DESCRIPTION
Fluorodyne™ II DJL membrane in Kleenpak™ capsules, a Pall Life Sciences product, are 0.1 micron-rated filters with serial layer (0.2/0.1 micron) membrane construction that deliver high flow rates and mycoplasma removal.
Fluorodyne II grade DJL filters are validated for removal of Acholeplasma laidlawii mycoplasma (ATCC 23206) with a typical TR >1011 and retention of B. diminuta (ATCC 19146) at 107 CFU/cm2 EFA. This allows for enhanced sterilization assurance as well as efficient mycoplasma control.
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 chemicals¹
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
+852-3069 6950
sales@gugent.com.hk
