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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 is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113, firstname.lastname@example.org.
James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, email@example.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.
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.
eBook: Biologics and Sterile Drug Manufacturing 2018
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).