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MCGBL4S03 Millidisk® Barrier Filter 0.22 µm hydrophilic/phobic

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MCGBL4S03
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberMCGBL4S03
Trade Name
  • Millidisk®
DescriptionMillidisk® Barrier Filter 0.22 µm hydrophilic/phobic
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 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
Sterilization4 SIP cycles of 60 min @ 135 °C; 4 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/Hydrophilic
Physicochemical Information
Pore Size0.22 µm
Bubble Point at 23 °C≥1280 mbar (18.5 psig) nitrogen with 70/30 % IPA/water
Flow Rate7.6 L/min @ 1 bar ΔP
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 Size3
Material PackageDouble Easy-Open bag
Transport Information
Supplemental Information
Specifications
Global Trade Item Number
Catalogue Number GTIN
MCGBL4S03 04053252354779

Documentation

Certificates of Quality

Title
Milidisk Barrier Cartridge Durapore Membrane C8DA44031
Millidisk Barrier Capsule Durapore Membrane C3JB45265
Millidisk Barrier Capsule Durapore Membrane C4NB98410
Millidisk Barrier Cartridge C0PB32209
Millidisk Barrier Cartridge Durapore Membrane C0AB93716
Millidisk Barrier Cartridge Durapore Membrane C9BA93977
Millidisk Barrier Cartridge Durapore Membrane C9EA32032
Millidisk Barrier Cartridge - C7BA77791
Millidisk Barrier Cartridge C9SA80062
Millidisk Barrier Cartridge Durapore Membrane C2DB07569Z

Technical Info

Title
Best Practices for Managing Reverse Pressure Filter Impact
Establishing Product Specific Bubble Point Specifications For Sterilizing-Grade Filters
Millipak®and Millidisk®Barrier Filters Technical Brief

Data Sheet

Title
Durapore® Family Guide