KVVLG2THH1

Opticap^® XL Capsule Filter

cartridge nominal length 20 in. (50 cm), filter diam. 4.2 in. (10.7 cm)

Properties

• material: polyester support; polypropylene filter (Gamma-stable); polypropylene housing; silicone seal
• Quality Level: 400
• reg. compliance: FDA 21CFR177-182 (all component materials)
• sterility: non-sterile
• sterilization compatibility: gamma compatible
• feature: hydrophilic
• manufacturer/tradename: Opticap^®
• parameter: ≤42.2 mL/min air diffusion at 3.9 bar (56 psig) and 23 °C (in water); 1 bar max. inlet pressure (15 psi) at 80 °C; 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward:); 2.8 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 (Reverse; intermittent); 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward:); 5.5 bar max. inlet pressure (80 psi) at 23 °C; 80 psig max. inlet pressure
• cartridge nominal length: 20 in. (50 cm)
• device L: 62.5 cm (24.6 in.)
• device size: 20 in.
• filter diam.: 4.2 in. (10.7 cm)
• filter filtration area: 1.24 m²
• inlet connection diam.: 5/8 in.
• inlet to outlet width: 19.8 cm (7.8 in.)
• outlet connection diam.: 5/8 in.
• impurities: ≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.5 EU/mL bacterial endotoxins (LAL test, sample aqueous extraction)
• matrix: Durapore^®
• pore size: 0.1 μm pore size
• bubble point: ≥4830 mbar (70 psig), air with water at 23 °C
• fitting: 16 mm (5/8 in.) fitting (hose barb inlet/oulet); 1/4 in. fitting (vent/drain hose barb with double O-ring seal)

Description

General description

Device Configuration: Capsule

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method:
3 autoclave cycles of 60min at 126°C; capable of 45 kilogray (4.5 Megarad) gamma exposure; not in-line steam sterilizable

This product was manufactured with a Durapore^® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(b)(6).

Analysis Note

Bacterial Retention: Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

Gravimetric Extractables: ≤ 50 mg per capsule after 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 Wetting Instructions for Filter Units with Durapore^® Membrane user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials

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

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