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KGW6A2TBB1

Millipore

Polysep™ II 1.0/0.5 µm nominal, Opticap® XLT Capsule

pore size 1.0/0.5 μm, Opticap® XLT 20, cartridge nominal length 20 in. (50 cm)

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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® XLT 20

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

20 in. (50 cm)

device L

62.5 cm (24.6 in.)

device size

20 in.

filter filtration area

0.92 m2

inlet connection diam.

1 in.

inlet to outlet width

19.8 cm (7.8 in.)

outlet connection diam.

1 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

1.0/0.5 μm nominal pore size
1.0/0.5 μm pore size

fitting

(25 mm (1 in.) Hose Barb Inlet and 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: ≤ 290 mg per capsule after a 10 L flush and 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 10 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

Regulatory Information

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