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ASTM E1174:21 Standard Test Method for Evaluation of the Effectiveness of Health Care Personnel Hand wash Formulations
ASTM E1174 is a key standard that determines the effectiveness of healthcare hand wash agents against transient skin microorganisms. This standard ensures that products like alcohol-based hand rubs and other leave-on formulations meet rigorous efficacy criteria. By adhering to ASTM E1174 manufacturers can guarantee their hand hygiene products provide reliable protection, which is essential for maintaining high hygiene standards in healthcare settings and ensuring patient safety.
ASTM E1174 Test Preparations
- Subjects – They are the group of participants who have not used any antimicrobial products for about a week prior to testing. Participants must not have any signs of skin problems such as open wounds, dermatoses, and other skin infections.
- Test microorganisms – At MIS, we perform the test using the following bacterial strains: Serratia marcescens or Escherichia coli.
ASTM E1174 Test Method
- The participant’s hands are subjected to an initial cleansing wash to remove the oil and dirt impurities before contaminating the hands with test microorganisms.
- An aliquot of test organisms suspension is spread over the entire surface of hands for 20 ± 5 seconds and is allowed to dry for 30 ± 5 seconds. This process is repeated 2 more times to minimize the loss of test organisms during spreading.
- After contamination, a baseline sample is recovered to determine the number of marker microorganisms surviving on hands.
- Subjects wash their hands using the test hand wash formulation following the specified procedure which includes a set duration for lathering and rinsing.
- After washing, the number of surviving test organisms on the hands is measured using the following steps:
- Hands are placed in sterile gloves containing a sampling solution.
- The hands are massaged to release organisms into the solution.
- Sampling and plating of the solution are performed to count the bacteria.
- The recovered sampling solution is enumerated either using the pour plate or spread plating method.
- The efficacy of the hand wash product is evaluated by comparing the bacterial counts before and after washing.
Importance of the Test
Hand hygiene products are regarded as one of the most effective and quick measures to prevent microbial contamination in healthcare settings. These products must meet specific regulatory standards to be marketed and used safely. Hence, evaluating the antimicrobial efficacy of such products is very important to ensure proper hygiene and protection from disease-causing germs.
The test is a widely recognized method that helps manufacturers demonstrate the effectiveness of their products to consumers. It provides valuable data that manufacturers can use to refine and improve their hand hygiene formulations. This continuous improvement process helps ensure that products remain effective against emerging bacterial strains and evolving hygiene needs.
ASTM E1174, thus plays a crucial role in maintaining personal hygiene by providing a standard method to determine the antimicrobial effectiveness of products before their real use.
Benefits of performing the test
Regulatory compliance
- Adherence to this standard helps manufacturers meet regulatory requirements.
- Facilitates product approval and market acceptance.
Consumer confidence
- Demonstrating compliance with this standard builds trust among healthcare personnel and consumers.
- It assures them that the products they use are effective in preventing the spread of infections.
Product improvement
- The results from the test can guide manufacturers in improving their formulation.
Health and safety
- This standard contributes to better infection control and overall public health by ensuring that hand hygiene products effectively reduce microbial load.
Market differentiation
- Products that meet this standard can be marketed as high-quality, reliable hand hygiene solutions thus differentiating them from competitors.
At Microbe Investigation Switzerland (MIS), we specialize in rigorous testing of hand hygiene products to ensure they meet the highest standards of safety and efficacy. With our state-of-the-art facilities and commitment to scientific excellence, we provide comprehensive validation services that help manufacturers comply with regulatory requirements and enhance the trustworthiness of their products. Partner with MIS for unparalleled expertise in hand hygiene product testing and validation.
In addition to ASTM E1174 testing, we also offer EN 1499, EN 1500, ASTM E2276 for assessing the effectiveness of hand wash products.
To learn more about our ASTM E1174 testing services or to schedule a consultation, please consult our specialists today.
FAQs
ASTM E1174 test is used to determine the antimicrobial efficacy of hand wash agents or formulations used in healthcare settings against transient microflora.
The test applies to hand wash agents/ formulations, hand rubs and leave-on products.
It takes 2-3 weeks to complete this test.
At Microbe Investigations Switzerland, we perform this test using Escherichia coli (ATCC 8739). Additional stains can be added at the customer’s request.
The test is conducted by having test subjects contaminate their hands with a specific test microorganism and then wash their hands with the test hand wash formulation. The microbial load on the hands is measured before and after washing to determine the efficacy of the hand wash.
This standard is important because it provides a standardized method to evaluate the efficacy of hand wash formulations in reducing microbial contamination thus ensuring that the product effectively prevents the spread of infections.
Test subjects are selected based on criteria such as age, health status and skin condition to ensure they represent the target user population. They are prepared by thoroughly cleaning their hands before the test and following specific protocols to ensure reliable results.
The efficacy of hand wash products is assessed by measuring the microbial reduction on the hand after washing.
Yes, it is applicable to antimicrobial and non-antimicrobial hand wash products.
The test supports regulatory compliance by offering a standard method for demonstrating the efficacy of hand wash formulations. Regulatory agencies often require such standardized testing to approve hand hygiene products for use in healthcare settings.
Benefits of this test include ensuring the efficacy of hand wash formulations and supporting regulatory compliance through science-backed test results.
Hand wash products should be tested regularly. Routine testing can help ensure that the product maintains consistent performance over time.
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