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SPHLA25NB6

Durapore® 0.45 µm, OptiScale® Capsule

OptiScale® 25, filtration area 3.5 cm²

Synonym(s):

Durapore® 0.45 μm Optiscale 25mm NB, Durapore® 0.45 µm, OptiScale® Capsule

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About This Item

UNSPSC Code:
23151806
NACRES:
NB.24
eCl@ss:
32031610
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Product Name

OptiScale® 25 CapsuleMedia: Durapore® 0.45 µm,

Quality Level

400

material

PVDF membrane, polypropylene , polypropylene support, polypropylene vent cap

reg. compliance

meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

sterility

non-sterile

sterilization compatibility

autoclavable compatible

product line

OptiScale® 25

feature

hydrophilic

manufacturer/tradename

OptiScale®

parameter

4.1 bar max. inlet pressure (60 psi) at 25 °C, 60 psi max. differential pressure (4.1 bar) at 25 °C (forward)

technique(s)

bioburden reduction: suitable

L

3.9 cm (1.52 in.)

W

1.21 in.

diam.

3.1 cm (1.2 in.)

filtration area

3.5 cm2

impurities

≤0.25 EU/mL (LAL test, Aqueous extraction), <0.25  EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

matrix

Durapore®

pore size

0.45 μm

fitting

female Luer-Lok® inlet connection, male Luer-Lok® outlet connection, (Female Luer-Lok® Inlet/Male Luer Slip Outlet)

shipped in

ambient

General description

Device Configuration: Capsule

Preparation Note

Sterilization Method
1 autoclave cycle of 60 min @ 123 °C
This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Analysis Note

TOC/Conductivity
After sterilization and a controlled water flush of 15 mL, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.
This product was tested and passes the USP <78> test for particulates in injectables.

Other Notes

Directions for Use

  • Organism Retention: Bacterial
  • Mode of Action: Filtration (size exclusion)
  • Application: Protein purification
  • Intended Use: Reduction or removal of microorganism/bioburden
  • Instructions for Use: Please refer installation and wetting sections of OPTISCALE®-25 user guide
  • Storage Statement: Please refer OPTISCALE®-25 user guide
  • 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

OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
Luer-Lok is a registered trademark of Becton-Dickinson & Co.

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Storage Class

10-13 - German Storage Class 10 to 13

Certificates of Analysis (COA)

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Global Trade Item Number

SKUGTIN
SPHLA25NB604053252679841