Environmental monitoring (EM) is a tool utilized by the pharmaceutical industry to measure and monitor microbial bioburden levels in a manufacturing facility. Periodic sampling of the air and surfaces within controlled environments allows the microbiologist to determine the approximate number and types of microorganisms present in a given area over a defined period of time. This data is analyzed through a process known as trending. Trending is performed in order to detect fluctuations in microbial levels, and allow firms to ensure that these levels remain within acceptable parameters. “Traditional” methods of trending EM data often include the use of excursion rates. “Excursion rate”, for the purpose of this article, is defined as the percentage of the total number of collected EM samples with counts exceeding either the alert or action level. Alert levels are defined as an established level of microorganisms that gives early warning of a potential drift from normal operating conditions.1 Action levels are defined as an established level of microorganisms that, when exceeded, indicate that a process is outside of its normal operating range.1 Exceeding an alert level does not necessarily warrant immediate investigation and corrective action, although some sort of follow-up action is generally required in order to determine the cause of the exceeded level, its impact, and to ensure that the affected area has returned to its normal operating conditions. Exceeding an action level usually requires an immediate investigation and subsequent corrective or preventative action (CAPA). Trending by excursion rate alone is limited in terms of the amount and type of information it provides… Click Here For Complete Abstract Text
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