CVPY71PK1

Vitipore^® II Plus Cartridge Filter

sterile; γ-irradiated, pore size 0.65 μm, cartridge nominal length 10 in. (25 cm), Code 7 (2-226; O-rings w/locking-tabs)

• Synonym(s): Vitipore^® II Plus Cartridge Filter 10 in. 0.65 μm Code 7
• UNSPSC Code: 23151806
• eCl@ss: 32031690

Properties

• 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: sterile; γ-irradiated
• feature: hydrophilic
• manufacturer/tradename: Vitipore^®
• parameter: ≤9.1 mL/min air diffusion at 620 mbar (9 psig) and 23 °C (in water); 0.35 bar max. differential pressure (5 psid) at 109 °C (Forward); 1.7 bar max. differential pressure (25 psid) at 25 °C (Reverse; intermittent); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
• cartridge nominal length: 10 in. (25 cm)
• diam.: 6.9 cm (2.7 in.)
• filtration area: 0.78 m²
• gravimetric extractables: ≤51 mg/cartridge
• matrix: Vitipore^® II Plus
• pore size: 0.65 μm nominal pore size; 0.65 μm pore size
• input: sample type beverage(s); sample type liquid; sample type beer; sample type wine; sample type bottled water; sample type food(s)
• bubble point: ≥965 mbar (14 psig), air with water at 23 °C
• cartridge code: Code 7 (2-226; O-rings w/locking-tabs)

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

Sterilization Method
100 SIP cycles of 30 min @ 109 °C; hot water sanitized 50 times for 30 min @ 80 °C maximum

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

Legal Information

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

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

Safety Information

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