설명
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.
규격사양
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 | ● | ● | ● | ● | ● | ● | |
종류
사용
관련 문서
Application Notes
Brochures
Datasheets
- Mini Kleenpak™ Capsules with Supor® EAV Membrane
- Kleenpak™ Capsules with Supor® EAV Membrane
- Supor® EAV Membrane Filter Cartridges
Posters
- Optimizing the Clarification of Viral Vector Culture for Gene Therapy
- Single-Use Platform for Scalable Purification of a VSV-G Lentiviral Vector
Regulatory/Quality Documentation
Reviews
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