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Safety Information

SVPVSMLNB9

Millipore

Optiscale® 25 Viresolve® NFP

Parvovirus removal

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Synonym(s):
OptiScale-25 with Viresolve NFP Validation Kit, single membrane lot
UNSPSC Code:
23151806
eCl@ss:
32031690

material

PVDF (modified)
silicone seal

manufacturer/tradename

OptiScale®

parameter

0.7 bar max. differential pressure (10 psid) (Reverse)
5.5 bar max. differential pressure (80 psid) (Forward)
70 mL process volume

technique(s)

protein purification: suitable

L

2.2 cm (0.87 in.)

filtration area

3.5 cm2

impurities

≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

matrix

Viresolve® NFP

fitting

female Luer-Lok® inlet connection
 male Luer outlet slip

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General description

Device Configuration: Validation Kit

Application

Parvovirus removal

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 refer ′Installation and Operation′ section of the user guide shipped with this product
  • Storage Statement: Store in dry location
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Preparation Note

Sterilization Method
Water wet filter for 5 min @ 3.4 bar (50 psi); liquid cycle, slow exhaust @ 123 °C maximum 60 min
This product was manufactured with a Viresolve® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Legal Information

Luer-Lok is a registered trademark of Becton-Dickinson & Co.
OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany
VIRESOLVE is a registered trademark of Merck KGaA, Darmstadt, Germany

Regulatory Information

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Certificates of Analysis (COA)

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