Free shipping on orders over $99
Practical Guide to Single-Use Technology

Practical Guide to Single-Use Technology

Design and Implementation

by Professor Andrew BrownAdriana G Lopes Director of Humanities Publishing Andrew Brown and others
Hardback
Publication Date: 25/08/2016

Share This Book:

 
$168.30
Single-use technology (SUT) is now available for all processing operations within the biopharmaceutical industry. It 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 handbook 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.Serving as an introduction and practical reference to this growing area of application within the biopharmaceutical industry, this handbook presents: * An approach for SUT implementation within an end-users facility with examples for bioreactors, tangential-flow filtration and fill-finish systems; * SUT within the context of regulatory guidance, such as ICH Q8, Q9, Q10 and GMP; * Strategy for standardisation of single-use bag systems and assessment of extractables and leachables; * Specifications of user requirements and design of specific SUT alongside process descriptions and flow diagrams; * Strategies and tools to evaluate risk with examples of risk assessments applicable to design, processing and product quality; and * Qualification approach for different SUT types.
With the information presented in this book, engineers, researchers and professionals involved in biopharmaceuticals will be better prepared to plan and make effective decisions to design and implement SUT.
ISBN:
9781911088127
9781911088127
Category:
Biotechnology
Format:
Hardback
Publication Date:
25-08-2016
Publisher:
Smithers Information
Country of origin:
United Kingdom
Pages:
178
Dimensions (mm):
254x178x11mm
Weight:
0.53kg
Andrew Brown

Andrew Brown is an artist, designer and film maker. In his twenties he joined Motor Sport, creating advertisements and drawing racing cars. After running his own advertising agency, he started producing corporate television programmes and then worked in the pharmaceutical industry. He is a member of the Guild of Motoring Writers and edited the Alfa Romeo Owners Club magazine for several years. Andrew owns four classic Alfas including a series 4 Spider.

Click 'Notify Me' to get an email alert when this item becomes available

Reviews

Be the first to review Practical Guide to Single-Use Technology.