Virucidal Efficacy Testing Service
Virucidal efficacy testing
Virucidal efficacy testing evaluates whether disinfectants, sanitizers, and other antiviral products can effectively eliminate or inactivate viruses from surfaces. Testing these products is crucial as it guarantees that these products are competent and satisfy specific performance requirements. This validation is particularly important for products used in critical areas such as healthcare facilities, food processing units and public transportation. The results of the virucidal test also allow manufacturers to brand the product as an antiviral agent or a virucidal agent.
Importance of Virucidal Testing in Disinfectant Registration.
Virucidal testing of disinfectants must be performed using standard test protocols that conform to the EPA (Environmental Protection Agency) or BPR (Biocidal Product Regulation) guidelines. These internationally recognized standards ensure that the testing services comply with industry standards and regulatory guidelines. Testing laboratories can also customize these standard protocols to suit the manufacturer’s product needs. The reports generated through these tests, mentioning test standards used, test conditions and requirements and the product efficacy, are essential documents that must be submitted during the product registration process.
Virucidal efficacy testing methods
Several methods have been devised to assess the virucidal efficacy of various products. The choice of the method used for testing depends on the product type, its intended use, the target virus, and regulatory requirements. Some common testing methods include surface testing, suspension testing, and aerosol testing that simulate different real-life situations where the product may be used.
BPR recognized testing methods
- EN 17914: 2022 – Quantitative (phase 2 step 1 suspension) test for virucidal activity of chemical disinfectants and antiseptics in food, industrial, domestic and institutional areas
- EN 17915: 2022 – Quantitative (phase 2 step 2 suspension) test for virucidal activity of chemical disinfectants on hard non-porous surfaces in food, industrial, domestic and institutional areas
- EN 17272: 2020 – Quantitative (phase 2 step 2 suspension) test for microbicidal activity of automated airborne room disinfection processes
- EN 14476: 2013 + A2: 2019 – Quantitative (phase 2 step 1 suspension) test for the virucidal activity of disinfectant or antiseptics used in medical areas
- EN 14675: 2015 – Quantitative (phase 2 step 1 suspension) test for virucidal activity of disinfectant or antiseptics used in veterinary areas
- EN 13610: 2002 – Quantitative (phase 2 step 1 suspension) test for virucidal activity of disinfectant against bacteriophages used in food, industrial and domestic areas
- EN 16777: 2018 – Quantitative (phase 2 step 2 suspension) test for virucidal activity of disinfectant used in the medical area
- EN 17111: 2018 – Quantitative (phase 2 step 2 suspension) test for virucidal activity of medical instrument disinfectants
- EN 17122: 2019 – Quantitative (phase 2 step 2 suspension) test for virucidal activity of chemical disinfectants or antiseptics used in veterinary areas
- ISO 18184: 20 – Determination of the antiviral activity of textile products
- JIS L 1922 – Determination of Antiviral Activity of Textile Products
- ISO 21702 – Standard for measuring antiviral activity on plastics and other non-porous surfaces
EPA recognized testing methods
The EPA Series 810 guidance provides the standard testing guidelines for evaluating the antiviral efficacy of treated products. Standard methods include:
- ASTM E1053: Evaluates the effectiveness of disinfectants on hard, non-porous surfaces against viruses.
- ASTM E1052: Assesses the virucidal activity of antimicrobial agents in suspension.
These methods are performed under controlled lab conditions to simulate practical use scenarios. Following standardized methods for testing product efficacy helps manufacturers ensure that their product claims are scientifically supported and all regulatory expectations are met.
Study preparation and timeline for virucidal testing
Preparations for the virucidal tests start with understanding the product’s intended use and target viruses. Thus, the amount of time taken to carry out the test can differ, but typically, it would take 4-6 weeks. However, more complex testing protocols or products targeting more than one virus may extend this time frame.
Commonly tested viruses in virucidal efficacy studies
Virucidal efficacy tests may involve testing a wide range of viruses, depending on the product’s target claims. At Microbe Investigations Switzerland, the commonly tested viruses include:
Enveloped viruses
- Vaccinia virus (ATCC VR-1549)
- Betacoronavirus 1 (ATCC VR-1558)
- Human coronavirus (ATCC VR-740)
- Influenza A virus (H3N2) (ATCC VR-1679)
- Influenza A virus (H1N1) (ATCC VR-1469)
Non-enveloped viruses
- Human adenoviruses (ATCC VR-5)
- Feline calicivirus (FCV) F-9 (US Patent strain)
- Poliovirus Type 1 (Sabin) (LSc-2ab)
- Murine norovirus (MNV) (S99)
Challenges in validating virucidal activity
Validating the virucidal activity of products can be challenging due to their complex structures and their varying behavior on different surfaces and product materials. Some of the commonly faced challenges include:
- Virus selection: Selecting the right target viral strain is important to ensure the accuracy of the test.
- Contact time: it is important to ensure that the antiviral product comes in contact with the target viruses for the right amount of time to ensure maximum efficacy.
- Surface variability: The type of surface being tested also poses a challenge in testing antiviral products such as disinfectants. For instance, smooth surfaces allow for the even application of the disinfectant thus exposing the target viruses to the disinfectant activity.
- Product type: The type of antiviral product tested, such as disinfectant, textile, paints, etc., must also be considered while choosing the test method for testing.
- Regulatory compliance: Keeping up with evolving regulations and standards in different regions can complicate the testing process.
Best practices for successful validation of antiviral products
Validating an antiviral product with proper efficiency is more than just following prescribed methods. Some best practices that can be followed to ensure successful outcomes include:
- Compliance with regulations: Test protocols used must comply with guidelines such as EPA 810 and generally accepted methods (such as ASTM E1053 and E1052) to assure consistent, reliable results from the testing.
- Tailored testing solutions: Tests can be customized to suit specific product needs and to yield precise and comprehensive validation.
- Quality control: Equipment calibration, controlled environments, and precise documentation to ensure accuracy.
- Stay updated: Be updated on evolving standards and testing methods to meet regulatory and market demands.
Importance of virucidal testing laboratory
Virucidal testing laboratories play an important role in safeguarding public health by validating the efficacy of antiviral products against specified viruses. These labs ensure that the products used in various sectors such as hospitals, schools, and public spaces are effective in reducing or eliminating the presence of viruses that can cause serious infections. Rigorous testing of these products helps manufacturers in producing reliable products that protect the consumers while meeting safety regulations.
Regulatory framework for virucidal testing service
Regulations that govern virucidal testing of treated products differ by region. For instance, in the United States, the EPA oversees the registration of antiviral products, a process that involves ensuring that these products pass the efficacy tests conducted against certain viral pathogens. Similarly, BPR regulates biocidal products in Europe, which outlines the requirements for product approval. Antiviral products must be highly effective as well as safe for use to be approved for market release.
Conclusion
Virucidal testing is essential for ensuring the effectiveness and safety of disinfectants intended to combat viral pathogens. Through rigorous testing methods and adhering to regulatory standards, manufacturers can market their products with validated claims. Businesses that aim to validate their antiviral products must choose an accredited laboratory with thorough knowledge of the testing protocol to ensure accuracy.
At Microbe Investigations Switzerland (MIS), we offer comprehensive virucidal efficacy testing services that comply with international standards and regulatory requirements. Our experienced team uses standard methodologies to provide accurate and reliable results, helping your products succeed in the market. Contact us today to learn more about our testing services or to schedule a consultation.
FAQs on Virucidal testing service
Virucidal efficacy tests help determine whether an antiviral product is effective in killing or inactivating viruses, thus making the product safe and effective in controlling viral infections.
General disinfectant testing assesses the ability of a product to kill or inhibit a wide range of microorganisms while the virucidal efficacy test specifically focuses on inactivating viruses.
The EPA (United States), BPR (European Union), and the European Chemicals Agency (ECHA) oversee virucidal efficacy tests to ensure products meet safety and effectiveness standards.
In the United States, the most commonly adopted standards for virucidal efficacy tests are ASTM E1053 and ASTM E1052.
Virucidal efficacy tests could depend on the product type, the type of virus tested, and the specific protocols used. In general, it may take 4-6 weeks.
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