Fluorodyne® EX EDT Membrane Filter Cartridges

Pall’s Fluorodyne EX grade EDT filter is a highly retentive mycoplasma control filter to be used where the sterility assurance and economical filtration of culture media or other hard-to-filter fluids is paramount.

A unique three-layer construction contributes to outstanding throughput, high flow rates and the superior retention of bacteria and mycoplasma during the filtration of process fluids.

The Pall patented Ultipleat® modular cartridge pleating design in combination with a narrow core ensures high effective filtration areas, small foot-print filter systems and improved process efficiencies. A complete validation package supports the assurance of safety within your process.

Pall’s AB style filters are disposable 254mm (10 inch) modular element cartridges assembled in 254, 508, 762 and 1016 mm lengths to be used with stainless steel housing assemblies, most suitable for medium to large scale manufacturing operations (100 L to >1000 L). With Code 7 fittings as standard, these are the most versatile filtration units in Pall’s range, and incorporate a broader range of filtration media than any other filter type. These filters, when encapsulated, become the Kleenpak™ Nova capsule format.

Key Features and Benefits

• Ultipleat® filter construction allows for high flow rates and smaller filtration systems
• Small core design for more area
• Asymmetric built-in prefilter for highest dirt-holding capacity
• > 10 log A.laidlawii and M. orale retention
• High flow rate
• Low protein and preservative binding
• Low extractables
• Designed for autoclaving or SIP under wet or dry conditions

Quality Standards

• 100% integrity tested
• 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. Test correlated to microbial retention
• Certificate of Test provided includes:
  
  • Fabrication Integrity 
  • Bacterial Retention 
  • Materials of constructions
  • Effluent quality for cleanliness, TOC and Water Conductivity, pH and Pyrogens

Published Articles

Effect of Prefiltration on Scalability of 0.1-μm rated Membrane Filters (PDF, 300 kb)

Evaluating the Performance of 0.1 µm-rated Filters for Mammalian Cell Culture Media Filtration

Evaluating the Scalability of 0.1 µm-rated Membrane Filters - Part 1

Contamination Costs: Current Trends in Process Economics for Mycoplasma-Retentive Filtration of Cell Culture Media*
(PDF, 600 kb)
* This article has been reproduced with the kind permission of Europeam Biopharmaceutical Review magazine

Materials of Construction

Filter Membrane	Prefilter Layer:         Hydrophilic asymmetric PES Final Filter Layers:   Hydrophilic PVDF
Support/Drainage	Polypropylene
Core/End Caps	Polypropylene
Cage	Polypropylene
O-rings	Silicone
Sealing Technology	Thermal bonding without adhesives

 

Operating Parameters¹

Maximum Differential Pressure (Forward Direction)	5.5 bar (80 psi) at 40 °C 4.0 bar (58 psi) at 80 °C
Maximum Differential Pressure (Reverse Direction)	2.0 bar (30 psi) at 40 °C

¹ In compatible fluids which do not soften, swell, or adversely affect the filter or its materials of construction

 

Sterilization

Autoclave	5 x 60 minutes at 135°C
In Situ Steam	5 x 60 minutes at 135°C

 

Integrity Test Values (Air test gas, water wet)

Values for 254 mm (10 in.) filter at 20 °C
Max. allowable Forward Flow (air test gas)	Water wet 32 mL/min at 4475 mbar (65 psi)

Contact Pall for multi-element integrity test values and recommended test procedures

 

Typical Extractables in Water at 20 °C²

< 50 mg after 24 hours extraction (per 254 mm module)

² Tested on elements without pre-flushing

 

Nominal Effective Filter Area (EFA)

9500 cm2 (10.2 ft2) per 254mm (10 in.) module

 

Typical Liquid Flow Rates

Item	Part Number
Fluorodyne® EX EDT Membrane Filter Cartridge Nominal length 254 mm (10 in.); Pall Code 7 double O-ring (silicone elastomer¹), bayonet lock and fin	AB1UEDT7PH4
Fluorodyne® EX EDT Membrane Filter Cartridge Nominal length 508 mm (20 in.); Pall Code 7 double O-ring (silicone elastomer¹), bayonet lock and fin	AB2UEDT7PH4
Fluorodyne® EX EDT Membrane Filter Cartridge Nominal length 762 mm (30 in.); Pall Code 7 double O-ring (silicone elastomer¹), bayonet lock and fin	AB3UEDT7PH4

¹ Other materials available on request