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MFGL10GL3 Non-sterilized Millipak® Final Fill 100 Filter Unit 0.22  µm 1 1/2  in. TC - 1/2  in. HB

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MFGL10GL3
3  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberMFGL10GL3
      Trade Name
      • Millipak®
      DescriptionNon-sterilized Millipak® Final Fill 100 Filter Unit 0.22  µm 1 1/2  in. TC - 1/2  in. HB
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38  mm (1½  in.) sanitary flange inlet and 13  mm (½  in.) stepped hose barb 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®
      Sterilitynon-sterilized
      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 ConnectionSanitary Flange
      Outlet ConnectionStepped Hose Barb
      Bubble Point at 23 °C≥ 50 psi (3450 mbar) air with water
      Flow Rate3.81 L/min @ 1.1   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 Area500 cm²
      Process Volume100 L
      Inlet Connection Diameter1 1/2 in.
      Outlet Connection Diameter1/2 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
      Catalogue Number GTIN
      MFGL10GL3 04054839379697

      Documentation

      Material Qualification Dossier

      TitleVersion
      1.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Operational Excellence Dossier (Second Sterilization)

      Title

      Certificates of Quality

      Title
      Millipak Final Fill Capsule Durapore Membrane C2NB26438
      Millipak Final Fill Capsule Durapore Membrane C3HB29751
      Millipak Final Fill Capsule Durapore Membrane C4AB80294
      Millipak Final Fill Capsule Durapore Membrane C4DB17725
      Millipak Final Fill Capsule Durapore Membrane C4EB09366
      Millipak Final Fill Capsule Durapore membrane C3KB46421

      Technical Info

      Title
      Improved Product Recovery using Blow-down and Millipak®Final Fill Filters
      Integrity Test Troubleshooting - Beyond Rewet and Retest
      Reduce Contamination Risks and Simplify Filtration System Design and Operation

      User Guides

      Title
      Wetting Instructions for Filter Units with Durapore Membrane

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