{"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\/es\/products\/aseptic-filling-isolator\/","title":{"rendered":"Aislador de llenado as\u00e9ptico"},"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 14px;line-height:1.24}\n.fg-lead{font-size:16px;color:#4a5568}\n.fg-sec{padding:60px 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13px;text-align:left}\ntable.fg-spec th{background:#eff4fb;color:#002B78;font-weight:700;width:23%}\ntable.fg-cmp{border-collapse:collapse;width:100%;margin:8px 0;font-size:14px}\ntable.fg-cmp th,table.fg-cmp td{border:1px solid #d7dfea;padding:11px 14px;text-align:left}\ntable.fg-cmp thead th{background:#002B78;color:#fff}\ntable.fg-cmp td:first-child{font-weight:600;color:#002B78;background:#f6f9fd}\n.fg-win{color:#003AA1;font-weight:700}\n.fg-app{font-size:15.5px;color:#3a4658;max-width:900px}\n.fg-chips{display:flex;flex-wrap:wrap;gap:12px;margin-top:6px}\n.fg-chips span{background:#eff4fb;border:1px solid #cfdcf0;color:#003AA1;font-weight:600;font-size:14.5px;padding:11px 20px;border-radius:8px}\n.fg-note{background:#fff;border:1px solid #dbe3f0;border-left:4px solid #003AA1;border-radius:6px;padding:16px 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=\"\/es\/\">Inicio<\/a> \u203a <a href=\"\/es\/products\/\">Productos<\/a> \u203a Isolatore de llenado as\u00e9ptico<\/div>\n<div class=\"fg-dtop\">\n<div>\n      <span class=\"fg-series-tag\">Sistemas de aislamiento y barreras<\/span><br \/>\n      <span class=\"fg-mdl\">FG-ISO-F<\/span><\/p>\n<h1>Aislador de llenado as\u00e9ptico<\/h1>\n<p class=\"sub\">Un entorno totalmente cerrado de clase A (ISO 5) para el llenado, el cierre y el tap\u00f3n est\u00e9ril de productos inyectables y biol\u00f3gicos \u2014 eliminando la principal fuente de contaminaci\u00f3n en el proceso as\u00e9ptico: la intervenci\u00f3n humana.<\/p>\n<p>      <a class=\"fg-btn fg-btn-p\" href=\"\/es\/contact\/\">Solicitar un presupuesto<\/a><br \/>\n      <a class=\"fg-btn fg-btn-o\" href=\"\/es\/products\/\">Todos los productos<\/a>\n    <\/div>\n<p>    <img width=\"1600\" height=\"1200\" decoding=\"async\" src=\"\/wp-content\/uploads\/site\/real-af-1.jpg\" alt=\"Insulet Fenggu Aseptic Filling Isolator FG-ISO-F\">\n  <\/div>\n<\/div>\n<\/section>\n<section class=\"fg-sec\">\n<div class=\"fg-wrap fg-body\">\n<h2>Resumen<\/h2>\n<p class=\"fg-lead\" style=\"max-width:none\">El aislador de llenado as\u00e9ptico Fenggu proporciona un entorno totalmente cerrado de grado A (ISO 5) para el llenado, el cierre y el tap\u00f3n de inyectables y biol\u00f3gicos. Al separar f\u00edsicamente al operador de la zona cr\u00edtica, elimina la fuente m\u00e1s importante de contaminaci\u00f3n en el proceso as\u00e9ptico: la intervenci\u00f3n humana, mientras que un sistema integrado de VHP desinfecciona biol\u00f3gicamente las superficies interiores expuestas hasta una reducci\u00f3n especificada de 6 log (equivalente a una inactivaci\u00f3n de 99,9999%), sujeto a validaci\u00f3n de ciclo, antes de cada campa\u00f1a. El flujo laminar unidireccional, la filtraci\u00f3n H14 HEPA y la monitorizaci\u00f3n continua de presi\u00f3n y part\u00edculas mantienen el proceso en un estado documentado y reproducible dise\u00f1ado para cumplir los requisitos aplicables del cGMP, incluidos el Anexo 1 de la UE GMP; la conformidad se confirma para la configuraci\u00f3n suministrada y su documentaci\u00f3n de calificaci\u00f3n.<\/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\">Caracter\u00edsticas clave<\/h2>\n<ul class=\"fg-tlist\">\n<li>Clase A \/ Flujo laminar unidireccional ISO 5 en toda la zona de llenado<\/li>\n<li>Desinfecci\u00f3n biol\u00f3gica integrada de VHP de superficies interiores expuestas \u2014 reducci\u00f3n de 6 log (99,9999%), sujeto a validaci\u00f3n del ciclo<\/li>\n<li>Filtraci\u00f3n H14 HEPA en la entrada y la salida; monitorizaci\u00f3n en tiempo real de la velocidad del aire, la temperatura, la humedad, la presi\u00f3n diferencial, el n\u00famero de part\u00edculas y la contaminaci\u00f3n viable en el aire<\/li>\n<li>Test autom\u00e1tico de fugas de la c\u00e1mara mediante decaimiento de presi\u00f3n; prueba de integridad de los guantes para los conjuntos de guantes instalados<\/li>\n<li>Control por PLC de Siemens con firmas electr\u00f3nicas y registros de auditor\u00eda especificados para el est\u00e1ndar FDA 21 CFR Parte 11<\/li>\n<li>Dimensiones personalizadas de la c\u00e1mara de trabajo y configuraci\u00f3n de los guantes para adaptarse a la l\u00ednea de llenado<\/li>\n<\/ul>\n<div class=\"fg-note\">Cada aislador de llenado as\u00e9ptico est\u00e1 dise\u00f1ado espec\u00edficamente para su l\u00ednea de llenado. La longitud de la c\u00e1mara, el dise\u00f1o de los puertos de los guantes, el r\u00e9gimen de presi\u00f3n y la integraci\u00f3n del equipo se configuran seg\u00fan su proceso \u2014 comun\u00edquese con nosotros para obtener una especificaci\u00f3n y una hoja de datos adaptados a su l\u00ednea.<\/div>\n<\/div>\n<\/section>\n<section class=\"fg-sec alt\">\n<div class=\"fg-wrap\">\n<h2>Par\u00e1metros t\u00e9cnicos<\/h2>\n<table class=\"fg-spec\">\n<tr>\n<th>Potencia nominal (c\u00e1mara de llenado)<\/th>\n<td>4 kW<\/td>\n<th>Rango de control de presi\u00f3n de la c\u00e1mara<\/th>\n<td>\u221280 a 150 Pa<\/td>\n<\/tr>\n<tr>\n<th>Eficacia de la desinfecci\u00f3n biol\u00f3gica<\/th>\n<td>Reducci\u00f3n \u22656 log (sujeta a validaci\u00f3n)<\/td>\n<th>M\u00e9todo de desinfecci\u00f3n biol\u00f3gica<\/th>\n<td>Per\u00f3xido de hidr\u00f3geno vaporizado (VHP)<\/td>\n<\/tr>\n<tr>\n<th>Velocidad del aire<\/th>\n<td>0,36\u20130,54 m\/s<\/td>\n<th>Limpieza de la c\u00e1mara<\/th>\n<td>Clase 100 \/ Grado A<\/td>\n<\/tr>\n<tr>\n<th>Tama\u00f1o de la c\u00e1mara de llenado (L\u00d7W\u00d7H)<\/th>\n<td>1900 \u00d7 950 \u00d7 2400 mm (tama\u00f1os personalizados disponibles)<\/td>\n<th>Tama\u00f1o de la c\u00e1mara de transferencia (L\u00d7W\u00d7H)<\/th>\n<td>700 \u00d7 950 \u00d7 2400 mm (tama\u00f1os personalizados disponibles)<\/td>\n<\/tr>\n<\/table>\n<\/div>\n<\/section>\n<section class=\"fg-sec\">\n<div class=\"fg-wrap\">\n<h2>Aplicaciones<\/h2>\n<div class=\"fg-chips\">\n    <span>Relleno inyectable est\u00e9ril<\/span><br \/>\n    <span>Compuesto as\u00e9ptico<\/span><br \/>\n    <span>Reemplazo de biol\u00f3gicos y vacunas<\/span><br \/>\n    <span>Dosificaci\u00f3n de polvo y l\u00edquido<\/span>\n  <\/div>\n<\/div>\n<\/section>\n<section class=\"fg-sec alt\">\n<div class=\"fg-wrap\">\n<h2>Productos relacionados<\/h2>\n<div class=\"fg-rel\">\n    <a href=\"\/es\/products\/sterility-test-isolator\/\"><span class=\"m\">FG-ISO-AF<\/span><\/p>\n<div class=\"t\">Aislador para pruebas de esterilidad<\/div>\n<p><\/a><br \/>\n    <a href=\"\/es\/products\/biosafety-airtight-pass-box\/\"><span class=\"m\">FG-PB-BIO<\/span><\/p>\n<div class=\"t\">Caja de transferencia de bioseguridad<\/div>\n<p><\/a><br \/>\n    <a href=\"\/es\/products\/\"><span class=\"m\">Aisladores<\/span><\/p>\n<div class=\"t\">Ver todos los aisladores \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>Solicite una hoja de datos o una cotizaci\u00f3n<\/h2>\n<p>H\u00e1ganos saber su l\u00ednea de llenado, el volumen de llenado y los requisitos de contenci\u00f3n, y nuestros ingenieros recomendar\u00e1n una configuraci\u00f3n.<\/p>\n<p>  <a class=\"fg-btn fg-btn-p\" href=\"\/es\/contact\/\">Contacte nuestro equipo<\/a>\n<\/div>\n<\/section>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Home &rsaquo; Products &rsaquo; Aseptic Filling Isolator Isolation &amp; Barrier Systems FG-ISO-F Aseptic Filling Isolator A fully enclosed Grade A [&hellip;]<\/p>\n","protected":false},"author":0,"featured_media":0,"parent":8,"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 center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-62","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/fenggu-bio.com\/es\/wp-json\/wp\/v2\/pages\/62","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/fenggu-bio.com\/es\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/fenggu-bio.com\/es\/wp-json\/wp\/v2\/types\/page"}],"replies":[{"embeddable":true,"href":"https:\/\/fenggu-bio.com\/es\/wp-json\/wp\/v2\/comments?post=62"}],"version-history":[{"count":7,"href":"https:\/\/fenggu-bio.com\/es\/wp-json\/wp\/v2\/pages\/62\/revisions"}],"predecessor-version":[{"id":436,"href":"https:\/\/fenggu-bio.com\/es\/wp-json\/wp\/v2\/pages\/62\/revisions\/436"}],"up":[{"embeddable":true,"href":"https:\/\/fenggu-bio.com\/es\/wp-json\/wp\/v2\/pages\/8"}],"wp:attachment":[{"href":"https:\/\/fenggu-bio.com\/es\/wp-json\/wp\/v2\/media?parent=62"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}