A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Cartridge Code
Code 7 (2-226) O-rings w/locking-tabs
Cartridge Nominal Length
30 in. (75 cm)
Catalogue Number
MSP000953
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Cartridge
Device Size
30 in.
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 20 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.
Length
30 in. (75 cm)
Material Size
48
Media
Durapore®
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).
Pore Size
0.22 µm
Sterility
Other
Trade Name
Durapore®
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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