Description
Fluorodyne™ II DFL membrane in Kleenpak™ capsules, part of our Pall filtration portfolio, are 0.2 micron-rated sterilizing grade filters that feature low extractable levels and high protein transmissions.
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 capsules are rugged and compact, can be supplied with a broad range of filter media, and can be offered in up to four different filter area sizes designed for a variety of applications in pharmaceutical manufacturing environments (volumes of 30 L to 1000 L) from small to large-scale. These in-line single-use assemblies are available with sanitary or hose barb inlet/outlet fittings.
Key features and benefits
Encapsulated format for higher flexibility, minimized cleaning and low installation costs
Built in prefiltration
Minimal hold up volume
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
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
Material of Construction
Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens
