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.
Nutzen und Einsatzmöglichkeiten von 3M™ Emphaze™ AEX Series Hybrid Purifier, BV120R, EMP513AEX020R, Scale-Up
- All product components comply with United States Pharmacopeia (USP) Class VI 70°C Biological Reactivity Tests, in vivo.
- Enhanced capture column performance and protection.
- Excellent throughput and mAb recovery.
- May offer differentiated protection of the protein A column for enhanced contaminant clearance performance.
- Reduced surface area requirement of the downstream sterilizing grade membrane.
- Reduces turbidity, HCP, DNA and bioburden.
- Substantial turbidity, DNA, HCP and bioburden reduction.
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.
