Cleanroom Cleaning: Understanding How To Trend EM Data
In cleanrooms and other controlled environments, maintaining a state of control is critical to preventing recalls and meeting regulatory requirements. Environmental monitoring (EM) enables detection of contaminants before they can reach the product. However, without trending the EM data, it’s impossible to know if the facility is operating consistently over time and whether cleaning and disinfection protocols need to be adjusted based on the season, whether or not it’s filling time, location, etc.
Trending EM data provides insights into several key metrics that can improve cleanroom operations, such as the sources of potential contamination, whether microorganisms are developing a resistance to cleaning products, and the effectiveness of disinfection protocols. With this information, opportunities for improvement and remediation can be identified.
Investigate and Remediate
For instance, if EM trend analysis shows repeat observations of certain microorganisms, the next step should be to examine whether there are fluctuations in training, equipment use, or chemical preparation. An investigation may find that standard operating procedures are interpreted differently by individual personnel, or that hand hygiene and garbing procedures are not being performed consistently. In these instances, re-training and clarification are necessary to remediate the adverse trend.
Failing to look at EM trends puts cleanroom operators on the defensive. EM alone captures data about one specific location and one point in time, but it doesn’t enable proactive measures to prevent contamination. An effective approach to EM trending should ensure the validation of procedures and products, provide insights into hazards and relevant indicators, and support ongoing training efforts.