KGW1A05TT1

Polysep^™ II 1.0/0.2/0.1 µm nominal, Opticap^® XL Capsule

Opticap^® XL 5, inlet connection diam. 1.5 in., cartridge nominal length 5 in. (12.5 cm), pore size 1.0/0.2/0.1 μm

• Sinônimo(s): Opticap XL5 Polysep II 1.0/0.2/0.1 μm 1-1/2 in. TC/TC
• Código UNSPSC: 23151806
• eCl@ss: 32031610

Propriedades

• Materiais: borosilicate glass fiber (BGF) membrane; mixed cellulose esters (MCE) membrane; 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 5
• Características: hydrophilic
• fabricante/nome comercial: Opticap^®
• Parâmetros: 1.0 bar max. inlet pressure (15 psi) at 80 °C; 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; 5.5 bar max. inlet pressure (80 psi) at 23 °C; 80 psig max. inlet pressure
• técnica(s): prefiltration: suitable
• Comprimento: 21.6 cm (8.5 in.)
• Largura: 4.2 in.
• comprimento nominal do cartucho: 5 in. (12.5 cm)
• Diâmetro: 10.7 cm (4.2 in.)
• área de filtração: 0.17 m²
• diâm. conexão de entrada: 1.5 in.
• L entrada para a saída: 21.6 cm (8.5 in.)
• diam. conexão de saída: 1.5 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: ≤61 mg/capsule
• matriz: Polysep^™ II
• pore size: 1.0/0.2/0.1 μm nominal pore size; 1.0/0.2/0.1 μm pore size
• entrada: sample type liquid
• conector: inlet sanitary flange; outlet sanitary flange; (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

Descrição

Descrição geral

Device Configuration: Capsule

Características e benefícios

Format: Triple Layer

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 to the first page of Visual Inspection Guide and introduction section of the Mixed cellulose esters Tech Brief
• Storage Statement: Please refer to the Mixed cellulose esters Tech Brief
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Ligação

Replaces: SN1M040A8

Nota de preparo

Sterilization Method
3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable

This product was manufactured with a media combination 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 a 5 L flush and 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L

Informações legais

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

Polysep is a trademark of Sigma-Aldrich Co. LLC

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.

Informações de segurança

• Código de classe de armazenamento: 11 - Combustible Solids
• Classe de risco de água (WGK): WGK 2