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ASTM E2613
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Quick understanding of the test
ASTM E2613 - Test Method for Determining Fungus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using Fingerpads of Adults
Application
- Candida albicans
- Aspergillus niger
- A known volume of fungal suspension is applied to demarcated fingerpads and allowed to dry.
- The contaminated hands are exposed to the test agent and control for a specified duration.
- Remaining organisms on the fingerpads are eluted and analysed to determine the fungal colony-forming units (CFU).
- Reductions in CFU are compared between the control and test agent.
- Provides reliable data on the efficacy of handwash and handrub agents to eliminate fungal contamination.
- Ensures consistency and reproducibility across different laboratories and studies.
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Abstract
The ASTM E2613 test method evaluates the efficacy of hygienic handwash and hand rub agents in removing fungal contamination from adult fingerpads. For this test, a suspension of fungi is applied to the fingerpads of adult volunteers followed by drying. The contaminated area is then exposed to the test handwash or hand rub product or a control solution, usually hard water after drying.
The remaining eluted fungi from the skin are then counted in terms of colony-forming units to find the extent to which the fungal contamination has been reduced. The variation between the CFU counts before and after treatment serves as a quantitative measure of how effective the product is in removing fungus. This method is especially useful in assessing products to be used in healthcare and food-handling environments where the threat of fungal contamination becomes an important factor.
ASTM E2613 Test Conditions
This test is carried out by trained personnel under controlled laboratory conditions with specific BSL-2 precautions. All testing is done strictly, under controlled, standardized conditions, to ensure consistency across different testing environments. Several factors affect the results of the test:
- Test Subjects: The test requires a healthy adult volunteer with intact skin with no dermatoses or other conditions that could interfere with test results. Subjects are instructed to avoid using any antimicrobial products for at least one week before the test.
- Test Environment: A test must be conducted in a facility equipped to work with infectious agents and the appropriate biosafety levels and it includes:
Temperature: The temperature typically ranges from 20ยฐC to 25ยฐC
Humidity: It is usually between 40-60%
- Fungal Suspension: A known concentration of a test fungal organism is prepared and applied to the fingerpads. Commonly used fungi in this test include Candida albicans and Aspergillus niger. The inoculum is then allowed to dry on the skin before exposure to the test agent.
- Control and Test Agents: The test uses a standard control agent, typically hard water, against which the performance of the test product is compared.
ASTM E2613 Test Requirements
The test method standardizes the type of equipment, materials, and control of the procedures to ensure the testing is accurate and reproducible. Such requirements include:
- Test Fungus Viability: The suspension used on the skin should contain at least 10^4 CFUs so that at least a 4-log reduction in viability is demonstrated after the treatment.
- Handwashing Equipment: The test subjects wash their hands in sinks that have been designed to conduct hygiene testing without coming into contact with contaminated surfaces. Hands-free faucets have to be used on the sinks; these are faucets operated by either the feet or elbows to minimize re-contamination
- Test Formulation and Control: The test measures the effectiveness of the handwash or hand-rub agent by comparing it to control (hard water), thereby establishing a baseline for removing fungus. Various formulations are tested to ensure constancy and account for variability in results.
- Data Collection: The remaining fungal organisms on the finger pads after treatment are eluted in a neutralizing solution to allow counting of the remaining CFUs to determine the efficacy of the test agent.
ASTM E2613 Test Methodology
The steps involved are as follows:-
- Preparation of Subjects: Subjects are prepared to ensure their hands are free from any antimicrobial substances. This includes providing them with non-antimicrobial personal care products during the study period.
- Application of Fungal Suspension: A well-demarcated area on the fingerpads is treated with a small volume of fungal suspension and is allowed to dry, simulating transient fungal contamination likely to occur in real life.
- Exposure to Test Agent: After drying the fungal suspension, expose the contaminated area to a test agent or control solution for a specified time.
- Elution and Counting: The fingerpads were washed after treatment, and fungi remaining in the fingerpads were recovered using an eluent. Viable fungal cells were enumerated using CFU assays.
- Data Analysis: The fungal count reduction is calculated as the difference in CFU counts before and after treatment. This provides a quantitative estimation of test product effectiveness.
Importance of ASTM E2613 Test
It includes:
- Fungal Infection Control: Fungi such as Candida albicans and Aspergillus niger are the most common contaminants in areas where hygiene is essential. This test method provides a reliable method to evaluate hand hygiene products in terms of their ability to reduce or eliminate fungi, potentially lessening the risks of fungal infections.
- Standardized Efficacy Assessment: It standardizes a repeatable procedure for assessing the effectiveness of hygienic handwash and hand rub products in ensuring that their products meet set standards of removal according to the benchmark. This will ensure manufacturers maintain quality levels while the regulatory body will be confident in the efficacy of products.
- Consumer Confidence: Products that have been evaluated and proven to be active, as measured by this standard, might bring more confidence to consumers.
Compliance and Industry Standards for ASTM E2613
Conforms to this standard, especially for manufacturers of products that could be applied to healthcare settings, food service sectors, and pharmaceutical industries. It is standardized to test the antimicrobial activity of products worldwide acknowledged by various regulatory bodies. By ensuring that they meet these high standards of health and safety, manufacturers increase their reputation in the market and thus edge out their competitors.
Pros of ASTM E2613 Test Standard
- Comprehensive Testing: This test method provides a detailed assessment of the fungus-eliminating efficacy of hand hygiene products, ensuring a thorough evaluation.
- Regulatory Compliance: Products tested under this standard can be certified as complying with the appropriate regulatory standards, thus offering a route into the regulated market for manufacturers.
- Consumer Safety: This test verifies the hygiene productโs effectiveness and, therefore, safeguards the consumers from infection caused by fungal contamination.
Benefits of ASTM E2613 Testing
Testing products under this standard offers several benefits for manufacturers:
- Increased Market Confidence: It creates market trust by establishing and ensuring the effectiveness of its hygiene agent.
- Competitive Advantage: Compliances to ASTM standards diffuse the competitive advantage of a product in a competitive market, therefore giving more significant advantages to manufacturers than competitors.
- Global Acceptance: These standardized test methods are recognized globally, allowing products to be marketed in various regions without additional testing.
Conclusion
The ASTM E2613 test is an excellent tool for proving the performance of hand hygiene products in high-risk services like healthcare and pharmaceutical, even food services. Compliance with standard test methods not only increases the value of the product but also increases market confidence, thereby creating an advantage in terms of market competition in a saturated market. It can also easily enter international markets without supplementing testing.
At Microbe Investigations Switzerland (MIS), we specialize in providing rigorous testing services that adhere to international standards like ASTM E2613. Contact us today to learn more about our comprehensive testing and validation services!
Frequently Asked Questions
DR. Martinoz Scholtz
The ASTM E2613 test is a standardized procedure to assess the efficacy of hygienic handwash and hand rub agents against fungal contamination. It provides a standardized approach to measure and compare the fungus-reducing efficacy of hand hygiene products.
Hygienic handwashes and hand rubs designed to specifically reduce fungal contamination on the skin can be evaluated based on ASTM E2613.
The ASTM E2613 test period is usually between 7 and 14 days, depending upon the capacity of the laboratory that conducts it and other requirements the specific test may have.
Candida albicans ,Aspergillus niger.
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