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Home » ALG Compliance Tests » EPA Tests

EPA Tests

Liquid Antimicrobial Efficacy

Single Tube Method for Determining the Efficacy of Disinfectants against Bacterial Biofilm (Pseudomonas Aeruginosa and Staphylococcus Aureus)

A biofilm is grown onto a series of coupon “carriers” and treated with a sample of product and allowed to expose. Following exposure, the carriers are neutralized and assayed for surviving bacteria. The resulting plates are incubated, enumerated, and the Log10 reduction is determined as compared to the population control. For biofilm claims, a 6 Log10 reduction must be observed. Currently draft guidance has been published to follow U.S. EPA BEAD SOPs.

OECD Quantitative Method for Testing Antimicrobial Products against Spores of Clostridium Difficile (ATCC 43598) on Inanimate, Hard, Non-Porous Surfaces

In this method, a series of stainless steel disks are inoculated with test organism. The carriers are desiccated and subsequently treated with a sample of the disinfectant. After exposure, the carriers are neutralized and quantitatively assayed for surviving test organism. The resulting plates are incubated, the number of survivors is enumerated and a Log10 reduction is determined as compared to the population control. In order to successfully demonstrate disinfection efficacy, the product must demonstrate a 6 Log10 reduction of Clostridium difficile spores. In addition, the disinfectant must have verification testing performed resulting in a 6 Log10 reduction of Clostridium difficile spores.

OECD Quantitative Method for Evaluating Efficacy of Liquid Antimicrobials against Candida Auris on Hard, Non-porous Surfaces

In this method, a series of stainless steel disks are inoculated with test organism. The carriers are desiccated and subsequently treated with a sample of the disinfectant. After exposure, the carriers are neutralized and quantitatively assayed for surviving test organism. The resulting plates are incubated, the number of survivors is enumerated and a Log10 reduction is determined as compared to the population control. In order to successfully demonstrate disinfection efficacy, the product must demonstrate a 5 Log10 reduction of Candida auris.

Mildew Fungistatic Test for Fabrics or Hard Surfaces

In this method, ceramic tile or cotton muslin carriers are treated with the product and the carriers are allowed to dry. Following drying, the carriers are inoculated with Aspergillus niger. The treated carriers are incubated in a high humidity environment and are visually rated for mold growth. For a product to be considered an effective mildew fungistat, the treated surfaces must demonstrate no mold growth following incubation.

Quantitative Disk Carrier Test Method (Modification of ASTM Method E2197)

In this method, a series of stainless steel disks are inoculated with the test organism. The carriers are desiccated and subsequently treated with a sample of the liquid disinfectant. After exposure, the carriers are neutralized and quantitatively assayed for surviving test organism. The resulting plates are incubated, the number of survivors is enumerated and a percent and log10 reduction is determined as compared to a population control. No regulated performance criteria have yet been established by the U.S. EPA however products may be evaluated using this method to investigate product performance. Common test organisms include Staphylococcus aureus, Enterococcus hirae and Pseudomonas aeruginosa.

Re-use Stress Testing and Evaluation of Disinfectants

In this method, products are processed through a series bio-burden stressing procedures to generate a product which has undergone simulated-use. Commonly, these products are combined with an organic soil load and undergo daily simulated-use cycles by processing medical equipment into and out of the product multiple times. Bio-burden stressing is performed each day by transferring a specific amount of inoculated carriers containing vegetative and spore-forming bacteria into the product. The products are typically stressed on a daily basis for up to 28 days to simulate the length of time the product would be re-used in a clinical setting. The final product is then evaluated for high-level disinfection efficacy using the AOAC Use Dilution, AOAC Sporicidal method and AOAC Tuberculocidal method, among others.

Test Method for Determining the Efficacy of Antimicrobial Surfaces as Sanitizers

In this method, a set of treated surfaces are inoculated with the test organism and are dried. Following drying, the test organism is allowed to expose to the treated surface. Following exposure, the surfaces are neutralized and quantitatively assayed for survivors. The resulting plates are incubated, the number of survivors is enumerated and a percent reduction is determined as compared to an untreated population control. In order to successfully demonstrate continuous reduction efficacy, the product must demonstrate at least a 99.9% reduction typically within 2 hours. Typical test organisms include Staphylococcus aureus and Enterobacter aerogenes. Additional pathogens of clinical, occupational or household relevance including but not limited to: Pseudomonas aeruginosa, Escherichia coli O157:H7 and Methicillin Resistant Staphylococcus aureus – MRSA are often tested as well.

Test Method for Determining the Residual Self-sanitizing Activity of Treated Surfaces

In this method, a set of treated surfaces undergo a series of physical wear procedures followed by systematic low-level inoculation of test organism to simulate routine use and contamination of the treated surface. After completion of the wear cycles, the treated surfaces are inoculated with the test organism to evaluate the residual sanitizing efficacy of the surface and the survivors are quantitatively assayed. The resulting plates are incubated, the number of survivors is enumerated and a percent reduction is determined as compared to an untreated population control. In order to successfully demonstrate continuous reduction efficacy, the product must demonstrate at least a 99.9% reduction typically within 2 hours. Typical test organisms include Staphylococcus aureus and Enterobacter aerogenes. Additional pathogens of clinical, occupational or household relevance including but not limited to: Pseudomonas aeruginosa, Escherichia coli O157:H7 and Methicillin Resistant Staphylococcus aureus – MRSA are often tested as well.

AOAC Method 966.04 Sporicidal Activity of Disinfectants

In this method, a series of porcelain cylinders and silk or Dacron sutures (“carriers”) are inoculated with the spores of Bacillus subtilis and Clostridium sporogenes and are desiccated. The carriers containing the dried spore film are then sequentially immersed into 10 mL of disinfectant and are exposed to the disinfectant for a predetermined exposure time. After exposure, the carriers are sequentially transferred to a liquid subculture medium specifically selected to neutralize the test substance active and to recover any surviving spores. The carriers are incubated and visually examined for the presence or absence of growth. Based on the desired claim and the requirements of the regulatory agency, the product must demonstrate kill on a predetermined number of carriers inoculated with test organisms applicable to the claim.

Efficacy of a Disinfectant or Sterilant Applied to a Room via a Fogger or Misting Device

In this method, a series of glass or stainless steel surfaces inoculated with the test organism (commonly Geobacillus stearothermophilus, Clostridium difficile, Staphylococcus aureus or Pseudomonas aeruginosa) are placed at specific locations inside a customized testing room. The room is sealed, the fogging, misting or vaporizing product is allowed to treat the room and following treatment, the surfaces are removed and evaluated for survivors. Based on the desired claim and the requirements of the regulatory agency, the product must demonstrate kill on a predetermined number of carriers inoculated with test organisms applicable to the claim.

ASTM E1153 Standard Test Method for Efficacy of Sanitizers Recommended for Inanimate Non-food Contact Surfaces

In this method, a series of glass slides (“carriers”) are inoculated with a representative test organism and the carriers are dried. The carriers containing the dried organism film are then sequentially treated with the product in a manner that represents its intended use and are exposed for a predetermined exposure time. After exposure, the carriers are neutralized and quantitatively assayed for survivors. The resulting plates are incubated, the number of survivors is enumerated and a percent reduction is determined as compared to an untreated population control. In order to successfully demonstrate sanitizing efficacy, the product must demonstrate a 99.9% reduction. Typical test organisms include Staphylococcus aureus and Enterobacter aerogenes or Klebsiella pneumoniae. Additional pathogens of clinical, occupational or household relevance are often tested as well.

Quantitative Tuberculocidal Suspension Method

In this method, quadruplicate samples of the product are inoculated with a suspension of Mycobacterium bovis – BCG. The inoculated products are allowed to expose for a series of exposure times. After each exposure time, a sample of product is removed, neutralized and is quantitatively assayed for surviving Mycobacterium. A percent reduction is determined for the test samples, at each time point, as compared to a population control. The U.S. EPA requires an effective product demonstrate at least a 99.99% (4 log10) reduction of Mycobacterium and an average of <1 survivor at the effective time. For high-level disinfectants, the U.S. FDA requires an effective product demonstrate at least a 99.9999% (6 log10) reduction of Mycobacterium and an average of <1 survivor at the effective time. When the minimum reduction is not met at any of the times utilized in the study, a survivor curve can be constructed to predict the effective time of the product.

ASTM E2149 Standard Test Method for Determining the Antimicrobial Agents

In this method, treated test samples are placed in a laboratory flask containing a dilute suspension of test organism, commonly Escherichia coli. The flask is placed onto a wrist-action shaker and shaken for a desired exposure time, typically 1 hour. Following exposure, a sample of the test organism suspension is removed quantitatively assayed for survivors. The resulting plates are incubated, the number of survivors is enumerated and a percent reduction is determined for the test flask as compared to the untreated control suspension. No regulated reduction limits currently exist for general antimicrobial claims made using this method.

EPA Residual Self-sanitizing Activity of Dried Chemical Residues on Hard, Nonporous Surfaces

In this method, a series of glass or stainless steel surfaces are treated with the product and the product is allowed to dry over the surfaces. The treated surfaces then undergo a series of physical wear procedures followed by systematic low-level inoculation of test organism to simulate routine use and contamination of the surface. After completion of the wear cycles, the treated surfaces are inoculated with the test organism to evaluate the residual sanitizing efficacy of the surface and the survivors are quantitatively assayed. The resulting plates are incubated, enumerated and a percent and log10 reduction is determined as compared to a population control. In order to successfully demonstrate residual self-sanitizing efficacy, the product must demonstrate a 99.9% reduction after 24 hours following application. Typical test organisms include Staphylococcus aureus and Enterobacter aerogenes or Klebsiella pneumoniae. Additional pathogens of clinical, occupational or household relevance are often tested as well.

AOAC Method 955.16 Available Chlorine in Disinfectants

In this method, a sample of the disinfectant is inoculated with a suspension of representative test organism. After 1 minute, a sample is removed and transferred to a tube containing a liquid subculture medium specifically selected to neutralize the test substance active and to recover any surviving test organism. Thirty seconds later, the same sample is re-inoculated. After an additional 1 minute of exposure, a second sample is removed and recovered. This is repeated until 10 samples have been removed. Side-by-side controls are identically evaluated using 50 ppm , 100 ppm and 200 ppm sodium hypochlorite. The subculture tubes are incubated, examined for growth, and the test subcultures are compared to the control sodium hypochlorite tubes. For food-contact sanitizing rinses, test results should demonstrate product concentrations equivalent in activity to 50, 100, or 200 ppm of sodium hypochlorite. For hand sanitizers, test results should demonstrate product concentrations equivalent in activity to 50 ppm of sodium hypochlorite. Typical test organisms include Staphylococcus aureus and Salmonella enterica serovar Typhi. Other foodborne pathogens are often tested as well.

AOAC Method 955.17 Fungicidal Activity Method

In this method, a sample of the disinfectant is inoculated with a suspension of fungi (Trichophyton interdigitale) and the suspension of fungi is then exposed to the disinfectant for 5 minutes, 10 minutes and 15 minutes. Following exposure, a sample of the exposed fungi is removed and is added to a tube containing a liquid subculture medium specifically selected to neutralize the test substance active and to recover any surviving fungi. The subculture tubes are incubated and visually examined for the presence or absence of growth. For disinfection claims, no growth must be observed after 10 minutes of exposure.

ASTM E2274 and E2406 Standard Test Method for the Evaluation of Laundry Disinfectants

In this method, a series of fabric swatches are inoculated with the test organism and are dried. The swatches containing the dried film of test organism are placed inside fabric-wrapped spindles and are treated in a simulated laundry apparatus. Following treatment, the swatches and a sample of the wash water are removed and are assayed for surviving test organism. In order to successful demonstrate disinfection efficacy, no test organism must be recovered on the treated fabric swatches or in the treated wash water. Typical test organisms include Staphylococcus aureus, Pseudomonas aeruginosa and Klebsiella pneumoniae.

AOAC Method 960.09 Germicidal and Detergent Sanitizing Action of Disinfectants

In this method, a sample of the disinfectant is inoculated with a suspension of representative test organism. Following a 30 second exposure, the sample is neutralized and quantitatively assayed for survivors. The resulting plates are incubated, the number of survivors is enumerated and a percent and log10 reduction is determined as compared to a population control. In order to successfully demonstrate sanitizing efficacy, the product must demonstrate a 99.999% (or 5 log10) reduction. Typical test organisms include Staphylococcus aureus and Escherichia coli. Additional food-borne pathogens of interest are often tested as well.

ASTM E2274 and E2406 Standard Test Method for the Evaluation of Laundry Sanitizers

In this method, a series of fabric swatches are inoculated with the test organism and are dried. The swatches containing the dried film of test organism are placed inside fabric-wrapped spindles and are treated in a simulated laundry apparatus. Following treatment, the swatches and a sample of the wash water are removed and are assayed for surviving test organism. The resulting plates are incubated, the survivors are enumerated and a percent reduction is determined on the test carriers as compared to a population control. In order to successfully demonstrate sanitizing efficacy, a 99.9% reduction of the test organism must be demonstrated on the treated fabric swatches and in the treated wash water as compared to the population control. Typical test organisms include Staphylococcus aureus, Pseudomonas aeruginosa and Klebsiella pneumoniae.

AOAC Method 961.02 Germicidal Spray Method

In this method, a series of glass slides (“carriers”) are inoculated with a representative test organism and the carriers are dried. The carriers containing the dried organism film are then sequentially treated with the spray product and are exposed for a predetermined exposure time. After exposure, the carriers are sequentially transferred to a liquid subculture medium specifically selected to neutralize the test substance active and to recover any surviving test organism. The carriers are incubated and visually examined for the presence or absence of growth. Based on the desired disinfection claim and the requirements of the regulatory agency, the product must demonstrate kill on a predetermined number of carriers inoculated with test organisms applicable to the claim. Standard disinfection organisms include but are not limited to: Staphylococcus aureus, Salmonella enterica, and Pseudomonas aeruginosa. Additional pathogens of clinical, occupational or household relevance including fungi are often tested.

ASTM E2315 Time Kill Assay for Antimicrobial Agents

In this method, a sample of the product is inoculated with a suspension of a representative test organism. After a series of pre-selected exposure times, a sample is removed, neutralized and quantitatively assayed for surviving test organism. The resulting plates are incubated, the survivors are enumerated and percent and log10 reductions are determined for each time point as compared to a population control. Common test organisms used to evaluate hand sanitizers as recommended by the Tentative Final Monograph include but are not limited to: Staphylococcus aureus, Acinetobacter baumanii, Klebsiella pneumoniae, Streptococcus pyogenes, Pseudomonas aeruginosa, Burkholderia cepacia, and Serratia marcesens.

AOAC Method 965.12 Tuberculocidal Activity of Disinfectants

In this method, a series of porcelain cylinders or glass slides (“carriers”) are inoculated with Mycobacterium bovis and the carriers are dried. The carriers containing the dried organism film are then sequentially treated with the disinfectant in a manner intended to simulate its intended use and are exposed for a predetermined exposure time. After exposure, the carriers are sequentially transferred to a series of liquid media specifically selected to neutralize the test substance active and subsequently recover Myocbacterium. The subculture media is incubated and visually examined for the presence or absence of growth. For tuberculocidal claims, all subcultures must demonstrate kill (no growth) of Mycobacterium bovis.

ASTM E2362 / AOAC METHOD 961.02 (Modification) Presaturated Towelettes for Hard Surface Disinfection Test Method

In this method, a series of glass slides (“carriers”) are inoculated with a representative test organism and the carriers are dried. The carriers containing the dried organism film are then sequentially treated with the towelette product and are exposed for a predetermined exposure time (≤10 minutes). After exposure, the carriers are sequentially transferred to a liquid subculture medium specifically selected to neutralize the test substance active and to recover any surviving test organism. The carriers are incubated and visually examined for the presence or absence of growth. Based on the desired disinfection claim and the requirements of the regulatory agency, the product must demonstrate kill on a predetermined number of carriers inoculated with test organisms applicable to the claim. Standard disinfection organisms include but are not limited to: Staphylococcus aureus, Salmonella enterica, and Pseudomonas aeruginosa. Additional pathogens of clinical, occupational or household relevance including fungi are often tested.

AOAC Method 965.13 Disinfectant (Water) for Swimming Pools Method

In this method, a sample of test substance is inoculated with the test organism, commonly Escherichia coli and Enterococcus faecium. Over a series of time points, samples are removed, the test active is neutralized and the sample is quantitatively assayed for surviving test organism. In a similar fashion, a known concentration of a sodium hypochlorite reference standard is inoculated, exposed, neutralized and assayed for survivors. The resulting subcultures are incubated and subsequently evaluated for survivors. The test subcultures are then compared to the sodium hypochlorite control subcultures. The lowest concentration of test substance providing results equivalent to the sodium hypochlorite control solution is considered the lowest effective for disinfection.

EPA Residual Self-sanitizing Activity of Dried Chemical Residues on Hard, Nonporous Surfaces

In this method, a series of glass or stainless steel surfaces are treated with the product and the product is allowed to dry over the surfaces. The treated surfaces then undergo a series of physical wear procedures followed by systematic low-level inoculation of test organism to simulate routine use and contamination of the surface. After completion of the wear cycles, the treated surfaces are inoculated with the test organism to evaluate the residual sanitizing efficacy of the surface and the survivors are quantitatively assayed. The resulting plates are incubated, enumerated and a percent and log10 reduction is determined as compared to a population control. In order to successfully demonstrate residual self-sanitizing efficacy, the product must demonstrate a 99.9% reduction after 24 hours following application. Typical test organisms include Staphylococcus aureus and Enterobacter aerogenes or Klebsiella pneumoniae. Additional pathogens of clinical, occupational or household relevance are often tested as well.

ASTM E2180 Standard Test Method for Determining Antimicrobial Actifity in Polymeric or Hydrophobic Materials

In this method, treated test samples are inoculated with the test organism mixed with in a semi-solid agar “slurry” to facilitate surface interaction. The test organism is allowed to expose on the surface of the treated material typically for 24 hours. Following exposure, the sample is neutralized, the surface is washed and the sample is quantitatively assayed for survivors. The resulting plates are incubated, the number of survivors is enumerated and a percent reduction is determined for the test sample as compared to the untreated control sample. No performance criteria currently exist for general antimicrobial claims made using this method. Common test organisms utilized in this method include Staphylococcus aureus, Pseudomonas aeruginosa and Klebsiella pneumoniae.

AOAC Use Dilution Test for Liquid Disinfectants (Methods 964.02, 955.14 and 955.15)

In this method, a series of stainless steel cylinders (“carriers”) are inoculated with a representative test organism and the carriers are dried. The carriers containing the dried organism film are then sequentially immersed into 10 mL of disinfectant and are exposed to the disinfectant for a predetermined exposure time. After exposure, the carriers are sequentially transferred to a liquid subculture medium specifically selected to neutralize the test substance active and to recover any surviving test organism. The carriers are incubated and visually examined for the presence or absence of growth. Based on the desired disinfection claim and the requirements of the regulatory agency, the product must demonstrate kill on a predetermined number of carriers inoculated with test organisms applicable to the claim. Standard disinfection organisms include but are not limited to: Staphylococcus aureus, Salmonella enterica, and Pseudomonas aeruginosa. Additional pathogens of clinical, occupational or household relevance including fungi are often tested.

AATCC 100 Assessment of Antibacterial Finishes on Textile Materials

In this method, treated test samples and untreated control samples are inoculated with a representative test organism, commonly Staphylococcus aureus and Klebsiella pneumoniae. The test organism is allowed to expose to the test material at an elevated temperature, typically for 24 hours. Following exposure, the samples are neutralized and quantitatively assayed for survivors. The resulting plates are incubated, the number of survivors is enumerated and a percent and log10 reduction is determined for the treated test material as compared to the untreated control material. No regulated reduction limits currently exist for general antibacterial claims made using this method.

Virology Testing

Virucidal Efficacy Validation of a Disinfectant Used to Clean and Disinfect the Exterior Surface of Blood Glucose Monitoring Devices Utilizing Duck Hepatitis B virus as a Surrogate for Human Hepatitis B Virus

Each material, compromising the exterior of the device, is inoculated with the test virus and the virus is dried. The inoculated materials are wiped with the disinfectant per the Sponsor instructions and held for the requested exposure time at the requested exposure temperature. Following exposure, the inoculated materials are individually neutralized and serial dilutions of the neutralized test substance are performed. The dilutions are then assayed for viral infectivity by an assay method specific for the test virus. Appropriate virus, test substance cytotoxicity, neutralization, and negative (cell) controls are run concurrently. The US FDA requires complete inactivation of the virus in all dilutions assayed.

Virucidal Efficacy of a Disinfectant Applied to a Room via a Fogger or Misting Device

An aliquot of the test virus is inoculated onto the surface of a glass Petri dish (used as the test “carrier”) and the virus is dried. The inoculated carriers are placed at diverse locations within the sealed room and exposed to the test substance for a specified exposure time. Following exposure, the carriers are neutralized and serial dilutions of the neutralized test substance are performed. The dilutions are then assayed for viral infectivity by an assay method specific for the test virus. Appropriate virus, test substance cytotoxicity, and neutralization controls are run concurrently. Typically, most regulatory agencies require complete inactivation of the virus in all dilutions assayed.

Virucidal Efficacy of a Disinfectant for use on Inanimate Environmental Surfaces for Hepatitis B Virus

Duplicate glass Petri dishes (“carrier”) are inoculated with the test virus and the virus is dried onto the carrier. The carriers are individually inoculated with an aliquot of the use dilution of the test substance (liquid products), or to the amount of spray released under use conditions (spray products). The inoculated carriers are held for the requested exposure time at the requested exposure temperature. Following exposure, the contents of the carriers are neutralized and serial dilutions of the neutralized test substance are performed. The dilutions are then assayed for viral infectivity by an assay method specific for the test virus. Appropriate virus, test substance cytotoxicity, and neutralization controls are run concurrently. Typically, most regulatory agencies require complete inactivation of the virus in all dilutions assayed.

Virucidal Efficacy of a Disinfectant for use on Inanimate Environmental Surfaces for Hepatitis C Virus

Duplicate glass Petri dishes (“carrier”) are inoculated with the test virus and the virus is dried onto the carrier. The carriers are individually inoculated with an aliquot of the use dilution of the test substance (liquid products), or to the amount of spray released under use conditions (spray products). The inoculated carriers are held for the requested exposure time at the requested exposure temperature. Following exposure, the contents of the carriers are neutralized and serial dilutions of the neutralized test substance are performed. The dilutions are then assayed for viral infectivity by an assay method specific for the test virus. Appropriate virus, test substance cytotoxicity, and neutralization controls are run concurrently. Typically, most regulatory agencies require complete inactivation of the virus at all dilutions assayed.

ASTM E1052 Standard Test Method for Efficacy of Antimicrobial Agents Against Viruses in Suspension

An aliquot of the test substance is inoculated with the test virus and held for the requested exposure time(s). At each predetermined exposure time an aliquot is removed, neutralized by serial dilution, and assayed for viral infectivity by an assay method specific for the test virus. Appropriate virus, test substance cytotoxicity, and neutralization controls are run concurrently. The percent and log reduction in viral infectivity are calculated as compared to the corresponding virus control.

ASTM E1053 Standard Test Method for Efficacy of Virucidal Agents Intended for Inanimate Environmental Surfaces

A glass Petri dish (“carrier”) is inoculated with a representative test virus and the virus is dried onto the carrier. The carrier is inoculated with an aliquot of the use dilution of the test substance (liquid products), or to the amount of spray released under use conditions (spray products). The inoculated carrier is held for the requested exposure time at the requested exposure temperature. Following exposure, the contents of the carrier are neutralized and serial dilutions of the neutralized test substance are performed. The dilutions are then assayed for viral infectivity by an assay method specific for the test virus. Appropriate virus, test substance cytotoxicity, and neutralization controls are run concurrently. Typically, most regulatory agencies require complete inactivation of the virus in all dilutions assayed.

Disinfectant Qualification Testing for Antiviral Activity

In this study, representative surfaces found in the GMP manufacturing facility are inoculated with test viruses utilized in the manufacturing production plus any routine viral contaminants isolated by the facility during the manufacturing process. The surfaces are disinfected using the disinfection practices commonly used at the facility. Following treatment, the surfaces are assayed for surviving viruses by an assay method specific for the test virus. The level of reduction deemed necessary for appropriate disinfection is determined by the GMP facility performing the qualification testing.

AATCC 100 Assessment of Antibacterial Finishes on Textile Materials Modified for Virucidal Efficacy

In this method, treated test and untreated control samples are inoculated with a test virus. The test virus is allowed to expose to the test material at the requested exposure temperature for the requested exposure time. Following exposure, the samples are neutralized, serially diluted, and the dilutions are assayed for viral infectivity by an assay method specific for the test virus. Appropriate virus, test substance cytotoxicity, and neutralization controls are run concurrently. The percent and log reduction in viral infectivity are calculated as compared to the corresponding virus control. No regulated reduction limits currently exist for general antiviral claims made using this method.

Virucidal Efficacy of a Disinfectant for Use on Inanimate Environmental Surfaces for Norovirus

Duplicate glass Petri dishes (“carrier”) are inoculated with the test virus and the virus is dried onto the carrier. The carriers are individually inoculated with an aliquot of the use dilution of the test substance (liquid products), or to the amount of spray released under use conditions (spray products). The inoculated carriers are held for the requested exposure time at the requested exposure temperature. Following exposure, the contents of the carriers are neutralized and serial dilutions of the neutralized test substance are performed. The dilutions are then assayed for viral infectivity by an assay method specific for the test virus. Appropriate virus, test substance cytotoxicity, and neutralization controls are run concurrently. Typically, most regulatory agencies require complete inactivation of the virus in all dilutions assayed.

Custom Studies

Treated Article Efficacy

An antimicrobial treated article is an article treated with, or containing, an antimicrobial pesticide that is intended to protect or preserve the article itself. The U.S. Environmental Protection Agency (EPA) does not require registration of treated articles if the active substance is registered for use in or on the article and the sole purpose is to protect the article, not the person using the product. The EPA requires certain labeling of these articles to ensure that they do not mislead the public with false claims and efficacy data must be generated to support these non-public health claims.

Fogging and Misting Efficacy

Gas and vapor technologies are being used with fogging or misting devices to disinfect, sanitize or sterilize enclosed areas. Many of these systems are remarkably effective at decontaminating all the hard, non-porous surfaces within an enclosed room. The U.S. Environmental Protection Agency (EPA) requires antimicrobial product registrants with current registered antimicrobial pesticides to provide efficacy data to the EPA to support fogging or misting claims. Any new registrations must also submit efficacy data for claims using fogging or misting to disinfect, sanitize or sterilize rooms.

Analytical Lab Group has a dedicated fogging and misting testing room on site equipped with independent air handling and temperature control to perform this testing. We can help you develop a custom protocol, screen the product and complete the final GLP testing.

Pesticide Device Efficacy

Antimicrobial Pesticide Devices that work by physical means are regulated by the United States Environmental Protection Agency (EPA) but do not require registration. However, pesticide regulations do require that device producers generate efficacy data to support all claims. Ultraviolet lights are a good example of antimicrobial pesticide devices as the antimicrobial is generated and used on site.