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MCGB40S01 Millidisk® Cartridge 40-stack 0.22 µm hydrophobic

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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MCGB40S01
1  Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberMCGB40S01
      Trade Name
      • Millidisk®
      DescriptionMillidisk® Cartridge 40-stack 0.22 µm hydrophobic
      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 30 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.
      WettabilityHydrophobic
      Physicochemical Information
      Pore Size0.22 µm
      Bubble Point at 23 °C≥1170 mbar (17.0 psig) nitrogen with 100% IPA
      Gravimetric ExtractablesThe extractables level was equal to or less than 10 mg per sterilized device after 24 hours in a 70/30% IPA/water mixture 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 Size1
      Material PackageEasy-Open bag
      Transport Information
      Supplemental Information
      Specifications
      Global Trade Item Number
      Catalogue Number GTIN
      MCGB40S01 04053252380471

      Documentation

      Certificates of Quality

      Title
      Millidisk 40 Cartridge Durapore Membrane C1BB03775
      Millidisk 40 Cartridge Durapore Membrane C1CB72035
      Millidisk 40 Cartridge Durapore Membrane C1SB89226
      Millidisk 40 Cartridge Durapore Cartridge - C9DA15883
      Millidisk 40 Cartridge Durapore Cartridge- C8SA67653
      Millidisk 40 Cartridge Durapore Membrane C7JA43064
      Millidisk 40 Cartridge Durapore Membrane C8DA58016
      Millidisk 40 Cartridge Durapore Membrane C0HB82077Z
      Millidisk 40 Cartridge Durapore Membrane C0JB91578Z
      Millidisk 40 Cartridge Durapore Membrane C1KB89219
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      Technical Info

      Title
      Best Practices for Managing Reverse Pressure Filter Impact
      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