W. H. O.

RECOMMENDATIONS

FOR

ALCOHOL HAND RUBS

INDEX

1. General Facts on alcohols used for Hand rubs 2. Alcohol Check! Implication on Skin and efficacy, when used as Hand Rubs

3. Guide to Local Production – WHO-Recommended 2009

4. Chart showing Ethanol percentage, volume to weight

5. Chart showing 2-propanol percentage, volume to weight

6. WHO Model List, Essential Medicines, 19th Edition 7. Alcohol content in Sterillium

8. Publication from Journal of Hospital Infection: “WHO Recommended Hand

Rub Formulations does not meet European requirements” 9. American Journal of Infection Control “Testing of WHO Hand rubs, proposal

for increase…” 10. Trend towards higher alcohol content: Journey from 2000 to 2012

11. References

12. Ebola Fighters chose Sterillium

12. International Testing Of Sterillium Brand of the Century.

ALCOHOL CHECK!

Some Facts on Alcohol

It should be noted, that alcohol available in India, are in many qualities as their base of production is different.

If the manufacturer does not use Pharma Grade ethanol, or propanol, the alcohol is crude, unrefined, and unfiltered.

Many samples show sedimentation of inorganic sulphates.

They have a strong objectionable smell, and on the chromatographic investigation, they are not conforming to the classifications of Pharma Grade alcohol.

If such grade alcohol is used for the manufacture of hand rubs, the following implications are to be understood:

Implications on Hand rubs:

Highly acidic alcohol hand rub with non synergistic skin protectors solution will cause:

a. Undue stress on the skin, damaging the skin, and exposing the deeper layers of the skin, to further attack.

b. A pathological process starts with one lesion formed on the skin by regular use of a non

skin-friendly alcohol rub. There is loss of elasticity, causing roughness, leading to scaling of skin and cracks.

c. The natural protective lipid layer is destroyed and such skin will harbor more

organisms.

d. A full blown subcutaneous dermatitis will develop on regular use.

e. It is to be remembered that alcohol rubs which are not skin-friendly will be of no benefit even if it kills micro-organisms. The natural skin of the hand should always be protected and should remain fully intact, so the process of disinfection does not compromise on the dermatological condition and cosmetic maintenance of the skin. Only then it will be an effective hand disinfectant.

f. Be careful of using, cheap alcohol hand rubs, as they are certainly, non skin compatible.

g. Most Important: SYNERGISTIC SKIN PROTECTORS, have to be added to an

alcohol hand rub. This means it is NOT interfering with the cidal effect of the alcohol on the micro-organisms.

If non synergistic or cheap skin protectors, are added to the alcohol rub, it will interfere, and diminish the killing or the cidal effect, on micro-organisms! This will make it a WEAK hand rub!

GUIDE TO LOCAL PRODUCTION: WHO-RECOMMENDED HANDRUB FORMULATIONS

Final products

FORMULATION 1 FORMULATION 2

Final concentrations: Final concentrations:

• Ethanol 80% (v/v), • Isopropyl alcohol 75% (v/v),

• Glycerol 1.45% (v/v), • Glycerol 1.45% (v/v),

• Hydrogen peroxide • Hydrogen peroxide

0.125% (v/v) 0.125% (v/v)

Quality control 1. 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.

2. 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).

3. The alcoholmeter shown in

this information pamphlet 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.

General information Labelling should be in accordance with national guidelines

and should include the following: • Name of institution • WHO-recommended handrub formulation • For external use only • Avoid contact with eyes • Keep out of the reach of children • Date of production and batch number • Use: Apply a palmful of alcohol-based handrub and cover all surfaces

of the hands. Rub hands until dry • Composition: ethanol or isopropanol, glycerol and hydrogen peroxide • Flammable: keep away from flame and heat

Production and storage facilities: • Production and storage facilities should ideally be air conditioned

or cool rooms. No naked flames or smoking should be permitted

in these areas. • WHO-recommended handrub formulations should not be produced

in quantities exceeding 50-litres locally or in central pharmacies

lacking specialised air conditioning and ventilation.

• Since undiluted ethanol is highly flammable and may ignite at

temperatures as low as 10°C, production facilities should directly

dilute it to the above-mentioned concentration. The flashpoints of

ethanol 80% (v/v) and of isopropyl alcohol 75% (v/v) are 17.5°C

and 19°C, respectively. • National safety guidelines and local legal requirements must

be adhered to the storage of ingredients and the final product. • Additional safety information is presented in Part B of this Guide.

PAGE 4 OF 9

All reasonable precautions have been taken by the World Health Organization to verify the information contained in this document. However, the published

material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with

the reader. In no event shall the World Health Organization be liable for damages arising from its use.

GUIDE TO LOCAL PRODUCTION: WHO-RECOMMENDED HANDRUB FORMULATIONS

Guide to Local Production:

WHO-recommended Handrub Formulations

Introduction: This Guide to Local Production of

WHO-recommended Handrub Formulations is

separated into two discrete but interrelated

sections:

Part A provides a practical guide for use at the

pharmacy bench during the actual preparation of

the formulation. Users may want to display the

material on the wall of the production unit.

Part B summarizes some essential background

technical information and is taken from WHO

Guidelines on Hand Hygiene in Health Care (2009).

Within Part B the user has access to important

safety and cost information and supplementary

material relating to dispensers and distribution.

PAGE 1 OF 9

Revised April 2010

All reasonable precautions have been taken by the World Health Organization to verify the information contained in this document. However, the published

material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with

the reader. In no event shall the World Health Organization be liable for damages arising from its use.

WHO Recommended Hand Rub Using Ethanol

Chart showing the conversion of Ethanol percentage by volume to weight

Commonly found in Hand rubs in India

WHO WHO

Recommended Recommended

Strength

Strength

WHO Recommended Hand Rub Using Propanol

WHO Rub (2009)

Modified WHO increased by 6%

Use following Specific Gravity in this Conversion.

Name Sp. Gravity

Sterillium : 0.85

2-Propanol : 0.78

1-Propanol : 0.803

Concentration of 2-Propanol Concentration of 2-Propanol

By weight ( w/w) By Volume ( v/v)

39% w /w 42.50 % v/v

40% w /w 43.59 % v/v

41% w /w 44.68 % v/v

42% w /w 45.77 % v/v

43% w /w 46.86 % v/v

44% w /w 47.95 % v/v

45% w /w 49.04 % v/v

46% w /w 50.13 % v/v

47% w /w 51.22 % v/v

48% w /w 52.31 % v/v

49% w /w 53.40 % v/v

50% w /w 54.49 % v/v

51% w /w 55.58 % v/v

52% w /w 56.67 % v/v

53% w /w 57.76 % v/v

54% w /w 58.85 % v/v

55% w /w 59.94 % v/v

56% w /w 61.03 % v/v

57% w /w 62.12 % v/v

58% w /w 63.21 % v/v

59% w /w 64.29 % v/v

60% w /w 65.38 % v/v

61% w /w 66.47 % v/v

62% w /w 67.56 % v/v

63% w /w 68.65 % v/v

64% w /w 69.74 % v/v

65% w /w 70.83 % v/v

66% w /w 71.92 % v/v

67% w /w 73.01 % v/v

68% w /w 74.10 % v/v

WHO Rub

69% w /w 75.19 % v/v

(2009)

70% w /w

76.28 % v/v

71% w /w 77.37 % v/v

72% w /w 78.46 % v/v

73% w /w 79.55 % v/v

74% w /w

80.64 % v/v

Modified WHO

75% w /w

81.73 % v/v

increased by

6.54%

Essential Medicines

WHO Model List 15. DISINFECTANTS AND ANTISEPTICS

15.1 Antiseptics

19th edition

� chlorhexidine Solution: 5% (digluconate).

� ethanol Solution: 70% (denatured).

� povidone iodine Solution: 10% (equivalent to 1% available iodine).

15.2 Disinfectants

Solution containing ethanol 80% volume /volume

alcohol based hand rub Solution containing isopropyl alcohol 75%

volume/volume

� chlorine base compound Powder: (0.1% available chlorine) for solution.

� chloroxylenol Solution: 4.8%.

glutaral Solution: 2%.

16. DIURETICS

amiloride Tablet: 5 mg (hydrochloride).

Injection: 10 mg/ mL in 2‐ mL ampoule.

� furosemide Oral liquid: 20 mg/5 mL

. [c]

Tablet: 10 mg

; 20 mg

; 40 mg. [c] [c]

� hydrochlorothiazide Solid oral dosage form: 25 mg.

mannitol Injectable solution: 10%; 20%.

spironolactone Tablet: 25 mg.

Complementary List [c]

� hydrochlorothiazide Tablet (scored): 25 mg.

mannitol Injectable solution: 10%; 20%.

spironolactone Oral liquid: 5 mg/5 mL; 10 mg/5 mL; 25 mg/5 mL.

Tablet: 25 mg.

17. GASTROINTESTINAL MEDICINES

Complementary List [c]

� pancreatic enzymes Age‐appropriate formulations and doses including lipase,

protease and amylase.

17.1 Antiulcer medicines

Powder for injection: 40 mg in vial

� omeprazole Powder for oral liquid: 20 mg; 40 mg sachets.

Solid oral dosage form: 10 mg; 20 mg; 40 mg.

19

th WHO Model List of Essential Medicines (April 2015) page - 31

Alcohol content of Sterillium

2-propanol (Iso Propyl Alcohol)

1-propanol (n - propanol)

45 g

30 g

Using following Specific Gravity in the conversion:

2-propanol 45 g 0.78

1-propanol 30 g 0.803

Concentration of 2-Propanol

By weight (w/w)

39 % w/w

41 % w/w

43 % w/w

45 % w/w

47 % w/w

49 % w/w

51 % w/w

Concentration of 2-Propanol

By volume (v/v)

42.50 % v/v

44.68 % v/v

46.86 % v/v

49.04 % v/v

51.22 % v/v

53.40 % v/v

55.58 % v/v

Concentration of 1-Propanol

By weight (w/w)

Concentration of 1-Propanol

By volume (v/v)

24 % w/w 25.40 % v/v

26 % w/w 27.52 % v/v

28 % w/w 29.64 % v/v

30 % w/w 31.76 % v/v

32 % w/w 33.87 % v/v

34 % w/w 35.99 % v/v

36 % w/w 38.11 % v/v

Total percentage of

=

80.80% v/v

Propanol v/v in Sterillium

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May 2012Volume 40, Issue 4, Pages 328–331

Testing of the World Health Organization recommended formulations in their application as hygienic hand rubs

and proposals for increased efficacy

Miranda Suchomel, PhD Michael Kundi, PhD Didier Pittet, MD Martina Weinlich Manfred L. Rotter, MD Published Online: December 02, 2011

DOI: http://dx.doi.org/10.1016/j.ajic.2011.06.012

Article Info • Abstract • Full Text • References

Background

In Central Europe, alcohol-based hand rubs have been the preferred choice for hand hygiene, whereas, in other countries, other

preparations have been used that are based on other active agents. Recently, a move towards alcohol-based hand rubs has begun,

but they may be costly and unaffordable to some. Therefore, the World Health Organization (WHO) has recommended 2 hand rub

formulations (WHO I and WHO II) for local production in health care settings where commercial products are not available or are too

expensive.

Objectives

WHO I, based on ethanol 80% (vol/vol), and WHO II, based on isopropanol 75% (vol/vol), were investigated for their bactericidal

efficacy in their application as hygienic hand rubs.

Methods

The investigation took place at the Institute for Hygiene and Applied Immunology, Medical University Vienna, Austria, as a

prospective, randomized, in vivo laboratory study, comparative in crossover design. Both formulations were tested according to the

European Standard EN 1500 in 2 applications (1 × 3 mL/30 seconds or 2 × 3 mL/2 × 30 seconds). Additionally, modifications with

increased alcohol concentrations (weight instead of volume percent) were tested in the short application. Bactericidal efficacies were

compared with those of the respective reference procedure “R,” ie, rubbing 2 × 3 mL 60% vol/vol isopropanol for 2 × 30 seconds onto hands artificially contaminated with Escherichia coli K12.

Results The short application of either WHO formulation resulted in bacterial reductions significantly inferior to the respective ones of R. However, prolonging the contact time to 60 seconds or increasing the alcohol content produced reductions similar to those of R.

Conclusion Both WHO-recommended formulations meet the efficacy requirements of EN 1500 within 60 seconds but not within 30 seconds. Increasing the respective alcohol concentrations from 80% vol/vol to 80% wt/wt and 75% vol/vol to 75% wt/wt renders the formulations sufficiently active to conform to the norm also within 30 seconds.

Key Words: Hygienic hand antisepsis, WHO formulation

Conflicts of interest: None to report.

© 2012 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

< Previous Article

Next Article > May 2012Volume 40, Issue 4, Pages 328–331

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such product or of the claims made for it by its manufacturer.

Trend towards higher alcohol content in hand disinfectants

05/2012

Study of Suchomel et al. : ethanol

content of the WHO formula should be

increased from 80 % (v/v) to 80 %

(w/w) to fulfil current efficacy standards

01/2008

Study of Rupp et al. : 62 % ethyl

alcohol was not associated with detectable changes in number of

hospital-acquired infections (HAI)

05/2009

WHO Guidelines recommend an ethanol con -

tent of 80 % (v/v) for local production of

hand disinfectants

10/2000

Study of Pittet et al. : alcohol content

of 75 % showed to increase compliance

and decrease infection rate

04/2002

Study of Kramer et al. : suggests at

least 80 % ethyl alcohol

References: Pittet D et al. 2000 Effectiveness of a hospital-wide programme to improve compliance with hand hygiene. Lancet;. 356: 1307-1312 Kramer A et al. 2002 Limited efficacy of alcohol-based hand gels. Lancet. 2002;359:1489-1490. Rupp ME et al. 2008 Prospective, controlled, cross-over trial of alcohol-based hand gel in critical care units. Infect Control Hosp Epidemiol. 2008; 29: 8-15. WHO 2009 WHO Guidelines on Hand Hygiene in Health Care. First Global Patient Safety Challenge Clean Care is Safer Care (revised Aug 2009). Available at http://whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf (accessed on 01 Aug 2013). Suchomel M et al. 2012 Testing of the World Health Organization recommended formulations in their application as hygienic hand rubs and proposals for icreased efficacy. Am J Infect Control. 2012; 40 (4): 328-31.

List of references and scientific study publications

1. Pittet D et al. 2000 Effectiveness of a hospital-wide programme to improve compliance with hand

hygiene. Lancet; 356: 1307-1312

2. Kramer A et al. 2002 Limited efficacy of alcohol-based hand gels. The Lancet 2002, 359: 1489-1490.

3. Kampf G et al. the

hand disinfectant

2002

agent

Spectrum

Sterillium

of antimicrobial activity and user acceptability of Gel.

Journal of Hospital Infection 2002, 52(2):141-147.

4. Kampf G et al. 2003 Comparison of two test methods for the determination of sufficient antimicrobial

efficacy of three different alcohol-based hand rubs for hygienic hand disinfection. Journal of Hospital

Infection 2003, 55 (3): 220-225. 5. Rupp ME et al. 2008 Prospective, controlled, cross-over trial of alcohol-based hand gel in critical care

units. Infect Control Hosp Epidemiol. 2008; 29: 8-15.

6. WHO 2009 WHO Guidelines on Hand Hygiene in Health Care. First Global Patient Safety Challenge

Clean Care is Safer Care (revised Aug 2009). Available at

http://whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf (accessed on 01 Aug 2013).

7. Suchomel M et al. 2012 Testing of the World Health Organization recommended formulations in their

application as hygienic hand rubs and proposals for increased efficacy. Am J Infect Control 2012, 40

(4): 328-331.

8. Kampf G et al. 2013 Efficacy of hand rubs with a low alcohol concentration listed as effective by a

national hospital hygiene society in Europe. Antimicrobial Resistance and Infection Control 2013, 2:

19.

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