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ASTM E2870
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Quick understanding of the test
ASTM E2870 - Test Method for Evaluating Relative Effectiveness of Antimicrobial Handwashing Formulations using the Palmar Surface and Mechanical Hand Sampling
Application
- Escherichia coli (ATCC 10536)
- Palms of the volunteers are artificially contaminated with Escherichia coli.
- One hand is washed with the antimicrobial formulation, while the other is treated with the reference formulation.
- The bacteria remaining on the palms are collected using the mechanical scrubber and glove juice technique. Subsequently, the collected samples are cultured and quantified.
- The reduced bacterial load from the test product is compared with that of the reference formulations.
- Provides a direct and reliable comparison between antimicrobial handwash formulations and their reference formulations.
- Utilizes the palmar surfaces of the hands and mechanical hand sampling, which mimic real-world handwashing practices.
Turnaround Time
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Abstract
This test assesses the antimicrobial efficacy of a handwashing formulation against transient microorganisms on palms by inoculating palms with E. coli and comparing performance between a test antimicrobial handwash and a non-antimicrobial reference. Residual bacteria are recovered after washing by mechanically scrubbing off the palm for proper sampling. This test provides a direct comparison between the two formulations, thus providing an appropriate basis for determining the validity of the claimed ability of the product formulation to reduce bacterial loads under controlled conditions.
ASTM E2870 Test Conditions
The test conditions are:-
- Participants must have healthy hands and avoid antimicrobial use for at least one week prior.
- Palms are inoculated with E. coli to simulate microbial contamination.
- The amount of water used for handwashing is maintained at a temperature of 40 ยฑ 2ยฐC with a flow rate of 3 L/min.
- Mechanical sampling is used to collect bacteria for assay.
ASTM E2870 Test Requirements
For this test to be valid, several key requirements must be met:
- Ethical Compliance: Human test subjects should give their informed consent, and the test should comply with the guidelines in 21 CFR Parts 50 and 56 for the protection of human subjects.
- Test Organism: The test involved the use of Escherichia coli (ATCC 10536) as a test organism for contamination. The organism is well distinguishable and acts as a marker for antimicrobial effectivity.
- Test Materials: The manufacturer’s instructions should be followed for the test and reference formulations. A neutralizer test may be validated using ASTM E1054 to validate that any antimicrobial activity present in the formulation is properly neutralized.
- Sampling Solutions: The solutions used in the test procedure should include the sterilized phosphate buffer, and neutralizers prepared using the instructions provided to minimize contamination.
ASTM E2870 Test Methodology
The steps are as follows:-
- Preparation of Test Subjects: The test subjects should not have used any antimicrobial products for at least a week before the test. Their hands are evaluated to check for any visible damage.
- Application of Test Organism: A small quantity of E. coli is dropped on both palms. The palms are rubbed against each other so that the bacteria distribute uniformly across the hands.
- Handwashing Procedure: The test subject washes one of his hands with the antimicrobial formulation and the other hand with the reference formulation. The hand washing procedure is standardized so that identical results can be obtained.
- Mechanical Sampling: After washing, the bacteria remaining on the palms are collected using the mechanical scrubber and glove juice technique. This method provides a higher recovery rate than conventional manual sampling.
- Bacterial Analysis: Recovered bacteria are cultured and counted for the evaluation of the efficacy of the hand wash product, and hence, the comparison of a reduced bacterial load between the test and the reference formulations can be made.
Importance of ASTM E2870 Test
- This test is essential for ensuring that formulations of antimicrobial hand washing are effective in meeting the hygiene requirements of the industry, infection control, and regulatory standards within health care, food processing, and personal care.
- Standard conditions and mechanical sampling produce accurate, reliable data and serve public health.
Compliance and Industry Standards for ASTM E2870
This test meets the international standards as well as FDA criteria so that the human subject is treated properly. Neutralizer validation following ASTM E1054 is required to have successful results. It helps companies to achieve government compliance, thereby increasing credibility among all the products. The test developed by ASTM Committee E35 is widely accepted in healthcare industries and food processing industries.
Strengths of ASTM E2870 Test Standard
- Direct Comparison: This test allows for the direct comparison of two formulations on the same test subject, thus reducing variability and giving a better result.
- Mechanical Sampling: Using mechanical scrubbers to retrieve bacteria minimizes bacterial loss considerably and is always recovered at a better, more reliable rate, resulting in much more accurate estimates for how effective the product is likely to be.
- Controlled Conditions: This test will allow control over the conditions like water temperature and hand washing technique so that results are consistent from one study to another.
Benefits of ASTM E2870 Testing
Testing handwashing formulations using this test standard provides several benefits:
- Ensures Product Efficacy: This test represents the standard process by which antimicrobial handwashing formulations have to be tested to determine their efficacy in preventing microbial contamination.
- Improvement in Infection Control: The utilization of products that ensure full compliance with this standard in healthcare facilities reduces infections, thereby increasing patient safety.
- Regulatory Compliance: Companies manufacturing antimicrobial handwashing formulations must adhere to stringent standards for regulatory compliance and increase their credibility in the marketplace.
Conclusion
The test standard is essential for evaluating the efficacy of relative antimicrobial handwashing formulations. It ensures a properly standardized approach to obtain reliable assessments, which would not only be ensured during controlled test conditions but also through mechanical sampling and direct product comparisons. It helps manufacturers meet stringent hygiene and legal requirements in various industries.
At MIS, we specialize in providing testing services that adhere to international standards like. ASTM E2870 Contact us today to learn more about our testing services.
Frequently Asked Questions
DR. Martinoz Scholtz
This standardized test method evaluates the effectiveness of various hand antiseptic formulations possessing antimicrobial activity in reducing the transient microbial population on the palmar surface under controlled conditions by mechanical sampling.
Products that can be tested under these test standards are antimicrobial hand soaps and hand sanitizers applied to reduce transient microorganisms.
The turnaround time for this test standard is typically a few days to one week or even longer, depending on the laboratory’s capacity and some specific requirements for testing.
At MIS, we can test for ASTM E 2870 by using bacterial strains such as E.coli.
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