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Key Documents

VPMG202NB1

Millipore

Viresolve® Pro Device

Parvovirus removal filter, Magnus 2.2 format, filtration area 1.53 m²

Synonym(s):

Viresolve® Pro Device Magnus 2.2

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About This Item

UNSPSC Code:
23151806
eCl@ss:
32031690

material

PVDF housing
polyethersulfone membrane
silicone gasket

Quality Level

product line

EMPROVE® Filter

manufacturer/tradename

Viresolve®

parameter

60 psig max. inlet pressure

dilution

(Large volume processing)

H

9.50 cm (3.74 in.)

L

34.29 cm (13.50 in.)

W

20.96 cm (8.25 in.)

device size

2.2 in.

filtration area

1.53 m2

impurities

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

fitting

1.5 in. sanitary TC inlet/outlet fitting(s) (Disposable)
3/4 in. sanitary TC vent fitting for port (disposable)

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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 Magnus Devices are typically used for filtration of mid to large scale batch volumes of proteins. The Viresolve® Pro Device Magnus 2.2 offers a filtration area of 1.53 m2 and has a primary use in large-volume processing.

Features and Benefits

  • Large scale manufacturing
  • Two different size formats
  • Integrated gaskets
  • Units are stackable in the Viresolve® Pro/Pro+ Magnus Holder (up to 7 units)
  • Alignment keys on each unit to minimize errors during installation
  • 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.
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

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

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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