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MPGL06CL1 Millipak®-60 Filling Machine Filter Unit 0.22 µm 1-1/2 in. TC-1/4 in.HB

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MPGL06CL1
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberMPGL06CL1
      Trade Name
      • Millipak®
      DescriptionMillipak®-60 Filling Machine Filter Unit 0.22 µm 1-1/2 in. TC-1/4 in.HB
      References
      Product Information
      HS Code8421 21 00
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange/6 mm (1/4 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.
      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 ConnectionHose Barb
      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 Diameter1-1/2 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 Size1
      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
      MPGL06CL1 04053252345890

      Documentation

      Certificates of Quality

      Title
      Milliapak 60 Capsule Durapore Membrane C3EB23237
      Millipak 60 Capsule Durapore Membrane C0KB91837
      Millipak 60 Capsule Durapore Membrane C1MB85735
      Millipak 60 Capsule Durapore Membrane C0HB81543
      Millipak 60 Capsule Durapore Membrane C0MB14260
      Millipak 60 Capsule Durapore Membrane C1EB03701
      Millipak 60 Capsule Durapore Membrane C1NB47272
      Millipak 60 Capsule Durapore Membrane C1SB85643Z
      Millipak 60 Capsule Durapore Membrane C2DB34395Z
      Millipak 60 Capsule Durapore Membrane C2EB34394Z
      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