Photonics in the Pharmaceutical Industry
By some estimates, as many as 7000 hospital patients die every year when health workers mistakenly administer the wrong drugs. In response, the Food and Drug Administration (FDA) has set forth a proposed regulation that would require drugmakers to place linear bar codes on the containers of all prescription drugs, as well as most over-the-counter medicines. Doctors and nurses will then be able to compare bar-code data from packages against that on patients’ wristbands, thus moving the health care industry one step closer to the FDA’s “five rights” mission: the right drug, in the right route of administration, dispensed in the right dose to the right patient at the right time.
The new regulation will mean changes to the way pharmaceutical companies do business, and a greater reliance on two photonics technologies in particular: machine vision and spectroscopy.
The following package of articles presents an overview of how both technologies are being used to regulate quality control in the pharmaceutical industry. The lead article, by Carl Gerst of Cognex Corp., examines some of the important trends in machine vision inspection, including optical character recognition for scanning printed matter and smart cameras for verifying that, for example, bottles have been correctly capped and safety seals properly mounted.
A related article, by PerkinElmer’s Peter Niedzielski, explores the crucial issue of illumination on the production line. The use of pulsed xenon lights, he writes, renders images so clear and accurate that even hairline cracks in vials can be detected — an important consideration with production line speeds increasing all the time. However, technology is not a panacea for business problems: Not every vision application needs to be solved with sophisticated machinery.
Meanwhile, Senior Editor Anne L. Fischer’s contribution offers a look at the new wave of mass spectrometry technologies and the ways in which they help drugmakers build quality into their manufacturing processes, rather than simply testing for it at the end of the production line. New techniques from companies such as Carl Zeiss are moving mass spectrometry devices ever closer to the production line for up-close, real-time analysis — a boon to factories not only because it moves them closer to regulatory compliance, but also because it helps them spot defects in products before they must be recalled from store shelves.
At press time, the FDA was expected to publish a final version of its regulation in 2004, and it will become effective three years after the date of publication. Already, several drugmakers and hospitals have voluntarily adopted bar-code technology, and, indeed, most of them have reported decreases in errors, both on the production line and at the point of care.
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