Real-Time Viable Particle Detection For Definitive Root Cause Investigation
By Mike Dingle, Field Application Specialist, TSI Inc.
Investigations into viable air excursions are very difficult to perform using traditional methods. The data generated is very limited and not very timely. This often leads to high levels of frustration as the problem persists, with vast amounts of time and resources being consumed while the root cause remains elusive.
No matter how extensive the investigation, due to the limitations of the traditional tools available, luck often plays a large role in actually identifying an elusive “smoking gun.” As stated by the FDA in the Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice: “Environmental monitoring methods do not always recover microorganisms present in the sampled area. In particular, low-level contamination can be particularly difficult to detect.”
An Introduction To Trending In Environmental Monitoring Programs
Trending environmental monitoring (EM) data is a regulatory requirement. However, it is useful in obtaining significant information about the facility. Trends can help determine if a facility is in a state of microbial control and relay the environmental monitoring data to facility management in a meaningful format. In this two-part article exploring environmental monitoring trending, I look first at the regulations and guidelines around EM. In part two, I will discuss tools and best practices for using the trends to ensure that an efficient environmental monitoring program is established.
EM is a required, essential component of current good manufacturing practices (cGMP). It is used to measure and monitor the microbial bioburden levels in a facility and to determine if the facility is in a state of microbial control. EM consists of many different data points that culminate in a single program. Some of the data point