As the COVID-19 pandemic of 2020 continues to increase the demand for hand sanitizer, it is useful to understand how different hand sanitizers work and their properties. In this paper, we will explore alcohol and non-alcohol-based hand sanitizers as well as hand washing within the context of SARS-CoV-2, COVID-19 or coronavirus, as it is more commonly known.  

II) Background 

Most people are aware that ‘germs’ are what cause illnesses, or even more explicitly that these ‘germs’ consist of bacteria and viruses. Bacteria are eukaryotic cells, an enveloped cell containing cytoplasm and organelles. ¹ They can cause illness by causing damage to the host cell, the overall body of the host, or through the delivery of toxins within the body. Viruses are structures which contain RNA or DNA in a protein structure that is sometimes surrounded by a lipid bilayer. They cause illness by entering a host cell and replicating, which causes altered function, structure, or death of the cell.  

COVID-19 is a lipophilic enveloped virus. It is part of the coronavirus family; a family of viruses which cause upper respiratory problems such as the common cold, severe acute respiratory syndrome from SARS-CoV, and Middle East respiratory syndrome. ² These viruses can be referred to collectively as coronaviruses.  

Hand sanitizers sold in Canada must follow the antiseptic skin cleansers (personal domestic use) monograph from Health Canada. ³ The monograph permits hand sanitizers to contain ethyl alcohol (ethanol) at 60-80% and 2-propanol (isopropanol) at 60-75% as active ingredients.  Hand sanitizers that use alcohols as their active ingredients are classed as Natural Health Products. The monograph also allows other active ingredients; these hand sanitizers are classed as non-prescription drugs. These actives include benzalkonium chloride at 0.1-0.15%, benzethonium chloride at 0.05-0.5%, chlorhexidine digluconate at 2-4%, chloroxylenol at 0.5-3%, and triclosan at 0.1-1%. In the United States, hand sanitizers are considered OTC antiseptics. ⁴ The US FDA declares that a product can be marketed as a hand sanitizer if it contains ethyl alcohol, isopropyl alcohol, or benzalkonium chloride as the active ingredient. 

III) Effectiveness of Alcohol-Based Hand Sanitizers 

Currently, many alcohol-based hand sanitizers use ethanol (ethyl alcohol) or isopropanol (isopropyl alcohol) as their active ingredient.⁵ These alcohol- based hand sanitizers have strong bactericidal properties when the active ingredient is within a 60-90% concentration within the product.⁶ The bacteriocidic properties come from the alcohols’ ability to denature bacterial proteins, resulting in their death. Alcohol-based hand sanitizers are also viricidal at alcohol concentrations between 60-80%. These alcohol-based hand sanitizers demonstrate strong viricidal and bactericidal properties even with a short period of contact. In fact, ethanol at concentrations between 62-71% have been shown to reduce coronavirus infectivity within one minute of exposure time by 2.0–4.0 log10. ⁷ 

In a study conducted by H.F. Rabenau et al. in the Efficacy of Various Disinfectants Against SARS Coronavirus, several different disinfectants were tested against SARS-Cov, including sanitizers based on ethanol. It was found that the sanitization products inactivated the SARS-CoV below the limit of detection. ⁵ This is an indication that ethanol-based hand sanitizers should also have an impact on the virus behind COVID-19 as the two demonstrate similar stability patterns on surfaces.⁸ Finally, it was found in a comparison study that although alcohol-based hand sanitizers that use ethanol or isopropanol are both effective, ethanol has been experimentally determined to be more effective within a shorter period of time.⁹ 

IV) Effectiveness of Non-Alcohol-Based Hand Sanitizers 

An alternative to alcohol-based hand sanitizers is non-alcohol-based hand sanitizers, which commonly consist of active ingredients benzalkonium chloride or benzethonium chloride. Hand sanitizers and other sanitization products based on these ingredients are known more for their impacts on bacteria than on viruses. 

The bactericidal actions of benzethonium and benzalkonium chloride comes from their ability to inactivate energy producing enzymes, denature essential proteins, and ultimately cause damage to the bacterial cell membrane.⁶ Due to the multiple levels of bacterial destruction that benzethonium and benzalkonium possess, they are considered better at managing bacteria than alcohol-based products, in certain cases. For example, benzethonium chloride is more effective than ethyl alcohol below 70% in destroying serratia marcenscens, a bacteria. ¹⁰ In fact, one test showed that benzethonium chloride destroyed the bacteria at 1.60 log, while alcohol cleansers such as ethyl alcohols below 70% only destroyed the bacteria below 1.55 log. This shows that non-alcohol-based hand sanitizers demonstrate strong bacterial destruction against some bacteria. With this being said, it is important to use these sanitization products only when necessary as it has been found that bacteria have begun adapting to overcome these methods of destruction. ¹¹ 

In addition to benzethonium or benzalkonium chloride-based products’ efficacy against certain bacteria, they are also effective against some viruses. ¹²  Specifically, benzethonium and benzalkonium chloride-based products have been shown to kill lipophilic and enveloped viruses. The mechanisms through which the chloride ingredients kill viruses requires the virus membrane to attract the benzalkonium molecules, which causes the initial damage to the virus membrane, resulting in apoptosis of the virus cell. As SARS-CoV-2 is an enveloped virus, these products would be expected to be effective in preventing Covid-19.¹³ 

It has been found that benzalkonium and benzethonium chloride products work better with longer contact. As such, these products can be found in surface cleaners more than hand sanitizers. It should also be noted that in some countries, hand sanitizers based on benzethonium and benzalkonium chloride cannot be advertised as a prevention against Covid-19.¹³ Although it has been hypothesized that these products have an effect against COVID-19, there are currently no studies that have clearly identified this. Therefore, regulatory bodies like US FDA and Health Canada encourage the use of an alcohol-based hand sanitizer over a non-alcohol-based hand sanitizer whenever possible, as non-alcohol-based hand sanitizers are ‘less reliable for tackling Covid-19′ (CDC, 2020). ¹⁴ 

V) Absorption of Ethanol through the Skin 

The question that is raised from time to time is whether or not ethyl alcohol can be absorbed through the skin and have health impacts on vulnerable groups, such as women who are pregnant or lactating. Evidence does not support this. Studies have shown that alcohol from hand sanitizers does not absorb in any significant quantities through the skin.¹⁵ Even with damage to the epidermis, dermis, or the frequent use of hand sanitizers, the slight alcohol absorption is still limited and does not cause a clinical concern.  

Other than the oral route, ethanol can be inhaled when boiled. Gaseous ethanol reaches pulmonary circulation from the alveoli in the lung. It can then pass directly via the pulmonary vein into the left ventricle and from there to the brain (without first-pass metabolism). However, this is not a concern as the levels inhaled from hand sanitizer at room temperature do not cause a significant blood-alcohol level to be of a clinical concern. Therefore, the choice between alcohol and non-alcohol-based hand sanitizers should not be decided through the consideration of safety, as both are safe even for vulnerable groups. ¹⁶ 

VI) Hand Washing 

It is important to understand that despite the effectiveness of hand sanitizers, the best method for removing traces of COVID-19 is thorough hand washing.¹⁷ This is due to the similarities between lipid bilayer membrane of the virus and the structure of soap and synthetic detergents. Soap attracts the virus membrane which causes unrepairable damage to the virus membrane killing it or making it nonvirulent. The use of water further aids in the destruction as it dissolves the virus, destroying it further. Additionally, the mixture of water and soap running off the hands carries the virus and its debris with it, further decreasing the chance of infection. ¹⁸ This is unlike hand sanitizer as although the virus is no longer a significant source of infection, the ‘dead’ viruses remain on your hands. Therefore, it is always best to choose hand washing rather than using hand sanitizer whenever possible.  

VII) Conclusions 

In the end, it is expected that both alcohol and non-alcohol-based hand sanitizers are likely to be effective in the defense against COVID-19. Alcohol-based hand sanitizers have been found to be more effective against this family of viruses than non-alcohol-based hand sanitizers, especially those containing ethanol as the active ingredient. Non-alcohol-based hand sanitizers with active ingredients such as benzalkonium and benzethonium are expected to still be effective against COVID-19, as it is an enveloped virus. Both types of hand sanitizers are safe for use as active ingredients are used within safe limits and have shown to not cause any clinical concerns. However, hand sanitizer should only be used secondary to hand washing as hand washing has been shown to be the most effective method against COVID-19.  

For more information, please contact Focal Point Research Inc at mail@focalpointresearch.net. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA. 

References  

1. Kumar, V., Abbas, A. K., Aster, J. C., & Robbins, S. L. (2018). Robbins Basic Pathology. Amsterdam: Elsevier. 
2. Coronaviruses. Retrieved July 30, 2020, from https://www.niaid.nih.gov/diseases-conditions/coronaviruses 
3. Government of Canada, H. (2007, May 08). Antiseptic Skin Cleansers (Personal Domestic Use). Retrieved July 30, 2020, from http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=antiseptic_antiseptique 
4. Commissioner, O. FDA issues final rule on safety and effectiveness of consumer hand sanitizers. Retrieved July 30, 2020, from https://www.fda.gov/news-events/press-announcements/fda-issues-final-rule-safety-and-effectiveness-consumer-hand-sanitizers 
5. H.F. Rabenau., G. Kampf., J. Cinati., H.W. Doerr. Efficacy of various disinfectants against SARS coronavirus. 61 (2005), 107-111. 
6. Chemical Disinfectants. (2016, September 18). Retrieved July 30, 2020, from https://www.cdc.gov/infectioncontrol/guidelines/disinfection/disinfection-methods/chemical.html 
7. G. Kampf., D. Todt., S.Pfaender., E. Steinmann. Persistence of coronaviruses on inanimate surfaces and their inactivation with biocidal agents. 104 (2020), 246-251. 
8. Seladi-Schulman, J. (2020, April 03). Coronavirus vs. SARS: How Do They Differ? Retrieved July 30, 2020, from https://www.healthline.com/health/coronavirus-vs-sars 
9. Yashpal S. Malik BVSc, PhD., Sunil Maherchandani BVSc, PhD., Sagar M. Goyal BVSc, PhD. Comparative efficacy of ethanol and isopropanol against feline calicivirus, a norovirus surrogate. 34 (2006), 31-35. 
10. Sickbert-Bennett. E., Weber. D., Gergen-Teague. M., Sobsey. M., Samsa. G., Rutala. W. Comparative efficacy of hand hygeine agents in the reduction of bacteria and viruses. 33 (2005), 67-77. 
11. Jackson, M. Safety and Effectivemess of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. (2018).  
12. Golin, A., Choi, D., & Ghahary, A. (2020, June 18). Hand sanitizers: A review of ingredients, mechanisms of action, modes of delivery, and efficacy against coronaviruses. Retrieved July 30, 2020, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7301780/ 
13. Center for Drug Evaluation and Research. QAs Hand sanitizer and COVID-19. Retrieved July 30, 2020, from https://www.fda.gov/drugs/information-drug-class/qa-consumers-hand-sanitizers-and-covid-19 
14. Murugesu, J. Hand sanitiser. Retrieved July 30, 2020, from https://www.newscientist.com/term/hand-sanitiser/ 
15. Brewer, Colin., Streel, Emmanuel. Is Alcohol in Hand Sanitizers Absorbed Through the Skin or Lungs? Implications for Disulfiram Treatment.  55 (2020), 354-356.  
16. Evans, Virginia A. MD; Orris, Peter. The Use of Alcohol-Based Hand Sanitizers by Pregnant Health Care Workers. Journal of Occupational and Environmental Medicine. 54 (2012).  
17. Rigby, S. (2020, April 20). Coronavirus: Is hand-washing really the best thing we can do to stop the spread of COVID-19? Retrieved July 30, 2020, from https://www.sciencefocus.com/news/coronavirus-can-hand-washing-really-stop-the-spread-of-covid-19/ 
18. Welsh, E. (Co-host)., Allmann Updyke, E. (Co-host)., Rasmussen, A. (Guest). (March 23, 2020). ‘COVID-19 Chapter 1: Virology’ This Podcast Will Kill You [Audio podcast]. Retrieved from https://thispodcastwillkillyou.com/2020/03/23/covid-19-chapter-1-virology/ 

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The Canadian Government released a contact tracing app called COVID Alert. After downloading the app, the app notifies you if you have possibly been exposed to someone with Covid-19. This is beneficial as symptoms of Covid-19 can appear days later or in some cases with symptoms not appearing at all. Many Canadians are wary about the app, believing it is too invasive. However, this should not be a concern as the app does not know your location, name, address, or your health information. The app uses Bluetooth to exchange codes with phones nearby and checks everyday if any of the codes It has received have identified as Covid-19 positive within a 14-day range. If it has, you will be notified. It should be noted that this app is not intended to replace manual contact tracing, nor does it replace medical advice. If you are feeling unwell you should still see a doctor or healthcare provider, and local public health authorities will conduct manual contact tracing if you are diagnosed with Covid-19.  

Apple Inc. Collaborated with the White House Coronavirus Task Force and the U.S. Department of Health and Human Services, including the Centers for Disease Control and Prevention (CDC), to create an app which guides its users through a Covid-19 screening questionnaire. The result of the questionnaire indicates if you should seek medical care for your symptoms.  The app also provides recommendations for social distancing, self-isolating, how to monitor symptoms, and when it is recommended, to contact a medical provider. Apps such as these are especially important in situations where screenings, tests, or medical care can be costly or unaffordable for families.  

The common theme between the two apps is that they are only good if people use them. It is important for your own safety and the safety of your community to monitor your symptoms and conduct Covid-19 safe practices, and these apps are there to help.  

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA. 

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Health Canada has provided interim expedited licensing to support facilities to manufacture, package, and label alcohol-based hand sanitizers during this desperate time of need for these products. It should be noted that hand sanitizers containing ethanol labeled as ‘anhydrous alcohol’, ‘ethyl alcohol’, or ‘grain alcohol’ are considered Natural Health Products (NHPs). Hand sanitizers containing isopropanol labeled as ‘isopropyl alcohol’ or ‘2-propanol’ are considered NHPs as well. A Site Licence (SL) is required to import, manufacture, package, or label hand sanitizers in Canada while a Product Licence is required to distribute and sell hand sanitizers. The final hand-sanitizer product should be 60-80% ethanol or 60-75% isopropanol, as per the Antiseptic Skin Cleansers (Personal Domestic Use) Monograph. The hand-sanitizer must also fully comply with the monograph in order to qualify for the expedited process onto the Canadian market. It should be noted that Health Canada still requires the reporting of adverse reactions to products, if any develop. These temporary regulations will be in place until March 31, 2021 or until a statement is made from Health Canada to licence holders regarding timelines and next steps for this interim process.

For Site Licences, companies must state which Good Manufacturing Practices (GMPs) they are attesting to when completing the application. This may be part three of the NHPR, Division 2 of Food and Drug Regulations, Guide to Food Safety, or Good manufacturing Practices for Cosmetic Products. Certain GMPs, such as stability testing and providing GMP evidence such as Quality Assurance Reports (QARs), are temporarily waved. With that being said, facilities should ensure that the appropriate controls are in place to avoid product contamination.  The Health Canada guidance document also includes details about Product Licence Applications (PLAs) and instructs to include that the application type is ‘Compendial’ and is a ‘Antiseptic Hand Cleanser’. The primary brand name should indicate generic descriptor of the product as well as alcohol content and should not have any reference to the coronavirus or any specific virus directly. The medicinal ingredients should only include ‘ethanol’, ‘ethyl alcohol’, ‘isopropanol’, or ‘isopropyl alcohol’ within the quality per dosage unit, as indicated above. If these measures and details are properly followed, the Product Licence for the hand sanitizer product should be made available quickly.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

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To begin, the United States has allowed non-traditional drug manufacturers to produce hand sanitizers, with the condition of following FDA guidance and registration procedures. The hope is that these more relaxed measures will allow a greater volume of hand sanitizer production and distribution (a key component in the fight against coronavirus).  The United States will also temporarily suspend all domestic routine facility inspections. This will allow for maximum physical distancing, and non-essential personnel to be able to remain at a distance.

The E.U. has also taken steps to aid the community through this troubling time. The European Chemicals Agency has announced their support of EU/EEA authorities in applying exemptions from normal authorization to speed up the process of disinfectants, such as hand sanitizers, during the pandemic. As well, the European Commission presented new temporary guidelines to ensure the continuous flow of goods across E.U. borders. These guidelines include minimizing procedures for checking transport trucks and their drivers to what is necessary.

Finally, Canada has also taken steps in updating their regulatory processes in order to provide ease during this time. Health Canada has streamlined the process for importing non-prescription drugs with the hope of making import of high demand of non-prescription products easier and quicker for consumers. Along the same lines, Health Canada has temporarily allowed exemptions for importing and releasing disinfectant and sanitization products onto the Canadian market by alleviating and reducing the normal authorization and approval procedures for disinfectant and sanitation products.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA

Emily Campbell

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Health Canada released a DEL Bulletin, No.74 Disinfectants and Hand Sanitizers, on March 17th with clarifications that followed on March 20th containing details on licensing requirements for disinfectant and sanitization products. Health Canada also released a proactive action plan to increase domestic capacity of these in demand products. The interim regulations will allow disinfectant and sanitization products authorized or registered in the US, MRA or a PIC/S jurisdictions to be imported and sold in Canada to assist with the supply and demand. This will permit these products to be imported and sold in Canada in the interim, even though they do not meet the full Canadian labelling and licensing requirements.

Facilities that currently possess a Drug Establishment License (DEL) or Site License (SL) can begin importing new products once they notify Health Canada of the product, update their import license to include the foreign manufacturer(s)/packager(s)/labeler(s) of the product (which also can be expedited because of this current process), and must maintain the appropriate records on file. Health Canada has also encouraged pre-authorized facilities capable of retooling to begin producing sanitization products.

Health Canada is putting in their best efforts to minimalize the spread of COVID-19 and to assist Canadians with obtaining products to help prevent them from contracting the virus. The release of these new interim regulations to expedite the production and importation of disinfectant and sanitization products is a step towards achieving a future without the virus. Let’s hope the future is soon.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA

Emily Campbell

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