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MPGL20CB3 Gamma Compatible Millipak®-200 Filter Unit 0.22 µm 1/4 in. NPTM

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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MPGL20CB3
3  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberMPGL20CB3
      Trade Name
      • Millipak®
      DescriptionGamma Compatible Millipak®-200 Filter Unit 0.22 µm 1/4 in. NPTM
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet6 mm (1/4 in.) NPTM
      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 Discs200 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 ConnectionNPT
      Outlet ConnectionNPT
      Bubble Point at 23 °C≥3450 mbar (50 psig) air with water
      Flow Rate18 L/min @ 3.0 bar ΔP
      Gravimetric ExtractablesThe extractables level was equal to or less than 5 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
      Length13.0 cm (5.1 in.)
      Diameter7.6 cm (3.0 in.)
      Filtration Area1000 cm²
      Process Volume100 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 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
      MPGL20CB3 04053252302442

      Documentation

      Operational Excellence Dossier

      Title

      Certificates of Quality

      Title
      Millipak 20 capsule durapore Membrane
      Millipak 200 Capsule Durapore Membrane C0DB61746
      Millipak 200 Capsule Durapore Membrane - C7NA75601
      Millipak 200 Capsule Durapore Membrane C2CB85785Z
      Millipak 200 Capsule Durapore Membrane C2HB85963Z
      Millipak 200 Capsule Durapore Membrane C3KB53716
      Millipak 200 Capsule Durapore Membrane C4AB85676
      Millipak 200 Capsule Durapore Membrane C4DB12692
      Millipak 200 Capsule Durapore Membrane C4JB66674
      Millipak 200 Capsule Durapore Membrane C5DB69755
      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