top of page
Glossary Term
Environmental Monitoring in Manufacturing
Definition
Environmental Monitoring (EM) in manufacturing refers to the systematic process of assessing and controlling environmental factors such as air quality, temperature, humidity, particulate levels, and microbial contamination in manufacturing and cleanroom environments. It ensures that production conditions meet regulatory standards and do not compromise the quality or sterility of medical devices.
Relevance to the MedTech Industry
Environmental Monitoring is essential for maintaining compliance with regulatory standards, such as ISO 14644 (Cleanroom Standards) and FDA requirements for Good Manufacturing Practices (GMP). It ensures that manufacturing conditions support product safety, effectiveness, and quality, particularly for sterile or high-precision medical devices.
Additional Information & Related Terms
bottom of page