CHGL03TP3

Multilayer Durapore^® 0.45/0.22 µm, Cartridge

cartridge nominal length 30 in. (75 cm), filter diam. 2.7 in. (6.9 cm), Code 0

• Código UNSPSC: 23151806

Propriedades

• Materiais: polypropylene device; polypropylene support; silicone seal
• Nível de qualidade: 400
• conformidade reg.: meets FDA 21 CFR 177-182 (all component materials)
• esterilidade: non-sterile
• Compatibilidade de esterilização: autoclavable compatible; steam-in-place compatible
• linha de produto: Durapore^®
• Características: hydrophilic
• fabricante/nome comercial: Durapore^®
• Parâmetros: ≤32.4 mL/min air diffusion at 2.75 bar (40 psig) (in water); 0.35 bar max. differential pressure (5 psid) at 135 °C (forward); 0.35 bar max. inlet pressure (5 psi) at 135 °C (forward); 1.7 bar max. differential pressure (25 psid) at 80 °C (forward); 1.7 bar max. inlet pressure (25 psi) at 80 °C (forward); 3.5 bar max. differential pressure (50 psid) at 25 °C (reverse; intermittent); 3.5 bar max. inlet temp. (50 psi) 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 (forward)
• técnica(s): sterile filtration: suitable
• Comprimento: 30 in.
• Largura: 2.7 in.
• comprimento nominal do cartucho: 30 in. (75 cm)
• device size: 30 in.
• diâmetro do filtro: 2.7 in. (6.9 cm)
• filter filtration area: 1.65 m²
• Impurezas: ≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• matriz: Multilayer Durapore^®
• pore size: 0.45/0.22 μm pore size
• ponto de bolha: ≥3450 mbar (50 psig), air with water
• código: Code 0

Descrição

Descrição geral

Device configuration: Cartridge
Cartridge type: Liquid

Nota de preparo

Sterilization Method: 30 SIP cycles of 30 min at 135°C; 30 autoclave cycles of 60 min at 126°C

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

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

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 4.5L

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 to 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