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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.
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.
| Erscheinungsjahr: | 2019 |
|---|---|
| Fachbereich: | Chemische Technik |
| Genre: | Mathematik, Medizin, Naturwissenschaften, Technik |
| Rubrik: | Naturwissenschaften & Technik |
| Medium: | Taschenbuch |
| Reihe: | De Gruyter STEM |
| Inhalt: |
VIII
146 S. 30 s/w Illustr. 30 s/w Tab. 30 b/w ill. 30 b/w tbl. |
| ISBN-13: | 9783110640557 |
| ISBN-10: | 3110640554 |
| Sprache: | Englisch |
| Ausstattung / Beilage: | Paperback |
| Einband: | Kartoniert / Broschiert |
| Autor: |
Brown, Andrew
Lopes, Adriana G. |
| Auflage: | 2nd edition |
| Hersteller: |
De Gruyter
de Gruyter, Walter, GmbH De Gruyter STEM |
| Maße: | 240 x 170 x 9 mm |
| Von/Mit: | Andrew Brown (u. a.) |
| Erscheinungsdatum: | 17.06.2019 |
| Gewicht: | 0,274 kg |
| Erscheinungsjahr: | 2019 |
|---|---|
| Fachbereich: | Chemische Technik |
| Genre: | Mathematik, Medizin, Naturwissenschaften, Technik |
| Rubrik: | Naturwissenschaften & Technik |
| Medium: | Taschenbuch |
| Reihe: | De Gruyter STEM |
| Inhalt: |
VIII
146 S. 30 s/w Illustr. 30 s/w Tab. 30 b/w ill. 30 b/w tbl. |
| ISBN-13: | 9783110640557 |
| ISBN-10: | 3110640554 |
| Sprache: | Englisch |
| Ausstattung / Beilage: | Paperback |
| Einband: | Kartoniert / Broschiert |
| Autor: |
Brown, Andrew
Lopes, Adriana G. |
| Auflage: | 2nd edition |
| Hersteller: |
De Gruyter
de Gruyter, Walter, GmbH De Gruyter STEM |
| Maße: | 240 x 170 x 9 mm |
| Von/Mit: | Andrew Brown (u. a.) |
| Erscheinungsdatum: | 17.06.2019 |
| Gewicht: | 0,274 kg |
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