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MCHL20S03 Millidisk® Cartridge 20-stack 0.45 µm Hydrophilic

Millidisk® Cartridge 20-stack 0.45 µm Hydrophilic MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
MCHL20S03
3  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberMCHL20S03
Trade Name
  • Millidisk®
DescriptionMillidisk® Cartridge 20-stack 0.45 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
WettabilityHydrophilic
Physicochemical Information
Pore Size0.45 µm
Bubble Point at 23 °C≥1790 mbar (26 psig) air with water
Flow Rate60 L/min @ 3.5 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
Katalogové číslo GTIN
MCHL20S03 04053252353413

Documentation

Certificates of Quality

Title
Millidisk 20 Cartridge Durapore Membrane C0KB07786
Millidisk 20 Cartridge Durapore Membrane C3BB92179
Millidisk 20 Cartridge Durapore Membrane - C8HA84193
Millidisk 20 Cartridge Durapore Membrane - C8HA92162
Millidisk 20 Cartridge Durapore Membrane C1AB90494
Millidisk 20 Cartridge Durapore Membrane C1PB43162
Millidisk 20 Cartridge Durapore Membrane C4EB25157
Millidisk 20 Cartridge Durapore Membrane C9BA93348
Millidisk 20 Cartridge Durapore Membrane C9DA28862
Millidisk 20 Cartridge Durapore membrane C3SB69834
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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