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MPVL1GCF3 Sterile Millipak®-100 Filter Unit 0.1 µm 3/4 in. TC/TC

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MPVL1GCF3
3  Double Easy-Open bag
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      Overview

      Description
      Catalogue NumberMPVL1GCF3
      Trade Name
      • Millipak®
      DescriptionSterile Millipak®-100 Filter Unit 0.1 µm 3/4 in. TC/TC
      Product Information
      Device ConfigurationGamma Gold Capsule
      Connections, Inlet/Outlet19 mm (3/4 in.) Sanitary Flange
      Maximum Differential Pressure, bar (psid)Forward: 4.1 bar (60 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 123 °C; Reverse: 0.7 bar (10 psid) @ 25 °C
      Maximum Inlet Pressure, bar (psi)5.2 bar (75 psi) @ 25 °C
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      Quality LevelMQ400
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaDurapore®
      SterilitySterile
      Sterilization3 autoclave cycles of 90 min @ 123 °C; not in-line steam sterilizable
      Bacterial RetentionSamples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.1 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Bubble Point at 23 °C≥4830 mbar (70 psig) air with water
      Flow Rate3.8 L/min @ 2.45 bar ΔP
      Gravimetric ExtractablesThe extractables level was equal to or less than 2.5 mg per sterilized device after a 200 mL flush and 24 hours in water at controlled room temperature.
      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).
      USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
      Dimensions
      Filtration Area500 cm²
      Process Volume50 L
      Inlet Connection Diameter3/4 in.
      Outlet Connection Diameter3/4 in.
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      Device Material
      • Polycarbonate
      Support MaterialPolycarbonate
      Vent Cap MaterialPolyvinylidene fluoride (PVDF)
      Packaging Information
      Material Size3
      Material PackageDouble Easy-Open bag
      Specifications
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL
      Global Trade Item Number
      Catalogue Number GTIN
      MPVL1GCF3 04053252252709