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Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry
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Single-Use Technology - A Practical Guide to Design and Implementation (Paperback, 2nd edition)
Loot Price: R1,867
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Single-Use Technology - A Practical Guide to Design and Implementation (Paperback, 2nd edition)
Series: De Gruyter STEM
Expected to ship within 10 - 15 working days
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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.
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