composi\u00e7\u00e3o irregular do produto devido \u00e0 sedimenta\u00e7\u00e3o de part\u00edculas suspensas no agente farmac\u00eautico causada pelo enchimento prolongado.<\/li>\n<\/ol>\n

       <\/p>\n

      Sistema de prepara\u00e7\u00e3o biol\u00f3gica<\/h3>\n
        \n
      1. O sistema de prepara\u00e7\u00e3o se comunica com o sistema de fermenta\u00e7\u00e3o e o sistema de purifica\u00e7\u00e3o e pode fornecer automaticamente o meio de cultura e o l\u00edquido auxiliar purificado para a posi\u00e7\u00e3o especificada e pode ser alternado com flexibilidade.<\/li>\n
      2. A estrutura de a\u00e7o e os tanques do sistema de prepara\u00e7\u00e3o podem ser colocados em \u00e1reas de Classe C e Classe B, respectivamente, reduzindo o risco de contamina\u00e7\u00e3o devido ao manuseio pelo pessoal.<\/li>\n
      3. Usamos v\u00e1lvulas duplas e unidade de feedback de v\u00e1lvula nas partes principais do equipamento, para que n\u00e3o haja risco de contamina\u00e7\u00e3o cruzada entre a limpeza e a tubula\u00e7\u00e3o de material.<\/li>\n
      4. O sistema \u00e9 equipado com um tanque de coleta ass\u00e9ptica e o cartucho do filtro de l\u00edquido pode ser testado on-line quanto \u00e0 integridade ap\u00f3s o SIP, em conformidade com as normas GMP da UE e FDA<\/li>\n<\/ol>\n

        O equipamento adota o sistema de controle autom\u00e1tico SCADA, que pode monitorar e controlar o equipamento de campo a qualquer momento e realizar a aquisi\u00e7\u00e3o de dados, o controle do equipamento, a medi\u00e7\u00e3o, o ajuste de par\u00e2metros e todos os tipos de alarmes de sinal, etc. na sala de controle central.<\/p>","protected":false},"excerpt":{"rendered":"

        O Sistema de Formula\u00e7\u00e3o Farmac\u00eautica \u00e9 um tipo de equipamento farmac\u00eautico usado para misturar e dispensar l\u00edquidos, adicionando um API a um solvente, como \u00e1gua para inje\u00e7\u00e3o, e depois formulando-o em um agente farmac\u00eautico que atenda \u00e0 concentra\u00e7\u00e3o desejada ap\u00f3s agita\u00e7\u00e3o, aquecimento, esteriliza\u00e7\u00e3o e filtragem.<\/p>","protected":false},"featured_media":171526,"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":"","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":"set","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 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