Single-Use Technology - A Practical Guide to Design and Implementation (Paperback, 2nd edition)

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.

General

Imprint:	De Gruyter
Country of origin:	Germany
Series:	De Gruyter STEM
Release date:	June 2019
First published:	2019
Authors:	Adriana G Lopes • Andrew Brown
Dimensions:	240 x 170 x 10mm (L x W x T)
Format:	Paperback - Paperback (DE)
Pages:	154
Edition:	2nd edition
ISBN-13:	978-3-11-064055-7
Categories:	Books > Arts & Architecture > Industrial / commercial art & design > Product design Books > Medicine > Pre-clinical medicine: basic sciences > General Books > Medicine > General issues > Medical equipment & techniques > General Books > Science & Mathematics > Chemistry > Organic chemistry > General Books > Professional & Technical > Technology: general issues > Technical design > General Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > General Promotions
LSN:	3-11-064055-4
Barcode:	9783110640557

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