{"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":"hoe-moeten-schone-ruimtes-worden-onderhouden","status":"publish","type":"post","link":"https:\/\/www.maryatech.com\/nl\/how-should-clean-rooms-be-maintained\/","title":{"rendered":"Hoe moeten cleanrooms worden onderhouden?"},"content":{"rendered":"
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Hoe moeten schone ruimten worden onderhouden om te voorkomen dat de lucht minder schoon wordt?<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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Tijdens het productieproces van geneesmiddelen is het noodzakelijk om deeltjes- en microbi\u00eble besmetting en kruisbesmetting in de lucht te voorkomen. Een cleanroom is een controleerbaar binnenmilieu dat is gecre\u00eberd om te voldoen aan een zeer schone productieomgeving. De stabiele werking ervan is een belangrijke garantie voor de schone productie van farmaceutische bedrijven.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Volgens de industrie, correct en redelijk ontwerp is de premisse om de stabiele werking van de te garanderen schone ruimte<\/a>. Als u geen aandacht besteedt aan bediening en onderhoud of een onwetenschappelijke handeling verricht, zal de luchtzuiverheid van de cleanroom geleidelijk afnemen, waardoor veel indicatoren in de werkelijke productieomgeving afwijken van de gespecificeerde vereisten, wat resulteert in een afname van de productkwaliteit of zelfs ongekwalificeerde omstandigheden. Aan welke aspecten moet aandacht worden besteed bij het onderhoud van een cleanroom?<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Ten eerste is personeelsvervuiling de belangrijkste bron van vervuiling. De activiteiten van het personeel in de schone omgeving verhogen uiteraard de vervuilingsgraad van de schone omgeving. Daarom moeten bedrijven de verantwoordelijkheden van fulltime managementpersoneel, het toegangssysteem voor cleanroompersoneel, de regels voor training en opleiding van personeel en het beheer van \"persoonsreinigende procedures\" voor personeel dat de cleanroom betreedt, formuleren.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Ten tweede, de apparatuur in de cleanroom, zoals vloeren, muren, plafonds, enz., zijn deeltjes verspreiden. Daarom, wanneer materialen en diverse apparatuur de cleanroom, en onderhoud en beheer van gerelateerde apparatuur en pijpleidingen in te voeren, moet ervoor worden gezorgd dat deeltjes en micro-organismen niet worden gebracht in de kamer. Tegelijkertijd moeten ondernemingen reinigings- en sterilisatiemethoden formuleren voor verschillende apparatuur en faciliteiten in de cleanroom om het ontstaan, het behoud en de reproductie van stofdeeltjes en micro-organismen in de cleanroom te voorkomen en te elimineren.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Ten derde moet het personeel schone kleding dragen bij het betreden van de cleanroom en moet er aandacht worden besteed aan het materiaal, het gebruik, de reiniging en andere aspecten van de kleding. Bedrijven moeten goed werk leveren bij het beheer van schone kleding, waaronder de inkoop en productie van schone kleding, het beheer van het gebruik van schone kleding en de reinigingsvoorschriften voor schone kleding.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Ten vierde, de veilige werking van verschillende apparatuur en faciliteiten is de premisse van het waarborgen van de veiligheid van cleanrooms. Om ervoor te zorgen dat de verschillende apparatuur en faciliteiten naar behoren functioneren, moeten overeenkomstige operationele procedures worden geformuleerd, met inbegrip van luchtzuiveringssystemen, verschillende water- en elektriciteitssystemen, apparatuur en faciliteiten voor productieprocessen, enz. Om te voldoen aan de eisen van het productieproces en de reinheidsgraad van de lucht.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Bijvoorbeeld, op een gespecificeerde tijd en plaats, het gebruik van een deeltjesteller om het aantal deeltjes met gecontroleerde deeltjesgrootte te meten; op een gespecificeerde tijd en plaats, het meten van het aantal gevestigde kolonies of planktonbacteri\u00ebn, enz. Daarnaast wordt het drukverschil van het filter van het zuiveringsairconditioningsysteem gemeten, wordt gecontroleerd of het luchtfilter verstopt is, of de ge\u00efnstalleerde pakking in goede staat is, of het filter beschadigd is of niet, en wordt het luchtvolume van de plaatselijke afzuiginrichting gecontroleerd met een anemometer, waarbij het geluidsniveau op een bepaalde tijd en plaats wordt gemeten met een geluidsniveaumeter.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Kortom, farmaceutische bedrijven moeten de netheid van de clean room strikt controleren op het gebied van personeel, apparatuur, faciliteiten, redelijk beheer en regelmatig onderhoud en inspecties. Het waarborgen van de reinheid van de productieomgeving van farmaceutische bedrijven is een belangrijke factor bij het waarborgen van de veilige en hoogwaardige productie van geneesmiddelen. Naast het kiezen van een cleanroom en cleanroomsysteem met een redelijk ontwerp, moeten bedrijven ook correct en redelijk onderhoud en beheer van de cleanroom uitvoeren om een veilige en hoogwaardige productie te garanderen. Farmaceutische bedrijven moeten voortdurend de apparatuur en faciliteiten van de cleanroom en het isolatiesysteem van de apparatuur verbeteren om kruisbesmetting te voorkomen die door de apparatuur zelf wordt veroorzaakt, om zo een solide basis te leggen voor de verbetering van de farmaceutische kwaliteit.<\/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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