Single-Use Technology
-
Adriana G. Lopes
About this book
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.
Author / Editor information
Dr. Adriana Gouveia Lopes; Dr. Andrew Brown, Independent Consultants to the Biopharmaceutical Industry, London, United Kingdom.
Topics
-
Download PDFPublicly Available
Frontmatter
I -
Download PDFPublicly Available
Preface
V -
Download PDFPublicly Available
Contents
VII -
Download PDFRequires Authentication UnlicensedLicensed
1. Introduction
1 -
Download PDFRequires Authentication UnlicensedLicensed
2. Strategies for implementation of single-use technology: A risk- and science-based approach
9 -
Download PDFRequires Authentication UnlicensedLicensed
3. Feasibility assessment of single-use technology and suppliers
19 -
Download PDFRequires Authentication UnlicensedLicensed
4. Specifications and design of single-use technology
39 -
Download PDFRequires Authentication UnlicensedLicensed
5. Validation
53 -
Download PDFRequires Authentication UnlicensedLicensed
6. Case studies
65 -
Download PDFRequires Authentication UnlicensedLicensed
Abbreviations
135 -
Download PDFRequires Authentication UnlicensedLicensed
Appendix 1 Scoring Tables
137 -
Download PDFRequires Authentication UnlicensedLicensed
Appendix 2 Risk Rating and Priority Number
139 -
Download PDFRequires Authentication UnlicensedLicensed
Index
141
-
Manufacturer information:
Walter de Gruyter GmbH
Genthiner Straße 13
10785 Berlin
productsafety@degruyterbrill.com
