설명
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.
규격사양
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
종류
사용
관련 문서
Published Articles
- Advanced Filtration Optimizes High-Viscosity Blow-Fill-Seal
- Factors Affecting Sterile Filtration of Sodium-Carboxymethylcellulose-Based Solutions
Application Notes
- Buffer Filter Selection Guidelines
- The Effect of Membrane Selection and Operating Parameters on Sterile Filtration of Hyaluronic Acid
Brochures
Datasheets
- Mini Kleenpak™ Filter Capsules with Supor® EX Grade ECV Filter Media
- Kleenpak™ Nova Capsules with Supor® EX Grade ECV Filter Membrane
- Supor® EX Grade ECV Membrane Filter Cartridges
Validation Guides
Regulatory/Quality Documentation
Reviews
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