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David Hussong, PhD, is a microbiologist at FDA's Center for Drug Evaluation and Research, Office of Pharmaceutical Science, 5600 Fishers Lane, Rockville, MD, 20857, tel. 301.827.7490, fax 301.827.3084, email@example.com.
Current microbiological methods cannot measure microbial contamination at the levels that engineers and regulators seek to establish for aseptic processing cleanrooms. New approaches for assessing data and establishing alert and action levels are advocated, and an example of one analytical tool is considered.