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

Ficha de datos de seguridad (MSDS o SDS), certificado de análisis y de calidad (CoA y CoQ), expedientes, folletos y otros documentos disponibles.
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MPGL20CB3
3  Double Easy-Open bag
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      Descripción

      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
      Número de referencia GTIN
      MPGL20CB3 04053252302442

      Documentation

      Operational Excellence Dossier

      Title

      Certificados de calidad

      Cargo
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      Licencias necesarias e Información técnica

      Cargo
      Best Practices for Managing Reverse Pressure Filter Impact
      Integrity Test Troubleshooting - Beyond Rewet and Retest

      Ficha técnica

      Cargo
      Durapore® Family Guide

      Manuales del usuario

      Cargo
      Wetting Instructions for Filter Units with Durapore Membrane