Environmental monitoring

Abstract

The materials, facilities, and personnel where sterile pharmaceutical products are manufactured are major factors to consider in the final product quality. To prevent microbial contamination, these facilities, materials, and personnel should provide an environment that will minimize the survival, growth, and distribution of microorganisms. Environmental monitoring provides the evidence and documentation necessary to determine the efficiency of different systems to prevent microbial contamination [1]. A process must be capable of controlling the presence, distribution, and survival of microorganisms in clean rooms and other controlled environments. This applies to manufacturing environments and testing laboratories.