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MFGL04GF3

Millipore

Durapore® 0.22 µm, Millipak® Final Fill Capsule

non-sterile (non-sterilized), Millipak® Final Fill 40, pore size 0.22 μm

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Synonym(s):
Millipak® Final Fill 40

material

PVDF membrane
polysulfone device
polysulfone support

Quality Level

Agency

certified by the ISO 9001:2015 (Quality Management Systems)
meets requirements for EP 2.6.14
meets requirements for JP 4.01
meets requirements for USP 85

sterility

irradiated
non-sterile (non-sterilized)

Sterilization Compatibility

gamma compatible

product line

Millipak® Final Fill 40

feature

hydrophilic

packaging

bag of 3 × double easy-open bag

parameter

1.0 L/min flow rate at 0.69 bar
10 psi max. differential pressure (0.7 bar) at 25 °C (Reverse)
25 psi max. differential pressure (1.7 bar) at 25 °C (Forward)
50 psi max. differential pressure (3.5 bar) at 25 °C (Forward)
60 psi max. differential pressure (4.1 bar) at 25 °C (Forward)
60 psi max. inlet pressure (4.1 bar) at 25 °C
80 psi max. differential pressure (5.5 bar) at 25 °C (Forward)
80 psi max. inlet pressure (5.5 bar) at 25 °C

technique(s)

sterile filtration: suitable

L

3.4 in.

W

3.0 in.

filtration area

200 cm2

impurities

<0.25 EU/mL bacterial endotoxins (LAL test)

matrix

Durapore®

pore size

0.22 μm pore size

bubble point

≥50 psi (3450 mbar), air with water at 23 °C

fitting

3/4 in. inlet connection
19 mm (3/4 in.) inlet/outlet connection (sanitary flange)
(19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)

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 <nbsp/>°C. Devices can withstand a dose ? 40<nbsp/> 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

Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per AST F838 methodology.

Other Notes

Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals.

Legal Information

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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