The Global Hand Sanitizer Market size was valued at $919 million in 2016 and is expected to reach $1,755 million by 2023 (1). These figures however were calculated before the current health crisis and should be substantially higher in the future.
A hand sanitizer is an antiseptic solution used to reduce the concentration of microorganisms on skin. Over-the-counter antiseptics are classified by the FDA as washes and rubs and are regulated as OTC drugs by the FDA (2). They must be registered and produced in FDA approved facilities. Disinfecting cleansers are meant for treating hard, inanimate surfaces. They are regulated and must be registered with the Environmental Protection Agency (EPA).
FDA classifications of antiseptics
- Wash products (also known as antibacterial soaps) are intended for use with water and are rinsed off after use, and include hand washes /soaps and body washes. The FDA position is that these products have not yet been shown to be more effective at preventing illness than plain soap and water and there currently are no approved actives for this application FDA supports the CDC’s recommendation to use plain soap and water to wash your hands.
- Rubs are leave-on products, or hand “sanitizers,” as well as antiseptic wipes. These products are intended to be used when soap and water are not available, and are left on and not rinsed off with water. Rubs are further classified by the FDA into health care and consumer antiseptics. Health care antiseptics are primarily used by health care professionals in hospitals, clinics, doctors’ offices, outpatient settings and nursing homes. Consumer antiseptics are primarily used in the home, schools, daycares or other public settings.
According to the EPA (Environmental Protection Agency), the following are standard definitions of clean, sanitize, and disinfect (3).
- Clean – The process that physically removes debris from the surface or area by scrubbing, washing, and rinsing. It may be accomplished with soap or detergent and water.
- Sanitize – A product that kills 99.9% of germs identified on its label. Sanitizers are used to reduce, but not necessarily eliminate microorganisms from the inanimate environment levels considered safe as determined by public health codes or regulations.
- Disinfect – A product that kills nearly 100% of germs identified on its label. Disinfectants are used on hard inanimate surfaces and objects to destroy or irreversibly inactivate infectious fungi and bacteria, but not necessarily their spores. There are two major types of disinfectants: hospital and general use. Hospital disinfectants are the most critical to infection control while general disinfectants are typically used in households, swimming pools, and water purifiers.
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Hand sanitizers are included in the OTC category Antiseptic Hand Wash or Healthcare Personnel Hand Wash category for products “designed for frequent use” and intended to “reduce the number of transient micro-organisms on intact skin.” This category also includes antimicrobial hand washes, which serve the same purpose as hand sanitizers and differ only in that they require water for use.
The 1994 tentative final monograph lists topical antimicrobial ingredients based on scientific data submitted to the FDA advisory review panel to determine their safety and efficacy. The ingredients were placed into 3 categories (4)
- Category I: GRASE (generally recognized as safe and effective)
- Category II: not GRASE
- Category III: cannot determine if safe and effective; more data needed
The only category I GRASE actives are Ethanol 60-95% and PVP-Iodine 5-10%. Note, PVP-Iodine is brown in color and will stain the skin a light brown color. Category III actives include Triclosan, Triclocarban, Benzalkonium chloride, Benzethonium chloride and Parachlorometaxylenol. All potential active ingredients for skin antiseptics, were placed into Category III because the FDA has concluded that they lack either safety or efficacy data sufficient for GRASE classification in hand sanitizers. The monograph currently is only tentative, and manufacturers can market hand sanitizers based on Category III ingredients. However, they are required by the FDA to submit further safety and/or efficacy data to prevent these ingredients from being excluded in the Final Monograph as GRASE active ingredients.
Consumer antiseptic hand sanitizers are available as gels, non-aerosol foams, wipes and sprays. The most popular forms are gels followed by non-aerosol foams however the fastest growing form is foam.
Formulating hand sanitizers
The most common type of commercial hand sanitizers are gel formulations which use 60-70% Ethanol thickened with ~.4% Acrylates/C10-30 Alkyl Acrylate Crosspolymer neutralized using ~.2% Aminomethyl Propanol (AMP). Other suitable thickeners include Carbomer, Acrylates/Vinyl Isodecanoate Crosspolymer, Polyacrylate Crosspolymer-11, Polyacrylate Crosspolymer-6, Polyquaternium 37, Hydroxypropylcellulose, and Hydroxypropyl Guar. Non-aerosol foam formulations are designed to be dispensed using pump foamer packages and are comprised of 60-70% Ethanol and 2-5% surfactant. Choice of the surfactant however is very critical since most will not produce a stable foam due to the high alcohol content. The best types of surfactants for this application are silicone based copolyols however there are numerous patents covering this application.
References
- https://www.alliedmarketresearch.com/hand-sanitizer-market
- https://www.fda.gov/drugs/information-drug-class/topical-antiseptic-products-hand-sanitizers-and-antibacterial-soaps
- https://www.epa.gov/
- https://www.cosmeticsandtoiletries.com/regulatory/region/northamerica/60657047.htm
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Thank you
Do Ineed to test the sanitizinf efficiency of hand sanitizer or it sufficient to relay on the formulation. If yew, what is the accepted test for hand sanitizer?
Very informative. Thank you Sir.
Would just like to further know what is the minimum percentage of Ethyl Alcohol & Iso-Propyl Alcohol required in a Hand Sanitizer, for claiming it to be effective in eliminating 99.99% germs ? Kindly enlighten. If any such references are available, please share.
Thank you so much
Regards
Dear Sir,
do we have any alternative for carbomer to use as thickner for alcohol?
regards
Can any one tell me I use a hand sanitizer or wàsh on hand and how time it will protect my skin against the microbacterial agent, so that I can claim in my product and another question is ISO propyl alcohol is been used as substitute for ethanol in hand sanitizer their is study regarding this kindly clearify it thanks
HI, Shlomo:
No need to test if you use 60% Ethanol by weight in the US.
Thanks for reading,
George
Hi, Vikram:
The OTC minimum level is 60% Ethanol by weight.
Thanks for reading,
George
Hi, Yusef:
Alcohol provides no residual protection.
Thanks for reading.
George
Good day!
Here are some options:
FlexiThik (Ashland Chemical)
Synthalen CR (3V)
Aristoflex Velvet (Clariant – Personal Care) SepiMax Zen (Seppic)
Thank you for reading,
George
Hi, why my Hand Sanitizer goes from see-through gel to yellow one within few days and I can’t have it lasting see-through: alcohol>60% and Hydroxypropylcellulose as thickener and corexhidine.
Hi George
There are quite a few works / articles that say that the QUAT, Triclosan etc are effective against pathogens including SARS, etc etc. Yet, they are still classed in Cat III under GRASE classification by the FDA. Can you please clarify
Thanks
IHK
Good day!
Can you propose any surfactant silicone based copolyols? It would be for production of foaming soap based on isopropyl alcohol?
Thank you,
Polina
Hi, Rodolfo!
It’s probably the Chorhexidine reacting with UV.
Thanks for reading,
George
Hi, Polina.
I don’t recommend using any silicone copolyols due to potential patent issues.
Thanks for reading,
George
George,
In the past four years, FDA has finalized monographs for consumer hand wash, consumer hand rub and healthcare personnel hand washes and rubs (and patient preoperative skin preparations). In the process, FDA classified triclosan and triclocarban as NOT GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE (basically, Category II). See 21 CFR 310.545(a)(27(iii).
Paul
Hi, IHK:
Many quats have antiviral activity and are used in hard surface disinfectants. These products need to be registered with the EPA. As far as I know only Benzalkonium and Benzalkonium chloride are category III skin antiseptics.
Thanks for reading,
George
Hi, Paul.
I agree and do not support their use.
Thank you for reading,
George
Hello,
It’s not clear to me if this article fully captures the issuance of the “Final rule; finding of ineligibility for inclusion in final monograph” regarding “Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use” issued by FDA in April of 2019: https://www.federalregister.gov/documents/2019/04/12/2019-06791/safety-and-effectiveness-of-consumer-antiseptic-rubs-topical-antimicrobial-drug-products-for
This rulemaking essentially let ethanol, IPA, and benzalkonium advance as deferred ingredients and still postponed their GRASE classification but found there was not sufficient evidence provided for the other Category III ingredients for them to be considered as such in the future.
Hi, Ryan:
Thank you for your comment clarifying the status of Benzalkonium Chloride. The focus of the article was how to formulate sanitizers.
Thanks for reading,
George
Good morning Mr. Decker:
Do you recommend any specific silicone based copolyols for Hand sanitizing foam (based alcohol) formulation???
My best regards.
Ramsés.
Hi, Gerardo:
You should not use any silicone copolyols in alcohol based pump foamer formulations due to potential patent infringement issues. You may be able to license to the technology. Seek legal advice.
Thank you for reading!
George
Hi, Mr. Decker:
Thank you because of your answer. In this case do you suggest any specific surfactant to formulate a hand sanitizing foam(Ethanol based)?
My best regards.
Ramsés.
Hi, Gerardo:
I have no other suggestions. Silicone or Flurocarbon based surfactants work the best.
Thanks for reading,
George
Hi Deckner,
My sanitizer gel failed the bactericidal efficacy test. What can I add to it.
It contains ethanol, carboxy methyl cellulose, water, glycerin, aloe Vera?
Dear Sekiwanzi:
You can’t make a 60% Ethanol clear sanitizer gel using CMC. The product probably didn’t contain 60% Ethanol.
Thanks for reading,
George