KPHLA04FH3

Cápsula Durapore^® 0,45 µm. Opticap^® XL

Opticap^® XL 4, inlet connection diam. 3/4 in., cartridge nominal length 4 in. (10 cm)

• Sinônimo(s): Opticap XL4 Durapore 0.45 μm without prefilter TC/HB
• Código UNSPSC: 23151806

Propriedades

• Materiais: PVDF ; polypropylene ; polypropylene housing; polypropylene support; polypropylene vent cap; silicone seal
• Nível de qualidade: 400
• conformidade reg.: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• esterilidade: non-sterile
• Compatibilidade de esterilização: autoclavable compatible
• linha de produto: Opticap^® XL 4
• Características: hydrophilic
• fabricante/nome comercial: Opticap^®
• Parâmetros: ≤4.5 mL/min air diffusion at 1.5 bar (22 psig) and 23 °C (in water); 1.0 bar max. inlet pressure (15 psi) at 80 °C; 2.8 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet temp.; 3.4 bar max. differential pressure (50 psid) at 25 °C (Forward); 3.4 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent); 5.5 bar max. inlet pressure (80 psi) at 23 °C; 80 psig max. inlet pressure
• técnica(s): bioburden reduction: suitable
• Comprimento: 7.7 in.
• Largura: 3.3 in.
• comprimento nominal do cartucho: 4 in. (10 cm)
• Diâmetro: 8.4 cm (3.3 in.)
• área de filtração: 0.19 m²
• diâm. conexão de entrada: 3/4 in.
• L entrada para a saída: 21.3 cm (8.4 in.)
• diam. conexão de saída: 9/16 in.
• Impurezas: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• extraíveis gravimétricos: ≤10 mg/capsule
• matriz: Durapore^®
• tamanho de poro: 0.45 μm
• entrada: sample type liquid
• ponto de bolha: ≥1930 mbar (28 psig), air with water at 23 °C
• conector: 1/4 in. drain/vent hose barb (with double O-ring Seal); inlet sanitary flange; outlet hose barb; (19 mm (3/4 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet)

Descrição

Descrição geral

Device Configuration: Capsule

Embalagem

Double Easy-Open bag

Outras notas

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

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.

Nota de preparo

Sterilization Method
3 autoclave cycles of 60 min @ 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 21 CFR 210.3 (b) (6).

Nota de análise

Gravimetric Extractables: after 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL

Informações legais

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

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

Exoneração de responsabilidade

EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.