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MPHL02GF2

Millipore

Durapore® 0.45 µm, Millipak® Capsule

Millipak® 20, sterile

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Synonym(s):
Sterile Millipak-20 Filter Unit 0.45 μm 3/4 in. TC/TC
UNSPSC Code:
23151806
eCl@ss:
32031690
NACRES:
NB.24

material

PVDF membrane
PVDF vent cap
polycarbonate
polycarbonate support

Quality Level

400

sterility

irradiated
sterile

product line

Millipak® 20

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)
10 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
6.4 L/min flow rate at 2.45 bar (ΔP)

technique(s)

bioburden reduction: suitable

filtration area

100 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 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

Related Categories

General description

Device Configuration: Gamma Gold Capsule
Number of stacked discs: 20 discs

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

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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