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Merck

CMP471TS1

Millipore

Milligard® PES 1.2/0.45 µm, Cartridge

pore size 1.2/0.45 μm, cartridge nominal length 10 in. (25 cm)

Synonym(s):

Milligard PES 10" 1.2/0.45 μm Cartridge

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About This Item

UNSPSC Code:
23151806
eCl@ss:
32031690

material

polyethersulfone membrane
polypropylene housing
polypropylene support
polypropylene vent cap

Quality Level

reg. compliance

meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

sterility

non-sterile

Sterilization Compatibility

autoclavable compatible
steam-in-place compatible

product line

EMPROVE® Filter
Milligard®

feature

hydrophilic

manufacturer/tradename

Milligard®

parameter

1.38 bar max. differential pressure (20 psid) at 25 °C (Reverse)
5.52 bar max. differential pressure (80 psid) at 4-25 °C (Forward)

technique(s)

prefiltration: suitable

L

317.5 mm (12.5 in.)

W

2.7 in.

cartridge nominal length

10 in. (25 cm)

diam.

69 mm (2.71 in.)

filtration area

0.6 m2

impurities

<0.25 EU/mL bacterial endotoxins (LAL test, per device; aqueous extraction; meeting requirements of USP <85>, EP 2.6.14 and JP 4.01)

matrix

Milligard® PES

pore size

1.2/0.45 μm pore size

input

sample type liquid

cartridge code

Code 7

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General description

Device Configuration: Cartridge

Other Notes

The product is manufactured in a facility which adheres to Good Manufacturing Practices. The manufacturing facility’s Quality Management System is approved by an accredited registering body to the appropriate ISO 9001 Quality Standard.
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 of Filters with MILLIGARD® PES Membrane user guide
  • Storage Statement: Please refer Filters with MILLIGARD® PES Membrane user guide
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Preparation Note

Sterilization Method
Autoclave wet 25x, 60 minute cycles at 128°C. In-line steam (wet): 10 forward cycles, 30 min.,
135 °C at ≤0.34 bar (5 psid) and 5 reverse cycles,
30 min., 135 °C at ≤0.07 bar (<1 psid)*.
*Devices were validated using steam at full differential pressure starting at 31 psid to a final differential pressure of 1 psid, resulting in a calculated average of 4 psid in forward and reverse directions.
This product was manufactured with materials that meet the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIGARD is a registered trademark of Merck KGaA, Darmstadt, Germany

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Certificates of Analysis (COA)

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