{"id":962,"date":"2026-02-22T17:25:38","date_gmt":"2026-02-22T22:25:38","guid":{"rendered":"https:\/\/www.grupoc4.co\/certificacoes\/"},"modified":"2026-05-03T15:02:47","modified_gmt":"2026-05-03T20:02:47","slug":"certificacoes","status":"publish","type":"page","link":"https:\/\/www.grupoc4.co\/pt-br\/certificacoes\/","title":{"rendered":"Certifica\u00e7\u00f5es"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"962\" class=\"elementor elementor-962 elementor-32\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0720136 e-con-full e-flex e-con e-parent\" data-id=\"0720136\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e78bc45 elementor-widget__width-inherit elementor-widget elementor-widget-html\" data-id=\"e78bc45\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t\t<style>.c4ce{\n  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rgba(0,61,109,0.06)}\n.c4ce .norm-card h3{font-family:var(--fn-d);font-size:0.88rem;font-weight:700;color:var(--c4-navy);margin-bottom:6px}\n.c4ce .norm-card p{font-size:0.8rem;color:var(--tx-body);line-height:1.6}\n.c4ce .norm-tag{display:inline-block;font-family:var(--fn-d);font-size:0.62rem;font-weight:600;padding:4px 10px;border-radius:60px;background:rgba(0,134,192,0.06);color:var(--c4-cyan);margin-bottom:8px}\n.c4ce .res-placeholder{background:var(--c4-ice);border-radius:var(--r-lg);padding:48px;text-align:center;color:var(--tx-muted);font-size:0.88rem}\n@media(max-width:900px){.c4ce .card-grid{grid-template-columns:repeat(2,1fr)}.c4ce .norm-grid{grid-template-columns:1fr}}\n@media(max-width:600px){.c4ce .card-grid{grid-template-columns:1fr}}\n<\/style><div class=\"c4ce\"><div class=\"breadcrumbs\"><div class=\"container\"><a href=\"\/\">Inicio<\/a><span class=\"sep\">\u203a<\/span><a href=\"https:\/\/www.grupoc4.co\/pt-br\/sobre-nos\/\">Empresa<\/a><span class=\"sep\">\u203a<\/span><span>Certificaciones<\/span><\/div><\/div><section class=\"page-hero\"><div class=\"container\"><div class=\"sec-label rv\"><div class=\"sec-dot\"><\/div><span class=\"label\">Cumplimiento internacional<\/span><\/div><h1 class=\"rv rv-d1\">Certificaciones <span>y normativas<\/span><\/h1><p class=\"rv rv-d2\">Todos nuestros equipos se dise\u00f1an, fabrican y validan bajo las normativas internacionales m\u00e1s exigentes. Proporcionamos documentaci\u00f3n de calificaci\u00f3n y trazabilidad completa para cada proyecto.<\/p><\/div><\/section><section class=\"section\"><div class=\"container\"><div class=\"sec-label rv\"><div class=\"sec-dot\"><\/div><span class=\"label\">Normas aplicables<\/span><\/div><h2 class=\"rv\">Normativas internacionales que cumplimos<\/h2><p class=\"lead rv\">Nuestro compromiso con la calidad se refleja en el cumplimiento riguroso de est\u00e1ndares reconocidos mundialmente para equipos de control de contaminaci\u00f3n.<\/p><div class=\"norm-grid\"><div class=\"norm-card rv\"><span class=\"norm-tag lab\">Cabinas de laboratorio<\/span><h3>NSF\/ANSI 49<\/h3><p>Est\u00e1ndar norteamericano para dise\u00f1o, construcci\u00f3n, rendimiento y certificaci\u00f3n de campo de cabinas de bioseguridad Clase II. Define pruebas de contenci\u00f3n, velocidad de flujo y hermeticidad.<\/p><div class=\"applies\">Aplica a: Cabinas de Bioseguridad<\/div><\/div><div class=\"norm-card rv\"><span class=\"norm-tag lab\">Cabinas de laboratorio<\/span><h3>EN 12469<\/h3><p>Norma europea que especifica los requisitos de rendimiento para cabinas de seguridad microbiol\u00f3gica, incluyendo protecci\u00f3n del operador, del producto y contaminaci\u00f3n cruzada.<\/p><div class=\"applies\">Aplica a: Cabinas de Bioseguridad<\/div><\/div><div class=\"norm-card rv\"><span class=\"norm-tag lab\">Cabinas de laboratorio<\/span><h3>ASHRAE 110<\/h3><p>M\u00e9todo est\u00e1ndar para evaluar el rendimiento de contenci\u00f3n de cabinas extractoras de laboratorio mediante pruebas de velocidad frontal, visualizaci\u00f3n de humo y prueba con trazador SF\u2086.<\/p><div class=\"applies\">Aplica a: Cabinas Extractoras de Gases<\/div><\/div><div class=\"norm-card rv\"><span class=\"norm-tag lab\">Cabinas de laboratorio<\/span><h3>EN 14175<\/h3><p>Norma europea para cabinas de extracci\u00f3n de gases de laboratorio. Establece requisitos de dise\u00f1o, seguridad, m\u00e9todo de prueba de contenci\u00f3n y rendimiento aerodin\u00e1mico.<\/p><div class=\"applies\">Aplica a: Cabinas Extractoras de Gases<\/div><\/div><div class=\"norm-card rv\"><span class=\"norm-tag hvac\">HVAC \/ Filtraci\u00f3n<\/span><h3>ISO 14644<\/h3><p>Norma internacional que define la clasificaci\u00f3n de limpieza del aire en salas limpias y ambientes controlados (ISO Clase 1 a 9). Base para dise\u00f1o de cuartos limpios farmac\u00e9uticos e industriales.<\/p><div class=\"applies\">Aplica a: UMAs, M\u00f3dulos de Flujo Laminar, Cuartos Limpios<\/div><\/div><div class=\"norm-card rv\"><span class=\"norm-tag hvac\">HVAC \/ Filtraci\u00f3n<\/span><h3>ISO 16890<\/h3><p>Sistema de clasificaci\u00f3n para filtros de part\u00edculas en ventilaci\u00f3n general. Clasifica filtros seg\u00fan eficiencia para part\u00edculas PM\u2081, PM\u2082.\u2085 y PM\u2081\u2080.<\/p><div class=\"applies\">Aplica a: Filtros y Sistemas de Filtraci\u00f3n, UMAs<\/div><\/div><div class=\"norm-card rv\"><span class=\"norm-tag gmp\">GMP \/ Farmac\u00e9utico<\/span><h3>FDA 21 CFR \/ EMA GMP Annex 1<\/h3><p>Regulaciones de Buenas Pr\u00e1cticas de Manufactura para la industria farmac\u00e9utica. Definen requerimientos de aire, diferenciales de presi\u00f3n y clasificaci\u00f3n de \u00e1reas para producci\u00f3n de medicamentos.<\/p><div class=\"applies\">Aplica a: Todos los equipos para sector farmac\u00e9utico<\/div><\/div><div class=\"norm-card rv\"><span class=\"norm-tag gmp\">GMP \/ Farmac\u00e9utico<\/span><h3>ISPE HVAC<\/h3><p>Gu\u00eda de la Sociedad Internacional de Ingenier\u00eda Farmac\u00e9utica para dise\u00f1o de sistemas HVAC en instalaciones farmac\u00e9uticas. Referencia para el dimensionamiento de UMAs y cascadas de presi\u00f3n.<\/p><div class=\"applies\">Aplica a: UMAs GMP, dise\u00f1o de cuartos limpios<\/div><\/div><div class=\"norm-card rv\"><span class=\"norm-tag safety\">Seguridad<\/span><h3>OSHA \/ ACGIH<\/h3><p>Regulaciones de seguridad ocupacional y directrices de higiene industrial para l\u00edmites de exposici\u00f3n a qu\u00edmicos, part\u00edculas y agentes biol\u00f3gicos en el lugar de trabajo.<\/p><div class=\"applies\">Aplica a: Cabinas Extractoras, Campanas, Scrubbers<\/div><\/div><div class=\"norm-card rv\"><span class=\"norm-tag safety\">Seguridad<\/span><h3>NFPA 30 \/ 45<\/h3><p>Est\u00e1ndares de la Asociaci\u00f3n Nacional de Protecci\u00f3n contra Incendios para almacenamiento de l\u00edquidos inflamables (NFPA 30) y uso de qu\u00edmicos en laboratorios (NFPA 45).<\/p><div class=\"applies\">Aplica a: Gabinetes de Almacenamiento de Reactivos<\/div><\/div><\/div><\/div><\/section><section class=\"section-alt\"><div class=\"container\"><div class=\"sec-label rv\"><div class=\"sec-dot\"><\/div><span class=\"label\">Proceso de calificaci\u00f3n<\/span><\/div><h2 class=\"rv\">Validaci\u00f3n y documentaci\u00f3n<\/h2><p class=\"lead rv\">Proporcionamos documentaci\u00f3n completa de calificaci\u00f3n para cada equipo, asegurando trazabilidad y cumplimiento regulatorio desde la f\u00e1brica hasta su instalaci\u00f3n.<\/p><div class=\"qual-steps\"><div class=\"qual-step rv\"><div class=\"step-num\">DQ<\/div><h4>Calificaci\u00f3n de Dise\u00f1o<\/h4><p>Verificaci\u00f3n de que el dise\u00f1o del equipo cumple los requerimientos del usuario (URS) y las normativas aplicables.<\/p><\/div><div class=\"qual-step rv rv-d1\"><div class=\"step-num\">IQ<\/div><h4>Calificaci\u00f3n de Instalaci\u00f3n<\/h4><p>Verificaci\u00f3n documentada de que el equipo est\u00e1 instalado seg\u00fan especificaciones y en conformidad con el dise\u00f1o aprobado.<\/p><\/div><div class=\"qual-step rv rv-d2\"><div class=\"step-num\">OQ<\/div><h4>Calificaci\u00f3n Operacional<\/h4><p>Pruebas de rendimiento: velocidad de flujo, conteo de part\u00edculas, integridad de filtros, presi\u00f3n diferencial y hermeticidad.<\/p><\/div><div class=\"qual-step rv rv-d3\"><div class=\"step-num\">PQ<\/div><h4>Calificaci\u00f3n de Desempe\u00f1o<\/h4><p>Verificaci\u00f3n de que el equipo funciona consistentemente dentro de los par\u00e1metros durante condiciones de operaci\u00f3n reales.<\/p><\/div><\/div><\/div><\/section><section class=\"section\"><div class=\"container\" style=\"text-align:center\"><h2 class=\"rv\">\u00bfNecesita documentaci\u00f3n de validaci\u00f3n?<\/h2><p class=\"lead rv\" style=\"margin:0 auto 24px\">Todos nuestros equipos pueden incluir protocolos DQ\/IQ\/OQ\/PQ adaptados a sus requerimientos regulatorios espec\u00edficos. Consulte con nuestro equipo.<\/p><a href=\"https:\/\/www.grupoc4.co\/pt-br\/contato\/\" class=\"btn btn-glow rv rv-d1\">Solicitar informaci\u00f3n \u2192<\/a><\/div><\/section><section class=\"cta-band\"><div class=\"container\"><h2>\u00bfNecesita asesor\u00eda t\u00e9cnica para su proyecto?<\/h2><p>Nuestro equipo de ingenieros est\u00e1 listo para ayudarle a encontrar la soluci\u00f3n ideal.<\/p><a href=\"https:\/\/www.grupoc4.co\/pt-br\/contato\/\" class=\"btn btn-glow\">Hablar con un ingeniero \u2192<\/a><\/div><\/section><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Inicio\u203aEmpresa\u203aCertificaciones Cumplimiento internacional Certificaciones y normativas Todos nuestros equipos se dise\u00f1an, fabrican y validan bajo las normativas internacionales m\u00e1s exigentes. Proporcionamos documentaci\u00f3n de calificaci\u00f3n y trazabilidad completa para cada proyecto. Normas aplicables Normativas internacionales que cumplimos Nuestro compromiso con la calidad se refleja en el cumplimiento riguroso de est\u00e1ndares reconocidos mundialmente para equipos de control [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"content-type":"","site-sidebar-layout":"no-sidebar","site-content-layout":"","ast-site-content-layout":"full-width-container","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":"disabled","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-962","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Certifica\u00e7\u00f5es e Normativas | C4 \u2014 Conformidade Internacional<\/title>\n<meta name=\"description\" content=\"Certifica\u00e7\u00f5es e normativas internacionais da C4. 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