Following the U.S. Food and Drug Administration's recent decision to participate in the inspection of overseas drug-manufacturing facilities, the pharmaceutical industry is reexamining its approach to quality control. In response to this trend, ASPEX Corporation (ASPEX) has announced the release of its Rx microanalysis solution, the first all-in-one system designed for detecting and characterizing microscopic contaminants in pharmaceuticals.
The Rx represents the only integrated solution for conducting particle size analysis on the production floor. Because counterfeit or contaminated drugs can result in allergic reactions or even death (as evidenced by the widely-publicized heparin epidemic), the Rx's ability to identify harmful particles as small as 30 nanometers yields far-reaching effects for consumer safety. Complete with a full complement of FDA compliance features, these instruments have been successfully installed at a wide range of cGMP facilities.
"Consistent quality control is critical to the safe and successful globalization of drug production, as well as developing and implementing new analytical methodologies to support emerging 'Quality by Design' initiatives," said Dr. Marie Vicens, Application Specialist at ASPEX and guest speaker at the 50th Rocky Mountain Conference on Analytical Chemistry. "Unlike traditional monitoring processes that rely on laser, video, or X-ray techniques, the Rx offers increased reliability and precision by integrating a scanning electron microscope (SEM) with an energy-dispersive spectrometer (EDS) and offering a comprehensive microanalysis solution."