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MCGL20S03 Millidisk® Cartridge 20-stack 0.22 µm Hydrophilic

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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MCGL20S03
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberMCGL20S03
Trade Name
  • Millidisk®
DescriptionMillidisk® Cartridge 20-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 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 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 Rate30 L/min @ 3.15 bar ΔP
Gravimetric ExtractablesThe extractables level was equal to or less than 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 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 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
MCGL20S03 04053252391576

Documentation

Material Qualification Dossier

TitleVersion
3.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Certificates of Quality

Title
Milidisk 20 Cartridge Durapore Membrane C4MB90029
Milldisk 20 Cartridge Durapore Membrane - C8DA65882
Millidisk 20 Capsule Durapore Membrane C8DA58025
Millidisk 20 Cartridge Duapore Membrane C0AB89476
Millidisk 20 Cartridge Duarpore Membrane C3MB58656
Millidisk 20 Cartridge Durapore Mambrane C9CA04303
Millidisk 20 Cartridge Durapore Membrane C0EB64959
Millidisk 20 Cartridge Durapore Membrane C0KB01164
Millidisk 20 Cartridge Durapore Membrane C1AB90324
Millidisk 20 Cartridge Durapore Membrane C8EA69254
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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