Overview:
Hand hygiene is an important part of the U.S. response to COVID-19. Washing hands regularly with soap and water for at least 20 seconds is essential, especially after going to the bathroom, before eating, and after coughing, sneezing or blowing one’s nose. If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommends consumers use an alcohol-based hand sanitizer that contains at least 60 percent alcohol (also referred to as ethanol or ethyl alcohol).
Hand Sanitizer Ingredients:
The hand sanitizer is compounded using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Ethanol or Isopropyl Alcohol
- Alcohol (ethanol) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20;
OR
- Isopropyl Alcohol (75%, v/v) in an aqueous solution.
- Glycerol (1.45% v/v)
- Hydrogen peroxide (0.125% v/v)
- Sterile distilled water or boiled cold water
The supplemental addition of other active or inactive ingredients may impact the quality and potency of the product.
Step by Step Process:
- The alcohol for the formula to be used is poured into the large bottle or tank up to the graduated mark.
- Hydrogen peroxide is added using the measuring cylinder.
- Glycerol is added using a measuring cylinder. As glycerol is very viscous and sticks to the wall of the measuring cylinder, it should be rinsed with some sterile distilled or cold boiled water and then emptied into the bottle/tank.
- The bottle/tank is then topped up to the 10-litre mark with sterile distilled or cold boiled water.
- The lid or the screw cap is placed on the tank/bottle as soon as possible after preparation, in order to prevent evaporation.
- The solution is mixed by shaking gently where appropriate or by using a paddle.
- Immediately divide up the solution into its final containers (e.g. 500 or 100 ml plastic bottles), and place the bottles in quarantine for 72 hours before use. This allows time for any spores present in the alcohol or the new/re-used bottles to be destroyed
FDA labeling:
The hand sanitizer is labeled consistent with the attached labeling in
- Appendix A (Labeling for Ethyl Alcohol Formulation Consumer Use)
- Appendix B (Labeling for Isopropyl Alcohol Formulation Consumer Use)
- Appendix C (Labeling for Ethyl Alcohol Formulation Health Care Personnel Hand-rub Use)
- Appendix D (Labeling for Isopropyl Alcohol Formulation Health Care Personnel Hand-rub Use).
General Safety Issues:
The main safety issues relate to the flammability of alcohol-based hand rubs and the adverse effects associated with accidental or deliberate ingestion. These are summarized in the Summary table of risks and mitigation measures concerning the use of alcohol-based hand hygiene preparations.
Flash points:
The flash points of ethanol 80% (v/v) and isopropyl alcohol 75% (v/v) are 17.5°C and 19°C, respectively.
WHO recommendations:
WHO recommends small scale production of hands sanitizer batches do not exceed more than 50 liters at a time.