DESCRIPTION
Fluorodyne™ II DJL membrane in Mini 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. These cartridges are well suited for process development and scale-up trials.
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.
Mini Kleenpak capsules are used in the laboratory for process development and in pilot and manufacturing scale operations if processing requirements do not demand a large filter (process volumes from 2 L to 50 L). These filters are excellent for modeling filter performance at large production scale
Key feaures
Encapsulated format for higher flexibility, minimized cleaning and low installation costs
Minimal hold up volume
Ideal for scale-up trials
Highest flow of comparable PVDF filters
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
Materials of construction
Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens
+852-3069 6950
sales@gugent.com.hk
