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Supor® EKV - Mini Kleenpak™ Capsules product photo Primary L

Supor® EKV - Mini 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.

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 UpScale™ 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
  • Hydrophilic polyethersulfone membrane for low adsorption and wide chemical compatibility
  • Good wettability for a reliable integrity test
  • 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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描述

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.

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 UpScale™ 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
  • Hydrophilic polyethersulfone membrane for low adsorption and wide chemical compatibility
  • Good wettability for a reliable integrity test
  • 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

规格

Materials of Construction

 
 Filter Membrane  Hydrophilic PES
 Support/Drainage  Polypropylene
 Capsule Shell  Polypropylene
 Filling Bell  Polycarbonate
 Sealing Technology  Thermal bonding without adhesives
 

Operating Parameters(1)

 
 Maximum Temperature  40 °C
 Maximum Operating Pressure  4.1 bar (60 psi) at 40 °C
 Maximum Differential Pressure  4.1 bar (60 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  3 x 60 minutes at 140 °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. Water wet Supor EKV capsules prior to steaming to retain full water wettability for integrity testing

Typical Extractables in Water at 20 °C

 
 < 5.0 mg per capsule
 

Nominal Dimensions

 
 Maximum diameter including valves  53 mm (2.1 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)
 

Flow Characteristics

类型

Filter Capsules

用途

Sterilizing-Grade Liquid Filtration

应用

Filters - Liquid - Sterile (0.2 micron)

订购信息

 
Part Number Description
KA02EKVP2G ¼ - ½ in. (6-13 mm) hosebarb, Non-sterile, Gamma irradiatable/autoclavable 
KA02EKVP2S ¼ - ½ in. (6-13 mm) hosebarb, Pre sterilized using gamma irradiation
KA02EKVP8G ½ - ¾ in. (13-19 mm) sanitary flange, Gamma irradiatable/autoclavable
KA02EKVP8S ½ - ¾ in. (13-19 mm) sanitary flange, Pre sterilized using gamma irradiation
 

分类信息

Filtration - Classic

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