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MCGB40S01 Millidisk® Cartridge 40-stack 0.22 µm hydrophobic

Millidisk® Cartridge 40-stack 0.22 µm hydrophobic MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
MCGB40S01
1  Easy-Open bag
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Replacement Information
Description
Catalogue NumberMCGB40S01
Trade Name
  • Millidisk®
DescriptionMillidisk® Cartridge 40-stack 0.22 µm hydrophobic
References
Product Information
HS Code8421 99 99
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 30 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.
WettabilityHydrophobic
Physicochemical Information
Pore Size0.22 µm
Bubble Point at 23 °C≥1170 mbar (17.0 psig) nitrogen with 100% IPA
Gravimetric ExtractablesThe extractables level was equal to or less than 10 mg per sterilized device after 24 hours in a 70/30% IPA/water mixture 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 Size1
Material PackageEasy-Open bag
Transport Information
Supplemental Information
Specifications
Global Trade Item Number
Numer katalogowy GTIN
MCGB40S01 04053252380471

Documentation

Certificates of Quality

Title
Millidisk 40 Cartridge Durapore Membrane C1BB03775
Millidisk 40 Cartridge Durapore Membrane C1CB72035
Millidisk 40 Cartridge Durapore Membrane C1SB89226
Millidisk 40 Cartridge Durapore Cartridge - C9DA15883
Millidisk 40 Cartridge Durapore Cartridge- C8SA67653
Millidisk 40 Cartridge Durapore Membrane C7JA43064
Millidisk 40 Cartridge Durapore Membrane C8DA58016
Millidisk 40 Cartridge Durapore Membrane C0HB82077Z
Millidisk 40 Cartridge Durapore Membrane C0JB91578Z
Millidisk 40 Cartridge Durapore Membrane C1KB89219
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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

Data Sheet

Title
Durapore® Family Guide

User Guides

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