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VBMSPDKNB9

Viresolve® Barrier Capsule

Process Development Kit

Synonym(s):

Viresolve® Barrier Micro Process Development Kit

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About This Item

eCl@ss:
32031690
UNSPSC Code:
23151806

Key Documents

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material

molded polypropylene component(s), polyethersulfone membrane, teal device

manufacturer/tradename

Viresolve®

parameter

4.1 bar max. inlet pressure (60 psig)

dilution

(process development studies)

H × diam.

3.83 cm (1.51 in.) × 3.07 cm (1.21 in.)

H

3.83 cm (1.51 in.)

diam.

3.07 cm (1.21 in.)

filtration area

3.3 cm2

impurities

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

fitting

female Luer inlet fitting, male Luer outlet fitting

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General description

Device Configuration: Micro

Application

Process Development Kit

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 40 L/m2, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.

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.

Legal Information

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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