A sample aqueous extraction contains less than 0.25 EU/ml as determined by the Limulus Amebocyte Lysate (LAL) test.
Cartridge Code
Code 7
Cartridge Nominal Length
10 in.
Catalogue Number
CSGB71E06
Chemistry
Polytetrafluoroethylene (PTFE)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
10 in.
Diameter
2.8 in.
Filtration Area
0.65 m2 (7.0 ft2) per 10 in. cartridge
Gravimetric Extractables
The extractables level was equal to or less than 35 mg per 10-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
Housing Material
Stainless Steel
Length
10 in.
Material Package
Double Easy-Open bag
Material Size
6
Maximum Differential Pressure
5.5 bar (80 psig) @ ambient temperature, 1.8 bar (25 psid) @80 °C
Media
Solvex™
Nominal Pore Size
0.2 µm
Non-Fiber Releasing
PTFE membrane meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6).
Pore Size
0.2 µm
Sterilization
Steam sterilized 50 times forward and 50 times reverse for 30 minutes at 135 °C
Support Material
Polypropylene
Trade Name
Solvex™
USP Bacterial Endotoxins
Aqueous extraction contains <0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
+852-3069 6950
sales@gugent.com.hk
