Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Cartridge Code
Code 0 (2-222) O-rings
Cartridge Nominal Length
20 in. (50 cm)
Catalogue Number
CTGB02TP3
Chemistry
Polytetrafluoroethylene (PTFE)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
20 in.
Diameter
6.9 cm (2.7 in.)
Filtration Area
1.3 m²
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 35 mg per 10-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
Length
20 in. (50 cm)
Material Package
Easy-Open bag
Material Size
3
Maximum Differential Pressure, bar (psid)
Forward: 6.9 bar (100 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 145 °C. Reverse: 5.2 bar (75 psid) @ 25 °C, intermittent
Maximum Inlet Pressure, bar (psi)
Forward - 7 bar (100 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 145 °C; Reverse - 5.2 bar (75 psi) @ 25 °C
Media
Aerex®
Non-Fiber Releasing
This product was manufactured with a PTFE membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Pore Size
0.2 µm
Seal Material
Silicone (SI)
Sterilization
200 (150 forward/50 reverse) SIP cycles of 30 min @ 145 °C; SIP up to 165 hours in forward direction @ 145 °C
Support Material
Polypropylene
Trade Name
Aerex®
USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
+852-3069 6950
sales@gugent.com.hk
