What is Environmental Monitoring (EM) in a Pharmaceutical facility?

Environmental Monitoring (EM) is the systematic collection of data to assess the cleanliness and control of manufacturing environments, especially in sterile or aseptic processing areas. It includes the monitoring of viable (microbiological) and non-viable (particulate) contaminants in air, surfaces, and personnel. EM helps ensure compliance with regulatory standards and protects product quality and patient safety.