CVHL02TP3

Durapore^® (w/Prefilter) 0.45 µm, Cartridge

pore size 0.45 μm, cartridge nominal length 20 in. (50 cm), Code 0 (2-222; O-rings)

• Synonym(s): Durapore Cartridge Filter with prefilter 20 in. 0.45 μm Code 0, Durapore^® (w/Prefilter) 0.45 µm, Cartridge
• eCl@ss: 32031690
• UNSPSC Code: 23151806

Properties

• Product Name: Durapore^® w/Prefilter Cartridge, Chemistry: 0.45 μm Hydrophilic Polyvinylidene Fluoride (PVDF)Configuration: 20 in. Code 0
• Quality Segment: 400
• material: PVDF , mixed cellulose esters (MCE) prefilter, polypropylene , polypropylene support, silicone seal
• 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: ≤30 mL/min air diffusion at 1.5 bar (22 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), 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)
• diam.: 6.9 cm (2.7 in.)
• 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: ≤90 mg/cartridge
• matrix: Durapore^® (w/Prefilter)
• pore size: 0.45 μm pore size
• input: sample type liquid
• bubble point: ≥1930 mbar (28 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

Preparation Note

Sterilization Method
10 SIP cycles of 30 min or 10 autoclave cycles of 60 min @ 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: 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 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.

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

Legal Information

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

Safety Information

• Storage Class: 11 - Combustible Solids
• wgk: WGK 2