Supor® EAV Filters

Bioburden Reduction Filters Suitable for High Particulate-Containing Biological Process Streams

Offered in a range of scalable formats, Supor EAV filters deliver high flow rates and effective bioburden reduction and particulate control. These filters are ideal for the following applications:

  • Bioburden control filtration of buffers and protein solutions
  • Prefiltration of high particulate-containing biological process streams
  • Applications where validated sterilizing-grade filters are not essential but reliable bioburden control is required

Superior Performance

Supor EAV filters have a 0.2 µm removal rating and feature a highly asymmetric single-layer polyethersulfone (PES) membrane. These filters can protect and extend the service life of critical sterile filters, mycoplasma control filters, downstream chromatography columns, and ultrafilters when consistent bioburden control is essential, but the use of validated sterilizing-grade filters is not necessary.

  • Hydrophilic PES membrane ensures maximum transmission of active ingredients
  • Fast and easy scale-up: all process development-scale filter formats are designed to scale directly to larger cGMP filter configurations
  • High microbial and particulate reduction with outstanding service life
  • Bacterial titer reduction in excess of 6 log guarantees excellent microbial filtration efficiency in processes with variable bioburden
  • High-capacity membrane ensures maximum flow and throughput performance for smaller, more cost-effective filtration systems
  • Broad pH compatibility due to PES membrane

Security of Supply and Reliability of Performance

Pall manufactures the PES membrane used in Supor EAV filter capsules and cartridges. All Supor EAV pleated filters are made at manufacturing sites in Puerto Rico and the United Kingdom.

Scientifically Validated

With a removal rating of 0.2 µm in liquids, Supor EAV filters are validated for the removal of Brevundimonas diminuta (ATCC 19146) with a typical titer reduction of 106 (6 LRV), assuring safety in applications where an absolute sterility claim is not essential. This rating is supported with comprehensive validation data.



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Description

Bioburden Reduction Filters Suitable for High Particulate-Containing Biological Process Streams

Offered in a range of scalable formats, Supor EAV filters deliver high flow rates and effective bioburden reduction and particulate control. These filters are ideal for the following applications:

  • Bioburden control filtration of buffers and protein solutions
  • Prefiltration of high particulate-containing biological process streams
  • Applications where validated sterilizing-grade filters are not essential but reliable bioburden control is required

Superior Performance

Supor EAV filters have a 0.2 µm removal rating and feature a highly asymmetric single-layer polyethersulfone (PES) membrane. These filters can protect and extend the service life of critical sterile filters, mycoplasma control filters, downstream chromatography columns, and ultrafilters when consistent bioburden control is essential, but the use of validated sterilizing-grade filters is not necessary.

  • Hydrophilic PES membrane ensures maximum transmission of active ingredients
  • Fast and easy scale-up: all process development-scale filter formats are designed to scale directly to larger cGMP filter configurations
  • High microbial and particulate reduction with outstanding service life
  • Bacterial titer reduction in excess of 6 log guarantees excellent microbial filtration efficiency in processes with variable bioburden
  • High-capacity membrane ensures maximum flow and throughput performance for smaller, more cost-effective filtration systems
  • Broad pH compatibility due to PES membrane

Security of Supply and Reliability of Performance

Pall manufactures the PES membrane used in Supor EAV filter capsules and cartridges. All Supor EAV pleated filters are made at manufacturing sites in Puerto Rico and the United Kingdom.

Scientifically Validated

With a removal rating of 0.2 µm in liquids, Supor EAV filters are validated for the removal of Brevundimonas diminuta (ATCC 19146) with a typical titer reduction of 106 (6 LRV), assuring safety in applications where an absolute sterility claim is not essential. This rating is supported with comprehensive validation data.

Specifications

Discs

Format Effective Filtration Area
(EFA) (cm2)
Typical Batch Volume
(L)
Sterilization Conditions
47 mm Filter Discs 17 0.05 – 2 Autoclave

Capsules

Format Effective Filtration Area
(EFA) (cm2)
Typical Batch Volume
(L)
Sterilization Conditions
Mini Kleenpak Syringe Filters 2.8 Up to 0.1 Available pre-sterilized, subject to a minimum of 25 kGy of gamma irradiation
Mini Kleenpak 20 Filter Capsules 20 0.05 – 2 Autoclave: 1 cycle at 125 °C (“kill cycle” only)
Mini Kleenpak Filter Capsules 260 2 – 50 Autoclave: 3 x 30 minutes at 135 °C
Gamma irradiation: maximum of 50 kGy
Kleenpak Filter Capsules 2,100 3 – 160 Autoclave: 10 x 60 minutes at 125 °C, slow exhaust
Gamma irradiation: maximum of 50 kGy
Kleenpak Nova Filter Capsules 5,300 – 31,800 100 – 1,000 Autoclave: 1 x 60 minutes at 135 °C
Gamma irradiation: maximum of 50 kGy

Cartridges

Format Effective Filtration Area
(EFA) (cm2)
Typical Batch Volume
(L)
Sterilization Conditions
Filter Cartridges 5,100 – 42,400 100 – 1,000 Autoclave or in situ steam: 10 x 60 minutes at 125 °C

Quality Release Criteria

47 mm Discs Mini Kleenpak Syringe Filters Mini Kleenpak 20 Capsules Mini Kleenpak Capsules Kleenpak Capsules Kleenpak Nova Capsules Filter Cartridges
Designed, developed, manufactured in accordance with an ISO 9000-certified Quality Management System
Process development
Manufacturing scale – cGMP
Integrity testing protocol during manufacture – lot only N/A
Integrity testing protocol during manufacture – each filter 100% tested N/A
Test correlated to microbial retention
Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics
Provided with a Pharmaceutical Certificate of Test

Type

Liquid Filters

Use

Bioburden Filtration

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