By Adam West, Course and Curriculum Manager at CriticalPoint
Imagine standing in a pitch-black room with a dangerous animal. You can’t see it, you can’t hear it, and you have absolutely no idea where it is—but you know it’s there. That’s the unseen threat you’re up against working in a hazardous compounding environment when you have no idea of the level of contamination. Hazardous drug residue doesn’t snarl, growl, or make itself obvious—yet it can harm staff, contaminate surfaces, and silently undermine safety. Performing HD wipe sampling is like the moment the lights flip on, revealing what’s lurking, where it’s hiding, and what needs to be fixed before anyone gets hurt.
This month, The Compounding Chronicles discusses why “turning on the lights” isn’t just recommended—it’s essential.
What to know about HD wipe sampling
In USP <800> Section 6. Environmental Quality and Control, HD wipe sampling is still a “should” (recommended practice)—for now. But why hasn’t this practice become required?
There are no established minimum or safe exposure limits for hazardous drugs, which necessitates strict precautions for those who come into contact with them. Logistically, more research and development are needed to determine clear and universal benchmarks for HD contamination before it can be an industry requirement. This is frustrating because, while analytical data is needed to drive monitoring requirements, we know some level of contamination is likely lurking on surfaces—from the BSC work deck to the front desk, where the general population is present. Facilities that don’t “routinely” perform HD wipe sampling are missing out on the foundational intent of the <800> chapter: worker and patient safety.
However, as it is now and as it remains perfectly imperfect, HD contamination monitoring is a site-specific, risk-based approach. As it should be!
Why pharmacies won’t sample until it’s required
The likeliest motive for not sampling for HD drug residue is the fear that, “if we know it exists, now we have to do something about it.” That’s not a can of worms many are eager to open, and I understand why. However, that is the wrong mindset. The more rational perspective is this: Contamination may not be as bad as you think. But how would you know if you don’t monitor it?
The purpose of monitoring for HD residue is not to check a recommended box for compliance. It’s a practical verification tool to evaluate whether engineering controls, work practices, cleaning/disinfection, and PPE are controlling occupational exposures to antineoplastic and other HDs. It is the verification engine of your entire USP <800> program. It validates whether standard practices are being followed and whether they need to be reviewed and improved.
As mentioned above, performing HD wipe sampling is a site-specific and risk-based approach. We shouldn’t wait for it to be required to test for it. Whether you perform a few hazardous compounds a week or hundreds, monitoring HD drug residue is imperative for your staff and others.
Baseline values and achieving ALARA
The best approach is to determine the likeliest “hotspots.” USP <800> provides sample locations as a starting point, but your final list should be implemented based on your specific practice and facility landscape.
The goal of initial sampling is to test many locations to see what yields. Whatever nanogram concentration you find is your baseline. It’s neither good nor bad; it’s neither pass nor fail. Technically, any measurable level is undesirable (remember, there’s no safe level). The real failure is inaction.
Now that you know what you have and where it’s found, the goal is to remediate through proper decontamination methods and compounding conduct. The objective is to achieve a result that is as low as reasonably achievable (ALARA). Keep in mind that initial baseline sampling and remediation efforts may take up a significant amount of the monitoring program’s time, especially at first.
Once repeated sampling results have achieved ALARA, that location’s level becomes the action limit. Now you have a site-specific benchmark and monitoring program that helps you verify that compounding practices are acceptable and safe.
Let’s not complicate this
The most rewarding aspect of implementing an HD-residue monitoring program begins after the initial sampling. The sampling results reveal where improvements can be made. The investigative process shows how poor practices reflect elevated contamination levels. This is the core reason for sampling: It reveals the unseen issues so you can fix your operational processes.
Although HD contamination is the scary animal lurking in the dark, it is not the cause—it is only the symptom of poor containment control. The amount of contamination reflects how effectively (or ineffectively) engineering controls, work practices, cleaning/disinfection, and PPE control occupational exposures in your daily environment.
Summary
Hazardous drug residue monitoring is not about compliance; it is about establishing conclusive control over your compounding environment. By using HD wipe sampling, facilities move out of the dark, replacing dangerous unknowns with actionable data. The process defines your baseline, allows you to implement necessary remediation to achieve the ALARA principle, and ultimately validates the effectiveness of your entire USP <800> safety program. Don’t wait for a requirement to prioritize the well-being of your staff and patients—use sampling to illuminate the threat and prove that your environment is truly safe.
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