{"id":310,"date":"2023-01-09T05:42:47","date_gmt":"2023-01-09T05:42:47","guid":{"rendered":"https:\/\/www.maryatech.com\/?post_type=product&p=310"},"modified":"2023-01-11T06:41:30","modified_gmt":"2023-01-11T06:41:30","slug":"aseptische-isolatieapparatuur","status":"publish","type":"product","link":"https:\/\/www.maryatech.com\/nl\/product\/aseptic-isolation-equipment\/","title":{"rendered":"Aseptische isolatieapparatuur"},"content":{"rendered":"

1. Inleiding<\/b><\/h1>\n

Aseptische isolatie apparatuur is speciaal ontworpen en geproduceerd volgens de drug productie kwaliteitsmanagement standaard (GMP), en gebruikt in de geneeskunde gezondheidszorg producten en vereisen een hoger niveau van milieu beschermende barri\u00e8re systeem, De farmaceutische isolator systeem kan de vervuiling van de preventie en controle van het product te maximaliseren, om de veiligheid van de exploitant te beschermen, om te voorkomen dat gekwetst door de giftige stoffen. Goede farmaceutische isolatorfabrikanten kunnen perfecte milieucontroletechnologieoplossingen bieden voor aseptische tests, aseptische productie en productiebescherming van zeer allergene en giftige medicijnen.<\/p>\n

Isolatieapparatuur is ofwel verzegeld of heeft een microbiologisch filtratiesysteem (HEPA) om lucht toe te voeren en is zelfzuiverend. In geopende toestand mogen materialen alleen in en uit door specifieke openingen die ontworpen en gevalideerd zijn om contaminatieoverdracht te voorkomen. Hij kan gebruikt worden om actieve mengsels te isoleren tijdens aseptische operaties of voor zowel sterilisatiebehandelingen als isolatie.<\/p>\n

Afhankelijk van het gebruik kan de isolator worden onderverdeeld in aseptische inspectie-isolator, aseptische weegisolator, aseptische voedingsisolator, API-isolator, enz;<\/p>\n

2. Prestatiekenmerk<\/b><\/h1>\n
    \n
  • Het machineontwerp, het materiaal, de productie, de assemblage, het foutzoeken enzovoort voldeden aan de nieuwe GMP farmaceutische productiespecificatievereisten;<\/li>\n
  • Kan kiezen voor roestvrij staal materiaal, de machine structuur en operatie platform op de top van de hele gesloten structuur ontwerp, de sterilisatie-systeem, ge\u00efntegreerde besturingseenheid, in en uit de lucht-systeem en lucht filtratie-eenheid, mooier en gemakkelijk te reinigen en te onderhouden;<\/li>\n
  • Het machinelichaam heeft gladde randen en hoeken en de lasplaats is gepolijst zonder braam. Het ontwerp van de interne booghoek is eenvoudig te reinigen;<\/li>\n
  • Elke kamer volgens de functionele eisen voor het ontwerp, handschoenen met een standaard maat, geen dode hoek werking, speciale romp buste kleding ontwerp kan worden aangenomen;<\/li>\n
  • Het ontwerp van de isolatiemateriaalmodule, gebruikt de verbinding van de rattengaten tussen elke module, heeft elk deel duidelijke differenti\u00eble drukgradi\u00ebnt belangrijke gebieden om ervoor te zorgen dat de hoeveelheid drukverschil met betrekking tot andere gebieden voor positieve druk;<\/li>\n
  • Het isolatiemateriaal kan volgens de behoefte aan twee soorten enige of dubbele zijverrichting ontwerpen; Het materiaal heeft twee ontwerpmethodes: gespleten type en ge\u00efntegreerd type;<\/li>\n
  • Isolator kan volgens de functie, verhogen de buffer tank shell, uitgaande module of andere chanbers werden gecombineerd met de belangrijkste romp, vervaardiging op maat isolatie systeem;<\/li>\n
  • Apparatuur uitlaat, verwijder overtollige waterstofperoxide ontleding, vermijd residuen;<\/li>\n
  • VHP-residugehalten: < 1 PPM (residuniveau bepaald door de technologische vereisten).<\/li>\n
  • Kamerafdichting: kamerlekkage is niet meer dan 5% binnen 10 minuten onder druk van 500 pa;<\/li>\n
  • Configureerbaar online lekdetectiesysteem voor handschoenen, kan worden gebruikt voor online integriteitsdetectie voor meerdere handschoenen tegelijk;<\/li>\n
  • Kan verschillende planken configureren voor verschillend gebruik;<\/li>\n
  • De isolator kan worden uitgerust met meerdere reinigingswaterpistolen, het reinigingsmedium kan water zijn (voor zeer actieve medicijnen kan een ge\u00efnactiveerd oplosmiddel worden gebruikt) en perslucht;<\/li>\n
  • Configureerbaar bag in\/bag out (BIBO) systeem, veilige vervangingsfilters, verzekeren de veiligheid van de mensen en het milieu tijdens het veranderingsproces;<\/li>\n
  • Configureerbare ge\u00efntegreerde VHP generator systeem zonder externe VHP generator, beter verdampt in gas, de waterstofperoxide vloeistof beter effect van sterilisatie, sterilisatie geprogrammeerde temperatuur, beschuldigd van nat te bereiken.<\/li>\n
  • Kan worden geconfigureerd om de waterstofperoxideconcentratie van gas, stofdeeltjes en planktonische bacteri\u00ebnpoort te controleren;<\/li>\n
  • Configureerbare RTP-klep voor aseptische materiaaloverdracht;<\/li>\n
  • Kan het materiaal automatische waterstofperoxyde het laden apparaat worden gevormd, vloeistof toevoegen kan automatisch volgens de sterilisatievoorwaarden zijn;<\/li>\n
  • Configureerbaar detectiesysteem voor hoge en lage concentraties, detectie van de waterstofperoxideconcentratie tijdens het sterilisatieproces;<\/li>\n
  • Het configureerbare ontvochtigingssysteem, maakt de luchtomloop door het ontvochtigingsapparaat binnen de isolator, zou de relatieve vochtigheid binnen de isolator, VHP-sterilisatieefficiency verminderen;<\/li>\n
  • Functies van het besturingssysteem: automatische regeling van de gasdruk, automatische regeling van het water- en zuurstofgehalte, zelfaanpassende circulatie van de reinigingslucht traploze variabele snelheid, veiligheidstips, foutdiagnose, gegevensopslag, wachtwoordbeveiliging en andere functies;<\/li>\n<\/ul>\n
      \n
    • Het steriele isolatorsysteem in de farmaceutische industrie kan met het verschillende materiaal, de toebehoren en de integratie dokken, de diverse functies en de technologische vereisten realiseren, aangepast ontwerp;<\/li>\n<\/ul>","protected":false},"excerpt":{"rendered":"

      Aseptische farmaceutische isolatoren zijn volledig afgesloten om farmaceutische en biologische producten te controleren en steriel te verwerken. Voor een complete operatie kan een systeem van isolatoren nodig zijn om het hele proces te scheiden van mogelijke besmettingsbronnen, zoals omringende apparatuur en operators.<\/p>","protected":false},"featured_media":588,"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":"default","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":"default","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":[83,15],"product_tag":[],"class_list":["post-310","product","type-product","status-publish","has-post-thumbnail","product_cat-aseptic-isolation-equipment","product_cat-uncategorized","desktop-align-left","tablet-align-left","mobile-align-left","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"\nAseptic isolation equipment - 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