-
Bacterial Endotoxins
Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
-
Cartridge Code
Code 5 (2-222) O-rings and spear
-
Cartridge Nominal Length
10 in. (25 cm)
-
Catalogue Number
CVHL51PP3
-
Chemistry
Polyvinylidene Fluoride (PVDF)
-
Device Configuration
Cartridge
-
Device Material
Polypropylene
-
Device Size
10 in.
-
Diameter
6.9 cm (2.7 in.)
-
Filtration Area
0.69 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 20 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.
-
Indirect Food Additive
All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. All component materials meet the requirements of the EU framework regulation [1935/2004/EC] regarding materials and articles intended to contact food.
-
Length
10 in. (25 cm)
-
Material Package
Double Easy-Open bag
-
Material Size
3
-
Maximum Differential Pressure, bar (psid)
Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 135 °C. Reverse: 3.5 bar (50 psid) @ 25 °C
-
Maximum Inlet Pressure, bar (psi)
Forward - 5.5 bar (80 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 135 °C; Reverse - 3.5 bar (50 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).
-
Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L
-
Pore Size
0.45 µm
-
Seal Material
Silicone (SI)
-
Sterility
Other
-
Sterilization
30 SIP cycles of 30 min @ 135 °C; 30 autoclave cycles of 60 min @ 126 °C
-
Support Material
Polypropylene
-
Trade Name
Durapore®
-
USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
-
Wettability
Hydrophilic
+852-3069 6950
sales@gugent.com.hk
