Description
Fluorodyne™ EX grade EDF filters, part of our Pall filtration portfolio, 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/cm 2 of membrane, Fluorodyne EX grade EDF filters are well suited for the sterile filtration of cell harvest material and challenging intermediate and final bulk biological process fluids. AB-style filters are replaceable cartridges used with stainless steel housing assemblies, suitable for medium-to-large-scale manufacturing operations (100 L to > 1000 L), supplied with -226 O-ring (Pall code 2 or code 7) fittings as standard. AB-style filters with Fluorodyne EX grade EDF membrane feature a laid over pleat membrane construction and high effective filtration area (>1 m 2 per 10” assembly) for outstanding throughput performance. A validation package supports the assurance of safety within your process.
Key features
Laid-over pleat filter construction allows for high flow rates and smaller filtration systems
Narrow core design for more area
Asymmetric built-in prefilter layer for higher dirt-holding capacity
Low protein and preservative binding
Low extractables
Designed for autoclaving or SIP under wet or dry conditions
2D Matrix Marking for electronic traceability via barcode scanner
High-Quality standards
All individual filter elements are integrity tested – test correlated to microbial retention
Manufactured for use in conformance with cGMP
ISO 9000 Certified Quality System
Meets USP Biological Reactivity Test in vivo for Class VI-121 °C plastics
Every filter tested during manufacture
Certificate of Test provided includes -Fabrication Integrity -Bacterial Retention -Materials of construction -Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens
