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MPGL04GF2 Sterile Millipak®-40 Filter Unit 0.22 µm 3/4 in. TC/TC

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MPGL04GF2
2  Blister
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      Replacement Information
      Description
      Catalogue NumberMPGL04GF2
      Trade Name
      • Millipak®
      DescriptionSterile Millipak®-40 Filter Unit 0.22 µm 3/4 in. TC/TC
      References
      Product Information
      HS Code8421 29 90
      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
      Applications
      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 Size0.22 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Bubble Point at 23 °C≥3450 mbar (50 psig) air with water
      Flow Rate2.8 L/min @ 1.75 bar ΔP
      Gravimetric ExtractablesThe extractables level was equal to or less than 1.5 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 Area200 cm²
      Process Volume20 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)
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size2
      Material PackageBlister
      Transport Information
      Supplemental Information
      Specifications
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL
      Global Trade Item Number
      Número de catálogo GTIN
      MPGL04GF2 04053252484674

      Documentation

      Operational Excellence Dossier

      Title

      Certificados de qualidade

      Título
      Millipak 40 Gamma Gold Capsule Durapore Membrane C7EA05950
      Millipak 40 Gamma Gold Capsule Durapore Membrane C0KB07788
      Millipak 40 Gamma Gold Capsule Durapore Membrane C1DB85158Z
      Millipak 40 Gamma Gold Capsule Durapore Membrane C1NB85561Z
      Millipak 40 Gamma Gold Capsule Durapore Membrane C1PB84706Z
      Millipak 40 Gamma Gold Capsule Durapore Membrane C2EB32070Z
      Millipak 40 Gamma Gold Capsule Durapore Membrane C2KB03098Z
      Millipak 40 Gamma Gold Capsule Durapore Membrane C3HB35219
      Millipak 40 Gamma Gold Capsule Durapore Membrane - C9MA87703
      Millipak 40 Gamma Gold Capsule Durapore Membrane - C9SA87034
      Show more

      Informações técnicas

      Título
      Best Practices for Managing Reverse Pressure Filter Impact
      Integrity Test Troubleshooting - Beyond Rewet and Retest

      Ficha de dados

      Título
      Durapore® Family Guide

      Manuais do usuário

      Título
      Wetting Instructions for Filter Units with Durapore Membrane