Presence of unsafe chemical impurities, accelerated evaporation of alcohol, and lack of key labeling requirements are risks and concerns for some alcohol-based hand sanitizers and dispenser practices during the COVID-19 pandemic.

Alcohol-based hand sanitizers (ABHS) have been an important hand hygiene tool during the COVID-19 pandemic. Recently, ABHS from non-traditional drug manufacturers have entered the market, triggered by a lack of ABHS availability. Some of these ABHS contain high levels of chemical impurities that may be harmful with frequent exposure. Additionally, the use of refillable dispensers designed to accept ABHS from bulk containers allows for mixing and evaporation that may compromise ABHS integrity. To understand the risks associated with low quality ABHS and bulk refilling practices, we collected 77 ABHS samples sourced from community settings (restaurants, grocery stores, etc.) and 40 samples from a single school district. All samples were obtained from bulk refillable dispensers that were in use. Samples were analyzed for alcohol content, chemical impurities, aesthetic qualities, and presence of drug labeling information. Additionally, we performed laboratory-based experiments to determine the impact of dispenser design on alcohol evaporation rates. Over 70% of samples for which photos were available showed lack of essential labeling information, including missing "Drug Facts Labels". For ABHS samples acquired from community settings, nearly 14% of samples had visible impurities, and over 30% of samples had concentrations of acetal and acetaldehyde in excess of FDA interim limits. Subpotent ethanol concentrations were observed in 9.09% and 82.05% of samples from community settings and the school district, respectively, with the school district sample results being associated with dispenser misuse. Laboratory-based experiments show dispenser design significantly impacts the rate of ethanol evaporation of ABHS products, especially if stored in open refillable dispensers without an internal reservoir. This study demonstrates risks associated with use of inferior ABHS and bulk refilling practices. Regulatory agencies should issue guidance on best practices in community settings to ensure the integrity of ABHS as an essential public health tool to prevent the spread of COVID-19 and other transmissible diseases.

Compliance with hand sanitizer quality during the SARS-CoV-2 pandemic: Assessing the impurities in an ethanol plant.

Using alcohol-based disinfectants is an effective method for preventing the spread of COVID-19. However, non-traditional manufacturers of alcohol-based disinfectants, such as ethanol plants, need to undergo additional treatment to curb their impurities to limits set by the Food and Drug Association (FDA) to produce alcohol-based disinfectants. To transform them to disinfectant-grade alcohol, 17 process streams in a dry-mill ethanol plant were analyzed to determine the quality parameters for acetaldehyde, acetal, propanol, methanol, and water, including chemical oxygen demand, total suspended solids, and nutrients. Results suggest that the process stream generated by the distillation column requires further treatment because the acetaldehyde and acetal concentrations are significantly higher than the impurity limit set by the FDA. The addition of a second distillation column could be a potential method for addressing impurities and it will have minimal influence on hazardous air pollutant generation and water use.

Quick determination and discrimination of commercial hand sanitisers using attenuated total reflectance-Fourier transform infrared spectroscopy and chemometrics.

Due to the outbreak of the COVID-19 pandemic, practicing personal hygiene such as frequent hand sanitising has become a norm. The making of effective hand sanitiser products should follow the recommended formulations, but the high demand worldwide for such affordable products could have made them a candidate for counterfeiting, thus deserving forensic determination and profiling for source determination or supply chain tracing. In this study, determination and discrimination of hand sanitisers was carried out by employing attenuated total reflectance-Fourier transform infrared (ATR-FTIR) spectroscopy combined with chemometrics. Fifty commercially available hand sanitisers were obtained from the market and analysed. ATR-FTIR profiles of each sanitiser were compared and decomposed by principal component analysis (PCA) followed by linear discriminant analysis (LDA). Physical observation enabled the discrimination of seven samples based on their respective colours, the presence of beads and their colours, and the physical forms of formulations. Subsequently, eight distinct patterns were observed through visual comparison of ATR-FTIR profiles of the remaining 43 samples. An initial unsupervised exploratory PCA model indicated the separation of two main groups with ATR-FTIR profiles similar to those of ethanol and isopropanol, respectively. The PCA score-LDA model provided good predictions, with a 100% correct classification into eight different groups. In conclusion, this study demonstrated a quick determination and discrimination of hand sanitiser samples, allowing screening for any restricted components and sample-to-sample comparison.

Analysis of Commercial Hand Sanitisers amid CoViD-19: Are We Getting the Products that We Need?

The CoViD-19 pandemic has caused a sudden spike in demand and production of hand sanitisers. Concerns are rising regarding the quality of such products, as the safeguard of consumers is a priority worldwide. We analyse here the ethanolic content of seven off-the-shelf hand sanitiser gels (two biocides and five cosmetics) from the Italian market, using gas chromatography. The WHO recommends that products containing ethanol should have 60-95% (v/v) alcohol. Four of the tested hand gels have ethanolic contents within the recommended range, while three products (all cosmetics) contain < 60% (v/v), i.e. 52.1% (w/w), ethanol. The product with the lowest alcoholic content has 37.1% w/w ethanol. Toxic methanol is not found in any of the hand sanitisers. We show, in addition, that products with the highest ethanolic content have generally greater antibacterial activity. In conclusion, all tested products are complying with the EU regulations, as the three "substandard" products are classified as cosmetics, whose purpose is cleaning and not disinfecting. Nevertheless, if such hand cleaners were inappropriately used as hand disinfectants, they might be ineffective. Thus, consumer safety relays on awareness and ability to distinguish between biocidal and cosmetics hand gels. The obtained results might sensitise the scientific community, health agencies and ultimately consumers towards the risks of using hand sanitisers of substandard alcoholic concentration. If the wrong product is chosen by consumers, public health can be compromised by the inappropriate use of "low-dosed" cosmetic gels as disinfectants, particularly during the period of the CoViD-19 pandemic.

Alcohol-based hand sanitisers as first line of defence against SARS-CoV-2: a review of biology, chemistry and formulations.

The pandemic due to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has emerged as a serious global public health issue. Since the start of the outbreak, the importance of hand-hygiene and respiratory protection to prevent the spread of the virus has been the prime focus for infection control. Health regulatory organisations have produced guidelines for the formulation of hand sanitisers to the manufacturing industries. This review summarises the studies on alcohol-based hand sanitisers and their disinfectant activity against SARS-CoV-2 and related viruses. The literature shows that the type and concentration of alcohol, formulation and nature of product, presence of excipients, applied volume, contact time and viral contamination load are critical factors that determine the effectiveness of hand sanitisers.

Evaluation of World Health Organization-Recommended Hand Hygiene Formulations.

As a result of the coronavirus disease pandemic, commercial hand hygiene products have become scarce and World Health Organization (WHO) alcohol-based hand rub formulations containing ethanol or isopropanol are being produced for hospitals worldwide. Neither WHO formulation meets European Norm 12791, the basis for approval as a surgical hand preparation, nor satisfies European Norm 1500, the basis for approval as a hygienic hand rub. We evaluated the efficacy of modified formulations with alcohol concentrations in mass instead of volume percentage and glycerol concentrations of 0.5% instead of 1.45%. Both modified formulations met standard requirements for a 3-minute surgical hand preparation, the usual duration of surgical hand treatment in most hospitals in Europe. Contrary to the originally proposed WHO hand rub formulations, both modified formulations are appropriate for surgical hand preparation after 3 minutes when alcohol concentrations of 80% wt/wt ethanol or 75% wt/wt isopropanol along with reduced glycerol concentration (0.5%) are used.

The pandemic of COVID-19 and its implications for the purity and authenticity of alcohol-based hand sanitizers: The health risks associated with falsified sanitizers and recommendations for regulatory and public health bodies.

With the beginning of the pandemic of COVID-19 throughout the world, the demand and consumption of hand sanitizers has increased, which had led to a sharp crunch in these products at all levels. This shortage has led to an increase in the prevalence of falsified alcohol-based hand sanitizers, including the illegal addition of methanol to hand sanitizers and the production of hand sanitizers with an alcohol concentration of less than 60%. These findings indicate that regulatory and public health bodies should take an active role in ensuring the safety and quality of antimicrobial products such as alcohol-based hand sanitizers at every stage of the products' lifecycle, including distribution, manufacture and import.