Single-Use Technology: A Practical Guide to Design and Implementation

✍ Scribed by Adriana G. Lopes; Andrew Brown

• Publisher: De Gruyter
• Year: 2019
• Tongue: English
• Leaves: 154
• Edition: 2
• Category: Library

✦ Synopsis

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.

✦ Table of Contents

Preface
Contents
1. Introduction
2. Strategies for implementation of single-use technology: A risk- and science-based approach
3. Feasibility assessment of single-use technology and suppliers
4. Specifications and design of single-use technology
5. Validation
6. Case studies
Abbreviations
Appendix 1 Scoring Tables
Appendix 2 Risk Rating and Priority Number
Index