KHVEG1TTB1H

Millipore Express^® SHRP High Area, Opticap^® XLT Capsule

Opticap^® XLT 10, cartridge nominal length 10 in. (25 cm), filter diam. 4.2 in. (10.7 cm)

• UNSPSC Code: 23151806

Properties

• material: polyester support; polypropylene housing; silicone seal; vent cap (gamma stable polypropylene)
• Quality Level: 400
• reg. compliance: meets FDA 21 CFR 177-182 (all component materials)
• sterility: non-sterile
• Sterilization Compatibility: gamma compatible
• product line: Opticap^® XLT 10
• feature: hydrophilic
• manufacturer/tradename: Millipore Express^®
• parameter: ≤54.2 mL/min air diffusion at 3.45 bar (50 psig) (in water); 0.07 bar max. differential pressure (1 psi) at 135 °C (Reverse); 1 bar max. differential pressure (15 psid) at 80 °C (Forward); 1.0 bar max. inlet pressure (15 psi) at 80 °C; 2.07 bar max. differential pressure (30 psi) at 25 °C (Reverse); 2.75 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet pressure; 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 25 °C; 6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent); 6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent); 80 psig max. inlet pressure
• technique(s): sterile filtration: suitable
• L: 14.8 in.
• W: 4.2 in.
• cartridge nominal length: 10 in. (25 cm)
• filter diam.: 4.2 in. (10.7 cm)
• filter size: 10 in.
• filtration area: 1.0 m²
• impurities: ≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction)
• matrix: Millipore Express^® SHR ((w/Prefilter High Area))
• pore size: 0.5/0.1 μm pore size
• bubble point: ≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water
• fitting: 1/4 in. drain/vent connection ( hose barb with double o-ring seal); (38 mm (1 1/2 in.) Sanitary Flange Inlet and 25 mm (1 in.) Hose Barb Outlet)
• application(s): filtration

Description

General description

Device Configuration: Capsule

Features and Benefits

T-line/Gauge Port: T-line

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method: Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min at 123 °C; 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

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

TOC/Conductivity: After sterilization and a controlled water flush of 20 L, samples exhibited <500 ppb TOC per USP 643 and <1.3 μS/cm per USP 645 at 25 °C.

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

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 wetting instructions of Filters with MILLIPORE EXPRESS^® Membrane user guide
• Storage Statement: Please refer 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

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