Supor® EX Grade ECV Filters

Sterilizing-Grade Filters With High Flow Rate and Capacity, Effective With High-Fouling and Highly Viscous Fluids

Offered in a range of scalable formats, Supor EX grade ECV polyethersulfone (PES) membrane filters are designed for filtration of:

  • Cell harvest material
  • Growth media
  • Final bulk biological process fluids
  • Buffers
  • Process intermediates

Superior Performance in Intensified Processing

Supor EX grade ECV sterilizing-grade filters incorporate a membrane pairing with a validated bacterial removal rating of 0.2 µm. This membrane pairing not only produces a sterile effluent, it delivers unrivalled efficiency with hard-to-filter process fluids with high viscosity or high fouling properties. A laid-over-pleat membrane geometry and narrow core permit even greater filtration efficiency, enabling compact filter systems that support ease of handling and reduce losses due to filter hold up.

Benefits From Using Supor EX Grade ECV Filters

  • 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
  • Built-in, asymmetric pre-filter layer and pleat geometry allows for compact filter systems
  • Exceptional throughput due to unique cartridge construction results in compact filter systems

Security of Supply and Reliability of Performance

Pall manufactures the PES membrane used in Supor EX grade ECV filter capsules and cartridges. This ensures high levels of quality control and allows us to maintain continuity of supply.

Scientifically Validated

With a removal rating of 0.2 µm in liquids, Supor EX grade ECV filters are validated by bacterial challenge using Brevundimonas (Pseudomonas) diminuta (ATCC 19146) at a level of 107 cfu/cm2, supported with comprehensive validation data.



Need Help?
Ask a Question
* Required

Description

Sterilizing-Grade Filters With High Flow Rate and Capacity, Effective With High-Fouling and Highly Viscous Fluids

Offered in a range of scalable formats, Supor EX grade ECV polyethersulfone (PES) membrane filters are designed for filtration of:

  • Cell harvest material
  • Growth media
  • Final bulk biological process fluids
  • Buffers
  • Process intermediates

Superior Performance in Intensified Processing

Supor EX grade ECV sterilizing-grade filters incorporate a membrane pairing with a validated bacterial removal rating of 0.2 µm. This membrane pairing not only produces a sterile effluent, it delivers unrivalled efficiency with hard-to-filter process fluids with high viscosity or high fouling properties. A laid-over-pleat membrane geometry and narrow core permit even greater filtration efficiency, enabling compact filter systems that support ease of handling and reduce losses due to filter hold up.

Benefits From Using Supor EX Grade ECV Filters

  • 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
  • Built-in, asymmetric pre-filter layer and pleat geometry allows for compact filter systems
  • Exceptional throughput due to unique cartridge construction results in compact filter systems

Security of Supply and Reliability of Performance

Pall manufactures the PES membrane used in Supor EX grade ECV filter capsules and cartridges. This ensures high levels of quality control and allows us to maintain continuity of supply.

Scientifically Validated

With a removal rating of 0.2 µm in liquids, Supor EX grade ECV filters are validated by bacterial challenge using Brevundimonas (Pseudomonas) diminuta (ATCC 19146) at a level of 107 cfu/cm2, supported with comprehensive validation data.

Specifications

Discs

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

Capsules

Format Effective Filtration Area
(EFA) (cm2)
Typical Batch Volume
(L)
Sterilization Conditions
Mini Kleenpak Capsules 220 2 – 50 Autoclave:
3 x 60 minutes at 125 ֯C
Gamma irradiation:
maximum of 50 kGy
Kleenpak Nova Capsules 1,000 – 30,000 5 – 1000 1-in. capsule: 5 x 60 minutes at 125 °C
Autoclavable (G option only): 1 x 60 minutes at 135 °C
Gamma Irradiation (G option only): Maximum of 50 kGy
5-, 10-, 20-, and 30-in. capsules: 3 x 60 minutes at 125 °C

Cartridges

Format Effective Filtration Area
(EFA) (cm2)
Typical Batch Volume
(L)
Sterilization Conditions
Filter Cartridges 5,200 – 31,200 100 – 1000 Autoclave: 5 x 60 minutes at 125 °C
In Situ Steam: 5 x 60 minutes at 125 °C ; 1 x 60 minutes at 135 °C

Quality Release Criteria

47 mm Discs Mini Kleenpak Capsules Kleenpak Nova Capsules Filter Cartridges
Designed, developed, manufactured in accordance with an ISO 9000-certified Quality Management System
Process development 1
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
1Applies to 25 mm (1 in.) format (NP1L*) only

Type

Liquid Filters

Use

Sterilizing-Grade Liquid Filtration