{"id":3882,"date":"2024-10-01T17:17:44","date_gmt":"2024-10-01T15:17:44","guid":{"rendered":"https:\/\/amsbiopharma.com\/microbiological-control\/"},"modified":"2026-09-16T06:17:13","modified_gmt":"2026-09-16T04:17:13","slug":"control-microbiologico","status":"publish","type":"page","link":"https:\/\/amsbiopharma.com\/es\/control-microbiologico\/","title":{"rendered":"Microbiolog\u00eda\/ GMP"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"3882\" class=\"elementor elementor-3882 elementor-530\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4fa3706d e-flex e-con-boxed e-con e-parent\" data-id=\"4fa3706d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-27ddc574 e-con-full e-flex e-con e-child\" data-id=\"27ddc574\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-286566f9 e-con-full e-flex e-con e-child\" data-id=\"286566f9\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-68eb73a9 elementor-widget elementor-widget-heading\" data-id=\"68eb73a9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Microbiolog\u00eda\/ GMP<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6cbffae6 e-con-full e-flex e-con e-child\" data-id=\"6cbffae6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-457926eb elementor-widget elementor-widget-text-editor\" data-id=\"457926eb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Servicios de an\u00e1lisis microbiol\u00f3gico para el control de calidad de productos farmac\u00e9uticos, materias primas y entornos de fabricaci\u00f3n.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6406b6b4 e-con-full e-flex e-con e-child\" data-id=\"6406b6b4\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;video&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-5db68516 e-con-full e-flex e-con e-child\" data-id=\"5db68516\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;video&quot;,&quot;background_video_link&quot;:&quot;https:\\\/\\\/amsbiopharma.com\\\/wp-content\\\/uploads\\\/Clip9_MicrobiologicalControl_SM.mp4&quot;,&quot;background_play_on_mobile&quot;:&quot;yes&quot;,&quot;background_video_start&quot;:0,&quot;background_video_end&quot;:6,&quot;background_play_once&quot;:&quot;yes&quot;}\">\n\t\t<div class=\"elementor-background-video-container\">\n\t\t\t\t\t\t\t<video class=\"elementor-background-video-hosted\" role=\"presentation\" autoplay muted playsinline><\/video>\n\t\t\t\t\t<\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-b8b24ec e-flex e-con-boxed e-con e-parent\" data-id=\"b8b24ec\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-c190c0b e-con-full e-flex e-con e-child\" data-id=\"c190c0b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8e05326 elementor-widget elementor-widget-text-editor\" data-id=\"8e05326\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">El <\/span><b>control microbiol\u00f3gico<\/b><span style=\"font-weight: 400;\"> es un requisito de seguridad cr\u00edtico y transversal en toda la cadena de fabricaci\u00f3n farmac\u00e9utica. Desde el control de la <\/span><b>carga microbiana<\/b><span style=\"font-weight: 400;\"> en productos no est\u00e9riles hasta la garant\u00eda de <\/span><b>esterilidad<\/b><span style=\"font-weight: 400;\"> de los productos parenterales, pasando por el control del agua, el entorno de fabricaci\u00f3n, la eficacia de conservantes y la validaci\u00f3n de los procesos de limpieza, la microbiolog\u00eda farmac\u00e9utica abarca un amplio espectro de ensayos cuya correcta ejecuci\u00f3n es determinante para la seguridad del paciente y la conformidad regulatoria del producto.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma proporciona una cartera de servicios de <\/span><b>an\u00e1lisis microbiol\u00f3gico<\/b><span style=\"font-weight: 400;\"> validados conforme a los m\u00e9todos de la <\/span><b>Ph. Eur.<\/b><span style=\"font-weight: 400;\">, la <\/span><b>USP<\/b><span style=\"font-weight: 400;\"> y los requisitos de las <\/span><b>BPF<\/b><span style=\"font-weight: 400;\"> aplicables, cubriendo las principales necesidades de control microbiol\u00f3gico de <\/span><b>sustancias activas<\/b><span style=\"font-weight: 400;\">, <\/span><b>productos farmac\u00e9uticos<\/b><span style=\"font-weight: 400;\">, excipientes, materias primas y entornos de fabricaci\u00f3n. Todos los ensayos se realizan bajo sistemas de documentaci\u00f3n controlada y con personal cualificado, generando datos aptos para su uso en expedientes regulatorios y en los procesos de <\/span><b>liberaci\u00f3n de lotes<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1360fba e-con-full e-flex e-con e-child\" data-id=\"1360fba\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-96531fb elementor-widget elementor-widget-image\" data-id=\"96531fb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"901\" height=\"545\" src=\"https:\/\/amsbiopharma.com\/wp-content\/uploads\/microbiology.png\" class=\"attachment-large size-large wp-image-3650\" alt=\"\" srcset=\"https:\/\/amsbiopharma.com\/wp-content\/uploads\/microbiology.png 901w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/microbiology-300x181.png 300w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/microbiology-768x465.png 768w\" sizes=\"(max-width: 901px) 100vw, 901px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4d84de04 e-con-full e-flex e-con e-parent\" data-id=\"4d84de04\" data-element_type=\"container\" data-e-type=\"container\" id=\"discover-menu-container\">\n\t\t<div class=\"elementor-element elementor-element-14f0a2a3 e-con-full title-container e-flex e-con e-child\" data-id=\"14f0a2a3\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-389147ef elementor-widget elementor-widget-heading\" data-id=\"389147ef\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Descubre<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-10bb03f8 elementor-widget elementor-widget-html\" data-id=\"10bb03f8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8zm144 276c0 6.6-5.4 12-12 12h-92v92c0 6.6-5.4 12-12 12h-56c-6.6 0-12-5.4-12-12v-92h-92c-6.6 0-12-5.4-12-12v-56c0-6.6 5.4-12 12-12h92v-92c0-6.6 5.4-12 12-12h56c6.6 0 12 5.4 12 12v92h92c6.6 0 12 5.4 12 12v56z\"><\/path><\/svg>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-519c63c8 elementor-nav-menu--dropdown-none discover-menu elementor-widget elementor-widget-nav-menu\" data-id=\"519c63c8\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;layout&quot;:&quot;vertical&quot;,&quot;submenu_icon&quot;:{&quot;value&quot;:&quot;&lt;svg aria-hidden=\\&quot;true\\&quot; class=\\&quot;e-font-icon-svg e-fas-caret-down\\&quot; viewBox=\\&quot;0 0 320 512\\&quot; xmlns=\\&quot;http:\\\/\\\/www.w3.org\\\/2000\\\/svg\\&quot;&gt;&lt;path d=\\&quot;M31.3 192h257.3c17.8 0 26.7 21.5 14.1 34.1L174.1 354.8c-7.8 7.8-20.5 7.8-28.3 0L17.2 226.1C4.6 213.5 13.5 192 31.3 192z\\&quot;&gt;&lt;\\\/path&gt;&lt;\\\/svg&gt;&quot;,&quot;library&quot;:&quot;fa-solid&quot;}}\" data-widget_type=\"nav-menu.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<nav aria-label=\"Men\u00fa\" class=\"elementor-nav-menu--main elementor-nav-menu__container elementor-nav-menu--layout-vertical e--pointer-underline e--animation-fade\">\n\t\t\t\t<ul id=\"menu-1-519c63c8\" class=\"elementor-nav-menu sm-vertical\"><li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4099\"><a href=\"https:\/\/amsbiopharma.com\/es\/impurezas-de-medicamentos\/\" class=\"elementor-item\">Impurezas Regulatorias GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4100\"><a href=\"https:\/\/amsbiopharma.com\/es\/soporte-analitico\/\" class=\"elementor-item\">Desarrollo de M\u00e9todos Anal\u00edticos\/ GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4101\"><a href=\"https:\/\/amsbiopharma.com\/es\/analisis-de-biofarmaceuticos-basados-en-proteinas\/\" class=\"elementor-item\">An\u00e1lisis de P\u00e9ptidos y Amino\u00e1cidos\/ NO GLP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4102\"><a href=\"https:\/\/amsbiopharma.com\/es\/analisis-de-biofarmaceuticos-basados-en-acidos-nucleicos\/\" class=\"elementor-item\">Oligonucle\u00f3tidos\/ No GLP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4103\"><a href=\"https:\/\/amsbiopharma.com\/es\/analisis-icp-ms\/\" class=\"elementor-item\">An\u00e1lisis ICP-MS<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4104\"><a href=\"https:\/\/amsbiopharma.com\/es\/control-de-calidad-y-estabilidades\/\" class=\"elementor-item\">Control de Calidad (QC Testing)\/ GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4105\"><a href=\"https:\/\/amsbiopharma.com\/es\/control-microbiologico\/\" class=\"elementor-item\">Microbiolog\u00eda\/ GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4106\"><a href=\"https:\/\/amsbiopharma.com\/es\/cannabis-medicinal\/\" class=\"elementor-item\">Cannabis medicinal<\/a><\/li>\n<\/ul>\t\t\t<\/nav>\n\t\t\t\t\t\t<nav class=\"elementor-nav-menu--dropdown elementor-nav-menu__container\" aria-hidden=\"true\">\n\t\t\t\t<ul id=\"menu-2-519c63c8\" class=\"elementor-nav-menu sm-vertical\"><li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4099\"><a href=\"https:\/\/amsbiopharma.com\/es\/impurezas-de-medicamentos\/\" class=\"elementor-item\" tabindex=\"-1\">Impurezas Regulatorias GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4100\"><a href=\"https:\/\/amsbiopharma.com\/es\/soporte-analitico\/\" class=\"elementor-item\" tabindex=\"-1\">Desarrollo de M\u00e9todos Anal\u00edticos\/ GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4101\"><a href=\"https:\/\/amsbiopharma.com\/es\/analisis-de-biofarmaceuticos-basados-en-proteinas\/\" class=\"elementor-item\" tabindex=\"-1\">An\u00e1lisis de P\u00e9ptidos y Amino\u00e1cidos\/ NO GLP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4102\"><a href=\"https:\/\/amsbiopharma.com\/es\/analisis-de-biofarmaceuticos-basados-en-acidos-nucleicos\/\" class=\"elementor-item\" tabindex=\"-1\">Oligonucle\u00f3tidos\/ No GLP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4103\"><a href=\"https:\/\/amsbiopharma.com\/es\/analisis-icp-ms\/\" class=\"elementor-item\" tabindex=\"-1\">An\u00e1lisis ICP-MS<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4104\"><a href=\"https:\/\/amsbiopharma.com\/es\/control-de-calidad-y-estabilidades\/\" class=\"elementor-item\" tabindex=\"-1\">Control de Calidad (QC Testing)\/ GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4105\"><a href=\"https:\/\/amsbiopharma.com\/es\/control-microbiologico\/\" class=\"elementor-item\" tabindex=\"-1\">Microbiolog\u00eda\/ GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4106\"><a href=\"https:\/\/amsbiopharma.com\/es\/cannabis-medicinal\/\" class=\"elementor-item\" tabindex=\"-1\">Cannabis medicinal<\/a><\/li>\n<\/ul>\t\t\t<\/nav>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9a1cf53 e-con-full e-flex e-con e-parent\" data-id=\"9a1cf53\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-6a725f6 e-con-full e-flex e-con e-child\" data-id=\"6a725f6\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f7175a8 elementor-widget elementor-widget-heading\" data-id=\"f7175a8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Nuestro cat\u00e1logo de servicios incluye<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-b359e11 e-con-full e-grid e-con e-child\" data-id=\"b359e11\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fe8550f elementor-widget elementor-widget-image\" data-id=\"fe8550f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"2156\" height=\"1641\" src=\"https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1.webp\" class=\"attachment-full size-full wp-image-6147\" alt=\"Aplicaciones de Metabol\u00f3mica\" srcset=\"https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1.webp 2156w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1-300x228.webp 300w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1-1024x779.webp 1024w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1-768x585.webp 768w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1-1536x1169.webp 1536w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1-2048x1559.webp 2048w\" sizes=\"(max-width: 2156px) 100vw, 2156px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c757932 elementor-widget elementor-widget-n-accordion\" data-id=\"c757932\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;expanded&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2090\" class=\"e-n-accordion-item\" open>\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"true\" aria-controls=\"e-n-accordion-item-2090\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Control Microbiol\u00f3gico de Productos (TAMC, TYMC) <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-down\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 137-111 248-248 248S8 393 8 256 119 8 256 8s248 111 248 248zM212 140v116h-70.9c-10.7 0-16.1 13-8.5 20.5l114.9 114.3c4.7 4.7 12.2 4.7 16.9 0l114.9-114.3c7.6-7.6 2.2-20.5-8.5-20.5H300V140c0-6.6-5.4-12-12-12h-64c-6.6 0-12 5.4-12 12z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zM140 300h116v70.9c0 10.7 13 16.1 20.5 8.5l114.3-114.9c4.7-4.7 4.7-12.2 0-16.9l-114.3-115c-7.6-7.6-20.5-2.2-20.5 8.5V212H140c-6.6 0-12 5.4-12 12v64c0 6.6 5.4 12 12 12z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2090\" class=\"elementor-element elementor-element-3d23e8d e-con-full e-flex e-con e-child\" data-id=\"3d23e8d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2090\" class=\"elementor-element elementor-element-e66a6b2 e-flex e-con-boxed e-con e-child\" data-id=\"e66a6b2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4fa6768 elementor-widget elementor-widget-text-editor\" data-id=\"4fa6768\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">El <\/span><b>control microbiol\u00f3gico<\/b><span style=\"font-weight: 400;\"> de productos farmac\u00e9uticos no est\u00e9riles es un requisito obligatorio de calidad y seguridad para el paciente. La determinaci\u00f3n del <\/span><b>recuento total de microorganismos aerobios<\/b><span style=\"font-weight: 400;\"> (<\/span><b>TAMC<\/b><span style=\"font-weight: 400;\">) y del <\/span><b>recuento total de levaduras y mohos<\/b><span style=\"font-weight: 400;\"> (<\/span><b>TYMC<\/b><span style=\"font-weight: 400;\">) proporciona la evidencia cuantitativa necesaria para demostrar que el producto cumple con los criterios de aceptaci\u00f3n microbiol\u00f3gicos establecidos en las especificaciones farmacopeicas aplicables, garantizando que la <\/span><b>carga microbiana<\/b><span style=\"font-weight: 400;\"> se encuentra dentro de los l\u00edmites que aseguran la seguridad del producto durante su vida \u00fatil.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma realiza ensayos validados de <\/span><b>TAMC<\/b><span style=\"font-weight: 400;\"> y <\/span><b>TYMC<\/b><span style=\"font-weight: 400;\"> conforme a los m\u00e9todos de la <\/span><b>Ph. Eur.<\/b><span style=\"font-weight: 400;\"> 2.6.12\/2.6.13 y <\/span><b>USP &lt;61&gt;<\/b><span style=\"font-weight: 400;\">\/<\/span><b>USP &lt;62&gt;<\/b><span style=\"font-weight: 400;\">, incluyendo los estudios de idoneidad del m\u00e9todo requeridos para cada tipo de producto y matriz. Los ensayos se realizan bajo condiciones controladas de laboratorio, con personal cualificado y procedimientos documentados conforme a los principios de las <\/span><b>Buenas Pr\u00e1cticas de Fabricaci\u00f3n<\/b><span style=\"font-weight: 400;\"> (<\/span><b>BPF<\/b><span style=\"font-weight: 400;\">).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">La validaci\u00f3n de los m\u00e9todos microbiol\u00f3gicos incluye la evaluaci\u00f3n de la idoneidad del m\u00e9todo para cada tipo de producto, abarcando los ensayos de recuperaci\u00f3n requeridos conforme a la <\/span><b>Ph. Eur.<\/b><span style=\"font-weight: 400;\"> 2.6.12\/2.6.13 y <\/span><b>USP &lt;61&gt;<\/b><span style=\"font-weight: 400;\">\/<\/span><b>USP &lt;62&gt;<\/b><span style=\"font-weight: 400;\">. Los resultados se entregan con documentaci\u00f3n completa de soporte para los programas de <\/span><b>liberaci\u00f3n de lotes<\/b><span style=\"font-weight: 400;\"> y <\/span><b>estabilidad<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><b>Capacidades anal\u00edticas clave:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Recuento total de microorganismos aerobios<\/b><span style=\"font-weight: 400;\"> (<\/span><b>TAMC<\/b><span style=\"font-weight: 400;\">) conforme a <\/span><b>Ph. Eur.<\/b><span style=\"font-weight: 400;\"> 2.6.12 y <\/span><b>USP &lt;61&gt;<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Recuento total de levaduras y mohos<\/b><span style=\"font-weight: 400;\"> (<\/span><b>TYMC<\/b><span style=\"font-weight: 400;\">) conforme a <\/span><b>Ph. Eur.<\/b><span style=\"font-weight: 400;\"> 2.6.13 y <\/span><b>USP &lt;62&gt;<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Aplicable en <\/span><b>sustancias activas<\/b><span style=\"font-weight: 400;\">, <\/span><b>productos farmac\u00e9uticos<\/b><span style=\"font-weight: 400;\">, excipientes y materias primas<\/span><\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2091\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2091\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> An\u00e1lisis de Agua <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-down\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 137-111 248-248 248S8 393 8 256 119 8 256 8s248 111 248 248zM212 140v116h-70.9c-10.7 0-16.1 13-8.5 20.5l114.9 114.3c4.7 4.7 12.2 4.7 16.9 0l114.9-114.3c7.6-7.6 2.2-20.5-8.5-20.5H300V140c0-6.6-5.4-12-12-12h-64c-6.6 0-12 5.4-12 12z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zM140 300h116v70.9c0 10.7 13 16.1 20.5 8.5l114.3-114.9c4.7-4.7 4.7-12.2 0-16.9l-114.3-115c-7.6-7.6-20.5-2.2-20.5 8.5V212H140c-6.6 0-12 5.4-12 12v64c0 6.6 5.4 12 12 12z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2091\" class=\"elementor-element elementor-element-f71d4d4 e-con-full e-flex e-con e-child\" data-id=\"f71d4d4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2091\" class=\"elementor-element elementor-element-33f0a64 e-flex e-con-boxed e-con e-child\" data-id=\"33f0a64\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9b49afb elementor-widget elementor-widget-text-editor\" data-id=\"9b49afb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">El <\/span><b>control microbiol\u00f3gico del agua<\/b><span style=\"font-weight: 400;\"> es un elemento cr\u00edtico del sistema de <\/span><b>garant\u00eda de calidad<\/b><span style=\"font-weight: 400;\"> en cualquier instalaci\u00f3n farmac\u00e9utica. La calidad microbiol\u00f3gica del agua utilizada en la fabricaci\u00f3n \u2014agua purificada (<\/span><b>PW<\/b><span style=\"font-weight: 400;\">), agua para preparaciones inyectables (<\/span><b>WFI<\/b><span style=\"font-weight: 400;\">) y agua altamente purificada (<\/span><b>HPW<\/b><span style=\"font-weight: 400;\">)\u2014 es un <\/span><b>atributo de calidad cr\u00edtico<\/b><span style=\"font-weight: 400;\"> que debe monitorizarse de forma sistem\u00e1tica conforme a los requisitos de la <\/span><b>Ph. Eur.<\/b><span style=\"font-weight: 400;\">, la <\/span><b>USP<\/b><span style=\"font-weight: 400;\"> y las <\/span><b>BPF<\/b><span style=\"font-weight: 400;\"> aplicables.\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma ofrece servicios de <\/span><b>an\u00e1lisis microbiol\u00f3gico de agua<\/b><span style=\"font-weight: 400;\"> aplicando m\u00e9todos conformes con los requisitos farmacopeicos y regulatorios aplicables. Los servicios de an\u00e1lisis de agua cubren la determinaci\u00f3n de la <\/span><b>carga microbiana<\/b><span style=\"font-weight: 400;\"> total (<\/span><b>TAMC<\/b><span style=\"font-weight: 400;\">\/<\/span><b>TYMC<\/b><span style=\"font-weight: 400;\">) y la detecci\u00f3n de microorganismos indicadores, conforme a las especificaciones de calidad del agua establecidas en la <\/span><b>Ph. Eur.<\/b><span style=\"font-weight: 400;\"> y la <\/span><b>USP<\/b><span style=\"font-weight: 400;\"> para cada tipo de agua de uso farmac\u00e9utico.<\/span><\/p>\n<p><b>Capacidades anal\u00edticas clave:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">An\u00e1lisis microbiol\u00f3gico de <\/span><b>agua purificada<\/b><span style=\"font-weight: 400;\"> (<\/span><b>PW<\/b><span style=\"font-weight: 400;\">), <\/span><b>agua para inyectables<\/b><span style=\"font-weight: 400;\"> (<\/span><b>WFI<\/b><span style=\"font-weight: 400;\">) y <\/span><b>agua altamente purificada<\/b><span style=\"font-weight: 400;\"> (<\/span><b>HPW<\/b><span style=\"font-weight: 400;\">)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Determinaci\u00f3n de <\/span><b>TAMC<\/b><span style=\"font-weight: 400;\">\/<\/span><b>TYMC<\/b><span style=\"font-weight: 400;\"> y microorganismos indicadores en agua conforme a <\/span><b>Ph. Eur.<\/b><span style=\"font-weight: 400;\"> y <\/span><b>USP<\/b><\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2092\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2092\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Evaluaci\u00f3n de la Eficacia de Conservantes Antimicrobianos <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-down\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 137-111 248-248 248S8 393 8 256 119 8 256 8s248 111 248 248zM212 140v116h-70.9c-10.7 0-16.1 13-8.5 20.5l114.9 114.3c4.7 4.7 12.2 4.7 16.9 0l114.9-114.3c7.6-7.6 2.2-20.5-8.5-20.5H300V140c0-6.6-5.4-12-12-12h-64c-6.6 0-12 5.4-12 12z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zM140 300h116v70.9c0 10.7 13 16.1 20.5 8.5l114.3-114.9c4.7-4.7 4.7-12.2 0-16.9l-114.3-115c-7.6-7.6-20.5-2.2-20.5 8.5V212H140c-6.6 0-12 5.4-12 12v64c0 6.6 5.4 12 12 12z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2092\" class=\"elementor-element elementor-element-f9b3071 e-con-full e-flex e-con e-child\" data-id=\"f9b3071\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2092\" class=\"elementor-element elementor-element-70d1013 e-flex e-con-boxed e-con e-child\" data-id=\"70d1013\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0dd5659 elementor-widget elementor-widget-text-editor\" data-id=\"0dd5659\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Los <\/span><b>conservantes antimicrobianos<\/b><span style=\"font-weight: 400;\"> son componentes cr\u00edticos de la formulaci\u00f3n en numerosos <\/span><b>productos farmac\u00e9uticos<\/b><span style=\"font-weight: 400;\"> multidosis, incluidas preparaciones oft\u00e1lmicas, parenterales, orales y t\u00f3picas. La demostraci\u00f3n de la <\/span><b>eficacia del conservante<\/b><span style=\"font-weight: 400;\"> \u2014su capacidad para prevenir el crecimiento microbiano y mantener la integridad microbiol\u00f3gica del producto durante su uso y almacenamiento\u2014 es un requisito regulatorio obligatorio que debe evaluarse mediante el <\/span><b>ensayo de eficacia de conservantes antimicrobianos<\/b><span style=\"font-weight: 400;\"> conforme a los m\u00e9todos farmacopeicos aplicables.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma realiza ensayos de <\/span><b>eficacia de conservantes<\/b><span style=\"font-weight: 400;\"> (<\/span><b>Ph. Eur.<\/b><span style=\"font-weight: 400;\"> 5.1.3, <\/span><b>USP &lt;51&gt;<\/b><span style=\"font-weight: 400;\">) utilizando los paneles de microorganismos de desaf\u00edo requeridos por la farmacopea \u2014bacterias, levaduras y mohos\u2014 y aplicando los criterios de aceptaci\u00f3n establecidos para cada categor\u00eda de producto. Los ensayos se realizan con cepas de referencia certificadas y bajo condiciones anal\u00edticas controladas, con documentaci\u00f3n completa de soporte para su inclusi\u00f3n en expedientes regulatorios.<\/span><\/p>\n<p><b>Capacidades anal\u00edticas clave:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Ensayo de eficacia de conservantes antimicrobianos<\/b><span style=\"font-weight: 400;\"> conforme a <\/span><b>Ph. Eur.<\/b><span style=\"font-weight: 400;\"> 5.1.3 y <\/span><b>USP &lt;51&gt;<\/b><\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2093\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"4\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2093\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Cuantificaci\u00f3n de Bioindicadores y Microorganismos <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-down\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 137-111 248-248 248S8 393 8 256 119 8 256 8s248 111 248 248zM212 140v116h-70.9c-10.7 0-16.1 13-8.5 20.5l114.9 114.3c4.7 4.7 12.2 4.7 16.9 0l114.9-114.3c7.6-7.6 2.2-20.5-8.5-20.5H300V140c0-6.6-5.4-12-12-12h-64c-6.6 0-12 5.4-12 12z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zM140 300h116v70.9c0 10.7 13 16.1 20.5 8.5l114.3-114.9c4.7-4.7 4.7-12.2 0-16.9l-114.3-115c-7.6-7.6-20.5-2.2-20.5 8.5V212H140c-6.6 0-12 5.4-12 12v64c0 6.6 5.4 12 12 12z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2093\" class=\"elementor-element elementor-element-fb3bafe e-con-full e-flex e-con e-child\" data-id=\"fb3bafe\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2093\" class=\"elementor-element elementor-element-81f8868 e-flex e-con-boxed e-con e-child\" data-id=\"81f8868\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-95e59f7 elementor-widget elementor-widget-text-editor\" data-id=\"95e59f7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">La <\/span><b>cuantificaci\u00f3n de bioindicadores<\/b><span style=\"font-weight: 400;\"> y microorganismos espec\u00edficos es un componente esencial en diversas aplicaciones de control microbiol\u00f3gico farmac\u00e9utico: la cualificaci\u00f3n y validaci\u00f3n de procesos de esterilizaci\u00f3n, el control de la <\/span><b>carga biol\u00f3gica<\/b><span style=\"font-weight: 400;\"> (<\/span><b>bioburden<\/b><span style=\"font-weight: 400;\">) previa a la esterilizaci\u00f3n, y la monitorizaci\u00f3n de procesos de fabricaci\u00f3n donde el control de microorganismos espec\u00edficos es relevante para la calidad y seguridad del producto.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma proporciona servicios de <\/span><b>cuantificaci\u00f3n de bioindicadores<\/b><span style=\"font-weight: 400;\"> y recuento de microorganismos espec\u00edficos aplicando m\u00e9todos validados adaptados a cada aplicaci\u00f3n concreta. Los <\/span><b>bioindicadores<\/b><span style=\"font-weight: 400;\"> son microorganismos con resistencia definida y caracterizada al proceso de esterilizaci\u00f3n evaluado \u2014habitualmente esporas de <\/span><b>Geobacillus stearothermophilus<\/b><span style=\"font-weight: 400;\"> para esterilizaci\u00f3n por vapor o <\/span><b>Bacillus atrophaeus<\/b><span style=\"font-weight: 400;\"> para esterilizaci\u00f3n por \u00f3xido de etileno\u2014 cuya cuantificaci\u00f3n antes y despu\u00e9s del proceso proporciona evidencia de la efectividad esterilizante.<\/span><\/p>\n<p><b>Capacidades anal\u00edticas clave:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Determinaci\u00f3n del <\/span><b>bioburden<\/b><span style=\"font-weight: 400;\"> previa a la esterilizaci\u00f3n conforme a <\/span><b>Ph. Eur.<\/b><span style=\"font-weight: 400;\"> 2.6.12 y <\/span><b>ISO 11737-1<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Recuento de microorganismos espec\u00edficos en muestras de producto y proceso<\/span><\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2094\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"5\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2094\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> An\u00e1lisis Microbiol\u00f3gico (Endotoxinas Bacterianas, TAMC\/TYMC) <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-down\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 137-111 248-248 248S8 393 8 256 119 8 256 8s248 111 248 248zM212 140v116h-70.9c-10.7 0-16.1 13-8.5 20.5l114.9 114.3c4.7 4.7 12.2 4.7 16.9 0l114.9-114.3c7.6-7.6 2.2-20.5-8.5-20.5H300V140c0-6.6-5.4-12-12-12h-64c-6.6 0-12 5.4-12 12z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zM140 300h116v70.9c0 10.7 13 16.1 20.5 8.5l114.3-114.9c4.7-4.7 4.7-12.2 0-16.9l-114.3-115c-7.6-7.6-20.5-2.2-20.5 8.5V212H140c-6.6 0-12 5.4-12 12v64c0 6.6 5.4 12 12 12z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2094\" class=\"elementor-element elementor-element-3c5f0b9 e-con-full e-flex e-con e-child\" data-id=\"3c5f0b9\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2094\" class=\"elementor-element elementor-element-e3ec513 e-flex e-con-boxed e-con e-child\" data-id=\"e3ec513\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f39da03 elementor-widget elementor-widget-text-editor\" data-id=\"f39da03\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Nuestros servicios de an\u00e1lisis microbiol\u00f3gico cubren el an\u00e1lisis de <\/span><b>endotoxinas bacterianas<\/b><span style=\"font-weight: 400;\"> (<\/span><b>BET<\/b><span style=\"font-weight: 400;\">) y la evaluaci\u00f3n de la <\/span><b>carga microbiana<\/b><span style=\"font-weight: 400;\"> mediante recuento total de microorganismos aerobios (<\/span><b>TAMC<\/b><span style=\"font-weight: 400;\">) y recuento total combinado de levaduras y mohos (<\/span><b>TYMC<\/b><span style=\"font-weight: 400;\">). Todos los an\u00e1lisis se realizan usando m\u00e9todos validados conformes con las especificaciones farmacopeicas aplicables.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">El an\u00e1lisis de <\/span><b>endotoxinas bacterianas<\/b><span style=\"font-weight: 400;\"> se realiza por el m\u00e9todo <\/span><b>LAL<\/b><span style=\"font-weight: 400;\"> (Lisado de Amebocitos de L\u00edmulo) en conformidad con la <\/span><b>Ph. Eur.<\/b><span style=\"font-weight: 400;\"> 2.6.14 y <\/span><b>USP &lt;85&gt;<\/b><span style=\"font-weight: 400;\">, con confirmaci\u00f3n de la idoneidad del m\u00e9todo para cada matriz de producto. El an\u00e1lisis de <\/span><b>carga microbiana<\/b><span style=\"font-weight: 400;\"> por <\/span><b>TAMC<\/b><span style=\"font-weight: 400;\"> y <\/span><b>TYMC<\/b><span style=\"font-weight: 400;\"> se realiza conforme a <\/span><b>Ph. Eur.<\/b><span style=\"font-weight: 400;\"> 2.6.12\/2.6.13 y <\/span><b>USP &lt;61&gt;<\/b><span style=\"font-weight: 400;\">\/<\/span><b>USP &lt;62&gt;<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><b>Capacidades anal\u00edticas clave:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">An\u00e1lisis de <\/span><b>endotoxinas bacterianas<\/b><span style=\"font-weight: 400;\"> (<\/span><b>BET<\/b><span style=\"font-weight: 400;\">) por el m\u00e9todo <\/span><b>LAL<\/b><span style=\"font-weight: 400;\"> conforme a <\/span><b>Ph. Eur.<\/b><span style=\"font-weight: 400;\"> 2.6.14 y <\/span><b>USP &lt;85&gt;<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Recuento total de microorganismos aerobios (<\/span><b>TAMC<\/b><span style=\"font-weight: 400;\">) conforme a <\/span><b>Ph. Eur.<\/b><span style=\"font-weight: 400;\"> 2.6.12 y <\/span><b>USP &lt;61&gt;<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Recuento total de levaduras y mohos (<\/span><b>TYMC<\/b><span style=\"font-weight: 400;\">) conforme a <\/span><b>Ph. Eur.<\/b><span style=\"font-weight: 400;\"> 2.6.13 y <\/span><b>USP &lt;62&gt;<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Idoneidad del m\u00e9todo y validaci\u00f3n espec\u00edfica del producto para todas las matrices<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Aplicable en <\/span><b>sustancias activas<\/b><span style=\"font-weight: 400;\">, <\/span><b>productos farmac\u00e9uticos<\/b><span style=\"font-weight: 400;\">, excipientes y materias primas<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Documentaci\u00f3n completa de validaci\u00f3n para presentaciones regulatorias y auditor\u00edas <\/span><b>BPF<\/b><\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<div class=\"entry-summary\">\nMicrobiolog\u00eda\/ GMP Servicios de an\u00e1lisis microbiol\u00f3gico para el control de calidad de productos farmac\u00e9uticos, materias primas y entornos de fabricaci\u00f3n. El control microbiol\u00f3gico es un requisito de seguridad cr\u00edtico y transversal en toda la cadena de fabricaci\u00f3n farmac\u00e9utica. Desde el&hellip;\n<\/div>\n<div class=\"link-more\"><a href=\"https:\/\/amsbiopharma.com\/es\/control-microbiologico\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &ldquo;Microbiolog\u00eda\/ GMP&rdquo;<\/span>&hellip;<\/a><\/div>\n","protected":false},"author":1,"featured_media":4763,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-3882","page","type-page","status-publish","has-post-thumbnail","hentry","entry"],"_links":{"self":[{"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/pages\/3882","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/comments?post=3882"}],"version-history":[{"count":24,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/pages\/3882\/revisions"}],"predecessor-version":[{"id":6687,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/pages\/3882\/revisions\/6687"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/media\/4763"}],"wp:attachment":[{"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/media?parent=3882"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}