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Merck
CN

MFHL06ST3

Millipak® Final Fill 60 Durapore®

Inlet: 1.5 in. Sanitary Flange Outlet: 1.5 in. Sanitary Flange Vent: 1/8 in. Hose Barb

别名:

Durapore® 0.45 µm, Millipak® Final Fill Capsule

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UNSPSC Code:
23151806

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产品名称

Durapore® 0.45 µm, Millipak® Final Fill灌装囊式过滤器, sterile; γ-irradiated, Millipak® Final Fill 60

material

polysulfone device, polysulfone support

agency

meets EP 2.6.14, meets JP 4.01, meets USP 85

sterility

irradiated, sterile; γ-irradiated

product line

Millipak® Final Fill 60

feature

hydrophilic

manufacturer/tradename

Millipak®

parameter

1.5 L/min flow rate at 0.69 bar (ΔP), 10 psi max. differential pressure (0.7 bar) at 25 °C (Reverse), 5.5 bar max. inlet pressure (80 psi) at 25 °C, 60 L process volume, 80 psi max. differential pressure (5.5 bar) at 25 °C (Forward)

technique(s)

bioburden reduction: suitable

filter filtration area

300 cm2

impurities

<0.25 EU/mL USP bacterial endotoxins (LAL test, per device; aqueous extraction), <0.25 EU/mL bacterial endotoxins (LAL test, per device; aqueous extraction)

matrix

Durapore®

pore size

0.45 μm pore size

bubble point

≥26 psi (1790 mbar), air with water

fitting

(38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

Quality Level

400

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General description

Device Configuration: Gamma Gold Capsule

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method: Device integrity and retention was maintained after 3 autoclave cycles of 90 minutes at 126  °C. Devices can withstand a dose ≤40  kGy gamma exposure.

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), validated based on large volume parenteral specifications as detailed in USP 788 Particulate Matter in Injections

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 general guidelines section of user guide shipped with this product
  • Storage Statement: Please refer user guide shipped with this product
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

These products are manufactured in a facility which is certified to ISO 9001:2015 Quality Management Systems.

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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