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MFHL02GH3

Millipak® Final Fill 20 Durapore®

Inlet: 1/4 in. Hose Barb Outlet: 1/4 in. Hose Barb Vent: 1/8 in. Hose Barb

Synonym(s):

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

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About This Item

UNSPSC Code:
23151806
Technical Service
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Product Name

Millipak® Final Fill 20 Durapore®, Inlet: 1/4 in. Hose Barb Outlet: 1/4 in. Hose Barb Vent: 1/8 in. Hose Barb

material

PVDF membrane, polysulfone housing, polysulfone support, silicone O-ring

reg. compliance

meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

sterility

non-sterile

sterilization compatibility

gamma compatible
x-ray compatible

product line

Millipak® Final Fill

feature

hydrophilic

manufacturer/tradename

Durapore®

parameter

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)

dilution

suitable ( Bioburden reduction)

filter diam.

7.6 cm (3.0 in.)

filtration area

100 cm2

impurities

<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

matrix

Durapore®

pore size

0.45 μm pore size

bubble point

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

fitting

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

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

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