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ELM President Lou Honary discussed the plant conversion process with Mary Moon, April 27, 2020
When the Coronavirus Disease 2019 (COVID-19) pandemic affected millions of citizens throughout the US and around the world earlier this year, hand sanitizers and other critical health care products suddenly were in short supply. A small lubricant manufacturer in the American heartland responded to this urgent situation. Staff willingly returned to work and swiftly modified underutilized equipment to produce and package hand sanitizers. To learn more about the challenges they faced and overcame, read on.
Environmental Lubricants Manufacturing (ELM) was formed in 2000 to commercialize bio-based lubricants and greases that were created at the University of Northern Iowa’s National Agricultural-Based Lubricants Center. The UNI-NABL Center was supported with funding from Soybean Growers of Iowa, USDA, US DOE, US DOT and private agriculture industry. ELM products, including biobased greases that match the price and performance of petroleum-based greases, are available through distributors or under private label.
Dr. Honary is President of ELM and Emeritus Professor/Director of UNI-NABL Center at University of Northern Iowa. He holds ten patents on bio-based products. He co-invented a grease manufacturing process that uses microwaves instead of conventional techniques with greater fire hazards.
Five gallon pails of Bio-Based Drill Rod Grease manufactured at ELM.
MM: In mid-April, ELM announced that it had started to produce hand sanitizer. Was this in response to shortages in supplies of hand sanitizers related to the COVID-19 pandemic?
LH: YES! This was when the original idea came to us. ELM is a wholesaler, and we sell bulk products. We had some underutilized packaging equipment, and we thought we could put it to use for this purpose and sell hand sanitizer to our distributors, who will sell it to end users.
It's important to understand the role of hand sanitizers. According to the Center for Disease Control, "CDC recommends the use of alcohol-based hand sanitizers with greater than 60% ethanol or 70% isopropanol as the preferred form of hand hygiene in healthcare settings… " (CDC Statement for Healthcare Personnel on Hand Hygiene during the Response to the International Emergence of COVID-19)
But outside of hospitals and other healthcare settings, "CDC recommends washing hands with soap and water whenever possible because handwashing reduces the amounts of all types of germs and chemicals on hands. But if soap and water are not available, using a hand sanitizer with at least 60% alcohol can help you avoid getting sick and spreading germs to others. Alcohol-based hand sanitizers can quickly reduce the number of microbes on hands in some situations, but sanitizers do not eliminate all types of germs." (Show Me the Science – When & How to Use Hand Sanitizer in Community Settings)
MM: Was it necessary to re-engineer your manufacturing facilities in order to make hand sanitizer? What did this involve?
LH: Yes! Hand sanitizers are formulated with ethanol or isopropanol, which are hazardous materials and regulated. Ethanol and isopropyl alcohol are both classified as highly flammable liquids and rated 3 on HMIS and NFPA scales (with 0 representing minimal hazards or risks, and 4 representing significant hazards or risks). Flammability as well as toxicity, health, and irritant hazards are described on safety data sheets for these chemicals.
First, we had to get a permit from the Bureau of Alcohol, Tobacco, Firearms and Explosives so we could bring bulk volumes of alcohol (ethanol) into our facility.
The on-line process to get a permit typically takes between 60 and 90 days. But after a week of trying to apply on-line, we reached out to our governor’s office, and they connected us with the Bureau. Staff at the federal office were extremely well prepared and ready to help. Since we had all the forms downloaded and completed, they issued our permit in one day.
Next, we learned that our alcohol supplier could not deliver bulk quantities due extremely high demands. We contacted ethanol plants in Iowa, but they told us they could not release alcohol to us due to regulations. So, we reached out to the Iowa Corn Growers Association and learned that they are aware of these regulations and they are working to modify them to allow companies like us to purchase alcohol for manufacturing hand sanitizers.
Then, we had to modify our storage tanks, filling lines, conveyors, etc. to ensure they follow the NFPA and other published guidelines for grounding and bonding to counter the problem of static electricity in the presence of flammable liquids or vapors.
MM: How did you and your staff make these changes so quickly?
LH: Staff had been on furlough for a week after Iowa Governor Kimberly K. Reynolds had proclaimed a State of Public Health Disaster Emergency on March 17, 2020. So this was pleasant news for them to be able to return to work.
It was necessary to train staff to safely handle flammable materials. I had taught a safety course at the University and had attended safety classes. So, with the help of on-line videos and downloads of print materials, I held training sessions for our employees. This was followed by grounding and bonding the relevant equipment to allow staff members to apply what they learned.
Eight ounce bottles of hand sanitizer on a conveyor belt in the packaging facility at ELM
MM: Did ELM change any policies and procedures for QC when you started to make hand sanitizer?
LH: Yes, we increased our inspection frequency. And we are monitoring our activities with more vigilance.
At ELM, we have a small crew of less than ten employees in an 87,000 square foot facility. Social distancing takes place naturally in our plant.
MM: Did ELM develop formulations for hand sanitizers?
LH: Yes. We had explored a few formulations for hand sanitizers on our own. FDA has been cooperative with sharing guidelines and formulation recommendations, which have been very helpful. So, in essence, we use FDA guidelines for our formulation, and the product works great. This is critical because FDA considers alcohol-based hand sanitizer products to be nonsterile drugs.
FDA guidance specifies the correct grade and amount of active ingredients and forbids the use of ingredients that may impact quality and potency, or improve smell or taste (to reduce risk of ingestion). Hand sanitizers are available in three formats, gels, foams, and liquids. Our hand sanitizers are liquids that contain 80% alcohol, moisturizers, and other ingredients. They are appropriate for use in offices, factories, and other places.
MM: Are there special precautions to store, handle, and manufacture hand sanitizers?
LH: Yes, because hand sanitizers contain alcohols, there are very stringent requirements for labeling them and providing safety data sheets during transportation. Again, the federal regulators at DOT and other agencies have been generous with providing guidance on all aspects of handling hand sanitizers.
MM: What have you and your staff learned from this experience about speedy product development and re-engineering production facilities?
LH: We have been very methodical and deliberate in this process to manufacture hand sanitizers. We are still working our way towards mass release of our hand sanitizer products. We have learned to slow down and walk through all the processes several times, and then practice in small steps before ramping up production.
In hindsight, we feel we should have started our research a month or two earlier, as making hand sanitizers certainly has its complexities. But this is a rewarding experience as it has allowed our employees to stay productive, and all of us feel we are contributing to the fight against the virus.
One gallon bottles of hand sanitizer from the packaging line at ELM