Dataset Information

Alcohol-based Hand Sanitizers amid COVID-19: Chemical Formulation, Analysis, Safety.

ABSTRACT: Alcohol-based hand sanitizers (ABHSs) containing ethanol (EtOH) or isopropyl alcohol (IPA) to inactivate microorganisms help prevent the spread of respiratory diseases. These products have become very popular during the COVID-19 pandemic. Apart from vaccines or other preventative antiseptic measures, the majority of consumers have relied on different types of ABHSs to disinfect their hands. As a result, there has been a global rush in the demand for these ABHSs and other antiseptic hygiene products. This has resulted in the formation of many new commercial sanitizer producers. There are around fifty companies of varying sizes that have been marketing their ABHSs in Bangladesh, most of which have only been manufacturing their products for the first time since the COVID-19 pandemic. To monitor the quality and components of these products, the Bangladesh Council of Scientific and Industrial Research (BCSIR) analyzed approximately 200 different hand sanitizer samples using GC-FID method. All samples were alcohol-based except for 3 which were alcohol-free aqueous hand sanitizers. Of the supplied formulated ABHSs, 80 samples were found to contain only IPA and 54 contained only EtOH. However, 28 samples were found to be contaminated with methanol (MeOH), 7 samples contained only MeOH and 18 samples contained both EtOH and IPA. This is the first study to explore the analysis of alcohol content in formulated ABHSs and their marketing status in Bangladesh, but the findings could be of use in other jurisdictions as similar issues have been raised in many parts of the world.

SUBMITTER: Islam M

PROVIDER: S-EPMC9877727 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Alcohol-based Hand Sanitizers amid COVID-19: Chemical Formulation, Analysis, Safety.

Islam Monarul M Shahin Ahmed Khondoker K Karim Rezaul R Nath Bikash Dev BD Prosad Moulick Shyama S Islam Rashedul R Mahmudul Hassan Sharkar Md SM Hossain Hemayet H Moniruzzaman Mohammad M Jahan M Sarwar MS Ali Shaikh Aftab A Georghiou Paris E PE

ChemistrySelect 20221201 45

Alcohol-based hand sanitizers (ABHSs) containing ethanol (EtOH) or isopropyl alcohol (IPA) to inactivate microorganisms help prevent the spread of respiratory diseases. These products have become very popular during the COVID-19 pandemic. Apart from vaccines or other preventative antiseptic measures, the majority of consumers have relied on different types of ABHSs to disinfect their hands. As a result, there has been a global rush in the demand for these ABHSs and other antiseptic hygiene produ ...[more]

PMID: 36718183

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Project description: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.

Project description:BackgroundFollowing the emergence of the global Coronavirus Disease-2019 (COVID-19) pandemic, alcohol-based hand sanitizers (ABHS) have been extensively used as one of the effective methods of preventing its transmission. The products are dispensed over the counter and used by the general population. Growing concerns have been reported, however, regarding the quality, efficacy and compliance to regulatory requirements calling for objective evidence that can facilitate proactive regulatory measures.ObjectivesThe study aimed at assessing the level of compliance to packaging and labeling regulatory requirements of selected locally manufactured ABHS products marketed in Addis Ababa, Ethiopia.MethodsA cross-sectional study design was employed to randomly collect 25 locally manufactured ABHS products from retail outlets located in Addis Ababa. The manufacturers were grouped under four categories considering their experience in manufacturing, resources and technical capacities. The collected samples were evaluated for compliance to packaging and labeling information regulatory requirements and the results subjected to descriptive analysis.ResultsMajority of the products were found to meet most of the packaging, general product description and manufacturer-related information requirements. However, concerning gaps were observed in storage, precaution and warning-related labeling information requirements. The overall compliance of the selected products (to a total of 29 requirements under 5 categories) was 56.9%. The highest level of compliance was for general product information requirements (80.2%) followed by packaging and manufacturer-related requirements accounting for 76.8% and 75.0%, respectively. Low level of compliance was observed for storage condition and precautions (10.2% and 42.4%, respectively). Better overall compliance to packaging and labeling requirements (62.9%) were observed by large pharmaceutical and cosmetics manufacturers, while the lowest compliance level was recorded for medium level pharmaceuticals and cosmetics manufacturers.ConclusionsEven though most of the selected products were able to comply with the majority of packaging, product description and manufacturer-related requirements, gaps were observed in essential labeling information requirements. Considering the extensive use of ABHS products among diverse population groups and the potential risks associated with inappropriate use of the products, improving regulatory law enforcement practices, strengthening continuing education of manufacturing personnel and raising public awareness is very timely.

Dataset Information

Alcohol-based Hand Sanitizers amid COVID-19: Chemical Formulation, Analysis, Safety.

Publications

Alcohol-based Hand Sanitizers amid COVID-19: Chemical Formulation, Analysis, Safety.

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