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MPVL02GH2 Sterile Millipak®-20 Filter Unit 0.1 µm 1/4 in. HB/HB w/bell

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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MPVL02GH2
2  Blister
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      Overview

      Replacement Information
      Description
      Catalogue NumberMPVL02GH2
      Trade Name
      • Millipak®
      DescriptionSterile Millipak®-20 Filter Unit 0.1 µm 1/4 in. HB/HB w/bell
      References
      Product Information
      HS Code8421 29 90
      Device ConfigurationGamma Gold Capsule
      Connections, Inlet/Outlet6 mm (1/4 in.) Hose Barb with bell
      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
      Maximum Operating Temperature25 °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 with Bell
      Bubble Point at 23 °C≥4830 mbar (70 psig) air with water
      Flow Rate0.7 L/min @ 1.75 bar ΔP
      Gravimetric ExtractablesThe extractables level was equal to or less than 1 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 Area100 cm²
      Process Volume10 L
      Inlet Connection Diameter1/4 in.
      Outlet Connection Diameter1/4 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
      Catalogue Number GTIN
      MPVL02GH2 04053252497377

      Documentation

      Certificates of Quality

      Title
      Milipak 20 Gamma Gold Capsule Durapore Membrane C4MB85050
      Millipak 20 Gamma Gold Capsule Durapore Membrane C0CB33101
      Millipak 20 Gamma Gold Capsule Durapore Membrane C0MB91899Z
      Millipak 20 Gamma Gold Capsule Durapore Membrane C1DB84498Z
      Millipak 20 Gamma Gold Capsule Durapore Membrane C5BB50110
      Millipak 20 Gamma Gold Capsule Durapore Membrane C7HA31275
      Millipak 20 Gamma Gold Capsule Durapore Membrane - C9HA55073
      Millipak 20 Gamma Gold Capsule Durapore Membrane - C9NA19977
      Millipak 20 Gamma Gold Capsule Durapore Membrane C1HB84704Z
      Millipak 20 Gamma Gold Capsule Durapore Membrane C1SB47328Z
      Show more

      Technical Info

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

      User Guides

      Title
      Wetting Instructions for Filter Units with Durapore Membrane