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Merck
CN

KGW2A04HH3

Polysep™ II 1.0/1.2 µm nominal, Opticap® XL Capsule

pore size 1.2/1.0 μm, Opticap® XL 4, filter diam. 5.7 in. (14.5 cm), cartridge nominal length 4 in. (10 cm)

别名:

Opticap XL 4 CapsuleMedia: Polysep II 1.0 / 1.2 µm Nominal

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UNSPSC Code:
23151806

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产品名称

Polysep™ II 1.0/1.2 µm nominal, Opticap® XL Capsule, pore size 1.2/1.0 μm, Opticap® XL 4, Chemistry: Mixed Cellulose Esters (MCE)Inlet: 9/16 in. Hose BarbOutlet: 9/16 in. Hose BarbMax Operating Pressure: 80 psi 25 °C, filter diam. 5.7 in. (14.5 cm), cartridge nominal length 4 in. (10 cm)

material

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

reg. compliance

FDA 21CFR177-182 (all component materials)

Quality Level

400

sterility

non-sterile

sterilization compatibility

autoclavable compatible

product line

Opticap® XL 4

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

4 in. (10 cm)

device L

19.6 cm (7.7 in.)

device size

4 in.

filter diam.

5.7 in. (14.5 cm)

filter filtration area

0.11 m2

inlet connection diam.

9/16 in.

inlet to outlet width

19.6 cm (7.7 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

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

fitting

(14 mm (9/16 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: ≤ 85 mg per capsule after a 1200 mL flush and 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 2 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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