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Merck
CN

MPSL06CL1

Millipak® 60 Capsule Media: Durapore® 5.0 µm

Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF) Inlet: 1-1/2 in. Sanitary Flange Outlet: 1/4 in. Hose Barb

Synonym(s):

Millipak-60 Filling Machine Filter Unit 5.0 μm 1-1/2 in. TC-1/4 in.HB, Durapore® 5.0 µm, Millipak® Capsule

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About This Item

UNSPSC Code:
23151806
NACRES:
NB.24
eCl@ss:
32031690

Key Documents

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Product Name

Millipak® 60 Capsule Media: Durapore® 5.0 µm, Millipak® 60, sterile, filtration area 300 cm2, matrix Durapore®

material

PVDF membrane, PVDF vent cap, polycarbonate , polycarbonate support

sterility

irradiated, sterile

product line

Millipak® 60

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), 30 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, 7.6 L/min flow rate at 700 mbar (ΔP)

technique(s)

prefiltration: suitable

filtration area

300 cm2

inlet connection diam.

1-1/2 in.

outlet connection diam.

1/4 in.

impurities

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

matrix

Durapore®

pore size

5.0 μm pore size

bubble point

≥138 mbar (2 psig), air with water at 23 °C

fitting

inlet sanitary flange, outlet hose barb, (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

shipped in

ambient

Quality Level

400

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General description

Device Configuration: Capsule
Number of stacked discs: 60 discs

Packaging

Double Easy-Open bag

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

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL

Other Notes

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Legal Information

Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIPAK is a registered trademark of Merck KGaA, Darmstadt, Germany

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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