3M™ Emphaze™ AEX Series Hybrid Purifier
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Details
Highlights
- Reduces turbidity, HCP, DNA and bioburden
- Excellent throughput and mAb recovery
- Enhanced capture column performance and protection
- Substantial turbidity, DNA, HCP and bioburden reduction
- Reduced surface area requirement of the downstream sterilizing grade membrane
- May offer differentiated protection of the protein A column for enhanced contaminant clearance performance
- All product components comply with United States Pharmacopeia (USP) Class VI 70°C Biological Reactivity Tests, in vivo
3M™ Emphaze AEX Hybrid Purifier is our single-use sterilisable and sanitisable. The all-synthetic purification media that contains a Q-functional anion exchange media and a fine particle and bioburden reduction membrane.
Remove impurities in biopharmaceutical process streams such as DNA, host cell proteins (HCP) and viruses with our all-synthetic, single use 3M™ Emphaze AEX Hybrid Purifier.
The composite purification media is comprised of three primary components: anion exchange nonwoven, microporous membrane, and membrane support. The anion exchange media is composed of four layers of polypropylene nonwoven with a covalently attached quaternary ammonium functional polymer.
The bioburden reduction membrane is a highly asymmetric polyamide membrane which has nine zones of decreasing pore size, spanning approximately a 20 X range, and terminating with a 0.2 μm rated qualifying layer. This is followed by a polypropylene nonwoven used as a support layer in the capsule.
Capsules
There are two primary capsule configurations for the Emphaze AEX Hybrid Purifier, Laboratory and Scale-up capsules:
- The Laboratory capsule (BV8) has an 8ml bed volume.
- The Scale-up capsules are constructed from a lenticular media cell design having bed volumes of 120 mls and 360 mls (BV 120 and BV 360 respectively).
- The Production capsules are scaled to meet your manufacturing requirements and utilise manifolds in a holder for ease of use.
A full support package is available for 3M Emphaze AEX Hybrid Purifiers. This package includes Installation and Operation Guides, a Certificate of Quality and a Regulatory Support File.
Specifications
| Application | Adsorptive Depth Filtration, Bioburden Reduction, Cell Culture Clarification, Chromatography and Column Protection, DNA Removal |
| Autoclavable | Yes |
| Brands | Emphaze™ |
| Capsule Material | Glass Filled Polypropylene, Polypropylene, Thermoplastic Elastomer (TPE), Glass Filled Polypropylene Oxide, Silicone, Polystyrene, Fluorocarbon, Polysulfone |
| Dimensions (Metric) | 4.5 cm x 7.7 cm, 8.8 cm x 7.7 cm, 20.3 cm x 45.2 cm, 10.3 cm x 21.6 cm, 15.2 cm x 21.6 cm, 5.7 cm x 45.2 cm |
| Effective Filtration Area (Metric) | 0.23 Square Centimetre, 1 Square Centimetre, 1.6 Square Centimetre, 4 m², 25 m², 170 Square Centimetre, 340 Square Centimetre, 1020 Square Centimetre |
| End Modification | 3/4 in Sanitary Connectors, 1 1/2 in Sanitary Connectors, Luer Loc |
| Factory Integrity Tested | Capsule Leak Test |
| Fill Volume | 0.55 mL, 1.4 mL, 2 mL, 3.4 mL, 5.5 L, 10.6 L, 13 L, 16 L |
| Filter Material | Functional Non-woven |
| Filter Technology | Anion exchange chromatography |
| Filter Type | Single Use |
| Flow Rate (Metric) | 0.4 Millilitre per Minute, 1.4 Millilitre per Minute, 8 Millilitre per Minute, 50 Millilitre per Minute, 100 Millilitre per Minute, 300 Millilitre per Minute, 680 Millilitre per Minute, 4700 Millilitre per Minute |
| Flux | 210 |
| Gamma Compatible | No |
| Gamma Sterilized | No |
| Gasket/O-ring Material | Silicone, Fluorocarbon |
| Industries | Life Sciences |
| Inlet Outlet Size | 1.5", 3/4" |
| Inlet/Outlet Connections | 3/4 in Sanitary Connectors, 1 1/2 in Sanitary Connectors, Luer Loc |
| Maximum Capacity | 400 |
| Maximum Operating Pressure (Metric) | 2.4 bar, 2.8 bar, 3.1 bar, 3.4 bar |
| Maximum Operating Temperature (Celsius) | 40 ℃ |
| Membrane Type | Polyamide |
| Micron Rating | 0.2 μm |
| Net Weight (Metric) | 1 g, 1.1 g, 1.6 g, 3.4 g, 9 kg, 9.5 kg, 14.5 kg, 71 kg, 77 kg |
| Product Series | AEX |
| Series | Emphaze™ AEX Series, Emphaze™ AEX |
| Shelf Life | 2 Year |
| Storage Temperature (Celsius) | 0 °C - 30 °C |
| Temperature Range (Celsius) | 0 °C - 40 °C |
| Units per Case | 1.0, 2.0, 4.0 |
| Overall Diameter (Metric) | 4.3 cm, 7.7 cm, 21.6 cm, 45.2 cm |
| Overall Height (Metric) | 4.5 cm, 4.8 cm, 5.7 cm, 5.9 cm, 8.8 cm, 10.3 cm, 15.2 cm, 20.3 cm |
