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MPGL06CF3 Millipak®-60 Filling Machine Filter Unit 0.22 µm 3/4 in. TC/TC

Millipak®-60 Filling Machine Filter Unit 0.22 µm 3/4 in. TC/TC MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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MPGL06CF3
3  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberMPGL06CF3
      Trade Name
      • Millipak®
      DescriptionMillipak®-60 Filling Machine Filter Unit 0.22 µm 3/4 in. TC/TC
      References
      Product Information
      Device ConfigurationCapsule
      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.
      Stacked Discs60 discs
      Quality LevelMQ400
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaDurapore®
      SterilityOther
      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 Rate7.6 L/min @ 2.9 bar ΔP
      Gravimetric ExtractablesThe extractables level was equal to or less than 2 mg per device after 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 Area300 cm²
      Process Volume30 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 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
      MPGL06CF3 04053252655180

      Documentation

      Certificates of Quality

      Title
      Millidisk 60 Capsule Durapore Membrane C3AB36832
      Millipak 60 Capsule Durapore Membrane C0SB73606
      Millipak 60 Capsule Durapore Membrane C1DB03821
      Millipak 60 Capsule Durapore Membrane C2EB78894Z
      Millipak 60 Capsule Durapore Membrane C3JB40074
      Millipak 60 Capsule Durapore Membrane - C8EA81616
      Millipak 60 Capsule Durapore Membrane C0NB29553
      Millipak 60 Capsule Durapore Membrane C1HB21204Z
      Millipak 60 Capsule Durapore Membrane C2EB60647Z
      Millipak 60 Capsule Durapore Membrane C2KB15732Z
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      Technical Info

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

      Data Sheet

      Title
      Durapore® Family Guide

      User Guides

      Title
      Wetting Instructions for Filter Units with Durapore Membrane