“Be adventurists in the sense of being bold and daring. Be opportunists and seize this opportunity, this moment in history, to go out and save our country. It’s your turn now.” — Abbie Hoffman
Since the COVID-19 pandemic started, we’ve been contacted several times by firms that are planning to jump into the business of producing hand sanitizer.
For most of us, the COVID-19 pandemic has been an unalloyed economic disaster. For some, though, the COVID-19 pandemic is not just a scourge, but an opportunity. Not just the profiteers that are buying up face masks and hand sanitizer, then reselling them at ten times the regular price, but also entrepreneurs who see the global shortage and, partly out of a sense of civic duty and partly out a fear of missed opportunity, have decided to begin manufacturing hand sanitizer.
Everybody’s Doing It
The Distilled Spirits Council reports that there are over 800 distilleries in the United States that have switched from making spirits to making hand sanitizer. A map posted by the American Distilling Institute shows craft distilleries across the world, on every continent except Antarctica, producing hand sanitizer.
Colleges are also producing hand sanitizer for distribution. There are stories from around the world about chemistry students, pharmacy students, and engineering students making industrial sized batches of the World Health Organization (WHO) recipe for hand sanitizer. There is even a story about a Russian Studies professor at a college in upstate New York making hand sanitizer for distribution.
So, it should come as no surprise that there are a lot of businesses looking to get into the hand sanitizer business.
What Is Hand Sanitizer?
There are all sorts of formulations for hand sanitizer, a disinfecting hand rub. Some don’t depend on alcohol, but most do—either ethanol or isopropanol, or in some commercial formulations, a combination of both. The alcohol is the active ingredient, and it works by breaking down the lipid wall of the microbe it is supposed to kill. The lipid wall is not especially soluble in water, which is why WHO and the Centers for Disease Control and Prevention (CDC) both insist that the concentration of alcohol in hand sanitizer be at least 60% alcohol.
That’s why typical 80 proof spirits, at 40% v/v alcohol, simply won’t do.
But hand sanitizer is not just alcohol. Hand sanitizer also contain moisturizers—humectants—to keep the alcohol from drying out skin. They also contain some kind of antibacterial to prevent microbes from growing in the sanitizer—ironically, the alcohol in hand sanitizer isn’t enough to protect the hand sanitizer from some microbial growth.
The WHO has published two recipes for hand sanitizer in its “Guide to Local Production: WHO-recommended Handrub Formulations”. One consists of 80% ethanol, 0.125% hydrogen peroxide (the antibacterial), and 1.45% glycerol (the humectant). The other consists of 75% isopropanol, 0.125% hydrogen peroxide (the antibacterial), and 1.45% glycerol (the humectant). In each, the balance is water.
A popular on-line recipe for home-made hand sanitizer consists of two parts 91% isopropanol and one part aloe vera gel. This gives a product that is right at 60% isopropanol and contains aloe vera as the humectant. If the aloe vera gel is a purchased product, it will contain preservatives that serve as the antibacterial. If the aloe vera gel is also home-made, not so much.
Safety Concerns
The Food and Drug Administration (FDA) requires that the producers of hand sanitizers be registered drug manufacturers. During the pandemic, the FDA has developed a temporary policy for temporarily registering as an over-the-counter drug manufacturer.
Likewise, the U.S Alcohol and Tobacco Tax and Trade Bureau (TTB) has developed temporary guidance for the use of distilled spirits for hand sanitizer.
The TTB cares about taxes and the FDA cares about making sure that hand sanitizer actually kills microbes. Neither are concerned about the safety of manufacturing hand sanitizer.
Hand Sanitizer is a Highly Hazardous Material
The flash point of typical spirits (80 proof) is 26 C (79°F), above room temperature.
The lower the flash point, the easier to ignite. The flash point of pure ethanol (200 proof) is 13 C (55°F), well below room temperature. The flash point of grain alcohol (190 proof) is 17 C (63°F), also below room temperature, and the flash point of hand sanitizer at 60% is 22 C (72°F), right at room temperature. This means that hand sanitizer and its likely active ingredient are both more hazardous than beverage alcohol, more likely to ignite.
The flash points of isopropanol at similar concentrations are even lower.
If it’s not the FDA or the TTB that care about the safety of manufacturing hand sanitizer, then who? WHO? The WHO recipes don’t talk about process safety, and neither does information from the CDC. But the need for a safe workplace doesn’t go away just because we are in the midst of a pandemic.
So, entrepreneurs looking to get into the hand sanitizer business need to be especially mindful of at least two regulations enforced by the Occupational Safety and Health Administration (OSHA): Flammable Liquids, 29 CFR 1910.106, and the Process Safety Management Standard, 29 CFR 1910.119. Whether a process is legally covered by these regulations or not, these regulations offer good guidance on how to keep a workplace safe to anyone manufacturing hand sanitizer.
What, More Red Tape?
Flammable liquids should not be trifled with. From the moment I began hearing about universities and other entities getting into the “industrial-scale” production of hand sanitizer, I’ve been dreading the day I heard about one of them suffering a catastrophic event. On April 13, it happened.
Shortly after witnessing the shortages in India, Galaxy Surfactants decided to get into the business of producing hand sanitizer. After all, they were already in the business of producing and formulating all sorts of ingredients for consumer products. This wasn’t just some Joe setting up a 55-gallon drum in his garage.
Moving quickly to take advantage of the opportunity, Galaxy Surfactants closed a plant in Mumbai to set up for hand sanitizer production. On April 13, they reopened the plant to begin production. On the first day they were open, at around 11 am local time, an explosion in the hand sanitizer unit rocked the plant, killing two and seriously injuring three others.
Learn from the Experience of Others
There is a demand for hand sanitizer. It will probably peak as the pandemic peaks, but it will probably not drop back to the levels it was at before the pandemic. Kudos to the entrepreneurs who are stepping into the breach to fill that demand. But they need to do it with their eyes wide open. Hand sanitizer and its key ingredients, ethanol or isopropanol, are highly hazardous chemicals. High hazardous chemicals need to be treated with respect.
Hand sanitizer can protect people from the coronavirus and other microbial threats. It can also threaten the safety of workers making hand sanitizer. If you are new to working with flammable liquids, get help. We all learn by experience, but it doesn’t have be our own experience. Fortunately, the experience is already out there. Don’t let your venture into hand sanitizer production turn into an opportunity to experience a catastrophic event.
