Disposable Bioprocessing Systems.
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Place / Publishing House: | Milton : : Taylor & Francis Group,, 2011. ©2012. |
Year of Publication: | 2011 |
Edition: | 1st ed. |
Language: | English |
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Physical Description: | 1 online resource (323 pages) |
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Niazi, Sarfaraz K. Disposable Bioprocessing Systems. 1st ed. Milton : Taylor & Francis Group, 2011. ©2012. 1 online resource (323 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Cover -- Half Title -- Title Page -- Copyright Page -- Dedication -- Table of Contents -- Disclaimer -- Preface -- Author -- 1 The Bioprocessing Industry-An Introduction -- Summary -- Appendix I: Complete Lines of Disposable Systems -- Chromatography Columns -- 2 Safety of Disposable Systems -- Polymers and Additives -- Material Selection -- Testing -- Partnering with Vendors -- Responsibility of Sponsors -- Regulatory Requirements -- United States and Canada -- Europe -- Risk Assessment -- Appendix I: Use of International Standard ISO-10993 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" -- Background -- International Guidance and Standards -- 3 Containers -- Proprietary Bag Suppliers -- Generic Bag Suppliers -- Tank Liners -- 2D Fluid Containers -- 2D Powder Bags -- 3D Bags -- Transportation Container -- Summary -- 4 Mixing Systems -- Types of Mixing -- Stirring Magnetic Mixer -- Stirring Mechanical Coupling Mixer -- Tumbling Mixer -- Oscillating Mixer -- Peristaltic Mixer -- Summary -- 5 Disposable Bioreactors -- Xcellerex Bioreactor -- Cellexus Bioreactor -- CELL-Tainer Cell Culture System -- Wave-Mixed Bioreactors -- Stirred Single-Use Bioreactors -- Integrity™ PadReactor™ -- CellReady Bioreactor -- Orbitally Shaken Single-Use Bioreactors -- Bioreactor Selection -- The Game Changers in Disposable Bioreactor Industry -- Appendix I. Current Literature Survey of the Use of Disposable Systems -- 6 Connectors and Transfers -- Tubing -- Fittings and Accessories -- Pumps -- Aseptic Coupling -- Aseptic Connectors -- Welding -- Aseptic Transfer Systems -- Tube Sealers -- Sampling -- Conclusion -- 7 Controls -- Sampling Systems -- TRACE System -- Optical Sensors -- Biomass Sensors -- Electrochemical Sensors -- Pressure Sensors -- Conclusions -- 8 Downstream Processing -- The Case of Monoclonal Antibodies: A GE Report. Membrane Chromatography -- Virus Removal -- Buffers -- Fluid Management -- Bioseparation -- Depth Filtration -- Ultrafiltration -- Integrated Systems -- 9 Filling and Finishing Systems -- Robert Bosch Packaging Systems -- PDC Aseptic Filling Systems -- Summary -- 10 Filtration -- Dead-End Filtration -- Cross-Flow Filtration -- Filtration Media -- Polymer Membranes -- Microfiltration Cross-Flow -- BioOptimal MF-SL™ -- TechniKrom™ -- GE Healthcare -- Spectrum -- Conclusion -- 11 Regulatory Compliance -- Regulatory Barriers -- Irradiation and Sterilization Validation -- 12 Environmental Concerns -- Biosafety -- Liquid Waste -- Incineration -- Pyrolysis -- Grind and Autoclave -- Landfill -- Treatment -- Overall Environmental Impact -- Summary -- Appendix B: Classification of Human Etiologic Agents on the Basis of Hazard -- Appendix B-I: Risk Group 1 (RG1) Agents -- Appendix B-II: Risk Group 2 (RG2) Agents -- Appendix B-II-A: Risk Group 2 (RG2)-Bacterial Agents Including Chlamydia -- Appendix B-II-B: Risk Group 2 (RG2)-Fungal Agents -- Appendix B-II-C: Risk Group 2 (RG2)-Parasitic Agents -- Appendix B-II-D: Risk Group 2 (RG2)-Viruses -- Appendix B-III: Risk Group 3 (RG3) Agents -- Appendix B-III-A: Risk Group 3 (RG3)-Bacterial Agents Including Rickettsia -- Appendix B-III-B: Risk Group 3 (RG3)-Fungal Agents -- Appendix B-III-C: Risk Group 3 (RG3)-Parasitic Agents -- Appendix B-III-D: Risk Group 3 (RG3)-Viruses and Prions -- Appendix B-IV: Risk Group 4 (RG4) Agents -- Appendix B-IV-A: Risk Group 4 (RG4)-Bacterial Agents -- Appendix B-IV-B: Risk Group 4 (RG4)-Fungal Agents -- Appendix B-IV-C Risk Group 4 (RG4)-Parasitic Agents -- Appendix B-IV-D Risk Group 4 (RG4)-Viral Agents -- Appendix B-V: Animal Viral Etiologic Agents in Common Use -- Appendix B-V-1: Murine Retroviral Vectors. Appendix K: Physical Containment for Large-Scale Uses of Organisms Containing Recombinant DNA Molecules -- Appendix K-I: Selection of Physical Containment Levels -- Appendix K-II: Good Large-Scale Practice (GLSP) -- Appendix K-III: Biosafety Level 1 (BL1)-Large Scale -- Appendix K-IV: Biosafety Level 2 (BL2)-Large Scale -- Appendix K-V: Biosafety Level 3 (BL3)-Large Scale -- Appendix K-VI: Footnotes of Appendix K -- Appendix K-VII: Definitions to Accompany Containment Grid and Appendix K -- 13 Epilogue -- Large Scale -- Integrity -- Flexibility -- Universal Use -- Scale-Up -- Cost -- Out of Steam -- Validation -- Leachables -- Animal Origins -- The Stainless Challenge -- Standardization -- Upstream -- Compliance -- High-Expression Cell Lines -- Flexible Factories -- Small Companies -- Unitary Systems -- Biosafety -- Autoclaves -- SIP/CIP -- Distilled Water Loops -- Low Ceiling Heights -- Modular Systems -- Gentle Mixing -- 2D Bags -- Fluoropolymer Bags -- Protein Capture -- Downstream Processing -- Closed Systems -- Molecule-Specific Facilities -- Max-Dispo Concept -- Leachables/Extractables -- Multipurpose Disposable Bioreactors -- Bibliography -- Index. Description based on publisher supplied metadata and other sources. Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2024. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries. Electronic books. Print version: Niazi, Sarfaraz K. Disposable Bioprocessing Systems Milton : Taylor & Francis Group,c2011 9781439866702 ProQuest (Firm) https://ebookcentral.proquest.com/lib/oeawat/detail.action?docID=7245594 Click to View |
language |
English |
format |
eBook |
author |
Niazi, Sarfaraz K. |
spellingShingle |
Niazi, Sarfaraz K. Disposable Bioprocessing Systems. Cover -- Half Title -- Title Page -- Copyright Page -- Dedication -- Table of Contents -- Disclaimer -- Preface -- Author -- 1 The Bioprocessing Industry-An Introduction -- Summary -- Appendix I: Complete Lines of Disposable Systems -- Chromatography Columns -- 2 Safety of Disposable Systems -- Polymers and Additives -- Material Selection -- Testing -- Partnering with Vendors -- Responsibility of Sponsors -- Regulatory Requirements -- United States and Canada -- Europe -- Risk Assessment -- Appendix I: Use of International Standard ISO-10993 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" -- Background -- International Guidance and Standards -- 3 Containers -- Proprietary Bag Suppliers -- Generic Bag Suppliers -- Tank Liners -- 2D Fluid Containers -- 2D Powder Bags -- 3D Bags -- Transportation Container -- Summary -- 4 Mixing Systems -- Types of Mixing -- Stirring Magnetic Mixer -- Stirring Mechanical Coupling Mixer -- Tumbling Mixer -- Oscillating Mixer -- Peristaltic Mixer -- Summary -- 5 Disposable Bioreactors -- Xcellerex Bioreactor -- Cellexus Bioreactor -- CELL-Tainer Cell Culture System -- Wave-Mixed Bioreactors -- Stirred Single-Use Bioreactors -- Integrity™ PadReactor™ -- CellReady Bioreactor -- Orbitally Shaken Single-Use Bioreactors -- Bioreactor Selection -- The Game Changers in Disposable Bioreactor Industry -- Appendix I. Current Literature Survey of the Use of Disposable Systems -- 6 Connectors and Transfers -- Tubing -- Fittings and Accessories -- Pumps -- Aseptic Coupling -- Aseptic Connectors -- Welding -- Aseptic Transfer Systems -- Tube Sealers -- Sampling -- Conclusion -- 7 Controls -- Sampling Systems -- TRACE System -- Optical Sensors -- Biomass Sensors -- Electrochemical Sensors -- Pressure Sensors -- Conclusions -- 8 Downstream Processing -- The Case of Monoclonal Antibodies: A GE Report. Membrane Chromatography -- Virus Removal -- Buffers -- Fluid Management -- Bioseparation -- Depth Filtration -- Ultrafiltration -- Integrated Systems -- 9 Filling and Finishing Systems -- Robert Bosch Packaging Systems -- PDC Aseptic Filling Systems -- Summary -- 10 Filtration -- Dead-End Filtration -- Cross-Flow Filtration -- Filtration Media -- Polymer Membranes -- Microfiltration Cross-Flow -- BioOptimal MF-SL™ -- TechniKrom™ -- GE Healthcare -- Spectrum -- Conclusion -- 11 Regulatory Compliance -- Regulatory Barriers -- Irradiation and Sterilization Validation -- 12 Environmental Concerns -- Biosafety -- Liquid Waste -- Incineration -- Pyrolysis -- Grind and Autoclave -- Landfill -- Treatment -- Overall Environmental Impact -- Summary -- Appendix B: Classification of Human Etiologic Agents on the Basis of Hazard -- Appendix B-I: Risk Group 1 (RG1) Agents -- Appendix B-II: Risk Group 2 (RG2) Agents -- Appendix B-II-A: Risk Group 2 (RG2)-Bacterial Agents Including Chlamydia -- Appendix B-II-B: Risk Group 2 (RG2)-Fungal Agents -- Appendix B-II-C: Risk Group 2 (RG2)-Parasitic Agents -- Appendix B-II-D: Risk Group 2 (RG2)-Viruses -- Appendix B-III: Risk Group 3 (RG3) Agents -- Appendix B-III-A: Risk Group 3 (RG3)-Bacterial Agents Including Rickettsia -- Appendix B-III-B: Risk Group 3 (RG3)-Fungal Agents -- Appendix B-III-C: Risk Group 3 (RG3)-Parasitic Agents -- Appendix B-III-D: Risk Group 3 (RG3)-Viruses and Prions -- Appendix B-IV: Risk Group 4 (RG4) Agents -- Appendix B-IV-A: Risk Group 4 (RG4)-Bacterial Agents -- Appendix B-IV-B: Risk Group 4 (RG4)-Fungal Agents -- Appendix B-IV-C Risk Group 4 (RG4)-Parasitic Agents -- Appendix B-IV-D Risk Group 4 (RG4)-Viral Agents -- Appendix B-V: Animal Viral Etiologic Agents in Common Use -- Appendix B-V-1: Murine Retroviral Vectors. Appendix K: Physical Containment for Large-Scale Uses of Organisms Containing Recombinant DNA Molecules -- Appendix K-I: Selection of Physical Containment Levels -- Appendix K-II: Good Large-Scale Practice (GLSP) -- Appendix K-III: Biosafety Level 1 (BL1)-Large Scale -- Appendix K-IV: Biosafety Level 2 (BL2)-Large Scale -- Appendix K-V: Biosafety Level 3 (BL3)-Large Scale -- Appendix K-VI: Footnotes of Appendix K -- Appendix K-VII: Definitions to Accompany Containment Grid and Appendix K -- 13 Epilogue -- Large Scale -- Integrity -- Flexibility -- Universal Use -- Scale-Up -- Cost -- Out of Steam -- Validation -- Leachables -- Animal Origins -- The Stainless Challenge -- Standardization -- Upstream -- Compliance -- High-Expression Cell Lines -- Flexible Factories -- Small Companies -- Unitary Systems -- Biosafety -- Autoclaves -- SIP/CIP -- Distilled Water Loops -- Low Ceiling Heights -- Modular Systems -- Gentle Mixing -- 2D Bags -- Fluoropolymer Bags -- Protein Capture -- Downstream Processing -- Closed Systems -- Molecule-Specific Facilities -- Max-Dispo Concept -- Leachables/Extractables -- Multipurpose Disposable Bioreactors -- Bibliography -- Index. |
author_facet |
Niazi, Sarfaraz K. |
author_variant |
s k n sk skn |
author_sort |
Niazi, Sarfaraz K. |
title |
Disposable Bioprocessing Systems. |
title_full |
Disposable Bioprocessing Systems. |
title_fullStr |
Disposable Bioprocessing Systems. |
title_full_unstemmed |
Disposable Bioprocessing Systems. |
title_auth |
Disposable Bioprocessing Systems. |
title_new |
Disposable Bioprocessing Systems. |
title_sort |
disposable bioprocessing systems. |
publisher |
Taylor & Francis Group, |
publishDate |
2011 |
physical |
1 online resource (323 pages) |
edition |
1st ed. |
contents |
Cover -- Half Title -- Title Page -- Copyright Page -- Dedication -- Table of Contents -- Disclaimer -- Preface -- Author -- 1 The Bioprocessing Industry-An Introduction -- Summary -- Appendix I: Complete Lines of Disposable Systems -- Chromatography Columns -- 2 Safety of Disposable Systems -- Polymers and Additives -- Material Selection -- Testing -- Partnering with Vendors -- Responsibility of Sponsors -- Regulatory Requirements -- United States and Canada -- Europe -- Risk Assessment -- Appendix I: Use of International Standard ISO-10993 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" -- Background -- International Guidance and Standards -- 3 Containers -- Proprietary Bag Suppliers -- Generic Bag Suppliers -- Tank Liners -- 2D Fluid Containers -- 2D Powder Bags -- 3D Bags -- Transportation Container -- Summary -- 4 Mixing Systems -- Types of Mixing -- Stirring Magnetic Mixer -- Stirring Mechanical Coupling Mixer -- Tumbling Mixer -- Oscillating Mixer -- Peristaltic Mixer -- Summary -- 5 Disposable Bioreactors -- Xcellerex Bioreactor -- Cellexus Bioreactor -- CELL-Tainer Cell Culture System -- Wave-Mixed Bioreactors -- Stirred Single-Use Bioreactors -- Integrity™ PadReactor™ -- CellReady Bioreactor -- Orbitally Shaken Single-Use Bioreactors -- Bioreactor Selection -- The Game Changers in Disposable Bioreactor Industry -- Appendix I. Current Literature Survey of the Use of Disposable Systems -- 6 Connectors and Transfers -- Tubing -- Fittings and Accessories -- Pumps -- Aseptic Coupling -- Aseptic Connectors -- Welding -- Aseptic Transfer Systems -- Tube Sealers -- Sampling -- Conclusion -- 7 Controls -- Sampling Systems -- TRACE System -- Optical Sensors -- Biomass Sensors -- Electrochemical Sensors -- Pressure Sensors -- Conclusions -- 8 Downstream Processing -- The Case of Monoclonal Antibodies: A GE Report. Membrane Chromatography -- Virus Removal -- Buffers -- Fluid Management -- Bioseparation -- Depth Filtration -- Ultrafiltration -- Integrated Systems -- 9 Filling and Finishing Systems -- Robert Bosch Packaging Systems -- PDC Aseptic Filling Systems -- Summary -- 10 Filtration -- Dead-End Filtration -- Cross-Flow Filtration -- Filtration Media -- Polymer Membranes -- Microfiltration Cross-Flow -- BioOptimal MF-SL™ -- TechniKrom™ -- GE Healthcare -- Spectrum -- Conclusion -- 11 Regulatory Compliance -- Regulatory Barriers -- Irradiation and Sterilization Validation -- 12 Environmental Concerns -- Biosafety -- Liquid Waste -- Incineration -- Pyrolysis -- Grind and Autoclave -- Landfill -- Treatment -- Overall Environmental Impact -- Summary -- Appendix B: Classification of Human Etiologic Agents on the Basis of Hazard -- Appendix B-I: Risk Group 1 (RG1) Agents -- Appendix B-II: Risk Group 2 (RG2) Agents -- Appendix B-II-A: Risk Group 2 (RG2)-Bacterial Agents Including Chlamydia -- Appendix B-II-B: Risk Group 2 (RG2)-Fungal Agents -- Appendix B-II-C: Risk Group 2 (RG2)-Parasitic Agents -- Appendix B-II-D: Risk Group 2 (RG2)-Viruses -- Appendix B-III: Risk Group 3 (RG3) Agents -- Appendix B-III-A: Risk Group 3 (RG3)-Bacterial Agents Including Rickettsia -- Appendix B-III-B: Risk Group 3 (RG3)-Fungal Agents -- Appendix B-III-C: Risk Group 3 (RG3)-Parasitic Agents -- Appendix B-III-D: Risk Group 3 (RG3)-Viruses and Prions -- Appendix B-IV: Risk Group 4 (RG4) Agents -- Appendix B-IV-A: Risk Group 4 (RG4)-Bacterial Agents -- Appendix B-IV-B: Risk Group 4 (RG4)-Fungal Agents -- Appendix B-IV-C Risk Group 4 (RG4)-Parasitic Agents -- Appendix B-IV-D Risk Group 4 (RG4)-Viral Agents -- Appendix B-V: Animal Viral Etiologic Agents in Common Use -- Appendix B-V-1: Murine Retroviral Vectors. Appendix K: Physical Containment for Large-Scale Uses of Organisms Containing Recombinant DNA Molecules -- Appendix K-I: Selection of Physical Containment Levels -- Appendix K-II: Good Large-Scale Practice (GLSP) -- Appendix K-III: Biosafety Level 1 (BL1)-Large Scale -- Appendix K-IV: Biosafety Level 2 (BL2)-Large Scale -- Appendix K-V: Biosafety Level 3 (BL3)-Large Scale -- Appendix K-VI: Footnotes of Appendix K -- Appendix K-VII: Definitions to Accompany Containment Grid and Appendix K -- 13 Epilogue -- Large Scale -- Integrity -- Flexibility -- Universal Use -- Scale-Up -- Cost -- Out of Steam -- Validation -- Leachables -- Animal Origins -- The Stainless Challenge -- Standardization -- Upstream -- Compliance -- High-Expression Cell Lines -- Flexible Factories -- Small Companies -- Unitary Systems -- Biosafety -- Autoclaves -- SIP/CIP -- Distilled Water Loops -- Low Ceiling Heights -- Modular Systems -- Gentle Mixing -- 2D Bags -- Fluoropolymer Bags -- Protein Capture -- Downstream Processing -- Closed Systems -- Molecule-Specific Facilities -- Max-Dispo Concept -- Leachables/Extractables -- Multipurpose Disposable Bioreactors -- Bibliography -- Index. |
isbn |
9781439866955 9781439866702 |
genre |
Electronic books. |
genre_facet |
Electronic books. |
url |
https://ebookcentral.proquest.com/lib/oeawat/detail.action?docID=7245594 |
illustrated |
Not Illustrated |
dewey-hundreds |
600 - Technology |
dewey-tens |
660 - Chemical engineering |
dewey-ones |
660 - Chemical engineering |
dewey-full |
660.6/3 |
dewey-sort |
3660.6 13 |
dewey-raw |
660.6/3 |
dewey-search |
660.6/3 |
oclc_num |
1202566273 |
work_keys_str_mv |
AT niazisarfarazk disposablebioprocessingsystems |
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(MiAaPQ)5007245594 (Au-PeEL)EBL7245594 (OCoLC)1202566273 |
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is_hierarchy_title |
Disposable Bioprocessing Systems. |
marc_error |
Info : MARC8 translation shorter than ISO-8859-1, choosing MARC8. --- [ 856 : z ] |
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