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ASTM E2197: 2017
Quantitative Disk Carrier Test for Determination of Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activities of Chemical Germicides
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Quick understanding of the test
ASTM E2197: 2017 - Quantitative Disk Carrier Test for Determination of Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activities of Chemical Germicides
Application
- Staphylococcus aureus (ATCC 6538P)
- Pseudomonas aeruginosa (ATCC 15442)
- Aspergillus niger (ATCC-16888)
- Candida albicans (MTCC 3017)
- Mycobacterium terrae
- Bacillus subtilis
- Ensures the effectiveness of germicidal products before market launch.
- Validates germicides performance by stimulating real word conditions intended for high-risk environments.
Turnaround Time
Colony-forming units (CFU)/ virus titre are averaged, converted to log10, and microbicidal activity is compared to controls.
Passing criteria
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Abstract
ASTM E2197 is designed to evaluate the performance of germicidal formulations in killing or inactivating bacteria, viruses, fungi, bacterial spores, and mycobacteria.
ASTM E2197 standard uses brushed stainless steel disks as carriers, mimicking real conditions for non-porous environmental surfaces and medical devices. The performance of the test product is interpreted by comparing the number of viable test microorganisms with respect to control carriers.
The test protocol does not incorporate any wiping or rubbing actions, hence, it is not utilized for assessing the effectiveness of germicide-soaked wipes.
ASTM E2197 Test Conditions & Requirements
- Mandatory test microorganisms –
Staphylococcus aureus (ATCC 6538P), Pseudomonas aeruginosa (ATCC 15442), Aspergillus niger (ATCC-16888), Candida albicans (MTCC 3017), Mycobacterium terrae, Bacillus subtilis, Clostridium sporogenes and Clostridium officinale.
- Contact time and temperature – As per the manufacturer’s recommendations
- Interfering substance – Tryptone + Bovine Serum Albumin + Mucine
ASTM E2197 Test Method
- Test microorganisms are inoculated to the center of stainless steel disks (1 cm in diameter).
- Inoculated carriers are allowed to dry under vacuum at room temperature.
- In the next step, dried inoculated carriers are individually placed into the bottom of sterile vessels.
- Test substance is added directly to the center of the dried inoculated carrier and allowed to interact for specific contact times.
- After contact time, neutralizer/elution media is added to each vessel and vortexed to separate any viable test microorganisms from carriers.
- The resulting eluent is passed through a membrane filter to ensure the screening of even minimal numbers of viable microbes.
- Membrane filter is further rinsed with saline to reduce the chances of carrying any inhibitory residues to the recovery medium that can interfere with the test.
- The filtrate is used to determine the number of viable microorganisms and virus infectivity titer.
- After incubation, the number of colony-forming units (CFU) or virus titre is calculated by observing cytopathic effects in cell culture. The results are averaged to determine log10 reduction in test sample and microbicidal activity of the test sample is compared with the control sample.
Key strengths of ASTM E2197
- The test design avoids viable organism loss, enabling statistically valid results with fewer carriers.
- The testing setup closely mimics real-life conditions by incorporating soil load, brushed stainless steel surfaces, and a low ratio of disinfectant to surface area to reflect actual disinfectant application scenarios.
- This is a versatile method for evaluating bactericidal, virucidal, fungicidal, mycobactericidal, and sporicidal activities
ASTM E2197 evaluates bactericidal, virucidal, fungicidal, mycobactericidal, and sporicidal activity using realistic stainless steel surfaces, precise log₁₀ reduction, soil load inclusion, and minimal carriers. It ensures controlled exposure and broad compatibility with various disinfectant chemistries.
Importance of ASTM E2197 Test
Germicidal products are commonly used for surface disinfection in hospital settings, households, food preparation areas and other similar environments. Such products effectively destroy or eliminate bacteria, viruses, fungi, and bacterial spores that can lead to infections. Therefore, in order to ensure a high level of cleanliness and hygiene in infection prone areas, it is important to use germicidal products which have passed the efficacy test for their intended use.
ASTM E2197 test method provides, efficacy criteria, and result data to understand product efficacy and facilitates enhancement in product performance prior to its market launch.
Conclusion
MIS offers a comprehensive range of germicidal efficacy tests for a variety of liquid formulations.
We also provide tailored/ customized services to our clients. Our team of experts is highly proficient in creating protocols that adhere to international standards like ASTM, AOAC, EN, and ISO.
We ensure that the microbiological interpretation of our test results is accurate, reliable, and delivered within a defined time frame to our clients.
Also, check, ASTM E1053 and ASTM E2362 are other frequently performed ASTM standards in our labs.
Looking for ASTM E2197 testing services, contact our microbiology team experts today.
Frequently Asked Questions
DR. Martinoz Scholtz
ASTM E2197 is a germicidal efficacy test method. This method uses stainless steel discs (referred as carriers) to evaluate the effectiveness of tested products against bacteria, viruses, fungi, and mycobacteria.
ASTM E2197 test method is applicable for germicidal products like disinfectants and antiseptics utilized for surface disinfection in critical areas.
ASTM E2197 test takes 3 – 4 weeks to complete.
At Microbe Investigations Switzerland, we test for ASTM E2197 using the following microbial strains: Staphylococcus aureus (ATCC 6538P), Pseudomonas aeruginosa (ATCC 15442), Aspergillus niger (ATCC-16888), Candida Albicans (MTCC 3017), Mycobacterium terrae, Bacillus subtilis, Clostridium sporogenes, Clostridium officinale, Human adenovirus, Canine parvovirus, Hepatitis A virus, Feline calcivirus, Human rhinovirus, Human rotavirus and Human norovirus.
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