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Key Documents

VPPH103NB1

Millipore

Viresolve® Pro Modus 1.3

Synonym(s):

Viresolve® Pro Modus 1.3 Shield H

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About This Item

UNSPSC Code:
23151806
eCl@ss:
32031690

material

PVDF housing
polyethersulfone membrane
silicone O-ring
white device

Quality Level

product line

EMPROVE® Filter

manufacturer/tradename

Viresolve®

parameter

4.1 bar max. inlet pressure (60 psig)

H

13.56 cm (5.34 in.)

L × W × H

13.6 cm (5.3 in.) × 18.2 cm (7.3 in.) × 9.2 cm (3.6 in.)

L

18.62 cm (7.33 in.)

W

9.22 cm (3.63 in.)

filtration area

0.22 m2

membrane nominal area

0.22 m2

weight

1.39 kg (3.06 lb)

impurities

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

fitting

3/4 in. inlet/outlet sanitary fitting(s)
1/8 in. integrated vent hose barb (with double O-ring seal)

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General description

The Viresolve® Pro Solution provides a comprehensive, flexible template solution for viral clearance within mAb and recombinant protein bioproduction. This proven viral clearance solution delivers the highest levels of retention assurance and productivity across a broad range of feed stream characteristics.

Viresolve Pro Modus Devices are typically used for filtration of pilot to mid-scale batch volumes of proteins. The Viresolve® Pro Modus 1.3 Shield H offers a filtration area of 0.22 m2 and has a primary use in pilot/small-volume processing.

Features and Benefits

  • Pilot and mid scale manufacturing
  • Three different size formats
  • Fully self contained (hardware holder not required)
  • Fully disposable single-use fluid path
  • Devices 100% tested with air/water diffusion and Binary Gas Test
  • Shield / Shield H 100% aerosol tested

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).

Storage and Stability

4°C - 30°C

Legal Information

Emprove 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.

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Certificates of Analysis (COA)

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