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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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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
Not Applicable
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Cartridge Nominal Length
4 in. (10 cm)
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Catalogue Number
LAGB04TP6
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Chemistry
Polyvinylidene Fluoride (PVDF)
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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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Filtration Area
0.18 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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Gravimetric Extractables
The extractables level was equal to or less than 10 mg per 4-inch cartridge after 24 hours in a 70/30% IPA/water mixture 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
6
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Maximum Differential Pressure, bar (psid)
Forward: 5.5 bar (80 psid) @ 25 °C; 3.5 bar (50 psid) @ 80 °C; 0.35 bar (5 psid) @ 121 °C. Reverse: 3.5 bar (50 psid) @ 25 °C KEEP
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Maximum Inlet Pressure, bar (psi)
Forward - 5.5 bar (80 psi) @ 25 °C; 3.5 bar (50 psi) @ 80 °C; 0.35 bar (5 psi) @ 135 °C; Reverse - 3.5 bar (50 psi) @ 25 °C
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Media
Durapore®
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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).
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Pore Size
0.22 µm
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Seal Material
Silicone (SI)
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Sterilization
30 SIP cycles of 30 min @ 135 °C; 10 autoclave cycles of 30 min @ 126 °C
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Support Material
Polypropylene
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Trade Name
Optiseal®
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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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Wettability
Hydrophobic
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