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Opticap® XL 10 Capsule Media: Viresolve® NFR

Chemistry: Polyethersulfone (PES) Inlet: 1-1/2 in. Sanitary Flange Outlet: 1-1/2 in. Sanitary Flange Max Operating Pressure: 80 psi @ 25 °C

Synonym(s):

Opticap XL10 Viresolve NFR 1-1/2 in. TC/TC, Opticap® XL Viresolve® NFR

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About This Item

eCl@ss:
32031690
UNSPSC Code:
23151806
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Product Name

Opticap® XL 10 Capsule Media: Viresolve® NFR, Chemistry: Polyethersulfone (PES) Inlet: 1-1/2 in. Sanitary Flange Outlet: 1-1/2 in. Sanitary Flange Max Operating Pressure: 80 psi @ 25 °C

Quality Segment

400

material

polyethersulfone , polypropylene , polypropylene support, polypropylene vent cap, 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), 25 °C max. inlet temp., 3.4 bar max. differential pressure (50 psid) (Reverse), 5.5 bar max. differential pressure (80 psid) (Forward), 600-1200 L process volume, 80 psig max. inlet pressure

technique(s)

protein purification: suitable

L

33 cm (13 in.)

device size

10 in.

filtration area

0.43 m2

inlet connection diam.

1.5 in.

outlet connection diam.

1.5 in.

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

matrix

Viresolve® NFR

fitting

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

General description

Device Configuration: Capsule

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

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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