Single-Use Technology - (De Gruyter Stem) by Adriana G Lopes & Andrew Brown (Paperback)
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Highlights
- 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.
- About the Author: Dr. Adriana Gouveia Lopes; Dr. Andrew Brown, Independent Consultants to the Biopharmaceutical Industry, London, United Kingdom.
- 154 Pages
- Science, Chemistry
- Series Name: de Gruyter Stem
Description
About the Book
Single-use technology (SUT) has the potential to reduce capital costs, improve plant throughput and reduce the risk of cross-contamination in the biopharmaceutical industry. However, clear guidelines are needed for its implementation in a validatedBook Synopsis
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.
About the Author
Dr. Adriana Gouveia Lopes; Dr. Andrew Brown, Independent Consultants to the Biopharmaceutical Industry, London, United Kingdom.
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