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MFGL06SH3 Gamma sterilized Millipak® Final Fill 60 Filter Unit 0.22  µm 1/4  in. HB/HB

MFGL06SH3
3  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberMFGL06SH3
      Trade Name
      • Millipak®
      DescriptionGamma sterilized Millipak® Final Fill 60 Filter Unit 0.22  µm 1/4  in. HB/HB
      References
      Product Information
      Device ConfigurationGamma Gold Capsule
      Connections, Inlet/Outlet6  mm (¼  in.) stepped hose barb 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 Size0.22 µm
      Inlet ConnectionStepped Hose Barb
      Outlet ConnectionStepped Hose Barb
      Bubble Point at 23 °C≥ 50 psi (3450 mbar) air with water
      Flow Rate1.51 L/min @ 0.86   bar ∆P
      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 Area300 cm²
      Process Volume60 L
      Inlet Connection Diameter1/4 in.
      Outlet Connection Diameter1/4 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
      Catalogue Number GTIN
      MFGL06SH3 04054839378515

      Documentation

      Material Qualification Dossier

      TitleVersion
      3.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Certificates of Quality

      Title
      Millipak Final FIll Capsule Durapore Membrane- C1DB03715
      Millipak Final Fill Capsule Durapore Membrane C1HB93087
      Millipak Final Fill Capsule Durapore Membrane C3DB59654
      Millipak Final Fill Capsule Durapore Membrane C3NB64640
      Millipak Final Fill Capsule Durapore Membrane C2KB10970
      Millipak Final Fill Capsule Durapore Membrane C2NB30932
      Millipak Final Fill Capsule Durapore Membrane C3NB61354
      Millipak Final Fill Capsule Durapore Membrane C9SA19524
      Millipak Final Fill Capsule Durapore Membrane- C1AB90310

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