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Merck

VPMD101NB1

Viresolve® Pro Device

Parvovirus removal filter, Modus 1.1 format, filtration area 0.017 m²

Synonym(s):

Viresolve® Pro Device Modus 1.1, Viresolve® Pro Device

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About This Item

eCl@ss:
32031690
UNSPSC Code:
23151806

Key Documents

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Product Name

Viresolve® Pro Device Modus 1.1, MAX PRESSURE 60 PSI (4.1 bar)

material

PVDF housing
polyethersulfone membrane
silicone gasket

product line

EMPROVE® Filter

manufacturer/tradename

Viresolve®

parameter

60 psig max. inlet pressure

dilution

(Scale studies/Pilot)

H

5.92 cm (2.33 in.)

L

18.62 cm (7.33 in.)

W

9.22 cm (3.63 in.)

device size

1.1 in.

filtration area

0.017 m2

impurities

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

fitting

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

Quality Level

400

Related Categories

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>.

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.

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

Other Notes

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.

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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Global Trade Item Number

SKUGTIN
VPMD101NB104053252494499

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