{"id":7681,"date":"2020-05-27T13:41:23","date_gmt":"2020-05-27T13:41:23","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=7681"},"modified":"2021-10-18T18:57:15","modified_gmt":"2021-10-18T18:57:15","slug":"a-guide-to-hand-sanitizer-formulation-quick-easy-and-fda-compliant","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/a-guide-to-hand-sanitizer-formulation-quick-easy-and-fda-compliant\/","title":{"rendered":"A Guide to Hand Sanitizer Formulation: Quick, Easy and FDA-Compliant"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f1d98c0ef81\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f1d98c0ef81\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/a-guide-to-hand-sanitizer-formulation-quick-easy-and-fda-compliant\/#How_do_hand_sanitizers_work\" title=\"How do hand sanitizers work?\">How do hand sanitizers work?<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/a-guide-to-hand-sanitizer-formulation-quick-easy-and-fda-compliant\/#Hand_sanitizer_formulation_-_2_choices_ethanol_or_isopropanol\" title=\"Hand sanitizer formulation &#8211; 2 choices: ethanol or isopropanol\">Hand sanitizer formulation &#8211; 2 choices: ethanol or isopropanol<\/a><\/li><\/ul><\/nav><\/div>\n<p><em><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/russel-walters\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HandSanitizerFormulation\">Russel Walters<\/a>, <a href=\"https:\/\/www.kolabtree.com\/blog\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">research<\/a> consultant on Kolabtree and technology inventor, provides a quick and easy guide to formulating hand sanitizer that&#8217;s FDA-compliant.\u00a0<\/em><\/p>\n<p><b>Key message:<\/b><span style=\"font-weight: 400;\"> With recent rule changes, it is now easy to begin formulation and manufacture of alcohol-based hand sanitizers. Follow the new rules from the FDA and you can quickly start producing hand sanitizers.\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"How_do_hand_sanitizers_work\"><\/span><b>How do hand sanitizers work?<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Hand sanitizers are designed to be an alternative to hand washing with water and surfactants. Hand sanitizers reduce the viral and bacterial load on skin. They don\u2019t necessarily <\/span><a href=\"https:\/\/aem.asm.org\/content\/76\/2\/394.short\"><span style=\"font-weight: 400;\">kill everything,<\/span><\/a><span style=\"font-weight: 400;\"> although, viruses, such as covid-19, are more susceptible. In order for a virus to infect a human host, the host needs to be exposed to a sufficient <\/span><a href=\"https:\/\/www.newscientist.com\/article\/2238819-does-a-high-viral-load-or-infectious-dose-make-covid-19-worse\/\"><span style=\"font-weight: 400;\">virus load,<\/span><\/a><span style=\"font-weight: 400;\"> typically hundreds or thousands or tens of thousands of viral particles. Hand sanitizer dramatically reduce the viral load on the skin, and thereby reduce infections, or perhaps infection severity.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Long sustained exposure is to an infected person is best for transmission. The hands are important to sanitizer because hands are the primary contact to the outside word and then hand subsequently touch eyes, mouth, food, etc. Hand sanitizers have repeatedly been shown to slow the spread of <\/span><a href=\"https:\/\/bmcpublichealth.biomedcentral.com\/articles\/10.1186\/1471-2458-4-50\"><span style=\"font-weight: 400;\">viruses.<\/span><\/a><\/p>\n<p><span style=\"font-weight: 400;\">Hand sanitizers are regulated in most countries. In the US, the FDA has recently liberalized manufacturing rules. This is a good thing for new hand sanitizer manufacturers and formulators. It opens a legal path for new manufacturers to expand hand sanitizer supply, and it also makes formulation straightforward. Unlike skin lotions, the options are few and constraints clear.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">This article will focus on the two <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/formulation-chemistry?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HandSanitizerFormulation\">hand sanitizer formulas<\/a> that are allowed by the FDA under the recent COVID-19 guidance.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Hand_sanitizer_formulation_-_2_choices_ethanol_or_isopropanol\"><\/span><b>Hand sanitizer formulation &#8211; 2 choices: ethanol or isopropanol<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><i><span style=\"font-weight: 400;\">Hand sanitizer before COVID-19:<\/span><\/i><span style=\"font-weight: 400;\"> think Purell.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Manufactured at very large and FDA-registered drug manufacturers. This article covers a wider <\/span><a href=\"https:\/\/www.cosmeticsandtoiletries.com\/formulating\/function\/antimicrobial\/premium-hand-sanitizer-actives-a-review-216615931.html?utm_source=Most+Read&amp;utm_medium=website&amp;utm_campaign=Most+Read\"><span style=\"font-weight: 400;\">variety of approaches to formulating<\/span><\/a><span style=\"font-weight: 400;\"> hand sanitizers.\u00a0\u00a0<\/span><\/p>\n<p><i><span style=\"font-weight: 400;\">New hand sanitizers after COVID-19: <\/span><\/i><span style=\"font-weight: 400;\">expanded manufacturing and production<\/span><i><span style=\"font-weight: 400;\">\u00a0<\/span><\/i><\/p>\n<p><span style=\"font-weight: 400;\">In March 2020, the FDA issued <\/span><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/guidance-industry-temporary-policy-preparation-certain-alcohol-based-hand-sanitizer-products-during\"><span style=\"font-weight: 400;\">guidance for expanded production<\/span><\/a><span style=\"font-weight: 400;\"> of hand sanitizers during COVID-19.\u00a0 The intention was to increase production of hand sanitizer by opening up which entities could manufacture them beyond previously licensed or registered drug manufacturers. It is very specific on the formula of hand sanitizers.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The World Health Organization has released an excellent <\/span><a href=\"https:\/\/www.who.int\/gpsc\/5may\/Guide_to_Local_Production.pdf\"><span style=\"font-weight: 400;\">step by step guide<\/span><\/a><span style=\"font-weight: 400;\"> to local production of hand sanitizers. The two formula options that the WHO recommends are the same as in the FDA guidance. Both hand sanitizer formulas are shown below.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cThe hand sanitizer is manufactured using only the following ingredients in the preparation of the product\u201d<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Either Ethanol or Isopropinal<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Glycerin<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Hydrogen Peroxide<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Sterile water<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">And that is it. 4 ingredients, mix them with care, and you have a hand sanitizer ready for this new post-COVID-19 world. The proportion of ingredients is also specified in volume %.\u00a0 Be aware of the difference between volume% and weight%. There is a big difference between wt% and vol% because different ingredients have different densities. While water has a density of 1g\/cm3, ethanol has a density of 0.789g\/cm3. Learn more about measuring ingredients in <\/span><a href=\"http:\/\/simplycq.com\/volume-vs-weight\/\"><span style=\"font-weight: 400;\">weight vs. volume%<\/span><\/a><span style=\"font-weight: 400;\">.\u00a0<\/span><\/p>\n<p><b>Formula 1: Ethanol (volume %)<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Ethanol 80%; Glycerin 1.45%; Hydrogen peroxide 0.125%; QS water<\/span><\/p>\n<p><b>Formula 2: Isopropanol (volume %)<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Ethanol 75%; Glycerin 1.45%; Hydrogen peroxide 0.125%; QS water<\/span><\/p>\n<p><span style=\"font-weight: 400;\">QS stands for the Latin <\/span><i><span style=\"font-weight: 400;\">quantum satis, <\/span><\/i><span style=\"font-weight: 400;\">sufficient quantity, meaning make the rest up in water. Also note that most raw materials are not supplied as 100% pure, single ingredients. They often contain some water. Ethanol is typically sourced as 95%\/5% ethanol\/water, or 190 proof. You need to factor the raw material composition into your calculations.<\/span><\/p>\n<p><b>Adding additional skin benefit ingredients and fragrance<\/b><\/p>\n<p><span style=\"font-weight: 400;\">These are explicitly not allowed under FDA guidance. Purell does contain glycerin and fragrance. Glycerin is a common and inexpensive skin benefit agent. Users tend to really like fragrances in skin care products. Both ingredients are not needed and will increase the raw material prices of your hand sanitizer. In skin care products, fragrances are often used to cover the underlying base odor, which can often have a negative odor. This is unneeded in hand sanitizers; their base odor is minimal.\u00a0 <\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><b>Thickening hand sanitizers, increasing viscosity<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Hand sanitizer gels, like Purell, use polymers to increase the viscosity. This adds some significant complications in the manufacturing.\u00a0 Thickening polymer are not part of the FDA formula described above, but you can read more about them the different polymeric options for thickening water\/alcohol solution <\/span><a href=\"https:\/\/www.chempoint.com\/insights\/thickening-binding-cleaners-and-hand-sanitizers\"><span style=\"font-weight: 400;\">here<\/span><\/a><span style=\"font-weight: 400;\">.\u00a0 Also, <\/span><a href=\"https:\/\/www.ashland.com\/industries\/personal-and-home-care\/home-i-and-i\/who-helps-formulate-for-healthy-hands-we-do\"><span style=\"font-weight: 400;\">Ashland<\/span><\/a><span style=\"font-weight: 400;\"> is a manufacture of thickener hydroxypropylmethyl cellulose, carbomer and a few more.\u00a0 The two simple water\/alcohol formulas above will be water thin and easily sprayable.<\/span><\/p>\n<p><b>Sourcing of materials, and notes of caution<\/b><\/p>\n<p><b>Sterile Water:<\/b><span style=\"font-weight: 400;\"> boiling is the easiest and most likely route. Just be careful of heating and boiling water near the high proof, flammable alcohol.<\/span><\/p>\n<p><b>Ethanol:<\/b><span style=\"font-weight: 400;\"> There are a few sources of ethanol. One important note: the ethanol must be denatured, made to taste bad to avoid consumption. While states are relaxing cocktails to-go, your hand sanitizer is not to be consumed.\u00a0\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">For additional cosmetic ingredients this <\/span><a href=\"http:\/\/dir.cosmeticsandtoiletries.com\/search\/cbr_ing.html\"><span style=\"font-weight: 400;\">ingredient search<\/span><\/a><span style=\"font-weight: 400;\"> is a useful tool.\u00a0<\/span><\/p>\n<p><b>Mixing your hand sanitizer: putting it all together<\/b><\/p>\n<p><span style=\"font-weight: 400;\">This is pretty straightforward with one caveat: Passivation. If you are using a glass or fiberglass vessel to mix your hand sanitizer, then passivation is not a concern. However, if you are using a metal vessel, such as stainless steel, and you don\u2019t know what passivation means, find out <\/span><a href=\"https:\/\/www.birkocorp.com\/wp-content\/uploads\/2018\/10\/Birko_Brew_StainlessSteelPassivation_Final_072518.pdf\"><span style=\"font-weight: 400;\">here<\/span><\/a><span style=\"font-weight: 400;\">.\u00a0 The short version is, in the presence of metal ions from the vessel, the hydrogen peroxide (H<\/span><span style=\"font-weight: 400;\">2<\/span><span style=\"font-weight: 400;\">0<\/span><span style=\"font-weight: 400;\">2<\/span><span style=\"font-weight: 400;\">) rapidly breaks down to water and oxygen.\u00a0<\/span><\/p>\n<p><b>Packing options<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Ensuring that the alcohol evaporation is limited between production and use is an important consideration. The packaging must seal sufficiently. Manual pumps are explicitly allowed in the FDA guidance.<\/span><\/p>\n<p><b>Options for natural alternatives<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Ethanol <\/span><i><span style=\"font-weight: 400;\">is<\/span><\/i><span style=\"font-weight: 400;\"> a natural product. There are natural antimicrobials; however, efficacy data on them is limited, and more importantly, hand sanitizers are a regulated product. In order to label and market a product as a hand sanitizer, the FDA guidelines must be met.\u00a0\u00a0\u00a0<\/span><\/p>\n<p><b>Skin safety &amp; dealing with allergies<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Hand sanitizers are likely better for the skin barrier than repeated washing with soap. Cleansing with soap often removes skin components and can disrupt the <\/span><a href=\"https:\/\/www.hindawi.com\/journals\/drp\/2012\/495917\/\"><span style=\"font-weight: 400;\">natural structure of the skin<\/span><\/a><span style=\"font-weight: 400;\">. In contrast, after killing bugs you\u2019re the skin the alcohol in hand sanitizers rapidly evaporates and has little impact on the skin barrier. The core of your hand sanitizer formula should not cause any skin problems. Fragrance is often the source of skin irritation, especially allergenic response.\u00a0<\/span><\/p>\n<p><b>Testing<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Many problems are solved if you are following the FDA guidance on hand sanitizers. There is no need to test the bug-killing efficacy of your formula. Hand sanitizers with the formulas outlined above are well proven to effectively kill bugs and be safe for the user. So you don\u2019t have to prove this any further. After production, the alcohol level \u2013 ethanol or isopropyl alcohol \u2013 needs to be checked by physical <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/formulation-chemistry\">chemistry<\/a> means such as alcoholmeter or hydrometer.<\/span><\/p>\n<p><b>More reading on hand sanitizers<\/b><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">A hand sanitizer \u201c<\/span><a href=\"https:\/\/youtu.be\/E9uPKaJOk5E\"><span style=\"font-weight: 400;\">how they work<\/span><\/a><span style=\"font-weight: 400;\">\u201d video<\/span><\/li>\n<li><span style=\"font-weight: 400;\">WHO <\/span><a href=\"https:\/\/www.who.int\/gpsc\/5may\/Guide_to_Local_Production.pdf\"><span style=\"font-weight: 400;\">guide to local hand sanitizer production<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">FDA <\/span><a href=\"https:\/\/www.fda.gov\/media\/136289\/download\"><span style=\"font-weight: 400;\">hand sanitizer guidance<\/span><\/a><\/li>\n<li><a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/drug-products\/applications-submissions\/guidance-documents\/covid-19-expediated-licensing-alcohol-hand-sanitizer.html\"><span style=\"font-weight: 400;\">Health Canada\u2019s<\/span><\/a><span style=\"font-weight: 400;\"> interim expedited licensing of hand sanitizers<\/span><\/li>\n<li><span style=\"font-weight: 400;\">GOJO (makers of Purell) <\/span><a href=\"https:\/\/www.gojo.com\/en\/Markets\/Acute-Care\/Hand-Hygiene-Education\/Technical-Publications\"><span style=\"font-weight: 400;\">Technical Publications<\/span><\/a><\/li>\n<li><a href=\"https:\/\/www.cosmeticsandtoiletries.com\/\"><span style=\"font-weight: 400;\">Cosmetics &amp; Toiletries journal<\/span><\/a><span style=\"font-weight: 400;\">\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Extensive details and background from <\/span><a href=\"https:\/\/www.usp.org\/sites\/default\/files\/usp\/document\/health-quality-safety\/usp-hand-sanitizer-ingredients.pdf\"><span style=\"font-weight: 400;\">USP<\/span><\/a><\/li>\n<\/ul>\n<p><strong>Need help with hand sanitizer formulation? Hire trusted <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/formulation-chemistry?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HandSanitizerFormulation\">freelance formulation chemists<\/a> on Kolabtree. Post your project and get quotes for free!<\/strong><\/p>\n<blockquote><p><strong>Work with the author<\/strong><\/p>\n<p><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/russel-walters\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HandSanitizerFormulation\"><img decoding=\"async\" loading=\"lazy\" class=\"size-full wp-image-7683 alignleft\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Russel_Walters.jpg\" alt=\"\" width=\"200\" height=\"200\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Russel_Walters.jpg 200w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Russel_Walters-150x150.jpg 150w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Russel_Walters-24x24.jpg 24w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Russel_Walters-48x48.jpg 48w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Russel_Walters-96x96.jpg 96w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Russel_Walters-96x96@2x.jpg 192w\" sizes=\"(max-width: 200px) 100vw, 200px\" \/><\/a>Previously a Research Fellow at J&amp;J, Russ has developed skin care technologies that were launched into dozens of products and 100\u2019s of SKU\u2019s. He is a prolific inventor with 20+ US patents and is an active researcher with 35+ scientific articles.\u00a0 Russ is on the advisory board of <\/span><span style=\"font-weight: 400;\">Cosmetics &amp; Toiletries<\/span><span style=\"font-weight: 400;\">.\u00a0 Currently the co-founder &amp; CTO of <\/span><a href=\"https:\/\/somn.co\/\"><span style=\"font-weight: 400;\">Somn<\/span><\/a><span style=\"font-weight: 400;\">, Russ also consultants in personal care and digital health.<br \/>\n<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/russel-walters\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HandSanitizerFormulation\"><strong>Hire Russel Now\u00a0<\/strong><\/a><\/span><\/p><\/blockquote>\n","protected":false},"excerpt":{"rendered":"<p>Russel Walters, research consultant on Kolabtree and technology inventor, provides a quick and easy guide to formulating hand sanitizer that&#8217;s FDA-compliant.\u00a0 Key message: With recent rule changes, it is now easy to begin formulation and manufacture of alcohol-based hand sanitizers. Follow the new rules from the FDA and you can quickly start producing hand sanitizers.\u00a0<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/a-guide-to-hand-sanitizer-formulation-quick-easy-and-fda-compliant\/\" title=\"Read More\">Read More<\/a><\/div>\n","protected":false},"author":12,"featured_media":7685,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[317,558,435],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>A Guide to Hand Sanitizer Formulation: Quick, Easy and FDA-Compliant<\/title>\n<meta name=\"description\" content=\"An ex-J&amp;J research consultant provides a quick guide to FDA-compliant hand sanitizer formulation for manufacturers of all sizes.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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