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



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Fluorodyne® EX EDT membrane in Mini Kleenpak™ capsules, 0.1 µm removal rating, 200 cm² EFA, ¼-½ in. hose barb connections, suitable for gamma irradiation, box of 3

Product ID: KA02EDTP2G
Unit of Measure
1/PAC
Min Order Qty
1
Membrane Material
Polyvinylidene fluoride (PVDF)
Industry-Specific Certification
Pharmaceutical Grade
Effective Filtration Area (Metric)
200 cm²
Format
Mini Kleenpak
Inlet Connection
¼-½ in (6-13 mm) hose barb
Outlet Connection
¼-½ in (6-13 mm) hose barb
See All Attributes
$ 333.72

Fluorodyne® EX EDT membrane in Mini Kleenpak™ capsule, 0.1 µm removal rating, 200 cm² EFA, ¼-½ in. hose barb connections, pre-sterilized by gamma irradiation, box of 3

Product ID: KA02EDTP2S
Unit of Measure
1/PAC
Min Order Qty
1
Membrane Material
Polyvinylidene fluoride (PVDF)
Industry-Specific Certification
Pharmaceutical Grade
Effective Filtration Area (Metric)
200 cm²
Format
Mini Kleenpak
Inlet Connection
¼-½ in (6-13 mm) hose barb
Outlet Connection
¼-½ in (6-13 mm) hose barb
See All Attributes
$ 452.00
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
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)
Product Summary
Fluorodyne® EX EDT Membrane in Mini Kleenpak™ Capsules have an asymmetric prefilter for highest dirt holding capacity. The capsules provide a high flow and retention rates for economical filtration of culture media. They are the smallest filters in Pall's UpScale Program range to utilize pleated membrane technology. Mini capsules are ideal for modeling large production scale.