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MCSL30S01 Millidisk® Cartridge 30-stack 5.0 µm Hydrophilic

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MCSL30S01
1  Double Easy-Open bag
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      개요

      Replacement Information
      Description
      Catalogue NumberMCSL30S01
      Trade Name
      • Millidisk®
      DescriptionMillidisk® Cartridge 30-stack 5.0 µm Hydrophilic
      References
      Product Information
      Device ConfigurationCartridge
      Maximum Differential Pressure, bar (psid)Forward: 4.1 bar (60 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 123 °C; Reverse: 0.7 bar (10 psid) @ 25 °C
      Maximum Inlet Pressure, bar (psi)Forward - 4.1 bar (60 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 123 °C; Reverse - 0.7 bar (10 psi) @ 25 °C
      Stack Design30 Stak
      Cartridge CodeNot Applicable
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      Quality LevelMQ400
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaDurapore®
      SterilityOther
      Sterilization5 SIP cycles of 60 min @ 135 °C; 5 autoclave cycles of 60 min @ 126 °C
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size5.0 µm
      Bubble Point at 23 °C≥138 mbar (2 psig) air with water
      Flow Rate75 L/min @ 2.1 bar ΔP
      Gravimetric ExtractablesThe extractables level was equal to or less than 7.5 mg per sterilized device after 24 hours in water at controlled room temperature.
      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).
      USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
      Dimensions
      Filtration Area1500 cm²
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      Device Material
      • Polysulfone
      Seal MaterialSilicone (SI)
      Support MaterialPolysulfone
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size1
      Material PackageDouble Easy-Open bag
      Transport Information
      Supplemental Information
      Specifications
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL
      Global Trade Item Number
      카탈로그 번호 GTIN
      MCSL30S01 04053252572579

      Documentation

      Certificates of Quality

      Title
      Millidisk 30 Cartridge Durapore Membrane - C8HA94785
      Millidisk 30 Cartridge Durapore Membrane - C9MA05046
      Millidisk 30 Cartridge Durapore Membrane C4CB12375

      Technical Info

      Title
      Best Practices for Managing Reverse Pressure Filter Impact
      Establishing Product Specific Bubble Point Specifications For Sterilizing-Grade Filters
      Integrity Test Troubleshooting - Beyond Rewet and Retest

      User Guides

      Title
      Hydrophilic Durapore® Cartridges and Capsules User Guide
      Wetting Instructions for Filter Units with Durapore Membrane