By Fran McAteer, Microbiology Research Associates, Inc., and Ryan Burke, Acusphere, Inc.
Environmental monitoring (E/M) is a surveillance system for microbiological control of cleanrooms and other controlled environments. The process provides monitoring, testing, and feedback regarding the microbiological quality levels in aseptic environments. Environmental surveillance monitors the effectiveness of various controls for microbiological contamination, sources of which can come from air, personnel, equipment, cleaning agents, containers, water and compressed gases, among other things.
Sound monitoring requires understanding the stringent regulatory specifications put into effect by organizations such as the U.S. Food and Drug Administration (FDA), International Standards Organization (ISO), Parenteral Drug Associates (PDA), European Union (EU), and United States Pharmacopeia (USP). Tables 1