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MCGL30S03 Millidisk® Cartridge 30-stack 0.22 µm Hydrophilic

MCGL30S03
3  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberMCGL30S03
      Trade Name
      • Millidisk®
      DescriptionMillidisk® Cartridge 30-stack 0.22 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
      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
      Bacterial RetentionSamples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.22 µm
      Bubble Point at 23 °C≥3450 mbar (50 psig) air with water
      Flow Rate38 L/min @ 3.15 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 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

      Documentation

      Material Qualification Dossier

      TitleLot Number
      1.0

      Quality Management Dossier (Open Access)

      Title

      Millidisk® Cartridge 30-stack 0.22 µm Hydrophilic SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Millidisk 30 Cartridge Duapore Membrane C5AA59209
      Millidisk 30 Cartridge Durapore Membrane C1PB43217Z
      Millidisk 30 Cartridge Durapore Membrane C6SA52544
      Millidisk 30 Cartridge Durapore Membrane C0CB44419
      Millidisk 30 Cartridge Durapore Membrane C0HB64979
      Millidisk 30 Cartridge Durapore Membrane C1EB85192Z
      Millidisk 30 Cartridge Durapore Membrane C1EB85233Z
      Millidisk 30 Cartridge Durapore Membrane - C6AA07650
      Millidisk 30 Cartridge Durapore Membrane - C6AA13825
      Millidisk 30 Cartridge Durapore Membrane - C6BA20065

      Technical Info

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

      Data Sheet

      Title
      Durapore® Family Guide

      User Guides

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