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MFHL06GT3

Millipore

Durapore® 0.45 µm, Millipak® Final Fill Capsule

Millipak® Final Fill 60

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About This Item

UNSPSC Code:
23151806

material

polysulfone device
polysulfone support

Quality Level

400

Agency

meets EP 2.6.14
meets JP 4.01
meets USP 85

sterility

irradiated
non-sterile

Sterilization Compatibility

gamma compatible

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

L

4.3 in.

W

3.0 in.

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)

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General description

Device Configuration: 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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Regulatory Information

新产品

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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