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Merck
CN

MPHL02GH2

Millipak® 20 Gamma Gold Capsule Media: Sterile Durapore® 0.45 µm

Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF) Inlet: 1/4 in. Hose Barb Outlet: 1/4 in. Hose Barb with Bell

Synonym(s):

Sterile Millipak-20 Filter Unit 0.45 μm 1/4 in. HB/HB w/bell, Millipak® 20 Gamma Gold Capsule Media: Sterile Durapore® 0.45 µm

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About This Item

UNSPSC Code:
23151806
NACRES:
NB.24
eCl@ss:
32031690

Key Documents

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Product Name

Durapore® 0.45 µm, Millipak® Capsule, sterile, Millipak®

material

PVDF membrane, PVDF vent cap, polycarbonate support, 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)

bioburden reduction: suitable

filter diam.

7.6 cm (3.0 in.)

filtration area

100 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

≤1 mg/device

matrix

Durapore®

pore size

0.45 μm

bubble point

≥1790 mbar (26 psig), air with water at 23 °C

fitting

6 mm (1/4 in.) inlet hose barb, 6 mm (1/4 in.) outlet filling bell

shipped in

ambient

General description

Device Configuration: Gamma Gold Capsule

Packaging

Blister

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

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

Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIPAK is a registered trademark of Merck KGaA, Darmstadt, Germany

Certificates of Analysis (COA)

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