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SPHLA25NB6

Millipore

Durapore® 0.45 µm, OptiScale® Capsule

OptiScale® 25, filtration area 3.5 cm2

Sinónimos:

Durapore® 0.45 μm Optiscale 25mm NB

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About This Item

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

material

PVDF membrane
polypropylene
polypropylene support
polypropylene vent cap

Quality Level

400

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

input

sample type liquid

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

Other Notes

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

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.

Legal Information

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

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Storage Class

10-13 - German Storage Class 10 to 13

Certificados de análisis (COA)

Busque Certificados de análisis (COA) introduciendo el número de lote del producto. Los números de lote se encuentran en la etiqueta del producto después de las palabras «Lot» o «Batch»

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