Disinfectant Efficacy & Microbial Cleaning Validation

Gillson Sciences partners with manufacturers to ensure effective cleaning, validated processes, and compliance with global standards.

Support Through Every Stage

The disinfectant efficacy testing defined by USP <1072> or various ASTM standards (such as TIR 12 or E2197) ensures that your chosen cleaners are effective at removing an array of microorganisms from the various materials of construction in your facility, following your use procedures or the manufacturer's instructions.

Our team supports you through every stage, from assessing your materials of construction to determining which organisms to use in the challenge. We provide method development, in-laboratory testing, and repeatability to method efficacy/training exercises at your facility. We ensure your process meets regulatory and quality requirements.

Variables to consider in this testing:

  • Materials of construction to include
  • Regulatory challenge organisms and inclusion of in-house isolates
  • Contact times
  • Use and inclusion of manufacturer data
  • Feasibility studies
  • Hold time studies
  • Appropriate acceptance criterion
  • Worst-case testing scenarios and methodology approaches

Our Approach

We will work with your team to ensure that a risk-based approach is used to determine the necessary scope of this testing to reach compliance. We can build or review the method for you and provide the necessary laboratory perspective and expertise, which will ensure a comprehensive and compliant test procedure.

We will ensure that representative materials, processes, and challenge organisms are procured for in-lab testing, which mimic the real-life cleaning process that takes place in your facility.

If results show unacceptable efficacy, the cleaning process is adjusted and retested. Adjustments may include adjustment of contact time, detergent hold times, dilution/concentrations, cleaning temperatures, cleaning agents, etc.

Once validated, a schedule and procedure are created or adjusted for routine environmental monitoring to ensure cleaning methods remain effective.

Our Process

  • Organism Selection – We follow USP guidance for organism types and strains, sourced from culture collection agencies. Resident organisms are typically identified through environmental monitoring or product contamination.
  • Testing Procedure – Panels are inoculated with high concentrations of each organism, treated with the disinfectant for the required contact time, and then swabbed to evaluate the reduction of organisms in logarithmic values.
  • Neutralization Confirmation – We confirm that compounds of interest are sufficiently neutralized and that microbial growth is not inhibited during testing.
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