CVDI01TPS

Durapore^® CBR 0.2 µm, Cartridge

pore size 0.2 μm, cartridge nominal length 10 in. (25 cm), Code 0 (2-222; O-rings)

• Synonym(s): Durapore CVDI Cartridge Filter 10 in. 0.22 μm Code 0 Silicone
• UNSPSC Code: 23151806
• eCl@ss: 32031690

Properties

• material: PVDF ; polypropylene ; polypropylene support; silicone seal
• Quality Level: 400
• reg. compliance: meets EU framework regulation [1935/2004/EC] (all component materials; regarding materials and articles intended to contact food); meets FDA Indirect Food Additive requirements cited in 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: ≤13.3 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water); 0.35 bar max. differential pressure (5 psid) at 135 °C (Forward); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 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)
• technique(s): bioburden reduction: suitable
• L: 10 in.
• W: 2.7 in.
• cartridge nominal length: 10 in. (25 cm)
• diam.: 6.9 cm (2.7 in.)
• filtration area: 0.69 m²
• gravimetric extractables: ≤25 mg/cartridge
• matrix: Durapore^®
• pore size: 0.2 μm pore size
• input: sample type liquid
• bubble point: ≥3100 mbar (45 psig), air with water at 23 °C
• cartridge code: Code 0 (2-222; O-rings)

Description

General description

Device Configuration: Cartridge

Other Notes

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

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.

Preparation Note

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

Bacterial Retention
Samples of the Durapore^® membrane used in this cartridge were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM F838 methodology.

Gravimetric Extractables: after 24 hours in water at controlled room temperature

Legal Information

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