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Merck
CN

VPPS101NB1

Viresolve® Pro Shield

Virus prefilter, Viresolve® Pro Shield, Modus 1.1 format, filtration area 0.017 m²

Synonym(s):

Viresolve® Pro Shield Modus 1.1

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About This Item

eCl@ss:
32031690
UNSPSC Code:
23151806

Key Documents

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Product Name

Viresolve® Pro Shield, Virus prefilter, Viresolve® Pro Shield, Modus 1.1 format, filtration area 0.017 m²

material

polyethersulfone

product line

EMPROVE® Filter

parameter

60 psig max. inlet pressure

device size

1.1 in.

impurities

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

Quality Level

400

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Analysis Note

TOC/Conductivity
After a controlled water flush of 100 L/m², samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.

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.

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

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 Shield Modus 1.1 offers a filtration area of 0.017 m2 and has a primary use in small-scale studies/pilot processing.

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).

Legal Information

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

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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