CGW904S01

Polysep^™ II 2.0/1.2 µm nominal, Cartridge

cartridge nominal length 40 in. (100 cm), filter diam. 2.8 in.

• UNSPSC Code: 23151806

Properties

• material: borosilicate glass fiber (BGF) membrane; mixed cellulose esters (MCE) membrane; polypropylene device; polypropylene support (spun bonded); 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^™ II
• parameter: 3.5 bar max. differential pressure (50 psid) at 25 °C
• technique(s): prefiltration: suitable
• L: 40 in.
• W: 2.7 in.
• cartridge nominal length: 40 in. (100 cm)
• device size: 40 in.
• filter diam.: 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: 2.0/1.2 μm nominal pore size; 2.0/1.2 μm pore size
• cartridge code: Code 0

Description

General description

Device Configuration: Cartridge
Cartridge Type: Liquid
Filter Grade: Prefilter

Application

mAb & r-protein intermediates; Plasma; Vaccines & viral vectors; SVPs LVPs; Cell Culture; Media Filtration; Colloid Removal; Lipid Removal

Features and Benefits

Format: Double Layer

Packaging

Double Easy-Open bag

Preparation Note

Sanitization: 30 min with hot water at 80 °C

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

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

Analysis Note

After autoclaving and a 24 hour soak in ASTM^® Type 1 reagent grade water at controlled room temperature, extractables level was ≤140 mg per 10-inch element after a 5000 mL flush.

Cartridges meet the requirements of the USP Oxidizable Substances Test after a water flush of 5000 mL per 10 inch Element

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

The product is manufuactured in a facility with a Quality Management System approved by an accredited registering body to an ISO 9001 Quality Systems Standard.

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials

Millipore is a registered trademark of Merck KGaA, Darmstadt, Germany

Polysep is a trademark of Sigma-Aldrich Co. LLC