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Effective containment in API and drug-product manufacturing encompasses a variety of process, equipment, and operational issues.
High-containment manufacturing, whether for an active pharmaceutical ingredient or finished drug product, requires specialized approaches in facility design, equipment selection, and manufacturing processes to achieve the desired levels of containment and minimize operator exposure. As with pharmaceutical manufacturing overall, science- and risk-based approaches to reach those goals serve as a crucial framework for optimizing high-potency manufacturing as well for specific elements in the process.
This article was also published in our US sister publication Pharmaceutical Technology and can be read here.