Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Cartridge Code
Not Applicable
Catalogue Number
MCGB10S02
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Cartridge
Device Material
Polysulfone
Filtration Area
500 cm²
Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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.
Material Package
Easy-Open bag
Material Size
2
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
Media
Durapore®
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).
Pore Size
0.22 µm
Seal Material
Silicone (SI)
Sterility
Other
Sterilization
5 SIP cycles of 30 min @ 135 °C; 5 autoclave cycles of 60 min @ 126 °C
Support Material
Polysulfone
Trade Name
Millidisk®
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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