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Safety Information

SGW2A47FH3

Millipore

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 3/4 in. TC-1/4 in. HB

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About This Item

UNSPSC Code:
23151806
eCl@ss:
32031690

material

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

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® 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.

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 sanitary flange
 outlet hose barb
 (19 mm (3/4 in.) Sanitary Flange Inlet and 6 mm (1/4 in.) Hose Barb Outlet)

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General description

Device Configuration: Capsule

Features and Benefits

Format: Double Layer

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
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

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

Signal Word

Danger

Hazard Statements

H350i

Hazard Classifications

Carc. 1B Inhalation

Storage Class Code

4.1B - Flammable solid hazardous materials

WGK

WGK 2

Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

JAN Code

SGW2A47FH3:

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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