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MPGL20CF3 Gamma Compatible Millipak®-200 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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MPGL20CF3
3  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberMPGL20CF3
      Trade Name
      • Millipak®
      DescriptionGamma Compatible Millipak®-200 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.
      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 Rate19 L/min @ 3.2 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 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
      MPGL20CF3 04053252456183

      Documentation

      Operational Excellence Dossier

      Title

      Certificates of Quality

      Title
      Millipak 200 Capsule Durapor Membrane C1BB08108Z
      Millipak 200 Capsule Durapore Membrane C0AB87104
      Millipak 200 Capsule Durapore Membrane C0EB74426
      Millipak 200 Capsule Durapore Membrane C0KB03167
      Millipak 200 Capsule Durapore Membrane C0NB33018
      Millipak 200 Capsule Durapore Membrane C0PB46619
      Millipak 200 Capsule Durapore Membrane C1EB04444Z
      Millipak 200 Capsule Durapore Membrane C1EB85738Z
      Millipak 200 Capsule Durapore Membrane C2JB28490Z
      Millipak 200 Capsule Durapore Membrane C2PB36915Z
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