Fluorodyne® EX EDT - Kleenpak™ Nova Capsules product photo Primary L

Fluorodyne® EX EDT - Kleenpak™ Nova Capsules

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 range of Kleenpak™ Nova capsules are designed for use in medium to large scale production environments (100 L > 1000 L), often selected by the end user following scaling studies using smaller Kleenpak capsule formats. With the AB style cartridge format at its core, this capsule filter style can be supplied with the most comprehensive range of filter media.

Key Features and Benefits

  • Encapsulated format for higher flexibility, minimized cleaning and low installation costs
  • 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

  • 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 constructions
    • Effluent quality for cleanliness, TOC and Water Conductivity, pH and Pyrogens

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: Contamination Costs - Current Trends in Process Economics for Mycoplasma-Retentive Filtration of Cell Culture Media ¹

Article: Evaluating Performance of 0.1 µm Filters for Mammalian Cell Culture Media Filtration ²

¹ Reproduced with the kind permission of European Biopharmaceutical Review magazine
² ³ External link



* Required
Need Help?
Download Datasheet
Description
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 range of Kleenpak™ Nova capsules are designed for use in medium to large scale production environments (100 L > 1000 L), often selected by the end user following scaling studies using smaller Kleenpak capsule formats. With the AB style cartridge format at its core, this capsule filter style can be supplied with the most comprehensive range of filter media.

Key Features and Benefits

  • Encapsulated format for higher flexibility, minimized cleaning and low installation costs
  • 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

  • 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 constructions
    • Effluent quality for cleanliness, TOC and Water Conductivity, pH and Pyrogens

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: Contamination Costs - Current Trends in Process Economics for Mycoplasma-Retentive Filtration of Cell Culture Media ¹

Article: Evaluating Performance of 0.1 µm Filters for Mammalian Cell Culture Media Filtration ²

¹ Reproduced with the kind permission of European Biopharmaceutical Review magazine
² ³ External link

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 (white colored)
 O-rings  Silicone elastomer
 Sealing Technology  Thermal bonding without adhesives
 Housing Bowl  Polypropylene
 Housing Head*  Polypropylene
 

*Formulated with TiO2 whitener which does not contribute to organic extractables

Operating Parameters(1)

 
 Maximum Temperature  40 °C
 Maximum Operating Pressure  3 bar (44 psi) at 40 °C
 Maximum Differential Pressure  3 bar (44 psi) at 40 °C
 

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

Sterilization(2)

 
 Autoclave 'G' version  3 x 30 minutes at 135 °C
 Gamma irradiation ' G version'  Maximum of 50 kGy
 

(2) • Pre-sterilized Kleenpak Nova capsules must not be re-sterilized
• Kleenpak Nova capsules must not be sterilized in-situ by passing steam under pressure

Typical Extractables in Water at 20 °C

 
 < 50 mg after 4 hours extraction (per 254 mm module)  
 

*Tested on elements without pre-flushing

Nominal Dimensions


 
In Line NP6 NP7 NP8
Maximum Diameter including valves 154 mm (6.1 in.) 154 mm (6.1 in.) 154 mm (6.1 in.)
Length with hose barb inlet/outlet 397 mm (15.6 in.) 644 mm (25.4 in.) 895 mm (35.2 in.)
Length with sanitary inlet/outlet 335 mm (13.2 in.) 584 mm (23.0 in.) 834 mm (32.8 in.)
 

 

 
T Style NT6 NT7 NT8
Maximum Diameter including valves 240 mm (9.5 in.) 240 mm (9.5 in.) 240 mm (9.5 in.)
 Length 349 mm (13.7 in.) 598 mm (23.5 in.) 848 mm (33.4 in.)
 

 

Nominal Effective Filter Area (EFA)

 

 0.95 m2 per 254 mm module (9.7 ft2 per 10 in. module)

 

Typical Flow Characteristics

In Line

T Style

Ordering Information
Part Number: example: NP5LUEDTP1G

N

 
Code Module Type
P In-line
T T-style
 


UEDT P

 
Code Filter Size
5L1 125 mm (5 in.)
6 254 mm (10 in.)
7 508 mm (20 in.)
8 762 mm (30 in.)
 


 
Code Inlet/Outlet Connections
1 1 - 11/2 in. sanitary flange inlet and outlet
9 1 in. (25 mm) single barb hose barb inlet and outlet
19 1 - 11/2 in. sanitary flange inlet and 1 in. (25 mm) single barb hose barb outlet
62 1/2 in. (13 mm) single barb hose barb inlet and outlet
162 1 - 11/2 in. sanitary flange inlet and 1/2 in. (13 mm) single barb hose barb outlet
1H3 1 - 11/2 in. sanitary flange inlet and outlet, with 1/2 in. sanitary port on outlet
1H93 1 - 11/2 in. sanitary flange inlet and 1 in. (25 mm) single barb hose barb outlet with 1/2 in. sanitary port on inlet
 


 
Code Shipping Format
G Non-sterile gamma
irradiatable/autoclavable
S Pre-sterilized using
gamma irradiation
 


 
Code Vent/Drain
Blank Staubli* vent and
stepped hose barb drain
A Staubli vent and drain
 


1Currently available only with in-line capsule format
2For In-line (code P) only
3For T-style (code T) only
*Staubli is a trademark of Staubli AG.
Application
Filters - Liquid - Mycoplasma Removal (0.1 micron)