{"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\/fr\/capabilities\/","title":{"rendered":"Fonctionnalit\u00e9s"},"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=\"\/fr\/\">Accueil<\/a> Capacit\u00e9s<\/div>\n<p>  <span class=\"fg-eyebrow\">Capacit\u00e9s d'ing\u00e9nierie<\/span><\/p>\n<h1>De la conception \u00e0 la livraison valid\u00e9e<\/h1>\n<p>Ing\u00e9nierie compl\u00e8te des \u00e9quipements de confinement et de st\u00e9rilisation pharmaceutiques \u2014 conception, fabrication, essais d\u2019acceptation de l\u2019usine, installation et validation, sous la responsabilit\u00e9 d\u2019un partenaire unique.<\/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\">Ing\u00e9nierie compl\u00e8te<\/span><\/p>\n<h2>Un partenaire, de la demande de l'utilisateur jusqu'au syst\u00e8me qualifi\u00e9<\/h2>\n<p class=\"fg-lead\">Nous assumons la responsabilit\u00e9 de l'ensemble du cycle de vie des \u00e9quipements afin qu'ils soient pr\u00eats \u00e0 \u00eatre install\u00e9s, \u00e0 \u00eatre valid\u00e9s et \u00e0 passer les contr\u00f4les.<\/p>\n<div class=\"fg-flow\">\n<div class=\"f\">\n<div class=\"n\">1<\/div>\n<p><b>Design<\/b><\/p>\n<p>Revision des exigences des utilisateurs, conception technique et qualification du projet selon les crit\u00e8res cGMP<\/p>\n<\/div>\n<div class=\"f\">\n<div class=\"n\">2<\/div>\n<p><b>Fabrication<\/b><\/p>\n<p>Fabrication interne des corps en SUS304\/316L, contr\u00f4le de l\u2019int\u00e9gration et de l\u2019assemblage<\/p>\n<\/div>\n<div class=\"f\">\n<div class=\"n\">3<\/div>\n<p><b>FAT<\/b><\/p>\n<p>Test d'acceptation de l'usine \u2014 v\u00e9rification des fuites, de la circulation de l'air, de la VHP et de la fonctionnalit\u00e9 avant l'exp\u00e9dition<\/p>\n<\/div>\n<div class=\"f\">\n<div class=\"n\">4<\/div>\n<p><b>Installer<\/b><\/p>\n<p>Installation sur site, connexion aux r\u00e9seaux d\u2019eau et d\u2019\u00e9lectricit\u00e9 et qualification de l\u2019installation<\/p>\n<\/div>\n<div class=\"f\">\n<div class=\"n\">5<\/div>\n<p><b>Valider<\/b><\/p>\n<p>OQ\/PQ, dossier de documentation et formation des op\u00e9rateurs pour une exploitation courante<\/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\">Capacit\u00e9s de base<\/span><\/p>\n<h2>L\u2019ing\u00e9nierie qui sous-tend les performances valables<\/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>Fabrication en acier inoxydable<\/h3>\n<p>Corps en SUS304 et SUS316L avec des angles arrondis, des soudures continues et des surfaces pr\u00eates au CIP pour une facilit\u00e9 d\u2019entretien et une r\u00e9sistance \u00e0 la corrosion.<\/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 Biodecontamination<\/h3>\n<p>Les syst\u00e8mes de vaporisation flash VHP con\u00e7us pour une distribution uniforme et sans condensation, ainsi qu'une r\u00e9duction des spores de 6 log, sont conditionn\u00e9s \u00e0 une concentration maximale de \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>Contr\u00f4les et int\u00e9grit\u00e9 des donn\u00e9es<\/h3>\n<p>Commande par PLC et HMI de Siemens, avec gestion de recettes, alarme et enregistrement des donn\u00e9es de tra\u00e7abilit\u00e9 conformes \u00e0 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>Ing\u00e9nierie de confinement<\/h3>\n<p>Barri\u00e8res \u00e0 pression n\u00e9gative, joints \u00e9tanches et conceptions compatibles avec OEB5, v\u00e9rifi\u00e9es par des essais de d\u00e9gradation de la pression et selon le syst\u00e8me 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>Traitement d'air HEPA<\/h3>\n<p>R\u00e9gulation d'air haute capacit\u00e9 gr\u00e2ce \u00e0 des filtres H14 HEPA pour l'alimentation et l'\u00e9vacuation d'air, un flux laminaire unidirectionnel et une filtration s\u00e9curis\u00e9e BIBO.<\/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>Support de validation<\/h3>\n<p>Protocole DQ\/IQ\/OQ\/PQ, essais de r\u00e9ception en usine et sur site, et dossiers de documentation compl\u00e8te de qualification.<\/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\">Les normes que nous construisons<\/span><\/p>\n<h2>Con\u00e7ue et document\u00e9e pour une conformit\u00e9 mondiale<\/h2>\n<ul class=\"fg-tlist\">\n<li>cGMP (Norme de fabrication actuelle)<\/li>\n<li>FDA 21 CFR Part 11 (enregistrements \u00e9lectroniques et int\u00e9grit\u00e9 des donn\u00e9es)<\/li>\n<li>Annexe 1 de la r\u00e9glementation GMP de l\u2019UE (fabrication de produits st\u00e9riles)<\/li>\n<li>ISO 14644 (classification des salles blanches)<\/li>\n<li>ISO 10648-2 (\u00e9tanch\u00e9it\u00e9 des enceintes de confinement)<\/li>\n<li>USP 1208 (validation de l'isolateur de test de st\u00e9rilit\u00e9)<\/li>\n<li>ISO 14644-7 (dispositifs s\u00e9paratifs \/ isolateurs)<\/li>\n<li>Filtration 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>Avez-vous un projet de confinement ou de st\u00e9rilisation ?<\/h2>\n<p>De l\u2019isolateur individuel \u00e0 la salle de st\u00e9rilisation cl\u00e9 en main, nous concevons, construisons et validons selon vos exigences.<\/p>\n<p>  <a class=\"fg-btn fg-btn-p\" href=\"\/fr\/contact\/\">D\u00e9buter un projet<\/a><br \/>\n  <a class=\"fg-btn fg-btn-o\" href=\"\/fr\/inspection-testing\/\">Inspection et essais<\/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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