ASTM E1153: Standard Test Method for Efficacy of Sanitizers Recommended for Inanimate, Hard, Nonporous Non-Food Contact Surfaces

Link: https://www.astm.org/Standards/E1153.htm

Purpose and Goals

• Evaluate and compare the antimicrobial activity of disinfectant products in laboratory-controlled testing. 

Testing

• This testing will be a modification of ASTM International’s Standard Test Method E1153.
• Nonporous surface carriers (glass or stainless steel slides) will be inoculated with a liquid microbial suspension spread over a 22 mm x 22 mm surface area, dried, and then placed at specified test locations for exposure to the disinfection product/device. After exposure, the microbes from each carrier will be recovered into a solution which will be dilution-plated to provide quantifiable viable microbial burden data for each carrier tested. 
• This testing will include 5% organic soil (serum) in the inoculum solution. 
• Each test will include one microbial strain:
  • Staphylococcus aureus​ ATCC 6538 (a standard test strain) Gram-positive bacteria
  • Methicillin-resistant ​Staphylococcus aureus​ ATCC 33592 (MRSA) Gram-positive bacteria
  • Klebsiella pneumoniae ATCC 4352 (a standard test strain) Gram-negative bacteria
  • Carbapenem-resistant Klebsiella pneumoniae ATCC BAA-1705 (KPC, CRE) Gram-negative bacteria
  • Candida auris CDC B11903 fungus 
  • Staphylococcus epidermidis ATCC 35984 Gram-positive bacteria
  • Salmonella enterica ATCC 10708 (formerly known as ​S. choleraesuis​) Gram-negative bacteria
  • Salmonella enterica​ ATCC 14028 (formerly known as ​S. typhimurium​) Gram-negative bacteria
  • Shigella flexneri ATCC 12022 Gram-negative bacteria
  • Escherichia coli ATCC 25922 (a standard test strain) Gram-negative bacteria
  • Escherichia coli ATCC 43888 (an O157:H7 strain) Gram-negative bacteria
  • Listeria monocytogenes ATCC 7644 Gram-positive bacteria
  • Pseudomonas aeruginosa ATCC 9027 or 15442 Gram-negative bacteria
  • Bacillus subtilis ATCC 19659 or 6633 Gram-positive bacterial spores
  • Clostridioides difficile ATCC BAA-1870 or 43598 (formerly known as Clostridium difficile) Gram-positive bacterial spores
  • Human Coronavirus strain OC43 (HCoV-OC43) ATCC VR-1558, an enveloped RNA betacoronavirus like the recent pandemic strain SARS-CoV-2
  • Human Coronavirus strain 229E (HCoV-229E) ATCC VR-740, an enveloped RNA alphacoronavirus
  • Human Coronavirus strain NL63 (HCoV-NL63) NIAID-BR NR-470, an enveloped RNA alphacoronavirus
  • Influenzavirus A (H1N1) ATCC VR-1469, an enveloped RNA virus
  • Influenzavirus A (H3N2) ATCC VR-1680, an enveloped RNA virus
  • Feline Calicivirus (FCV) strain F-9 ATCC VR-782, a non-enveloped RNA virus laboratory surrogate for human norovirus 
• Each test will include 39 total carriers:
  • 13 carrier locations within ResInnova Laboratories’ Mock Hospital Suite:
    • 9 carrier locations within the mock hospital patient room
    • 3 carrier locations within the mock bathroom
    • 1 unexposed control carrier 
  • 1 exposure time: TBD minutes. 
  • 3 replicate carriers will be tested for each testing condition (sample size n=3).
• Alternate strains can be validated for testing upon request for a New Strain Fee. 
• Note: Optional GLP services are available for an additional fee.

Data Analysis

• Data will be calculated to determine the quantifiable bacterial/fungal burden in colony-forming units per carrier (CFU/carrier) or viral burden in plaque- or foci-forming units per carrier (PFU/carrier or FFU/carrier) remaining on each test location.
• Data will be analyzed to determine the consistency between replicate carriers (sample size n=3).
• Data will be analyzed to compare the efficacies of each testing condition to determine the percent reductions and log reductions of microbial burdens compared to unexposed carriers. 

Turn Around Time

• Bacterial/fungal (per strain): 4-6 weeks following receipt of the test devices.
• Viral (per strain): 6-8 weeks following receipt of the test devices