This Guide to Local Production of WHO-recommended Hand Sanitizer Formulations is separated into two discrete but interrelated sections: This guide will help in preventing the spread of Coronavirus pandemic across the globe by using WHO recommended hand sanitizer
Part A provides a practical guide for use at the pharmacy bench during the actual preparation of the formulation (Hand Sanitizer).
Part B summarizes some essential background technical information and is taken from the WHO Guidelines on Hand Hygiene in Health Care (2009).
PART A: GUIDE TO LOCAL PRODUCTION OF HAND SANITIZER
Part A is intended to guide a local producer in the actual preparation of the formulation (Hand Sanitizer).
Materials required (small volume production)
| REAGENTS FOR FORMULATION 1: | REAGENTS FOR FORMULATION 2: |
| Ethanol 96% • Hydrogen peroxide 3% • Glycerol 98% • Sterile distilled or boiled cold water | • Isopropyl alcohol 99.8% • Hydrogen peroxide 3% • Glycerol 98% • Sterile distilled or boiled cold water |
• 1-liter glass or plastic bottles with screw-threaded stoppers, or
• 10-liter plastic tanks (preferably in polypropylene or high density
polyethylene, translucent so as to see the liquid level)
• Stainless steel tanks with a capacity of 80–100 liters
(for mixing without overflowing)
• Wooden, plastic or metal paddles for mixing
• Measuring cylinders and measuring jugs
• Plastic or metal funnel
• 100 ml plastic bottles with leak-proof tops
• 500 ml glass or plastic bottles with screw tops
• An alcoholometer: the temperature scale is at the bottom
and the ethanol concentration (percentage v/v) at the top
METHOD: 1-LITRE PREPARATIONS
These can be prepared in 1-liter glass or plastic bottles with screw-threaded stoppers.
Recommended amounts of products:
| FORMULATION 1 | FORMULATION 2 |
| • Ethanol 96%: 833.3 ml • Hydrogen peroxide 3%: 41.7 ml • Glycerol 98%: 14.5 ml | • Isopropyl alcohol 99.8%: 751.5 ml • Hydrogen peroxide 3%: 41.7 ml • Glycerol 98%: 14.5 ml |
Step by step preparation:
- 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 1-liter 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.
- 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.
Final Products
| FORMULATION 1 | FORMULATION 2 |
| Final concentrations: • Ethanol 80% (v/v), • Glycerol 1.45% (v/v), • Hydrogen peroxide 0.125% (v/v) | Final concentrations: • Isopropyl alcohol 75% (v/v), • Glycerol 1.45% (v/v), • Hydrogen peroxide 0.125% (v/v) |
Quality Control
Pre-production analysis should be made every time an analysis certificate is not available to guarantee the titration of alcohol (i.e. local production). Verify the alcohol concentration with the alcoholmeter and make the necessary adjustments in volume in the preparation formulation to obtain the final recommended concentration.
Post-production analysis is mandatory if either ethanol or an isopropanol solution is used. Use the alcoholmeter to control the alcohol concentration of the final use solution. The accepted limits should be fixed to ± 5% of the target concentration (75%–85% for ethanol).
The alcoholmeter is for use with ethanol; if used to control an isopropanol solution, a 75% solution will show 77% (± 1%) on the scale at 25°C
Efficacy
It is the consensus opinion of a WHO expert group that WHO recommended hand rub formulations can be used both for hygienic hand antisepsis and for presurgical hand preparation.
Hygienic Hand Rub
The microbicidal activity of the two WHO-recommended formulations was tested by WHO reference laboratories according to EN standards (EN 1500). Their activity was found to be equivalent to the reference substance (isopropanol 60% v/v) for hygienic hand antisepsis.
