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About This Item

UNSPSC Code:
23151806
eCl@ss:
32031690
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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

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_germany

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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