KVVLA02FH3

Durapore^® 0,1 µm, Opticap^® XL Cápsula

Opticap^® XL 2, cartridge nominal length 2 in. (5 cm), filter diam. 5.7 in. (14.5 cm)

• UNSPSC Code: 23151806

Propiedades

• material: 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: ≤3.5 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; 1.0 bar max. differential pressure (15 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
• technique(s): sterile filtration: suitable
• cartridge nominal length: 2 in. (5 cm)
• device L: 14.0 cm (5.5 in.)
• device size: 2 in.
• filter diam.: 5.7 in. (14.5 cm)
• filter filtration area: 0.2 m²
• inlet connection diam.: 3/4 in.
• inlet to outlet width: 14 cm (5.5 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: Durapore^®
• pore size: 0.1 μm pore size
• bubble point: ≥4830 mbar (70 psig), air with water at 23 °C
• fitting: 19 mm (3/4 in.) fitting (sanitary flange inlet/oulet); 1/4 in. fitting (vent/drain hose barb with double O-ring seal); (19 mm (3/4 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet)

Descripción

General description

Device Configuration: Capsule

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method:
3 autoclave cycles of 60min at 126°C; 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: ≤ 10 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 ≥ 500 mL

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