Viresolve^® Pro Modus 1.1

32031690

Device Configuration: Modus 1.1 Device

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.

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).

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>.

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

400

PVDF housing
polyethersulfone membrane
silicone gasket

EMPROVE^® Filter

Viresolve^®

60 psig max. inlet pressure

(Scale studies/Pilot)

5.92 cm (2.33 in.)

18.62 cm (7.33 in.)

9.22 cm (3.63 in.)

0.017 m²

1.1 in.

<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

1/4 in. integrated vent hose barb (with double O-ring seal)
3/4 in. sanitary TC inlet/outlet fitting(s)

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.