By Adriana G. Lopes, Andrew Bown
Single-use expertise (SUT) is now on hand for all processing operations in the biopharmaceutical undefined. It has the capability to lessen capital expenses, increase plant throughput and decrease the danger of cross-contamination. even though, there aren't any transparent instructions to help the end-user on implementation of those applied sciences right into a tested, solid production perform (GMP) atmosphere. This guide is the 1st entire ebook of sensible concerns for every degree of the implementation means of SUT, and covers the choice, specification, layout and qualification of structures to fulfill end-user requirements.
Serving as an advent and sensible connection with this turning out to be sector of software in the biopharmaceutical undefined, this instruction manual presents:
- An process for SUT implementation inside an end-users facility with examples for bioreactors, tangential-flow filtration and fill-finish systems;
- SUT in the context of regulatory advice, comparable to ICH Q8, Q9, Q10 and GMP;
- Strategy for standardisation of single-use bag structures and evaluation of extractables and leachables;
- Specifications of person requisites and layout of particular SUT along procedure descriptions and stream diagrams;
- Strategies and instruments to guage possibility with examples of probability tests acceptable to layout, processing and product caliber; and
- Qualification procedure for various SUT types.
With the knowledge awarded during this e-book, engineers, researchers and pros curious about biopharmaceuticals may be higher ready to devise and make powerful judgements to layout and enforce SUT.
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