Distinguishing Between Cleanroom Classification and Monitoring

James E. Akers

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

Russell Madsen

James P. Agalloco

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

Pharmaceutical Technology, Pharmaceutical Technology-05-15-2019, Volume 2019 eBook, Issue 1
Pages: 10–13

A one-size-fits-all approach to monitoring practices and results is never appropriate, given the diversity of practice within the pharmaceutical industry.

Cleanroom monitoring and classification are vital to operations but are still separate functions. This article discusses the differences between the two concepts and emphasizes the need for the two to remain independent. As they write, “A one-size-fits-all approach to cleanroom monitoring will not reflect the diversity of practices” within the industry. In addition, they write, classification values should not be used as monitoring targets.

Read this article in Pharmaceutical TechnologyBiologics and Sterile Drug Manufacturing 2019 eBook.

Article Details

Pharmaceutical Technology
eBook: Biologics and Sterile Drug Manufacturing 2019
May 2019
Pages: 10­–13


When referring to this article, please cite it as J. Agalloco, R. Madsen, and J. Akers, “Distinguishing Between Cleanroom Classification and Monitoring," Pharmaceutical Technology Biologics and Sterile Drug Manufacturing eBook (May 2019).