Practical guide to single-use technology :: design and implementation /
Single-use technology (SUT) is now available for all processing operations within the biopharmaceutical industry. It has the potential to reduce capital costs, improve plant throughput and reduce the risk of cross-contamination. However, there are no clear guidelines to aid the end-user on implement...
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| Hauptverfasser: | , |
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| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Shawbury :
Smithers Rapra Technology,
©2016.
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| Schlagworte: | |
| Online-Zugang: | Volltext |
| Zusammenfassung: | Single-use technology (SUT) is now available for all processing operations within the biopharmaceutical industry. It has the potential to reduce capital costs, improve plant throughput and reduce the risk of cross-contamination. However, there are no clear guidelines to aid the end-user on implementation of these technologies into a validated, good manufacturing practice (GMP) environment. This handbook is the first comprehensive publication of practical considerations for each stage of the implementation process of SUT, and covers the selection, specification, design and qualification of systems to meet end-user requirements. Serving as an introduction and practical reference to this growing area of application within the biopharmaceutical industry, this handbook presents: An approach for SUT implementation within an end-users facility with examples for bioreactors, tangential-flow filtration and fill-finish systems; SUT within the context of regulatory guidance, such as ICH Q8, Q9, Q10 and GMP; Strategy for standardisation of single-use bag systems and assessment of extractables and leachables; Specifications of user requirements and design of specific SUT alongside process descriptions and flow diagrams; Strategies and tools to evaluate risk with examples of risk assessments applicable to design, processing and product quality; and Qualification approach for different SUT types. With the information presented in this book, engineers, researchers and professionals involved in biopharmaceuticals will be better prepared to plan and make effective decisions to design and implement SUT. |
| Beschreibung: | 1 online resource |
| Bibliographie: | Includes bibliographical references and index. |
| ISBN: | 1910242047 9781910242049 9781523105472 152310547X 9781911088127 1911088122 9781910242032 1910242039 |
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| 520 | 8 | |a Single-use technology (SUT) is now available for all processing operations within the biopharmaceutical industry. It has the potential to reduce capital costs, improve plant throughput and reduce the risk of cross-contamination. However, there are no clear guidelines to aid the end-user on implementation of these technologies into a validated, good manufacturing practice (GMP) environment. This handbook is the first comprehensive publication of practical considerations for each stage of the implementation process of SUT, and covers the selection, specification, design and qualification of systems to meet end-user requirements. Serving as an introduction and practical reference to this growing area of application within the biopharmaceutical industry, this handbook presents: An approach for SUT implementation within an end-users facility with examples for bioreactors, tangential-flow filtration and fill-finish systems; SUT within the context of regulatory guidance, such as ICH Q8, Q9, Q10 and GMP; Strategy for standardisation of single-use bag systems and assessment of extractables and leachables; Specifications of user requirements and design of specific SUT alongside process descriptions and flow diagrams; Strategies and tools to evaluate risk with examples of risk assessments applicable to design, processing and product quality; and Qualification approach for different SUT types. With the information presented in this book, engineers, researchers and professionals involved in biopharmaceuticals will be better prepared to plan and make effective decisions to design and implement SUT. | |
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| spelling | Lopes, Adriana G., author. Practical guide to single-use technology : design and implementation / Adriana G. Lopes and Andrew Brown. Shawbury : Smithers Rapra Technology, ©2016. 1 online resource text txt rdacontent computer c rdamedia online resource cr rdacarrier data file Print version record. Includes bibliographical references and index. Single-use technology (SUT) is now available for all processing operations within the biopharmaceutical industry. It has the potential to reduce capital costs, improve plant throughput and reduce the risk of cross-contamination. However, there are no clear guidelines to aid the end-user on implementation of these technologies into a validated, good manufacturing practice (GMP) environment. This handbook is the first comprehensive publication of practical considerations for each stage of the implementation process of SUT, and covers the selection, specification, design and qualification of systems to meet end-user requirements. Serving as an introduction and practical reference to this growing area of application within the biopharmaceutical industry, this handbook presents: An approach for SUT implementation within an end-users facility with examples for bioreactors, tangential-flow filtration and fill-finish systems; SUT within the context of regulatory guidance, such as ICH Q8, Q9, Q10 and GMP; Strategy for standardisation of single-use bag systems and assessment of extractables and leachables; Specifications of user requirements and design of specific SUT alongside process descriptions and flow diagrams; Strategies and tools to evaluate risk with examples of risk assessments applicable to design, processing and product quality; and Qualification approach for different SUT types. With the information presented in this book, engineers, researchers and professionals involved in biopharmaceuticals will be better prepared to plan and make effective decisions to design and implement SUT. Pharmaceutical biotechnology. http://id.loc.gov/authorities/subjects/sh90004049 Medical supplies, Disposable. http://id.loc.gov/authorities/subjects/sh85083041 Disposable medical devices. http://id.loc.gov/authorities/subjects/sh00005324 Disposable Equipment https://id.nlm.nih.gov/mesh/D004209 Biotechnologie pharmaceutique. Matériel médical jetable. MEDICAL Pharmacology. bisacsh Disposable medical devices fast Medical supplies, Disposable fast Pharmaceutical biotechnology fast Brown, Andrew, author. has work: Practical Guide to Single-use Technology (Text) https://id.oclc.org/worldcat/entity/E39PD37xFGP8k4C9gbDjpcdgjC https://id.oclc.org/worldcat/ontology/hasWork FWS01 ZDB-4-EBA FWS_PDA_EBA https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=1365876 Volltext |
| spellingShingle | Lopes, Adriana G. Brown, Andrew Practical guide to single-use technology : design and implementation / Pharmaceutical biotechnology. http://id.loc.gov/authorities/subjects/sh90004049 Medical supplies, Disposable. http://id.loc.gov/authorities/subjects/sh85083041 Disposable medical devices. http://id.loc.gov/authorities/subjects/sh00005324 Disposable Equipment https://id.nlm.nih.gov/mesh/D004209 Biotechnologie pharmaceutique. Matériel médical jetable. MEDICAL Pharmacology. bisacsh Disposable medical devices fast Medical supplies, Disposable fast Pharmaceutical biotechnology fast |
| subject_GND | http://id.loc.gov/authorities/subjects/sh90004049 http://id.loc.gov/authorities/subjects/sh85083041 http://id.loc.gov/authorities/subjects/sh00005324 https://id.nlm.nih.gov/mesh/D004209 |
| title | Practical guide to single-use technology : design and implementation / |
| title_auth | Practical guide to single-use technology : design and implementation / |
| title_exact_search | Practical guide to single-use technology : design and implementation / |
| title_full | Practical guide to single-use technology : design and implementation / Adriana G. Lopes and Andrew Brown. |
| title_fullStr | Practical guide to single-use technology : design and implementation / Adriana G. Lopes and Andrew Brown. |
| title_full_unstemmed | Practical guide to single-use technology : design and implementation / Adriana G. Lopes and Andrew Brown. |
| title_short | Practical guide to single-use technology : |
| title_sort | practical guide to single use technology design and implementation |
| title_sub | design and implementation / |
| topic | Pharmaceutical biotechnology. http://id.loc.gov/authorities/subjects/sh90004049 Medical supplies, Disposable. http://id.loc.gov/authorities/subjects/sh85083041 Disposable medical devices. http://id.loc.gov/authorities/subjects/sh00005324 Disposable Equipment https://id.nlm.nih.gov/mesh/D004209 Biotechnologie pharmaceutique. Matériel médical jetable. MEDICAL Pharmacology. bisacsh Disposable medical devices fast Medical supplies, Disposable fast Pharmaceutical biotechnology fast |
| topic_facet | Pharmaceutical biotechnology. Medical supplies, Disposable. Disposable medical devices. Disposable Equipment Biotechnologie pharmaceutique. Matériel médical jetable. MEDICAL Pharmacology. Disposable medical devices Medical supplies, Disposable Pharmaceutical biotechnology |
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