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Merck
CN

KVPVA10TH1

Opticap® XL Viresolve® NFR过滤器

Parvovirus removal

别名:

Opticap XL10 Viresolve NFP 1-1/2 in. TC-5/8 in. HB

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eCl@ss:
32031690
UNSPSC Code:
23151806

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material

PVDF (modified), polypropylene , polypropylene support, polypropylene vent cap, silicone seal

manufacturer/tradename

Viresolve®

parameter

≤10 mL/min air diffusion at 3.45 bar (50 psig) and 23 °C (in water), 25 °C max. inlet temp., 250 L process volume, 3.4 bar max. differential pressure (50 psid) (Reverse), 5.5 bar max. differential pressure (80 psid) (Forward), 80 psig max. inlet pressure

technique(s)

protein purification: suitable

L

33 cm (13 in.)

device size

10 in.

filtration area

0.42 m2

inlet connection diam.

1.5 in.

outlet connection diam.

9/16 in.

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

1/4 in. drain/vent hose barb (with double O-ring Seal), inlet sanitary flange, 38 mm (1 1/2 in.) inlet sanitary flange, outlet hose barb, 16 mm (5/8 in.) outlet hose barb

General description

Device Configuration: 取样皿滤膜

Application

Parvovirus removal

Packaging

Double Easy-Open bag

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).

Analysis Note

TOC/Conductivity
After sterilization and a controlled water flush of 12 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.

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

OPTICAP 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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