SVPVSMLNB9

Optiscale^® 25 Viresolve^® NFP

Parvovirus removal

• Synonym(s): OptiScale-25 with Viresolve NFP Validation Kit, single membrane lot
• UNSPSC Code: 23151806
• eCl@ss: 32031690

Properties

• material: PVDF (modified); silicone seal
• manufacturer/tradename: OptiScale^®
• parameter: 0.7 bar max. differential pressure (10 psid) (Reverse); 5.5 bar max. differential pressure (80 psid) (Forward); 70 mL process volume
• technique(s): protein purification: suitable
• L: 2.2 cm (0.87 in.)
• filtration area: 3.5 cm²
• impurities: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• matrix: Viresolve^® NFP
• fitting: female Luer-Lok^® inlet connection; male Luer outlet slip

Description

General description

Device Configuration: Validation Kit

Application

Parvovirus removal

Other Notes

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

Directions for Use

• Organism Retention: Parvovirus
• Mode of Action: Filtration (size exclusion)
• Application: Protein purification
• Intended Use: Viral clearance
• Instructions for Use: Please refer ′Installation and Operation′ section of the user guide shipped with this product
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Preparation Note

Sterilization Method
Water wet filter for 5 min @ 3.4 bar (50 psi); liquid cycle, slow exhaust @ 123 °C maximum 60 min

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).

Legal Information

Luer-Lok is a registered trademark of Becton-Dickinson & Co.

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

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