Safety and engineering hurdles to HPAPI manufacture
TREVOR CALKINS
Director of Process Development and Manufacturing
SAFC, 645 Science Drive, Madison, WI 53711, USA
Abstract
When manufacturing highly potent APIs, a great deal of care is necessary to protect operators and the environment,and equipping a facility represents a substantial investment. This article looks at how highly potent APIs are categorised, and thecontainment and other engineering requirements that have to be put in place to ensure safety.
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