Designing Disinfectant Efficacy Studies for All of Your Facility Locations

WuXi AppTec’s team of technical experts and trained laboratory analysts understand how to design and execute robust validations to control your facility’s environment along with monitoring your overall environmental program.

But what if your company has more than one location?

What is the best course of action to ensure each one meets regulatory requirements?

Our experts agree: Since each facility could use different spray bottles, mop heads and wipes to apply the sanitizer and disinfectants—and since there are typically different environmental isolates at each facility—it is critical to ensure the products are effective against each facility’s environmental isolates, and that means designing a disinfectant efficacy study for each site.

When considering a single validation versus multiple studies, keep in mind the different surface materials at each location. Although multiple facilities refer to surface materials by the same name, there may be different surface variations that could yield different efficacy results. For example, stainless steel comes in different grades and finishes, all of which may affect the efficacy of the sanitizer when applied. The condition of a stainless steel surface in an older facility would differ from the condition of one in a brand-new facility.

Whether you are expanding a facility, building a new manufacturing space, managing an environmental excursion, or validating a new disinfectant or sanitizer against established cleaning protocols, we recommend considering the design factors for each facility, surface and cleaner.

We recognize that these studies may be a large undertaking for a manufacturer, and that they require a resource investment. We work with you to strike a balance between meeting regulatory scrutiny and the necessary economical investment.

 For more information about establishing best practices for disinfecting efficacy studies for one facility or multiple locations, contact us. 

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Topics: Medical Device, Technical Expertise, Microbiology, Regulatory Expertise, USP<1072>, Efficacy Study