MPGL10ZW1

Millipak^® Filter

Removes bacteria from pure water before entering the analyzer., For use with AFS^® systems

• Synonym(s): Millipak^® 100 Bacteria Filter
• UNSPSC Code: 41104212
• eCl@ss: 33050190
• NACRES: JA.14

Properties

• material: PVDF membrane
• Quality Level: 300
• sterility: non-sterile
• feature: hydrophilic
• packaging: pkg of 1 unit
• manufacturer/tradename: Millipak^®
• L: 13 cm (5.12 in.)
• inlet connection diam.: 1/4 in.
• outlet connection diam.: 1/4 in.
• impurities: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤2.5 mg/device
• matrix: Durapore^®
• pore size: 0.22 μm pore size
• fitting: NPT inlet connection; NPT outlet connection
• compatibility: for use with AFS^®
• shipped in: ambient

Description

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 that provide particulate-free and bacteria-free purified water to benefit the stringent requirements for pure water.
Millipak^® 100 Bacteria Filter removes bacteria from pure water before entering the analyzer.

Application

Provides bacteria-free and particulate-free 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

Components

0.22 μm Durapore^® filter membrane for bacteria removal

Other Notes

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

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.

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

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