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Merck
CN

MFGL20SL3

Durapore® 0.22 µm, Millipak® Final Fill灌装囊式过滤器

sterile; γ-irradiated, Millipak® Final Fill 200

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UNSPSC Code:
23151806

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产品名称

Durapore® 0.22 µm, Millipak® Final Fill灌装囊式过滤器, sterile; γ-irradiated, Millipak® Final Fill 200

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 200

feature

hydrophilic

manufacturer/tradename

Millipak®

parameter

10 psi max. differential pressure (0.7 bar) at 25 °C (Reverse)
200 L process volume
5.5 bar max. inlet pressure (80 psi) at 25 °C
7.61 L/min flow rate at 1.1 bar (ΔP)
80 psi max. differential pressure (5.5 bar) at 25 °C (Forward)

technique(s)

sterile filtration: suitable

filter filtration area

1000 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

0.22 μm pore size

bubble point

≥50 psi (3450 mbar), air with water

fitting

(38 mm (1 1/2 in.) Sanitary Flange Inlet and 13 mm (1/2 in.) Hose Barb Outlet)

Quality Level

400

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Analysis Note

Bacterial Grow-Through: Quantitative retention of 1 x 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per ASTM® F838 methodology.

General description

Device Configuration: Gamma Gold Capsule

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.

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

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials
ATCC is a registered trademark of American Type Culture Collection
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIPAK is a registered trademark of Merck KGaA, Darmstadt, Germany

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