{"id":62,"date":"2026-07-20T01:16:57","date_gmt":"2026-07-20T01:16:57","guid":{"rendered":"https:\/\/fenggu-bio.com\/products\/aseptic-filling-isolator\/"},"modified":"2026-10-04T14:54:41","modified_gmt":"2026-10-04T14:54:41","slug":"aseptic-filling-isolator","status":"publish","type":"page","link":"https:\/\/fenggu-bio.com\/de\/products\/aseptic-filling-isolator\/","title":{"rendered":"Isolator f\u00fcr die aseptische Abf\u00fcllung"},"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:1160px;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:1.6}\n.fg-page h2{font-size:27px;color:#002B78;margin:0 0 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20px;font-size:14.5px;color:#3a4658;margin-top:24px}\n.fg-rel{display:grid;grid-template-columns:repeat(3,1fr);gap:18px;margin-top:30px}\n.fg-rel a{background:#fff;border:1px solid #dbe3f0;border-radius:10px;padding:18px 20px;text-decoration:none;transition:.18s;display:block}\n.fg-rel a:hover{box-shadow:0 6px 20px rgba(0,58,161,.13);transform:translateY(-2px)}\n.fg-rel .m{font-family:Consolas,monospace;font-size:11.5px;color:#EC001B;font-weight:700}\n.fg-rel .t{font-size:15px;color:#002B78;font-weight:600;margin-top:5px}\n.fg-cta{background:linear-gradient(rgba(0,22,60,.9),rgba(0,35,100,.9)),url(\/wp-content\/uploads\/site\/scene3.jpg) center\/cover;color:#fff;text-align:center}\n.fg-cta h2{color:#fff;font-size:30px}.fg-cta p{color:#dce7f7;font-size:16.5px;max-width:600px;margin:8px auto 26px}\n@media(max-width:900px){.fg-dtop{grid-template-columns:1fr;gap:26px}.fg-dhero h1{font-size:27px}.fg-rel{grid-template-columns:1fr}}\n<\/style>\n<div class=\"fg-page\">\n<section class=\"fg-full fg-dhero\">\n<div class=\"fg-wrap\">\n<div class=\"fg-crumb\"><a href=\"\/de\/\">Startseite<\/a> \u203a <a href=\"\/de\/products\/\">Produkte<\/a> Aseptischer F\u00fcllisolator<\/div>\n<div class=\"fg-dtop\">\n<div>\n      <span class=\"fg-series-tag\">Isolations- und Absperrsysteme<\/span><br \/>\n      <span class=\"fg-mdl\">FG-ISO-F<\/span><\/p>\n<h1>Isolator f\u00fcr die aseptische Abf\u00fcllung<\/h1>\n<p class=\"sub\">Eine vollst\u00e4ndig abgeschlossene Umgebung der Klasse A (ISO 5) f\u00fcr die sterile F\u00fcllung, Versiegelung und Abdeckung von Injektionsmitteln und Biologika \u2013 wodurch die gr\u00f6\u00dfte Ursache f\u00fcr Kontamination in der aseptischen Verarbeitung beseitigt wird: die menschliche Intervention.<\/p>\n<p>      <a class=\"fg-btn fg-btn-p\" href=\"\/de\/contact\/\">Angebot anfordern<\/a><br \/>\n      <a class=\"fg-btn fg-btn-o\" href=\"\/de\/products\/\">Alle Produkte<\/a>\n    <\/div>\n<p>    <img width=\"1600\" height=\"1200\" decoding=\"async\" src=\"\/wp-content\/uploads\/site\/real-af-1.jpg\" alt=\"Fenggu Aseptische F\u00fcllisolator FG-ISO-F\">\n  <\/div>\n<\/div>\n<\/section>\n<section class=\"fg-sec\">\n<div class=\"fg-wrap fg-body\">\n<h2>\u00dcbersicht<\/h2>\n<p class=\"fg-lead\" style=\"max-width:none\">Der Fenggu-Aseptik-F\u00fcllisolator bietet eine vollst\u00e4ndig geschlossene Umgebung der Klasse A (ISO 5) f\u00fcr die sterile F\u00fcllung, Abstopfung und Verschlie\u00dfung von Injektions- und Biologika. Durch die physische Trennung des Bedieners von der kritischen Zone wird die gr\u00f6\u00dfte Kontaminationsquelle in der aseptischen Verarbeitung beseitigt \u2013 der menschliche Eingriff \u2013, w\u00e4hrend ein integrierter VHP-System die exponierten Innenfl\u00e4chen bis zu einer festgelegten 6-Log-Reduktion (entspricht einer 99,9999% -fachen Inaktivierung) biologisch reinigt \u2013 vorbehaltlich einer Zyklusvalidierung \u2013 vor jeder Kampagne. Ein einseitiger lamin\u00e4rer Luftstrom, H14 HEPA-Filterung und kontinuierliche Druck- und Partikel\u00fcberwachung halten den Prozess in einem dokumentierten, reproduzierbaren Zustand, der darauf ausgelegt ist, die geltenden cGMP-Anforderungen zu unterst\u00fctzen, einschlie\u00dflich der EU-GMP-Anlage 1; die Einhaltung wird f\u00fcr die gelieferte Konfiguration und ihre Qualifizierungspapiere best\u00e4tigt.<\/p>\n<p class=\"fg-lead\" style=\"max-width:none;margin-top:14px\">Each isolator is engineered around the customer&#8217;s filling line, with configurable chamber length, glove-port layout, SUS316L product-contact surfaces and control interface. Turnkey integration with existing filling and lyophilization equipment is available.<\/p>\n<h2 style=\"margin-top:44px\">Hauptmerkmale<\/h2>\n<ul class=\"fg-tlist\">\n<li>Stufe A \/ ISO 5-Unidirektionaler Laminarstrom \u00fcber die gesamte F\u00fcllzone<\/li>\n<li>Integrierte VHP-Biodekontamination von exponierten Innenfl\u00e4chen \u2013 6-Log-Reduktion (99,9999%), unterliegt einer Validierung des Zyklus<\/li>\n<li>H14-HEPA-Filterung an der Zuf\u00fchrung und am Abgassystem; Echtzeit\u00fcberwachung der Luftgeschwindigkeit, Temperatur, Luftfeuchtigkeit, Differenzdruck, Partikelanzahl und lebensf\u00e4higer Luftschadstoffbelastung<\/li>\n<li>Automatische Leckpr\u00fcfung der Kammer durch Druckabfall; Pr\u00fcfung der Handschutzintegrit\u00e4t f\u00fcr die installierten Handschutzsysteme<\/li>\n<li>Steuerung mit Siemens-PLC mit elektronischen Signaturen und Audit-Trails gem\u00e4\u00df FDA 21 CFR Part 11<\/li>\n<li>Eigene Arbeitskammerabmessungen und Handschuhkonfiguration, die den F\u00fclllinien entsprechen<\/li>\n<\/ul>\n<div class=\"fg-note\">Jeder aseptische F\u00fcllisolator wurde speziell f\u00fcr Ihre spezifische F\u00fclllinie entwickelt. Die Kammerl\u00e4nge, die Handhandschlaufeinrichtung, der Druckregime und die Integration der Ger\u00e4te sind so konfiguriert, dass sie Ihren Prozess unterst\u00fctzen \u2013 teilen Sie uns Ihre Linieinformationen mit, um eine ma\u00dfgeschneiderte Spezifikation und ein Datenblatt zu erhalten.<\/div>\n<\/div>\n<\/section>\n<section class=\"fg-sec alt\">\n<div class=\"fg-wrap\">\n<h2>Technische Parameter<\/h2>\n<table class=\"fg-spec\">\n<tr>\n<th>Nennleistung (F\u00fcllkammer)<\/th>\n<td>4 kW<\/td>\n<th>Bereich der Druckregelung in der Kammer<\/th>\n<td>\u221280 bis 150 Pa<\/td>\n<\/tr>\n<tr>\n<th>Effektivit\u00e4t der Biodekontamination<\/th>\n<td>\u22656-Log-Reduktion (vorbehaltlich Validierung)<\/td>\n<th>Biodekontaminationsmethode<\/th>\n<td>Verdampftes Wasserstoffperoxid (VHP)<\/td>\n<\/tr>\n<tr>\n<th>Luftgeschwindigkeit<\/th>\n<td>0,36\u20130,54 m\/s<\/td>\n<th>Reinheit der Kammer<\/th>\n<td>Klasse 100 \/ Grad A<\/td>\n<\/tr>\n<tr>\n<th>Gr\u00f6\u00dfe der F\u00fcllkammer (L\u00d7B\u00d7H)<\/th>\n<td>1900 \u00d7 950 \u00d7 2400 mm (zus\u00e4tzliche Gr\u00f6\u00dfen erh\u00e4ltlich)<\/td>\n<th>Gr\u00f6\u00dfe der Transferkammer (L\u00d7B\u00d7H)<\/th>\n<td>700 \u00d7 950 \u00d7 2400 mm (individuelle Gr\u00f6\u00dfen erh\u00e4ltlich)<\/td>\n<\/tr>\n<\/table>\n<\/div>\n<\/section>\n<section class=\"fg-sec\">\n<div class=\"fg-wrap\">\n<h2>Antr\u00e4ge<\/h2>\n<div class=\"fg-chips\">\n    <span>Steriles Injektionsf\u00fcllmittel<\/span><br \/>\n    <span>Aseptische Herstellung<\/span><br \/>\n    <span>Biologika und Impfstofff\u00fcllung<\/span><br \/>\n    <span>Pulver- und Fl\u00fcssigkeitsdosierung<\/span>\n  <\/div>\n<\/div>\n<\/section>\n<section class=\"fg-sec alt\">\n<div class=\"fg-wrap\">\n<h2>Verwandte Produkte<\/h2>\n<div class=\"fg-rel\">\n    <a href=\"\/de\/products\/sterility-test-isolator\/\"><span class=\"m\">FG-ISO-AF<\/span><\/p>\n<div class=\"t\">Isolator f\u00fcr Sterilit\u00e4tstests<\/div>\n<p><\/a><br \/>\n    <a href=\"\/de\/products\/biosafety-airtight-pass-box\/\"><span class=\"m\">FG-PB-BIO<\/span><\/p>\n<div class=\"t\">Biosicherheits-Durchreichschachtel<\/div>\n<p><\/a><br \/>\n    <a href=\"\/de\/products\/\"><span class=\"m\">Isolatoren<\/span><\/p>\n<div class=\"t\">Alle Isolatoren ansehen \u2192<\/div>\n<p><\/a>\n  <\/div>\n<\/div>\n<\/section>\n<section class=\"fg-full fg-cta fg-sec\">\n<div class=\"fg-wrap\">\n<h2>Anfrage nach einem Datenblatt oder einem Kostenvoranschlag<\/h2>\n<p>Informieren Sie uns \u00fcber Ihre F\u00fclllinie, den F\u00fcllvolumenbedarf und die Anforderungen an die Beh\u00e4lterkapazit\u00e4t, und unsere Ingenieure werden Ihnen eine entsprechende Konfiguration empfehlen.<\/p>\n<p>  <a class=\"fg-btn fg-btn-p\" href=\"\/de\/contact\/\">Kontaktieren Sie unser Team<\/a>\n<\/div>\n<\/section>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Home &rsaquo; 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