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Merck
CN

CGW1M4S03

Polysep™ II 1.0/0.2/0.1 µm nominal, Cartridge

pore size 1.0/0.2/0.1 μm, cartridge nominal length 10 cm (4 in.), filter diam. 7.1 cm (2.8 in.)

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UNSPSC Code:
23151806

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material

borosilicate glass fiber (BGF) membrane, mixed cellulose esters (MCE) membrane, polypropylene prefilter, polypropylene support, silicone seal

reg. compliance

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

sterility

non-sterile

sterilization compatibility

autoclavable compatible
steam-in-place compatible

product line

Polysep™

feature

hydrophilic

manufacturer/tradename

Polysep™

parameter

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

technique(s)

prefiltration: suitable

L

4 in.

W

2.7 in.

cartridge nominal length

10 cm (4 in.)

filter diam.

7.1 cm (2.8 in.)

filter filtration area

0.17 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

1.0/0.2/0.1 μm nominal pore size, 1.0/0.2/0.1 μm pore size

cartridge code

Code M

Quality Level

400

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General description

Device Configuration: Cartridge

Features and Benefits

Triple 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 ≥ 2 L

Other Notes

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

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

Legal Information

Polysep is a trademark of Sigma-Aldrich Co. LLC

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