KHGES3FTT1

Millipore Express^® SHC, cápsula Opticap^® XLT

Opticap^® XLT 30, sterile, inlet connection diam. 1.5 in., pore size 0.5/0.2 μm, cartridge nominal length 30 in. (75 cm)

• Sinónimos: Sterile Opticap XLT 30 Millipore Express SHC 0.5/0.2 μm TC/TC 1pk w/3/4" TC top
• Código UNSPSC: 23151806

Propiedades

• Materiales: polyester support; polyethersulfone ; polypropylene ; polypropylene housing; polypropylene vent cap; polysulfone ; silicone seal
• Nivel de calidad: 400
• cumplimiento norm.: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• esterilidad: irradiated; sterile
• Línea del producto: Opticap^® XLT 30
• Características: hydrophilic
• fabricante / nombre comercial: Millipore Express^®
• Parámetros: 1.0 bar max. inlet pressure (15 psi) at 80 °C; 1000 bar max. differential pressure (15 psi) at 80 °C (Forward); 2.75 bar max. inlet pressure (40 psi) at 60 °C; 2100 bar max. differential pressure (30 psi) at 25 °C (Reverse; intermittent); 25 °C max. inlet temp.; 5.5 bar max. inlet pressure (80 psi) at 25 °C; 5500 mbar max. differential pressure (80 psi) at 25 °C (Forward); 6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent); 6900 mbar max. differential pressure (100 psi) at 25 °C (Forward; intermittent); 80 psig max. inlet pressure
• técnicas: sterile filtration: suitable
• Longitud: 87.2 cm (34.3 in.)
• longitud nominal del cartucho: 30 in. (75 cm)
• Diámetro: 19.8 cm (7.8 in.)
• filtración área: 1.63 m²
• diám. conexión a entrada: 1.5 in.
• diám. conexión a salida: 1.5 in.
• impurezas: ≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• matriz: Millipore Express^® SHC
• pore size: 0.5/0.2 μm pore size
• punto de burbuja: ≥4000 mbar (58 psig), air with water at 23 °C
• Adaptador: 3/4 in. gauge port; inlet sanitary flange; outlet sanitary flange; 1/4 in. vent hose barb (with double O-ring Seal); (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

Descripción

Descripción general

Device Configuration: Capsule

T-line/Gauge Port: T-line with 3/4 in. Gauge Port

Envase

Double Easy-Open bag

Otras 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 installation section of OPTICAP^® XL Capsules and OPTICAP^® XLT Capsules user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Nota de preparación

Sterilization Method
3 autoclave cycles of 60 min @ 126 °C; capable of 45 kilogray (4.5 Megarad) gamma exposure; not in-line steam sterilizable

This product was manufactured with a Millipore Express^® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Nota de análisis

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

TOC/Conductivity
After sterilization and a controlled water flush of 63 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥6 L

Información legal

ASTM is a registered trademark of American Society for Testing and Materials

MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany

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