KHGLS10FH1

Multilayer Durapore^® 0.45/0.22 µm, Opticap^® XL Capsule

Opticap^® XL 10, cartridge nominal length 10 in. (25 cm)

• UNSPSC Code: 23151806

Properties

• material: polyester support; polyethylene support; silicone outer O-ring; silicone-coated EPDM rubber lead O-ring
• Quality Level: 400
• reg. compliance: FDA 21CFR177-182 (all component materials)
• sterility: sterile; irradiated
• product line: Opticap^® XL 10
• feature: hydrophilic
• manufacturer/tradename: Opticap^®
• parameter: 1 bar max. inlet pressure (15 psi) at 80 °C; 25 °C max. inlet temp.; 80 psig max. inlet pressure
• technique(s): sterile filtration: suitable
• cartridge nominal length: 10 in. (25 cm)
• device size: 10 in.
• inlet connection diam.: 3/4 in.
• outlet connection diam.: 9/16 in.
• matrix: Multilayer Durapore^®
• pore size: 0.45/0.22 μm pore size
• fitting: (19 mm (3/4 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet)

Description

General description

Device Configuration: Capsule

Preparation Note

Sterilization Method:
This product was manufactured with a Durapore^® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(b)(6).

Analysis Note

TOC/Conductivity: After sterilization and a controlled water flush, samples exhibited less than 500ppb TOC per USP < 643 > and less than 1.3μS/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 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

Legal Information

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

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