KHGLG10TH1

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

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

• UNSPSC Code: 23151806

Properties

• material: polyester support; polyethylene support; polypropylene filter; polypropylene housing; silicone outer O-ring; silicone-coated EPDM rubber lead O-ring
• Quality Level: 400
• reg. compliance: FDA 21CFR177-182 (all component materials)
• sterility: non-sterile
• Sterilization Compatibility: gamma compatible
• product line: Opticap^® XL 10
• feature: hydrophilic
• manufacturer/tradename: Opticap^®
• parameter: ≤15.0 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water); 1 bar max. inlet pressure (15 psi) at 80 °C; 1.05 bar max. differential pressure (15 psid) at 80 °C (Forward:); 2.75 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet temp.; 3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent); 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward:); 5.5 bar max. inlet pressure (80 psi) at 23 °C; 80 psig max. inlet pressure
• technique(s): sterile filtration: suitable
• W: 4.2 in.
• cartridge nominal length: 10 in. (25 cm)
• device L: 33.5 cm (13.2 in.)
• device size: 10 in.
• filter diam.: 4.2 in. (10.7 cm)
• filter filtration area: 1.86 m²
• inlet connection diam.: 1-1/2 in.
• inlet to outlet width: 33.5 cm (13.2 in.)
• outlet connection diam.: 9/16 in.
• impurities: ≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.25 EU/mL bacterial endotoxins (LAL test, sample aqueous extraction)
• matrix: Multilayer Durapore^®
• pore size: 0.45/0.22 μm pore size
• bubble point: ≥3450 mbar (50 psig), air with water at 23 °C
• fitting: 1/4 in. fitting (vent/drain hose barb with double O-ring seal); (38 mm (1 1/2 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet)

Description

General description

Device Configuration: Capsule

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method:
Gamma compatible to 45 kGy; 3 autoclave cycles of 60min at 3°C; not in-line steam sterilizable

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

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, samples exhibited less than 500ppb TOC per USP < 643 > and less than 1.3μS/cm per USP < 645 > at 25°C.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 1.5 L

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

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

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

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