CVDR53TP3

Durapore^® (w/Prefilter) 0.65 µm, Cartridge

cartridge nominal length 30 in. (75 cm), filter diam. 2.7 in. (6.9 cm), Code 5

• UNSPSC Code: 23151806

Properties

• material: mixed cellulose esters (MCE) prefilter; polypropylene device; polypropylene support; silicone seal
• Quality Level: 400
• 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 620 mbar (9 psig) (in water); 0.35 bar max. differential pressure (5 psid) at 121 °C (forward); 0.35 bar max. inlet pressure (5 psi) at 121 °C (forward); 1.7 bar max. differential pressure (25 psid) at 25 °C (reverse); 1.7 bar max. differential pressure (25 psid) at 80 °C (forward); 1.7 bar max. inlet pressure (25 psi) at 80 °C (forward); 1.7 bar max. inlet temp. (25 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): prefiltration: suitable
• L: 30 in.
• W: 2.7 in.
• cartridge nominal length: 30 in. (75 cm)
• device size: 30 in.
• filter diam.: 2.7 in. (6.9 cm)
• filter filtration area: 2.07 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: ≤45 mg/cartridge
• matrix: Durapore^® (w/Prefilter)
• pore size: 0.65 μm pore size
• bubble point: ≥965 mbar (14 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: 8 SIP cycles of 30 min or 8 autoclave cycles of 60 min at 121°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 ≤ 45 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 ≥ 1 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