Single-Use Technology
A Practical Guide to Design and Implementation
Seiten
2019
|
2nd edition
De Gruyter (Verlag)
978-3-11-064055-7 (ISBN)
De Gruyter (Verlag)
978-3-11-064055-7 (ISBN)
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.
Dr. Adriana Gouveia Lopes; Dr. Andrew Brown, Independent Consultants to the Biopharmaceutical Industry, London, United Kingdom.
| Erscheinungsdatum | 18.06.2019 |
|---|---|
| Reihe/Serie | De Gruyter STEM |
| Zusatzinfo | 30 b/w ill., 30 b/w tbl. |
| Verlagsort | Berlin/Boston |
| Sprache | englisch |
| Maße | 170 x 240 mm |
| Gewicht | 323 g |
| Themenwelt | Naturwissenschaften ► Chemie ► Technische Chemie |
| Technik | |
| Schlagworte | Allied Health Services • Biopharmaceutical. • Biopharmazeutikum • Chemische Technik • Chemistry • Clinical • Industrial & Technical • Industrial Design • Medical • MEDICAL / Allied Health Services / Medical Technology • Medical technology • organic • Organic Chemistry • Pharmaceutical and Medicinal Chemistry • Product • Science • SCIENCE / Chemistry / Clinical • SCIENCE / Chemistry / Industrial & Technical • SCIENCE / Chemistry / Organic • Technical & Manufacturing Industries & Trades • TECHNOLOGY & ENGINEERING • Technology & Engineering / Industrial Design / Product • Technology & Engineering / Technical & Manufacturing Industries & Trades |
| ISBN-10 | 3-11-064055-4 / 3110640554 |
| ISBN-13 | 978-3-11-064055-7 / 9783110640557 |
| Zustand | Neuware |
| Haben Sie eine Frage zum Produkt? |
Mehr entdecken
aus dem Bereich
aus dem Bereich
Grundlagen, technische Anwendungen, Rohstoffe, Analytik und …
Buch | Softcover (2023)
Springer Vieweg (Verlag)
CHF 55,95
erneuerbare Energien und Speichertechnologien für die Energiewende
Buch | Softcover (2023)
De Gruyter Oldenbourg (Verlag)
CHF 97,90
Daten, Formeln, Normen, vergleichende Betrachtungen
Buch | Softcover (2024)
Europa-Lehrmittel (Verlag)
CHF 54,45
