CGW2F2E03

Millipore

Polysep II Cartridge Filter

nominal pore size 1.0 μm, nominal pore size 1.2 μm, cartridge nominal length 50 cm (20 in.), filter diam. 7.1 cm (2.8 in.)

价格与库存信息目前不能提供

material

borosilicate glass fiber (BGF) prefilter
polypropylene prefilter
polypropylene seal
polypropylene support

Quality Level

reg. compliance

meets FDA 21 CFR 177-182 (all component materials)

mfr. no.

Polysep

parameter

3.5 bar max. differential pressure (50 psid) at 25 °C
3.5 bar max. inlet pressure (50 psi) at 25 °C

cartridge nominal length

50 cm (20 in.)

filter diam.

7.1 cm (2.8 in.)

filter filtration area

0.92 m2

impurities

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

matrix

Polysep II

pore size

1.0 μm nominal pore size
1.0 μm pore size
1.2 μm nominal pore size
1.2 μm pore size

cartridge code

Code F

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General description

Device Configuration: Cartridge

Features and Benefits

Double Layer

Packaging

Double Easy-Open bag

Preparation Note

Non-Fiber Releasing: This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(b)(6).
Sterilization Method: 10 autoclave cycles or SIP for 30 min at 121 °C

Analysis Note

Gravimetric Extractables: the extractables level was equal to or less than 140 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 10 L

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 first page of Visual Inspection Guide and introduction section of Mixed cellulose esters Tech Brief
  • Storage Statement: Please refer Mixed cellulose esters Tech Brief
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

Legal Information

Polysep is a trademark of Merck KGaA, Darmstadt, Germany

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