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.
Suggested Content
Technical Tip
Best Practices for Disinfectant Validation in Cleanrooms
Find out best practices for test coupons, environmental monitoring and more.
Technical Tip
Disinfectants and Sporicides for 503A Sterile Compounding Facilities: Selection and Use Guide
Product selection and development of an effective disinfection routine is essential for maintaining your sterile compounding facility. Utilizing the table from USP <797> (2019 proposed), this technical tip is a useful aid in selecting products and developing effective routines for best results.
Technical Tip
How to Remove Residue Buildup
Residue has many sources and stubborn residue buildup due to poor cleaning and rinsing practices or chemical incompatibility raises special challenges.
Join our email list for the latest industry news and product updates.
By clicking Subscribe you're confirming that you agree with our Terms and Conditions.



