CCGL02TP1

Charged Durapore^® 0.22 µm, Cartridge

pore size 0.22 μm, cartridge nominal length 20 in. (50 cm), Code 0 (2-222; O-rings)

• Synonym(s): Charged Durapore Cartridge 20 in. 0.22 μm Code 0
• UNSPSC Code: 23151806
• eCl@ss: 32031690

Properties

• material: PVDF ; polypropylene ; polypropylene support; silicone seal
• Quality Level: 400
• sterility: non-sterile
• Sterilization Compatibility: autoclavable compatible; steam-in-place compatible
• product line: Durapore^®
• feature: hydrophilic
• manufacturer/tradename: Durapore^®
• parameter: ≤20 mL/min air diffusion at 2.1 bar (30 psig) and 23 °C (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 pressure (50 psi) at 25 °C (Reverse); 45 L/min flow rate at 600 mbar (ΔP); 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): sterile filtration: suitable
• L: 20 in.
• cartridge nominal length: 20 in. (50 cm)
• diam.: 6.9 cm (2.7 in.)
• filtration area: 1.4 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: ≤40 mg/cartridge
• matrix: Charged Durapore^®
• pore size: 0.22 μm pore size
• input: sample type liquid
• bubble point: ≥2760 mbar (40 psig), air with water at 23 °C
• cartridge code: Code 0 (2-222; O-rings)

Description

General description

Device Configuration: Cartridge

Packaging

Double Easy-Open bag

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

Sterilization Method
10 SIP cycles of 30 min @ 135 °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

Bacterial Retention
Samples 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

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL

Legal Information

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

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