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ASTM E1052
Test method for Evaluating Virucidal Activity of Microbicides in Suspension
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Quick understanding of the test
ASTM E1052 - Test method for Evaluating Virucidal Activity of Microbicides in Suspension
Application
- Adenovirus type 2 or type 5
- Canine Parvovirus
- Feline Calicivirus
- Hepatitis A Virus
- A viral suspension is prepared and standardized to a known concentration.
- The microbicidal product is added to the viral suspension and incubated for a specified contact time followed by neutralization.
- The remaining viruses are quantified using methods like plaque assays or TCID50.
- Antiviral efficacy is assessed by measuring the reduction in viral activity.
- Provides a consistent and standardized approach to evaluate the effectiveness of virucidal agents, ensuring reliable and comparable results.
- Helps manufacturers comply with regulatory standards
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Abstract
It is a standard test for assessing the efficacy of liquid microbicides against suspended viruses in solution. The test itself is conducted in controlled laboratory settings where a knoASTM E1052wn concentration of the virus is introduced into a suspension. This would subsequently be followed by the addition of a disinfectant or sanitizer to the suspension and allowed for a specified contact time.
After the incubation period, a neutralizing agent is added to end the action of the microbicide. Several methods are then used to quantify residual viral particles, such as plaque assays or TCID50 (tissue culture infectious dose) assays. The decline in titers of viruses is measured as an indicator of the potency of the microbicide in inactivating or killing the virus.
This test is relevant for antiviral product manufacturing companies as it helps to develop a scientific approach to judge the efficacy of formulations. This standard test method is used for products to be applied across various industries including healthcare, pharmaceuticals, and sanitation, to ensure that products receive regulatory compliance regarding antiviral activity.
ASTM E1052 Test Conditions
The test conditions are:-
- Temperature: Testing is conducted at temperatures between 20ยฐC and 25ยฐC, similar to conditions that the finished products are expected to be applied in, such as room temperatures.
- Contact Time: The contact time of the microbicide with the virus determines the efficacy of the microbicide. Some products take anywhere from 5 minutes to an hour or more to show the effect, depending on the product and purpose of use.
- Viral Strains: Depending upon the intended use of the microbicide, various enveloped and non-enveloped viruses may be used. The commonly used viral strains for such a test include influenza, norovirus, coronaviruses, etc.
- Suspension Medium: The virus is usually suspended in a defined medium for stability during the test. This medium should include a phosphate-buffered saline solution or any other appropriate liquid.
ASTM E1052 Test Requirements
The key requirements are:
- Standardized Virus Concentration: The suspension should contain the virus in a standardized concentration to facilitate the adoption of the same testing condition for all products and different formulations under test.
- Concentration of Microbicide: In addition, the concentration for test product needs to be standardized and prepared according to the manufacturer’s procedure or industry standard.
- Process of Neutralization: This is the process of neutralizing the action of microbicide after the passage of contact time to enable accurate determination of the antiviral activity. This is normally achieved through the addition of a neutralizing agent that destroys the action of the microbicide without interfering with the virus and the test.
- Controls: Positive and negative controls are used to validate the test. A control group that has no microbicide is meant to provide an estimate of the natural degradation of the virus. The known effective microbicide is used as a benchmark.
- Replication: The results of a test are made reproducible and reliable by carrying out the experiment in triplicate. Therefore, any variation that may be present in the process of testing is covered, and the reproducibility of the results is ensured.
ASTM E1052 Test Methodology
The ASTM E1052 test procedure are:-
- Viral suspension preparation: A known concentration of the virus is used in preparing a defined viral suspension. The suspension then becomes the test medium in which the microbicide will be introduced.
- Introduction of Microbicide: The microbicidal agent is combined with the viral suspension and allowed to incubate for an appropriate contact time. This incubation time plays an important role in determining whether a product inactivates the virus in a given solution.
- Neutralization: At the prescribed contact time, a neutralizing agent is added to stop the action of the microbicide. This will ensure that further reduction in virus will not be observed beyond the contact period.
- Virus Titration: The remaining viruses are titrated using a plaque assay, TCID50, or any suitable method. This step is meant to find out how many viruses survived treatment as well as the reduction of viral load.
- Data Analysis: The efficacy of a microbicide is determined in terms of percent reduction in viral activity. Data are usually expressed as log reduction values that give an idea of the productโs efficacy. The greater the value, the higher the antiviral activity.
Importance of ASTM E1052 Test
It is essential in determining the effectiveness of microbicides as antiviral agents and ensures that products such as disinfectants and sanitizers act against viruses. Manufacturers may validate formulations to satisfy regulatory requirements; thus, all their product claims will be supported. The exact information on viral inactivation contributes to public health and safety, especially for the healthcare-related, pharmaceutical, and sanitation industries, where control of viral contamination is widely emphasized.
Compliance and Industry Standards for ASTM E1052
It is an essential step for the manufacturers to comply with this test method to fulfill the standards that are required by the regulatory bodies for the products showing antiviral activity. This universally accepted test method supports agencies, such as EPA and ECHA, to take necessary decisions regarding the effects of disinfectants and sanitizers against viruses. Compliance with this standard ensures that the products would be acceptable with regards to safety and performance requirements. It also accelerates market approvals, thereby building confidence with consumers and minimizing the possibility of legal and regulatory issues concerning antiviral claims.
Pros of ASTM E1052 Test Standard
- Accurate and Reliable Results: This standard test method provides highly reliable data on a microbicideโs antiviral activity, ensuring that products meet stringent efficacy standards.
- International acceptance: Standards are accepted worldwide, which makes it easier for a company to comply with all the requirement laws in the regions.
- Multi-versatile: Due to this fact, the test can be applied to a wide range of viruses and formulations thus making it highly versatile for manufacturers who come up with different antiviral products.
- Support of product claims: If a material passes this test, the manufacturer can validate antiviral claims necessary for regulatory clearances and consumer acceptance.
Benefits of ASTM E1052 Testing
- Verifies Product Efficacy: It gives confirmation regarding the efficiency of antiviral disinfectants and sanitizers against specific viruses.
- Ensures Regulatory Compliance: Helps meet worldwide regulatory standards that reduce market approval times.
- Supports Valid Product Claims:It supports valid claims of a product by providing scientific proof for antiviral statements, thereby enhancing credibility and trust.
- Contributes to Public Health:It contributes to public health by ensuring that these products effectively reduce viral contamination in critical industries such as healthcare and sanitation.
Conclusion
ASTM E1052 plays a very critical role in testing the efficacy of microbicides against viruses in suspension and ensuring compliance with stringent regulatory and safety standards. Beyond evaluating antiviral disinfectants and sanitizers, it aids in creating products that meet the highest standards for public health and consumer confidence. Success in meeting the requirements of this standard shall ensure regulatory approvals for the manufacturers, eliminate chances of litigation, and provide for public health through safe and effective use of antivirus solutions.
MIS offers comprehensive validation services that meet the highest industry standards, ensuring your products are safe, effective, and ready for market success. Contact MIS today to learn how our testing solutions can help you achieve your product development and regulatory goals.
Frequently Asked Questions
DR. Martinoz Scholtz
It is a standardized procedure adopted for the assessment of antiviral effectiveness of microbicides in liquid suspension by measuring the reduction of viral activity.
Products suitable for testing with this test standards include disinfectants and sanitizers and other liquid microbicides that are applied against viruses.
The ASTM E 1052 test can take 2-3 weeks depending on the testing facilities and product complexity.
Common viral strains include influenza A virus, Murine Norovirus, Parvovirus, Adenovirus, Vaccinia virus. Other viruses may be taken depending on the manufacturer’s need and according to our facility.
Testing is applied in the healthcare sector, pharmaceuticals, cosmetics, and disinfectant manufacturing industries to determine the antiviral efficiency of various products.
ASTM E1052 tests the antiviral activity of topically applied products, disinfectants, hand sanitizers, and coatings for medical devices.
The ASTM E1052 procedure exposes a virus to controlled conditions with the test product and quantifies the decrease in viral infectivity for a specified contact time.
The ASTM E1052 test is considered to be successful if the test product reduces at least 99.99% (4-log) of viral infectivity.
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