Evaluation of Disinfection Procedures for Control of Potential Contamination of Biologicals

by Kathryn Martin Remington, PhD and Marian L. McKee, PhD
Volume 14, Issue 2 (Summer 2015)

An effective disinfection program is an essential component of a pharmaceutical/biopharmaceutical manufacturer’s contamination control strategy. A good disinfection program can help prevent microbial or viral contamination of the manufactured product, further ensuring product safety for patients. The term disinfection is often used interchangeably with cleaning, but the purpose of disinfection is quite different from that of cleaning. Disinfection of a surface will result in inactivation of infectious agents such as bacteria, fungi, and viruses, whereas cleaning a surface removes soil, debris, and other residues. A dirty surface that contains soil or cleaner/disinfectant residues can complicate disinfection or even contain infectious agents, yet a visibly clean surface may still require disinfection. Cleaning and disinfection programs complement each other. In contrast to a cleaning procedure, the effectiveness of a disinfection procedure is dependent on factors such as the type of disinfectant used, the application method, and contact time...

Remington KM, McKee ML. Evaluation of disinfection procedures for control of potential contamination of biologicals. BioProcess J, 2015; 14(2): 14–21. http://dx.doi.org/10.12665/J142.Remington.

Posted online July 10, 2015.