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
General description
Device Configuration: Validation Kit
Application
Parvovirus removal
Preparation Note
Sterilization Method
Water wet filter for 5 min @ 3.4 bar (50 psi); liquid cycle, slow exhaust @ 123 °C maximum 60 min
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).
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 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.
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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