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SSPVA40NB9

OptiScale® 40 Viresolve® Prefilter

Prefiltration before parvovirus removal

Synonym(s):

OptiScale-40 Viresolve Prefilter, Optiscale® 40 Viresolve® Prefilter

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About This Item

eCl@ss:
32031690
UNSPSC Code:
23151806
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Product Name

OptiScale® 40 CapsuleMedia: Viresolve® Prefilter,

Quality Segment

400

material

cellulose fiber prefilter (inorganic filter aid), mixed cellulose esters (MCE) , polypropylene , polypropylene support

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

General description

Device Configuration: Capsule

Application

Prefiltration before parvovirus removal

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).

Other Notes

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

Storage Class

11 - Combustible Solids

wgk

WGK 3

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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