VPMSKITNB9

Viresolve^® Pro Shield

Virus prefilter, Viresolve^® Pro Shield, Micro kit, filtration area 3.1 cm²

• Synonym(s): Viresolve^® Pro Shield Micro Kit
• UNSPSC Code: 23151806
• eCl@ss: 32031690

Properties

• material: molded polypropylene component(s); polyethersulfone membrane; white device (magenta band)
• Quality Level: 400
• manufacturer/tradename: Viresolve^®
• parameter: 3.5 bar max. inlet pressure (50 psig); 4.1 bar max. pressure (60 psid) at 25 °C (Samples were integral based on an Air/ Water Diffusion Test, before and after a forward stress.)
• H × diam.: 3.83 cm (1.51 in.) × 3.07 cm (1.21 in.)
• H: 3.83 cm (1.51 in.)
• diam.: 3.07 cm (1.21 in.)
• filtration area: 3.1 cm²
• impurities: <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• fitting: female Luer-Lok^® inlet (inlet and vent); female Luer inlet fitting; male Luer outlet (Slip); male Luer outlet fitting
• application(s): (Process development studies, Viral clearance evaluations)
• shipped in: ambient

Description

General description

The Viresolve Pro PD kit is ideally suited for performing your evaluation, optimization and scaling studies. Each kit contains 9 Micro devices from one membrane layering combination*, a user guide and certificate of quality. The air vent prevents air locking within the device.


* Viresolve Pro devices are built with two membrane layers. Each Viresolve Pro Shield Micro device is packaged in a blister pack and labeled with the device lot and the top layer membrane lot/roll number.

Features and Benefits

• Small scale devices for process development, optimization and validation studies
• Membrane based adsorptive prefilters to remove protein aggregates and other fouling species
• Nine units per kit (one Membrane lot)

Other Notes

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

Preparation Note

This product was manufactured with materials that meet the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Analysis Note

TOC/Conductivity
After a controlled water flush of 50 L/m², samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.

Legal Information

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

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