White Paper

Critical Elements of Disinfectant Efficacy Testing: STERIS SurePath DET™ and What You Need to Know

Disinfectant Efficacy Testing (DET) is a critical yet complex process that demands precision, scientific rigor and regulatory alignment. This white paper explains how common mistakes in study design, like poor coupon creation, improper microorganism selection or flawed inoculum concentration, can lead to unreliable results and costly delays. 
October 27, 2025
Dave Shields

Key Takeaways:

  • A risk-based approach, with a formal documented risk assessment is best practice to create a DET study test matrix.
  • A risk-based approach and regulatory expectations necessitate that facility EM isolates (not only culture collection reference strains) are challenged in a DET study.
  • Creating representative and high quality coupons is essential to generating sound, representative efficacy data.
  • The inoculum level of different types of microorganisms can have a significant impact upon the observed efficacy results.
  • It is a regulatory expectation to generate data for disinfectants that are diluted (the use dilution) and stored in a secondary container, to support internally set expiry periods.

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