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MPGL10CF3 Gamma Compatible Millipak®-100 Filter Unit 0.22 µm 3/4 in. TC/TC

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MPGL10CF3
3  Double Easy-Open bag
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      Replacement Information
      Description
      Catalogue NumberMPGL10CF3
      Trade Name
      • Millipak®
      DescriptionGamma Compatible Millipak®-100 Filter Unit 0.22 µm 3/4 in. TC/TC
      References
      Product Information
      HS Code8421 29 90
      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 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 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
      Número de catálogo GTIN
      MPGL10CF3 04053252603440

      Documentation

      Operational Excellence Dossier

      Title

      Certificados de qualidade

      Título
      Millipak 100 Capsule Durapore Membrane C1BB03786
      Millipak 100 Capsule Durapore Membrane C1NB85622Z
      Millipak 100 Capsule Durapore Membrane - C0CB36954
      Millipak 100 Capsule Durapore Membrane - C8JA00268
      Millipak 100 Capsule Durapore Membrane C0NB33285
      Millipak 100 Capsule Durapore Membrane C1HB85510Z
      Millipak 100 Capsule Durapore Membrane C2CB51787Z
      Millipak 100 Capsule Durapore Membrane C3BB77831
      Millipak 100 Capsule Durapore Membrane C3DB07989
      Millipak 100 Capsule Durapore Membrane C3NB64731
      Show more

      Informações técnicas

      Título
      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

      Ficha de dados

      Título
      Durapore® Family Guide

      Manuais do usuário

      Título
      Wetting Instructions for Filter Units with Durapore Membrane