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Bacterial Endotoxins
Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
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Cartridge Code
Code M (2-118) O-rings
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Cartridge Nominal Length
4 in. (10 cm)
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Catalogue Number
CWL6M4S03
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Chemistry
Low Protein-Binding Mixed Cellulose Esters (MCE)
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Device Configuration
Cartridge
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Device Material
Polypropylene
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Device Size
4 in.
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Diameter
7.1 cm (2.8 in.)
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Filter Grade
Low Protein Binding Milligard® Media
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Filtration Area
0.32 m²
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Format
Single Layer
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Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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Gravimetric Extractables
The extractables level was equal to or less than 40 mg per 4-inch cartridge after a 2 L flush and 24 hours in water at controlled room temperature.
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Length
4 in. (10 cm)
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Material Package
Double Easy-Open bag
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Material Size
3
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Maximum Differential Pressure, bar (psid)
3.5 bar (50 psid) @ 25 °C
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Maximum Inlet Pressure, bar (psi)
3.5 bar (50 psi) @ 25 °C
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Media
Maximum Differential Pressure, bar (psid)
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Nominal Pore Size
0.5 µm
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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).
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Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L
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Pore Size
0.5 µm
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Seal Material
Silicone (SI)
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Sterilization
10 autoclave cycles or SIP @ 121 °C for 30 min
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Support Material
Polyester
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Trade Name
Milligard®
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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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