I recently saw a question about how pharmacies are going to handle the extra surface sampling in their cleanrooms. Will people incubate samples themselves, send off to a third party for identification? I have suggestions for those questions, but let’s first talk about why we are sampling. The real purpose is to be able to track trends of environmental organisms and try to eliminate them through process improvement with your environmental sampling program. That’s to say that organizations need to establish and follow an environmental sampling program as part of their quality management system.
The first thing to do is to establish a baseline of what your classified environment looks like. Next, begin routinely sampling category 1 and 2 CSPs once a month, or perform surface sampling weekly if compounding Category 3 CSPs. If you are properly following up on each of the results and investigating growth, overtime you will be able to see a clearer picture of what organisms inhabit your environment, where they may be coming from (e.g., being brought in on materials, water source organism), and how you can remediate the contamination. This is true even if initially the number of CFU doesn’t reach the action level.
Conducting more sampling is a bit of a double-edged sword because you can find more microbes. If you aren’t properly documenting and remediating, it is like you know there’s a problem but you’re doing nothing about it. Not good. But you can also look at it as an opportunity for improvement of your environment, procedures and practices! My point here is that if you are going to do the sampling, take it seriously. Don’t just sample to check off a compliance box. There is real, actionable data that can be used to improve the environment and your processes and procedures.
Where to sample? USP Chapter 797’s recent update says to surface sample the interior of each ISO class 5 PEC, pass-through chambers connecting to classified areas. Other areas of 797 specify that samples should be taken from equipment inside the PEC, staging or work area(s)s near the PEC, and frequently touched surfaces.
My suggestion for handling the extra sampling is to procure enough incubators to accommodate all the samples you will need to perform. Only send off to a third-party lab for identification when there is growth. Again, it’s worth repeating that, for the first year, I suggest sending off media for identification if there are any colony forming units, even if they don’t meet or exceed the action limits. This will allow you to gather data to begin making improvements immediately. After a year, you will have a good idea of what organisms are there, and you will have learned a lot about how to remediate different types or organisms.
There is a particular lab that I recommend because they keep all the data in a nice dashboard. In addition, you can filter the results by organism, room, location, person taking the samples, etc. I don’t want to show bias, and I don’t receive anything for recommending them (I promise!), but I have used them in the past and their service is excellent. I would be happy to share this on an individual basis, feel free to contact me.
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