SEM Provides Critical Process Information in Pharmaceutical Applications

Extract

A number of trends in pharmaceutical manufacturing are driving rapid growth in the use of scanning electron microscopes (SEM) for high-resolution imaging and analysis. At the same time, continued development of SEM technology is enhancing system performance while simultaneously reducing usability barriers that have historically limited the acceptance of these techniques in pharmaceutical applications.

Among the most significant industry trends is a concerted effort by governmental regulatory agencies to encourage improvements in pharmaceutical manufacturing processes by applying the same scientific principles and engineering techniques that have lead to successful improvements in other industries, notably automobiles and semiconductors. The exceptionally high requirements for product quality within the pharmaceutical industry have generated a regulatory regime that imposes prohibitively high costs in both time and money to gain approval for process changes, even though the changes result in substantial performance gains.