KGW9A02FH3

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

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

• UNSPSC Code: 23151806

Properties

• 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)

Description

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