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MFVL10ST3 Gamma sterilized Millipak® Final Fill 100 Filter Unit 0.1  µm 1 1/2  in. TC/TC

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MFVL10ST3
3  Double Easy-Open bag
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      Descripción

      Replacement Information
      Description
      Catalogue NumberMFVL10ST3
      Trade Name
      • Millipak®
      DescriptionGamma sterilized Millipak® Final Fill 100 Filter Unit 0.1  µm 1 1/2  in. TC/TC
      References
      Product Information
      Device ConfigurationGamma Gold Capsule
      Connections, Inlet/Outlet38  mm (1½  in.) sanitary flange inlet and outlet
      Maximum Differential Pressure, bar (psid)Foward:80 psi (5.5 bar) at 25 °C (0.1 µm, 0.22 µm, 0.45 µm, hydrophobic 0.22 µm); Reverse: 10 psi (0.7 bar) at 25 °C
      Maximum Inlet Pressure, bar (psi)80 psi (5.5 bar) at 25 °C
      Good Manufacturing PracticesThese products are manufactured in a facility which is certified to ISO® 9001:2015 Quality Management Systems.
      Quality LevelMQ400
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains < 0.25 EU/mL per device as determined using the Limulus Amebocyte Lysate (LAL) test, meeting requirements of USP <85>, EP 2.6.14 and JP 4.01.
      MediaDurapore®
      Sterilitysterilized by gamma irradiation
      SterilizationDevice integrity and retention was maintained after 3 autoclave cycles of 90 minutes at 126  °C. Devices can withstand a dose ≤ 40  kGy gamma exposure.
      Bacterial RetentionQuantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per AST® F838 methodology.
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.1 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Bubble Point at 23 °C≥ 70 psi (4830 mbar) air with water
      Flow Rate1.31 L/min @ 0.86 bar ΔP
      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), validated based on large volume parenteral specifications as detailed in USP <788> Particulate Matter in Injections
      USP Bacterial EndotoxinsAqueous extraction contains < 0.25 EU/mL per device as determined using the Limulus Amebocyte Lysate (LAL) test, meeting requirements of USP <85>, EP 2.6.14 and JP 4.01.
      Dimensions
      Filtration Area500 cm²
      Process Volume100 L
      Inlet Connection Diameter1 1/2 in.
      Outlet Connection Diameter1 1/2 in.
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      Device Material
      • Polysulfone
      Support MaterialPolysulfone
      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
      Global Trade Item Number
      Número de referencia GTIN
      MFVL10ST3 04054839379208

      Documentation

      Material Qualification Dossier

      CargoVersión
      1.0

      Operational Excellence Dossier

      Title

      Certificados de calidad

      Cargo
      Millipak Final Fill Capsule Durapore Membrane C1PB47242
      Millipak Final Fill Capsule Durapore Membrane C3PB67038
      Millipak Final Fill Capsule Durapore Membrane C3SB69814
      Millipak Final Fill Capsule Durapore Membrane C4AB76980

      Licencias necesarias e Información técnica

      Cargo
      Integrity Test Troubleshooting - Beyond Rewet and Retest
      Reduce Contamination Risks and Simplify Filtration System Design and Operation

      Manuales del usuario

      Cargo
      Wetting Instructions for Filter Units with Durapore Membrane

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