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MPGL10CL3 Gamma Compatible Millipak®-100 Filter Unit 0.22 µm 1-1/2 in. TC/TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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MPGL10CL3
3  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberMPGL10CL3
      Trade Name
      • Millipak®
      DescriptionGamma Compatible Millipak®-100 Filter Unit 0.22 µm 1-1/2 in. TC/TC
      References
      Product Information
      HS Code8421 29 90
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 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.
      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 Rate11 L/min @ 2.8 bar ΔP
      Gravimetric ExtractablesThe extractables level was equal to or less than 2.5 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 cm (5.12 in.)
      Diameter7.6 cm (3.0 in.)
      Filtration Area500 cm²
      Process Volume50 L
      Inlet Connection Diameter1-1/2 in.
      Outlet Connection Diameter1-1/2 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
      MPGL10CL3 04053252384790

      Documentation

      Operational Excellence Dossier

      Title

      Certificates of Quality

      Title
      MILLIPAK 100 CAPSULE DURAPORE MEMBRANE C1EB85485Z
      Millidisk 100 Capsule Durapore membrane C3BB59664
      Millipak 100 Capsule Durapore Membrane C0PB39717
      Millipak 100 Capsule Durapore C1BB03592
      Millipak 100 Capsule Durapore Membrane C7DA99128
      Millipak 100 Capsule Durapore Membrane C7MA68360
      Millipak 100 Capsule Durapore Membrane C0CB26274
      Millipak 100 Capsule Durapore Membrane C0DB58169
      Millipak 100 Capsule Durapore Membrane C0PB39721
      Millipak 100 Capsule Durapore Membrane C2BB89234Z
      Show more

      Technical Info

      Title
      Best Practices for Managing Reverse Pressure Filter Impact
      Establishing Product Specific Bubble Point Specifications For Sterilizing-Grade Filters
      Integrity Test Troubleshooting - Beyond Rewet and Retest
      Simplified, efficient sizing of sterilizing-grade normal flow filters for buffer solutions

      Data Sheet

      Title
      Durapore® Family Guide

      User Guides

      Title
      Wetting Instructions for Filter Units with Durapore Membrane