KVGLS3TTT1

Cápsula Durapore^® 0,22 µm, Opticap^® XLT

sterile, Opticap^® XLT 30, inlet connection diam. 1.5 in., cartridge nominal length 30 in. (75 cm)

• Sinônimo(s): Opticap Sterile XLT30 Durapore 0.22 μm1-1/2 in. TC
• Código UNSPSC: 23151806

Propriedades

• Materiais: PVDF ; polyester support; polyethylene support; polypropylene (gamma-stable); polypropylene housing; 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: irradiated; sterile
• linha de produto: Opticap^® XLT 30
• Características: hydrophilic
• fabricante/nome comercial: Opticap^®
• Parâmetros: ≤42 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water); 1.0 bar max. inlet pressure (15 psi) at 80 °C; 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 2.8 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 23 °C; 80 psig max. inlet pressure
• técnica(s): sterile filtration: suitable
• Comprimento: 87.1 cm (34.3 in.)
• comprimento nominal do cartucho: 30 in. (75 cm)
• Diâmetro: 10.7 cm (4.2 in.)
• área de filtração: 2.17 m²
• diâm. conexão de entrada: 1.5 in.
• L entrada para a saída: 15.2 cm (6.0 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: ≤75 mg/capsule
• matriz: Durapore^®
• tamanho de poro: 0.22 μm
• entrada: sample type liquid
• ponto de bolha: ≥3450 mbar (50 psig), air with water at 23 °C
• conector: 1/4 in. drain/vent hose barb (with double O-ring Seal); (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

Descrição

Descrição geral

Device Configuration: Capsule

T-line/Gauge Port: T-line

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 @ 123 °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

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: after 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L

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