{"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\/de\/capabilities\/","title":{"rendered":"Funktionen"},"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=\"\/de\/\">Startseite<\/a> \u203a F\u00e4higkeiten<\/div>\n<p>  <span class=\"fg-eyebrow\">Engineering-F\u00e4higkeiten<\/span><\/p>\n<h1>Von der Designphase bis zur verifizierten Lieferung<\/h1>\n<p>Die gesamte Prozessentwicklung f\u00fcr pharmazeutische Einwegbeh\u00e4lter und Sterilisationsger\u00e4te \u2013 Design, Fertigung, Fabrik\u00fcberpr\u00fcfung, Installation und Validierung \u2013 unter einem einzigen, verantwortlichen Partner.<\/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\">Volle Prozess-Engineering<\/span><\/p>\n<h2>Ein Partner \u2013 von den Anforderungsdefinitionen bis hin zu einem qualifizierten System<\/h2>\n<p class=\"fg-lead\">Wir \u00fcbernehmen die Verantwortung f\u00fcr den gesamten Lebenszyklus, damit die Ger\u00e4te bereit zur Installation, zur Validierung und zur Pr\u00fcfung bereit sind.<\/p>\n<div class=\"fg-flow\">\n<div class=\"f\">\n<div class=\"n\">1<\/div>\n<p><b>Design<\/b><\/p>\n<p>\u00dcberpr\u00fcfung der Anforderungen des Anwenders, Konstruktion und Qualifizierung der Konstruktion gem\u00e4\u00df cGMP-Kriterien<\/p>\n<\/div>\n<div class=\"f\">\n<div class=\"n\">2<\/div>\n<p><b>Fertigung<\/b><\/p>\n<p>In-house Fertigung von Geh\u00e4usen aus SUS304\/316L, Integration der Steuerung und Montage<\/p>\n<\/div>\n<div class=\"f\">\n<div class=\"n\">3<\/div>\n<p><b>FAT<\/b><\/p>\n<p>Fabrik\u00fcberpr\u00fcfung \u2013 Leckage, Luftstrom, VHP und Funktionstests vor dem Versand<\/p>\n<\/div>\n<div class=\"f\">\n<div class=\"n\">4<\/div>\n<p><b>Installieren<\/b><\/p>\n<p>Installierung vor Ort, Anschluss an die Versorgungsleitungen und Installationsqualifizierung<\/p>\n<\/div>\n<div class=\"f\">\n<div class=\"n\">5<\/div>\n<p><b>Validieren<\/b><\/p>\n<p>OQ\/PQ, Dokumentationspaket und Operator-Schulung f\u00fcr den routinem\u00e4\u00dfigen Betrieb<\/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\">Kernf\u00e4higkeiten<\/span><\/p>\n<h2>Die Technik hinter validierbaren Leistungsmerkmalen<\/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>Edelstahl-Herstellung<\/h3>\n<p>Geh\u00e4use aus SUS304 und SUS316L mit abgerundeten Ecken, durchgehenden Schwei\u00dfn\u00e4hten und CIP-tauglichen Oberfl\u00e4chen f\u00fcr einfache Reinigung und Korrosionsbest\u00e4ndigkeit.<\/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 Biodekontamination<\/h3>\n<p>Flash-Verdampfungssysteme VHP, entwickelt f\u00fcr gleichm\u00e4\u00dfige, kondensfrei verteilte Luft und eine best\u00e4tigte Sporenbefreiung um 6-Log, mit einer Luftfeuchtigkeit von \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>Steuerung und Datensicherheit<\/h3>\n<p>Steuerung mit Siemens-PLC und HMI mit Rezeptenmanagement, Alarme und Datenspeicherung f\u00fcr Audit-Trails gem\u00e4\u00df 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>Containment Engineering<\/h3>\n<p>Negative-Pressure-Barrieren, luftdichte Abdichtungen und OEB5-f\u00e4hige Konstruktionen, gepr\u00fcft durch Druckabfall- und SMEPAC-Tests.<\/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>HEPA-Luftbehandlung<\/h3>\n<p>H14 HEPA-Zulauf- und -abgase, einseitiger lamin\u00e4rer Luftstrom und BIBO-sicherer Filterwechsel f\u00fcr eine hohe Luftbehandlungsdichte.<\/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>Validierungssupport<\/h3>\n<p>DQ\/IQ\/OQ\/PQ-Protokolle, Fabrik- und Standort-Eignungspr\u00fcfung sowie komplexe Dokumentationspakete zur Qualifizierung.<\/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\">Standards, die wir erstellen<\/span><\/p>\n<h2>Entwickelt und dokumentiert f\u00fcr weltweite Compliance<\/h2>\n<ul class=\"fg-tlist\">\n<li>cGMP (aktueller Good Manufacturing Practice)<\/li>\n<li>FDA 21 CFR Teil 11 (elektronische Aufzeichnungen und Datensicherheit)<\/li>\n<li>EU-GMP-Anhang 1 (Herstellung von sterilen Produkten)<\/li>\n<li>ISO 14644 (Reinraumklassifizierung)<\/li>\n<li>ISO 10648-2 (Dichtheit der Absperrboxen)<\/li>\n<li>USP 1208 (Validierung des Sterilit\u00e4tstests f\u00fcr Isolatoren)<\/li>\n<li>ISO 14644-7 (separative Ger\u00e4te \/ Isolatoren)<\/li>\n<li>H14 HEPA-Filterung (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>Haben Sie ein Projekt zur Eind\u00e4mmung oder Sterilisation?<\/h2>\n<p>Von einem Einzelisolator bis hin zu einer schl\u00fcsselfertigen Sterilisationsanlage \u2013 wir entwickeln, bauen und validieren entsprechend Ihren Anforderungen.<\/p>\n<p>  <a class=\"fg-btn fg-btn-p\" href=\"\/de\/contact\/\">Starten Sie ein Projekt<\/a><br \/>\n  <a class=\"fg-btn fg-btn-o\" href=\"\/de\/inspection-testing\/\">Pr\u00fcfung und Test<\/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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