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

Opticap^® XLT 10, non-sterile, pore size 0.5/0.2 μm, cartridge nominal length 10 in. (25 cm)

• Synonym(s): Gamma Compatible High Area Opticap^® XLT 10 Millipore Express^® SHC 0.5 µm/0.2 µm 1-1/2 in. TC
• UNSPSC Code: 23151806

Properties

• material: polyester support; polyethersulfone ; polypropylene ; polypropylene housing; polypropylene vent cap; polysulfone ; silicone seal
• Quality Level: 400
• reg. compliance: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• sterility: irradiated; non-sterile
• Sterilization Compatibility: gamma compatible
• product line: Opticap^® XLT 10
• feature: hydrophilic
• manufacturer/tradename: Millipore Express^®
• parameter: ≤56.4 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water); 1.0 bar max. differential pressure (15 psi) at 80 °C (Forward); 2.1 bar max. differential pressure (30 psi) at 25 °C (Reverse; intermittent); 25 °C max. inlet temp.; 5.5 bar max. differential pressure (80 psi) at 25 °C (Forward); 6.9 bar max. differential pressure (100 psi) at 25 °C (Forward; intermittent); 80 psig max. inlet pressure
• technique(s): sterile filtration: suitable
• L: 37.6 cm (14.8 in.)
• W: 4.2 in.
• cartridge nominal length: 10 in. (25 cm)
• diam.: 10.7 in. (4.2 cm)
• filtration area: 1.0 m²
• inlet to outlet W: 15.2 cm (6.0 in.)
• outlet connection diam.: 1.5 in.
• impurities: ≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
• matrix: Millipore Express^® SHC High Area
• pore size: 0.5/0.2 μm pore size
• bubble point: ≥4000 mbar (58 psig), air with water at 23 °C
• fitting: 1/4 in. drain/vent hose barb (with double O-ring seal); inlet sanitary flange; outlet sanitary flange; (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)
• application(s): sample preparation

Description

General description

T-line/Gauge Port: T-line

Packaging

Double Easy-Open bag

Other Notes

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

Preparation Note

Sterilization Method
Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 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

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 21 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 ≥2 L

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

Disclaimer

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.