{"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\/es\/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=\"\/es\/\">Inicio<\/a> Capacidades<\/div>\n<p>  <span class=\"fg-eyebrow\">Capacidades de ingenier\u00eda<\/span><\/p>\n<h1>De dise\u00f1o a entrega validada<\/h1>\n<p>Ingenier\u00eda integral para el dise\u00f1o y fabricaci\u00f3n de equipos de contenci\u00f3n y esterilizaci\u00f3n farmac\u00e9uticos \u2014 dise\u00f1o, fabricaci\u00f3n, ensayos de aceptaci\u00f3n en f\u00e1brica, instalaci\u00f3n y validaci\u00f3n \u2014 bajo un \u00fanico socio responsable.<\/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\">Ingenier\u00eda de proceso completo<\/span><\/p>\n<h2>Un partner, desde los requisitos del usuario hasta un sistema cualificado<\/h2>\n<p class=\"fg-lead\">Nos asumimos la responsabilidad durante todo el ciclo de vida del equipo para que llegue listo para instalarse, validarse y pasar la inspecci\u00f3n.<\/p>\n<div class=\"fg-flow\">\n<div class=\"f\">\n<div class=\"n\">1<\/div>\n<p><b>Dise\u00f1o<\/b><\/p>\n<p>Revisi\u00f3n de los requisitos del usuario, dise\u00f1o de ingenier\u00eda y calificaci\u00f3n del dise\u00f1o seg\u00fan los criterios cGMP<\/p>\n<\/div>\n<div class=\"f\">\n<div class=\"n\">2<\/div>\n<p><b>Fabricaci\u00f3n<\/b><\/p>\n<p>Fabricaci\u00f3n interna de cuerpos de acero inoxidable SUS304\/316L, integraci\u00f3n de controles y montaje<\/p>\n<\/div>\n<div class=\"f\">\n<div class=\"n\">3<\/div>\n<p><b>FAT<\/b><\/p>\n<p>Prueba de aceptaci\u00f3n en f\u00e1brica \u2014 verificaci\u00f3n de fugas, flujo de aire, VHP y funcionalidad antes del env\u00edo<\/p>\n<\/div>\n<div class=\"f\">\n<div class=\"n\">4<\/div>\n<p><b>Instalar<\/b><\/p>\n<p>Instalaci\u00f3n in situ, conexi\u00f3n a las redes de servicios p\u00fablicos y homologaci\u00f3n de la instalaci\u00f3n<\/p>\n<\/div>\n<div class=\"f\">\n<div class=\"n\">5<\/div>\n<p><b>Validar<\/b><\/p>\n<p>OQ\/PQ, paquete de documentaci\u00f3n y formaci\u00f3n del operador para el funcionamiento habitual<\/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 b\u00e1sicas<\/span><\/p>\n<h2>La ingenier\u00eda que subyace a un rendimiento validable<\/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>Fabricaci\u00f3n de acero inoxidable<\/h3>\n<p>Carcasas de SUS304 y SUS316L con esquinas redondeadas, soldaduras continuas y superficies preparadas para CIP para una f\u00e1cil limpieza y resistencia a la corrosi\u00f3n.<\/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 Biodecontaminaci\u00f3n<\/h3>\n<p>Sistemas de vaporizaci\u00f3n por flash VHP dise\u00f1ados para una distribuci\u00f3n uniforme y sin condensaci\u00f3n, as\u00ed como una reducci\u00f3n de los esporas de hasta 6 log, aireados hasta \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>Control y integridad de los datos<\/h3>\n<p>Control por PLC y HMI de Siemens con gesti\u00f3n de recetas, alarmas y registro de datos de seguimiento de auditor\u00eda conforme a la FDA 21 CFR Part 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>Ingenier\u00eda de contenci\u00f3n<\/h3>\n<p>Barreras de presi\u00f3n negativa, sellados herm\u00e9ticos y dise\u00f1os compatibles con OEB5, verificados mediante pruebas de decaimiento de presi\u00f3n y seg\u00fan el est\u00e1ndar 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>Control de la calidad del aire mediante HEPA<\/h3>\n<p>Suministro y extracci\u00f3n de H14 HEPA, flujo laminar unidireccional y filtraci\u00f3n segura BIBO para la gesti\u00f3n de aire de alta contenci\u00f3n.<\/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 validaci\u00f3n<\/h3>\n<p>Protocolos DQ\/IQ\/OQ\/PQ, pruebas de aceptaci\u00f3n en f\u00e1brica y en el sitio, y paquetes completos de documentaci\u00f3n de calificaci\u00f3n.<\/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\">Est\u00e1ndares que construimos<\/span><\/p>\n<h2>Dise\u00f1ado y documentado para cumplir con los requisitos globales<\/h2>\n<ul class=\"fg-tlist\">\n<li>cGMP (Buenas Pr\u00e1cticas de Fabricaci\u00f3n actuales)<\/li>\n<li>FDA 21 CFR Parte 11 (registros electr\u00f3nicos e integridad de los datos)<\/li>\n<li>Anexo 1 de la GMP de la UE (fabricaci\u00f3n de productos est\u00e9riles)<\/li>\n<li>ISO 14644 (clasificaci\u00f3n de los espacios limpios)<\/li>\n<li>ISO 10648-2 (rigidez contra fugas en el recinto de contenci\u00f3n)<\/li>\n<li>USP 1208 (validez del aislador para pruebas de esterilidad)<\/li>\n<li>ISO 14644-7 (dispositivos separadores \/ aisladores)<\/li>\n<li>Filtraci\u00f3n 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>\u00bfTiene un proyecto de contenci\u00f3n o esterilizaci\u00f3n?<\/h2>\n<p>De un \u00fanico aislador hasta una suite de esterilizaci\u00f3n llave en mano, dise\u00f1amos, construimos y validamos seg\u00fan sus requisitos.<\/p>\n<p>  <a class=\"fg-btn fg-btn-p\" href=\"\/es\/contact\/\">Inicie un proyecto<\/a><br \/>\n  <a class=\"fg-btn fg-btn-o\" href=\"\/es\/inspection-testing\/\">Inspecci\u00f3n y ensayos<\/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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