{"id":66218,"date":"2024-05-09T09:26:42","date_gmt":"2024-05-09T09:26:42","guid":{"rendered":"https:\/\/www.maryatech.com\/?p=66218"},"modified":"2024-05-09T09:50:37","modified_gmt":"2024-05-09T09:50:37","slug":"wie-sollten-reinraume-gewartet-werden","status":"publish","type":"post","link":"https:\/\/www.maryatech.com\/de\/how-should-clean-rooms-be-maintained\/","title":{"rendered":"Wie sollten Reinr\u00e4ume gewartet werden?"},"content":{"rendered":"
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Wie sollten Reinr\u00e4ume gewartet werden, um eine Verschlechterung der Luftreinheit zu vermeiden?<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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Bei der Herstellung von Arzneimitteln muss eine Verunreinigung durch Partikel und Mikroorganismen sowie eine Kreuzkontamination der Luft verhindert werden. Ein Reinraum ist eine kontrollierbare Innenraumumgebung, die f\u00fcr eine hochreine Produktionsumgebung geschaffen wurde, und sein stabiler Betrieb ist eine wichtige Garantie f\u00fcr die saubere Produktion von Pharmaunternehmen.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Nach Ansicht der Industrie ist eine korrekte und vern\u00fcnftige Konstruktion die Voraussetzung f\u00fcr einen stabilen Betrieb der Reinraum<\/a>. Wenn man nicht auf Betrieb und Wartung achtet oder unwissenschaftlich vorgeht, wird die Luftreinheit des Reinraums allm\u00e4hlich abnehmen, was dazu f\u00fchrt, dass viele Indikatoren in der tats\u00e4chlichen Produktionsumgebung von den spezifizierten Anforderungen abweichen, was zu einem R\u00fcckgang der Produktqualit\u00e4t oder sogar zu unqualifizierten Bedingungen f\u00fchrt. Welche Aspekte m\u00fcssen bei der Instandhaltung eines Reinraums beachtet werden?<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Erstens ist die Verschmutzung durch das Personal die Hauptquelle der Verschmutzung. Die Aktivit\u00e4ten des Personals in der reinen Umgebung erh\u00f6hen nat\u00fcrlich den Verschmutzungsgrad der reinen Umgebung. Daher sollten die Unternehmen die Verantwortlichkeiten des hauptamtlichen F\u00fchrungspersonals, das Zugangssystem f\u00fcr das Reinraumpersonal, die Vorschriften f\u00fcr die Schulung und Ausbildung des Personals und das Management der \u201cPersonenreinigungsverfahren\u201d f\u00fcr das Personal, das den Reinraum betritt, festlegen.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Zweitens verbreiten die Einrichtungen im Reinraum, wie B\u00f6den, W\u00e4nde, Decken usw., Partikel. Wenn Materialien und verschiedene Ausr\u00fcstungen in den Reinraum gelangen, sowie bei der Wartung und Verwaltung der entsprechenden Ausr\u00fcstungen und Rohrleitungen sollte daher sichergestellt werden, dass keine Partikel und Mikroorganismen in den Raum gebracht werden. Gleichzeitig sollten die Unternehmen Reinigungs- und Sterilisationsverfahren f\u00fcr verschiedene Ger\u00e4te und Einrichtungen im Reinraum entwickeln, um die Entstehung, Speicherung und Vermehrung von Staubpartikeln und Mikroorganismen im Reinraum zu verhindern und zu beseitigen.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Drittens muss das Personal saubere Kleidung tragen, wenn es den Reinraum betritt, und es muss auf das Material, die Verwendung, die Reinigung und andere Aspekte der Kleidung geachtet werden. Die Unternehmen sollten bei der Verwaltung der sauberen Kleidung gute Arbeit leisten, einschlie\u00dflich der Beschaffung und Herstellung sauberer Kleidung, der Verwaltung der Verwendung sauberer Kleidung und der Reinigungsvorschriften f\u00fcr saubere Kleidung.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Viertens ist der sichere Betrieb verschiedener Ger\u00e4te und Anlagen die Voraussetzung f\u00fcr die Gew\u00e4hrleistung der Sicherheit von Reinr\u00e4umen. Es sollten entsprechende Betriebsverfahren formuliert werden, damit verschiedene Ger\u00e4te und Einrichtungen wie Klimaanlagen, verschiedene Wasser- und Stromsysteme, Ger\u00e4te und Einrichtungen f\u00fcr den Produktionsprozess usw. wie vorgeschrieben funktionieren. Um die Anforderungen an den Produktionsprozess und den Reinheitsgrad der Luft zu gew\u00e4hrleisten.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Zum Beispiel zu einer bestimmten Zeit und an einem bestimmten Ort mit einem Partikelz\u00e4hler die Anzahl der Partikel mit kontrollierter Partikelgr\u00f6\u00dfe messen; zu einer bestimmten Zeit und an einem bestimmten Ort die Anzahl der angesiedelten Kolonien oder planktonischen Bakterien usw. messen; in Bezug auf Temperatur und Luftfeuchtigkeit das kontinuierliche Messprotokoll messen und \u00fcberpr\u00fcfen. Au\u00dferdem Messung der Druckdifferenz des Filters der Reinigungsklimaanlage, \u00dcberpr\u00fcfung, ob der Luftfilter verstopft ist, ob die eingebaute Dichtung in gutem Zustand ist, ob der Filter besch\u00e4digt ist oder nicht, und \u00dcberpr\u00fcfung des Luftvolumens der lokalen Abluftanlage mit einem Anemometer, Verwendung eines Schallpegelmessers zur Messung des Ger\u00e4uschpegels zu einer bestimmten Zeit und an einem bestimmten Ort.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Zusammenfassend l\u00e4sst sich sagen, dass Pharmaunternehmen die Sauberkeit des Reinraums in Bezug auf Personal, Ausr\u00fcstung, Einrichtungen, angemessenes Management sowie regelm\u00e4\u00dfige Wartung und Inspektionen streng kontrollieren m\u00fcssen. Die Gew\u00e4hrleistung der Sauberkeit der Produktionsumgebung von Pharmaunternehmen ist ein wichtiger Faktor f\u00fcr die sichere und hochwertige Produktion von Arzneimitteln. Neben der Auswahl eines Reinraums und eines angemessenen Reinraumsystems m\u00fcssen die Unternehmen auch eine korrekte und angemessene Wartung und Verwaltung des Reinraums durchf\u00fchren, um eine sichere und hochwertige Produktion zu gew\u00e4hrleisten. Die Pharmaunternehmen m\u00fcssen die Ausr\u00fcstung und die Einrichtungen des Reinraums sowie das Isolationssystem der Ausr\u00fcstung kontinuierlich verbessern, um eine durch die Ausr\u00fcstung selbst verursachte Kreuzkontamination zu vermeiden und so eine solide Grundlage f\u00fcr die Verbesserung der pharmazeutischen Qualit\u00e4t zu schaffen.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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How should clean rooms be maintained to avoid a decrease in air cleanliness? During the production process of medicines, it is necessary to prevent particulate and microbial contamination and cross-contamination in the air. A cleanroom is a controllable indoor environment created to meet a high-cleanliness production environment, and its stable operation is an important guarantee […]<\/p>\n","protected":false},"author":1,"featured_media":2239,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","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":"disabled","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":"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":""}},"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[1,103],"tags":[],"class_list":["post-66218","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-all","category-industry-information"],"yoast_head":"\nHow should clean rooms be maintained? - Shanghai Marya<\/title>\n<meta name=\"description\" content=\"How should clean rooms be maintained to avoid a decrease in air cleanliness? 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