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CGW904S01

Millipore

Polysep™ II 2.0/1.2 µm nominal, Cartridge

cartridge nominal length 40 in. (100 cm), filter diam. 2.8 in.

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About This Item

UNSPSC Code:
23151806

material

borosilicate glass fiber (BGF) membrane
mixed cellulose esters (MCE) membrane
polypropylene device
polypropylene support (spun bonded)
silicone seal

Quality Level

400

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™ II

parameter

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

technique(s)

prefiltration: suitable

L

40 in.

W

2.7 in.

cartridge nominal length

40 in. (100 cm)

device size

40 in.

filter diam.

2.8 in.

filter filtration area

1.84 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

2.0/1.2 μm nominal pore size
2.0/1.2 μm pore size

cartridge code

Code 0

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General description

Device Configuration: Cartridge
Cartridge Type: Liquid
Filter Grade: Prefilter

Application

mAb & r-protein intermediates; Plasma; Vaccines & viral vectors; SVPs LVPs; Cell Culture; Media Filtration; Colloid Removal; Lipid Removal

Features and Benefits

Format: Double Layer

Packaging

Double Easy-Open bag

Preparation Note

Sanitization: 30 min with hot water at 80 °C
Sterilization Method: 10 autoclave cycles or SIP at 121 °C for 30 min
This product was manufactured with a Millipore® media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Analysis Note

After autoclaving and a 24 hour soak in ASTM® Type 1 reagent grade water at controlled room temperature, extractables level was ≤140 mg per 10-inch element after a 5000 mL flush.
Cartridges meet the requirements of the USP Oxidizable Substances Test after a water flush of 5000 mL per 10 inch Element

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

The product is manufuactured in a facility with a Quality Management System approved by an accredited registering body to an ISO 9001 Quality Systems Standard.

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials
Millipore is a registered trademark of Merck KGaA, Darmstadt, Germany
Polysep is a trademark of Sigma-Aldrich Co. LLC

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