{"id":23108,"date":"2019-01-08T13:33:00","date_gmt":"2019-01-08T12:33:00","guid":{"rendered":"https:\/\/kymos.com\/news\/estabilidad-microbiana-en-uso\/"},"modified":"2025-08-07T20:33:26","modified_gmt":"2025-08-07T18:33:26","slug":"estabilidad-microbiana-en-uso","status":"publish","type":"post","link":"https:\/\/kymos.com\/es\/news\/estabilidad-microbiana-en-uso\/","title":{"rendered":"Estabilidad microbiana en uso"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:calc( 1170px + 20px );margin-left: calc(-20px \/ 2 );margin-right: calc(-20px \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:10px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:10px;--awb-width-medium:100%;--awb-spacing-right-medium:10px;--awb-spacing-left-medium:10px;--awb-width-small:100%;--awb-spacing-right-small:10px;--awb-spacing-left-small:10px;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p><span style=\"font-size: 14pt;\">Las pruebas de estabilidad en uso para productos multidosis se basaron inicialmente en la <b>Nota orientativa sobre pruebas de estabilidad en uso de medicamentos humanos<\/b> del CPMP de la EMA, en marzo de 2001. Seg\u00fan esta nota, el objetivo de las pruebas de estabilidad en uso es establecer un per\u00edodo de tiempo durante el cual se puede utilizar un producto multidosis manteniendo la calidad dentro de una especificaci\u00f3n aceptada una vez abierto el envase. <\/span><\/p>\n<div class=\"blog-content\">\n<div class=\"field field-name-body field-type-text-with-summary field-label-hidden\">\n<div class=\"field-items\">\n<div class=\"field-item even\">\n<p><span style=\"font-size: 14pt;\">Posteriormente, la <b>Serie de Informes T\u00e9cnicos de la OMS, No. 953, 2009, Anexo 2, Pruebas de estabilidad de ingredientes farmac\u00e9uticos activos y productos farmac\u00e9uticos terminados<\/b> , defini\u00f3 que el prop\u00f3sito de las pruebas de estabilidad en uso es proporcionar informaci\u00f3n para el etiquetado sobre la preparaci\u00f3n, las condiciones de almacenamiento y el per\u00edodo de utilizaci\u00f3n de los productos multidosis despu\u00e9s de la apertura, reconstituci\u00f3n o diluci\u00f3n de una soluci\u00f3n.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Como se indica en el \u00faltimo documento, las propiedades f\u00edsicas, qu\u00edmicas y microbianas del producto farmac\u00e9utico terminado susceptibles de cambios durante el almacenamiento deben determinarse a lo largo de la vida \u00fatil propuesta. Sin embargo, la posible contaminaci\u00f3n microbiol\u00f3gica de los medicamentos est\u00e9riles es una preocupaci\u00f3n importante. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">El dise\u00f1o de un estudio de estabilidad microbiana en uso de un medicamento inyectable debe tener en cuenta las especificaciones del producto en t\u00e9rminos de fecha de caducidad, condiciones de almacenamiento, temperatura, protecci\u00f3n contra la luz, instrucciones de reconstituci\u00f3n, diluyentes utilizados y cualquier otra informaci\u00f3n relevante. Adem\u00e1s, el protocolo debe simular la forma en que se utilizar\u00e1 el producto en la pr\u00e1ctica cl\u00ednica real. Un procedimiento general se basa en una contaminaci\u00f3n intencional tanto del vial reconstituido como de la bolsa de gran volumen donde se diluye el producto. Se prueban diferentes microorganismos: <i>Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus, Candida albicans, Aspergillus brasiliensis,<\/i> utilizando suspensiones de una concentraci\u00f3n equivalente a 100 UFC\/ml. La contaminaci\u00f3n se mide mediante un procedimiento de filtraci\u00f3n por membrana, que incluye controles negativos y de medios, y el recuento microbiano generalmente se realiza en tres momentos: tiempo inicial, tiempo final de uso esperado y un per\u00edodo mayor. Se considera un resultado positivo si la poblaci\u00f3n microbiana de las muestras dentro de este per\u00edodo no aumenta m\u00e1s de 0,5 log <sup>10<\/sup> .     <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Si desea conocer m\u00e1s sobre nuestros servicios en estudios de estabilidad, <a href=\"https:\/\/kymos.com\/es\/servicios\/analisis-y-control-de-calidad-de-cmc\/estudios-de-estabilidad\/\" data-wpel-link=\"internal\">haga click aqu\u00ed<\/a> .<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":6,"featured_media":21707,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[183],"tags":[],"class_list":["post-23108","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc-es"],"acf":[],"yoast_head":"<!-- This site is optimized with 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