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CGW6N4S03

Polysep^™ II 1.0/0.5 µm nominal, Cartridge

Name: Polysep<SUP>™</SUP> II 1.0/0.5 µm nominal, Cartridge
Brand: MM

pore size 1.0/0.5 μm, cartridge nominal length 4 in. (10 cm)

Synonym(s):

Polysep II Cartridge Filter 4 in. 0.5 μm Code N

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About This Item

UNSPSC Code:

23151806

eCl@ss:

32031610

material

borosilicate glass fiber (BGF) prefilter
mixed cellulose esters (MCE)
polypropylene
polypropylene support (Spun bonded)
silicone seal

Quality Level

400

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^™

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

4 in. (10 cm)

diam.

7.1 cm (2.8 in.)

filtration area

0.19 m²

impurities

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

gravimetric extractables

≤56 mg/cartridge

matrix

Polysep^™ II

pore size

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

input

sample type liquid

cartridge code

Code N

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General description

Device Configuration: Cartridge

Features and Benefits

Format: Double Layer

Packaging

Double Easy-Open bag

Preparation Note

Sanitization Protocol
30 min with hot water @ 80 °C

Sterilization Method
10 autoclave cycles or SIP @ 121 °C for 30 min

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

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 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

Pictograms

GHS02

Signal Word

Danger

Hazard Statements

H228

Precautionary Statements

P210 - P240 - P241 - P280 - P370 + P378

Hazard Classifications

Flam. Sol. 1

Storage Class Code

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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Global Trade Item Number

SKU	GTIN
CGW6N4S03	04053252446498

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