Medicinal products, and especially sterile drugs like vaccines, must be pure, that is, free of contaminants that are not part of the product’s intended composition. The microbiological quality of drugs is necessary for their efficacy and patient safety, because microbial contamination of drugs causes immediate adverse effects on patient health in terms of morbidity and mortality, as well as long-term adverse effects, such as cancer, autoimmune, and other diseases. Therefore, control of microbes in drugs is essential and a carefully planned and executed environmental monitoring (EM) program provides increased assurance of sterility for aseptically produced products. EM describes the microbiological testing undertaken in order to detect changing trends of microbial counts and micro-flora growth within clean rooms or controlled environments. The results obtained provide information about the physical construction of the room, the performance of the Heating, Ventilation, and Air-Conditioning (HVAC) system, personnel cleanliness, gowning practices, the equipment, and cleaning operations.
Two interesting readings to continue on the topic :
Environmental Monitoring of Clean Rooms in Vaccine Manufacturing Facilities, WHO, November 2012
Role of Environmental Monitoring and Microbiological Testing During Manufacture of Sterile Drugs and Biologics, Rajesh K. Gupta, PhD, November 2014