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.