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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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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 7 (2-226) O-rings w/locking-tabs
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Cartridge Nominal Length
30 in. (75 cm)
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Catalogue Number
MSP000953
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Chemistry
Polyvinylidene Fluoride (PVDF)
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Device Configuration
Cartridge
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Device Size
30 in.
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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 20 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.
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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
30 in. (75 cm)
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Material Size
48
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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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Sterility
Other
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Trade Name
Durapore®
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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
Hydrophilic
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