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MFGL02GH3 Non-sterilized Millipak® Final Fill 20 Filter Unit 0.22  µm 1/4  in. HB/HB

MFGL02GH3
3  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberMFGL02GH3
      Trade Name
      • Millipak®
      DescriptionNon-sterilized Millipak® Final Fill 20 Filter Unit 0.22  µm 1/4  in. HB/HB
      References
      Product Information
      HS Code8421 29 90
      Device ConfigurationCapsule
      Connections, Inlet/Outlet6  mm (¼  in.) stepped hose barb inlet and outlet
      Maximum Differential Pressure, bar (psid)Forward:60 psi (4.1 bar) at 25 °C; 50 psi(3.5 bar) at 25 °C; (5 µm) 25 psi (1.7 bar) at 80 °C; Reverse: 10 psi (0.7 bar) at 25 °C
      Maximum Inlet Pressure, bar (psi)60 psi (4.1 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 ConnectionStepped Hose Barb
      Outlet ConnectionStepped Hose Barb
      Bubble Point at 23 °C≥ 50 psi (3450 mbar) air with water
      Flow Rate0.51 L/min @ 0.69 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 Area100 cm²
      Process Volume20 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
      MFGL02GH3 04054839378263

      Documentation

      Material Qualification Dossier

      TitleVersion
      3.0

      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 C2SB36872
      Millipak Final Fill Capsule Durapore Membrane C3KB52123
      Millipak Final Fill Capsule Durapore Membrane C4PB10970
      Millipak Final Fill Capsule Durapore Membrane C5AB32968
      Millipak Final Fill Capsule Durapore Membrane C5BB49018
      Millipak Final Fill Capsule Durapore Membrane C5EB75623
      Millipak Final Fill Capsule Durapore Membrane C1EB92064
      Millipak Final Fill Capsule Durapore Membrane C1JB35038
      Millipak Final Fill Capsule Durapore Membrane C2BB17895
      Millipak Final Fill Capsule Durapore Membrane C2HB31903
      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

      User Guides

      Title
      Wetting Instructions for Filter Units with Durapore Membrane

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