Sreedhar Nalabolu, Director of Research and Development • Allure Labs12.27.21
Sales of hand sanitizers soared in 2020 as the COVID-19 pandemic spread throughout the world. Hand sanitizers reduce the microbial load of disease-causing microorganisms on skin. Use of these topical antiseptics has been a standard for proper hand hygiene in healthcare settings for more than two decades. Hand sanitizer use is strongly endorsed by the World Health Organization (WHO), Centers for Disease Control (CDC), and many other global organizations.
At their peak, hand sanitizer sales were 10-fold from sales prior to the pandemic. In addition to the increase in demand for health care antiseptics, the consumer antiseptic industry saw an exponential growth overnight. This unexpected global demand led to changes in formulation, manufacturing and production processes in the hand sanitizer market, especially the consumer-use hand sanitizers.
During the pandemic, the heightened need for health safety has made hand sanitizer a true household item with prevalent use. US Food and Drug Administration (FDA), the regulatory body for hand sanitizers, evaluates these products for their safety and efficacy. It has different regulations for health care antiseptics versus consumer antiseptics. At the start of the pandemic, FDA issued a guide for expanding manufacturing and production by liberalizing the manufacturing rules. Last year, at the beginning of the pandemic, FDA issued Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19). The guidance was issues to help meet unprecedented demand, allowing non-traditional sanitizer companies to manufacture FDA-regulated hand sanitizers. While FDA’s temporary guidance provides instructions for developing hand sanitizers, the newer manufacturers were not required to meet FDA’s standard manufacturing quality and safety requirements which have historically applied to companies that traditionally make the products. Some experts have suggested that move led to a number of products getting recalled due to benzene contamination.
In October, FDA withdrew its temporary guidance for the manufacturing of alcohol-based hand sanitizer products. Industry groups, including the American Cleaning Institute, applauded FDA’s guidance withdrawal.
Hand sanitizer is available in both alcohol and non-alcohol formulations. The majority are alcohol-based formulas. Those that aren’t typically include quaternary ammonium compounds as the antimicrobial agent. They usually use benzalkonium chloride as their active ingredient. Although they are positioned as a non-flammable alternative, and as less adverse reactions for accidental or intentional consumption, they do have some limitations. Benzalkonium chloride is mostly a biostatic agent that works by via adsorption to the cytoplasmic membrane, causing leakage of low molecular weight cytoplasmic constituents. Benzalkonium chloride has biocidal activity at high concentrations with more activity against gram-positive bacteria than gram-negative bacteria, with relatively weak activity against mycobacteria and fungi. They are ineffective against non-enveloped viruses. There is a concern for promotion of antibiotic resistance. Several types of bacteria (most common of which is staphylococcal aureus) can carry genes that encode how to extrude the noxious compounds from the cells. For these reasons, non-alcohol hand sanitizers are not as widely used as alcohol-based formulas.
Traditional alcohol-based hand sanitizer formations are most common. They feature ethanol or isopropyl alcohol as the active ingredients. Alcohol-based hand sanitizers effectively kill germs by very non-specific denaturation of proteins. Ethanol is the only active ingredient generally recognized as safe and effective (GRASE) by the FDA. It has outstanding biocidal activity against gram-positive and gram-negative bacteria, enveloped viruses and a variety of fungi. It is variably effective against enveloped viruses and ineffective against bacterial spores. It is also not associated with resistance.
For these reasons alcohol-based hand sanitizers are preferred in the healthcare setting and have increased in popularity in the commercial setting due to the COVID-19 pandemic. The FDA guidance was exclusively directed toward alcohol-based sanitizers, and it limited the ingredients to four major ingredients: active ingredient (ethanol or isopropanol), glycerin, hydrogen peroxide and sterile water. This limitation and/or simplification, enabled smaller contract manufacturers to begin production of hand sanitizers in accordance to the CDC guidance of at least 60% alcohol content. This saw several small businesses start manufacturing hand sanitizers, and the diversity of forms and formulations increased.
Hand sanitizers can be formulated as liquids, gels, wipes and aerosols. Initially, hand sanitizers were developed as thin liquid rinses. Now gels are most commonly used because they provide emollients and moisturizers. More recently, wipes, sprays and foaming aerosols have become available, although their superiority in efficacy is yet to be proven. With increased use of these products, the consumer market has expanded and created space to have multitude options and new niche markets. They now come in a rainbow of colors and smell delightful. They can be vegan, cruelty-free, environmentally friendly, and organically sourced. They can come in minimalist formulas and contain only natural ingredients (ethanol made from sugar cane). Each variant’s formula, delivery system and packaging component must be congruent with its chemical properties. Even as the pandemic begins to subside, this health habit of using hand sanitizer has not. In fact, as new variants emerge, demand for niche hand sanitizers is expected to expand, creating new opportunities.
References
https://www.precisepackaging.com/blog/product-development-tips-for-the-falls-hottest-backpack-essential-hand-sanitizer/
https://www.cosmeticsandtoiletries.com/cosmetic-ingredients/actives/article/21837425/hand-sanitizer-actives-a-review?utm_source=Most+Read&utm_medium=website&utm_campaign=Most+Read
About the Author
Sreedhar Nalabolu is director of research and development at Allure Labs. He may be reached at sree@allurelabs.com, www.allurelabs.com
At their peak, hand sanitizer sales were 10-fold from sales prior to the pandemic. In addition to the increase in demand for health care antiseptics, the consumer antiseptic industry saw an exponential growth overnight. This unexpected global demand led to changes in formulation, manufacturing and production processes in the hand sanitizer market, especially the consumer-use hand sanitizers.
During the pandemic, the heightened need for health safety has made hand sanitizer a true household item with prevalent use. US Food and Drug Administration (FDA), the regulatory body for hand sanitizers, evaluates these products for their safety and efficacy. It has different regulations for health care antiseptics versus consumer antiseptics. At the start of the pandemic, FDA issued a guide for expanding manufacturing and production by liberalizing the manufacturing rules. Last year, at the beginning of the pandemic, FDA issued Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19). The guidance was issues to help meet unprecedented demand, allowing non-traditional sanitizer companies to manufacture FDA-regulated hand sanitizers. While FDA’s temporary guidance provides instructions for developing hand sanitizers, the newer manufacturers were not required to meet FDA’s standard manufacturing quality and safety requirements which have historically applied to companies that traditionally make the products. Some experts have suggested that move led to a number of products getting recalled due to benzene contamination.
In October, FDA withdrew its temporary guidance for the manufacturing of alcohol-based hand sanitizer products. Industry groups, including the American Cleaning Institute, applauded FDA’s guidance withdrawal.
Hand sanitizer is available in both alcohol and non-alcohol formulations. The majority are alcohol-based formulas. Those that aren’t typically include quaternary ammonium compounds as the antimicrobial agent. They usually use benzalkonium chloride as their active ingredient. Although they are positioned as a non-flammable alternative, and as less adverse reactions for accidental or intentional consumption, they do have some limitations. Benzalkonium chloride is mostly a biostatic agent that works by via adsorption to the cytoplasmic membrane, causing leakage of low molecular weight cytoplasmic constituents. Benzalkonium chloride has biocidal activity at high concentrations with more activity against gram-positive bacteria than gram-negative bacteria, with relatively weak activity against mycobacteria and fungi. They are ineffective against non-enveloped viruses. There is a concern for promotion of antibiotic resistance. Several types of bacteria (most common of which is staphylococcal aureus) can carry genes that encode how to extrude the noxious compounds from the cells. For these reasons, non-alcohol hand sanitizers are not as widely used as alcohol-based formulas.
Traditional alcohol-based hand sanitizer formations are most common. They feature ethanol or isopropyl alcohol as the active ingredients. Alcohol-based hand sanitizers effectively kill germs by very non-specific denaturation of proteins. Ethanol is the only active ingredient generally recognized as safe and effective (GRASE) by the FDA. It has outstanding biocidal activity against gram-positive and gram-negative bacteria, enveloped viruses and a variety of fungi. It is variably effective against enveloped viruses and ineffective against bacterial spores. It is also not associated with resistance.
For these reasons alcohol-based hand sanitizers are preferred in the healthcare setting and have increased in popularity in the commercial setting due to the COVID-19 pandemic. The FDA guidance was exclusively directed toward alcohol-based sanitizers, and it limited the ingredients to four major ingredients: active ingredient (ethanol or isopropanol), glycerin, hydrogen peroxide and sterile water. This limitation and/or simplification, enabled smaller contract manufacturers to begin production of hand sanitizers in accordance to the CDC guidance of at least 60% alcohol content. This saw several small businesses start manufacturing hand sanitizers, and the diversity of forms and formulations increased.
Hand sanitizers can be formulated as liquids, gels, wipes and aerosols. Initially, hand sanitizers were developed as thin liquid rinses. Now gels are most commonly used because they provide emollients and moisturizers. More recently, wipes, sprays and foaming aerosols have become available, although their superiority in efficacy is yet to be proven. With increased use of these products, the consumer market has expanded and created space to have multitude options and new niche markets. They now come in a rainbow of colors and smell delightful. They can be vegan, cruelty-free, environmentally friendly, and organically sourced. They can come in minimalist formulas and contain only natural ingredients (ethanol made from sugar cane). Each variant’s formula, delivery system and packaging component must be congruent with its chemical properties. Even as the pandemic begins to subside, this health habit of using hand sanitizer has not. In fact, as new variants emerge, demand for niche hand sanitizers is expected to expand, creating new opportunities.
References
https://www.precisepackaging.com/blog/product-development-tips-for-the-falls-hottest-backpack-essential-hand-sanitizer/
https://www.cosmeticsandtoiletries.com/cosmetic-ingredients/actives/article/21837425/hand-sanitizer-actives-a-review?utm_source=Most+Read&utm_medium=website&utm_campaign=Most+Read
About the Author
Sreedhar Nalabolu is director of research and development at Allure Labs. He may be reached at sree@allurelabs.com, www.allurelabs.com