-
Bacterial Endotoxins
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
MCGB30S01
-
Chemistry
Polyvinylidene Fluoride (PVDF)
-
Device Configuration
Cartridge
-
Device Material
Polysulfone
-
Filtration Area
1500 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 7.5 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
1
-
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.
-
Wettability
Hydrophobic
+852-3069 6950
sales@gugent.com.hk
