ABSTRACT
Bioburden is a measure of viable microbial contaminants associated with personnel, manufacturing environments (air and surfaces), product packaging, raw materials (including water), in-process materials, and finished products (Adley et al. 2015). Since drug substance manufacture is typically not sterile, bioburden can be introduced at any step of the manufacturing processes shown in Figure 7.1, from nonsterile raw materials, manual and mechanical handling of containers and closures, and the environment in which the product is processed. In addition, bioburden can contribute endotoxins and other impurities to the drug product, thus further compromising product quality.
