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    Design ofMembrane Filtration Systems

    for

    Biotechnology Process

    Applications

    June 19, 2003

    AFS Conference 2003, Reno, NV

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    April 15, 2003 Template 2

    AFS Conference 2003, Reno, NV

    Who is GEA Filtration ?

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    April 15, 2003 Template 3

    AFS Conference 2003, Reno, NV

    Who is GEA Filtration ?Who is GEA Filtration ?

    mg Technologies

    Frankfurt, Germany

    mg Engineering mg Chemical

    Lurgi AG Lurgi Lentjes AG

    GEA AG

    Bochum, Germany Zimmer AG

    Process Divisions Thermal Divisions

    Mech. Separation Process Components Process Engineering

    Refrigeration Dairy Farm Systems

    Strategic Business Units

    Food & Dairy Drying Technology

    Chemical Drying technology

    Pharma Equipments

    Evaporation Technology

    Membrane Filtration

    Barr Rosin

    Dairy, Food & Juice Liquid Processing

    Brewery & Beverage

    Personal & Health Care

    Spare Parts & Service

    GEA

    Filtration

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    April 15, 2003 Template 4AFS Conference 2003, Reno, NV

    What is Biotechnology ?What is Biotechnology ?

    Biotechnology ..All lines of work by which products are produced from raw

    materials with the aid of living things.

    As defined by Karl Ereky, 1917

    Biotechnology

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    April 15, 2003 Template 5AFS Conference 2003, Reno, NV

    Biotech Market SegmentsBiotech Market Segments

    Food

    Pharmaceuticals

    Chem

    ical

    Bio-pharmaceuticals Antibiotics Proteins & peptides

    Vaccines

    Vitamins

    Bio-chemicals Enzymes

    Ethanol

    Insecticides &Pesticides

    Poly-lactates

    BiotechnologyNutraceuticals Food

    supplements Health Foods

    Bio-food Wine & Beer

    Lactic acid

    Citric acid

    Flavors &

    fragrances

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    April 15, 2003 Template 6AFS Conference 2003, Reno, NV

    Biotechnology ProcessBiotechnology Process

    Microfiltration

    Ultrafiltration Diafiltration

    Precoat Filters

    UpstreamProcessing

    Media Preparation

    Fermentation

    Concentration

    Ultrafiltration

    Diafiltration Nanofiltration

    Cell Harvesting /Clarification

    DownstreamProcessing /

    Purification

    Cell Rupture Chromatography

    Centrifugation

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    Typical Biotechnology ApplicationsTypical Biotechnology Applications

    Clarification of Fermentation Broths to recover active

    compounds

    Cell Harvesting to concentrate and recover whole cellscontaining product

    Enzymes

    APIs (Active Pharmaceutical Ingredients)

    Proteins and Amino Acids

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    What is a

    Membrane Filtration System?

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    Sections of a Membrane Filtration System (Simplified)Sections of a Membrane Filtration System (Simplified)

    Permeate

    PT

    FICFT

    Concentrate

    Feed

    Tank

    FT

    VSD

    FIC

    Feed

    LT

    MembraneMembrane

    StagesStages

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    April 15, 2003 Template 10AFS Conference 2003, Reno, NV

    Engineering and Design CriteriaEngineering and Design Criteria

    Membrane ConfigurationsMembrane Configurations Conventional Configurations

    Polymeric Membranes

    Spiral

    Tubular & Hollow Fiber

    Plate & Frame

    Inorganic Membranes

    Tubular Specialized and / or Proprietary Configurations

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    April 15, 2003 Template 11AFS Conference 2003, Reno, NV

    Engineering and Design CriteriaEngineering and Design Criteria

    SpiralSpiral--Wound Membrane ElementWound Membrane Element

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    Engineering and Design CriteriaEngineering and Design Criteria

    Tubular Polymeric Membrane Elements and ModulesTubular Polymeric Membrane Elements and Modules

    Pictures Courtesy of Koch Membrane Systems

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    Engineering and Design CriteriaEngineering and Design Criteria

    Ceramic Membrane Elements and ModulesCeramic Membrane Elements and Modules

    Pictures Courtesy of TAMI

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    Engineering and Design CriteriaEngineering and Design Criteria

    Scepter Membrane Elements and ModulesScepter Membrane Elements and Modules

    Pictures Courtesy of Graver Technologies

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    A Few Important

    Terms & Concepts

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    Important TermsImportant Terms

    Feed or Product

    Initial material into system on feed side of membrane

    Retentate or Concentrate The fraction of the feed which is rejected by the membrane.

    Permeate

    The fraction of the feed which passes through the membrane

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    April 15, 2003 Template 17AFS Conference 2003, Reno, NV

    Important TermsImportant Terms

    Flux

    rate of permeate flow per unit area per unit time

    lmh - liters/square meter/hour

    gfd - gallons/square foot/day

    Cross-Flow Rate

    flow rate of feed material through feed channel or feed side of a

    membrane element or module determines feed flow characteristics which impacts performance

    parameters

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    Important TermsImportant Terms

    Concentration Factor (CF)

    feed volume (or flow rate) divided by the concentrate volume (or flow

    rate)

    % Rejection

    100 x ( 1 - [permeate]i / [retentate]i )

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    Important TermsImportant Terms

    Pressure Drop ( P)

    Difference between the inlet and outlet feed-side pressures

    Transmembrane Pressure (TMP) Difference between feed & permeate pressure

    Driving force for all membrane filtration processes

    Osmotic Pressure ( )

    Function of MW and component concentration

    Counter-pressure which TMP must overcome

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    Membrane Filtration System

    Design Considerations

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    Steps in the Design ProcessSteps in the Design Process

    Review of Application

    Review of System Design Criteria

    Pilot Testing

    Engineering and Design

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    Key Factors of System DesignKey Factors of System Design

    Stability of Product

    Shear Sensitivity

    Volume of Product to be Processed

    Up and Down Stream Operation Steps

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    Steps in the Design ProcessSteps in the Design Process

    Review of System Design Criteria

    Materials of Construction

    Design Specifications

    Food industry Standards Food Grade

    Dairy Standards 3A

    Pharmaceutical / Biotechnology Standards GMP Compliance

    Specialized Requirements

    XP system

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    AFS Conference 2003, Reno, NV

    GMP Regulatory Compliance RequirementsGMP Regulatory Compliance Requirements

    Examples of Validation Documentation (if required)

    Bill of Materials

    Certificates of Compliance and Conformance

    Component Calibration Verification

    Material Test Reports

    Factory Acceptance Test (FAT)

    Weld logs, weld maps, etc.

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    Steps in the Design ProcessSteps in the Design Process

    Pilot Testing

    Test on representative feed(s)

    Validate membrane type and configuration

    Compilation and review of data

    Membrane Configuration Selection

    Selection between spiral, ceramic, hollow fiber, cassette, others

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    Engineering and Design CriteriaEngineering and Design Criteria

    Membrane Design Factors

    Type and Material of Membrane

    Configuration and Construction of Membrane

    Housing and Module Design

    System Design Criteria

    Operating Parameters

    T, P, Flux, CF, DP, TMP, etc. Mode of Operation

    Feed and bleed, batch, etc.

    System Design

    Stages-in-series, array, etc Control Scheme

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    Engineering and Design CriteriaEngineering and Design Criteria

    Integration of System Design with Plant Process

    Coordination with upstream operations, i.e. fermenters

    Coordination with downstream operations, i.e. extraction,

    chromatographic separation, formulation

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    SummarySummary

    With proper design and successful integration in the plants

    process, a membrane filtration system can become a key and

    integral process step within the recovery operation of a

    biotechnology processor.

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    Americas & Rest of the world

    GEA Filtration Division

    Niro Inc.

    1600 OKeefe Road

    Hudson, WI 54016

    USA

    +1 715 386 9371 Telephone

    +1 715 386 9376 Telefax

    [email protected]

    Europe, Near & Middle EastDairy, Biotech & Pharma

    GEA Filtration Division

    GEA Liquid Processing

    Scandinavia A/S

    Norskovvej 1 b

    8660 SkanderborgDenmark

    +45 70 15 22 00 Telephone

    +45 70 15 22 44 Telefax

    [email protected]

    Food & Waste Water

    GEA Filtration Division

    GEA Wiegand GmbH

    Einsteinstrasse 9-15

    76275 Ettlingen

    Germany+49 7243 7050 Telephone

    +49 7243 7053 30 Telefax

    [email protected]

    NZ & AustraliaLiquid Technologies Division

    Niro (NZ) Limited

    356 Church Street

    Penrose, Auckland

    New Zealand

    +64 9 526 3877 Telephone

    +64 9 526 3873 Telefax

    [email protected]

    Liquid Technologies Division

    Niro Australia Pty Limited141 St. Georges Road

    N Fitzroy, Victoria

    3068

    Australia

    +61 3 9482 6333 Telephone

    +61 3 9482 6366

    Telefax

    [email protected]

    Who is GEA Filtration ?Who is GEA Filtration ?