ASTM E1053: Standard Practice to Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate, Nonporous Environmental Surfaces

Link: https://www.astm.org/Standards/E1053.htm

Purpose and Goals

  • Evaluate and compare the antiviral activity of a/multiple disinfectant products in laboratory-controlled testing. 

Testing

  • This testing will be a modification of ASTM E1053 – Standard Practice to Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate, Nonporous Environmental Surfaces. A nonporous glass or stainless steel carrier surface will be inoculated with a liquid viral suspension and dried. The test product, an aerosol spray or trigger spray or foam prepared at use-dilution, will then be applied to the carrier surface per the manufacturer’s instructions and incubated at room temperature and ambient relative humidity for a specified contact time. After exposure, the carrier will be recovered into a neutralization solution* which will be dilution-plated in cell cultures to provide quantifiable viable viral burden data for each carrier tested.

* Note: Any disinfectant product requiring gel filtration for complete neutralization will require an additional fee of $1,000 per formulation. 

  • Testing will include 5% soil (serum) in the inoculum solution. 
  • Testing will include residual durability evaluation:
    • After the initial viral inoculation and disinfectant application, the carrier surface will be worn with 12 cycles of abrasions (alternating dry and wetted with sterile distilled water)  and re-inoculations of viral suspension to simulate 24 hours of wear before recovery into the neutralization solution. Abrasions will be made with the standard Gardco D10V Wear Tester equipment fitted with a weighted abrasion boat of sterilized foam. 
  • Testing will include the viral strains:
    • Influenza A virus (H1N1) ATCC VR-1469
    • Human Coronavirus strain ​OC43​ ATCC VR-​1558 (a betacoronavirus like SARS-CoV-2)
    • Feline calicivirus (FCV) strain F-9 ATCC VR-782 (a surrogate for human norovirus) (a non-enveloped virus)
  • Testing will include 72 total data points: 
    • 3 formulations (Formula A, Formula B, and Formula C)
      • Note: Please provide enough product for at least 5 mL use-dilution of each formula per data point. 
    • 2 disinfectant residual durability time-points (0 and 24 hours).
    • 4 disinfectant contact time-points (0 minutes, 2 minutes, 5 minutes, and 10 minutes).
    • 3 replicate carriers for each test condition
      • Note: the number of lots and total replicates is determined by the application submission requirements of the regulatory agency (EPA). 
  • Note: Optional GLP services are available for an additional 25% fee.

Data Analysis

  • In-house control results will be used to verify test validity. 
  • Data will be calculated to determine the quantifiable viral burden in plaque- or foci-forming units per disc (PFU/disc or FFU/disc) remaining on each test location.
  • Data will be analyzed to determine the consistency between replicate swatches.
  • Data will be analyzed to determine the percent reductions and log reductions of viral burdens on each/the test carrier compared to the provided negative control at each test condition. 

Typical Turn Around Time

  • 8 weeks following receipt of the test materials