Disinfection Qualification Testing—Considerations for the Aseptic and Cleanroom Maufacturing Environment

Obtaining the highest confidence that aseptic, cleanroom, and other critical manufacturing environments are properly cleaned, sanitized and disinfected is paramount in assuring the production of safe and effective pharmaceutical products and/or medical devices. The microbiological safety of these products is primarily determined by the quality of raw materials, the integrity of the manufacturing process, as well as the effectiveness of cleaning and disinfection procedures performed in the facility. It is for this reason that the U.S. Food and Drug Administration (FDA) requires manufacturers of pharmaceutical and other critical products to qualify and validate the disinfection procedures used in these manufacturing environments. This paper is intended to provide an overview of disinfection qualification testing and the considerations that must be addressed when designing and executing these studies.