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MCSL30S01 Millidisk® Cartridge 30-stack 5.0 µm Hydrophilic

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MCSL30S01
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberMCSL30S01
Trade Name
  • Millidisk®
DescriptionMillidisk® Cartridge 30-stack 5.0 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 Design30 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 Size5.0 µm
Bubble Point at 23 °C≥138 mbar (2 psig) air with water
Flow Rate75 L/min @ 2.1 bar ΔP
Gravimetric ExtractablesThe extractables level was equal to or less than 7.5 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 Area1500 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 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
MCSL30S01 04053252572579

Documentation

Certificates of Quality

Title
Millidisk 30 Cartridge Durapore Membrane - C8HA94785
Millidisk 30 Cartridge Durapore Membrane - C9MA05046
Millidisk 30 Cartridge Durapore Membrane C4CB12375

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

User Guides

Title
Hydrophilic Durapore® Cartridges and Capsules User Guide
Wetting Instructions for Filter Units with Durapore Membrane