Pall™ Fluorodyne™ II DFL membrane in Kleenpak™ Nova capsules
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.
1. Effective filtration area
2. Format
Overview
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 107 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
