{"id":27178,"date":"2019-01-08T13:33:00","date_gmt":"2019-01-08T12:33:00","guid":{"rendered":"https:\/\/kymos.com\/news\/mikrobielle-stabilitaet-im-gebrauch\/"},"modified":"2025-12-03T18:58:33","modified_gmt":"2025-12-03T17:58:33","slug":"mikrobielle-stabilitaet-im-gebrauch","status":"publish","type":"post","link":"https:\/\/kymos.com\/de\/news\/mikrobielle-stabilitaet-im-gebrauch\/","title":{"rendered":"Mikrobielle Stabilit\u00e4t im Gebrauch"},"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;\">Die Stabilit\u00e4tspr\u00fcfung von Mehrdosenpr\u00e4paraten w\u00e4hrend der Anwendung basierte urspr\u00fcnglich auf der <b>Leitlinie zur Stabilit\u00e4tspr\u00fcfung von Humanarzneimitteln<\/b> des CPMP der EMA vom M\u00e4rz 2001. Laut dieser Leitlinie besteht der Zweck der Stabilit\u00e4tspr\u00fcfung w\u00e4hrend der Anwendung darin, einen Zeitraum zu ermitteln, in dem ein Mehrdosenpr\u00e4parat nach dem \u00d6ffnen des Beh\u00e4ltnisses verwendet werden kann und dabei die Qualit\u00e4t innerhalb der akzeptierten Spezifikationen beibeh\u00e4lt. <\/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;\">Sp\u00e4ter wurde in der <b>WHO-Reihe technischer Berichte Nr. 953 aus dem Jahr 2009, Anhang 2, Stabilit\u00e4tspr\u00fcfung von pharmazeutischen Wirkstoffen und Fertigarzneimitteln<\/b> , festgelegt, dass der Zweck der Stabilit\u00e4tspr\u00fcfung w\u00e4hrend der Anwendung darin besteht, Informationen f\u00fcr die Kennzeichnung \u00fcber die Zubereitung, die Lagerbedingungen und die Nutzungsdauer von Mehrdosenpr\u00e4paraten nach dem \u00d6ffnen, der Rekonstitution oder der Verd\u00fcnnung einer L\u00f6sung bereitzustellen.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Wie im letzten Dokument dargelegt, sollten die physikalischen, chemischen und mikrobiellen Eigenschaften des Fertigarzneimittels, die sich w\u00e4hrend der Lagerung ver\u00e4ndern k\u00f6nnen, \u00fcber den Zeitraum der geplanten Haltbarkeitsdauer bestimmt werden. Eine m\u00f6gliche mikrobiologische Kontamination steriler Arzneimittel stellt jedoch ein erhebliches Problem dar. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Die Konzeption einer Studie zur mikrobiellen Stabilit\u00e4t eines injizierbaren Arzneimittels w\u00e4hrend der Anwendung sollte die Produktspezifikationen hinsichtlich Verfallsdatum, Lagerbedingungen, Temperatur, Lichtschutz, Rekonstitutionsanleitung, verwendetem Verd\u00fcnnungsmittel und allen weiteren relevanten Informationen ber\u00fccksichtigen. Dar\u00fcber hinaus sollte das Protokoll die Anwendung des Produkts in der klinischen Praxis simulieren. Ein g\u00e4ngiges Verfahren basiert auf der gezielten Kontamination sowohl der rekonstituierten Durchstechflasche als auch des Gro\u00dfvolumenbeutels, in dem das Produkt verd\u00fcnnt wird. Verschiedene Mikroorganismen werden getestet: <i>Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus, Candida albicans und Aspergillus brasiliensis. Hierf\u00fcr<\/i> werden Suspensionen mit einer Konzentration von 100 KBE\/ml verwendet. Die Kontamination wird mittels Membranfiltration gemessen, einschlie\u00dflich Negativ- und Medienkontrollen. Die Keimzahlbestimmung erfolgt \u00fcblicherweise zu drei Zeitpunkten: zu Beginn, zum Zeitpunkt der erwarteten Anwendung und nach einem l\u00e4ngeren Zeitraum. Ein Ergebnis wird als positiv angesehen, wenn die mikrobielle Population der Proben innerhalb dieses Zeitraums nicht um mehr als 0,5 log <sup>10<\/sup> ansteigt.     <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Wenn Sie mehr \u00fcber unsere Dienstleistungen im Bereich Stabilit\u00e4tsstudien erfahren m\u00f6chten, <a href=\"https:\/\/kymos.com\/de\/dienstleistungen\/cmc-analyse-und-qualitaetskontrolle\/stabilitaetsstudien\/\" data-wpel-link=\"internal\">klicken Sie hier<\/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":27180,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[266],"tags":[],"class_list":["post-27178","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc"],"acf":[],"yoast_head":"<!-- This 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