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SN03A47FF3

Millipore

Optiscale® Capsule Filter Polygard® CN

filtration area 17.7 cm2, pore size 0.3 μm

Synonym(s):

Optiscale Capsule Polygard-CN 0.3 μm 3/4 in. TC/TC

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About This Item

UNSPSC Code:
23151806
eCl@ss:
32031610

material

PVDF vent cap
fluoroelastomer FKM seal
polycarbonate
polypropylene
polypropylene support

Quality Level

400

reg. compliance

meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

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

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

Polygard®-CN

pore size

0.3 μm nominal pore size
0.3 μm pore size

input

sample type liquid

fitting

inlet sanitary flange
19 mm (3/4 in.) inlet/outlet sanitary flange
 outlet sanitary flange

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General description

Device Configuration: Capsule

Features and Benefits

Format: Single 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)
  • Appliication: Protein Purification
  • Intended Use: Reduction or removal of microorganism/bioburden
  • Instructions for Use: Please refer to the installation and wetting sections of OptiScale® 47 Capsulle Filter with Polygard® CN Media user guide
  • Storage Statement: Store in original packaging at room temperature
  • Disposal Statement: Dispose of in accordance with applicable federal, state, and local regulations

Preparation Note

Sterilization Method
3 autoclave cycles of 60 min @ 126 °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
POLYGARD is a registered trademark of Merck KGaA, Darmstadt, Germany

Regulatory Information

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