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MFGL20GT3 Non-sterilized Millipak® Final Fill 200 Filter Unit 0.22  µm 1 1/2  in. TC/TC

MFGL20GT3
3  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberMFGL20GT3
      Trade Name
      • Millipak®
      DescriptionNon-sterilized Millipak® Final Fill 200 Filter Unit 0.22  µm 1 1/2  in. TC/TC
      References
      Product Information
      HS Code8421 29 90
      Device ConfigurationCapsule
      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®
      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 ConnectionSanitary Flange
      Bubble Point at 23 °C≥ 50 psi (3450 mbar) air with water
      Flow Rate7.61 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 Area1000 cm²
      Process Volume200 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
      Catalog Number GTIN
      MFGL20GT3 04054839379383

      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 200 Capsule Durapore membrane C2EB28255Z
      Millipak Final Fill Capsule Durapore Membrane C1DB92056
      Millipak Final Fill Capsule Durapore Membrane - C9MA96304
      Millipak Final Fill Capsule Durapore Membrane C1BB97921
      Millipak Final Fill Capsule Durapore Membrane C1JB33358
      Millipak Final Fill Capsule Durapore Membrane C1PB33497
      Millipak Final Fill Capsule Durapore Membrane C2DB60646
      Millipak Final Fill Capsule Durapore Membrane C2HB85697
      Millipak Final Fill Capsule Durapore Membrane C3BB36959
      Millipak Final Fill Capsule Durapore Membrane C3NB64618
      Show more

      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

      Data Sheet

      Title
      Durapore® Family Guide

      User Guides

      Title
      Wetting Instructions for Filter Units with Durapore Membrane

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