Supor® EKV Membrane
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
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Description
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
We manufacture the PES membrane used in our 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 107 cfu/cm2, and extensively scientifically validated and supported with a comprehensive validation guide.
Documents
White Papers
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An End-to-End Process for Large-Scale Adenovirus Manufacturing for Gene Therapy
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Posters
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Single-Use Platform for Scalable Purification of a VSV-G Lentiviral Vector
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Available Formats
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 Conditions |
---|---|---|---|
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 |
200 | 2 – 50 | Autoclave: 3 x 60 minutes at 140 ֯C Gamma irradiation: maximum of 50 kGy |
|
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 | ● | ● | ● | ● | ● | ● | ● | ● |