Requirements and environmental monitoring in pharmaceutical production versus operating rooms in hospitals with focus on airborne particles and microorganisms

摘要

Clean areas used for aseptic manufacturing of sterile medicinal products are subject to governmental requirements and guidelines in order to minimise risks of particulate and microbiological contamination. High cleanliness is also a necessity in hospital environments to ensure safe conditions for the patients. The requirements for premises within the pharmaceutical industry are compared to those of the hospital, e.g. operating rooms including environmental monitoring with a focus on particle and microorganism levels.