Fluorodyne™ EX grade EDF membrane in Mini Kleenpak™ capsules, a Pall Life Sciences product, 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 107 cfu per cm2 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