K003A10FF1

Opticap^® XL Capsule Filter

pore size 0.3 μm, cartridge nominal length 10 in. (25 cm), filter diam. 4.2 in. (10.7 cm)

• UNSPSC Code: 23151806

Propiedades

• material: polypropylene filter; polypropylene housing; polypropylene support; silicone seal
• Quality Level: 400
• reg. compliance: meets FDA 21 CFR 177-182 (all component materials)
• manufacturer/tradename: Opticap^®
• parameter: max. inlet temp. at 25 °C; 1.0 bar max. inlet pressure (15 psi) at 80 °C; 2.75 bar max. inlet pressure (40 psi) at 60 °C; 4.8 bar max. differential pressure (70 psid) at 20 °C; 5.5 bar max. inlet pressure (80 psi) at 23 °C; 80 psig max. inlet pressure
• cartridge nominal length: 10 in. (25 cm)
• device size: 10 in.
• filter L: 13.2 in. (33.5 cm)
• filter diam.: 4.2 in. (10.7 cm)
• inlet connection diam.: 3/4 in. , sanitary flange
• inlet to outlet width: 33.5 cm (13.2 in.)
• impurities: ≤0.25 EU/mL USP bacterial endotoxins (LAL test, aqueous extraction)
• matrix: Clarigard^®
• pore size: 0.3 μm pore size
• fitting: inlet/outlet connection for 19 mm (3/4 in.) sanitary flange

Descripción

General description

Cartridge Type: Liquid

Device Configuration: Capsule

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method:
3 autoclave cycles of 30min at 126°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: ≤ 55mg per capsule after 24 hours in water at controlled room temperature.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3L

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

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

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