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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 |
| 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 |
| Einband: | Kartoniert / Broschiert |
| Autor: |
Brown, Andrew
Lopes, Adriana G. |
| Auflage: | 2nd edition |
| Hersteller: |
De Gruyter
Mercury Learning and Information |
| Verantwortliche Person für die EU: | Walter de Gruyter GmbH, De Gruyter GmbH, Genthiner Str. 13, D-10785 Berlin, productsafety@degruyterbrill.com |
| 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 |
| 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 |
| Einband: | Kartoniert / Broschiert |
| Autor: |
Brown, Andrew
Lopes, Adriana G. |
| Auflage: | 2nd edition |
| Hersteller: |
De Gruyter
Mercury Learning and Information |
| Verantwortliche Person für die EU: | Walter de Gruyter GmbH, De Gruyter GmbH, Genthiner Str. 13, D-10785 Berlin, productsafety@degruyterbrill.com |
| 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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