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MPGL2GCA3 Sterile Millipak®-200 Filter Unit 0.22 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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MPGL2GCA3
3  Blister
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      Overview

      Replacement Information
      Description
      Catalogue NumberMPGL2GCA3
      Trade Name
      • Millipak®
      DescriptionSterile Millipak®-200 Filter Unit 0.22 µm 9/16 in. HB/HB
      References
      Product Information
      HS Code8421 29 90
      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 Size0.22 µm
      Inlet ConnectionHose Barb
      Outlet ConnectionHose Barb
      Bubble Point at 23 °C≥3450 mbar (50 psig) air with water
      Flow Rate19 L/min @ 2.8 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 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
      MPGL2GCA3 04053252258237

      Documentation

      Operational Excellence Dossier

      Title

      Certificates of Quality

      Title
      MIllipak 200 Gamma Gold Capsule Durapore Membrane C1DB97111Z
      Millipak 20 Gamma Gold Capsule Durapore Membrane C2DB63797Z
      Millipak 200 Gamma Gold Capsule Durapore Membrane C3MB61321
      Millipak 200 Capsule Durapore Membrane C1JB85597Z
      Millipak 200 Capsule Durapore Membrane C2CB52606Z
      Millipak 200 Gamma Gold C4AB69824
      Millipak 200 Gamma Gold Capsule Durapor Membrane C0DB60926
      Millipak 200 Gamma Gold Capsule Durapore Membrane C0NB32530
      Millipak 200 Gamma Gold Capsule Durapore Membrane C2EB58936Z
      Millipak 200 Gamma Gold Capsule Durapore Membrane 200.00
      Show more

      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