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.