Ensuring product safety and efficacy of alcohol-based hand sanitizers

The Centers for Disease Control and Prevention (CDC) first revised its hand hygiene guidelines in 2002 to recommend alcohol-based hand sanitizer as a possible alternative to hand cleansing with soap and water for the public and health care personnel. The majority of alcohol-based hand sanitizers contain either isopropanol, ethanol, n-propanol, or a combination of two of these
alcohols. The antimicrobial activity of alcohols can be attributed to their ability to denature proteins. The best antimicrobial efficacy can be achieved with ethanol (60 to 85%) and isopropanol (60 to 80%) solutions. Higher concentrations are less potent because proteins are not denatured easily in the absence of water, whereas solutions with lower than 60% alcohol may only reduce
the growth of germs but not kill them. In response to the Coronavirus Disease 2019 (COVID-19) pandemic, the Food and Drug Administration (FDA) has recently issued guidelines3,4 that temporarily allows compounders and certain entities that are not currently regulated by FDA as drug manufacturers to prepare and distribute hand sanitizer products for the duration of the public health emergency. Despite the relatively simple formulations and preparation protocols, it is critically important that proper quality assurance and control measures be in place to ensure
the safety and efficacy of hand sanitizer products.

Application note for QC of hand sanatizers AN53310-Hand Sanitizer-EN-AN-53310

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