The summer is over, the kids are back to school, and in the Northeast it is getting cooler, darker and damper. Already there are dead leaves on the ground and friends with allergies are popping diphenhydramine and blaming leaf mold, as good an indicator that air flora is changing as an open Malt Extract Agar settling plate. Reflecting on these seasonal changes, on my way into the lab last week, I noticed a large fungus growing in the mulch that wasn’t there just the day before.
Mutinus elegans comes up often this time of year, poking up out of compost and dead leaves. This phallic fungus goes by a few common names elegant stinkhorn, dog stink horn, devil’s lipstick because of its shape but also because it smells downright awful — like dead carrion. As any other microbiologist would, I got down to take a good look and to snap some pictures, and noticed the sticky tips were covered with ants and flies. The awful smell attracts these insects, which in turn help distribute the fungal spores. This is not the sort of rude guest you want poking around your Labor Day barbecue! Back in the straight laced Victorian day, Charles Darwin’s eldest daughter used to roam the woods around her house with a spear, collecting and burning these basidiomycetes, in order to protect the morals of maids.
But what interested me that morning was how quickly this thing erected itself from spore to full on fruiting body — all in one evening. It got me thinking about environmental monitoring. Recent revisions to USP <797> upheld the twice a year air sampling strategy that some sterile compounding pharmacies cling to. For me, this stink horn was a rude reminder of why this is not a sound strategy.
Microflora change in quantity and quality through the seasons. Bacteria and mold found in spring will be much different than those found in the fall. And even day to day, variances in humidity, wind, foot traffic, gowning, travel will impact what microbes are brought into the sterile manufacturing area no matter how diligent the attempts to control. We monitor the air to know what the threats are, not to triple clean and get a good grade. We cannot react to what we aren’t monitoring.
Take a look at our laboratory data. We monitor daily and weekly, depending on the site. The trend witnessed in an uncontrolled ISO 8 area shows we must react more stringently at different times of year. And we do react, with increased air filtration and sanitization. Our reaction to the fluctuating background helps assure our clients are not wasting time with false positive test results. (All microbial analysis is performed in ISO 5 hoods by the way, this information helps us assess what we are protecting against) But we wouldn’t be reacting if we didn’t have these data. Imagine compounding sterile drugs with out these data.
Or conversely, consider New England Compounding Center and it’s black mold. Interesting the owners also had a mattress recycling center about 100 feet upwind of the sterile compounding pharmacy (true polymath entrepreneurs). Can you imagine the mold that would grow on old mattresses kept outdoors in the rain Whether this was the source or not, who knows. But the fungus showed up in the fall in the lab. Good thing they were monitoring. Bad thing they didn’t do anything about it. See our EM Blog for more information on how to react to Alert and Action Levels.
Perhaps the reason some sterile compounders do not monitor more frequently is cost. But EM doesn’t have to be expensive. For ongoing monitoring, between biannual certification events, FOCUS Labs can set customers up with equipment, media and training to perform their your own EM. See our link on Lab in a Box and call us to discuss further. What you can’t see CAN kill you, and ignorance is NOT bliss. Let us help, give us a call.