Single-Use Technology

Name: Single-Use Technology
SKU: 30594899
Price: 185.00 NZD
Availability: InStock

A Practical Guide to Design and Implementation

By:

Format:

Paperback / softback

Series:

De Gruyter STEM

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$185.00

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Around 14-26 June using International Courier

Description

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.

Author Biography:

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

Release date NZ

June 17th, 2019

Author

Audience

Professional & Vocational

Edition

2nd edition

Illustrations

30 Illustrations, black and white; 30 Tables, black and white

Pages

154

Series

De Gruyter STEM

Dimensions

168x239x10

ISBN-13

9783110640557

Product ID

30594899

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