{"id":9,"date":"2026-07-15T03:18:20","date_gmt":"2026-07-15T03:18:20","guid":{"rendered":"https:\/\/fenggu-bio.com\/capabilities\/"},"modified":"2026-07-20T01:09:09","modified_gmt":"2026-07-20T01:09:09","slug":"capabilities","status":"publish","type":"page","link":"https:\/\/fenggu-bio.com\/pt\/capabilities\/","title":{"rendered":"Capacidades"},"content":{"rendered":"<style>\n.entry-title,.ast-single-post .entry-header{display:none!important}\n.fg-full{width:100vw;position:relative;left:50%;right:50%;margin-left:-50vw;margin-right:-50vw}\n.fg-wrap{max-width:1120px;margin:0 auto;padding:0 24px}\n.fg-page{font-family:-apple-system,BlinkMacSystemFont,\"Segoe UI\",Roboto,\"Helvetica Neue\",Arial,\"PingFang SC\",\"Microsoft YaHei\",sans-serif;color:#1e2838;line-height:1.65}\n.fg-page h2{font-size:29px;color:#002B78;margin:0 0 14px;line-height:1.22}\n.fg-lead{font-size:16.5px;color:#4a5568;max-width:840px}\n.fg-sec{padding:62px 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capability cards *\/\n.fg-grid3{display:grid;grid-template-columns:repeat(3,1fr);gap:22px;margin-top:34px;text-align:left}\n.fg-card{background:#fff;border:1px solid #dbe3f0;border-radius:11px;padding:26px;box-shadow:0 2px 14px rgba(0,58,161,.05)}\n.fg-card svg{width:32px;height:32px;stroke:#003AA1;fill:none;stroke-width:1.6;stroke-linecap:round;stroke-linejoin:round}\n.fg-card .bar{width:40px;height:4px;background:#EC001B;border-radius:2px;margin:14px 0}\n.fg-card h3{color:#002B78;font-size:18px;margin:0 0 8px}\n.fg-card p{font-size:14px;color:#5a6472;margin:0}\n\/* tlist *\/\n.fg-tlist{margin:18px 0 0;padding:0;list-style:none;columns:2;column-gap:44px;max-width:900px}\n.fg-tlist li{font-size:15px;color:#3a4658;padding:8px 0 8px 26px;position:relative;break-inside:avoid}\n.fg-tlist li::before{content:\"\\203A\";position:absolute;left:4px;top:6px;color:#EC001B;font-weight:700;font-size:17px}\n.fg-cta{background:linear-gradient(rgba(0,22,60,.9),rgba(0,35,100,.9)),url(\/wp-content\/uploads\/site\/scene1.jpg) center\/cover;color:#fff;text-align:center}\n.fg-cta h2{color:#fff;font-size:31px}.fg-cta p{color:#dce7f7;font-size:16.5px;max-width:620px;margin:8px auto 26px}\n@media(max-width:900px){.fg-flow{grid-template-columns:1fr 1fr}.fg-grid3{grid-template-columns:1fr}.fg-tlist{columns:1}.fg-phero h1{font-size:31px}.fg-page h2{font-size:23px}}\n<\/style>\n<div class=\"fg-page\">\n<section class=\"fg-full fg-phero\">\n<div class=\"fg-wrap\">\n<div class=\"fg-crumb\"><a href=\"\/pt\/\">In\u00edcio<\/a> Capacidades<\/div>\n<p>  <span class=\"fg-eyebrow\">Capacidades de engenharia<\/span><\/p>\n<h1>Do Design \u00e0 Entrega Validada<\/h1>\n<p>Engenharia completa para equipamentos de conten\u00e7\u00e3o e esteriliza\u00e7\u00e3o farmac\u00eautico \u2014 design, fabrica\u00e7\u00e3o, testes de aceita\u00e7\u00e3o na f\u00e1brica, instala\u00e7\u00e3o e valida\u00e7\u00e3o, sob a responsabilidade de um s\u00f3 parceiro.<\/p>\n<\/div>\n<\/section>\n<p><!-- lifecycle --><\/p>\n<section class=\"fg-sec\">\n<div class=\"fg-wrap fg-center\">\n  <span class=\"fg-tag\">Engenharia de Processo Completo<\/span><\/p>\n<h2>Um parceiro, desde as necessidades do usu\u00e1rio at\u00e9 um sistema qualificado<\/h2>\n<p class=\"fg-lead\">N\u00f3s assumimos a responsabilidade durante todo o ciclo de vida do equipamento, para que ele chegue pronto para instala\u00e7\u00e3o, validado e apto para passar pela inspe\u00e7\u00e3o.<\/p>\n<div class=\"fg-flow\">\n<div class=\"f\">\n<div class=\"n\">1<\/div>\n<p><b>Design<\/b><\/p>\n<p>Revis\u00e3o de requisitos do usu\u00e1rio, projeto de engenharia e qualifica\u00e7\u00e3o do projeto de acordo com os crit\u00e9rios do cGMP<\/p>\n<\/div>\n<div class=\"f\">\n<div class=\"n\">2<\/div>\n<p><b>Fabrica\u00e7\u00e3o<\/b><\/p>\n<p>Fabrica\u00e7\u00e3o interna de corpos em SUS304\/316L, integra\u00e7\u00e3o de controles e montagem<\/p>\n<\/div>\n<div class=\"f\">\n<div class=\"n\">3<\/div>\n<p><b>FAT<\/b><\/p>\n<p>Testes de aceita\u00e7\u00e3o da f\u00e1brica \u2014 verifica\u00e7\u00e3o de vazamento, fluxo de ar, VHP e funcionalidade antes da expedi\u00e7\u00e3o<\/p>\n<\/div>\n<div class=\"f\">\n<div class=\"n\">4<\/div>\n<p><b>Instalar<\/b><\/p>\n<p>Instala\u00e7\u00e3o no local, liga\u00e7\u00e3o \u00e0s redes de servi\u00e7os p\u00fablicos e qualifica\u00e7\u00e3o da instala\u00e7\u00e3o<\/p>\n<\/div>\n<div class=\"f\">\n<div class=\"n\">5<\/div>\n<p><b>Validar<\/b><\/p>\n<p>OQ\/PQ, pacote de documenta\u00e7\u00e3o e treinamento de operadores para opera\u00e7\u00e3o rotineira<\/p>\n<\/div><\/div>\n<\/div>\n<\/section>\n<p><!-- core capabilities --><\/p>\n<section class=\"fg-sec alt\">\n<div class=\"fg-wrap fg-center\">\n  <span class=\"fg-tag\">Capacidades fundamentais<\/span><\/p>\n<h2>A engenharia por tr\u00e1s do desempenho valid\u00e1vel<\/h2>\n<div class=\"fg-grid3\">\n<div class=\"fg-card\"><svg viewbox=\"0 0 24 24\"><path d=\"M12 2l3 3-9 9-3-3zM14 4l6 6-9 9H5v-6z\"\/><\/svg><\/p>\n<div class=\"bar\"><\/div>\n<h3>Fabrica\u00e7\u00e3o de a\u00e7o inoxid\u00e1vel<\/h3>\n<p>Carca\u00e7as em SUS304 e SUS316L com cantos arredondados, soldaduras cont\u00ednuas e superf\u00edcies prontas para CIP, para facilidade de limpeza e resist\u00eancia \u00e0 corros\u00e3o.<\/p>\n<\/div>\n<div class=\"fg-card\"><svg viewbox=\"0 0 24 24\"><path d=\"M3 12c3-4 15-4 18 0M3 12c3 4 15 4 18 0M8 12h.01M16 12h.01\"\/><\/svg><\/p>\n<div class=\"bar\"><\/div>\n<h3>VHP Biodecontamina\u00e7\u00e3o<\/h3>\n<p>Sistemas de vaporiza\u00e7\u00e3o por flash VHP concebidos para uma distribui\u00e7\u00e3o uniforme e sem condensa\u00e7\u00e3o, com uma redu\u00e7\u00e3o comprovada de 6 log de pat\u00f3genos aerados at\u00e9 \u2264 1 ppm.<\/p>\n<\/div>\n<div class=\"fg-card\"><svg viewbox=\"0 0 24 24\"><rect x=\"3\" y=\"4\" width=\"18\" height=\"14\" rx=\"2\"\/><path d=\"M7 8h10M7 12h6M8 21h8M12 18v3\"\/><\/svg><\/p>\n<div class=\"bar\"><\/div>\n<h3>Controles e integridade dos dados<\/h3>\n<p>Controle PLC e HMI da Siemens com gerenciamento de receitas, alarmes e registro de dados em trilha de auditoria compat\u00edveis com a FDA 21 CFR Parte 11.<\/p>\n<\/div>\n<div class=\"fg-card\"><svg viewbox=\"0 0 24 24\"><path d=\"M4 20V10l8-6 8 6v10M4 20h16M9 20v-6h6v6\"\/><\/svg><\/p>\n<div class=\"bar\"><\/div>\n<h3>Engenharia de conten\u00e7\u00e3o<\/h3>\n<p>Barreiras de press\u00e3o negativa, vedas herm\u00e9ticas e projetos compat\u00edveis com OEB5, verificados atrav\u00e9s de testes de decaimento de press\u00e3o e de acordo com o padr\u00e3o SMEPAC.<\/p>\n<\/div>\n<div class=\"fg-card\"><svg viewbox=\"0 0 24 24\"><path d=\"M2 12h4l2-7 4 14 3-9 2 2h5\"\/><\/svg><\/p>\n<div class=\"bar\"><\/div>\n<h3>Processamento de Ar HEPA<\/h3>\n<p>Fornecimento e exaust\u00e3o de ar H14 HEPA, fluxo laminar unidirecional e filtragem segura BIBO para gest\u00e3o de ar de alta conten\u00e7\u00e3o.<\/p>\n<\/div>\n<div class=\"fg-card\"><svg viewbox=\"0 0 24 24\"><path d=\"M9 11l3 3L22 4M21 12v7a2 2 0 0 1-2 2H5a2 2 0 0 1-2-2V5a2 2 0 0 1 2-2h11\"\/><\/svg><\/p>\n<div class=\"bar\"><\/div>\n<h3>Suporte de valida\u00e7\u00e3o<\/h3>\n<p>Protocolos DQ\/IQ\/OQ\/PQ, testes de aceita\u00e7\u00e3o na f\u00e1brica e no local de instala\u00e7\u00e3o, e pacotes completos de documenta\u00e7\u00e3o de qualifica\u00e7\u00e3o.<\/p>\n<\/div><\/div>\n<\/div>\n<\/section>\n<p><!-- standards --><\/p>\n<section class=\"fg-sec\">\n<div class=\"fg-wrap\">\n  <span class=\"fg-tag\">Padr\u00f5es que constru\u00edmos<\/span><\/p>\n<h2>Desenvolvido e documentado para conformidade global<\/h2>\n<ul class=\"fg-tlist\">\n<li>cGMP (Pr\u00e1tica de Fabrica\u00e7\u00e3o Adequada atual)<\/li>\n<li>FDA 21 CFR Parte 11 (registros eletr\u00f4nicos e integridade dos dados)<\/li>\n<li>Anexo 1 da UE GMP (fabrica\u00e7\u00e3o de produtos est\u00e9reis)<\/li>\n<li>ISO 14644 (classifica\u00e7\u00e3o de salas limpas)<\/li>\n<li>ISO 10648-2 (prova de vazamento do recinto de conten\u00e7\u00e3o)<\/li>\n<li>USP 1208 (valida\u00e7\u00e3o do isolador para testes de esterilidade)<\/li>\n<li>ISO 14644-7 (dispositivos separadores \/ isoladores)<\/li>\n<li>Filtragem H14 HEPA (EN 1822)<\/li>\n<\/ul>\n<\/div>\n<\/section>\n<section class=\"fg-full fg-cta fg-sec\">\n<div class=\"fg-wrap\">\n<h2>Voc\u00ea tem um projeto de conten\u00e7\u00e3o ou esteriliza\u00e7\u00e3o?<\/h2>\n<p>De um isolador \u00fanico a uma suite de esteriliza\u00e7\u00e3o pronta para uso, projetamos, constru\u00edmos e validamos de acordo com suas necessidades.<\/p>\n<p>  <a class=\"fg-btn fg-btn-p\" href=\"\/pt\/contact\/\">Iniciar um projeto<\/a><br \/>\n  <a class=\"fg-btn fg-btn-o\" href=\"\/pt\/inspection-testing\/\">Inspe\u00e7\u00e3o e ensaio<\/a>\n<\/div>\n<\/section>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Home &rsaquo; Capabilities Engineering Capabilities From Design to Validated Delivery Full-process engineering for pharmaceutical containment and sterilization equipment \u2014 design, [&hellip;]<\/p>\n","protected":false},"author":0,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"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":"default","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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