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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
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Product Name

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

Quality Segment

400

material

PVDF membrane, PVDF vent cap, polycarbonate support, polycarbonate housing

sterility

non-sterile

sterilization compatibility

gamma compatible
x-ray compatible

product line

Millipak®

feature

hydrophilic

manufacturer/tradename

Durapore®

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)

technique(s)

prefiltration: suitable

filter diam.

7.6 cm (3.0 in.)

filtration area

300 cm2

inlet connection diam.

1-1/2 in.

outlet connection diam.

1/4 in.

impurities

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

matrix

Durapore®

pore size

5.0 μm pore size

bubble point

≥140 mbar (2 psig), air with water at 23 °C

fitting

38 mm (1 1/2 in.) inlet sanitary flange, 6 mm (1/4 in.) outlet hose barb

shipped in

ambient

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

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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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