The answer to this question is yes, and yes. The two subjects co-exist within pharmaceutical manufacturing in aseptic and sterile environments. This poster will highlight how environmental monitoring and disinfection provide continuous trending, process improvement, and final product evaluations. The processes need to be designed to identify outliers (biological and numerical) and objectionable organisms and assess cleaning protocols based on data collected. The information acquired through environmental monitoring and disinfectant efficacy studies helps to determine effective Root Cause Analysis and Corrective Action when issues with contamination are encountered. The processes, when performed and evaluated consistently will ensure that manufacturing environments are in a state of control and the products manufactured in sterile and aseptic environments are pure, safe, and effective.
Nyssa-Marie Finegan (Thu,) studied this question.