KVPVA10TT1

Opticap^® XL Viresolve^® NFR

Parvovirus removal

• Synonym(s): Opticap XL10 Viresolve NFP 1-1/2 in. TC/TC
• eCl@ss: 32031690

Properties

• material: PVDF (modified); polypropylene ; polypropylene support; polypropylene vent cap; silicone O-ring (for vent); silicone seal
• manufacturer/tradename: Viresolve^®
• parameter: ≤10 mL/min air diffusion at 3.45 bar (50 psig) and 23 °C (in water); 25 °C max. inlet temp.; 250 L process volume; 3.4 bar max. differential pressure (50 psid) (Reverse); 5.5 bar max. differential pressure (80 psid) (Forward); 80 psig max. inlet pressure
• technique(s): protein purification: suitable
• L: 33 cm (13 in.)
• device size: 10 in.
• filtration area: 0.42 m²
• inlet connection diam.: 1.5 in.
• outlet connection diam.: 1.5 in.
• 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: 1/4 in. drain/vent hose barb (with double O-ring Seal); 1/4 in. drain/vent hose barb (with double O-ring seal); inlet sanitary flange; 38 mm (1 1/2 in.) inlet/outlet sanitary flange; outlet sanitary flange

Description

General description

Device Configuration: Capsule

Application

Parvovirus 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: Parvovirus
• Mode of Action: Filtration (size exclusion)
• Application: Protein purification
• Intended Use: Viral clearance
• Instructions for Use: Please see the user guide 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
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).

Analysis Note

TOC/Conductivity
After sterilization and a controlled water flush of 12 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.

Legal Information

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

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

Disclaimer

EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.