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MPHL04GF2

Millipore

Durapore® 0.45 µm, Millipak® Capsule

sterile, Millipak® 40

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Synonym(s):
Sterile Millipak-40 Filter Unit 0.45 μm 3/4 in. TC/TC
eCl@ss:
32031690
NACRES:
NB.24

material

PVDF membrane
PVDF vent cap
polycarbonate
polycarbonate support

Quality Level

sterility

irradiated
sterile

product line

Millipak® 40

feature

hydrophilic

manufacturer/tradename

Millipak®

parameter

0.35 bar max. differential pressure (5 psid) at 123 °C (Forward)
0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse)
1.7 bar max. differential pressure (25 psid) at 80 °C (Forward)
20 L process volume
4.1 bar max. differential pressure (60 psid) at 25 °C (Forward)
5.2 bar max. inlet pressure (75 psi) at 25 °C
8.5 L/min flow rate at 2.45 bar (ΔP)

technique(s)

bioburden reduction: suitable

filtration area

200 cm2

inlet connection diam.

3/4 in.

outlet connection diam.

3/4 in.

impurities

≤0.5 EU/mL (LAL test, Aqueous extraction)
<0.5  EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

gravimetric extractables

≤1.5 mg/device

matrix

Durapore®

pore size

0.45 μm

bubble point

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

fitting

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

shipped in

ambient

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This Item
MPVL04GF2MPGL04GF2MPHL04GH2
matrix

Durapore®

matrix

Durapore®

matrix

Durapore®

matrix

Durapore®

product line

Millipak® 40

product line

Millipak® 40

product line

Millipak®

product line

Millipak® 40

feature

hydrophilic

feature

hydrophilic

feature

hydrophilic

feature

hydrophilic

pore size

0.45 μm

pore size

0.1 μm

pore size

0.22 μm

pore size

0.45 μm

fitting

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

fitting

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

fitting

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

fitting

inlet hose barb, outlet hose barb (with bell), (6 mm (1/4 in.) Hose Barb Inlet and Outlet with filling bell)

General description

Device Configuration: Gamma Gold Capsule

Packaging

Blister

Other Notes

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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 Wetting Instructions for Filter Units with Durapore® Membrane user guide
  • Storage Statement: Store in dry location
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Preparation Note

Sterilization Method
3 autoclave cycles of 90 min @ 123 °C; not in-line steam sterilizable
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).

Analysis Note

Gravimetric Extractables: using sterilized device after a 200 mL flush and 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL

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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