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SGW2A47HH3

Polysep™ II 1.0/1.2 µm nominal, OptiScale® Capsule

filtration area 17.7 cm², OptiScale® 47, pore size 1.2/1.0 μm

Synonym(s):

Optiscale Capsule Polysep II 1.0/1.2 μm 1/4 in. HB/HB, Polysep™ II 1.0/1.2 µm nominal, OptiScale® Capsule

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About This Item

eCl@ss:
32031690
UNSPSC Code:
23151806
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Product Name

OptiScale® 47 Capsule Media: Polysep™ II 1.0 / 1.2 µm Nominal, Max Pressure: 80 psi @ 25 °C

Quality Segment

400

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.

1/4 in.

outlet connection diam.

1/4 in.

impurities

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

matrix

Polysep™ II

pore size

1.0/1.2 μm nominal pore size, 1.2/1.0 μm pore size

input

sample type liquid

fitting

inlet hose barb, outlet hose barb, (6 mm (1/4 in.) Hose Barb Inlet and Outlet)

General description

Device Configuration: Capsule

Features and Benefits

Format: Double Layer

Preparation Note

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

Analysis Note

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

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
Polysep is a trademark of Sigma-Aldrich Co. LLC

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pictograms

Health hazard
GHS08

signalword

Danger

hcodes

H350i

Hazard Classifications

Carc. 1B Inhalation

Storage Class

4.1B - Flammable solid hazardous materials

wgk

WGK 2

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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