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Bacterial Endotoxins
Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
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Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
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Catalogue Number
MPVL10CF3
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Chemistry
Polyvinylidene Fluoride (PVDF)
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Device Configuration
Capsule
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Device Material
Polycarbonate
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Diameter
7.6 cm (3.0 in.)
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Filtration Area
500 cm²
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Flow Rate
3.8 L/min @ 2.45 bar ΔP
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Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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Gravimetric Extractables
The extractables level was equal to or less than 2.5 mg per device after 24 hours in water at controlled room temperature.
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Inlet Connection
Sanitary Flange
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Inlet Connection Diameter
3/4 in.
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Length
13 cm (5.12 in.)
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Material Package
Double Easy-Open bag
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Material Size
3
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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
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Maximum Inlet Pressure, bar (psi)
5.2 bar (75 psi) @ 25 °C
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Media
Durapore®
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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).
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Outlet Connection
Sanitary Flange
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Outlet Connection Diameter
3/4 in.
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Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL
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Pore Size
0.1 µm
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Process Volume
50 L
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Sterility
Other
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Sterilization
3 autoclave cycles of 90 min @ 123°C; not in-line steam sterilizable
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Support Material
Polycarbonate
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Trade Name
Millipak®
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USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
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Vent Cap Material
Polyvinylidene fluoride (PVDF)
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Volume
50 L
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Wettability
Hydrophilic
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