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MPGL10ZW1

Milli-Q

Millipak® Filter

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

Synonym(s):

Millipak® 100 Bacteria Filter

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About This Item

UNSPSC Code:
41104212
eCl@ss:
33050190
NACRES:
JA.14

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

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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

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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