Antibiotic resistance pattern of bacterial strains emerged using frequent hand sanitizers during corona pandemic.

Hands are in fact the main route of transmission of pathogenic infections. By using proper hand sanitization, we can break the virus's transmission chain, which is especially important in the ongoing COVID pandemic outbreaks. The effectiveness of hand sanitization is solely dependent on the use of sufficient antibacterial agents, which come in a variety of levels and types, including antimicrobials commercial, water-based, or alcohol-based hand sanitizer, the latter being widely used during pandemics. Therefore, the sudden overuse of sanitizers also could lead to an increase in the tolerance limit for normal hand flora and the new development of antimicrobial resistance (AMR). In this study, we investigated the relationship between hand sanitizer-tolerant bacteria and their antibiotic resistance profile to multiple antibiotic agents. On a timely basis before and after using different hand sanitizers, bacterial strains were collected from the volunteers of CSIR-Central Salt and Marine Chemicals Research Institute (CSIR-CSMCRI). Sanitizer tolerant bacterial strains were observed also just after the application of sanitizers, which also showed the AMR phenomenon. The resultant sanitizers' resistant microbiome showed the dominant presence of Bacillus sp., Staphyloccocus sp., Paenibacillus sp., Lysinibacillus sp., Exiguobacterium sp. and Leclercia sp. All 36 nos of bacterial strains showed MDR (> 5 nos).

Herpes Simplex Virus-1 and Hand Sanitizer: A pilot study.

Purpose Herpes Simplex Virus type 1 (HSV-1) is a highly contagious virus that manifests as a painful lesion and recurrences can be distressing to patients. The purpose of this pilot study was to determine if the use of a 70% ethanol alcohol hand sanitizer alters the duration, size of the lesion, level of pain upon administering treatment, and overall daily discomfort during outbreak.Methods This study was a double-blind randomized controlled trial (RCT) using 70% ethanol alcohol hand sanitizer for the experiment and medical grade mineral oil for the control group. The treatment and the control were dispensed in lip gloss applicators for applying medicament. Data was collected through the initial examination, a daily journal, photographs, and a reexamination day. Descriptive statistics and the independent sample t-test were used to analyze data (p=0.05).Results A total of 20 individuals completed the research study: ten in the experimental group and ten in the control group. The mean duration of HSV-1 lesions for the control group was 10.3 days while the mean duration of the HSV-1 lesions for the experimental group was 7.6 days. The mean size of lesions for the control group was 4.87 mm; the mean size for the experimental group was 4.25 mm. The mean pain score for the control group was 1.08 and the mean pain score for the experimental group was 2.74. The mean discomfort score for the control group was 1.33 while the mean discomfort score for the experimental group was 1.72. There was no statistically significant difference between the experimental and control groups in terms of duration, size of lesions, pain, and discomfort.Conclusion Based on the results of this pilot study, 70% ethanol alcohol hand sanitizer did not demonstrate statistical significance in the treatment and management of HSV-1 lesions. Additional research is needed with a larger sample size to determine if statistical differences can be measured.

Dangerous exposures to chemicals managed by Poison Centers all around the world during the COVID-19 pandemic: a systematic review and proportional meta-analysis.

INTRODUCTION: During COVID-19 pandemic, cleaning/disinfection activities were highly recommended. This study summarizes the state of art and estimates the prevalence of dangerous exposures to specific chemicals managed by Poison Centers (PCs) from all over the world during 2020 vs 2019, trying to overcome the critical aspects of the product categorization systems used by PCs. MATERIALS AND METHODS: A systematic research was conducted in 3 major databases and 2 websites of PCs associations. Proportional meta-analyses were performed to estimate the prevalence of exposures to disinfectants, household products and hand sanitizers in 2020 vs 2019. RESULTS: The pooled prevalence of exposures to disinfectants, household products and hand sanitizers were respectively 5.9% (95% CI 4.9-7.0) (2019: 4.4% vs 2020: 7.8%; p=0.22), 25.9% (95% CI 24.0-27.7) (2019: 25.0% vs 2020: 28.6%; p=0.71) and 1.6% (95% CI 1.3-1.9) (2019: 0.6% vs 2020: 2.8%; p<0.001). CONCLUSIONS: This study detected overall increases of exposures to specific chemicals in 2020, suggesting that the awareness on topics related to the safe use of these products should be improved, especially during health emergencies, highlighting the need to develop standardized systems to better compare data coming from PCs all over the world.

The Rising Concern of Ethanol Intoxication from Easy Access to Hand Sanitizers: A Case Report.

BACKGROUND Ethanol intoxication is very common, and several forms of alcohol intoxication can lead to emergency department visits. Excessive alcohol users, when in withdrawal, might seek replacement alcoholic beverages; one of the common sources of ethanol is hand sanitizer, which contains 45-95% alcohol. It becomes even more challenging to deal with alcohol use disorder patients when they seek these replacement products inside hospital premises, and medical clinics and hospitals have increased their use of ethanol-based hand sanitizer since the start of the COVID-19 pandemic. CASE REPORT We report the case of a 26-year-old man with alcohol dependence presenting with a fictitious illness leading to hospital admission and consumption of ethanol-based hand sanitizer in the emergency department (ED). The patient initially presented reporting severe abdominal pain that persisted despite medications. The initial laboratory tests and imaging were non-significant. The patient was later caught stealing hand sanitizer bottles, consuming them within 4-6 h. The COVID-19 pandemic has increased alcohol intoxication, especially in EDs. Hand sanitizers, including ethanol, are toxic and hazardous when misused, mostly by adolescents and young adults. Treatments include glucose determination, dextrose infusion, and thiamine perfusion. Strategies to reduce ethanol intoxication include eliminating hand sanitizers, using wall-fixed sanitizers, and using sanitizer wipes. CONCLUSIONS Patients with alcohol use disorder are known to develop alcohol-seeking behaviors. This report has highlighted that healthcare professionals should be aware that the increased availability of ethanol-based hand sanitizers, some of which contain toxic antiviral chemical agents, may be targeted by individuals with alcohol dependency.

Microbiological Evaluation of Commercial Hand Sanitisers Available in Pakistan Using European Standard and Membrane Filtration Method.

OBJECTIVE: To evaluate the antibacterial efficacy of various commercially available alcohol-based hand sanitisers (ABHS) using European standard (EN 1500) method and perform ABHS testing with membrane filtration method. STUDY DESIGN: A Cross-sectional observational study. Place and Duration of the Study: Quality Control Section of the Microbiology Laboratory, The Aga Khan University Hospital, Karachi, Pakistan, from February to April 2023. METHODOLOGY: Efficacy of 14 commercially and widely accessible hand sanitisers was defined as reducing micro-organism growth. It was determined using the EN 1500 European standard test and membrane filtration method. RESULTS: Majority (92.8%) ABHS showed a significant bacterial reduction except one ABHS tested with the EN 1500 method. Only six ABHS products were tested through the membrane filtration method because high viscosity of hand sanitisers was causing damage to filter membranes. CONCLUSION: Continued vigilance in evaluating hand sanitiser's efficacy through robust testing methods is essential to ensure public health and prevent the dissemination of misleading products that may compromise hand hygiene practices. KEY WORDS: Hand sanitisers, European standard, Membrane filtration method, Antibacterial efficacy.

Skin- and Eco-Friendly Hand Sanitizer: A Novel Composition of Natural Extracts to Prevent the Spread of Respiratory Viruses.

Respiratory diseases caused by viruses are a serious global health threat. Although the use of hand sanitizers containing alcohol and synthetic antiseptic agents is recognized as an effective, simple, and low-cost measure to combat viral transmission, they can harm human health and the environment. Thus, this work aimed to study the efficacy of combining Camellia sinensis and Chamomilla recutita extracts in a skin- and eco-friendly leave-on hand sanitizer to prevent the spread of respiratory viruses. An oil-in-water emulsion containing C. recutita oily extract (5.0%), C. recutita glycolic extract (0.2%) and C. sinensis glycolic extract (5.0%) showed virucidal activity against HAdV-2 (respiratory virus) and two surrogate viruses of SARS-CoV-2 (HSV-1 and MVH-3), showing great potential to prevent the spread of respiratory viruses. These natural extracts combined are also promising to combat a broad spectrum of other viruses, in the form of antiseptic mouthwashes or throat sprays, surface disinfectants, and veterinary products, among others. Complementally, the developed hand sanitizer demonstrated efficacy against bacteria and fungus.

Hand hygiene compliance in nursing home wards: The effects of feedback with lights on alcohol-based hand rub dispensers.

BACKGROUND: Hand hygiene (HH) among health care workers (HCWs) is crucial in preventing infections in nursing homes. However, HH compliance (HHC) among HCWs remains low. This study aimed to investigate the effect of feedback lights on HCWs' HHC. METHODS: A 5-month interventional study was conducted in 3 wards in a nursing home in Denmark. During the intervention period, a green light with a smiley appeared on the alcohol-based hand rub (ABHR) dispensers when HCWs used the ABHR, acknowledging HCWs for using the ABHR. HHC was monitored using an automatic HH monitoring system (AHHMS). RESULTS: A total of 64 HCWs were enrolled. The AHHMS collected 23,696 HH opportunities in apartments and dirty utility rooms. Overall, HHC in the apartments increased from 50% at baseline (95% CI: 48, 53) to 56% (95% CI: 54, 58) during the intervention. However, the increased HHC level was not sustained during follow-up. CONCLUSIONS: The AHHMS enabled the assessment of the intervention. We found a significant effect of light-guided feedback in the apartments. However, the increased HHC was not sustained after the light was switched off.

SmartAnalysis: A sustainable digital-image colorimetry method for ethanol determination in alcohol-based hand sanitizer / SmartAnalysis: Un método sostenible de colorimetría de imagen digital para la determinación de etanol en desinfectante de manos a base de alcohol

Introducción: El consumo de desinfectantes de manos a base de alcohol ha aumentado significativamente después de la pandemia causada por el SARS-CoV-2. A pesar de la conclusión de la emergencia sanitaria declarada por la OMS en 2023, la costumbre de desinfectar las manos con geles sanitizantes a base de etanol ha sido adoptada a nivel mundial por la población. Dado que los métodos generales descritos en los compendios oficiales para la de-terminación del etanol, como la cromatografía de gases o la destilación, son laboriosos y no específicos para geles que contienen carbómero, este trabajo propone un método alternativo basado em la colorimetría de imágenes digitales. Método: La imagen digital (proporcionada por la reacción etanol-fenolftaleína) fue capturada y transformada en una señal analítica basada en el sistema de colores Rojo-Verde-Azul. Las adquisiciones de imágenes se realizaron utilizando un smartphone Samsung Galaxy J6, y las señales se generaron mediante el programa gratuito Photometrix Pro®. El método fue validado de acuerdo con las directrices de la ICH y se aplicó en muestras comerciales. Además, el método propuesto fue evaluado por su impacto ambiental utilizando la herramienta Índice del Proceso Analítico Verde (GAPI). Se generaron pictogramas utilizando el programa gratuito ComplexGAPI®.Resultados: El canal verde mostró una respuesta lineal en las curvas de calibración para concentraciones de etanol que van desde el 5 hasta el 40 % (p/p) en medio ácido. El método demostró linearidad, precisión, exactitud y robustez. Conclusiones: El método propuesto presentó como principales ventajas el uso de dispositivos de bajo costo y fáciles de manejar, así como un consumo reducido de reactivos, de acuerdo con los principios de la química analítica verde. (AU)

Introduction: The consumption of alcohol-based hand sanitizers has increased significantly after the pandemic caused by SARS-CoV-2. Despite the conclusion of the health emergency declared by the WHO in 2023, the habit of sanitizing hands with ethanol-based gel sanitizers has been globally adopted by the population. Since general methods described in official compendia for ethanol determination such as gas chromatography or distillation are laborious and not-specific to carbomer-containing gels, this work proposes an alternative method based on digital image colorimetry. Method: The digital image (provided by ethanol-phenolphthalein reaction) was captured and transformed into an analytical signal based on the Red-Green-Blue system. The image acquisitions were performed using a Samsung Galaxy J6 smartphone, and the signals were generated using the Photometrix Pro® free program. The method was validated in accordance with ICH and applied in commercial samples. Additionally, the proposed method was eval-uated for its environmental impact using the Green Analytical Process Index (GAPI) tool. Pictograms were generated using the ComplexGAPI® free program. Results: Green channel exhibited a linear response in the calibration curves for ethanol concentrations ranging from 5 to 40 % (w/w) in acidic medium. The method showed linearity, precision, accuracy, and robustness. Conclusions: The proposed method presented as main advantages the use of low-cost and easy-to-handle devices and reduced reagent consumption, in accordance with green analytical chemistry principles. (AU)

Hand hygiene compliance in nursing home wards: the effect of increased accessibility of alcohol-based hand rub.

BACKGROUND: Elderly nursing home residents are vulnerable to infection from micro-organisms. Hand hygiene is considered one of the most important measures to prevent transmission. AIM: To determine the effect of increased accessibility to alcohol-based hand rub (ABHR) in nursing home wards by monitoring hand hygiene compliance (HHC) among healthcare workers (HCWs). METHODS: An 11-month intervention study was conducted in a Danish six-ward nursing home. Data were collected using an automatic hand hygiene monitoring system (AHHMS). After a baseline period, one extra ABHR dispenser was placed in each of the 150 apartments. Baseline HHC was compared with the HHC during an immediate intervention period and a long-term intervention period. FINDINGS: A total of 159 HCWs were included. The AHHMS registered 341,078 hand hygiene opportunities. Overall baseline HHC was 31% (95% confidence interval: 30-32). A significant +18% absolute immediate effect (first five months) (95% CI: 17-19; P < 0.0001) and +13 percentage points (95% CI: 11-14; P < 0.0001) long-term effect (another four months) were recorded. HCWs working day shifts and short-term employees had a higher baseline HHC than HCWs working evening/night shifts. However, HCWs working night shifts achieved the greatest long-term effect with a mean +27 percentage point difference (P < 0.0001). CONCLUSION: Placing an additional ABHR dispenser strategically within staff workflow significantly increased HHC among HCWs, demonstrating a noteworthy effect. The study is the first to report the effect on nursing home dispenser accessibility as a single intervention and to show a significant unmet potential.

Purification and use of crude green glycerol from the transesterification of triglycerides in the formulation of an alcohol gel hand sanitizer.

The aim of this study was to produce an alcohol gel hand sanitizer containing green glycerol. Crude glycerol was purified using chemical and physical treatments. The sanitizer was prepared using 71.100 g of 99.3° GL ethanol, 28.0 g H2O, 0.5 g of Carboxypolymethylene [Carbopol 940® or Carbomer], 5 drops of triethanolamine (pH 5-7), and glycerol (1.5% w/w). The thermal behavior of the ethanol, carbopol, triethanolamine, glycerol, and alcohol gels were evaluated using Thermogravimetry and Differential Thermal Analysis. The apparent viscosity was obtained using a rotary viscometer. The determination of in vitro spreadability was achieved by an adaptation of the Knorst method. The ethanol content was measured by headspace gas chromatography using a flame ionization detector. The thermal behavior of the gels was influenced by the presence of glycerol, which confirms the possible network interactions formed. The relative densities of the samples were between 0.887 and 0.890 g/cm3. No alteration of the pH of the formulation resulted from the incorporation of glycerol. The apparent viscosities of the alcohol gels were greater than 20,000 cP. No alteration in the in vitro spreadability of the gel alcohol (530.6 mm2) resulted from the addition of glycerol. Hand sanitizer was produced using glycerol from a transesterification reaction. It represents an alternative use for the glycerol being produced in biodiesel processes. The product satisfied the requirements of WHO that preconize a formulation containing 1.45% glycerol as an humectant to protect skin against dryness and dermatitis.

Transmission of Viruses from Restroom Use: A Quantitative Microbial Risk Assessment.

Restroom use has been implicated in a number of viral outbreaks. In this study, we apply quantitative microbial risk assessment to quantify the risk of viral transmission by contaminated restroom fomites. We estimate risk from high-touch fomite surfaces (entrance/exit door, toilet seat) for three viruses of interest (SARS-CoV-2, adenovirus, norovirus) through eight exposure scenarios involving differing user behaviors, and the use of hand sanitizer following each scenario. We assessed the impacts of several sequences of fomite contacts in the restroom, reflecting the variability of human behavior, on infection risks for these viruses. Touching of the toilet seat was assumed to model adjustment of the seat (open vs. closed), a common touch point in single-user restrooms (home, small business, hospital). A Monte Carlo simulation was conducted for each exposure scenario (10,000 simulations each). Norovirus resulted in the highest probability of infection for all exposure scenarios with fomite surfaces. Post-restroom automatic-dispensing hand sanitizer use reduced the probability of infection for each virus by up to 99.75%. Handwashing within the restroom, an important risk-reduction intervention, was not found to be as effective as use of a non-touch hand sanitizer dispenser for reducing risk to near or below 1/1,000,000, a commonly used risk threshold for comparison.

Development of spray-dried powder hand sanitiser with prolonged effectivity.

Since the outbreak of the COVID-19 pandemic, the use of hand sanitisers has become an inseparable part of our personal hygiene. However, the short-term effect and the need for frequent application are shortcomings that impair the overall protection. Another aspect is that repeated use of some products (typically alcohol-based) may cause skin irritation or eventually more severe health problems. This work proposes spray-drying as a suitable method for the preparation of swellable chitosan carriers, allowing for encapsulation and sustained release of antibacterial chlorhexidine digluconate as a model active substance. After application to hands, micron-sized particles preferentially accommodate space between epidermal ridges, protected against attrition. Thanks to their small size (d < 10 µm), particles are comfortable to carry since they are not recognisable by somatosensory receptors. The performance of formulations with various amounts of chlorhexidine and cross-linker was tested and compared with selected commercial disinfectants available on the Czech market (ethanol gel and alcoholic solution with chlorhexidine) against E. coli and S. epidermidis. The real-life performance was investigated with twelve volunteers performing various activities for up to 2 h. Finally, a replica of the human index finger with accurately captured micro-topology was proposed and compared with volunteers' fingers concerning the total amount of adhered and detached particles.

Determination and Quantification of Acetaldehyde, Acetone, and Methanol in Hand Sanitizers Using Headspace GC/MS: Effect of Storage Time and Temperature.

Accurate determination of the concentration of alcohols and their metabolites is important in forensics and in several life science areas. A new headspace gas chromatography-mass spectrometry method has been developed to quantify alcohols and their oxidative products using isotope-labeled internal standards. The limit of detection (LOD) of the analytes in the developed method was 0.211 µg/mL for methanol, 0.158 µg/mL for ethanol, 0.157 µg/mL for isopropanol, 0.010 µg/mL for n-propanol, 0.157 µg/mL for acetone, and 0.209 µg/mL for acetaldehyde. The precision and accuracy of the method were evaluated, and the relative standard deviation percentages were found to be less than 3%. This work demonstrates the application of this method, specifically in quantifying the concentration of oxidative products of alcohol and other minor alcohols found in hand sanitizers, which have become an essential household item since the COVID-19 pandemic. Apart from the major components, the minor alcohols found in hand sanitizers include methanol, isopropanol, and n-propanol. The concentration range of these minor alcohols found in ethanol-based hand sanitizer samples was as follows: methanol, 0.000921-0.0151 mg/mL; isopropanol, 0.454-13.8 mg/mL; and n-propanol, 0.00474-0.152 mg/mL. In ethanol-based hand sanitizers, a significant amount of acetaldehyde (0.00623-0.231 mg/mL) was observed as an oxidation product, while in the isopropanol-based hand sanitizer, acetone (0.697 mg/mL) was observed as an oxidation product. The concentration of acetaldehyde in ethanol-based hand sanitizers significantly increased with storage time and temperature, whereas no such increase in acetone concentration was observed in isopropanol-based hand sanitizers with storage time and temperature. In two of the selected hand sanitizers, the acetaldehyde levels increased by almost 200% within a week when stored at room temperature. Additionally, exposing the hand sanitizers to a temperature of 45 °C for 24 h resulted in a 100% increase in acetaldehyde concentration. On the contrary, the acetone level remained constant upon the change in storage time and temperature.

The impact of alcohol hand sanitizer use on skin health between healthcare worker: Cross-sectional study.

BACKGROUND: 2020 Coronavirus disease 2019 (COVID-19) has become a global health crisis, so hand alcohol-based sanitizers have become essential to preventive measures. Previous studies reported that hand sanitizers could kill bacteria and viruses; however, using them excessively can lead to health problems if misused. In light of sanitizer overuse, the availability of various products and qualities in the market, and the absence of data on skin problems, we conducted a survey study about the impact of commonly used sanitizers on skin health, particularly on hands. The study aimed to determine the prevalence and the correlation between hand sanitizer and skin health during the COVID-19 pandemic at the National Guard Institute- Jeddah, Saudi Arabia. METHODS: A cross-sectional study was conducted using a self-administered online questionnaire by sending an invitation link to students and employees of the National Guard Institute- Jeddah, Saudi Arabia, in 2021. A chi-squared test was used to obtain differences concerning awareness of hand sanitizer use/type and hand skin health. RESULTS: In the total 216 participants, there were considerably more skin conditions reported by women (62.5%) and respondents ages 31-40 (36.6%). For the types of hand sanitizers, 89.8%, 40.9%, 30.2%, 4.7%, and 6% were recorded: gel, spray, wipes, foam, and others, respectively, and the survey applicants were filled by 60.6% of non-medical workers. According to the survey, 32.9% of participants experienced a hand crack, which was the most common hand side effect. The handwashing frequency was reported between 3 to 7 times per day during the COVID-19 pandemic, and 9.3% of participants used hand sanitizers more than 10 times daily. CONCLUSION: It was found that during the pandemic, skin changes were common among the NGHA population and healthcare workers. Consequently, the adverse health effects of these hand sanitizers on human health may result in multiple infections and toxicity. The present study provides appropriate knowledge on the types and ingredients of hand sanitizers as essential factors for skin health, preventing health risks during this pandemic.

Availability of Hand Sanitizers in Food Establishments of New York City: An Observational Study.

Hand hygiene is a crucial tool to limit the transmission of common respiratory and gastrointestinal infections. While hand sanitizers were ubiquitous early in the COVID-19 pandemic, the number of food establishments that have adequately maintained them remains unknown. Through systematic observations in 89 New York City food establishments, we found that hand sanitizer dispensers were present in only 40% of the stores, and only 23% had functional ones. This scarcity highlights the necessity of providing ongoing support to small business owners nationwide to promote and maintain primary prevention measures at all times, extending beyond periods of public health crises.

A comparative study on the effect of alcohol-based hand sanitizers in spray and gel formulation on the skin: A prospective, randomised, crossover trial.

BACKGROUND: Many formulations of Alcohol-based hand rubs (ABHRs), such as liquid, gel, and spray have been developed and used for preventing infections. This study aimed to compare skin irritation from using ABHRs in gel and spray formulations. METHOD: This was a prospective, randomised, crossover trial conducted to investigate the effect of skin irritation caused by ABHRs in gel compared to spray formulation after 21 days of using each formulation. Clinical outcomes were assessed using subjective Larson's skin assessment score and Frosch and Kligman observer skin assessment score, as well as bioengineering measures: transepidermal water loss (TEWL) and skin capacitance on days 3, 7, 14, and 21. RESULTS: Among 38 participants, both formulations showed no significant change in clinical scores and skin capacitance during the study. However, TEWL increased significantly from baseline on day 3 (p = 0.029) for the spray formulation and on day 21 (p = 0.019) for the gel formulation, with no statistically significant difference between the formulations (p = 0.46). CONCLUSION: Our research supports the safety of gel and spray ABHRs for regular use, with the only potential issue being mild skin irritation. For those with sensitive skin, the gel formulation is preferable.

Quality and safety of South African hand sanitisers during the COVID-19 pandemic.

Health agencies recommend using hand sanitisers as protection against the coronavirus. Thus far, the emphasis on hand sanitiser studies is limited to an analysis of disinfectant content only. This study aims to provide an extended analysis of 60 off-the-shelf alcohol-based hand sanitisers by using gas chromatography to report on alcohol content and the presence of impurities, a recombinant yeast estrogen screen to assess estrogenic activity, and an investigation into labelling compliance with the South African National Standard. Fifty hand sanitisers had an alcohol content of ≥60% v/v alcohol; however, most contained skin irritants and substances that could harm human and environmental health. Estrogenic activity was detected in 29 hand sanitisers and none of the products complied with all the labelling requirements. Since off-the-shelf hand sanitisers in South Africa are not regulated and monitored, evidence-based public awareness programmes on hand sanitiser quality and safety should become a priority.

Effectiveness of plant-based hand sanitizer incorporating Quercus infectoria gall extract.

AIMS: Quercus infectoria (Qi), a traditional herbal plant with a broad spectrum of activities on multidrug-resistant bacteria, has been developed for hand sanitizer applications. METHODS AND RESULTS: Antimicrobial activity was evaluated using agar-well diffusion and broth microdilution method. Bactericidal activity was determined following the European Standard 1276 antibacterial suspension test. Neutralization assay was performed to assess antirespiratory syncytial virus. Safety, stability, and skin permeation of Qi hand gel was investigated. Qi hand sanitizer gel inhibited microorganisms ranging from 99.9% to 99.999% against Enterococcus faecalis, Staphylococcus aureus, methicillin-resistant Staph. aureus, Staph. epidermidis, Staph. pseudintermedius, Staph. saprophyticus, Streptococcus pyogenes, Acinetobacter baumannii, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Candida albicans. A significant reduction in main human dermatophytes including Microsporum canis, M. gypseum, and Talaromyces marneffei of ∼50% was observed (P < .05). Qi hand sanitizer gel inactivated >99% viral particles entering human laryngeal epidermoid carcinoma cells in a dose-dependent manner. Scanning electron micrographs further illustrated that Qi hand sanitizer gel disrupted microbial cell membrane after 1-min contact time resulting in cell death. Qi hand sanitizer gel delivered emollient compounds through simulated human skin layers and showed no cytotoxicity on fibroblast cells. Moreover, Qi hand sanitizer gel demonstrated stability under extreme conditions. CONCLUSIONS: Qi hand sanitizer gel was able to inhibit various microorganisms including bacteria, dermatophytes, and virus.

Quality of New Domestic Hand Sanitizer Drug Product Manufacturers During COVID-19.

The FDA initiated a cross-sectional, statistically based sampling and testing study to characterize the quality of marketed alcohol-based hand sanitizer (ABHS) by evaluating the alcohol content and impurities present in ABHS products manufactured by establishments that registered with the FDA during March-April 2020. A stratified sampling design divided the population of manufacturers into independent groups based on each establishment's level of experience with FDA oversight and its geographic location. ABHS products were collected and analyzed by spatially offset Raman spectroscopy and gas chromatography with mass spectrometry (GC-MS). The GC-MS results for 310 products, from 196 newly registered domestic manufacturers, showed that 71.6% (± 5.7%) of these manufacturers had violative products. In 104 (33.5%) cases, the alcohol content did not meet label claim assay specifications but still fell within CDC efficacy ranges. Ethanol ABHS products failed more often overall (assay and impurities) (84.3%) and for impurities (84.3%), than isopropanol ABHS products (11.2% and 6.2%, respectively). Differences in test results across active ingredients were statistically significant. Ethanol ABHS products often (63.5% of cases) failed due to the presence of acetal or acetaldehyde, particularly in products with pH ≤ 6. Other impurities were also detected in several ABHS products, suggesting the use of low-grade alcohol in the manufacture of these products. Evidence was insufficient to conclude that having experience manufacturing FDA-regulated products, or lack thereof, influenced product-level violative results. This study highlights the importance of sourcing and testing active pharmaceutical ingredients to produce quality drug products.