Merck - MCGL20S03 - Millidisk Cartridge 20-stack 0.22µm Hydrophilic

ITEM #: 11567598
Catalogue Number MCGL20S03
Trade Name

• Millidisk ®

Millidisk ® Cartridge 20-stack 0.22 µm Hydrophilic
Device Configuration Cartridge
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 Design 20 Stak
Cartridge Code Not Applicable
Good Manufacturing Practices These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Quality Level MQ400
Bacterial Endotoxins Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Media Durapore ®
Sterility Other
Sterilization 5 SIP cycles of 60 min @ 135 °C; 5 autoclave cycles of 60 min @ 126 °C
Bacterial Retention Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10 CFU/cm² using ASTM ®  F838 methodology.
Wettability Hydrophilic
Pore Size 0.22 µm
Bubble Point at 23 °C ≥3450 mbar (50 psig) air with water
Flow Rate 30 L/min @ 3.15 bar ΔP
Gravimetric Extractables The extractables level was equal to or less than 5 mg per sterilized device after 24 hours in water at controlled room temperature.
Non-Fiber Releasing This 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 Endotoxins A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Filtration Area 1000 cm²
Chemistry

• Polyvinylidene Fluoride (PVDF)

Device Material

• Polysulfone

Seal Material Silicone (SI)
Support Material Polysulfone
Material Size 3
Material Package Double Easy-Open bag
Oxidizable Substances Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL