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MFSL06GH3 Non-sterilized Millipak® Final Fill 60 Filter Unit 5.0  µm 1/4  in. HB/HB

MFSL06GH3
3  Double Easy-Open bag
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      Description
      Catalogue NumberMFSL06GH3
      Trade Name
      • Millipak®
      DescriptionNon-sterilized Millipak® Final Fill 60 Filter Unit 5.0  µm 1/4  in. HB/HB
      Product Information
      HS Code8421 29 90
      Device ConfigurationCapsule
      Connections, Inlet/Outlet6  mm (¼  in.) stepped hose barb inlet and outlet
      Maximum Differential Pressure, bar (psid)Foward:80 psi (5.5 bar) at 25 °C (0.1 µm, 0.22 µm, 0.45 µm, hydrophobic 0.22 µm); Reverse: 10 psi (0.7 bar) at 25 °C
      Maximum Inlet Pressure, bar (psi)80 psi (5.5 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
      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®
      Sterilitynon-sterilized
      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.
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size5.0 µm
      Inlet ConnectionStepped Hose Barb
      Outlet ConnectionStepped Hose Barb
      Bubble Point at 23 °C≥ 2.0   psi (138 mbar) air with water
      Flow Rate4.5 L/min @ 0.69  bar ∆P
      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 Area300 cm²
      Process Volume60 L
      Inlet Connection Diameter1/4 in.
      Outlet Connection Diameter1/4 in.
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      Device Material
      • Polysulfone
      Support MaterialPolysulfone
      Packaging Information
      Material Size3
      Material PackageDouble Easy-Open bag
      Global Trade Item Number
      Bestellnummer GTIN
      MFSL06GH3 04054839378409