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ASTM E2011
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Quick understanding of the test
ASTM E2011 - Test method for evaluation of hygienic handwash and handrub formulations for virus-eliminating activity using the entire hand
Application
- A viral suspension is applied to the hands, followed by the application of handwash or hand rub.
- After a specified exposure time, the virus is recovered and its infectivity is measured.
- The reduction in viral titer is calculated by comparing the virus levels before and after treatment.
- Serves as a benchmark for developing more effective antiviral hand hygiene products.
- Supports compliance with regulatory requirements for product approval and marketing.
Turnaround Time
Passing criteria
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Abstract
The ASTM E2011 standard represents an important test method that can be used in investigating the virus-eliminating activity of hygienic handwash and handrub formulations. Hand hygiene, in general, serves as a practice aimed at preventing the spread of viruses, mainly in healthcare settings and in high-contact environments. In contrast to all the other test methods, the ASTM E2011 assesses virus reduction across all surfaces of hands, both the palmar and the dorsal sides. It’s an overall test of hand hygiene products and assesses both mechanical removal and inactivation of viruses through exposure to these formulations. This means that they will indeed be effective under proper exposure field conditions.
In the test, volunteers’ hands are artificially contaminated with a known virus suspension and after washing or applying handrub, the virus titer is measured to determine how much of the virus remains. By focusing on the entire hand, this test more accurately simulates real-world hand hygiene practices, particularly in environments where thorough hand disinfection is critical, such as hospitals, daycare centers and food-handling establishments
Test conditions
- Test subjects
A healthy adult volunteer whose hands are free of apparent damage and skin problems is allowed into the test. With regards to this, hands are observed for micro-breaks, cuts, or irritation since these findings can affect the outcome of the test.
- Virus contamination
A high-titer virus suspension, usually with a concentration of at least 107 pfu, is prepared and applied to the subjects’ hands. The virus used in the experiment would act as the contaminant to be eradicated by either the handwash or the handrub.
- Handwash or handrub application
The formulation of the handwash or handrub product is applied using the recommended manufacturer’s procedure for a fixed time, usually in the range of 10 to 30 seconds. Handwashes are performed under running water and handrubs do not require water.
- Virus Recovery and Measurement
Any virus remaining on hands after exposure is recovered and the viral titer is enumerated in cell culture systems that can determine how effectively the formulation removed or inactivated the virus. Comparisons are made to untreated control groups.
Test requirements
- Volunteer preparation
The volunteers should not use any antimicrobial products one week prior to the test so that interference with the test results is avoided if some residual antimicrobial agents remain.
- Virus titer
The titer of the test virus should be at least 107 pfu/ ml. This ensures that it challenges the product under test with an appropriate concentration of viruses.
- Control groups
Control groups should be provided with non-antimicrobial agents, including standard hard water, in comparison to the test product, which will be evaluated. In this manner, the inherent effect of the handwash or hand rub can be determined.
- Multiple subjects
For every product-virus combination, more than six subjects are required for testing to assure statistical validity.
Test Methodology
The ASTM E2011 test performs the virus-eradicating activity of hand hygiene products through structured methodology.
- Virus inoculation
Virus suspension is inoculated onto the subjects’ hands with both palms and dorsum to represent real contamination.
- Application of test substance
Volunteers wash their hands or apply hand rub according to manufacturer’s instructions. The duration of handwashing or hand rubbing is standardized and recorded.
- Virus recovery
After treatment, virus recovery is conducted by scrubbing the hands with an eluent, which is then tested for viral content in cell cultures.
- Viral assay
The recovered virus is titrated and the viral infectivity is measured to determine how much of the virus remains after the handwash or handrub treatment.
- Data analysis
The viral reduction is calculated by comparing the viral infectivity before and after treatment, with results typically reported as a log10 reduction or percentage reduction in viral infectivity.
Importance
Comprehensive assessment
Enables a comprehensive assessment of hand hygiene products rather than tests that may focus mainly on specific areas, such as fingerpads. This is important because accurate disinfection must involve all components of the hand.
Public health
The test ensures that hand hygiene products are able to remove or inactivate viruses, an essential measure of preventing viral infections from spreading within the highly interactive settings of hospitals, nursing homes and daycare centers.
Product validation
For manufacturers, the test is used to validate their product’s efficacy which is necessary for marketing and regulatory approval.
Compliance and Industry Standard for ASTM E2011
Compliance with ASTM E2011 is required for products that aim to meet regulatory standards for virus-eliminating hand hygiene products. Regulatory agencies like the FDA and ECHA require efficacy data for handwash and handrub formulations and the standard is one of the accepted methods for generating this data.
Hand hygiene products that pass the testing are more likely to be approved for use in healthcare and food-handling industries. Additionally, compliance with this standard gives manufacturers a competitive advantage by demonstrating that their products meet high performance standards.
Advantages of the Test Standard
- Realistic simulation
The test simulates real-world hand hygiene practices by evaluating the entire hand, providing more accurate data on how well a product performs in actual use conditions.
- Versatility
The test can be used to evaluate a wide range of products, including handwashes, handrubs, gels and foams. This makes it a flexible standard for testing various hand hygiene formulations.
- Comprehensive results
By assessing viral elimination across the entire hand, the test ensures that products offer full protection, not just in selected areas like fingerpads.
- Regulatory approval
Products of hand hygiene that are passed by ASTM E2011 testing have a greater chance of getting approved by the regulatory bodies and are allowed to be marketed as effective in the elimination of viruses.
- Enhanced consumer trust
Products tested may be projected to fill consumer needs by using superior virus-eliminating attributes.
- Market differentiation
Manufacturers may enhance the strength of their product by obtaining substantial competitive differentiation through the results of test performance, which may draw special attention to the comprehensive virus-eliminating capabilities of the product.
Conclusion
The standard ASTM E2011 describes vigorous and reliable means for testing the formulations of handwash and handrub for virus elimination efficacy. The above methods enable the technical professionals to make scientific decisions for the selection of handwash products and handrub products. This test examines the whole hand and thus gives a comprehensive review of how well products work under real conditions.
For manufacturers looking to get their hand hygiene products verified, Microbe Investigations Switzerland (MIS) is here to provide professional testing services. Contact MIS today to ensure your products reach their best in removing viruses and their efficiency in hand hygiene.
Frequently Asked Questions
DR. Martinoz Scholtz
The standard test method under ASTM E2011 tests the virus-eliminating activity of handwash and handrub formulations that utilize the entire surface of both hands.
ASTM E2011 tests for liquid, gel and foam hygienic handwash and handrub products whether alcohol-based or non-alcohol-based.
The typical turnaround time for ASTM E2011 testing ranges between 2-3 weeks depending on the product formulation and testing requirements
Our testing laboratory can conduct various viral strains which are usually used in determining the efficacy of hygienic products.
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