Documents
Datasheets
Download:Description
Pall's Fluorodyne EX grade EDT filter 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 unique 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 Pall patented 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..
Pall's 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
Further Reading
Poster: A. laidlawii Filtration Through a 0.1-micron Rated Filter at Elevated Pressures Poster: Scale Up of Direct Flow Membrane Filters Article: Effect of Prefiltration on Scalability of 0.1-μm rated Membrane Filters Article: A New Direction In Mycoplasma Removal Article: Bacterial Penetration of 0.2 μm Sterilizing-Grade Filters with a Cholesterol Liposome Carrier: A Comparison of Data Article: Retention of Mycoplasma at Elevated Pressure and Cell Concentration by Pall Fluorodyne® EX Grade EDT Filters
Article: Contamination Costs - Current Trends in Process Economics for Mycoplasma-Retentive Filtration of Cell Culture Media 1 Article: Retention of Highly Penetrative Mycoplasma cells by A New 0.1 µm Rated Membrane Filter at Elevated Pressure and at an Elevated Challenge Concentration 4
1 Reproduced with the kind permission of European Biopharmaceutical Review magazine
2 3 External link
4 Reproduced with the kind permission of Bioprocessing International, www.bioprocessintl.com
Specifications
Materials of Construction
| Filter Membrane | Prefilter Layer: Hydrophilic asymmetric PES Final Filter Layers: Hydrophilic PVDF |
| Support/Drainage | Polypropylene |
| Core/End Caps | Polypropylene |
| Cage | Polypropylene with TiO2 whitener1 |
| O-rings | Silicone |
| Sealing Technology | Thermal bonding without adhesives |
1 TiO2 is an insoluble inorganic mineral filler that does not contribute to organic extractables
Operating Parameters2
| 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 |
2 In compatible fluids which do not soften, swell, or adversely affect the filter or its materials of construction
Sterilization
| Autoclave | 3 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 °C3
| < 50 mg after 24 hours extraction (per 254 mm module) |
3 Tested on elements without pre-flushing
Nominal Effective Filter Area (EFA)
| 9500 cm2 (10.2 ft2) per 254 mm (10 in.) module 4600 cm2 (4.9 ft2 ) per 125 mm (5 in.) module |
Typical Liquid Flow Rates
Type
Use
Related Documents
Regulatory/Quality Documentation
Ordering Information
| Item | Part Number |
| Fluorodyne® EX EDT Membrane Filter Cartridge Nominal Length 127 mm (5 in.); Pall Code 2 double O-ring (silicone elastomer¹), bayonet lock and flat top end cap |
AB05UEDT2PH4 |
| 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
Product Summary
Reviews
We appreciate your review of this product. Please login to your account to leave a review.
