Lies That Environmental Monitoring Systems Tell

Russell E. Madsen Jr.

Russell E. Madsen is the former senior vice-president of science and technology at PDA, and is a current member of Pharmaceutical Technology's editorial advisory board.

James E. Akers

James E. Akers is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113,

James P. Agalloco

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, He is also a member of Pharmaceutical Technology’s editorial advisory board.

Pharmaceutical Technology, Pharmaceutical Technology-05-15-2018, Volume 2018 eBook, Issue 1
Pages: 4–7

Environmental monitoring, which operates below the limit of detection, is little more than a rote exercise that provides limited real value. So why does it figure so prominently in current regulatory requirements for aseptic manufacturing?

In this extended op-ed, aseptic processing consultants James Agalloco, Russell Madsen, and James Akers discuss the current regulatory emphasis on environmental monitoring requirements. Based on the mistaken belief that monitoring is an exact measurement of reality, many current requirements emphasize monitoring when the real focus should be on minimizing operator contact with the process, they write. 

Read this article from in Pharmaceutical Technology’s Biologics and Sterile Drug Manufacturing 2018 eBook.

Article Details

Pharmaceutical Technology
eBook: Biologics and Sterile Drug Manufacturing 2018
Vol. 42
May 2018
Pages: 4–7


When referring to this article, please cite it as J. Agalloco, R. Madsen, and J. Akers," Lies That Environmental Monitoring Systems Tell," Pharmaceutical Technology Biologics and Sterile Drug Manufacturing 2018 eBook (May 2018).