Environmental Monitoring: Safeguarding the Sterile Manufacturing Process

Ever wondered what keeps sterile manufacturing environments actually sterile? The answer lies in environmental monitoring (EM)—the critical practice that safeguards product quality by detecting microbial and particulate contamination before it becomes problematic. In this deep dive, hosts Rafiq and Tiffany unpack the five core components every effective environmental monitoring program needs: risk assessment, sample plan development, setting alert and action limits, data trending, and respon...