CVHL52PP3

Durapore^® 0.45 µm, Cartridge

cartridge nominal length 20 in. (50 cm), filter diam. 2.7 in. (6.9 cm), Code 5

• UNSPSC Code: 23151806

Properties

• material: polypropylene device; polypropylene support; silicone seal
• reg. compliance: meets EU 1935/2004/EC (all component materials; regarding materials and articles intended to contact food); meets FDA 21 CFR 177-182 (all component materials)
• sterility: non-sterile
• Sterilization Compatibility: autoclavable compatible; steam-in-place compatible
• product line: Durapore^®
• feature: hydrophilic
• manufacturer/tradename: Durapore^®
• parameter: ≤30 mL/min air diffusion at 1.5 bar (22 psig) (in water); 0.35 bar max. differential pressure (5 psid) at 135 °C (forward); 0.35 bar max. inlet pressure (5 psi) at 135 °C (forward); 1.7 bar max. differential pressure (25 psid) at 80 °C (forward); 1.7 bar max. inlet pressure (25 psi) at 80 °C (forward); 3.5 bar max. differential pressure (50 psid) at 25 °C (reverse); 3.5 bar max. inlet temp. (50 psi) at 25 °C (reverse); 5.5 bar max. differential pressure (80 psid) at 25 °C (forward); 5.5 bar max. inlet pressure (80 psi) at 25 °C (forward)
• technique(s): bioburden reduction: suitable
• L: 20 in.
• W: 2.7 in.
• cartridge nominal length: 20 in. (50 cm)
• device size: 20 in.
• filter diam.: 2.7 in. (6.9 cm)
• filter filtration area: 1.38 m²
• impurities: ≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤20 mg/cartridge
• matrix: Durapore^®
• pore size: 0.45 μm pore size
• bubble point: ≥1930 mbar (28 psig), air with water
• code: Code 5

Description

General description

Device configuration: Cartridge
Cartridge type: Liquid

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method: 30 SIP cycles of 30 min at 135°C; 30 autoclave cycles of 60 min at 126°C

This product was manufactured with a Durapore^®   membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Analysis Note

Gravimetric Extractables: The extractables level was ≤ 20 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 2 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 to 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