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

Kleenpak™ Capsules with Supor® EKV Membrane

Supor EKV filters are 0.2 micron rated validated sterilizing-grade membrane filters. A PES membrane ensures very high compatibility over the whole pH range plus very low protein binding to ensure the maximum transmission of active ingredients.

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

Key Features and Benefits

  • Encapsulated format for higher flexibility, minimized cleaning and low installation costs
  • Minimal hold up volume
  • Hydrophilic polyethersulfone membrane for low adsorption and wide chemical compatibility
  • Good wettability for a reliable integrity test
  • Patented Ultipleat technology for high-area and good flow rates
  • Built-in, MachV asymmetric prefilter layer for long-life and low filtration costs
  • High-strength construction tolerates up to 1 bard (14.5 psid) differential pressure during steam-in-place sterilization

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


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Description

Supor EKV filters are 0.2 micron rated validated sterilizing-grade membrane filters. A PES membrane ensures very high compatibility over the whole pH range plus very low protein binding to ensure the maximum transmission of active ingredients.

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

Key Features and Benefits

  • Encapsulated format for higher flexibility, minimized cleaning and low installation costs
  • Minimal hold up volume
  • Hydrophilic polyethersulfone membrane for low adsorption and wide chemical compatibility
  • Good wettability for a reliable integrity test
  • Patented Ultipleat technology for high-area and good flow rates
  • Built-in, MachV asymmetric prefilter layer for long-life and low filtration costs
  • High-strength construction tolerates up to 1 bard (14.5 psid) differential pressure during steam-in-place sterilization

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
Specifications

Materials of Construction

 
 Filter Membrane Hydrophilic PES 
 Support/Drainage Polypropylene
 End Cap, Core and Cage Polypropylene 
 Capsule Shell Polypropylene
 Sealing Technology Thermal bonding without adhesives
 

Operating Parameters(1)

 
 Maximum Temperature 40 °C
 Maximum Operating Pressure

5.2 bar (75 psi) at 20 °C
4.0 bar (58 psi) at 40 °C

  Maximum Differential Pressure  4.0 bar (58 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  5 x 60 minutes at 125 °C, slow exhaust
 Gamma Irradiation  Maximum of 50 kGy
 

(2) Pre-sterilized Kleenpak capsules must not be re-sterilized
Kleenpak capsules must not be sterilized in-situ by passing steam under pressure
Water wet Supor EKV capsules prior to steaming to retain full water wettability for integrity testing

Typical Extractables in Water at 20 °C

 
 KA1 / KA2  < 5 mg per capsule
 KA3  < 10 mg per capsule
 

Nominal Dimensions

 
  KA1 KA2 KA3
 Diameter incl. Valves  94 mm (3.7 in.)   94 mm (3.7 in.)  105 mm (4.1 in.)
 Length - Code 1  117 mm (4.6 in.)  157 mm (6.2 in.)  174 mm (6.8 in.)
 Length - Code 6  157 mm (6.2 in.)  197 mm (7.7 in.)  210 mm (8.3 in.)
  Length - Code 16  137 mm (5.4 in.)  177 mm (7.0 in.)  192 mm (7.6 in.)
 

Nominal Effective Filter Area (EFA)

 
 KA1 375 cm² (0.4 ft²) 
 KA2 750 cm² (0.8 ft²)
 KA3 1500 cm² (1.6 ft²)
 

Flow Characteristics

Application
Filters - Liquid - Sterile (0.2 micron)