KV03A10FF1

Multimedia Durapore^® 0.2/0.22 µm, Opticap^® XL Capsule

Opticap^® XL 10, cartridge nominal length 10 in. (25 cm), filter diam. 4.2 in. (10.7 cm)

• Código UNSPSC: 23151806

Propriedades

• Materiais: mixed cellulose esters (MCE) prefilter; polypropylene filter; polypropylene housing; polypropylene support; silicone seal
• Nível de qualidade: 400
• conformidade reg.: FDA 21CFR177-182 (all component materials)
• esterilidade: non-sterile
• Compatibilidade de esterilização: autoclavable compatible
• linha de produto: Opticap^® XL 10
• Características: hydrophilic
• fabricante/nome comercial: Opticap^®
• Parâmetros: ≤13.3 mL/min air diffusion at 2.75 bar (40 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:); 2.75 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 (Reverse; intermittent); 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward:); 5.5 bar max. inlet pressure (80 psi) at 25 °C; 80 psig max. inlet pressure
• técnica(s): prefiltration: suitable
• comprimento nominal do cartucho: 10 in. (25 cm)
• device L: 33.5 cm (13.2 in.)
• device size: 10 in.
• diâmetro do filtro: 4.2 in. (10.7 cm)
• filter filtration area: 0.2 m²
• diâm. conexão de entrada: 3/4 in.
• diam. conexão de saída: 3/4 in.
• Impurezas: ≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.5 EU/mL bacterial endotoxins (LAL test, sample aqueous extraction)
• matriz: Multimedia Durapore^®
• pore size: 0.2/0.22 μm pore size
• ponto de bolha: ≥3450 mbar (50 psig), air with water at 23 °C
• conector: 1/4 in. fitting (vent/drain hose barb with double O-ring seal); (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)

Descrição

Descrição geral

Device Configuration: Capsule

Embalagem

Double Easy-Open bag

Nota de preparo

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).

Nota de análise

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 ≥ 5 L

Outras notas

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

Informações legais

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