My eight-day conference experience began December 3-4, 2012, when I attended the Pharmaceutical Microbiology Forum’s Conference on Environmental Monitoring entitled, “Major Challenges in Environmental Monitoring: A Systems Approach.” This conference presented an overview of USP Chapter <1116> Microbiological Control and Monitoring of Aseptic Processing Environments. I was familiar with this chapter prior to the event; however, the guidelines were updated in 2012, and I had not yet read them to their full depth.
This conference re-presented the idea that environmental monitoring for viable organisms is one factor that can be addressed to demonstrate continued control of a sterile environment. Interestingly, it was stated that an environmental monitoring program cannot detect ALL events that could potentially compromise sterile compounding. According to one of the conference presenters, the expectation of zero organisms recovered is unrealistic … but this doesn’t mean that patient safety is compromised. According to this individual, it is important for medical professionals to remember that in any environment where a human component is involved, a degree of microbial contamination is, to a certain degree, inevitable. This was a somewhat controversial topic, but very intriguing.
The second factor discussed was the idea that the recovery of one colony-forming unit (CFU) per sample is no different than three CFU. The objective in environmental monitoring is to capture viable organisms; if the recovery reaches 15 CFU or more, it equates to a larger problem in your environment.
The environmental monitoring conference reviewed the FDA aseptic processing guidelines using a chart of air quality limits based upon environments: IV hoods, buffer room, etc. There was also a presentation of data analyses examining incident rates where positive growth was found. The focus was monitor sites that pose the highest risk and analyze the data. The idea was to test these critical sites more frequently. USP 797 mandates that pharmacies test at least twice a year; here at Hartley Medical we perform environmental monitoring weekly.
One of the most memorable presentations given at this conference was by Scott Sutton, a new friend of mine with a PhD in microbiology. His talk was also on USP <1116> and the concept of trending “Non- Zeros.” He presented a unique concept of trending data versus alert and action levels – thus establishing levels at which to take notice and at which to take action. We have explored this concept and the idea of alert and action levels at Hartley Medical for many years. We plan to expand on this new information by analyzing the environmental data based upon date, location, preparation, season, and examining the specific genus and species. Dr. Sutton also stated that environmental monitoring programs need to build a microbiological lot library to assess the environment.
The last lecture I attended at this conference was, “Microbial Identification: Why, How, and What’s New” by Kevin Jensen of Nelson Laboratories out of Salt Lake City, Utah. In the beginning, he discussed three types of clients: 1) clients who ask, “Do we have to?”, 2) those who state we do it because we have to, and 3) those who do it because it’s good science, quality is our job, and we care about our end users! We, at Hartley Medical consider ourselves to be Type 3. Mr. Jensen reviewed case studies of contaminated products and their impacts on humans.
This was a fantastic conference. I developed some new, professional relationships. I am very proud of Hartley Medical’s environmental monitoring program, but this event has motivated me to go even further.
For more information on environmental monitoring, visit Hartley Medical’s Knowledge Center by clicking here.
For more conference recaps, click here.
To watch William Stuart, RPh, give his notations on both the 2012 Environmental Monitoring Conference and ASHP Midyear Meeting, click the video below: