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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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Cartridge Code
Not Applicable
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Catalogue Number
MCGL10S03
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Chemistry
Polyvinylidene Fluoride (PVDF)
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Device Configuration
Cartridge
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Device Material
Polysulfone
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Filtration Area
500 cm²
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Flow Rate
15 L/min @ 3.5 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 sterilized device after 24 hours in water at controlled room temperature.
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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)
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
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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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Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL
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Pore Size
0.22 µm
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Seal Material
Silicone (SI)
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Sterility
Other
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Sterilization
5 SIP cycles of 60 min @ 135 °C; 5 autoclave cycles of 60 min @ 126 °C
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Support Material
Polysulfone
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Trade Name
Millidisk®
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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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Wettability
Hydrophilic
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