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Wednesday, March 18, 2020

How to Make a WHO-Recommended Hand Sanitizer and Rubbing Disinfectant Formulation

According to the available evidence on efficacy, tolerability, and cost-effectiveness, World Health Organization recommends using an alcohol-based hand rub or Sanitizers for routine hand antisepsis in most clinical situations. 

WHO recommends the local production of the following formulations as an alternative when suitable commercial products are either unavailable or too costly. To help countries and health-care facilities to achieve system change and adopt alcohol-based hand rubs, WHO has identified formulations for their local preparation. 

Part A is intended to guide home or local producers in the actual preparation of the formulation. 

Materials required (small volume production) 

• Ethanol 96% 
• Hydrogen peroxide 3% 
• Glycerol 98% (Aloevera or Glycerin based Cream)
• Sterile distilled or boiled cold water  

• Isopropyl alcohol 99.8% 
• Hydrogen peroxide 3% 
• Glycerol 98% (Aloevera or Glycerin based Cream)
• Sterile distilled or boiled cold water

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Additional Materials for Hand Sanitizer

• 10-litre glass or plastic bottles with screw-threaded stoppers ( See Image 1 ), or 
• 50-litre plastic tanks (preferably in polypropylene or high density polyethylene, translucent so as to see the liquid level) ( See Image 2 ), or 
• Stainless steel tanks with a capacity of 80–100 litres (for mixing without overflowing) ( See Images 3 , 4 ) 
• Wooden, plastic or metal paddles for mixing (See Image 5) 
• Measuring cylinders and measuring jugs (See Images 6, 7)
 • Plastic or metal funnel 
• 100 ml plastic bottles with leak-proof tops (See Image 8 )
 • 500 ml glass or plastic bottles with screw tops (8)
 • An alcoholometer: the temperature scale is at the bottom and the ethanol concentration (percentage v/v) at the top (See Images 9, 10 , 11)
• Glycerol: used as humectant, but other emollients may be used for skin care, provided that they are cheap, widely available and miscible in water and alcohol and do not add to toxicity, or promote allergy. 
• Hydrogen peroxide: used to inactivate contaminating bacterial spores in the solution and is not an active substance for hand antisepsis. 
• Any further additive to both formulations should be clearly labelled and be non-toxic in case of accidental ingestion. 
• A colorant may be added to allow differentiation from other fluids, but should not add to toxicity, promote allergy, or interfere with antimicrobial properties. The addition of perfumes or dyes is not recommended due to risk of allergic reactions.

These can be prepared in 10-litre glass or plastic bottles with screw-threaded stoppers. Recommended amounts of products: 

 • Ethanol 96%: 8333 ml 
• Hydrogen peroxide 3%: 417 ml
 • Glycerol 98%: 145 ml 

• Isopropyl alcohol 99.8%: 7515 ml 
• Hydrogen peroxide 3%: 417 ml 
• Glycerol 98%: 145 ml 

Step by step preparation: 
 1. The alcohol for the formula to be used is poured into the large bottle or tank up to the graduated mark. 

 2. Hydrogen peroxide is added using the measuring cylinder. 

 3. 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.

 4. The bottle/tank is then topped up to the 10-liter mark with sterile distilled or cold boiled water. 

 5. The lid or the screw cap is placed on the tank/bottle as soon as possible after preparation, in order to prevent evaporation. 

 6. The solution is mixed by shaking gently where appropriate or by using a paddle. 

7. 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.
 The following two alcohol-based handrub formulations are recommended for preparation in-house or in a local production facility, up to a maximum of 50 litres: Formulation 1 To produce final concentrations of ethanol 80% v/v, glycerol 1.45% v/v, hydrogen peroxide (H2O2) 0.125% v/v. Formulation 2 To produce final concentrations of isopropyl alcohol 75% v/v, glycerol 1.45% v/v, hydrogen peroxide (H2O2) 0.125% v/v: Only pharmacopoeial quality reagents should be used (e.g. The International Pharmacopoeia) and not technical grade products


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