Description
Fluorodyne™ II DFL membrane in Kleenpak™ Nova capsules, part of our Pall filtration portfolio, are 0.2 micron-rated sterilizing grade filters that are well suited for medium- to large-scale biopharmaceuticals production.
These filters retain Brevundimonas diminuta (ATCC 19146) at 10 7 CFU/cm² effective filter area (EFA) and ensure very low extractables and adsorption. They are recommended for sterilizing filtration of pharmaceutical fluids including solutions with active ingredients, biologicals, biotech proteins, ophthalmics and other dilute preservative solutions.
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 the smaller Kleenpak capsule formats. Kleenpak Nova capsules can be offered in ‘In-line’ (NP) or ‘T’ style (NT) inlet/outlet configurations with sanitary flange or hose barb fittings. With the AB-style filter cartridge at their core, Kleenpak Nova filter capsules can be supplied with the most comprehensive range of filter media among our single-use capsules.
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 shedding¹
Except 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
