Harmonized Method for Cleanroom Hard Surface Disinfectant Efficacy Evaluations

Harmonized Method for Cleanroom Hard Surface Disinfectant Efficacy Evaluations

04/18/2018, 1:15 PM - 2:00 PM

Technical Conference Stage 4, Booth 1477, Exhibit Hall

Disinfectant efficacy validation testing can be a daunting task as there are various factors to consider. There are a number of standardized test methods available that can be used to demonstrate disinfectant efficacy. However, there are differences between the methods generally used in the EU and the US and all existing standards have individual pitfalls and unique challenge, all of which can lead to variation in results. Currently there are few detailed and explicit regulatory expectations with regards to disinfectant efficacy testing that end users should perform, but there are guidance documents available which should be considered when embarking on this task. It is important to note that the existing methods are not specifically designed for cleanroom disinfectants and so modifications to the methods to reflect a cleanroom environment should be considered, with the support of guidance documents such as (USP) 40-NF35 Chapter . The purpose of this presentation is to provide guidance to end users of disinfectant products to help them produce a strategy and rationale for their disinfectant validation testing that is in line with a global harmonized approach. Use of a harmonized method can give companies a transferable platform to achieve replicable results between laboratories and between countries. In addition to discussing methodology development, this presentation also details some of the factors that should be considered prior to any testing being performed, in order to minimize the potential for validation failures or retests. The use of the harmonized method and consideration of the factors discussed will aid the creation of a robust disinfectant efficacy study that will stand up to regulatory scrutiny across the globe.


  • Rachel Blount


    Global Technical Consultant Manager - Ecolab Life Sciences

    Ecolab Life Sciences

  • Brandy Koslop


    Sr. Regulatory Affairs Manager – Ecolab Life Sciences

    Ecolab Life Sciences

Type of Session

  1. Type of Session

Learning Objectives

  1. Learning Objectives 1. Understand the requirements for cleanroom hard surface disinfection validation 2. Understand the efficacy test methods recommended 3. Learn how to adopt rationales behind a harmonized method


  1. Track
    Risk Management

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