KGSKG3TTT1

Millipore Express^® SHC, Opticap^® XLT Capsule

Opticap^® XLT 30, cartridge L 34.3 in. (87.2 cm), filter diam. 2.7 in. (6.9 cm)

• Synonym(s): Gamma Opticap^® XLT HBP 30 Express SHC TC/TC
• UNSPSC Code: 23151806

Properties

• material: polyethersulfone filter (PES); polyethylene support; polypropylene housing (PP); silicon seal
• Quality Level: 400
• reg. compliance: meets FDA CFR 210.3 (b) (6) (all component materials)
• sterility: irradiated; non-sterile
• Sterilization Compatibility: gamma compatible
• product line: Opticap^® XLT 30
• feature: hydrophilic
• parameter: 1.0 bar max. inlet pressure (15 psi) at 80 °C; 1000 mbar max. differential pressure (15 psi) at 80 °C; 2.75 bar max. inlet pressure (40 psi) at 60 °C; 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; 6.9 bar max. inlet pressure (100 psi) at 25 °C; 76 L/min flow rate at 69 mbar (1 psi) and 23 °C; 80 psig max. inlet pressure
• technique(s): sterile filtration: suitable
• W: 7.8 in.
• cartridge L: 34.3 in. (87.2 cm)
• device size: 30 in. (75 cm)
• filter diam.: 2.7 in. (6.9 cm)
• filtration area: 1.62 m²
• impurities: ≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction)
• matrix: Millipore Express^® SHC
• pore size: 0.5/0.2 μm pore size
• bubble point: ≥4000 mbar (≥70 psig), air with water
• fitting: 1/4 in. fitting (vent/drain hose barb with double O-ring seal); (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

Description

General description

Cartidge Type: Liquid

Device Configuration: Capsule

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Note:
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).

Analysis Note

TOC/Conductivity: After sterilization and a controlled water flush of 63 L, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 μS/cm per USP <645> at 25 °C.

Other Notes

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 of Filters with Millipore Express^® Membrane use guide
• Storage Statement: Please refer to Filters with Millipore Express^® Membrane user guide
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

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

Legal Information

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

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