Millipore Sigma Vibrant Logo

MFGL04GC3 Non-sterilized Millipak® Final Fill 40 Filter Unit 0.22  µm 3/4  in. TC - 1/4 HB

MFGL04GC3
3  Double Easy-Open bag
Retrieving price...
Price could not be retrieved
Minimum Quantity is a multiple of
Maximum Quantity is
Upon Order Completion More Information
You Saved ()
 
—
Request Pricing
—
Fulfillment and delivery delayed Fulfillment and delivery delayed
In Stock 
Discontinued
Limited Quantities Available
Availability to be confirmed
    Remaining : Will advise
      Remaining : Will advise
      Will advise
      Contact Customer Service
      Contact Customer Service

       

      Contact Customer Service

      Overview

      Replacement Information
      Description
      Catalogue NumberMFGL04GC3
      Trade Name
      • Millipak®
      DescriptionNon-sterilized Millipak® Final Fill 40 Filter Unit 0.22  µm 3/4  in. TC - 1/4 HB
      References
      Product Information
      HS Code8421 29 90
      Device ConfigurationCapsule
      Connections, Inlet/Outlet19  mm (¾  in.) sanitary flange inlet and 6  mm (¼  in.) 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 ConnectionHose Barb
      Bubble Point at 23 °C≥ 50 psi (3450 mbar) air with water
      Flow Rate1.0 L/min @ 0.69   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 Area200 cm²
      Process Volume40 L
      Inlet Connection Diameter3/4 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
      MFGL04GC3 04054839378867

      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 C1EB93045
      Millipak Final Fill Capsule Durapore Membrane C1MB93085
      Millipak Final Fill Capsule Durapore Membrane C4BB12859
      Millipak Final Fill Capsule Durapore Membrane C4EB43370
      Millipak Final Fill Capsule Durapore membrane C4DB24082
      Millipak Final Fill Capsule Durapore membrane C4JB74370

      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

      Related Products & Applications

      Product Families

      Millipak® Final Fill Filters

      Stacked disc filters designed to maximize recovery and enhance protection of your high value product
      Learn More >>