SSPVA40NB9

Optiscale^® 40 Viresolve^® Prefilter

Prefiltration before parvovirus removal

• Synonym(s): OptiScale-40 Viresolve Prefilter
• eCl@ss: 32031690

Properties

• material: cellulose fiber prefilter (inorganic filter aid); mixed cellulose esters (MCE) ; polypropylene ; polypropylene support
• Quality Level: 400
• reg. compliance: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• manufacturer/tradename: OptiScale^®
• parameter: 0.03 bar max. differential pressure (0.5 psid) (Reverse); 100 mL process volume; 2.1 bar max. differential pressure (30 psid) (Forward)
• technique(s): protein purification: suitable
• filtration area: 5 cm²
• impurities: ≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• matrix: Viresolve^® Prefilter
• fitting: female Luer-Lok^® inlet connection; male Luer outlet slip

Description

General description

Device Configuration: Capsule

Application

Prefiltration before parvovirus removal

Other Notes

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Preparation Note

Sterilization Method
3 autoclave cycles of 60 min @ 123 °C

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

Safety Information

• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3