When the US Food and Drug Administration (FDA) created a program for companies to make a hand and surface sanitizing product, Lisa Gregor, owner of the Church Street Brewing Company, applied for a manufacturing license. Once her application was accepted, Church Street engaged technical specialists at the FDA. The FDA answered every technical question in detail, and all of the program objectives and requirements were made crystal clear. Lisa’s husband Joe is a retired chemical engineer. He was tasked with overseeing the manufacturing process so that the formulation was exactly as specified by the FDA. The appropriate operating procedures and quality assurance measures were in place from the first day of production.
In early April, the primary demand for sanitizer was coming from hospitals, EMS teams, and health care providers. One large hospital group had a specific requirement for tamper-proof containers. Church Street was able to put sanitizer into 16-ounce cans, and thereby meet the requirement. As time progressed, more customers needed sanitizer in larger containers. Church Street started packaging more in 1-gallon plastic bottles, and 5-gallon plastic pails with re-sealable lids.
In early May, more businesses began to anticipate what type and quantity of supplies they needed to have in place for reopening to the general public. Church Street has been working with a wide-variety of businesses to understand their needs for hand sanitizer dispensing, as well as general surface disinfecting. Every business type and location has different needs.
The sanitizer formulation specified by the FDA is very thin. Many people ask if Church Street can make a gel instead. From a technical perspective, making a gel is simple. You just add a thickening agent. However for maximum effectiveness versus a virus, the FDA is very clear in their program requirements. Companies such as Church Street, working under the FDA waiver-program are absolutely prohibited from making a gel. Gels formulated primarily for preventing bacterial infection are not necessarily optimal against a virus. This does not mean a gel is not effective. However, the FDA deems their required formulation within this specific FDA program to be better suited for the war against COVID-19.
The FDA also defines the maximum glycerin content as 1.45 volume-%. Glycerin is a plant-derived fatty alcohol. Too much glycerin may impede the ethanol from penetrating into the skin, or reaching under fingernails. There is a trade-off, but the FDA has taken the position that destroying the virus is the number one objective for their sanitizer formulation as opposed to skin conditioning.
Customers often ask about the concentration and type of the active ingredient. In Church Street’s case the active ingredient is 80 volume-% ethanol. In discussions with the FDA, the technical experts stated that both 75 volume-% isopropanol and 80 volume-% ethanol formulations were equally suitable. Of course it would be less expensive to make a lower-concentration sanitizer, but the FDA requires Church Street to target 80% ethanol. This FDA program that Church Street is operating under only allows for ethanol or isopropanol formulations. Other materials may well be suitable, but they are outside of the scope if this specific FDA program.
Unfortunately, there is a lot of counterfeit sanitizer in the market. Some companies make a product that is not licensed by the FDA, and not even close to compliance with FDA requirements. With the right experience, it is relatively easy to spot fake sanitizers for sale in hardware and grocery stores. If there is any doubt, consumers should access the FDA web site, and verify that the manufacturer is actually licensed to make this over-the-counter pharmaceutical product.
Ordering info for Church Street Brewing Company’s Canitizer Sanitizer here.
#### Church Street Brewing Company: The Church Street Brewing Company is an award winning craft brewery located in Itasca – a western suburb of Chicago. We love what we do! We brew traditional and unpretentious lagers and ales that represent the old and new beer styles of European influence. A family business built on a dream to make quality beer for our loyal clientele. Although we have won several awards, our real passion is to serve our patrons with consistently good-tasting craft beer. We serve locally, nationally and internationally. Come on down and enjoy a beer and tour (free) of our brewery. We love to connect, converse and share our craft beer knowledge with fellow beer lovers! All are welcome! Righteously Good Beer from Itasca, Illinois