Analysis of Environmental Microbiology Data from Cleanroom Samples

May 1, 2004
David Hussong, PhD

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, hussong@cder.fda.gov.

Pharmaceutical Technology, Pharmaceutical Technology-05-01-2004, Volume 2004 Supplement, Issue 3

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.