Description
Fluorodyne™ II DBL membrane in Kleenpak™ Nova and Kleenpak™ formats feature a unique hydrophilic modified polyvinylidene fluoride (PVDF) membrane with low binding properties, broad chemical and temperature resistance, and high flow rates
The DBL grade filters are 0.45 micron filters are predominantly used in pre-filtration applications or viscous fluid filtrations. Validated removal of Serratia marcescens (ATCC 14756) with a typical titer reduction (T R ) of > 10 6 ensures that they are also suitable for bioburden control. A serial layer (0.65/0.45 µm) membrane construction allows for high throughputs and high flow rates compared with other 0.45 micron-rated filters.
Kleenpak™ Nova capsules are designed for use in medium-to-large-scale production environments (100 L to > 1000 L) and are often selected by the end-user following scaling studies using smaller formats. These Kleenpak™ Nova capsules are offered in ‘In-line’'(NP) or ‘T-style’ (NT) inlet/outlet configurations with sanitary flange or hose barb fittings.
Key Features and Benefits
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 chemicals¹ Resin and surfactant-free Melt-sealed, non-shedding ¹ Except for ketones and amides
Quality Standards
Manufactured for use in conformance with cGMP 100% integrity tested ISO 9000 Certified Quality System Meets USP Biological Reactivity Test in vivo for Class VI-121°C plastics Every filter tested during manufacture Test correlated to microbial retention Certificate of Test provided includes
Fabrication Integrity Bacterial Retention Materials of Construction Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens
