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Fluorodyne™ II DBL membrane in Kleenpak™ capsule formats

Encapsulated for higher flexibility while minimizing cleaning and installation costs

Fluorodyne™ II DBL membrane in Kleenpak™ Nova and Kleenpak™ capsule 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 (TR) of > 106 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

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