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CGW173S09

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

pore size 1.0/0.2/0.1 μm, cartridge nominal length 30 in. (75 cm)

Synonym(s):

Polysep II Cartridge Filter 30 in. 1.0/0.2/0.1 μm Code 7

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About This Item

eCl@ss:
32031610
UNSPSC Code:
23151806
Technical Service
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Quality Level

400

material

borosilicate glass fiber (BGF) membrane, mixed cellulose esters (MCE) membrane

reg. compliance

meets EU framework regulation [1935/2004/EC] (all component materials; regarding materials and articles intended to contact food), 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

Polysep™

feature

hydrophilic

manufacturer/tradename

Polysep™

technique(s)

prefiltration: suitable

L

30 in.

W

2.7 in.

cartridge nominal length

30 in. (75 cm)

filtration area

1.26 m2

impurities

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

gravimetric extractables

≤420 mg/cartridge

matrix

Polysep™ II

pore size

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

input

sample type liquid

cartridge code

Code 7

General description

Device Configuration: Cartridge

Features and Benefits

Format: Triple Layer

Preparation Note

This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Analysis Note

Gravimetric Extractables: after 24 hours in water at controlled room temperature

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 to the first page of Visual Inspection Guide and introduction section of the Mixed cellulose esters Tech Brief
  • Storage Statement: Please refer to the 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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pictograms

Flame
GHS02

signalword

Danger

hcodes

H228

Hazard Classifications

Flam. Sol. 1

Storage Class

4.1B - Flammable solid hazardous materials

wgk

WGK 2

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’.

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