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Safety Information

MFHL02GH3

Durapore® 0.45 µm, Millipak® Final Fill Capsule

Millipak® Final Fill 20

Synonym(s):

Durapore® 0.45 μm Millipak® Final Fill 20 Gamma-compatible , HB/HB

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About This Item

UNSPSC Code:
23151806

material

PVDF membrane (hydrophilic)
polysulfone housing
polysulfone support
silicone O-ring

sterility

irradiated
sterile; γ-irradiated (compatible)

Sterilization Compatibility

gamma compatible

product line

Millipak® Final Fill 20

feature

hydrophilic

dilution

(Prefilters and Bioburden Filtration)

filtration area

0.01 m2

matrix

Durapore®

pore size

0.45 μm pore size

fitting

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

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Features and Benefits

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.

Packaging

3 Qty/Pk

Preparation Note

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

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

Legal Information

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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