By Adam West, Course and Curriculum Manager at CriticalPoint
Environmental monitoring (EM) trending measures compounding quality
Trending the results of sampling gives you several vantage points for understanding your compounding environments. The immediate results of viable sampling provide direct feedback on the current condition of the environment. However, EM trending is gathering information over time to provide a clear picture and understanding of the environmental conditions.
While it can seem like a chore at times, trending offers significant insight. It proves the sustainability of a microbial state of control within the compounding space during compounding activity and can act as a warning light when sampling metrics are underperforming. Trending allows for early detection of potential contamination issues within your facility. And if that weren’t reason enough, USP <797> requires it: “Regular review of the sampling data must be performed to detect trends and the results of the review must be documented.”
Trending is more than capturing monthly surface sampling results
Because of the monthly minimum frequency required by USP <797>, you’ll likely have more data from surface sampling than from air sampling. But even if you only follow the USP minimum frequencies (according to your compounding category), trending air sampling will also begin adding up.
Unfortunately, if you follow the minimum frequency for air sampling, you cannot accurately assess how your facility is truly doing on the days when sampling has not occurred (because so much time has passed between sample sessions). It’s really not enough data to prove anything. Greater sampling frequency = more data to trend = a better system of detection for identifying quality environmental control.
Let’s not forget that trending and tracking personnel monitoring is crucial to compounding quality as well. The immediate benefit is that it aids in capturing important competency elements by supplying individual compounding performance data of the compounders. On the other hand, capturing data from a random sampling session that reveal underperforming results (drifting or excursion) identifies areas for improvement from the mechanics of compounding, general behavior, and cleaning efficacy.
EM trending is an elusive art
The opposition most pharmacy organizations face to personnel and environmental metrics is trending all that data. Data trending plays a critical role in an environmental monitoring program (EMP). It reenforces that you aren’t simply checking a box. All of this sampling, monitoring, and analysis mean something. In order for the data to really work and provide valuable information, sampling frequency must be increased to beyond the minimum requirements of the chapter. Even if minimum frequency is good enough, is it enough to gather sufficient data to effectively analyze trends? The tagline: Time will tell.
Trending is nearly a full full-time job (at least initially) to perform and manage properly. Designated persons (DPs) tasked with managing EM and trending are still challenged with how to interpret their data. The most important thing about trending EM data is having a system to collect the information and understand that trending is month to month, season by season, and year over year. DPs must interpret the real-time occurrences, excursions, and exceeded levels and determine the next steps accordingly.
The data are important, but the actions required during the upward and downward micro-trends are what drives the daily operations toward a microbial state of control. Being successful in this endeavor results in overall sustained compounding quality and peace of mind.
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