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Single-Use Technology Adriana G. Lopes

Single-Use Technology By Adriana G. Lopes

Single-Use Technology by Adriana G. Lopes


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Single-Use Technology Summary

Single-Use Technology: A Practical Guide to Design and Implementation by Adriana G. Lopes

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 Adriana G. Lopes

Dr. Adriana Gouveia Lopes; Dr. Andrew Brown, Independent Consultants to the Biopharmaceutical Industry, London, United Kingdom.

Additional information

NLS9783110640557
9783110640557
3110640554
Single-Use Technology: A Practical Guide to Design and Implementation by Adriana G. Lopes
New
Paperback
De Gruyter
2019-06-17
154
N/A
Book picture is for illustrative purposes only, actual binding, cover or edition may vary.
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