{"id":16337,"date":"2025-12-16T07:43:55","date_gmt":"2025-12-16T07:43:55","guid":{"rendered":"https:\/\/www.epicmicron.com\/?post_type=astra-portfolio&#038;p=16337"},"modified":"2025-12-16T07:43:57","modified_gmt":"2025-12-16T07:43:57","slug":"metformin-api-jet-mill-grinding-production-line-in-russia","status":"publish","type":"astra-portfolio","link":"https:\/\/www.epicmicron.com\/de\/cases\/metformin-api-jet-mill-grinding-production-line-in-russia\/","title":{"rendered":"Metformin-API-Strahlm\u00fchlen-Produktionslinie in Russland"},"content":{"rendered":"<h3 class=\"wp-block-heading\"><strong>1. Zusammenfassung<\/strong><\/h3>\n\n\n\n<p>A major pharmaceutical manufacturer specializing in diabetes medications needed to scale production of Metformin hydrochloride\u2014one of the world\u2019s most prescribed oral antidiabetic APIs. Their challenge: achieving consistent coarse micronization (D99 \u2264 150 \u03bcm) at an industrial throughput of 480 kg\/h, without compromising particle uniformity or process stability. Epic Powder\u2019s MQW20 Fluidized Bed Jet Mill was selected to replace their conventional metformin grinding system, resulting in enhanced control, higher yield, and reliable continuous operation.<\/p>\n\n\n\n<figure class=\"wp-block-image aligncenter size-large is-resized\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"765\" src=\"https:\/\/www.epicmicron.com\/wp-content\/uploads\/2025\/07\/Jet-Mill-MQW40-P-1024x765.jpg\" alt=\"Strahlm\u00fchle MQW40\" class=\"wp-image-15536\" style=\"width:862px;height:auto\" srcset=\"https:\/\/www.epicmicron.com\/wp-content\/uploads\/2025\/07\/Jet-Mill-MQW40-P-1024x765.jpg 1024w, https:\/\/www.epicmicron.com\/wp-content\/uploads\/2025\/07\/Jet-Mill-MQW40-P-300x224.jpg 300w, https:\/\/www.epicmicron.com\/wp-content\/uploads\/2025\/07\/Jet-Mill-MQW40-P-768x574.jpg 768w, https:\/\/www.epicmicron.com\/wp-content\/uploads\/2025\/07\/Jet-Mill-MQW40-P-16x12.jpg 16w, https:\/\/www.epicmicron.com\/wp-content\/uploads\/2025\/07\/Jet-Mill-MQW40-P-600x448.jpg 600w, https:\/\/www.epicmicron.com\/wp-content\/uploads\/2025\/07\/Jet-Mill-MQW40-P.jpg 1520w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. Die Produktionsherausforderung<\/strong><\/h3>\n\n\n\n<p>Die Wirksamkeit von Metformin h\u00e4ngt von einer kontrollierten Partikelgr\u00f6\u00dfenverteilung ab, um eine vorhersagbare Aufl\u00f6sung und Bioverf\u00fcgbarkeit zu gew\u00e4hrleisten. Der Hersteller sah sich folgenden Herausforderungen gegen\u00fcber:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Durchsatzbeschr\u00e4nkungen<\/strong> \u2013 Mit den vorhandenen Anlagen kann eine Durchsatzleistung von 300 kg\/h ohne Schwankungen der Partikelgr\u00f6\u00dfe nicht nachhaltig \u00fcberschritten werden.<\/li>\n\n\n\n<li><strong>Pr\u00e4zisionsanforderungen<\/strong> \u2013 Ein strenger <strong>D99 von 150 \u03bcm<\/strong> war erforderlich, um die Konsistenz von Charge zu Charge zu gew\u00e4hrleisten.<\/li>\n\n\n\n<li><strong>Flie\u00dff\u00e4higkeit und Handhabung<\/strong> \u2013 Gr\u00f6bere, gleichm\u00e4\u00dfige Partikel waren f\u00fcr die Direktverpressung in Hochgeschwindigkeits-Tablettenanlagen unerl\u00e4sslich.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>3. Warum die MQW20 ausgew\u00e4hlt wurde<\/strong><\/h3>\n\n\n\n<p>Der MQW20 vereint eine robuste Konstruktion mit intelligentem Luftstrom- und Klassifizierungsdesign und ist damit ideal f\u00fcr die Verarbeitung gro\u00dfer Mengen von APIs geeignet:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Erweiterter dynamischer Klassifikator<\/strong> \u2013 Gew\u00e4hrleistet eine pr\u00e4zise Kontrolle der Partikelgr\u00f6\u00dfe und stellt sicher, dass keine Partikel den Schwellenwert von 150 \u03bcm \u00fcberschreiten.<\/li>\n\n\n\n<li><strong>Hochleistungs-Mahlkammer<\/strong> \u2013 Die optimierte D\u00fcsengeometrie und das optimierte Kammervolumen erm\u00f6glichen einen stabilen Betrieb bei 480 kg\/h.<\/li>\n\n\n\n<li><strong>Temperatursichere Verarbeitung<\/strong> \u2013 Keine W\u00e4rmeentwicklung durch mechanische Teile, wodurch die chemische Stabilit\u00e4t von Metformin erhalten bleibt.<\/li>\n\n\n\n<li><strong>Einfache Skalierbarkeit und Reinigung<\/strong> \u2013 Konzipiert, um die pharmazeutischen GMP-Standards zu erf\u00fcllen, mit kurzen Durchlaufzeiten zwischen den Chargen.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>4. Verifizierte Leistungsergebnisse<\/strong><\/h3>\n\n\n\n<p>Nach Installation und Prozessoptimierung lieferte die MQW20 folgende Ergebnisse:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Durchsatz<\/strong>Kontinuierliche Leistung von <strong>480 kg\/h<\/strong> mit der F\u00e4higkeit zum kontinuierlichen 24\/5-Betrieb.<\/li>\n\n\n\n<li><strong>Partikelgr\u00f6\u00dfenkontrolle<\/strong>: Konsistent <strong>D99 \u2264 150 \u03bcm<\/strong>, mit steilen PSD-Kurven f\u00fcr ausgezeichnete Flie\u00dff\u00e4higkeit.<\/li>\n\n\n\n<li><strong>Prozesseffizienz<\/strong>: 30% h\u00f6here Energieeffizienz pro Kilogramm im Vergleich zum Vorg\u00e4ngersystem.<\/li>\n\n\n\n<li><strong>Betriebszeit<\/strong>: Reduzierte Ausfallzeiten dank Vermeidung von Bildschirmblockierungen und \u00dcberhitzungsproblemen.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>5. Schlussfolgerung<\/strong><\/h3>\n\n\n\n<p>Die MQW20 erm\u00f6glicht die skalierbare, pr\u00e4zise und wirtschaftliche Mikronisierung von Metformin und beweist damit, dass hoher Durchsatz und strenge Partikelkontrolle in der Wirkstoffherstellung vereinbar sind. F\u00fcr Hersteller von oralen Feststoffpr\u00e4paraten in gro\u00dfen Mengen bietet die MQW20 einen zuverl\u00e4ssigen, GMP-konformen Weg zu h\u00f6herer Kapazit\u00e4t ohne Qualit\u00e4tseinbu\u00dfen.<\/p>\n\n\n\n<p><strong>Sind Sie bereit, Ihren API-Mahlprozess zu skalieren?<\/strong><br>Kontakt <a href=\"https:\/\/www.epicmicron.com\/de\/products\/\">Episches Pulver<\/a> Vereinbaren Sie einen Materialtest und erfahren Sie, wie die MQW20 Ihre Produktion von Metformin oder anderen pharmazeutischen Produkten mit hohem Produktionsvolumen optimieren kann.<\/p>","protected":false},"featured_media":15536,"template":"","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","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":"","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":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center 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