For aseptic manufacture of pharmaceutical products there has been a shift in procedures for particle measurement, primarily due to legislative regulations. Traditionally, monitoring has been the classic portable monitoring of a cleanroom. New regulations have led to a requirement for an automated, remote monitoring solution. This paper reviews the various steps for the implementation of an automated monitoring solution for a non-viable particle counting system. The steps also apply if you later enhance the nonviable-particle counting system to include a viable-particle monitoring or other environmental parameter component.
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