Supor® EKV Filters

Sterilizing-Grade Filter Membrane With High Chemical (pH) Compatibility and Maximum Transmission of High-Value Active Ingredients

Offered in a range of scalable formats, Supor EKV polyethersulfone (PES) membrane filters are designed for cost-effective filtration of a wide range of liquids including:

  • Growth media
  • Bioreactor feeds 
  • Buffers
  • Intermediates

Superior Performance

Supor EKV filters feature 0.2-micron-rated validated sterilizing-grade membranes. With standard 5- and 10-inch format filters utilizing a laid-over-pleat membrane geometry in capsules and cartridges for high flow rates and throughput performance, their PES membrane ensures very high compatibility over the whole pH range and very low protein binding to ensure the maximum transmission of active ingredients.

Benefits

  • Very low protein and preservative binding: 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
  • Broad pH compatibility due to PES membrane
  • Long life and low filtration costs thanks to a built-in, asymmetric pre-filter layer
  • Good wettability for reliable integrity tests

Security of Supply and Reliability of Performance

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

Scientifically Validated

With an absolute removal rating of 0.2 µm in liquids, the filters are bacterially challenged using Brevundimonas (Pseudomonas) diminuta (ATCC 19146) liquid challenge at 10cfu/cm2, and extensively scientifically validated and supported with a comprehensive validation guide.



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Description

Sterilizing-Grade Filter Membrane With High Chemical (pH) Compatibility and Maximum Transmission of High-Value Active Ingredients

Offered in a range of scalable formats, Supor EKV polyethersulfone (PES) membrane filters are designed for cost-effective filtration of a wide range of liquids including:

  • Growth media
  • Bioreactor feeds 
  • Buffers
  • Intermediates

Superior Performance

Supor EKV filters feature 0.2-micron-rated validated sterilizing-grade membranes. With standard 5- and 10-inch format filters utilizing a laid-over-pleat membrane geometry in capsules and cartridges for high flow rates and throughput performance, their PES membrane ensures very high compatibility over the whole pH range and very low protein binding to ensure the maximum transmission of active ingredients.

Benefits

  • Very low protein and preservative binding: 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
  • Broad pH compatibility due to PES membrane
  • Long life and low filtration costs thanks to a built-in, asymmetric pre-filter layer
  • Good wettability for reliable integrity tests

Security of Supply and Reliability of Performance

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

Scientifically Validated

With an absolute removal rating of 0.2 µm in liquids, the filters are bacterially challenged using Brevundimonas (Pseudomonas) diminuta (ATCC 19146) liquid challenge at 10cfu/cm2, and extensively scientifically validated and supported with a comprehensive validation guide.

Specifications

Discs

Format Effective Filtration Area (EFA) (cm²) Recommended Batch Volume (L) Sterilization Options
47 mm Discs 14 0.05 – 2 Autoclave

Capsules

Format Effective Filtration Area (EFA) (cm²) Recommended Batch Volume (L) Sterilization Options
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 Capsules 20 0.05 – 2 Autoclave: 1 x 60 minutes at 125 ֯C
Mini Kleenpak Capsules 200 2 – 50 Autoclave: 3 x 60 minutes at 140 ֯C
Gamma irradiation: maximum of 50 kGy
Kleenpak Capsules 375 – 1500 2 – 160 Autoclave: 5 x 60 minutes at 125 ֯C, slow exhaust
Gamma irradiation: maximum of 50 kGy
Kleenpak Nova Capsules 2600 – 6000 100 – 1000 Autoclave: 1 x 60 minutes at 125 ֯C, slow exhaust
Gamma irradiation: maximum of 50 kGy

Steam-In-Place Capsules

Format Effective Filtration Area (EFA) (cm²) Recommended Batch Volume (L) Sterilization Conditions
Novasip™ Filter Capsules 1500 2 – 160 Autoclave: 5 x 60 minutes at 125 ֯C, slow exhaust
Inline: 5 x 60 minutes at 125 ֯C

Cartridges

Format Effective Filtration Area (EFA) (cm²) Recommended Batch Volume (L) Sterilization Conditions
Junior Filter Cartridges 1500 30 – 500 Autoclave: 5 x 60 minutes at 125 ֯C, slow exhaust
In Situ Steam: 30 x 60 minutes at 125 ֯C
Filter Cartridges 2600 – 6000 100 – 1000 Autoclave: 30 x 60 minutes at 125 ֯C, slow exhaust
In Situ Steam: 5 x 60 minutes at 142 ֯C

Quality Release Criteria

47 mm Discs Mini Kleenpak
Syringe Filters
Mini Kleenpak
20 Capsules
Mini Kleenpak Capsules Kleenpak Capsules Kleenpak Nova Capsules Novasip Filter Capsules Junior Filter Cartridges Filter Cartridges
Designed, developed, manufactured in accordance with an ISO 9000-certified Quality Management System
Process development        
Manufacturing scale – cGMP    
Quantitative bubble point of membrane
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

Sterilizing-Grade Liquid Filtration