Single-Use Technology: A Practical Guide to Design and Implementation
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 proc...
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| Main Authors: | , |
|---|---|
| Format: | Electronic eBook |
| Language: | English |
| Published: |
Berlin ; Boston
De Gruyter
[2019]
|
| Edition: | 2nd edition |
| Series: | De Gruyter STEM
|
| Subjects: | |
| Links: | https://doi.org/10.1515/9783110640588 https://doi.org/10.1515/9783110640588 https://doi.org/10.1515/9783110640588 https://doi.org/10.1515/9783110640588 https://doi.org/10.1515/9783110640588 https://doi.org/10.1515/9783110640588 https://doi.org/10.1515/9783110640588 https://doi.org/10.1515/9783110640588 |
| Summary: | 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 |
| Item Description: | Description based on online resource; title from PDF title page (publisher's Web site, viewed 23. Jul 2019) |
| Physical Description: | 1 online resource (154 pages) |
| ISBN: | 9783110640588 |
| DOI: | 10.1515/9783110640588 |
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| id | DE-604.BV046089927 |
| illustrated | Not Illustrated |
| indexdate | 2025-02-18T17:11:38Z |
| institution | BVB |
| isbn | 9783110640588 |
| language | English |
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| spelling | Lopes, Adriana G. Verfasser aut Single-Use Technology A Practical Guide to Design and Implementation Adriana G. Lopes, Andrew Brown 2nd edition Berlin ; Boston De Gruyter [2019] © 2019 1 online resource (154 pages) txt rdacontent c rdamedia cr rdacarrier De Gruyter STEM Description based on online resource; title from PDF title page (publisher's Web site, viewed 23. Jul 2019) 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 In English SCIENCE / Chemistry / Industrial & Technical bisacsh Einwegprodukt (DE-588)4745574-3 gnd rswk-swf Pharmazeutische Technologie (DE-588)4045699-7 gnd rswk-swf Biopharmazie (DE-588)4006890-0 gnd rswk-swf Pharmazeutische Technologie (DE-588)4045699-7 s Biopharmazie (DE-588)4006890-0 s Einwegprodukt (DE-588)4745574-3 s 1\p DE-604 Brown, Andrew aut Erscheint auch als Druck-Ausgabe 9783110640557 https://doi.org/10.1515/9783110640588 Verlag URL des Erstveröffentlichers Volltext 1\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk |
| spellingShingle | Lopes, Adriana G. Brown, Andrew Single-Use Technology A Practical Guide to Design and Implementation SCIENCE / Chemistry / Industrial & Technical bisacsh Einwegprodukt (DE-588)4745574-3 gnd Pharmazeutische Technologie (DE-588)4045699-7 gnd Biopharmazie (DE-588)4006890-0 gnd |
| subject_GND | (DE-588)4745574-3 (DE-588)4045699-7 (DE-588)4006890-0 |
| title | Single-Use Technology A Practical Guide to Design and Implementation |
| title_auth | Single-Use Technology A Practical Guide to Design and Implementation |
| title_exact_search | Single-Use Technology A Practical Guide to Design and Implementation |
| title_full | Single-Use Technology A Practical Guide to Design and Implementation Adriana G. Lopes, Andrew Brown |
| title_fullStr | Single-Use Technology A Practical Guide to Design and Implementation Adriana G. Lopes, Andrew Brown |
| title_full_unstemmed | Single-Use Technology A Practical Guide to Design and Implementation Adriana G. Lopes, Andrew Brown |
| title_short | Single-Use Technology |
| title_sort | single use technology a practical guide to design and implementation |
| title_sub | A Practical Guide to Design and Implementation |
| topic | SCIENCE / Chemistry / Industrial & Technical bisacsh Einwegprodukt (DE-588)4745574-3 gnd Pharmazeutische Technologie (DE-588)4045699-7 gnd Biopharmazie (DE-588)4006890-0 gnd |
| topic_facet | SCIENCE / Chemistry / Industrial & Technical Einwegprodukt Pharmazeutische Technologie Biopharmazie |
| url | https://doi.org/10.1515/9783110640588 |
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