{"id":27169,"date":"2019-01-08T13:33:00","date_gmt":"2019-01-08T12:33:00","guid":{"rendered":"https:\/\/kymos.com\/news\/stabilita-microbica-in-uso\/"},"modified":"2025-12-03T18:58:33","modified_gmt":"2025-12-03T17:58:33","slug":"stabilita-microbica-in-uso","status":"publish","type":"post","link":"https:\/\/kymos.com\/it\/news\/stabilita-microbica-in-uso\/","title":{"rendered":"Stabilit\u00e0 microbica in 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;\">I test di stabilit\u00e0 in uso per i prodotti multidose si basavano inizialmente sulla <b>Nota di orientamento sui test di stabilit\u00e0 in uso dei prodotti medicinali per uso umano<\/b> del CPMP dell&#8217;EMA, del marzo 2001. Secondo tale documento, lo scopo dei test di stabilit\u00e0 in uso \u00e8 stabilire un periodo di tempo durante il quale un prodotto multidose pu\u00f2 essere utilizzato mantenendo la qualit\u00e0 entro una specifica accettata una volta aperto il contenitore. <\/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;\">Successivamente, la <b>serie di rapporti tecnici dell&#8217;OMS, n. 953, 2009, allegato 2, test di stabilit\u00e0 degli ingredienti farmaceutici attivi e dei prodotti farmaceutici finiti<\/b> , ha definito che lo scopo dei test di stabilit\u00e0 in uso \u00e8 quello di fornire informazioni per l&#8217;etichettatura sulla preparazione, le condizioni di conservazione e il periodo di utilizzo dei prodotti multidose dopo l&#8217;apertura, la ricostituzione o la diluizione di una soluzione.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Come affermato nell&#8217;ultimo documento, le propriet\u00e0 fisiche, chimiche e microbiche del prodotto farmaceutico finito, soggette a modifica durante la conservazione, devono essere determinate durante il periodo di validit\u00e0 in uso proposto. Tuttavia, la potenziale contaminazione microbiologica dei prodotti farmaceutici sterili rappresenta un problema di primaria importanza. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">La progettazione di uno studio di stabilit\u00e0 microbica in uso di un farmaco iniettabile deve tenere conto delle specifiche del prodotto in termini di data di scadenza, condizioni di conservazione, temperatura, protezione dalla luce, istruzioni per la ricostituzione, diluenti utilizzati e qualsiasi altra informazione pertinente. Inoltre, il protocollo deve simulare il modo in cui il prodotto verr\u00e0 utilizzato nella pratica clinica reale. Una procedura generale si basa sulla contaminazione intenzionale sia della fiala ricostituita che della sacca di grande volume in cui il prodotto viene diluito. Vengono testati diversi microrganismi: <i>Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus, Candida albicans, Aspergillus brasiliensis,<\/i> utilizzando sospensioni a una concentrazione equivalente a 100 UFC\/ml. La contaminazione viene misurata mediante filtrazione a membrana, inclusi controlli negativi e di terreno, e la conta microbica viene solitamente eseguita in tre momenti: momento iniziale, momento finale dell&#8217;uso previsto e un periodo pi\u00f9 lungo. Un risultato positivo \u00e8 considerato tale se la popolazione microbica dei campioni entro questo periodo non aumenta pi\u00f9 di 0,5 log <sup>10<\/sup> .     <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Se desideri saperne di pi\u00f9 sui nostri servizi di studi di stabilit\u00e0, <a href=\"https:\/\/kymos.com\/it\/servizi\/analisi-cmc-e-controllo-qualita\/studi-di-stabilita\/\" data-wpel-link=\"internal\">clicca qui<\/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":27170,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[264],"tags":[],"class_list":["post-27169","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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