{"id":171519,"date":"2025-03-07T07:16:44","date_gmt":"2025-03-07T07:16:44","guid":{"rendered":"https:\/\/www.maryatech.com\/?post_type=product&#038;p=171519"},"modified":"2025-03-07T07:16:48","modified_gmt":"2025-03-07T07:16:48","slug":"gmp-zellarzneimittel-zubereitungsstation","status":"publish","type":"product","link":"https:\/\/www.maryatech.com\/de\/product\/gmp-cell-drug-preparation-station\/","title":{"rendered":"GMP-Station zur Herstellung von Zellarzneimitteln"},"content":{"rendered":"<h2>Leistung und Merkmale<\/h2>\n<ol>\n<li><strong><b>Schutz der Umwelt:<\/b><\/strong>bieten eine saubere Umgebung der Klasse A f\u00fcr den gesamten Prozess der Zellproduktion und den Betrieb und erf\u00fcllen die sterilen Anforderungen der GMP.<\/li>\n<li><strong><b>Neue VHPS-Technologie: <\/b><\/strong>integriertes verdampftes H<sub>2<\/sub>O<sub>2<\/sub>biologisches Dekontaminationssystem zur effektiven biologischen Dekontamination von Arbeitsbereichen und Materialkan\u00e4len;<\/li>\n<li><strong><b>Modularer Aufbau: <\/b><\/strong>frei kombinierbare Funktionsmodule und Konfigurationen je nach Kundenbedarf;<\/li>\n<li><strong><b>Intelligentes Kontrollsystem:<\/b><\/strong>Siemens PLC+IPC Steuerungssystem; intelligente Alarme f\u00fcr Druck, H<sub>2<\/sub>O<sub>2<\/sub>\u00a0L\u00f6sungskonzentration, Temperatur und Luftfeuchtigkeit, Luftgeschwindigkeit und andere \u00dcberwachungsparameter; das System verf\u00fcgt \u00fcber eine mehrstufige Zugangskontrolle; erf\u00fcllt die Anforderungen von FDA 21 CFR Teil 11;<\/li>\n<li><strong><b>Online-Umwelt\u00fcberwachung:<\/b><\/strong>Online-Erkennung einer sterilen Produktionsumgebung, die den gesetzlichen Anforderungen entspricht, mit h\u00f6herer Sterilit\u00e4tssicherheit;<\/li>\n<li><strong><b>Drahtloser Handschuh-Leckdetektor:<\/b><\/strong>Ein integrierter oder drahtloser Handschuh-Dichtheitssensor ist optional;<\/li>\n<li><strong><b>Energieeinsparung und Verbrauchsreduzierung: <\/b><\/strong>die in einer Umgebung installiert werden, deren Reinheit \u00fcber der Klasse D liegt, wodurch die Kosten f\u00fcr den Bau und den Betrieb hochwertiger Reinr\u00e4ume gesenkt werden;<\/li>\n<li><strong><b>Vollst\u00e4ndiger Datensatz: <\/b><\/strong>konfiguriert mit einem Kontrollsystem zur Aufzeichnung wichtiger Parameterdaten und zur Gew\u00e4hrleistung der R\u00fcckverfolgbarkeit<\/li>\n<li><strong><b>Hochwertige Fertigungsmaterialien: <\/b><\/strong>die innere Kammer besteht aus 316L oder PTFE, und der Poliergrad der Kammer betr\u00e4gt 0,4\u03bcm~0,6\u03bcm;<\/li>\n<li><strong><b>Zersetzungsfilter:<\/b><\/strong>das Abluftmodul mit einem Zersetzungsfilter ausgestattet werden kann, kann die Abbauzeit nach H<sub>2<\/sub>O<sub>2<\/sub>\u00a0Sterilisation und wirksame Verringerung der R\u00fcckstandskonzentration;<\/li>\n<li><strong><b>CDCV-Dienst:<\/b><\/strong>Entwicklung von Sterilisationszyklen, Validierungsstudien und Dienstleistungen;<\/li>\n<\/ol>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>Die GMP-Zellpr\u00e4parationsstation kann mit den wichtigsten Instrumenten in einer Klasse-A-Umgebung entsprechend dem Kundenprozess konfiguriert werden und ist ergonomisch und einfach zu bedienen. Sie kann die Sterilit\u00e4t des gesamten Prozesses der Zellvorbereitung garantieren und verschiedene Operationen wie Trennung und Extraktion durchf\u00fchren. In Verbindung mit dem selbst entwickelten Managementsystem eignet sich die Anlage f\u00fcr die Chargenproduktion und die klinische Pr\u00fcfung von Zelltherapeutika. Es handelt sich um ein geschlossenes, integriertes Betriebssystem, das die Anforderungen der sterilen GMP-Produktion erf\u00fcllt. Dar\u00fcber hinaus kann es das traditionelle GMP-Labor ersetzen und mehrere funktionale Ger\u00e4te integrieren, um eine sterile Umgebung zu schaffen.<\/p>","protected":false},"featured_media":171520,"template":"","meta":{"om_disable_all_campaigns":false,"_templately_pack_id":"","_templately_imported_at":"","_templately_source":"","_templately_import_session_id":"","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":"default","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":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}}},"product_brand":[],"product_cat":[119,115],"product_tag":[],"class_list":["post-171519","product","type-product","status-publish","has-post-thumbnail","product_cat-gmp-cell-drug-preparation-station","product_cat-isolator-system","desktop-align-left","tablet-align-left","mobile-align-left","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.8 (Yoast SEO v28.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>GMP Cell Drug Preparation Station - cell therapy isolator<\/title>\n<meta name=\"description\" content=\"The cell preparation workstation can be configured with key instruments in Class A environment according to customer process, which is ergonomic and easy to operate.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.maryatech.com\/de\/produkt\/gmp-zellarzneimittel-zubereitungsstation\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GMP Cell Drug Preparation Station\" \/>\n<meta property=\"og:description\" content=\"High-end sterile pharmaceutical filling lines manufacturer, with core strengths in complying with EU GMP\/FDA certification, serving multinational pharmaceutical companies.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.maryatech.com\/de\/produkt\/gmp-zellarzneimittel-zubereitungsstation\/\" \/>\n<meta property=\"og:site_name\" content=\"Shanghai Marya Pharmaceutical Engineering &amp; 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