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

Supor® EKV Membrane in Kleenpak™ Capsules

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

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.

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

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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설명

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

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.

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

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

규격사양

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

종류

Filter Capsules

사용

Sterilizing-Grade Liquid Filtration

적용분야

Filters - Liquid - Sterile (0.2 micron)

영역

Filtration - Classic