Key Documents

View All Documentation

CGW2M4S03

Polysep^™ II 1.0/1.2 µm nominal, Cartridge

Name: Polysep<SUP>™</SUP> II 1.0/1.2 µm nominal, Cartridge
Brand: MM

pore size 1.2/1.0 μm, filter diam. 7.1 cm (2.8 in.), cartridge nominal length 10 cm (4 in.)

Select a Size

Change View

About This Item

UNSPSC Code:

23151806

Technical Service

Need help? Our team of experienced scientists is here for you.

Let Us Assist

Properties

Quality Level

400

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.)

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 )

matrix

Polysep^™ II

pore size

1.0/1.2 μm nominal pore size, 1.2/1.0 μm pore size

cartridge code

Code M

Description

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 ≥ 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

Still not finding the right product?

Explore all of our products under Polysep^™ II 1.0/1.2 µm nominal, Cartridge

pictograms

GHS02,GHS08

signalword

Danger

hcodes

H228,H350i

pcodes

P202 - P210 - P240 - P241 - P280 - P308 + P313

Hazard Classifications

Carc. 1B Inhalation - Flam. Sol. 1

Storage Class

4.1B - Flammable solid hazardous materials

wgk

WGK 3

Regulatory Information

新产品

This item has

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

Global Trade Item Number

SKU	GTIN
CGW2M4S03	04053252574962