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...
Gespeichert in:
| Hauptverfasser: | , |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Berlin ; Boston
De Gruyter
[2019]
|
| Ausgabe: | 2nd edition |
| Schriftenreihe: | De Gruyter STEM
|
| Schlagworte: | |
| Online-Zugang: | FAB01 FAW01 FCO01 FHA01 FHM01 FKE01 FLA01 UPA01 Volltext |
| Zusammenfassung: | 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 |
| Beschreibung: | Description based on online resource; title from PDF title page (publisher's Web site, viewed 23. Jul 2019) |
| Beschreibung: | 1 online resource (154 pages) |
| ISBN: | 9783110640588 |
| DOI: | 10.1515/9783110640588 |
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Datensatz im Suchindex
| _version_ | 1804180387937648640 |
|---|---|
| any_adam_object | |
| author | Lopes, Adriana G. Brown, Andrew |
| author_facet | Lopes, Adriana G. Brown, Andrew |
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| author_sort | Lopes, Adriana G. |
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| id | DE-604.BV046089927 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-10T08:34:58Z |
| institution | BVB |
| isbn | 9783110640588 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-031470929 |
| oclc_num | 1189951465 |
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| owner_facet | DE-1046 DE-Aug4 DE-859 DE-860 DE-739 DE-M347 DE-1043 DE-858 |
| physical | 1 online resource (154 pages) |
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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 Biopharmazie (DE-588)4006890-0 gnd rswk-swf Einwegprodukt (DE-588)4745574-3 gnd rswk-swf Pharmazeutische Technologie (DE-588)4045699-7 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 Biopharmazie (DE-588)4006890-0 gnd Einwegprodukt (DE-588)4745574-3 gnd Pharmazeutische Technologie (DE-588)4045699-7 gnd |
| subject_GND | (DE-588)4006890-0 (DE-588)4745574-3 (DE-588)4045699-7 |
| 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 Biopharmazie (DE-588)4006890-0 gnd Einwegprodukt (DE-588)4745574-3 gnd Pharmazeutische Technologie (DE-588)4045699-7 gnd |
| topic_facet | SCIENCE / Chemistry / Industrial & Technical Biopharmazie Einwegprodukt Pharmazeutische Technologie |
| url | https://doi.org/10.1515/9783110640588 |
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