Environmental Monitoring (EM) programs for pharmaceutical manufacturing are evolving to a risk-based approach. The use of sampling data for the identification and mitigation of risk becomes a critical element in this process. It is no longer enough to utilize data for reactive excursion reporting. Before exploring this concept in detail, it is important to get a good understanding of what environmental monitoring is at its core. Environmental monitoring is the sampling of controlled environments for non-viable and viable air particulates as well as surface viables. It allows for assessment of effectiveness of cleaning/disinfection, identification of trends and it can help facilitate early detection of potential problems. Environmental monitoring describes the microbiological testing undertaken in order to detect changing trends of microbial count and microflora within cleanroom or controlled environments. The results obtained provide information about the physical construction of the room, the performance of the HVAC system, personnel cleanliness, gowning practices, the equipment and cleaning operations.
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