Merck - MPVL2GCF3 - Sterile Millipak-200 Filter Unit 0.1µm 3/4in. TC/TC

ITEM #: 11567957
Catalogue Number MPVL2GCF3
Trade Name

• Millipak ®

Sterile Millipak ® -200 Filter Unit 0.1 µm 3/4 in. TC/TC
Device Configuration Gamma Gold Capsule
Connections, Inlet/Outlet 19 mm (3/4 in.) Sanitary Flange
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) 5.2 bar (75 psi) @ 25 °C
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 Sterile
Sterilization 3 autoclave cycles of 90 min @ 123 °C; not in-line steam sterilizable
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 0.1 µm
Inlet Connection Sanitary Flange
Outlet Connection Sanitary Flange
Bubble Point at 23 °C ≥4830 mbar (70 psig) air with water
Flow Rate 8.5 L/min @ 2.45 bar ΔP
Gravimetric Extractables The extractables level was equal to or less than 5 mg per sterilized device after a 200 mL flush and 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
Process Volume 100 L
Inlet Connection Diameter 3/4 in.
Outlet Connection Diameter 3/4 in.
Chemistry

• Polyvinylidene Fluoride (PVDF)

Device Material

• Polycarbonate

Support Material Polycarbonate
Vent Cap Material Polyvinylidene fluoride (PVDF)
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