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

Fluorodyne® EX EDT - Mini Kleenpak™ 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 Mini Kleenpak™ capsules are compact filters used in the laboratory for volumes of 2 L to 50 L in process development, and in pilot and manufacturing scale operations if processing requirements do not demand a large filter. These filters are the smallest capsule filters in the UpscaleSM Program range to utilize a pleated membrane, and are excellent for modelling filter performance at large production scale.

Key Features and Benefits

  • Encapsulated format for higher flexibility, minimized cleaning and low installation costs
  • Minimal hold up volume
  • Ideal for upscale trials
  • Asymmetric built-in prefilter for highest dirt-holding capacity
  • High flow rate
  • Low protein and preservative binding
  • Low extractables

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



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Capsules

List Price
$ 324.00
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 Mini Kleenpak™ capsules are compact filters used in the laboratory for volumes of 2 L to 50 L in process development, and in pilot and manufacturing scale operations if processing requirements do not demand a large filter. These filters are the smallest capsule filters in the UpscaleSM Program range to utilize a pleated membrane, and are excellent for modelling filter performance at large production scale.

Key Features and Benefits

  • Encapsulated format for higher flexibility, minimized cleaning and low installation costs
  • Minimal hold up volume
  • Ideal for upscale trials
  • Asymmetric built-in prefilter for highest dirt-holding capacity
  • High flow rate
  • Low protein and preservative binding
  • Low extractables

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:         Single-layer hydrophilic asymmetric PES
Final Filter Layers:   Dual-layer hydrophilic PVDF
Support/Drainage Polypropylene
Capsule Shell Polypropylene
Core, Endcaps, Filling Bell Polycarbonate
 Sealing Technology Thermal bonding without adhesives
 

 

Operating Parameters ¹

 
Maximum Operating Temperature  40 °C
 Maximum Operating Pressure  4.1 bar (60 psi) at 38 °C
 
1 In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction

 

Sterilization Conditions ²

 
 Autoclavable 'G' option  3 x 30 minutes at up to 135 °C
 Gamma Irradiation 'G' option Maximum of 50 kGy
 
 • Pre-sterilized 'S' option Mini Kleenpak capsules must not be re-sterilized.
   • Mini Kleenpak capsules must not be sterilized in-situ by passing steam under pressure

 

Typical Extractables in Water at 20 °C

 
 < 5 mg NVR
 

 

Nominal Dimensions

 
Maximum Diameter including valves 68 mm (2.7 in.)
Length – Code 2 105 mm (4.1 in.)
Length – Code 8 73 mm (2.9 in.)
 

 

Nominal Effective Filter Area (EFA)

 
 200 cm² (0.22 ft²)
 

Removal Rating ³

 
0.1 μm sterilizing grade 
 
³ Sterile effluent when challenged with 107/cm2 Brevundimonas diminuta. Zero recovery for Acholeplasma laidlawii when challenged with 2 x 109 organisms per capsule (107/cm2) consistent with the titer reduction claim for this organism of > 1010 for the AB style and Kleenpak Nova configurations. Please contact Pall for integrity test values.

Typical Liquid Flow Rates

Ordering Information
 
Item Part Number*
Mini Kleenpak™ Capsule with Fluorodyne® EX EDT Membrane
¼ in - ½ in (6 mm - 13 mm) hosebarb, supplied non sterile, gamma irradiatable/autoclavable

KA02EDTP2G
Mini Kleenpak™ Capsule with Fluorodyne® EX EDT Membrane
¼ in - ½ in (6 mm - 13 mm) hosebarb, supplied pre-sterilized using gamma irradiation

KA02EDTP2S¹
Mini Kleenpak™ Capsule with Fluorodyne® EX EDT Membrane
½ in - ¾ in (13 mm - 19 mm) sanitary flange, supplied non sterile, gamma irradiatable/autoclavable
 
KA02EDTP8G
Mini Kleenpak™ Capsule with Fluorodyne® EX EDT Membrane
½ in - ¾ in (13 mm - 19 mm) sanitary flange, supplied pre-sterilized using gamma irradiation
 
KA02EDTP8S¹
 
* Supplied in boxes of 3
¹ ‘S’ option with Code 2 connection is provided with filling bell on outlet. It is removable for in-line use
Application
Filters - Liquid - Mycoplasma Removal (0.1 micron)