Millipak^®过滤器

33050190

JA.14

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.

Provides bacteria-free and particulate-free water suitable for laboratory use, including clinical analyzers.
For use with AFS^® water purification systems.

0.22 μm Durapore^® filter membrane for bacteria removal

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 and is a device that meets requirements under FIFRA. 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.

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).

Gravimetric Extractables: after 24 hours in water at controlled room temperature
Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

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

PVDF membrane

400

non-sterile

hydrophilic

pkg of 1 unit

Millipak^®

13 cm (5.12 in.)

1/4  in.

1/4 in.

<0.5  EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

≤2.5 mg/device

Durapore^®

0.22 μm pore size

NPT inlet connection
NPT outlet connection

for use with AFS^®

ambient