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Key Documents

MPGL10CB

Millipore

Gamma Compatible Millipak® -100

pore size 0.22 μm, filtration area 500 cm2, matrix Durapore®

Synonym(s):

Gamma Compatible Millipak®-100 Filter Unit 0.22 µm 1/4 in. NPTM

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About This Item

UNSPSC Code:
23151806

material

PVDF

Quality Level

400

sterility

sterile

product line

EMPROVE® Filter

feature

hydrophilic

manufacturer/tradename

Millipak®

filtration area

500 cm2

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

General description

Device Configuration: Capsule
Number of stacked discs: 100 discs

Other Notes

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

  • Organism Retention: Microorganism
  • Mode of Action: Filtration (size exclusion)
  • Application: BioProcessing
  • Intended Use: Reduction or removal of microorganism/bioburden
  • Instructions for Use: Please refer Wetting Instructions for Filter Units with Durapore® Membrane user guide
  • Storage Statement: Store in dry location
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Preparation Note

Sterilization Method
3 autoclave cycles of 90 min @ 123°C; not in-line steam sterilizable
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

ASTM is a registered trademark of American Society for Testing and Materials
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIPAK is a registered trademark of Merck KGaA, Darmstadt, Germany

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