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MCGL10S03 Millidisk® Cartridge 10-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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MCGL10S03
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberMCGL10S03
Trade Name
  • Millidisk®
DescriptionMillidisk® Cartridge 10-stack 0.22 µm Hydrophilic
References
Product Information
HS Code8421 29 90
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 Design10 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 Rate15 L/min @ 3.5 bar ΔP
Gravimetric ExtractablesThe extractables level was equal to or less than 2.5 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 Area500 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
MCGL10S03 04053252716515

Documentation

Material Qualification Dossier

TitleVersion
3.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Certificates of Quality

Title
C1KB89216Z
MIllidisk 10 Cartridge Durapore Membrane- C8AA19278
Milidisk 10 Cartridge Durapore Membrane C8DA58023
Millidisk 10 Capsule Durapore Membrane C3PB69660
Millidisk 10 Capsule Durapore Membrane C9EA33290
Millidisk 10 Cartridge Durapore Membrane C4NB99802
Millidisk 10 Cartridge Durapore C1HB89228Z
Millidisk 10 Cartridge Durapore Membrane C1PB89223Z
Millidisk 10 Cartridge Durapore Membrane C8NA40477
Millidisk 10 Cartridge Durapore Membrane C0CB39347
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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

User Guides

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