5A10TT1

Opticap^® XL10 Polygard^® CR

inlet connection diam. 1.5 in., pore size 25.0 μm, cartridge nominal length 10 in. (25 cm)

• Sinônimo(s): Opticap^® XL10 Polygard^®-CR 25 µm 1-1/2 in. TC/TC
• Código UNSPSC: 23151806
• eCl@ss: 32031690

Propriedades

• Materiais: 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)
• 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.; 4.8 bar max. differential pressure (70 psid) at 20 °C; 5.5 bar max. inlet pressure (80 psi) at 25 °C; 80 psig max. inlet pressure
• Comprimento: 33.5 cm (13.2 in.)
• comprimento nominal do cartucho: 10 in. (25 cm)
• Diâmetro: 10.7 cm (4.2 in.)
• diâm. conexão de entrada: 1.5 in.
• L entrada para a saída: 33.5 cm (13.2 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: ≤55 mg/capsule
• matriz: Polygard^®-CR
• tamanho de poro: 25.0 μm nominal pore size; 25.0 μm pore size
• entrada: sample type liquid
• conector: inlet sanitary flange; 38 mm (1 1/2 in.) inlet/outlet sanitary flange; outlet sanitary flange

Descrição

Descrição geral

Device Configuration: Capsule

Características e benefícios

Format: Single Layer

Embalagem

Double Easy-Open bag

Outras notas

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

Ligação

Replaces: KR2501TC1

Nota de preparo

Sterilization Method
3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable

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 ≥5 L

Informações legais

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

POLYGARD 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.