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.
Catalogue Number
LAGR04TP1
Chemistry
Polytetrafluoroethylene (PTFE)
Device Configuration
Cartridge
Device Size
4 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 10 mg per 4-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
Material Size
1
Media
Aervent®
Non-Fiber Releasing
This product was manufactured with a PTFE membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Pore Size
0.2 µm
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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