Merck - MCGB10S02 - Millidisk Cartridge 10-stack 0.22µm hydrophobic

ITEM #: 11567593
Catalogue Number MCGB10S02
Trade Name

• Millidisk ®

Millidisk ® Cartridge 10-stack 0.22 µm hydrophobic
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 10 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 30 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 Hydrophobic
Pore Size 0.22 µm
Bubble Point at 23 °C ≥1170 mbar (17.0 psig) nitrogen with 100% IPA
Gravimetric Extractables The extractables level was equal to or less than 2.5 mg per sterilized device after 24 hours in a 70/30% IPA/water mixture 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 500 cm²
Chemistry

• Polyvinylidene Fluoride (PVDF)

Device Material

• Polysulfone

Seal Material Silicone (SI)
Support Material Polysulfone
Material Size 2
Material Package Easy-Open bag