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
MPGL10ZW1
Chemistry
Polyvinylidene Fluoride (PVDF)
Components
0,22 µm Durapore® filter membrane for bacteria removal
Device Configuration
Capsule
Diameter
1/4 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 2.5 mg per device after 24 hours in water at controlled room temperature.
Inlet Connection
NPT
Inlet Connection Diameter
1/4 in.
Length
13 cm (5.1 in.)
Material Size
1
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).
Outlet Connection
NPT
Outlet Connection Diameter
1/4 in.
Overview
Millipak® filters are best-in-class proven products, utilized in water purification systems to provide particulate-free and bacteria-free water at the point of dispense. The Millipak® 100 Bacteria Filter removes bacteria from pure water before entering the analyzer to reduce the risk of microbial contamination. This filter contains hydrophilic 0.22 μm Durapore® PVDF membranes for high flow rates and throughput. Low protein binding membrane yields high sample recovery with minimal loss of valuable product ensuring high-value filtration.
Pore Size
0.22 µm
Sterility
Non-Sterile
Trade Name
Millipak®
USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Wettability
Hydrophilic
DESCRIPTION
Sterile 0.22 μm Durapore® PVDF membrane for particulate- and bacteria-free purified water Low protein binding membrane For use with AFS® systems
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