CZRV71TP1

Viresolve^® NFR Cartridge Filter

Retrovirus removal

• Sinónimos: Viresolve NFR Cartridge Filter 10 in. Code 7
• UNSPSC Code: 23151806
• eCl@ss: 32031690

Propiedades

• material: polyethersulfone ; polypropylene ; silicone seal
• Quality Level: 400
• feature: holdup volume 175 mL
• manufacturer/tradename: Viresolve^®
• parameter: ≤16 mL/min air diffusion at 3.45 bar (50 psig) and 23 °C (in water); 3.4 bar max. differential pressure (50 psid) at 25 °C (Reverse); 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 600-1200 L process volume
• technique(s): protein purification: suitable
• cartridge nominal length: 10 in. (25 cm)
• filtration area: 0.43 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: ≤35 mg/cartridge
• matrix: Viresolve^® NFR
• cartridge code: Code 7

Descripción

General description

Device Configuration: Cartridge

Application

Retrovirus removal

Packaging

Double Easy-Open bag

Other Notes

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Directions for Use

• Organism Retention: Retrovirus
• Mode of Action: Filtration (size exclusion)
• Application: Protein purification
• Intended Use: Viral clearance
• Instructions for Use: Please see the user guide (pg. 3) shipped with this product
• Storage Statement: Store at room temperature
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Preparation Note

Sterilization Method
After wetting, may be autoclaved for 3 cycles of up to 60 min at 125 °C,

using liquid cycle, slow exhaust.

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

Analysis Note

Gravimetric Extractables: after a 10 minute 1.5 LPM/ft² flush and 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥4 L

Legal Information

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