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Merck
CN

SVSCA25NB6

Multimedia Durapore® 1.2/0.5/0.22 µm, OptiScale® Capsule

OptiScale® 25, filtration area 3.5 cm², pore size 1.2/0.5/0.22 μm

别名:

Multimedia Durapore® 1.2 μm/0.5 μm/0.22 μm Optiscale 25mm NB, Multimedia Durapore® 1.2/0.5/0.22 µm, OptiScale® Capsule

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

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产品名称

OptiScale®囊式过滤器，带Durapore® 1.2/0.5/0.22 µm滤膜，多介质,

material

PVDF membrane
mixed cellulose esters (MCE) 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

Quality Level

400

feature

hydrophilic

manufacturer/tradename

OptiScale®

parameter

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

technique(s)

sterile filtration: 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

Multimedia Durapore®

pore size

1.2/0.5/0.22 μm pore size

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: 取样皿滤膜

Analysis Note

TOC/Conductivity
After sterilization and a controlled water flush of 35 mL, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
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.

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).

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

存储类别

11 - Combustible Solids

wgk

WGK 3

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