{"id":171483,"date":"2025-03-07T05:11:31","date_gmt":"2025-03-07T05:11:31","guid":{"rendered":"https:\/\/www.maryatech.com\/?post_type=product&p=171483"},"modified":"2025-03-07T05:11:36","modified_gmt":"2025-03-07T05:11:36","slug":"koppeling-productielijn-isolator","status":"publish","type":"product","link":"https:\/\/www.maryatech.com\/nl\/product\/linkage-production-line-isolator\/","title":{"rendered":"Koppeling productielijn isolator"},"content":{"rendered":"

De kerntaken omvatten:
\nZekerheid van steriliteit: Zorg bij de productie van steriele preparaten (zoals injecties en biologische producten) voor een schone omgeving van klasse A om microbi\u00eble besmetting te voorkomen.
\nPreventie en controle van kruisbesmetting: Bij de productie van API's of zeer actieve geneesmiddelen (zoals cytotoxische geneesmiddelen en hormonen) moet lekkage van schadelijke stoffen worden voorkomen en moeten de veiligheid van personeel en omgeving worden beschermd.
\nProcesstabiliteit: Minder menselijke tussenkomst en minder invloed van omgevingsschommelingen op de productkwaliteit.<\/p>\n

Prestaties en functies<\/p>\n

    \n
  1. Uitgebreide productportfolio:<\/b><\/strong>isolatiesystemen voor waterinjectie, poederinjectie, voorgevulde spuiten en steriele poederproductielijnen;<\/li>\n
  2. Stabiele en betrouwbare omgeving:<\/b><\/strong>betrouwbare en stabiele klasse A-omgeving, die voldoet aan de vereisten van cGMP, FDA, ISO, ISPE en farmacopee;<\/li>\n
  3. Nieuwe VHPS-technologie:<\/b><\/strong>de nieuwste H2<\/sub>O2<\/sub>\u00a0sterilisatiesysteem, dat een snelle sterilisatie kan bereiken, de concentratie en verzadiging van H2<\/sub>O2<\/sub>, met een goede reproduceerbaarheid van de sterilisatie;<\/li>\n
  4. Intelligent besturingssysteem:<\/b><\/strong>Siemens PLC+IPC-besturingssysteem; intelligente alarmen voor druk, H2<\/sub>O2<\/sub>\u00a0oplossingconcentratie, temperatuur en vochtigheid, luchtsnelheid en andere bewakingsparameters; het systeem heeft toegangscontrole op meerdere niveaus; voldoet aan de vereisten van FDA 21 CFR deel 11;<\/li>\n
  5. Onafhankelijke temperatuur- en vochtigheidsregeling:<\/b><\/strong>Met het ge\u00efntegreerde onafhankelijke airconditioningsysteem kan worden gerealiseerd dat de interne temperatuur en vochtigheid in de kamer niet worden be\u00efnvloed door de externe omgeving;<\/li>\n
  6. MOCK-UP:<\/b><\/strong>complete houtmodelcontroleservice, ergonomische bedieningskwalificatie en 3D-modelweergave in het midden van het project.<\/li>\n
  7. Ondersteuning voor de ontwikkeling van sterilisatieprocessen: <\/b><\/strong>kwalificatie- en validatiediensten voor de ontwikkeling van sterilisatiecycli voor het hele proces kunnen worden geleverd;<\/li>\n
  8. Aanpassing:<\/b><\/strong>ondersteunen het ontwerp van aangepaste isolatiesystemen en bieden systematische gesloten isolatieoplossingen en CE-certificeringsdiensten;<\/li>\n
  9. Ge\u00efntegreerd monitoringsysteem: <\/b><\/strong>ge\u00efntegreerde bewakingssystemen voor temperatuur en vochtigheid, drukverschil, luchtsnelheid, H2<\/sub>O2<\/sub>concentratie, optische tralie, deeltjes en levensvatbare bacteri\u00ebn in de lucht, enz;<\/li>\n
  10. Meerdere steriele transferoplossingen:<\/b><\/strong>Er zijn meerdere en gecombineerde steriele transferoplossingen beschikbaar om te voldoen aan de uiteenlopende productiebehoeften van klanten;<\/li>\n
  11. Volledige levenscyclusondersteuning:<\/b><\/strong>voor advies, projectontwerp, ontwerp van installatieschema's en verificatieontwerp, enz;<\/li>\n
  12. Draadloze handschoenlekkagedetector: <\/b><\/strong>Optioneel is een bedrade handschoenlekkagedetector met meerdere koppen of een draadloze handschoenlekkagedetector verkrijgbaar;<\/li>\n
  13. CDCV-dienst:<\/b><\/strong>sterilisatiecyclusontwikkeling, validatiestudies en -diensten;<\/li>\n<\/ol>\n

     <\/p>\n

     <\/p>","protected":false},"excerpt":{"rendered":"

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