Description
Fluorodyne™ EX grade EDF membrane in Mini Kleenpak™ capsules, part of our Pall filtration portfolio, are compact filters used in in process development and pilot manufacturing for volumes of 2 L to 50 L.
Fluorodyne EX grade EDF filters are 0.2 micron rated high capacity, low protein binding sterilizing grade filters. Incorporating a built-in prefiltration layer and validated to retain B. diminuta at a challenge level of 10 7 cfu per cm 2 membrane, Fluorodyne EX grade EDF filters are ideal for the sterile filtration of cell harvest material and challenging intermediate and final bulk biological process fluids..
Mini Kleenpak capsules are compact filters used in the laboratory for volumes of 2 L to 50 L in process development, and in pilot and manufacturing scale operations if processing requirements do not demand a large filter. These filters utilize a pleated membrane, and are excellent for modeling filter performance at large production scale.
Key features
Encapsulated format for higher flexibility, minimized cleaning and low installation costs
Minimal hold up volume vIdeal for scaling trials
Asymmetric, built-in prefilter layer for highest dirt-holding capacity
Validated for retention of B. diminuta when challenged with a minimum concentration of 107 CFU/cm² EFA
High flow rate
Low protein and preservative binding
Low extractables
Designed for autoclaving or SIP under wet or dry conditions
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
