Fluorodyne® EX EDF Membrane in Mini Kleenpak™ Capsules product photo Primary L

Fluorodyne® EX EDF Membrane in Mini Kleenpak™ Capsules

Fluorodyne EX grade EDF filters are 0.2 micron rated high capacity, low protein binding sterilizing grade filters. Incorporating a built-in prefiltration layer and validated to retain B. diminuta at a challenge level of 107 cfu/ cm2 of membrane, Fluorodyne EX grade EDF filters are ideal for the sterile filtration of cell harvest material and challenging intermediate and final bulk biological process fluids..

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 modeling 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 scaling trials
  • Asymmetric, built-in prefilter layer for highest dirt-holding capacity
  • Validated for retention of B. diminuta when challenged with a minimum concentration of 107 CFU/cm² EFA
  • 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 construction
    • Effluent quality for cleanliness, TOC and Water Conductivity, pH and Pyrogens

Further Reading

 Poster: Scale Up of Direct Flow Membrane Filters

 Article: Bacterial Penetration of 0.2 μm Sterilizing-Grade Filters with a Cholesterol Liposome Carrier: A Comparison of Data


* Required

Capsules

List Price
$ 356.00
List Price
$ 400.00
Description

Fluorodyne EX grade EDF filters are 0.2 micron rated high capacity, low protein binding sterilizing grade filters. Incorporating a built-in prefiltration layer and validated to retain B. diminuta at a challenge level of 107 cfu/ cm2 of membrane, Fluorodyne EX grade EDF filters are ideal for the sterile filtration of cell harvest material and challenging intermediate and final bulk biological process fluids..

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 modeling 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 scaling trials
  • Asymmetric, built-in prefilter layer for highest dirt-holding capacity
  • Validated for retention of B. diminuta when challenged with a minimum concentration of 107 CFU/cm² EFA
  • 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 construction
    • Effluent quality for cleanliness, TOC and Water Conductivity, pH and Pyrogens

Further Reading

 Poster: Scale Up of Direct Flow Membrane Filters

 Article: Bacterial Penetration of 0.2 μm Sterilizing-Grade Filters with a Cholesterol Liposome Carrier: A Comparison of Data
Specifications

Materials of Construction

 
Filter Membrane Prefilter Layer:         Hydrophilic asymmetric PES
Final Filter Layer:   Hydrophilic PVDF
Support/Drainage Polypropylene
Capsule Shell, Core and Endcaps  Polypropylene
Filling Bell Polycarbonate
 Sealing Technology Thermal bonding without adhesives
 

 

Operating Parameters¹

 
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

 

Sterilization²

 
 Autoclave  3 x 30 minutes at 135 °C
 Gamma Irradiation  Maximum of 50 kGy
 
² Pre-sterilized 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 for the non-irradiated filter capsule
 

 

Nominal Dimensions

 
Maximum diameter including valves  53 mm (2.1 in.)
 Length - Code 2
 Length - Code 8
 105 mm (4.1 in.)
73 mm (2.9 in)
 

 

Nominal Effective Filter Area (EFA)

 
 230 cm² (0.25 ft²)
 

Removal Rating³

 
0.2 micron
 
³ Validated retention of B. diminuta when challenged with a minimum concentration of 107 CFU/cm2 effective filtration area. Please contact Pall for integrity test values.
Ordering Information
 
Item Part Number*
Mini Kleenpak™ Capsule with Fluorodyne® EX EDF Membrane
¼ in - ½ in (6 mm - 13 mm) hosebarb, supplied non sterile, gamma irradiatable/autoclavable

KA02EDFP2G
Mini Kleenpak™ Capsule with Fluorodyne® EX EDF Membrane
¼ in - ½ in (6 mm - 13 mm) hosebarb, supplied pre-sterilized using gamma irradiation
 
KA02EDFP2S
Mini Kleenpak™ Capsule with Fluorodyne® EX EDF Membrane
½ in - ¾ in (13 mm - 19 mm) sanitary flange, supplied non sterile, gamma irradiatable/autoclavable
 
KA02EDFP8G
Mini Kleenpak™ Capsule with Fluorodyne® EX EDF Membrane
½ in - ¾ in (13 mm - 19 mm) sanitary flange, supplied pre-sterilized using gamma irradiation
 
KA02EDFP8S
 
* Minidisc capsules are supplied in boxes of 3
Application
Filters - Liquid - Sterile (0.2 micron)
Segment
Filtration