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Merck
CN

SGW9A47FF3

Polysep™ II 2.0/1.2 µm nominal, OptiScale® Capsule

filtration area 17.7 cm2, OptiScale® 47, pore size 2.0/1.2 μm

别名:

Optiscale Capsule Polysep II 2.0/1.2 μm 3/4 in. TC/TC

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eCl@ss:
32031690
UNSPSC Code:
23151806

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产品名称

Polysep™ II 2.0/1.2 µm nominal, OptiScale® Capsule, filtration area 17.7 cm2, OptiScale® 47, pore size 2.0/1.2 μm

material

PVDF vent cap
borosilicate glass fiber (BGF) membrane
fluoroelastomer FKM seal
mixed cellulose esters (MCE) membrane
polycarbonate
polypropylene support

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® 47

feature

hydrophilic

manufacturer/tradename

OptiScale®

parameter

25 °C max. inlet temp.
5.5 bar max. inlet pressure (80 psi) at 25 °C
80 psig max. inlet pressure

technique(s)

prefiltration: suitable

diam.

6.9 cm (2.7 in.)

filtration area

17.7 cm2

inlet connection diam.

3/4 in.

outlet connection diam.

3/4 in.

impurities

≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)

matrix

Polysep™ II

pore size

2.0/1.2 μm nominal pore size
2.0/1.2 μm pore size

input

sample type liquid

fitting

inlet sanitary flange
 outlet sanitary flange
 (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)

Quality Level

400

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Analysis Note

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥100 mL

Features and Benefits

Format: Double Layer

General description

Device Configuration: Capsule

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
3 autoclave cycles of 60 min @ 121 °C; not in-line steam sterilizable

Legal Information

OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany
Polysep is a trademark of Sigma-Aldrich Co. LLC

pictograms

Health hazard
GHS08

signalword

Danger

hcodes

H350i

Hazard Classifications

Carc. 1B Inhalation

存储类别

4.1B - Flammable solid hazardous materials

wgk

WGK 2

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