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Merck
CN

MPHL10CL3

Millipak® 100 Capsule Media: Durapore® 0.45 µm

Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF) Inlet: 1-1/2 in. Sanitary Flange Outlet: 1-1/2 in. Sanitary Flange

别名:

Gamma Compatible Millipak -100 Filter Unit 0.45 μm 1-1/2 in. TC/TC, Durapore® 0.45 µm, Millipak® Capsule

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UNSPSC Code:
23151806

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产品名称

Millipak®囊式过滤器，带Durapore® 0.45 µm滤膜, Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF) Inlet: 1-1/2 in. Sanitary Flange Outlet: 1-1/2 in. Sanitary Flange

sterility

non-sterile

sterilization compatibility

gamma compatible
x-ray compatible

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.

3.0 in. (7.6 cm)

filtration area

500 cm2

inlet connection diam.

1.5 in.

outlet connection diam.

1.5 in.

material

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

Quality Level

400

impurities

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

gravimetric extractables

≤2.5 mg/device

matrix

Durapore®

pore size

0.45 μm

bubble point

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

fitting

38 mm (1 1/2 in.) inlet sanitary flange, 38 mm (1 1/2 in.) outlet sanitary flange

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General description

Device Configuration: 取样皿滤膜

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

使用 ≥200 mL 水冲洗后，将符合“USP 氧化物检测”要求
Gravimetric Extractables: after 24 hours in water at controlled room temperature

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

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