DESCRIPTION
Fluorodyne™ EX grade EDT filter, a Pall Life Sciences product, is a 0.1 micron rated, validated, highly retentive mycoplasma control filter to be used where the sterility assurance and economical filtration of growth media or other hard-to-filter fluids is paramount.
A triple membrane layer construction contributes to outstanding throughput, high flow rates and the superior retention of bacteria and mycoplasma during the filtration of process fluids.
The laid-over pleat modular cartridge pleating geometry in combination with a narrow core design allows for a high effective filtration area per filter element, resulting in, small foot-print filter systems with improved process efficiencies.
AB style filters are disposable 125 mm (5 inch), 254 mm (10 inch), 508 mm (20 inch), 762 mm (30 inch) and 1016 mm (40 inch) modular element cartridges to be used with stainless steel housing assemblies. Fitted with 226 o-rings as standard suitable for medium to large scale manufacturing operations (100 L to >1000 L).
These filters can be supplied encapsulated as the Kleenpak™ Nova capsule format.
A validation package for Fluorodyne EX EDT Filters supports the assurance of safety within your process.
Key Features and Benefits
Retentive for B. diminuta as per ASTM838-05
Laid over pleat filter construction allows for high flow rates and smaller filtration systems
Narrow core design for more area
Asymmetric built-in prefilter for highest dirt-holding capacity
Typically > 10 LRV Acholeplasma laidlawii and Mycoplasma orale removal
High flow rates
Low protein and preservative binding
Low extractables
Designed for autoclaving or SIP under wet or dry conditions
2D Matrix marking for electronic traceability *
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
Certificate of Test provided includes:
Fabrication Integrity
Bacterial Retention
Materials of constructions
Effluent quality for cleanliness, TOC and Water Conductivity, pH and Pyrogens
* not currently included in 125 mmm (5 in.) filter cartridges