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KGW2A05TT1

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

pore size 1.2/1.0 μm, Opticap® XL 5, cartridge nominal length 5 in. (12.5 cm), filter diam. 5.7 in. (14.5 cm)

Synonym(s):

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

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About This Item

UNSPSC Code:
23151806
Technical Service
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Product Name

Opticap® XL 5 CapsuleMedia: Polysep™ II 1.0 / 1.2 µm Nominal, Chemistry: Mixed Cellulose Esters (MCE)Inlet: 1-1/2 in. Sanitary FlangeOutlet: 1-1/2 in. Sanitary FlangeMax Operating Pressure: 80 @ 25 °C

Quality Segment

400

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)

sterility

non-sterile

sterilization compatibility

autoclavable compatible

product line

Opticap® XL 5

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

5 in. (12.5 cm)

device L

21.6 cm (8.5 in.)

device size

5 in.

filter diam.

5.7 in. (14.5 cm)

filter filtration area

0.19 m2

inlet connection diam.

1-1/2 in.

inlet to outlet width

21.6 cm (8.5 in.)

outlet connection diam.

1-1/2 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

(38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

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: ≤ 61 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 ≥ 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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Certificates of Analysis (COA)

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