In 2023, the USP <797> standard for compounded sterile preparations was significantly revised to improve patient safety. Not only are there more protocols to follow, but pharmacies may need to demonstrate their adherence to USP <797> to various Authorities Having Jurisdiction (AHJ). Proving adherence includes documenting standard operating procedures (SOPs), but it also includes providing ample evidence that these SOPs are followed and effective.
In early August, our team collaborated with Stratix Labs™, the developers of Enverify™, to do a deep dive into how to demonstrate competency. It’s a big topic, so we specifically focused on surface sampling in the webinar. In this post, I’ll share some of the highlights from the session. You can also access the full presentation on demand:
Watch: How To Demonstrate Your USP <797> Surface Sampling Competency and Why It’s Important
Why USP <797> 2023?
The 2023 revisions to USP <797> were extensive. Not only do more samples need to be taken, but there is also a significant focus on environmental monitoring and personnel competency – everything needs to be documented and verifiable. As frustrating as compliance can be, I think it helps to take a step back and consider why these changes were made.
Mark Mulvahill, CEO at Stratix Labs™, shared several relevant data points in the webinar. From 2001 to 2019, 73 separate instances of compounding error and contamination led to over 1500 adverse events. It probably comes as no surprise that surveys suggest adverse events with compounded pharmaceuticals are underreported.
Surface sampling is a critical quality control activity conducted to establish a state of microbial control in your facility. Compounding pharmacies naturally want to show that they’ve “passed the test.” That is, their results are consistently below the action levels based on the area being sampled. It’s easy to forget that passing the test isn’t the goal of USP <797>. Minimizing patient harm is. If the results you’re getting, no matter how good, aren’t accurate or reliable, you’re putting your patients and your business at risk.
How to Use Your USP <797> Results
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Let’s say your surface sample from a Primary Engineering Control (PEC) area showed 5 colony-forming units (CFU) on your media device. That, of course, would be above the action level of <3 CFU per media device for that area classification and would require additional action to be taken.
While it can be disheartening to see elevated results, I’d argue that the results are critically informative. You can’t do something about a problem if you don’t know you have one. The only question is where you go from here. There are numerous areas of investigation, but in the webinar, we talked about three primary paths:
Personnel practices: Most often, the root cause is garbing or aseptic technique.
Cleaning and disinfecting processes: Are your cleaning processes effective? If you’re incubating your samples in-house, this would include cleaning of the incubators as well.
Environmental quality: Are proper procedures being followed to ensure the environment meets the required standards, and are regular risk assessments being performed to identify potential sources of contamination?
For more details on how to use USP <797> results, I encourage you to watch the full webinar. Mark went much deeper into these three areas in his presentation than I have here.
Watch: How To Demonstrate Your USP <797> Surface Sampling Competency and Why It’s Important
The Case for Genus-Typing Sample Results
While it wasn’t discussed in the webinar, I’d like to take a moment to discuss the importance of a quality environmental monitoring program and the Genus ID debate. Genus-typing your samples can help you identify where the problem lies. For instance, Micrococcus is a relatively common bacteria that colonizes human skin. From a USP <797> standpoint, it would be appropriate to consideration evaluating your risk assessments and competencies in that controlled space. If Micrococcus is showing up in incubated samples, it may point to a personnel problem, often a gowning issue or a training SOP (Standard Operating Procedures) that needs further review and updating.
Aspergillus is another microorganism that commonly shows up on sample plates. Aspergillus is a little more challenging as it’s a common mold that can come from almost anywhere: the HVAC system, improper cleaning, incoming supplies, etc. You might need to do a wider investigation, but at least you have some clues to start with based on knowing the genus type of your CFUs.
These are two simple examples. The bottom line is that without identifying the genus type of your micro-organism you have some gaps in your environmental monitoring that could lead to an ineffective program.
EnverifyTM Your Results
Finally, section 17 of USP <797> states that a designated person must ensure that personnel doing surface sampling “demonstrate competency.” Josh Erickson, President and CTO of Stratix Labs™ went into how to use Enverify™ to validate surface sampling competency. AHJs widely recognize Enverify™ results as sufficient for demonstrating competency. To simplify adherence to USP <797>, Pace® has partnered with Enverify™ to allow customers to order their kits through the Pace® web store.
How Can We Help?
Surface sampling seems simple, but it can get complicated. Proving competency is even more challenging still. We’ll be diving deeper into employee competency and environmental monitoring in our September webinar. Register here.
You are also welcome to reach out to us. I’d be happy to discuss your specific scenario or provide a quote for services.
