Skip to Content
MilliporeSigma
All Photos(1)

Documents

CGW604S03

Millipore

Polysep™ II 1.0/0.5 µm nominal, Cartridge

pore size 1.0/0.5 μm, cartridge nominal length 100 cm (40 in.), filter diam. 7.1 cm (2.8 in.)

Sign Into View Organizational & Contract Pricing
All Photos(1)

About This Item

UNSPSC Code:
23151806

material

borosilicate glass fiber (BGF) membrane
mixed cellulose esters (MCE) membrane
polypropylene prefilter
polypropylene support
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™

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

40 in.

W

2.7 in.

cartridge nominal length

100 cm (40 in.)

filter diam.

7.1 cm (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

1.0/0.5 μm nominal pore size
1.0/0.5 μm pore size

cartridge code

Code 0

Looking for similar products? Visit Product Comparison Guide

Related Categories

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 ≥ 20 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

Not finding the right product?  

Try our Product Selector Tool.

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’.

Already Own This Product?

Find documentation for the products that you have recently purchased in the Document Library.

Visit the Document Library

Our team of scientists has experience in all areas of research including Life Science, Material Science, Chemical Synthesis, Chromatography, Analytical and many others.

Contact Technical Service