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CZRV71TP1

Viresolve® NFR Cartridge Filter

Retrovirus removal

Synonym(s):

Viresolve NFR Cartridge Filter 10 in. Code 7, Viresolve® NFR Cartridge Filter

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About This Item

eCl@ss:
32031690
UNSPSC Code:
23151806
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Product Name

VIRESOLVE® NFR Cartridge, Chemistry: Polyethersulfone (PES)Configuration: 10 in. Code 7

Quality Segment

400

material

polyethersulfone , polypropylene , silicone seal

description

Retrovirus removal

feature

holdup volume 175 mL

manufacturer/tradename

Viresolve®

parameter

≤16 mL/min air diffusion at 3.45 bar (50 psig) and 23 °C (in water), 3.4 bar max. differential pressure (50 psid) at 25 °C (Reverse), 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward), 600-1200 L process volume

technique(s)

protein purification: suitable

cartridge nominal length

10 in. (25 cm)

filtration area

0.43 m2

impurities

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

gravimetric extractables

≤35 mg/cartridge

matrix

Viresolve® NFR

cartridge code

Code 7

General description

Device Configuration: Cartridge

Application

Retrovirus removal

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
After wetting, may be autoclaved for 3 cycles of up to 60 min at 125 °C,

using liquid cycle, slow exhaust.
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

Gravimetric Extractables: after a 10 minute 1.5 LPM/ft² flush and 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥4 L

Other Notes

Directions for Use

  • Organism Retention: Retrovirus
  • Mode of Action: Filtration (size exclusion)
  • Application: Protein purification
  • Intended Use: Viral clearance
  • Instructions for Use: Please see the user guide (pg. 3) 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

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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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