KWL6A04FF3

Opticap^® XL Capsule Filter

nominal pore size 0.5 μm, cartridge nominal length 4 in. (10 cm), filter diam. 4.9 in. (12.5 cm)

Properties

• material: polyester support; polypropylene filter; polypropylene housing; silicone seal
• Quality Level: 400
• reg. compliance: FDA 21CFR177-182 (all component materials)
• sterility: non-sterile
• product line: Opticap^® XL
• 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.: 4.9 in. (12.5 cm)
• filter filtration area: 0.2 m²
• inlet connection diam.: 3/4 in.
• inlet to outlet width: 19.6 cm (7.7 in.)
• outlet connection diam.: 3/4 in.
• impurities: ≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.5 EU/mL bacterial endotoxins (LAL test, sample aqueous extraction)
• matrix: Milligard^® LPB
• pore size: 0.5 μm nominal pore size; 0.5 μm pore size
• fitting: (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)

Description

General description

Device Configuration: Capsule

Features and Benefits

Single Layer

Packaging

Double Easy-Open bag

Specifications

Filter Grade: Low Protein Binding Milligard^® Media

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 2 L 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 installation section of Opticap^® XL Capsules and Opticap^® XLT Capsules user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

Legal Information

MILLIGARD is a registered trademark of Merck KGaA, Darmstadt, Germany

OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany