Kleenpak™ Capsules with Supor® EAV Membrane product photo Primary L

Kleenpak™ Capsules with Supor® EAV Membrane

Pall Supor® EAV filters are designed for effective bioburden and particle control.  The Pall-patented Supor machV membrane incorporated in these filters ensures high throughputs and flow rates when utilized for the protection of buffers and biological process fluids. 

Supor EAV filters allow for reduced sizing of filter systems with improved process efficiencies when use of validated sterilizing grade filters is not essential, but reliable bioburden control is.  Supor EAV filters are also effective prefilters for protection and extended life of 0.2 µm sterilizing grade and finer membrane filters where required.

Pall Kleenpak™ capsules are rugged and compact filter capsules available with a broad range of filter media and in 4 different sized formats designed for a variety of small to large scale pharmaceutical manufacturing applications with volumes of 30 L to 1000 L.

Features and Benefits of Supor EAV Filters

  • Hydrophilic, controlled asymmetric polyethersulfone (PES) membrane ensures high microbial and particulate reduction with outstanding service life
  • Bacterial titer reduction in excess of 6 log for Brevundimonas diminuta ensures low bioburden levels in filtrate regardless of bacterial loading
  • Broad pH compatibility for processing a wide range of buffers and other fluids
  • Kleenpak™ capsule format eliminates housing cleaning and associated validation, for ease of use and integration into single use disposable systems
  • Low binding polyethersulfone membrane for maximum transmission of proteins

Quality Standards

  • 100% integrity tested
  • Manufactured for use in conformance with cGMP
  • Each filter is fully traceable by individual marked lot and serial number
  • ISO 9001 Certified Quality System
  • Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics
  • Certificate of Test provided includes:
    • Fabrication Integrity 
    • Materials of constructions
    • Effluent quality for cleanliness, TOC , water conductivity, pH and pyrogens


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Description
Pall Supor® EAV filters are designed for effective bioburden and particle control.  The Pall-patented Supor machV membrane incorporated in these filters ensures high throughputs and flow rates when utilized for the protection of buffers and biological process fluids. 

Supor EAV filters allow for reduced sizing of filter systems with improved process efficiencies when use of validated sterilizing grade filters is not essential, but reliable bioburden control is.  Supor EAV filters are also effective prefilters for protection and extended life of 0.2 µm sterilizing grade and finer membrane filters where required.

Pall Kleenpak™ capsules are rugged and compact filter capsules available with a broad range of filter media and in 4 different sized formats designed for a variety of small to large scale pharmaceutical manufacturing applications with volumes of 30 L to 1000 L.

Features and Benefits of Supor EAV Filters

  • Hydrophilic, controlled asymmetric polyethersulfone (PES) membrane ensures high microbial and particulate reduction with outstanding service life
  • Bacterial titer reduction in excess of 6 log for Brevundimonas diminuta ensures low bioburden levels in filtrate regardless of bacterial loading
  • Broad pH compatibility for processing a wide range of buffers and other fluids
  • Kleenpak™ capsule format eliminates housing cleaning and associated validation, for ease of use and integration into single use disposable systems
  • Low binding polyethersulfone membrane for maximum transmission of proteins

Quality Standards

  • 100% integrity tested
  • Manufactured for use in conformance with cGMP
  • Each filter is fully traceable by individual marked lot and serial number
  • ISO 9001 Certified Quality System
  • Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics
  • Certificate of Test provided includes:
    • Fabrication Integrity 
    • Materials of constructions
    • Effluent quality for cleanliness, TOC , water conductivity, pH and pyrogens
Specifications

Materials of Construction

Membrane   Hydrophilic polyethersulfone
Support and Drainage Layers   Polypropylene
End Cap, Core and Cage  Polypropylene
Outer Shell  Polypropylene

Physical Dimensions

 Diameter incl. Valves  109 mm (4.2 in.)
 Total Length (Code 1)    174 mm (6.8 in.)
 Total Length (Code 6)   210 mm (8.3 in.)
 Total Length (Code 16)  192 mm (7.5 in.)
 Effective Surface Area   0.21 m2 (1.6 ft2)

Operating Parameters1

 Maximum Temperature  40 °C
 Maximum Operating Pressure  5.2 bar (75 psi)
  Maximum Differential Pressure  4.1 bar (59 psi)
1 In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction

Sterilization2

 Autoclave  10 cycles x 60 minutes at 125 °C, slow exhaust
 Gamma Irradiation  Maximum dose: 50 kGy
2 For Code G version only. Membrane has to be wet for autoclave sterilization
Please refer to service instructions or contact Pall for more details.

Extractables

 Typical Extractables in water at 20 °C  < 10 mg per capsule

Typical Liquid Flow vs. Differential Pressure

Application
Filters - Liquid - Bioburden Reduction (0.45 micron)