19. ENUMERATION AND ISOLATION OF MICROBIAL CONTAMINANTS THROUGH ENVIRONMENTAL MONITORING
The monitoring is done to check the bioburden of the aseptic area of the controlled environment. The purpose of this is to understand the various issues that is related to aseptic processing of bulk drug substance or finished products (sterile), dose forms, and in certain cases and to establishments maintenance and control of the microbiological quantity in the controlled environment. Environmental monitoring describes the processes and activities that need to take place to characterise and monitor the quality of the environment. Environmental monitoring is used in the preparation of environmental impact assessments, as well as in many circumstances in which human activities carry a risk of harmful effects on the natural environment. All monitoring strategies and programmes have reasons and justifications which are often designed to establish the current status of an environment or to establish trends in environmental parameters. In all cases the results of monitoring will be reviewed, analysed statistically, and published. The design of a monitoring programme must therefore have regard to the final use of the data before monitoring starts. The number of viable microorganisms detected during routine monitoring may be within the relevant acceptance limits. However, it is necessary to characterize and identify these microorganisms to their genus and species level. Also, and identification of different types of microbial isolates found during routine monitoring is required to check whether the microorganisms obtained are not objectionable types. Objectionable types microorganisms are the ones which may be detrimental to the product or the process or pathogenic in nature.