Description
The Fluorodyne™ EX grade EDF membrane in Kleenpak™ Nova Capsules, part of our Pall filtration portfolio, provide a high flexibility format with low installation costs.
Fluorodyne EX grade EDF filters are 0.2 micron rated high capacity, low protein binding sterilizing grade filters. Incorporating a built-in prefiltration layer and validated to retain B. diminuta at a challenge level of 10 7 cfu per cm 2 membrane, Fluorodyne EX grade EDF filters are ideal for the sterile filtration of cell harvest material and challenging intermediate and final bulk biological process fluids..
Kleenpak Nova capsules are designed for use in medium-to-large-scale production environments (50 L to > 1000 L). Kleenpak Nova capsules can be offered in ‘In-line’ (NP) or ‘T’ style (NT) inlet/outlet configurations with sanitary flange or hose barb fittings.
Kleenpak Nova filters with Fluorodyne EX grade EDF membrane feature a laid over pleat membrane construction and high effective filtration area (> 1 m2 per 10” assembly) for outstanding throughput performance.
Key features
Encapsulated format for higher flexibility, minimized cleaning and low installation costs Incorporated prefiltration layer Low extractables High protein transmission Rapid preservative recoveries Easy integrity testing Compatible with organic solvents, acids and chemicals 1 Resin and surfactant-free Melt-sealed, non shedding 1 Except ketones and amides
Quality Standards
Manufactured for use in conformance with cGMP Individual filter elements are 100% integrity tested - test correlated to microbial retention ISO 9000 Certified Quality System Meets USP Biological Reactivity Test in vivo for Class VI-121°C Plastics Certificate of Test provided includes:
Fabrication Integrity Bacterial Retention Materials of Construction Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens
