Facility Disinfectant Efficacy Studies – Complex, Resource Demanding and Extremely Necessary

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.

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Topics: Medical Device, Technical Expertise, Microbiology, Validation Study, Surface Disinfectant

Important to Address the Stacked Effects of Soil Accumulation on Medical Devices

Posted by Dan Fowler, Principal Scientist on July 03, 2018

After each use of a medical device, soil may accumulate at a microscopic or macroscopic level that could potentially impede the terminal disinfection or sterilization process.

Over the course of a medical device’s life cycle, it may be used from one to many hundreds of times. For a reusable or third-party reprocessed product, it may be contaminated, cleaned and disinfected/sterilized multiple times throughout its clinical use.

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Topics: Medical Device, Regulatory, Technical Expertise, Reprocessing, Validation Study