Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l...
Transcript of Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l...
![Page 1: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/1.jpg)
Design of Membrane Filtration Systems
forBiotechnology Process
Applications
June 19, 2003
AFS Conference 2003, Reno, NV
![Page 2: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/2.jpg)
April 15, 2003 Template 2AFS Conference 2003, Reno, NV
Who is GEA Filtration ?
![Page 3: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/3.jpg)
April 15, 2003 Template 3AFS Conference 2003, Reno, NV
Who is GEA Filtration ?Who is GEA Filtration ?
mg TechnologiesFrankfurt, Germany
mg Engineering mg Chemical
Lurgi AG Lurgi Lentjes AG GEA AGBochum, Germany Zimmer AG
Process Divisions Thermal Divisions
Mech. Separation Process Components Process Engineering Refrigeration Dairy Farm Systems
Strategic Business UnitsFood & Dairy Drying TechnologyChemical Drying technologyPharma EquipmentsEvaporation TechnologyMembrane Filtration Barr RosinDairy, Food & Juice Liquid ProcessingBrewery & BeveragePersonal & Health CareSpare Parts & Service
GEA Filtration
![Page 4: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/4.jpg)
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
![Page 5: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/5.jpg)
April 15, 2003 Template 5AFS Conference 2003, Reno, NV
Biotech Market SegmentsBiotech Market Segments
Food
Pharmaceuticals
Chemical
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
![Page 6: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/6.jpg)
April 15, 2003 Template 6AFS Conference 2003, Reno, NV
Biotechnology ProcessBiotechnology Process
• Microfiltration• Ultrafiltration• Diafiltration
• Precoat Filters
Upstream Processing
• Media Preparation• Fermentation
• Concentration• Ultrafiltration• Diafiltration• Nanofiltration
Cell Harvesting / Clarification
Downstream Processing / Purification
• Cell Rupture • Chromatography
• Centrifugation
![Page 7: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/7.jpg)
April 15, 2003 Template 7AFS Conference 2003, Reno, NV
Typical Biotechnology ApplicationsTypical Biotechnology Applications
Clarification of Fermentation Broths to recover active compoundsCell Harvesting to concentrate and recover whole cells containing productEnzymesAPIs (Active Pharmaceutical Ingredients)Proteins and Amino Acids
![Page 8: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/8.jpg)
April 15, 2003 Template 8AFS Conference 2003, Reno, NV
What is a Membrane Filtration System?
![Page 9: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/9.jpg)
April 15, 2003 Template 9AFS Conference 2003, Reno, NV
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
MembraneMembraneStagesStages
![Page 10: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/10.jpg)
April 15, 2003 Template 10AFS Conference 2003, Reno, NV
Engineering and Design CriteriaEngineering and Design Criteria
Membrane ConfigurationsMembrane Configurations
Conventional ConfigurationsPolymeric Membranes
• Spiral• Tubular & Hollow Fiber• Plate & Frame
Inorganic Membranes• Tubular
Specialized and / or Proprietary Configurations
![Page 11: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/11.jpg)
April 15, 2003 Template 11AFS Conference 2003, Reno, NV
Engineering and Design CriteriaEngineering and Design Criteria
SpiralSpiral--Wound Membrane ElementWound Membrane Element
![Page 12: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/12.jpg)
April 15, 2003 Template 12AFS Conference 2003, Reno, NV
Engineering and Design CriteriaEngineering and Design Criteria
Tubular Polymeric Membrane Elements and ModulesTubular Polymeric Membrane Elements and Modules
Pictures Courtesy of Koch Membrane Systems
![Page 13: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/13.jpg)
April 15, 2003 Template 13AFS Conference 2003, Reno, NV
Engineering and Design CriteriaEngineering and Design Criteria
Ceramic Membrane Elements and ModulesCeramic Membrane Elements and Modules
Pictures Courtesy of TAMI
![Page 14: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/14.jpg)
April 15, 2003 Template 14AFS Conference 2003, Reno, NV
Engineering and Design CriteriaEngineering and Design Criteria
Scepter Membrane Elements and ModulesScepter Membrane Elements and Modules
Pictures Courtesy of Graver Technologies
![Page 15: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/15.jpg)
April 15, 2003 Template 15AFS Conference 2003, Reno, NV
A Few Important Terms & Concepts
![Page 16: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/16.jpg)
April 15, 2003 Template 16AFS Conference 2003, Reno, NV
Important TermsImportant Terms
Feed or ProductInitial material into system on feed side of membrane
Retentate or ConcentrateThe fraction of the feed which is rejected by the membrane.
PermeateThe fraction of the feed which passes through the membrane
![Page 17: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/17.jpg)
April 15, 2003 Template 17AFS Conference 2003, Reno, NV
Important TermsImportant Terms
Fluxrate of permeate flow per unit area per unit time“lmh” - liters/square meter/hour“gfd” - gallons/square foot/day
Cross-Flow Rateflow rate of feed material through feed channel or feed side of a membrane element or moduledetermines feed flow characteristics which impacts performance parameters
![Page 18: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/18.jpg)
April 15, 2003 Template 18AFS Conference 2003, Reno, NV
Important TermsImportant Terms
Concentration Factor (“CF”)feed volume (or flow rate) divided by the concentrate volume (or flow rate)
% Rejection100 x ( 1 - [permeate]i / [retentate]i )
![Page 19: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/19.jpg)
April 15, 2003 Template 19AFS Conference 2003, Reno, NV
Important TermsImportant Terms
Pressure Drop (“∆P”)Difference between the inlet and outlet feed-side pressures
Transmembrane Pressure (“TMP”)Difference between feed & permeate pressureDriving force for all membrane filtration processes
Osmotic Pressure (“Π”)Function of MW and component concentrationCounter-pressure which TMP must overcome
![Page 20: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/20.jpg)
April 15, 2003 Template 20AFS Conference 2003, Reno, NV
Membrane Filtration SystemDesign Considerations
![Page 21: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/21.jpg)
AFS Conference 2003, Reno, NV
Steps in the Design ProcessSteps in the Design Process
Review of ApplicationReview of System Design CriteriaPilot TestingEngineering and Design
![Page 22: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/22.jpg)
AFS Conference 2003, Reno, NV
Key Factors of System DesignKey Factors of System Design
Stability of ProductShear SensitivityVolume of Product to be ProcessedUp and Down Stream Operation Steps
![Page 23: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/23.jpg)
AFS Conference 2003, Reno, NV
Steps in the Design ProcessSteps in the Design Process
Review of System Design CriteriaMaterials of ConstructionDesign Specifications
• Food industry Standards “Food Grade”• Dairy Standards 3A• Pharmaceutical / Biotechnology Standards GMP Compliance
Specialized RequirementsXP system
![Page 24: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/24.jpg)
AFS Conference 2003, Reno, NV
GMP Regulatory Compliance RequirementsGMP Regulatory Compliance Requirements
Examples of Validation Documentation (if required)Bill of MaterialsCertificates of Compliance and ConformanceComponent Calibration VerificationMaterial Test ReportsFactory Acceptance Test (FAT)Weld logs, weld maps, etc.
![Page 25: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/25.jpg)
AFS Conference 2003, Reno, NV
Steps in the Design ProcessSteps in the Design Process
Pilot TestingTest on representative feed(s)Validate membrane type and configurationCompilation and review of data
Membrane Configuration SelectionSelection between spiral, ceramic, hollow fiber, cassette, others
![Page 26: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/26.jpg)
AFS Conference 2003, Reno, NV
Engineering and Design CriteriaEngineering and Design Criteria
Membrane Design FactorsType and Material of MembraneConfiguration and Construction of MembraneHousing and Module Design
System Design CriteriaOperating 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
![Page 27: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/27.jpg)
AFS Conference 2003, Reno, NV
Engineering and Design CriteriaEngineering and Design Criteria
Integration of System Design with Plant ProcessCoordination with upstream operations, i.e. fermentersCoordination with downstream operations, i.e. extraction, chromatographic separation, formulation
![Page 28: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/28.jpg)
AFS Conference 2003, Reno, NV
SummarySummary
With proper design and successful integration in the plant’s process, a membrane filtration system can become a key and integral process step within the recovery operation of a biotechnology processor.
![Page 29: Design of Membrane Filtration Systems for Biotechnology ... · o d Pharmaceuticals Ch e m i c a l Bio-pharmaceuticals • Antibiotics • Proteins & peptides • Vaccines • Vitamins](https://reader034.fdocuments.us/reader034/viewer/2022052003/6016e00bbc135b73d1709ec0/html5/thumbnails/29.jpg)
April 15, 2003 Template 29AFS Conference 2003, Reno, NV
Americas & Rest of the worldGEA Filtration DivisionNiro Inc.1600 O’Keefe Road Hudson, WI 54016USA+1 715 386 9371 Telephone+1 715 386 9376 [email protected]
Europe, Near & Middle EastDairy, Biotech & PharmaGEA Filtration DivisionGEA Liquid Processing
Scandinavia A/SNorskovvej 1 b8660 SkanderborgDenmark+45 70 15 22 00 Telephone+45 70 15 22 44 [email protected]
Food & Waste WaterGEA Filtration DivisionGEA Wiegand GmbHEinsteinstrasse 9-1576275 EttlingenGermany+49 7243 7050 Telephone+49 7243 7053 30 [email protected]
NZ & AustraliaLiquid Technologies DivisionNiro (NZ) Limited356 Church StreetPenrose, AucklandNew Zealand+64 9 526 3877 Telephone+64 9 526 3873 [email protected]
Liquid Technologies DivisionNiro Australia Pty Limited141 St. Georges RoadN Fitzroy, Victoria3068Australia+61 3 9482 6333 Telephone+61 3 9482 6366 [email protected]
Who is GEA Filtration ?Who is GEA Filtration ?