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ASTM E1115
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ASTM E1115 - Standard Test Method for Evaluation of Surgical Hand Scrub Formulations
Application
- A baseline measurement of the bacterial load on the hands is obtained by the volunteers prior to scrubbing.
- The simulated surgical scrub is carried out by the selected subjects under the supervision of an expert in aseptic techniques.
- Microbial sampling is conducted immediately after the scrub and again following an allotted period of 6 hours.
- For cumulative-effect products, the scrubbing process is repeated daily over five days and hands are sampled after the final treatment.
- Ensures surgical hand scrubs effectively reduce and prevent microbial growth.
- Helps manufacturers meet regulatory standards and improve product formulations.
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Abstract
ASTM E1115 is a standard test method for surgical hand scrub formulations to be specifically evaluated. The test evaluates a surgical hand scrub for its ability to immediately reduce and provide residual antimicrobial activity to hands, which is crucial in healthcare or surgical environments. Cumulative antimicrobial activity after repeated use is also measured during this test. Here, we will discuss the test conditions, methodology, and the significance of ASTM E1115, as it relates to the validation of surgical hand scrub products.
Test Method for Evaluation of Surgical Hand Scrub Formulations
ASTM E1115 is an analytical test used to measure the effectiveness of surgical hand scrubs in reducing microbial flora on the skin, especially the hands. The test on human subjects simulates real-life surgical conditions to ensure the formulation tested will provide an immediate and extended duration of antimicrobial effectivity.
The test assesses two critical aspects:
- Immediate reduction: The antimicrobial effect is immediately evaluated after applying the scrubs. This aspect is important in operating theaters where healthcare professionals need to attain an immediate and extended reduction of microbes as soon as possible before conducting surgery procedures.
- Persistent Antimicrobial Activity: The test also evaluates the product’s capability of preventing microbes from growing on the skin for about 6 hours, so healthcare providers are free from microbial load even after their first scrub.
Test Conditions
- Subject Selection: The subjects should not use any antimicrobial products for at least one week prior to the test. They are selected based on high initial bacterial count, which should be at least 1 x 10⁵ CFU (colony forming units) per hand.
- Environmental Control: The environment of the test is strictly controlled. The water used in the scrubbing process should have a temperature of between 40°C ± 2°C to mimic surgical conditions.
- Simulated Surgical Scrub: The subjects perform a simulated surgical hand scrub as led by trained personnel. One hand is sampled immediately after the scrub and the other after 6 hours to measure residual activity.
- Sampling Intervals: Testing is carried out at several sampling times (e.g., 3 hours and 6 hours) in order to illustrate prolonged antimicrobial activity of the product over the time period. For cumulative activity testing, patients are required to apply scrubs repeatedly for days.
Test Requirements
- Colony Counter- Any of several types.
- Incubator- Any incubator able to maintain a temperature of 30 ± 2°C.
- Sterilizer-Any suitable steam sterilizer.
- Timer (stop-clock)-one that displays minutes and seconds.
- Hand Washing Sink- A sink of adequate size to permit subjects to wash without touching their hands to the sink surface or other subjects.
- Water Faucet(s)—To be installed above the sink at a height that allows the hands to be held above the elbows during the cleaning process. (It is desirable for the faucets to be adjustable.)
- Tap Water Temperature Regulator and Temperature Monitor—To monitor and control the temperature of water to 40 ± 2°C
Test Methodology
- Baseline Determination: Before scrubbing, scrub volunteers should obtain a baseline measurement of the bacterial load on their hands. This is a good way to assess the effectiveness of scrubbing by comparing microbiology counts both before and after the scrub process.
- Simulated Scrub Procedure: The products are used by the volunteers to simulate the surgical hand scrubbing following the manufacturers’ instructions or the standard method.
- Sampling and Bacterial Recovery: After the scrub, microbial sampling from one hand is made immediately after the scrub and the same from the other hand is made after an allotted period of 6 hours.
- Optional Cumulative Testing: For cumulative products that release active chemicals over 5 days, additional scrubs are conducted. Hands are sampled after the final treatment.
Importance
The ASTM E1115 test is an important means to ensure surgical hand scrubs significantly reduce microbial loads immediately and over time. Infections acquired, particularly in healthcare, are dangerous, so the products approved by this test standard prevent harmful pathogens from being transmitted through the hands during surgery. Hence the test standard is critically important for validating the effectiveness of surgical hand scrubs.
Compliance and Industry Standard
Manufacturers’ adherence to ASTM E1115 is important to gain market entry for their surgical hand scrubs. The FDA and EMA among other regulatory agencies require manufacturers to prove their product passes recognized test standards such as ASTM E1115 to ensure it is safe for use and also effective. Manufacturers are also obliged to respect guidelines on ethical usage of human subjects in testing(21 CFR Parts 50 and 56) and all procedures carried out under controlled conditions.
Pros of ASTM E1115 Test Standard
- Relevance: The test standard demands a simulated real-time environment for testing the products.
- Comprehensive: The test measures not only the immediate antimicrobial action but also the long-term effect which gives a more comprehensive overview about efficacy of the product.
- International Recognition: The test is accepted by all the regulatory agencies in the world. This makes it possible to use it with confidence as a point of reference for validating the product.
- Enhanced Product Safety: Manufacturers can ensure their surgical hand scrubs sold worldwide are effective in removing microbial loads, an important prophylaxis against infection in clinical settings.
- Regulatory Compliance: Passing the test means the product meets the stringent regulatory requirements, thus gaining faster approval by regulatory bodies, such as the FDA.
- Informed Product Development: A better understanding of the results of this test informs manufacturers of potential areas of revision, enhancement, or reformulation of products toward improving effectiveness.
Conclusion
ASTM E1115 becomes an essential test method for establishing the effectiveness of surgical hand scrubs. It assesses both immediate and long-term antimicrobial activity. ASTM E1115 test ensures that hand scrubs used in healthcare settings are effective at reducing the risk of infection. For manufacturers, meeting the requirements of ASTM E1115 not only ensures compliance with regulatory standards but enhances the development and marketability of products of high quality.
To ensure your surgical hand scrub products work effectively and are safe for use, Microbe Investigations Switzerland(MIS) offers comprehensive testing services. Contact MIS today to learn how our testing expertise can help authenticate your products’ safety and compliance with regulatory requirements.
Frequently Asked Questions
DR. Martinoz Scholtz
ASTM E1115 is the test method that determines the effectiveness of surgical hand scrub formulations in reducing skin microbial flora.
ASTM E1115 test can be applied for testing of surgical hand scrubs and other types of antimicrobial handwash products.
The typical turnaround time for testing by ASTM E1115 is between 7 and 10 business days
Our laboratory conducts tests on several strains of microbes, depending upon the requirement of the test.
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