Cytiva, NP6UEDFP16G, Fluorodyne™ EX EDF membrane in Kleenpak™ Nova capsules

Fluorodyne EX EDF membrane in Kleenpak Nova capsule, 0.2 µm removal rating, in-line style, 10-inch filter, 1½ in. sanitary flange inlet and ½ in. hose barb outlet connections, suitable for gamma irradiation The Fluorodyne™ EX grade EDF membrane in Kleenpak™ Nova Capsules, a Pall Life Sciences product, 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