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MFGB20SB3

Millipore

Hydrophobic Durapore® 0.22 µm, Millipak® Final Fill Capsule

sterile; γ-irradiated, Millipak® Final Fill 200

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material

polysulfone device
polysulfone support

Quality Level

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

fitting

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

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This Item
MFGL20SL3MFGL20GL3MFGB20GT3
sterility

irradiated, sterile; γ-irradiated

sterility

irradiated, sterile; γ-irradiated

sterility

irradiated, non-sterile

sterility

irradiated, non-sterile

matrix

Durapore®

matrix

Durapore®

matrix

Durapore®

matrix

Durapore®

feature

hydrophilic

feature

hydrophilic

feature

hydrophilic

feature

hydrophilic

material

polysulfone device, polysulfone support

material

polysulfone device, polysulfone support

material

polysulfone device, polysulfone support

material

polysulfone device, polysulfone support

fitting

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

fitting

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

fitting

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

fitting

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

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

Analysis Note

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

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

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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