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MCGB20S02 Millidisk® Cartridge 20-stack 0.22 µm hydrophobic

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MCGB20S02
2  Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberMCGB20S02
Trade Name
  • Millidisk®
DescriptionMillidisk® Cartridge 20-stack 0.22 µm hydrophobic
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 Design20 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 5 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 Area1000 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 Size2
Material PackageEasy-Open bag
Transport Information
Supplemental Information
Specifications
Global Trade Item Number
Catalogue Number GTIN
MCGB20S02 04053252309854

Documentation

Certificates of Quality

Title
Millidisk 20 Cartridge Durapore Membrane C0HB80252
Millidisk 20 Cartridge Durapore Membrane C3HB37635
Millidisk 20 Cartridge Durapore Membrane C1KB89215Z
Millidisk 20 Cartridge Durapore Membrane C1SB08886Z
Millidisk 20 Cartridge Durapore Membrane C4EB28155
Millidisk 20 Cartridge Durapore Membrane C9CA04947
Millidisk 20 Cartridge Durapore Membrane C9KA71287
Millidisk 20 Cartridge Durapore Membrane- C2CB56297Z
Millidisk 20 Cartridge Durapore Membrane- C7NA75542
Millidisk 20 Cartridge Durapore Membrane- C7PA80822
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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