Maintaining a controlled environment within your facility includes performing a robust validation on the cleaning, disinfecting and sanitizing agents used on surface materials. This validation is beneficial to controlling the manufacturing environment and critical to reducing environmental excursions and contamination risks.
Disinfectant efficacy studies, which are regulatory requirements, are complex, time consuming and can be costly. This is because there are many factors to consider when designing a disinfectant efficacy validation for your facility’s disinfectants and sanitizers. As you work to meet the regulatory requirement, you’ll probably face constraints related to labor hours, financial cost, and time to design and execute a study.
An advantage of partnering with WuXi AppTec is that we have a strong, foundational understanding of the regulatory requirements and the applicable standards, such as ASTM and USP. Our technical experts can design and execute a disinfectant efficacy study to help determine how selected sanitizers and disinfectants perform when applied to specific surfaces representative of your facility and challenged against clinically important ATCC microorganisms as well as your facility’s most predominate in-house isolates.
Our experts collaborate with you, making sure no factors are overlooked and putting our technical and regulatory expertise to work. Some of the factors we consider when building the study protocol and scope of work include:
- How disinfectants and sanitizers are used in your facility and how they are applied to each surface
- The types of surfaces where disinfectants and sanitizers are used
- The types of isolates that are being recovered in your facility
- The surface exposure time of the sanitizer and disinfectant
- How the sanitizers and disinfectants are stored once prepared
- The expiration date once opened or prepared
- The temperature in the area of application
Working with our experts alleviates operational constraints and ensures the study meets the latest regulatory scrutiny. We also encourage our customers to perform validations at all of their facilities—not just at one location
For more information on working with us to create robust and complete disinfectant efficacy studies for one facility or multiple locations, contact us.