Synopsis
Single-Use Technology (SUT) 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.
Having become readily available for all processing operations within the biopharmaceutical industry, SUT 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 book presents approaches for the implementation within various end-user facilities and systems, SUT within regulatory frameworks (ICH Q8, Q9, Q10 and GMP), standardisation and assessment strategies, specifation of user requirements and SUT design, risk assessment and evaluation as well as qualification for different SUT types.
Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.
À propos de l?auteur
Dr. Adriana Gouveia Lopes; Dr. Andrew Brown, Independent Consultants to the Biopharmaceutical Industry, London, United Kingdom.
Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.
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Single-Use Technology: A Practical Guide to Design and Implementation (De Gruyter STEM)
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Single-Use Technology
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Paperback. Etat : New. 2nd edition. Single-Use Technology (SUT) 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. Having become readily available for all processing operations within the biopharmaceutical industry, SUT 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 book presents approaches for the implementation within various end-user facilities and systems, SUT within regulatory frameworks (ICH Q8, Q9, Q10 and GMP), standardisation and assessment strategies, specifation of user requirements and SUT design, risk assessment and evaluation as well as qualification for different SUT types. N° de réf. du vendeur LU-9783110640557
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PAP. Etat : New. New Book. Delivered from our UK warehouse in 4 to 14 business days. THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000. N° de réf. du vendeur IQ-9783110640557
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Single-Use Technology: A Practical Guide to Design and Implementation (De Gruyter STEM)
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Single-use Technology: A Practical Guide to Design and Implementation
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Paperback. Etat : Brand New. 2nd edition edition. 195 pages. 9.44x6.69x0.50 inches. In Stock. N° de réf. du vendeur x-3110640554
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Single-Use Technology
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De Gruyter, Mercury Learning And Information Jun 2019, 2019
ISBN 10 : 3110640554
ISBN 13 : 9783110640557
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Taschenbuch. Etat : Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -Single-Use Technology (SUT) 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. Having become readily available for all processing operations within the biopharmaceutical industry, SUT 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 book presents approaches for the implementation within various end-user facilities and systems, SUT within regulatory frameworks (ICH Q8, Q9, Q10 and GMP), standardisation and assessment strategies, specifation of user requirements and SUT design, risk assessment and evaluation as well as qualification for different SUT types. 154 pp. Englisch. N° de réf. du vendeur 9783110640557
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Single-Use Technology
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Paperback. Etat : New. 2nd edition. Single-Use Technology (SUT) 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. Having become readily available for all processing operations within the biopharmaceutical industry, SUT 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 book presents approaches for the implementation within various end-user facilities and systems, SUT within regulatory frameworks (ICH Q8, Q9, Q10 and GMP), standardisation and assessment strategies, specifation of user requirements and SUT design, risk assessment and evaluation as well as qualification for different SUT types. N° de réf. du vendeur LU-9783110640557
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Single-Use Technology
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De Gruyter, 2019
ISBN 10 : 3110640554
ISBN 13 : 9783110640557
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Kartoniert / Broschiert. Etat : New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Dr. Adriana Gouveia Lopes Dr. Andrew Brown, Independent Consultants to the Biopharmaceutical Industry, London, United Kingdom. Single-Use Technology (SUT) is the first compreh. N° de réf. du vendeur 284218299
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