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MCGL40S03 Millidisk® Cartridge 40-stack 0.22 µm Hydrophilic

Millidisk® Cartridge 40-stack 0.22 µm Hydrophilic MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
MCGL40S03
3  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberMCGL40S03
Trade Name
  • Millidisk®
DescriptionMillidisk® Cartridge 40-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
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
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 Rate53 L/min @ 2.8 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
Katalogové číslo GTIN
MCGL40S03 04053252608551

Documentation

Material Qualification Dossier

TitleVersion
3.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Certificates of Quality

Title
MILLIDISK 40 CARTRIDGE DURAPORE MEMBRANE C1DB85148
Milldisk 40 Cartridge Durapore Membrane C0SB82237
Milldisk 40 Cartridge Durapore Membrane - C9BA99132
Millidik 40 Cartridge Durapore Membrane C4CB03160
Millidisk 40 Cartridge Durapore Membrane C1AB90326
Millidisk 40 Cartridge Durapore Membrane C1AB90468
Millidisk 40 Cartridge Durapore Membrane C1AB90492
Millidisk 40 Cartridge Durapore Membrane C1BB10986
Millidisk 40 Cartridge Durapore Membrane C1BB14684
Millidisk 40 Cartridge Durapore Membrane C1BB14685
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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
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