UPDATE: The Food and Drug Administration withdrew these temporary guidelines on October 12, 2021. Refer to their announcement for the most up-to-date information.
In early April, the U.S. Food and Drug Administration (FDA) released a temporary guidance document that allows companies without current FDA facilities to make hand sanitizer. This decision allows companies to temporarily distribute a single, specific hand sanitizer liquid formula to assist in creating a needed supply during the COVID-19 national emergency.
To be able to make hand sanitizer, companies must register on the FDA website and follow all instructions and requirements in the temporary guidelines. View the tips below from Tilley Distribution to learn how to properly formulate and make hand sanitizer and hand soap.
Hand Sanitizer Formulation
After receiving approval from the FDA, a company will be able to make hand sanitizer. The formulation must be made as instructed in the guidelines. No modifications or omissions are allowed and only these exact ingredients can be used.
Below are the ingredients to formulate hand sanitizer, which is also consistent with World Health Organization (WHO) recommendations:
- Alcohol (ethanol) (80%, volume/volume (v/v)) in an aqueous solution; or Isopropyl Alcohol (75%, v/v) in an aqueous solution.
- Glycerin (glycerol) (1.45% v/v)*
- Hydrogen peroxide (0.125% v/v)
- Sterile distilled water or boiled cold water
Common ethyl alcohol types used in hand sanitizers are specified as including SDA 40A, 40B, or SDA 3C. The final alcohol concentration must be 80% (v/v) if using ethanol and 75% (v/v) if using isopropanol.
- Although WHO’s recommended formulation includes glycerol 1.45% (v/v), reports indicate that glycerol negatively impacts the effectiveness of isopropyl alcohol and reports studying the effectiveness of WHO’s formulation have suggested a reduction from 1.45% to 0.725%.
5-Step Hand Sanitizer Manufacturing Process
Using measuring cylinders, a large bottle or tank (depending on the amount of hand sanitizer needed, we will use a tank in the example below) and individual bottles, you can combine the above ingredients to create 10 liters of hand sanitizer. Follow these steps to make hand sanitizer:
- Pour 7515 milliliters of alcohol into the tank.
- Add in 417 milliliters of hydrogen peroxide.
- Add in 145 milliliters glycerol to the tank and rinse the cylinder immediately, as glycerol is very viscous and will stick to the wall of the cylinder. The water used to release the glycerol from the wall can be emptied into the tank.
- Fill the remainder of the 10-liter tank with sterile distilled water or boiled cold water. Immediately screw the top on to prevent evaporation.
- Mix the solution by stirring it in the tank and then immediately divide the solution up into individual bottles. Let the bottles and solution set for three days before distributing. This will help ensure that all spores are destroyed, and the bottle and sanitizer mixture is safe for use.
How to Make Hand Soap
In addition to hand sanitizer, regular hand washing should also be utilized to prevent diseases and infections. Follow the steps below to create a Tilley formulated hand soap that can be used daily.
Remember to always use PPE and mix items in order as they are listed below. Monitor mixing speed and adjust to prevent air entrainment. The formulation is based on percentage by weight to create a bio-based dioxane-free liquid hand soap.
- Deionized Water, 74.050% by weight (Diluent)
- Hydroxyethyl Cellulose (HEC), 0.350% by weight (Thickener)
- Stepanol WA Extra, 18.000% by weight (Detergency)
- Amphosol HCG, 3.750% by weight (Detergency)
- Propylene Glycol, 3.750% by weight (Cosolvent)
- Citric Acid (Citric Acid 50%), qs (pH adjust down if necessary)
- KOH (KOH 10%), qs (pH adjust up if necessary)
- Kathon CG, 0.100% by weight (Preservative)
- Fragrance, qs (Optional)
- Dye, qs (Optional)
Note the following before creating the hand soap:
- Heat water to 120 ± 5 degrees Fahrenheit before adding the HEC, stir for 30 minutes and then turn the heat off.
- Keep the drum of propylene glycol in a warm room between 120 to 130 degrees Fahrenheit before adding it in.
- The pH should be 7.3 ± 0.3.
- Typical viscosity = 700-1200 cP (#3 spindle, 60 rpm).
- Specific Gravity = 1.00-1.02.
The information contained herein is based on an internal study and the study of others. No warranty as to the adequacy, accuracy, or completeness of this information is implied or made. Tilley will not be liable for any consequential, special or direct damages as a result of the provision of this information.
Find Hand Sanitizer Ingredients Near Me
Are you ready to start making hand sanitizer or hand soap? Tilley is here to help. Whether you are searching for enough hand sanitizer ingredients to fill a large tank or custom formulation and packing services, our team can support you. Contact our team or give us a call at 1 (800) 638-6968 to get started today.
