CGW2M4S03

Polysep^™ II 1.0/1.2 µm nominal, Cartridge

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

• UNSPSC Code: 23151806

Properties

• 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: 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

Safety Information

• Pictograms: GHS02,GHS08
• Signal Word: Danger
• Hazard Statements: H228,H350i
• Precautionary Statements: P202 - P210 - P240 - P241 - P280 - P308 + P313
• Hazard Classifications: Carc. 1B Inhalation - Flam. Sol. 1
• Storage Class Code: 4.1B - Flammable solid hazardous materials
• WGK: WGK 3