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KGW9A02FH3

Millipore

Polysep™ II 2.0/1.2 µm nominal, Opticap® XL Capsule

pore size 2.0/1.2 μm, Opticap® XL 2, filter diam. 5.7 in. (14.5 cm), cartridge nominal length 2 in. (5 cm)

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About This Item

UNSPSC Code:
23151806

material

borosilicate glass fiber (BGF) membrane
mixed cellulose esters (MCE) membrane
polypropylene filter
polypropylene housing
polypropylene support
silicone seal

Quality Level

400

reg. compliance

FDA 21CFR177-182 (all component materials)

sterility

non-sterile

Sterilization Compatibility

autoclavable compatible

product line

Opticap® XL 2

feature

hydrophilic

manufacturer/tradename

Opticap®

parameter

1 bar max. inlet pressure (15 psi) at 80 °C
2.75 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
3.5 bar max. differential pressure (50 psid) at 25 °C
5.5 bar max. inlet pressure (80 psi) at 23 °C
80 psig max. inlet pressure

technique(s)

prefiltration: suitable

cartridge nominal length

2 in. (5 cm)

device L

14.2 cm (5.6 in.)

device size

2 in.

filter diam.

5.7 in. (14.5 cm)

filter filtration area

0.06 m2

inlet connection diam.

3/4 in.

inlet to outlet width

14.2 cm (5.6 in.)

outlet connection diam.

9/16 in.

impurities

≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction)
<0.5 EU/mL bacterial endotoxins (LAL test, sample aqueous extraction)

matrix

Polysep™ II

pore size

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

fitting

(19 mm (3/4 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet)

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General description

Device Configuration: Capsule

Features and Benefits

Double Layer

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method:
3 autoclave cycles of Sterilization Method: 30min at 121°C; not in-line steam sterilizable

This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(b)(6).

Analysis Note

Gravimetric Extractables: ≤ 45 mg per capsule after a 600 mL flush and 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 1 L

Other Notes

Directions for Use:

  • Organism Retention: Microorganism
  • Mode of Action: Filtration (size exclusion)
  • Application: BioProcessing
  • Intended Use: Reduction or removal of microorganism/bioburden
  • Instructions for Use: Please refer first page of Visual Inspection Guide and introduction section of Mixed cellulose esters Tech Brief
  • Storage Statement: Please refer Mixed cellulose esters Tech Brief
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

Legal Information

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

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Regulatory Information

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Certificates of Analysis (COA)

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