Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Cartridge Code
Code 7
Cartridge Nominal Length
30 in. (75 cm)
Catalogue Number
CW0373S03
Chemistry
Mixed Cellulose Esters (MCE)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
30 in.
Diameter
7.1 cm (2.8 in.)
Filter Grade
Standard Milligard® Media
Filtration Area
2.4 m²
Format
Single Layer
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 50 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
30 in. (75 cm)
Material Package
Double Easy-Open bag
Material Size
3
Maximum Differential Pressure, bar (psid)
3.5 bar (50 psid) @ 25 °C
Maximum Inlet Pressure, bar (psi)
3.5 bar (50 psi) @ 25 °C
Media
Maximum Differential Pressure, bar (psid)
Nominal Pore Size
0.2 µm
Non-Fiber Releasing
This product was manufactured with a media combination 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
10 autoclave cycles or SIP @ 121 °C for 30 min
Support Material
Polyester
Trade Name
Milligard®
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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