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Bacterial Endotoxins
Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
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Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
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Cartridge Code
Code 0 (2-222) O-rings
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Cartridge Nominal Length
10 in. (25 cm)
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Catalogue Number
CGEP01TP3
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Chemistry
Polyethersulfone (PES)
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Device Configuration
Cartridge
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Device Material
Polypropylene/Polysulfone
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Device Size
10 in.
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Diameter
6.9 cm (2.7 in.)
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Filtration Area
0.54 m²
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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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Indirect Food Additive
All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
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Length
10 in. (25 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
Forward: 6900 mbar (100 psi) @ 25 °C; 1700 bar (25 psi) @ 80 °C; 340 mbar (5 psi) @ 135 °C. Reverse: 2100 mbar (30 psi) @ 25 °C, 69 mbar (1 psi) @ 135 °C
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Maximum Inlet Pressure, bar (psi)
Forward - 7 bar (100 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 135 °C; Reverse - 2.07 bar (30 psi) @ 25 °C; 0.07 bar (1 psi) @ 135 °C
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Media
Millipore Express® SHF
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Non-Fiber Releasing
This product was manufactured with a Millipore Express® membrane 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 ≥1 L
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Pore Size
0.2 µm
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Seal Material
Silicone (SI)
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Sterilization
25 forward or 22 forward and 3 reverse SIP cycles of 30 min @ 135 °C; 25 autoclave cycles of 60 min @ 126 °C
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Support Material
Polypropylene
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Trade Name
Millipore Express®
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USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
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Wettability
Hydrophilic
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