Merck, MPGL10ZW1, Millipak® 100 Capsule Media: Non-Sterile Durapore® 0.22 µm

General description
Millipak® membrane products are designed for routine filtration applications in the laboratory. Millipak® filters are best-in-class, proven products, utilized in lab water purification systems to remove particulates and bacteria to benefit the stringent requirements for pure water.

Millipak® 100 Bacteria Filter removes bacteria from pure water before entering the analyzer.
Application
Removes bacteria and particulates in pure water. Suitable for laboratory use, including clinical analyzers. For use with AFS® water purification systems.
Features and Benefits
Hydrophilic 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.
Reduces the risk of microbial contamination.
Ideally suited for high value-added applications.
Device Configuration: Capsule

Preparation Note
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).
Analysis Note
Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Gravimetric Extractables: after 24 hours in water at controlled room temperature
Other Notes
0.22 μm Durapore® filter membrane for bacteria removal
Directions for Use

Organism Retention: Microorganisms
Mode of Action: Filtering
Application: General laboratory analysis
Intended Use: Water purification
Instructions for Use: This item provides water filtered through 0.22 μm sterilizing-grade membranes. Refer to system equipment user guide section "Using the System" (available on USB key in the system box).
Storage Statement: Store in dry location
Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Legal Information
AFS is a registered trademark of Merck KGaA, Darmstadt, Germany
ASTM is a registered trademark of American Society for Testing and Materials
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIPAK is a registered trademark of Merck KGaA, Darmstadt, Germany