Millipore Sigma Vibrant Logo

MFGL02SH3 Gamma sterilized Millipak® Final Fill 20 Filter Unit 0.22  µm 1/4  in. HB/HB

MFGL02SH3
3  Double Easy-Open bag
Recuperando preço...
O preço não pôde ser recuperado
Quantidade mínima necessária para ser múltipla de
Maximum Quantity is
Após finalização do pedido Mais informações
Você salvou ()
 
—
Solicitar preço
—
Disponibilidade limitada Disponibilidade limitada
Insira quantidade 
Descontinuado
Quantidades limitadas disponíveis
Disponibilidade a ser confirmada
    Restante: será informado
      Restante: será informado
      Vai informar
      Contatar o serviço de atendimento ao cliente
      Contact Customer Service

       

      Contatar o serviço de atendimento ao cliente

      Panorama geral

      Replacement Information
      Description
      Catalogue NumberMFGL02SH3
      Trade Name
      • Millipak®
      DescriptionGamma sterilized Millipak® Final Fill 20 Filter Unit 0.22  µm 1/4  in. HB/HB
      References
      Product Information
      HS Code8421 29 90
      Device ConfigurationGamma Gold Capsule
      Connections, Inlet/Outlet6  mm (¼  in.) stepped hose barb inlet and outlet
      Maximum Differential Pressure, bar (psid)Forward:60 psi (4.1 bar) at 25 °C; 50 psi(3.5 bar) at 25 °C; (5 µm) 25 psi (1.7 bar) at 80 °C; Reverse: 10 psi (0.7 bar) at 25 °C
      Maximum Inlet Pressure, bar (psi)60 psi (4.1 bar) at 25 °C
      Good Manufacturing PracticesThese products are manufactured in a facility which is certified to ISO® 9001:2015 Quality Management Systems.
      Quality LevelMQ400
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains < 0.25 EU/mL per device as determined using the Limulus Amebocyte Lysate (LAL) test, meeting requirements of USP <85>, EP 2.6.14 and JP 4.01.
      MediaDurapore®
      Sterilitysterilized by gamma irradiation
      SterilizationDevice integrity and retention was maintained after 3 autoclave cycles of 90 minutes at 126  °C. Devices can withstand a dose ≤ 40  kGy gamma exposure.
      Bacterial RetentionQuantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per AST® F838 methodology.
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.22 µm
      Inlet ConnectionStepped Hose Barb
      Outlet ConnectionStepped Hose Barb
      Bubble Point at 23 °C≥ 50 psi (3450 mbar) air with water
      Flow Rate0.51 L/min @ .69 bar ΔP
      Non-Fiber ReleasingThis product was manufactured with a Durapore® membrane which meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b)(6), validated based on large volume parenteral specifications as detailed in USP <788> Particulate Matter in Injections
      USP Bacterial EndotoxinsAqueous extraction contains < 0.25 EU/mL per device as determined using the Limulus Amebocyte Lysate (LAL) test, meeting requirements of USP <85>, EP 2.6.14 and JP 4.01.
      Dimensions
      Filtration Area100 cm²
      Process Volume20 L
      Inlet Connection Diameter1/4 in.
      Outlet Connection Diameter1/4 in.
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      Device Material
      • Polysulfone
      Support MaterialPolysulfone
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size3
      Material PackageDouble Easy-Open bag
      Transport Information
      Supplemental Information
      Specifications
      Global Trade Item Number
      Número de catálogo GTIN
      MFGL02SH3 04054839378454

      Documentation

      Material Qualification Dossier

      TítuloVersão
      1.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Certificados de qualidade

      Título
      Millipak Final Fill Capsule Durapore Membrane C1EB93050
      Millipak Final Fill Capsule Durapore Membrane C3NB59536
      Millipak Final Fill Capsule Durapore Membrane C4AB69836
      Millipak Final Fill Capsule Durapore Membrane C2DB58019
      Millipak Final Fill Capsule Durapore Membrane- C0EB71687
      Millipak Final Fill Capsule Durapore membrane C3HB37507
      Millipak Final Fill Capsule Durapore membrane C4AB69672

      Informações técnicas

      Título
      Integrity Test Troubleshooting - Beyond Rewet and Retest
      Reduce Contamination Risks and Simplify Filtration System Design and Operation

      Ficha de dados

      Título
      Durapore® Family Guide

      Manuais do usuário

      Título
      Wetting Instructions for Filter Units with Durapore Membrane

      Produtos e aplicações relacionadas

      Famílias de produtos

      Millipak® Final Fill Filters

      Stacked disc filters designed to maximize recovery and enhance protection of your high value product
      Saiba mais >>