3M™ Emphaze™ AEX Series Hybrid Purifier

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Reduces turbidity, HCP, DNA and bioburden.

Excellent throughput and mAb recovery.

Enhanced capture column performance and protection.

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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

Applications

Cell Culture Clarification, Chromatography and Column Protection, Adsorptive Depth Filtration, Bioburden Reduction, DNA Removal, Plasma Fractionation

Autoclavable

Yes

Brands

Emphaze™

Capsule Material

Glass Filled Polypropylene, Polypropylene, Polysulfone, Thermoplastic Elastomer (TPE), Fluorocarbon, Glass Filled Polypropylene Oxide, Silicone, Polystyrene

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 cm², 1 cm², 1.6 cm², 4 cm², 25 m², 170 cm², 340 cm², 1020 m²

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

Fluorocarbon, Silicone

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

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