KGW2A05TT1

Opticap^® XL Capsule Filter

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

Properties

• material: borosilicate glass fiber (BGF) prefilter; 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
• 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)

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: ≤ 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 Merck KGaA, Darmstadt, Germany