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MCHL40S03 Millidisk® Cartridge 40-stack 0.45 µm Hydrophilic

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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MCHL40S03
3  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberMCHL40S03
      Trade Name
      • Millidisk®
      DescriptionMillidisk® Cartridge 40-stack 0.45 µm Hydrophilic
      References
      Product Information
      HS Code8421 99 99
      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 Design40 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 Size0.45 µm
      Bubble Point at 23 °C≥1790 mbar (26 psig) air with water
      Flow Rate75 L/min @ 2.7 bar ΔP
      Gravimetric ExtractablesThe extractables level was equal to or less than 10 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 Area2000 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 Size3
      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
      Catalogue Number GTIN
      MCHL40S03 04053252459863

      Documentation

      Certificates of Quality

      Title
      MILLIDISK 40 CARTRIDGE DURAPORE MEMBRANE C1DB85174
      Millidisk 40 Cartridge Durapore Membrane - C7JA36654
      Millidisk 40 Cartridge Durapore Membrane C1AB90499
      Millidisk 40 Cartridge Durapore Membrane C1BB03549
      Millidisk 40 Cartridge Durapore Membrane C1EB85254
      Millidisk 40 Cartridge Durapore Membrane C1HB85163
      Millidisk 40 Cartridge Durapore Membrane C1PB89235
      Millidisk 40 Cartridge Durapore Membrane C1SB47228
      Millidisk 40 Cartridge Durapore Membrane C1SB92868
      Millidisk 40 Cartirdge Durapore Membrane C1PB47224
      Show more

      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

      Data Sheet

      Title
      Durapore® Family Guide

      User Guides

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