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Singleuse Technology A Practical Guide To Design And Implementation 2nd Edition Adriana G Lopes Andrew Brown

  • SKU: BELL-50336974
Singleuse Technology A Practical Guide To Design And Implementation 2nd Edition Adriana G Lopes Andrew Brown
$ 31.00 $ 45.00 (-31%)

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Singleuse Technology A Practical Guide To Design And Implementation 2nd Edition Adriana G Lopes Andrew Brown instant download after payment.

Publisher: De Gruyter
File Extension: PDF
File size: 1.09 MB
Pages: 154
Author: Adriana G. Lopes; Andrew Brown
ISBN: 9783110640588, 3110640589
Language: English
Year: 2019
Edition: 2

Product desciption

Singleuse Technology A Practical Guide To Design And Implementation 2nd Edition Adriana G Lopes Andrew Brown by Adriana G. Lopes; Andrew Brown 9783110640588, 3110640589 instant download after payment.

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.


  • Serves as an introduction as well as a practical guide.
  • Contains several case studies.
  • Readers will be equipped to plan and make effective decisions to design and implement SUT.

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