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Merck
CN

KGW1A1THH1

Polysep™ II 1.0/0.2/0.1 µm nominal, Opticap® XLT Capsule

Opticap® XLT 10, pore size 1.0/0.2/0.1 μm, cartridge nominal length 10 in. (25 cm)

别名:

Opticap XLT 10 CapsuleMedia: Polysep II 1.0 / 0.2 / 0.1 µm Nominal

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UNSPSC Code:
23151806

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产品名称

Polysep™ II 1.0/0.2/0.1 µm nominal, Opticap® XLT Capsule, pore size 1.0/0.2/0.1 μm, Chemistry: Mixed Cellulose Esters (MCE)Inlet: 5/8 in. Hose BarbOutlet: 5/8 in. Hose BarbT-lineMax Operating Pressure: 80 psi @ 25 °C, Opticap® XLT 10, cartridge nominal length 10 in. (25 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® XLT 10

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

10 in. (25 cm)

device L

37.6 cm (14.8 in.)

device size

10 in.

filter filtration area

0.42 m2

inlet connection diam.

5/8 in.

inlet to outlet width

19.8 cm (7.8 in.)

outlet connection diam.

5/8 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

1.0/0.2/0.1 μm nominal pore size, 1.0/0.2/0.1 μm pore size

fitting

(16 mm (5?8 in.) Hose Barb Inlet and Outlet)

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General description

Device Configuration: Capsule

Features and Benefits

Triple 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: ≤ 145 mg per capsule after a 5 L flush and 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 5 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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