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MFGL10SF3 Gamma sterilized Millipak® Final Fill 100 Filter Unit 0.22  µm 3/4  in. TC/TC

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MFGL10SF3
3  Double Easy-Open bag
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      Aperçu

      Replacement Information
      Description
      Catalogue NumberMFGL10SF3
      Trade Name
      • Millipak®
      DescriptionGamma sterilized Millipak® Final Fill 100 Filter Unit 0.22  µm 3/4  in. TC/TC
      References
      Product Information
      HS Code8421 29 90
      Device ConfigurationGamma Gold Capsule
      Connections, Inlet/Outlet19  mm (¾ 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®
      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 ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      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 Diameter3/4 in.
      Outlet Connection Diameter3/4 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
      Référence GTIN
      MFGL10SF3 04054839379154

      Documentation

      Material Qualification Dossier

      TitreVersion
      3.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Certificats de qualité

      Titre
      Millipak Final Fill Capsule Durapore Membrane C1JB93037
      Millipak Final Fill Capsule Durapore Membrane C5CB61349
      Millipak Final Fill Capsule Durapore Membrane C1PB33501
      Millipak Final Fill Capsule Durapore Membrane C3NB67035
      Millipak Final Fill Capsule Durapore Membrane C3PB67075
      Millipak Final Fill Capsule Durapore Membrane C3SB64726
      Millipak Final Fill Capsule Durapore membrane C4AB75186

      Informations techniques

      Titre
      Integrity Test Troubleshooting - Beyond Rewet and Retest
      Reduce Contamination Risks and Simplify Filtration System Design and Operation

      Manuels d'utilisation

      Titre
      Wetting Instructions for Filter Units with Durapore Membrane

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