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MPVL2GCA3 Sterile Millipak®-200 Filter Unit 0.1 µm 9/16 in. HB/HB

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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MPVL2GCA3
3  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberMPVL2GCA3
      Trade Name
      • Millipak®
      DescriptionSterile Millipak®-200 Filter Unit 0.1 µm 9/16 in. HB/HB
      References
      Product Information
      Device ConfigurationGamma Gold Capsule
      Connections, Inlet/Outlet14 mm (9/16 in.) Hose Barb
      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 Size0.1 µm
      Inlet ConnectionHose Barb
      Outlet ConnectionHose Barb
      Bubble Point at 23 °C≥4830 mbar (70 psig) air with water
      Flow Rate8.5 L/min @ 2.45 bar ΔP
      Gravimetric ExtractablesThe extractables level was equal to or less than 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 Area1000 cm²
      Process Volume100 L
      Inlet Connection Diameter9/16 in.
      Outlet Connection Diameter9/16 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 Size3
      Material PackageDouble Easy-Open bag
      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
      Catalogue Number GTIN
      MPVL2GCA3 04053252260711

      Documentation

      Certificates of Quality

      Title
      Millipak 200 Gamma Gold Capsule Durapore Membrane C2PB36669Z
      Millipak 200 Gamma Gold Capsule Durapore Membrane C3EB20151
      Millipak 200 Gamma GOld Capsule Durapore Membrane C1PB85745Z
      Millipak 200 Gamma Gold Capsule Durapore Membrane C1KB85670Z
      Millipak 200 Gamma Gold Capsule Durapore Membrane C7NA75557
      Millipak 200 Gamma Gold Capsule Durapore Membrane C8EA69579
      Millipak 200 Gamma Gold Capsule Durapore Membrane C0AB03866
      Millipak 200 Gamma Gold Capsule Durapore Membrane C0NB28069Z
      Millipak 200 Gamma Gold Capsule Durapore Membrane C0PB37515Z
      Millipak 200 Gamma Gold Capsule Durapore Membrane C2EB68865Z
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