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Merck
CN

MPVL2GCF3

Millipak®-200 Capsule Filter Unit

sterile, Millipak®

Synonym(s):

Sterile Millipak-200 Filter Unit 0.1 μm 3/4 in. TC/TC

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About This Item

UNSPSC Code:
23151806

Key Documents

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material

PVDF vent cap, polycarbonate support, PVDF membrane, polycarbonate housing

Quality Level

400

sterility

sterile

product line

Millipak®

feature

hydrophilic

manufacturer/tradename

Durapore®

parameter

0.35 bar max. differential pressure (5 psid) at 123 °C (Forward), 0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse), 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward), 4.1 bar max. differential pressure (60 psid) at 25 °C (Forward)

technique(s)

sterile filtration: suitable

filter diam.

7.6 cm (3.0 in.)

filtration area

1000 cm2

inlet connection diam.

3/4 in.

outlet connection diam.

3/4 in.

impurities

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

gravimetric extractables

≤5 mg/device

matrix

Durapore®

pore size

0.1 μm

bubble point

≥70 psi (4830 mbar), air with water at 23 °C

fitting

19 mm (3/4 in.) inlet sanitary flange, 19 mm (3/4 in.) outlet sanitary flange

General description

Device Configuration: Gamma Gold Capsule

Packaging

Double Easy-Open bag

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: using sterilized device after a 200 mL flush and 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL

Other Notes

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.

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

Legal Information

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

Regulatory Information

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