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Merck

MPGL10ZW1

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

Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF) Inlet: 1/4 in. NPT Outlet: 1/4 in. NPT

Synonym(s):

Millipak® 100 Bacteria Filter, Millipak® Filter

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About This Item

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

Key Documents

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Product Name

Millipak® 100 Capsule Media: Non-Sterile Durapore® 0.22 µm, Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF) Inlet: 1/4 in. NPT Outlet: 1/4 in. NPT

material

PVDF membrane

Quality Level

300

description

0.22 μm membrane filter. Removes particulates and bacteria from pure water before entering the analyzer. For AFS® systems.

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 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

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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Global Trade Item Number

SKUGTIN
MPGL10ZW108436037122118

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